A double-blind , randomized , controlled , multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax . The vaccine Zostavax has been shown to prevent herpes zoster ( HZ ) and postherpetic neuralgia and is recommended for individuals > or =60 years of age . This study compared the safety and the immunogenicity of a refrigerator-stable formulation ( Zostavax refrigerated ) with those of the current formulation ( Zostavax frozen ) in subjects > or =50 years of age . Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation . Enrollment was stratified 1:2 by age ( 50 to 59 years and > or =60 years ) . Safety was evaluated for 28 days postvaccination . Varicella-zoster virus ( VZV ) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay ( gpELISA ) . The primary endpoints were the VZV antibody geometric mean titer ( GMT ; day 28 ) , the VZV antibody geometric mean rise ( GMR ; days 1 to 28 ) , and the incidence of vaccine-related serious adverse experiences ( AEs ) over 28 days . The refrigerated ( n = 182 ) and frozen ( n = 185 ) formulations induced similar GMTs ( 727.4 and 834.4 gpELISA units/ml , respectively ) ; the estimated GMT ratio ( refrigerated formulation/frozen formulation ) was 0.87 ( 95 % confidence interval , 0.71 to 1.07 ) . The GMRs were 2.6- and 2.9-fold , respectively . No vaccine-related serious AEs were reported in either group , and the safety profiles of the formulations were generally similar . The frequencies of injection-site AEs during follow-up were 35.6 % and 46.4 % in the refrigerated and the frozen formulation groups , respectively , and were generally mild . The frequencies of systemic AEs were similar in the two groups , and those of vaccine-related AEs were approximately 6 % in both groups . The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation ; thus , the vaccine may be used in clinical settings where freezer availability is limited .

Zostavax .

Zostavax

Zostavax

Zostavax

Zostavax

safety

immunogenicity

Safety

VZV antibody geometric mean titer ( GMT

VZV antibody geometric mean rise ( GMR

GMTs

GMT

GMRs

vaccine-related serious AEs

safety

injection-site AEs

systemic AEs

vaccine-related AEs

safety

immunogenic

subjects > or =50 years of age .

Subjects with a negative history for HZ


Feasibility of two dose-dense FEC regimens with growth factor support for adjuvant therapy in patients with early breast cancer : results from a randomised study of the Central European Cooperative Oncology Group ( CECOG ) . Addition of epirubicin to adjuvant chemotherapy can provide important benefits for patients with early breast cancer , but the optimal dose remains unclear . Further improvements can be achieved with dose-dense regimens , but densification of fluorouracil/epirubicin/cyclophosphamide ( FEC ) has proved difficult , with FEC ( 60 ) providing little benefit over standard chemotherapy and FEC ( 100 ) associated with toxicity . We investigated the feasibility of two intermediate dose-dense FEC regimens . Patients were randomised to six cycles of FEC ( 75 ) or FEC ( 90 ) , with all three drugs given on day 1 of each 14-day cycle . Patients also received pegfilgrastim 6 mg as a single subcutaneous injection on day 2 of each cycle . The primary efficacy endpoint was the proportion of subjects receiving > or =85 % relative dose intensity and was achieved by 96 % and 88 % of patients in the FEC ( 75 ) and FEC ( 90 ) arms , respectively . Of 147 FEC ( 75 ) infusions , 4.1 % were delayed , while 9.8 % of 143 FEC ( 90 ) infusions were delayed . The most common reasons for delay were adverse events and personal/logistical reasons . One dose reduction occurred during the study ( FEC ( 90 ) ) , related to diarrhoea . Grade 3-4 haematological toxicities were reported in two patients in the FEC ( 90 ) arm . There were no incidences of febrile neutropenia during the study . The most common adverse events were increases in liver enzymes and gastrointestinal events ; no event resulted in discontinuation . Only one patient ( FEC ( 90 ) ) experienced serious adverse events ( vomiting and throat oedema ) . In conclusion , dose-dense FEC ( 75 ) and FEC ( 90 ) are feasible with pegfilgrastim support . These regimens are associated with a very low risk of Grade 3-4 toxicity .

FEC

epirubicin

FEC ( 100 )

FEC

FEC ( 75 )

FEC ( 90 )

pegfilgrastim

FEC ( 75 )

FEC ( 90 )

FEC ( 90 )

FEC ( 90 )

( FEC ( 90 ) )

FEC ( 75

FEC ( 90 )

adverse events

diarrhoea .

haematological toxicities

febrile neutropenia

patients with early breast cancer :

patients with early breast cancer


Language outcome in autism : randomized comparison of joint attention and play interventions . This study reports results of a randomized controlled trial aimed at joint attention ( JA ) and symbolic play ( SP ) in preschool children with autism , with prediction to language outcome 12 months later . Participants were 58 children ( 46 boys ) with autism between 3 and 4 years of age . Children were randomized to a JA intervention , an SP intervention , or control group . Interventions were conducted 30 min daily for 5-6 weeks . Assessments of JA skills , SP skills , mother-child interactions , and language development were collected at 4 time points : pre- and postintervention and 6 and 12 months postintervention by independent testers . Results indicate that expressive language gains were greater for both treatment groups compared with the control group , and results could not be explained by differences in other interventions in which children participated . For children beginning treatment with the lowest language levels , the JA intervention improved language outcome significantly more than did the SP or control interventions . These findings suggest clinically significant benefits of actively treating JA and SP skills in young children with autism .

joint attention

play interventions .

joint attention ( JA )

symbolic play ( SP )

JA

SP

JA

SP

JA

SP

JA

SP

Language outcome

language outcome

expressive language gains

language outcome

autism :

preschool children

with autism

children

autism

between 3 and 4 years of age

young children with autism .


Once-daily amoxicillin versus twice-daily penicillin V in group A beta-haemolytic streptococcal pharyngitis . BACKGROUND Rheumatic fever is a preventable chronic disease preceded by group A beta-haemolytic streptococcal ( GABHS ) pharyngitis . OBJECTIVE To test the non-inferiority of once-daily ( QD ) oral amoxicillin to the recommended twice-daily ( BID ) oral penicillin V in GABHS pharyngitis . METHODS This was a randomised non-inferiority trial carried out in a school-based clinic in New Zealand . Children presenting with GABHS pharyngitis were randomised to oral amoxicillin 1500 mg QD ( or 750 mg if bodyweight was < or=30 kg ) or to oral penicillin V 500 mg BID ( or 250 mg if bodyweight was < or=20 kg ) for 10 days . Observed medication and weekend diary cards were used to monitor adherence . OUTCOME Eradication of GABHS , determined with follow-up throat cultures on days 3-6 , 12-16 and 26-36 . GABHS isolates were serotyped to distinguish bacteriological treatment failures ( and relapses ) from new acquisitions . Non-inferiority was defined as an upper 95 % confidence limit ( CL ) for the difference in success of eradication in the amoxicillin and penicillin V treatment groups of < or=10 % . RESULTS 353 children with positive throat swabs for GABHS were randomised to amoxicillin ( n = 177 ) or penicillin V ( n = 176 ) . The upper 95 % CL for the differences in positive cultures between the antibiotics was 4.9 % at days 3-6 , 6.5 % at days 12-16 and 8.5 % at days 26-36 . Treatment failures ( including relapses ) occurred at each visit in 5.8 % , 12.7 % and 10.7 % of amoxicillin recipients and 6.2 % , 11.9 % and 11.3 % of penicillin V recipients , respectively . No significant differences in resolution of symptoms were noted between treatment groups . One case of unsubstantiated acute rheumatic fever occurred after 7 days of amoxicillin . CONCLUSION In this adequately powered study , once-daily oral amoxicillin is not inferior to twice-daily penicillin V for the treatment and eradication of GABHS in children with pharyngitis .

amoxicillin

penicillin V

amoxicillin

penicillin V

amoxicillin

penicillin

amoxicillin

penicillin

amoxicillin

penicillin

amoxicillin

penicillin

amoxicillin .

amoxicillin

penicillin

non-inferiority

non-inferiority

Eradication of GABHS

bacteriological treatment failures

relapses

Non-inferiority

Treatment failures

relapses

resolution of symptoms

school-based clinic in New Zealand

Children

GABHS pharyngitis

GABHS in children with pharyngitis .


A multi-component social skills intervention for children with Asperger syndrome : the Junior Detective Training Program . BACKGROUND The study aimed to investigate the effectiveness of a new multi-component social skills intervention for children with Asperger syndrome ( AS ) : The Junior Detective Training Program . This 7-week program included a computer game , small group sessions , parent training sessions and teacher handouts . METHOD Forty-nine children with AS were recruited to participate and randomly assigned to intervention ( n = 26 ) or wait-list control ( n = 23 ) conditions . RESULTS Relative to children in the wait-list group , program participants showed greater improvements in social skills over the course of the intervention , as indicated by parent-report measures . Teacher-report data also confirmed that children receiving the intervention made significant improvements in social functioning from pre- to post-treatment . Treatment group participants were better able to suggest appropriate emotion-management strategies for story characters at post-intervention than at pre-intervention , whereas control participants were not . However , there was no difference in the improvements made by children in the intervention and control conditions on facial expression and body-posture recognition measures . Follow-up data suggested that treatment gains were maintained by children at 5-months post-intervention . CONCLUSIONS The Junior Detective Training Program appeared to be effective in enhancing the social skills and emotional understanding of children with AS . Limitations and suggestions for future research are discussed .

Junior Detective Training Program

Junior Detective Training Program

effectiveness

improvements in social skills

social functioning

emotion-management strategies

children

Asperger syndrome

children

Asperger syndrome ( AS )

Forty-nine

children with AS

children with AS .


In school-aged children a combination of galacto-oligosaccharides and Lactobacillus GG increases bifidobacteria more than Lactobacillus GG on its own . The aim of this study was to compare a combination of Lactobacillus GG ( LGG ) and galacto-oligosaccharides ( GOS ) with LGG on its own , and their effects on the intestinal microbiota in school-aged children . The randomized , double-blinded , crossover study comprised 30 healthy children . There were two 3-week study periods with a 4-week wash-out period in between . The children ingested daily 65 ml of milk-based fruit juice containing either LGG alone ( 6.5 x 10 ( 9 ) CFU ) or LGG plus 2 g of GOS . Symptom diaries were filled during the study periods . Fecal samples were collected at the beginning and end of both study periods . At the end of both study periods , the amount of bifidobacteria was significantly greater after the ingestion of LGG + GOS compared with LGG alone ( geometric mean 9.33 x 10 ( 9 ) vs. 4.28 x 10 ( 9 ) CFU/g , p < 0.001 ) . No significant differences were seen in the amount of lactobacilli or LGG , nor did gastrointestinal symptoms , defecation frequency , consistency of stools or ease of defecation differ between the two study periods . Ingestion of LGG combined with 2 g of GOS increased the bifidobacteria more than LGG on its own and thus GOS clearly has a prebiotic effect in children . The children tolerated well a daily intake of 2 g of GOS .

galacto-oligosaccharides

Lactobacillus GG

Lactobacillus GG

Lactobacillus GG ( LGG )

galacto-oligosaccharides ( GOS )

LGG

LGG

LGG

GOS .

LGG + GOS

LGG

LGG

LGG

GOS

LGG

GOS

GOS .

amount of bifidobacteria

lactobacilli

bifidobacteria

school-aged children

healthy


Vibrotactile -- auditory interactions are post-perceptual . Vibrotactile stimuli can elicit compelling auditory sensations , even when sound energy levels are minimal and undetectable . It has previously been shown that subjects judge auditory tones embedded in white noise to be louder when they are accompanied by a vibrotactile stimulus of the same frequency . A first experiment replicated this result at four different levels of auditory stimulation ( no tone , tone at detection threshold , tone at 5 dB above threshold , and tone at 10 dB above threshold ) . The presence of a vibrotactile stimulus induced an increase in the perceived loudness of auditory tones at three of the four values in this range . In two further experiments , a 2-interval forced-choice procedure was used to assess the nature of this cross-modal interaction . Subjects were biased when vibrotaction was applied in one interval , but applying vibrotaction in both intervals produced performance comparable to conditions without vibrotactile stimuli . This demonstrates that vibrotaction is sometimes ignored when judging the presence of an auditory tone . Hence the interaction between vibrotaction and audition does not appear to occur at an early perceptual level .

Vibrotactile stimuli

vibrotactile stimulus

vibrotactile stimulus

vibrotaction

vibrotaction

vibrotactile stimuli .

vibrotaction

vibrotaction

auditory tones

Subjects


Psychological mediators of bupropion sustained-release treatment for smoking cessation . AIM The study aimed to test simultaneously our understanding of the effects of bupropion sustained-release ( SR ) treatment on putative mediators and our understanding of determinants of post-quit abstinence , including withdrawal distress , cigarette craving , positive affect and subjective reactions to cigarettes smoked during a lapse . The specificity of bupropion SR effects was also tested in exploratory analyses . DESIGN Data from a randomized , placebo-controlled clinical trial of bupropion SR were submitted to mediation analyses . SETTING Center for Tobacco Research and Intervention , Madison , WI , USA . PARTICIPANTS A total of 403 adult , daily smokers without contraindications to bupropion SR use . INTERVENTION Participants were assigned randomly to receive a 9-week course of bupropion SR or placebo pill and to receive eight brief individual counseling sessions or no counseling . MEASUREMENTS Ecological momentary assessment ratings of smoking behavior and putative mediators were collected pre- and post-quit . FINDINGS Results of structural equation and hierarchical linear models did not support the hypothesis that bupropion SR treatment improves short-term abstinence by reducing withdrawal distress or affecting the subjective effects of a lapse cigarette , but provided partial support for mediation by cigarette craving reduction and enhanced positive affect . Bupropion SR effects on point-prevalence abstinence at 1 month post-quit were also mediated partially by enhanced motivation to quit and self-efficacy . CONCLUSIONS Results provided some support for models of bupropion SR treatment and relapse and suggested that motivational processes may partially account for bupropion SR efficacy .

bupropion sustained-release

bupropion sustained-release ( SR )

bupropion SR

bupropion SR

bupropion SR

bupropion SR

placebo

Bupropion SR

bupropion SR

short-term abstinence

cigarette craving reduction

positive affect .

abstinence

Madison , WI , USA


Identifying patients at high risk for neutropenic complications during chemotherapy for metastatic breast cancer with doxorubicin or pegylated liposomal doxorubicin : the development of a prediction model . OBJECTIVE To develop a cycle-based risk prediction model for neutropenic complications ( NC ) during chemotherapy with doxorubicin ( DOX ) or a pegylated liposomal formulation ( PLD ) for patients with metastatic breast cancer ( MBC ) . METHODS Data analyzed was from a phase III , randomized clinical trial of DOX ( 60 mg/m ( 2 ) every 3 weeks ) or PLD ( 50 mg/m ( 2 ) every 4 weeks ) for the first line therapy for MBC ( n = 509 ) ( O'Brien et al , Ann Oncol . 2004 ; 15:440-449 ) . NC were defined as an absolute neutrophil count < or =1.5 x 10 ( 9 ) cells/L ( ie , > or =grade II ) before the next cycle , febrile neutropenia or neutropenia with a documented infection . Patient and hematologic factors potentially associated with NC were evaluated . Factors with a P value of < or =0.25 within a cycle were included in a generalized estimating equations regression model . Using backward elimination , we derived a risk scoring algorithm ( range 0-63 ) from the final reduced model . RESULTS Risk factors retained in the model included poor performance status , absolute neutrophil count < or =2.0 x 10 ( 9 ) cells/L in the previous cycle , the first cycle of chemotherapy , DOX versus PLD and advanced age . A precycle risk score from > or =25 to < 40 for a given patient was identified as being the optimal threshold for sensitivity ( 58.0 % ) and specificity ( 78.7 % ) . Patients with a score at or beyond this threshold would be considered at high risk for developing NC in later cycles . CONCLUSION The use of this model may enhance patient care by targeting preventative therapies ( eg , granulocyte colony stimulating factor or PLD ) to those MBC patients most likely to experience NC during anthracycline-based chemotherapy .

doxorubicin

pegylated liposomal doxorubicin

doxorubicin ( DOX )

pegylated liposomal formulation ( PLD )

DOX

PLD

DOX

PLD

neutropenic complications

neutropenic complications ( NC )

NC

age

precycle risk score

risk

NC

metastatic breast cancer

patients


Neural basis of self and other representation in autism : an FMRI study of self-face recognition . BACKGROUND Autism is a developmental disorder characterized by decreased interest and engagement in social interactions and by enhanced self-focus . While previous theoretical approaches to understanding autism have emphasized social impairments and altered interpersonal interactions , there is a recent shift towards understanding the nature of the representation of the self in individuals with autism spectrum disorders ( ASD ) . Still , the neural mechanisms subserving self-representations in ASD are relatively unexplored . METHODOLOGY/PRINCIPAL FINDINGS We used event-related fMRI to investigate brain responsiveness to images of the subjects ' own face and to faces of others . Children with ASD and typically developing ( TD ) children viewed randomly presented digital morphs between their own face and a gender-matched other face , and made " self/other " judgments . Both groups of children activated a right premotor/prefrontal system when identifying images containing a greater percentage of the self face . However , while TD children showed activation of this system during both self- and other-processing , children with ASD only recruited this system while viewing images containing mostly their own face . CONCLUSIONS/SIGNIFICANCE This functional dissociation between the representation of self versus others points to a potential neural substrate for the characteristic self-focus and decreased social understanding exhibited by these individuals , and suggests that individuals with ASD lack the shared neural representations for self and others that TD children and adults possess and may use to understand others .

self-face recognition

brain responsiveness

right premotor/prefrontal system

autism

Children


Bolus injection of contrast agents with various iodine concentrations and delivery rates for intracranial three-dimensional CT angiography : evaluation of intracranial arteriovenous contrast using a multidetector-row CT scanner . PURPOSE We evaluated the difference in computed tomography ( CT ) attenuation values of the intracranial arterial and venous systems among the various contrast injection protocols ( higher iodine delivery rate or higher concentration of the agent ) on the source images of intracranial three-dimensional CT angiography ( 3D-CTA ) using a multidetector-row CT ( MDCT ) scanner . MATERIALS AND METHODS We used 100 ml of iopamidol 300 at an injection rate of 3.0 ml/s , 100 ml of iopamidol 300 at an injection rate of 3.7 ml/s , and 80 ml of iopamidol 370 at an injection rate of 3.0 ml/s . There were 10 patients in each group . Attenuation values of the bilateral internal carotid arteries ( ICAs ) , basilar artery trunk , bilateral cavernous sinuses ( CSs ) , and Galenic vein were measured quantitatively on the axial CT angiographic source images obtained by four-channel MDCT . RESULTS Injection of the high-concentration contrast with a higher iodine-delivery rate achieved good arteriovenous contrast at the cavernous portion . With the same rate of iodine delivery , injection of the intermediate concentrate agent increased the CT value of not only the ICAs but also the CSs . CONCLUSION High-concentration contrast could increase ICA attenuation without intracavernous attenuation gain during the " first-pass " phase .

iopamidol

iopamidol

iopamidol

intracranial arteriovenous contrast

difference

arteriovenous contrast

CT value

ICA attenuation

intracavernous attenuation

10 patients in each group .


Trial design challenges when combining medication and parent training in children with pervasive developmental disorders . This paper presents the rationale for a 24-week , randomized trial designed to test whether risperidone plus structured parent training would be superior to risperidone only on measures of noncompliance , irritability and adaptive functioning . In this model , medication reduces tantrums , aggression and self-injury ; parent training promotes improvement in noncompliance and adaptive functioning . Thus , medication and parent training target related , but separate , outcomes . At week 24 , the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse . Both symptom reduction and functional improvement are important clinical treatment targets . Thus , experimental evidence on the beneficial effects of combining pharmacotherapy and exportable behavioral interventions is needed to guide clinical practice .

medication

parent training

risperidone

structured parent training

risperidone

noncompliance

irritability

adaptive functioning

tantrums

aggression

self-injury

symptom

functional

children

pervasive developmental disorders


Comparison of propofol , droperidol , and metoclopramide for prophylaxis of postoperative nausea and vomiting after breast cancer surgery : a prospective , randomized , double-blind , placebo-controlled study in Japanese patients . BACKGROUND Breast cancer surgery performed with the patient under general anesthesia has been associated with a relatively high incidence of postoperative nausea and vomiting ( PONV ) . Between 60 % and 80 % of patients who undergo mastectomy ( with axillary dissection ) experience PONV . We previously reported that propofol at a subhypnotic dose of 0.5 mg/kg was more effective than placebo in preventing PONV in women who undergo mastectomy . OBJECTIVE The purpose of this study was to compare the efficacy of a subhypnotic dose of propofol with the conventional antiemetics droperidol and metoclopramide for the prophylaxis of PONV after breast cancer surgery in Japanese patients . METHODS In this prospective , randomized , double-blind , placebo-controlled study , Japanese women were randomized to 1 of 4 groups to receive IV administration of propofol 0.5 mg/kg , droperidol 20 microg/kg , metoclopramide 0.2 mg/kg , or placebo ( isotonic saline ) immediately after skin suture . A standard general anesthetic technique , including sevoflurane and air in oxygen , was used . All episodes of PONV during the first 24 hours after anesthesia administration were recorded by an investigator who was blinded to treatment assignment . The investigator questioned the patients as to whether they experienced extrapyramidal symptoms . To maintain the integrity of the study results , none of the patients received preanesthetic medication . RESULTS A total of 100 women ( mean [ SD ] age , 52 [ 7 ] years ; height , 154 [ 6 ] cm ; weight , 54 [ 7 ] kg ) were included in the study . Each study group comprised 25 patients . There were no significant differences between treatment groups with regard to patient demographics , surgery type , or awakening time . The prevalences of PONV 0 to 24 hours after anesthesia were 28 % with propofol ( P = 0.005 ) , 32 % with droperidol ( P = 0.011 ) , and 60 % with metoclopramide ( P = NS ) , compared with placebo ( 68 % ) . No significant difference in the prevalence of PONV was found between patients receiving propofol and those receiving droperidol , and propofol and droperidol were associated with significantly lower prevalences of PONV compared with metoclopramide ( P = 0.022 and P = 0.043 , respectively ) . Extrapyramidal symptoms were not reported in any of the groups . CONCLUSIONS The prevalences of PONV were not significantly different between propofol 0.5 mg/kg and droperidol 20 microg/kg 0 to 24 hours after anesthesia in this small , select group of Japanese women who underwent breast cancer surgery . The prevalences of PONV were significantly lower with propofol and droperidol compared with metoclopramide 0.2 mg/kg and placebo .

propofol

droperidol

metoclopramide

propofol

placebo

propofol

droperidol

metoclopramide

propofol

droperidol

metoclopramide

placebo ( isotonic saline )

propofol

droperidol

metoclopramide

placebo

propofol

droperidol

propofol

droperidol

metoclopramide

propofol

droperidol

propofol

droperidol

metoclopramide

placebo

postoperative nausea and vomiting

PONV .

PONV

efficacy

PONV

PONV

extrapyramidal symptoms

PONV

PONV

PONV

Extrapyramidal symptoms

PONV

PONV

breast cancer surgery :

Japanese patients .

Japanese women

mean [ SD ] age , 52 [ 7 ] years

height , 154 [ 6 ] cm

weight , 54 [ 7 ] kg


To compare the efficacy and safety of nifedipine sustained release with Ginkgo biloba extract to treat patients with primary Raynaud 's phenomenon in South Korea ; Korean Raynaud study ( KOARA study ) . This study examined the efficacy and safety of nifedipine sustained release ( nifedipine SR ) compared with Ginkgo biloba extract as treatment for primary Raynaud 's phenomenon ( RP ) in Korea . Primary RP were screened and assigned to either the nifedipine SR group ( Group N ) or the Ginkgo biloba extract group ( Group G ) in the ratio of 2:1 . After a run-in period of 2 weeks , patients received treatment for 8 weeks . We observed the percent improvement of the RP attack rate between before and after the 8-week treatment . Ninety-three subjects were randomly assigned . The percent improvement in Group N was 50.1 % at 8 weeks after treatment , while it was 31.0 % in Group G ( p = 0.03 ) . No serious adverse events occurred , and almost adverse events were mild and improved without specific treatment . nifedipine SR was more effective than Ginkgo biloba extract for treatment of primary RP in Korean patients . Both drugs were tolerable with primary RP patients .

nifedipine sustained release

Ginkgo biloba extract

Ginkgo biloba extract

nifedipine SR

Ginkgo biloba extract

nifedipine SR

Ginkgo biloba extract

efficacy

safety

efficacy

safety

serious adverse events

adverse events

effective

tolerable

Ninety-three subjects

Korean patients .

RP patients .


A comparison of continuous femoral nerve block ( CFNB ) and continuous epidural infusion ( CEI ) in postoperative analgesia and knee rehabilitation after total knee arthroplasty ( TKA ) . BACKGROUND Postoperative epidural analgesia ( EA ) and femoral nerve block ( FNB ) provided effective pain relief However , EA has common side effects such as nausea , vomiting , pruritus , dizziness , and hypotension . Some investigations found that those side effects were less in FNB than in EA . However the analgesic equivalent of both techniques have not been confirmed . OBJECTIVE The authors compared continuous epidural infusion ( CEI ) with continuous femoral nerve block ( CFNB ) regarding the postoperative analgesic efficacy , side effects , postoperative knee rehabilitation , and hospital length of stay ( LOS ) . MATERIAL AND METHOD In this prospective , randomized controlled study , 61 ASA physical status I-III patients scheduled for elective unilateral total knee arthroplasty ( TKA ) under spinal anesthesia ( SA ) participated . The patients were allocated into two groups . In the ward , patients in Group I ( CEI ) were maintained by continuous infusion of 0.125 % levobupivacaine with morphine 0.0125 mg/ml ( 4 ml/hr ) , Group II ( CFNB ) were maintained by 0.125 % levobupivacaine ( 8 ml/hr ) . RESULTS Patients in the CFNB group , the VAS scores at PO6-12 hr and tramadol IV requirement were significantly greater than the CEI group ( VAS : PO6 hr p-value = 0.001 , PO12 hr p-value = 0.004 ) . Patients in the CEI group experienced dizziness , pruritus , and PONV more than the CFNB group significantly . Patient satisfaction was greater with the CFNB group although postoperative knee rehabilitation and the hospital LOS were not different . CONCLUSION CFNB represents the optimal analgesia with fewer side effects and greater patient , satisfaction . The rehabilitation indices and duration of hospital stay are comparable in both groups .

continuous femoral nerve block ( CFNB )

continuous epidural infusion ( CEI )

femoral nerve block ( FNB )

continuous epidural infusion ( CEI )

continuous femoral nerve block ( CFNB )

( CEI )

levobupivacaine

morphine

( CFNB )

levobupivacaine

CFNB

CEI

CEI

CFNB

CFNB

CFNB

postoperative analgesic efficacy

side effects

postoperative knee rehabilitation

hospital length of stay ( LOS )

VAS scores

tramadol IV requirement

dizziness

pruritus

PONV

Patient satisfaction

postoperative knee rehabilitation

hospital LOS

side effects

patient , satisfaction

rehabilitation indices

duration of hospital stay

total knee arthroplasty ( TKA ) .


Rationale and design of RE-LY : randomized evaluation of long-term anticoagulant therapy , warfarin , compared with dabigatran . Vitamin K antagonists ( VKAs ) are effective for stroke prevention in patients with atrial fibrillation ( AF ) but are difficult to use . Dabigatran etexilate is a prodrug that is rapidly converted to the active direct thrombin inhibitor dabigatran . It is administered in a fixed dose without laboratory monitoring and is being compared with warfarin ( international normalized ratio 2-3 ) in the RE-LY trial . Two doses of dabigatran ( 110 and 150 mg BID ) are being evaluated . RE-LY is a phase 3 , prospective , randomized , open-label multinational ( 44 countries ) trial of patients with nonvalvular AF and at least 1 risk factor for stroke . Recruitment concluded with a total of 18,113 patients . Patients who were VKA-naive and experienced are included in balanced proportions . The primary outcome is stroke ( including hemorrhagic ) or systemic embolism . Safety outcomes are bleeding , liver function abnormalities , and other adverse events . Adjudication of end points is blinded to drug assignment . The trial is expected to accrue a minimum of 450 events with a minimum 1-year of follow-up . RE-LY is the largest AF stroke prevention trial yet undertaken . It is unique because it includes equal numbers of VKA-experienced and naive patients and evaluates 2 different dosages of dabigatran , which may allow tailoring of dosing to individual patient needs . The worldwide site distribution and broad range of stroke risk further increase the general applicability of the trial . Results are expected in 2009 .

warfarin

dabigatran .

Dabigatran etexilate

dabigatran .

warfarin

dabigatran

dabigatran

stroke ( including hemorrhagic )

systemic embolism

bleeding

liver function abnormalities

other adverse events

atrial fibrillation

AF


Effects of cuff inflation on self-recorded blood pressure . Changes in continuously recorded 'Finapres ' finger blood pressure in ten normotensive and seven hypertensive subjects induced by self-inflation of the cuff or just wearing the inflated cuff were studied . Inflating the cuff caused an instantaneous rise in systolic blood pressure of 13 and 12 mm Hg ( hypertensive and normotensive subjects , respectively ) . Wearing the inflated cuff did not change blood pressure . Thus the rise in pressure was related to the muscular activity required for cuff inflation . Systolic blood pressure took on average 7 s and at most 21 s to return to baseline level after stopping cuff inflation . Since first Korotkoff sounds may already be heard after 10-15 s when following recommended procedures , self-recorded systolic blood pressure may be recorded as too high when subjects inflate their cuff at too low a pressure or deflate it too fast .

cuff inflation

self-inflation of the cuff

just wearing the inflated cuff

Inflating the cuff

inflated cuff

cuff inflation .

self-recorded blood pressure .

'Finapres ' finger blood pressure

systolic blood pressure

blood pressure .

pressure

Systolic blood pressure

self-recorded systolic blood pressure

ten

normotensive

seven

hypertensive


[ Effect of transcranial electrostimulation on clinical and laboratory characteristics in patients with gastric ulcer ] . The study included 100 patients with gastric ulcer aged from 16 to 60 years . In 58 patients , traditional treatment was supplemented by transcranial electrotherapy using a TRANSAIR-02 apparatus . Laboratory studies included measurements of lactoferrin ( LF ) and tumour necrosis factor-alpha ( TNF-alpha ) , besides standard analyses . Combined treatment ( traditional therapy plus electrostimulation ) resulted in a significant reduction in duration of the main symptoms of the gastric ulcer depending on the severity of ulceration process , patients ' age and sex . Moreover , it facilitated ulcer scarring and had beneficial effect on dynamics of serum LF and TNF-alpha levels .

transcranial electrostimulation

traditional treatment

transcranial electrotherapy

traditional therapy

electrostimulation

lactoferrin ( LF )

duration of the main symptoms

ulcer scarring

serum LF and TNF-alpha levels .

patients with gastric ulcer ]

patients with gastric ulcer

aged from 16 to 60 years


[ Effects of auditory integrative training on autistic children ] . OBJECTIVE To explore the short-term treatment effect of the auditory integrative training on autistic children and provide them with clinical support for rehabilitative treatment . METHODS A total of 81 cases of autistic children were selected through the standard of DSM-4 and clinical case study was used . They were divided randomly into experimental group and control one , and respectively received auditory integrative training and no training based on the multiple therapies . The patients were investigated using clinical manifestation and Autism Behavior Checklist ( ABC ) and intelligence quotient ( IQ ) before and after six months of treatment . The effect was evaluated through the changes of clinical manifestations and scores of ABC and IQ . The changes of scores of IQ were determined with Gesell and WPPSI or WISC-R . RESULTS Compared with 40 patients of the control group after the six months of the auditory integrative training , 41 of the experimental group had greatly improved in many aspects , such as the disorders of their language , social interactions and typical behavior symptoms while they had not changed in their abnormal behaviors . The scores of IQ or DQ had increased and scores of ABC had dropped . The differences between the two groups were greatly significant in statistics ( P < 0.01 ) . The decreasing level of both ABC scores and the increasing level of the IQ scores were negatively correlated with age , and the decreasing level of ABC scores was in line regression ( positive correlation ) with base IQ . CONCLUSION The treatment of auditory integrative training ( AIT ) could greatly improve on language disorders , the difficulties of social interactions , typical behavior symptoms and developmental levels , therefore it is positive to the autistic children in its short-term treatment effect .

auditory integrative training

auditory integrative training

auditory integrative training

auditory integrative training

auditory integrative training ( AIT )

clinical manifestation

Autism Behavior Checklist ( ABC )

intelligence quotient ( IQ )

changes of clinical manifestations

ABC

IQ .

IQ

disorders of their language

social interactions

typical behavior symptoms

abnormal behaviors .

scores of IQ or DQ

ABC

ABC scores

IQ scores

ABC scores

language disorders

difficulties of social interactions

typical behavior symptoms

developmental levels

autistic

children

autistic

children

cases of autistic children

autistic children


The effect of weight training on bone mineral density and bone turnover in postmenopausal breast cancer survivors with bone loss : a 24-month randomized controlled trial . SUMMARY This study examined whether 24 months of weight training exercises enhanced the effectiveness of risedronate , calcium , and vitamin D in maintaining or improving bone mineral density ( BMD ) in 223 postmenopausal breast cancer survivors . Subjects who were > or =50 % adherent to exercise had no improvement in BMD but were less likely to lose BMD . INTRODUCTION This study examined whether ( 1 ) postmenopausal breast cancer survivors ( BCS ) with bone loss taking 24 months of risedronate , calcium , and vitamin D had increased bone mineral density ( BMD ) at the total hip , femoral neck , L1-L4 spine , total radius and 33 % radius , and decreased bone turnover ; ( 2 ) subjects who also participated in strength/weight training ( ST ) exercises had greater increases in BMD and greater decreases in bone turnover ; and ( 3 ) subjects who also exercised were more likely to preserve ( at least maintain ) BMD . METHODS Postmenopausal BCS ( 223 ) were randomly assigned to exercise plus medication or medication only groups . Both groups received 24 months of 1,200 mg of calcium and 400 IU of vitamin D daily and 35 mg of risedronate weekly , and the exercise group additionally had ST exercises twice weekly . RESULTS After 24 months , women who took medications without exercising had significant improvements in BMD at the total hip ( +1.81 % ) and spine ( +2.85 % ) and significant decreases in Alkphase B ( -8.7 % ) and serum NTx ( -16.7 % ) . Women who also exercised had additional increases in BMD at the femoral neck ( +0.29 % ) , total hip ( +0.34 % ) , spine ( +0.23 % ) , total radius ( +0.30 % ) , and additional decreases in Alkphase B ( -2.4 % ) and Serum NTx ( -6.5 % ) . Additional changes in BMD and bone turnover with exercise were not significant . Subjects who were > or =50 % adherent to exercise were less likely to lose BMD at the total hip ( chi-square [ 1 ] = 4.66 , p = 0.03 ) and femoral neck ( chi-square [ 1 ] = 4.63 , p = 0.03 ) . CONCLUSION Strength/weight training exercises may prevent loss of BMD in postmenopausal BCS at risk for bone loss .

weight training

weight training exercises

risedronate

calcium

vitamin D

exercise

medication

medication

calcium

vitamin D

risedronate

exercise

ST exercises

medications

exercising

exercised

exercise

Strength/weight training exercises

bone mineral density

bone turnover

bone mineral density ( BMD )

BMD

BMD .

bone mineral density ( BMD )

bone turnover ;

BMD

bone turnover ;

BMD .

BMD

Alkphase B

serum NTx

BMD

Alkphase B

Serum NTx

BMD

bone turnover

BMD

BMD

postmenopausal breast cancer survivors

Postmenopausal BCS


Randomized phase II study of two different schedules of gemcitabine and oral S-1 in chemo-naïve patients with advanced non-small cell lung cancer . INTRODUCTION This study was conducted to evaluate the efficacy and safety and to compare dosing schedules of gemcitabine combined with S-1 in chemo-naïve non-small cell lung cancer patients . METHODS Patients with chemo-naïve stage IIIB/IV non-small cell lung cancer were randomized into two treatment arms . Patients were given oral S-1 ( 60 mg/m/d , twice a day ) from days 1 to 14 with gemcitabine ( 1000 mg/m/d ) on days 1 and 8 ( arm A ) or on days 8 and 15 ( arm B ) . This cycle was repeated every 21 days . RESULTS A total of 80 patients were entered in this trial . The primary end point of this study was response rate . The response rates of arm A and arm B were 22.0 and 28.9 % , respectively ( p = 0.606 ) . Median time to treatment failure in arm A was 3.6 months and 4.8 months in arm B . Median time to progression in arm A was 4.1 months and 5.5 months in arm B . Median survival time in arm A and arm B was 15.5 months and 18.8 months , respectively . The toxicity profile was relatively mild and did not differ very much between two arms . CONCLUSION The combination of gemcitabine and S-1 was determined to be feasible and effective for advanced non-small cell lung cancer . We selected arm B for further studies because of its higher response rate and survival data .

gemcitabine

gemcitabine

gemcitabine

gemcitabine

efficacy

safety

response rate

response rates

Median time to treatment failure

Median time to progression

Median survival time

toxicity profile

feasible

effective

response rate

survival data

chemo-naïve

advanced non-small cell lung cancer


Remote ischaemic conditioning before hospital admission , as a complement to angioplasty , and effect on myocardial salvage in patients with acute myocardial infarction : a randomised trial . BACKGROUND Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty . We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infarction , and done before primary percutaneous coronary intervention , increases myocardial salvage . METHODS 333 consecutive adult patients with a suspected first acute myocardial infarction were randomly assigned in a 1:1 ratio by computerised block randomisation to receive primary percutaneous coronary intervention with ( n=166 patients ) versus without ( n=167 ) remote conditioning ( intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff ) . Allocation was concealed with opaque sealed envelopes . Patients received remote conditioning during transport to hospital , and primary percutaneous coronary intervention in hospital . The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention , measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment ; analysis was per protocol . This study is registered with ClinicalTrials.gov , number NCT00435266 . FINDINGS 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria , 32 were lost to follow-up , and 77 did not complete the follow-up with data for salvage index . Median salvage index was 0.75 ( IQR 0.50-0.93 , n=73 ) in the remote conditioning group versus 0.55 ( 0.35-0.88 , n=69 ) in the control group , with median difference of 0.10 ( 95 % CI 0.01-0.22 ; p=0.0333 ) ; mean salvage index was 0.69 ( SD 0.27 ) versus 0.57 ( 0.26 ) , with mean difference of 0.12 ( 95 % CI 0.01-0.21 ; p=0.0333 ) . Major adverse coronary events were death ( n=3 per group ) , reinfarction ( n=1 per group ) , and heart failure ( n=3 per group ) . INTERPRETATION Remote ischaemic conditioning before hospital admission increases myocardial salvage , and has a favourable safety profile . Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes . FUNDING Fondation Leducq .

Remote ischaemic conditioning

Remote ischaemic preconditioning

remote ischaemic conditioning

remote conditioning

remote conditioning

remote conditioning

Remote ischaemic conditioning

remote conditioning

myocardial salvage

myocardial salvage .

myocardial salvage index

myocardial perfusion imaging

Median salvage index

mean salvage index

Major adverse coronary events

death

reinfarction

heart failure

myocardial salvage

safety

were lost to follow-up , and

did not complete the follow-up


Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions . OBJECTIVE Forceps biopsy is the standard method to obtain specimens in endoscopically visible lesions . It is common to combine forceps biopsy with cytology methods to increase the diagnostic yield . Although the flexible cryoprobe has been established for bronchoscopic interventions in malignant stenosis , the obtained biopsies , called " cryobiopsies , " have not been investigated in a large cohort of patients . The aim of this feasibility study was to prospectively evaluate the diagnostic yield and safety of cryobiopsy and forceps biopsy . METHODS During a 6-year period , 296 patients with visible endoluminal tumor lesions were included in the study at the bronchoscopy unit of a university hospital . In the first consecutively conducted 55 cases , both techniques , forceps biopsy and cryobiopsy , were applied simultaneously . Pathologic and quantitative image analyses were performed to evaluate the size and quality of the obtained specimens . We evaluated the safety and diagnostic yield to describe the feasibility of cryobiopsy . RESULTS Comparative analysis of the first conducted and randomly assigned 55 cases revealed a significantly higher diagnostic yield for cryobiopsy compared with forceps biopsy ( 89.1 % vs 65.5 % , P < .05 ) . In this cohort , quantitative image analysis showed significantly larger biopsies regarding size and artifact-free tissue sections for cryobiopsy compared with forceps biopsy ( P < .0001 ) . The overall diagnostic yield of cryobiopsy was 89.5 % . Mild bleeding occurred in 11 cases ( 3.7 % ) , moderate bleeding occurred in 3 cases ( 1.0 % ) , and severe bleeding occurred in 1 case ( 0.3 % ) . CONCLUSION Cryobiopsy is safe and increases the diagnostic yield in endobronchial tumor lesions . The method also is feasible under routine conditions .

Cryoprobe biopsy

cryoprobe

cryobiopsy

forceps biopsy .

forceps biopsy

cryobiopsy

cryobiopsy .

cryobiopsy

forceps biopsy

cryobiopsy

forceps biopsy

cryobiopsy

Cryobiopsy

safety

diagnostic yield

diagnostic yield

size

diagnostic yield

bleeding

bleeding

bleeding

safe

diagnostic yield

feasible

endobronchial tumor lesions .


Virtual reality hypnosis for pain associated with recovery from physical trauma . Pain following traumatic injuries is common , can impair injury recovery and is often inadequately treated . In particular , the role of adjunctive nonpharmacologic analgesic techniques is unclear . The authors report a randomized , controlled study of 21 hospitalized trauma patients to assess the analgesic efficacy of virtual reality hypnosis ( VRH ) -hypnotic induction and analgesic suggestion delivered by customized virtual reality ( VR ) hardware/software . Subjective pain ratings were obtained immediately and 8 hours after VRH ( used as an adjunct to standard analgesic care ) and compared to both adjunctive VR without hypnosis and standard care alone . VRH patients reported less pain intensity and less pain unpleasantness compared to control groups . These preliminary findings suggest that VRH analgesia is a novel technology worthy of further study , both to improve pain management and to increase availability of hypnotic analgesia to populations without access to therapist-provided hypnosis and suggestion .

Virtual reality hypnosis

VRH

Subjective pain ratings

pain intensity

pain unpleasantness

pain management

physical trauma .

hospitalized trauma patients


Influence of diets rich in Maillard reaction products on calcium bioavailability . Assays in male adolescents and in Caco-2 cells . The effects of the high intake of Maillard reaction products ( MRP ) on calcium availability in adolescents and across Caco-2 cell monolayers were examined . In a 2 week randomized two-period crossover trial , 18 male adolescents consumed two diets , named white diet ( WD ) and brown diet ( BD ) , which were poor and rich in MRP , respectively . A 3 day balance was performed at the end of each period , and fasting blood samples were collected . Calcium solubility and absorption across Caco-2 cells were studied after the in vitro digestion of the diets . The in vitro assay showed similar solubility after the in vitro digestion and similar transport across Caco-2 cells . In accordance , calcium bioavailability in adolescents did not vary between the diets ( % WD = 40.4 +/- 5.1 , % BD = 38.2 +/- 3.6 ) . Serum and urine biochemical parameters related to calcium status and bone metabolism remained unaltered . Only deoxypyridinoline values were significantly lower after consumption of the BD ( 13.0 +/- 1.1 compared to 18.3 +/- 2.1 nM/Mm Cr in the WD ) , possibly indicative of less efficient bone turnover during this period . As calcium acquired during adolescence is essential to maximize peak bone mass and to prevent osteoporosis , possible long-term effects of excessive MRP intake during this period warrant attention .

Maillard reaction products

Maillard reaction products ( MRP )

white diet ( WD )

brown diet ( BD )

MRP

MRP

calcium bioavailability .

calcium availability

fasting blood samples

Calcium solubility

absorption across Caco-2 cells

solubility

calcium bioavailability

deoxypyridinoline

bone turnover

male adolescents

adolescents

male

adolescents


Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with depression : study protocol of a randomized controlled trial . BACKGROUND In recent years some studies have been published supporting the efficacy of light exposure , physical activity , sleep control and a Mediterranean diet pattern on the improvement or prevention of depression . However , to our knowledge , there have been no studies using all these measures together as an adjuvant antidepressant strategy . METHODS Multicenter , randomized , controlled , two arm-parallel , clinical trial . Eighty depressed patients undergoing standard antidepressant treatment will be advised to follow four additional hygienic-dietary recommendations about exercise , diet , sunlight exposure and sleep . Outcome measures will be assessed before and after the 6 month intervention period . DISCUSSION We expect the patients in the active recommendations group to experience a greater improvement in their depressive symptoms . If so , this would be a great support for doctors who might systematically recommend these simple and costless measures , especially in primary care . TRIAL REGISTRATION ISRCTN59506583 .

hygienic-dietary recommendations

Mediterranean diet

hygienic-dietary recommendations

Effectiveness

depressive symptoms .

patients with depression :

Eighty


Therapeutic effects of combined treatment using tetracycline-immobilized collagen film and root planing in periodontal furcation pockets . 46 upper and lower molars with furcation grade II involvement were selected from 16 patients with periodontal disease . The teeth were randomly allocated to the following groups according to treatment ; ( 1 ) 4 consecutive administrations of tetracycline-immobilized cross-linked collagen film ( TC film ) at intervals of 1 week ( TC group ) ; ( 2 ) 1 root planing treatment ( RP group ) ; ( 3 ) combination treatment ( TC + RP group ) ; ( 4 ) no treatment ( control group ) . The therapeutic effects of each treatment were compared both clinically and microbiologically . Records of plaque index , gingival index , bleeding on probing , probing depth , probing attachment level and microscopic counts were obtained at 0 , 4 , 6 and 8 weeks . The results showed marked decreases in probing depth and density of micro-organisms in both the RP and TC + RP groups . In particular , the TC + RP group was characterized by a decreased rate of bleeding on pocket probing and an increased probing attachment gain . The above findings demonstrated that root planning is effective in the treatment of furcation involvement and that the effects are enhanced by the local administration of TC films .

tetracycline-immobilized collagen film

root planing

root planing treatment ( RP

TC + RP

RP

TC + RP

TC + RP

TC

rate of bleeding on pocket probing

probing attachment gain .

patients with periodontal disease


Eltrombopag for management of chronic immune thrombocytopenia ( RAISE ) : a 6-month , randomised , phase 3 study . BACKGROUND Eltrombopag is an oral thrombopoietin receptor agonist for the treatment of thrombocytopenia . We aimed to compare the response to once daily eltrombopag versus placebo in patients with chronic immune thrombocytopenia during a 6-month period . METHODS We undertook a phase 3 , double-blind , placebo-controlled study in adults with previously treated immune thrombocytopenia of more than 6 months ' duration who had baseline platelet counts lower than 30,000 per μL . Patients were randomly allocated ( in a 2:1 ratio ) treatment with local standard of care plus 50 mg eltrombopag or matching placebo once daily for 6 months . Randomisation was done centrally with a computer-generated randomisation schedule and was stratified by baseline platelet count ( ≤ 15,000 per μL ) , use of treatment for immune thrombocytopenia , and splenectomy status . Patients , investigators , and those assessing data were masked to allocation . Dose modifications were made on the basis of platelet response . Patients were assessed for response to treatment ( defined as a platelet count of 50,000-400,000 per μL ) weekly during the first 6 weeks and at least once every 4 weeks thereafter ; the primary endpoint was the odds of response to eltrombopag versus placebo . Analysis was by intention to treat . This study is registered at ClinicalTrials.gov , number NCT00370331 . FINDINGS Between Nov 22 , 2006 , and July 31 , 2007 , 197 patients were randomly allocated to treatment groups and were included in the intention-to-treat analysis ( 135 eltrombopag , 62 placebo ) . 106 ( 79 % ) patients in the eltrombopag group responded to treatment at least once during the study , compared with 17 ( 28 % ) patients in the placebo group . The odds of responding were greater in patients in the eltrombopag group compared with those in the placebo group throughout the 6-month treatment period ( odds ratio 8·2 , 99 % CI 3·59-18·73 ; p < 0·0001 ) . 37 ( 59 % ) patients receiving eltrombopag reduced concomitant treatment versus ten ( 32 % ) patients receiving placebo ( p=0·016 ) . 24 ( 18 % ) patients receiving eltrombopag needed rescue treatment compared with 25 ( 40 % ) patients receiving placebo ( p=0·001 ) . Three ( 2 % ) patients receiving eltrombopag had thromboembolic events compared with none in patients on placebo . Nine ( 7 % ) eltrombopag-treated patients and two ( 3 % ) in the placebo group had mild increases in alanine aminotransferase concentration , and five ( 4 % ) eltrombopag-treated patients ( vs none allocated to placebo ) had increases in total bilirubin . Four ( 7 % ) patients taking placebo had serious bleeding events , compared with one ( < 1 % ) patient treated with eltrombopag . INTERPRETATION Eltrombopag is effective for management of chronic immune thrombocytopenia , and could be particularly beneficial for patients who have not responded to splenectomy or previous treatment . These benefits should be balanced with the potential risks associated with eltrombopag treatment . FUNDING GlaxoSmithKline .

Eltrombopag

Eltrombopag

eltrombopag

placebo

placebo-controlled

eltrombopag

placebo

eltrombopag

placebo

eltrombopag

placebo

eltrombopag

eltrombopag

placebo

eltrombopag

eltrombopag

eltrombopag

eltrombopag-treated

eltrombopag-treated

eltrombopag

Eltrombopag

eltrombopag

response

response to treatment

platelet count

responded to treatment

thromboembolic

serious bleeding

chronic immune thrombocytopenia

adults


Randomized controlled trial of acupuncture versus sham acupuncture in autism spectrum disorder . OBJECTIVE We aim to study the efficacy of acupuncture versus sham acupuncture in children with autism spectrum disorder . METHODS A single-blind randomized control trial was conducted in 50 children . These children were randomly assigned to the treatment group with tongue acupuncture ( 40 sessions over 8 weeks ) or the control group ( sham tongue acupuncture to nonacupoints in the tongue ) . RESULTS There was improvement in both the treatment and control groups in all assessed measures but more so in the treatment than in the control group : ( 1 ) eye-hand coordination , performance , and practical reasoning of Griffiths Mental Developmental Scale ; ( 2 ) sensory-motor , social , affectual , language , and total score of Ritvo-Freeman Real Life Scale ; ( 3 ) Comprehension Language age in the Reynell Language Developmental Scale ; and ( 4 ) Total Score and Mental Age in Symbolic Play Test . The only statistically significant improvement in the treatment as compared to the control group was seen in self-care and cognition domains of the Functional Independence Measure for children . CONCLUSIONS We had demonstrated that a short course of acupuncture had efficacy in improving various developmental and behavioral aspects of children with autism . The long-term efficacy in functional gain needs to be further explored .

acupuncture

sham acupuncture

acupuncture

sham acupuncture

tongue acupuncture

sham tongue acupuncture

acupuncture

efficacy

autism spectrum disorder .

children

autism spectrum disorder

children

children with autism .


The immediate efficacy of adjunctive doxycycline in treatment of localized juvenile periodontitis . A randomized , double-blind , placebo-controlled study on the immediate clinical and microbiological efficacy of doxycycline ( 100 mg for 14 days ) was carried out to determine the benefit of adjunctive medication in 16 patients with localized juvenile periodontitis . Measurements of gingival fluid flow , probing depths , bleeding on probing and suppuration were determined at 2 periodontal sites with and 2 without radiographic attachment loss , at weeks 0 , 1 , 3 and 8 . Subgingival bacterial samples were taken with curettes from the same sites . Spirochaetes were searched for by dark-field microscopy . Actinobacillus actinomycetemcomitans , pigmented and non-pigmented Bacteroides spp. , Capnocytophaga , Fusobacterium and Actinomyces spp . were cultured on various selective and non-selective media . Bacterial species found at least in 50 % of the patients and comprising on average 5 % or more of the cultivable flora were included in the analysis . Neither short-term clinical nor microbiological efficacy beyond that of a course of mechanical debridement alone was found by using systemic medication with doxycycline in patients with localized juvenile periodontitis .

doxycycline

doxycycline

doxycycline

immediate efficacy

Subgingival bacterial samples

Spirochaetes

dark-field microscopy .

localized juvenile periodontitis .


Visual and kinesthetic locomotor imagery training integrated with auditory step rhythm for walking performance of patients with chronic stroke . OBJECTIVE To compare the effect of visual and kinesthetic locomotor imagery training on walking performance and to determine the clinical feasibility of incorporating auditory step rhythm into the training . DESIGN Randomized crossover trial . SETTING Laboratory of a Department of Physical Therapy . SUBJECTS Fifteen subjects with post-stroke hemiparesis . INTERVENTION Four locomotor imagery trainings on walking performance : visual locomotor imagery training , kinesthetic locomotor imagery training , visual locomotor imagery training with auditory step rhythm and kinesthetic locomotor imagery training with auditory step rhythm . MAIN OUTCOME MEASURES The timed up-and-go test and electromyographic and kinematic analyses of the affected lower limb during one gait cycle . RESULTS After the interventions , significant differences were found in the timed up-and-go test results between the visual locomotor imagery training ( 25.69 ± 16.16 to 23.97 ± 14.30 ) and the kinesthetic locomotor imagery training with auditory step rhythm ( 22.68 ± 12.35 to 15.77 ± 8.58 ) ( P < 0.05 ) . During the swing and stance phases , the kinesthetic locomotor imagery training exhibited significantly increased activation in a greater number of muscles and increased angular displacement of the knee and ankle joints compared with the visual locomotor imagery training , and these effects were more prominent when auditory step rhythm was integrated into each form of locomotor imagery training . The activation of the hamstring during the swing phase and the gastrocnemius during the stance phase , as well as kinematic data of the knee joint , were significantly different for posttest values between the visual locomotor imagery training and the kinesthetic locomotor imagery training with auditory step rhythm ( P < 0.05 ) . CONCLUSIONS The therapeutic effect may be further enhanced in the kinesthetic locomotor imagery training than in the visual locomotor imagery training . The auditory step rhythm together with the locomotor imagery training produces a greater positive effect in improving the walking performance of patients with post-stroke hemiparesis .

auditory step rhythm

auditory step rhythm

locomotor imagery trainings

visual locomotor imagery training

kinesthetic locomotor imagery training

visual locomotor imagery training

kinesthetic locomotor imagery training

auditory step rhythm

kinesthetic locomotor imagery

visual locomotor imagery training

step rhythm

visual locomotor imagery training

kinesthetic locomotor imagery training

auditory step rhythm

kinesthetic locomotor imagery training

visual locomotor imagery training

auditory step rhythm

locomotor imagery training

walking performance

timed up-and-go test

patients with chronic stroke .

Fifteen

subjects with post-stroke hemiparesis

post-stroke hemiparesis


[ Efficacy of paliperidone extended-release tablets in the improvement of social functions in schizophrenics : a randomized and controlled study ] . OBJECTIVE To explore the efficacy of paliperidone extended-release tablets in the improvement of social functions in schizophrenics . METHODS A total of 81 schizophrenics were randomly divided into study group with paliperidone extended-release tablets and control group with risperidone for a 12-week treatment . They were assessed and analyzed by positive and negative symptoms scales ( PANSS ) , social disability screening schedule ( SDSS ) and treatment emergent symptom scale ( TESS ) at baseline , 6 ( th ) weekend and 12 ( th ) weekend . RESULTS In study group , the factors and total scores of PANSS in the 12 ( th ) weekend of treatment [ ( 12.0 ± 2.8 ) , ( 12.1 ± 3.6 ) , ( 26.2 ± 5.0 ) , ( 50.2 ± 8.7 ) ] were all significantly lower than those at baseline [ ( 24.7 ± 5.3 ) , ( 23.8 ± 3.6 ) , ( 45.0 ± 2.9 ) , ( 93.5 ± 6.8 ) ] ( t = 9.60-16.78 , P < 0.05 ) . In study group , the positive factor , negative factor and total scores of PANSS in the 12 ( th ) weekend of treatment [ ( 12.0 ± 2.8 ) , ( 12.1 ± 3.6 ) , ( 50.2 ± 8.7 ) ] were all significantly lower than those in the 6 ( th ) weekend of treatment [ ( 14.2 ± 1.8 ) , ( 14.6 ± 2.4 ) , ( 56.5 ± 6.4 ) ] ( t = 2.58-4.26 , P < 0.05 ) . In the 12 ( th ) weekend of treatment , the factors and total scores of PANSS in study group [ ( 12.0 ± 2.8 ) , ( 12.1 ± 3.6 ) , ( 26.2 ± 5.0 ) , ( 50.2 ± 8.7 ) ] were all significantly lower than those in control group [ ( 16.9 ± 4.9 ) , ( 18.7 ± 5.3 ) , ( 32.5 ± 5.1 ) , ( 68.1 ± 13.0 ) ] ( t = -4.28 -- 5.67 , P < 0.05 ) . In study group , the total scores of SDSS in the 12 ( th ) weekend of treatment ( 5.93 ± 2.78 ) were significantly lower than those at baseline ( 13.9 ± 3.4 ) ( t = 10.83 , P < 0.05 ) . In study group , the total scores of SDSS in the 12 ( th ) weekend of treatment ( 5.9 ± 2.8 ) were significantly lower than those in the 6 ( th ) weekend of treatment ( 7.6 ± 2.9 ) ( t = 5.21 , P < 0.05 ) . But there was no significant improvement in control group ( t = 1.88 , P > 0.05 ) . In the 12 ( th ) weekend of treatment , the total scores of SDSS in study group ( 5.9 ± 2.8 ) were significantly lower than those in control group ( 8.8 ± 2.9 ) ( t = -4.49 , P < 0.05 ) . No severe adverse effect was reported in either group . CONCLUSION Paliperidone extended-release tablets are effective to improve social functions and psychiatric symptoms of schizophrenics .

paliperidone

paliperidone

paliperidone

risperidone

social functions

social functions

factors and total scores of PANSS

schizophrenics

schizophrenics .

schizophrenics


Time-varying smoking abstinence predicts lower depressive symptoms following smoking cessation treatment . INTRODUCTION The question of whether abstinence during the months following a planned quit attempt exacerbates or improves depressive symptoms is an important clinical issue . Extant research has primarily modeled between-person covariation between postquit abstinence and depressive symptom trajectories . However , this approach can not account for potential third variables between participants that may affect both smoking and depression . Accordingly , the current study examined within-person covariation between time-varying abstinence and depressive symptom in a multilevel model ( MLM ) , which allowed for transitions between smoking statuses within a participant . METHODS Participants were 236 heavy drinking smokers in a randomized clinical trial testing the efficacy of incorporating brief alcohol intervention into smoking cessation treatment . Depressive symptoms and biochemically verified abstinence were assessed 1 week prior to and 2 , 8 , 16 , and 26 weeks after quit date . RESULTS MLMs indicated a slight increase in depressive symptoms over time in the sample as a whole . However , there was an inverse relation between time-varying abstinence ( vs. smoking ) and concurrent level of depressive symptoms , indicating that transitions from smoking to abstinence within individuals were associated with reductions in depressive symptoms . CONCLUSIONS During the first 6 months following a planned quit attempt , being abstinent in a particular week appears to be associated with lower levels of concurrent depressive symptoms . These results are not concordant with the view that intentional smoking abstinence exacerbates depressive symptoms . Efforts to promote smoking cessation should highlight that individuals are likely to feel more rather than less psychologically healthy when they successfully quit smoking .

alcohol intervention

depressive symptoms

depressive symptoms

depressive symptom

Depressive symptoms

biochemically verified abstinence

depressive symptoms

level of depressive symptoms

depressive symptoms .

depressive symptoms .

depressive symptoms .

heavy drinking smokers


Serum biochemical characteristics of Beluga , Huso huso ( L. ) , in response to blood sampling after clove powder solution exposure . In order to investigate the effect of anesthesia on serum parameters , Beluga , Huso huso ( L. ) were blood-sampled immediately without anesthesia ( control ) or subjected to following anesthesia procedure : 40 , 120 , and 240 s exposure to 3,000 , 700 , and 500 mg l⁻¹ clove solution , respectively . Blood samples were collected after these periods , when fish were immobile and reached stage 4 anesthesia . Results showed that cortisol and glucose levels were significantly high in 700 and 500 but not 3,000 mg l⁻¹ group compared to control . Serum lactate levels were significantly high in 500 mg l⁻¹ group compared to control group . Lactate levels were not significantly differed between control , 3,000 , and 700 mg l⁻¹ groups . There were no significant differences in serum levels of cholesterol , total protein , lactate dehydrogenase , aspartate aminotransferase , alanine aminotransferase , Na⁺ , Cl⁻ , K⁺ , and Ca²⁺ . Results suggest that rapid anesthesia with higher dose is better than slow anesthesia with lower dose for blood sampling in Beluga .

anesthesia

anesthesia

Beluga , Huso huso ( L. )

Beluga , Huso huso ( L. )


Lowering the triglyceride/high-density lipoprotein cholesterol ratio is associated with the beneficial impact of pioglitazone on progression of coronary atherosclerosis in diabetic patients : insights from the PERISCOPE ( Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation ) study . OBJECTIVES The purpose of this study was to determine the factors associated with the favorable effect of pioglitazone on atheroma progression . BACKGROUND Diabetes mellitus is associated with accelerated coronary atheroma progression . Pioglitazone slowed progression compared with glimepiride in this population . METHODS In all , 360 diabetic patients with coronary artery disease were treated with pioglitazone or glimepiride for 18 months in the PERISCOPE ( Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation ) study . Coronary atheroma progression was evaluated by serial intravascular ultrasound . The relationship between changes in biochemical parameters , percent atheroma volume , and total atheroma volume was investigated . RESULTS Pioglitazone-treated patients demonstrated greater increases in high-density lipoprotein cholesterol ( HDL-C ) and reductions in glycated hemoglobin , triglycerides , and C-reactive protein . Significant correlations were observed between changes in percent atheroma volume and triglycerides ( r = 0.15 , p = 0.04 ) , triglyceride/HDL-C ratio ( r = 0.16 , p = 0.03 ) , and glycated hemoglobin ( r = 0.16 , p = 0.03 ) with pioglitazone , and changes in low-density lipoprotein cholesterol ( r = -0.15 , p = 0.05 ) , apolipoprotein B ( r = -0.16 , p = 0.04 ) , and apolipoprotein A-I ( r = -0.20 , p = 0.01 ) with glimepiride . Substantial atheroma regression , compared to progression , was associated with greater relative increases in HDL-C ( 14.2 % vs. 7.8 % , p = 0.04 ) , relative decreases in triglycerides ( -13.3 % vs. -1.9 % , p = 0.045 ) , triglyceride/HDL-C ratio ( -22.5 vs. -9.9 % , p = 0.05 ) , and decrease in glycated hemoglobin ( -0.6 % vs. -0.3 % , p = 0.01 ) . Multivariable analysis revealed that pioglitazone-induced effects on triglyceride/HDL-C were associated with changes in percent atheroma volume ( p = 0.03 ) and total atheroma volume ( p = 0.02 ) . CONCLUSIONS Favorable effects of pioglitazone on the triglyceride/HDL-C ratio correlated with delayed atheroma progression in diabetic patients . This finding highlights the potential importance of targeting atherogenic dyslipidemia in diabetic patients with coronary artery disease .

pioglitazone

pioglitazone

Pioglitazone

pioglitazone

glimepiride

Pioglitazone-treated

pioglitazone

glimepiride .

pioglitazone-induced

pioglitazone

coronary atherosclerosis

Coronary atheroma progression

changes in biochemical parameters

percent atheroma volume

total atheroma volume

glycated hemoglobin

triglycerides

C-reactive protein

triglyceride/HDL-C ratio

glycated hemoglobin

low-density lipoprotein cholesterol

apolipoprotein B

apolipoprotein A-I

HDL-C

triglycerides

triglyceride/HDL-C ratio

glycated hemoglobin

triglyceride/HDL-C

percent atheroma volume

total atheroma volume

triglyceride/HDL-C ratio

atheroma progression

diabetic patients

diabetic patients .


Distinct fast and slow processes contribute to the selection of preferred step frequency during human walking . Humans spontaneously select a step frequency that minimizes the energy expenditure of walking . This selection might be embedded within the neural circuits that generate gait so that the optimum is pre-programmed for a given walking speed . Or perhaps step frequency is directly optimized , based on sensed feedback of energy expenditure . Direct optimization is expected to be slow due to the compounded effect of delays and iteration , whereas a pre-programmed mechanism presumably allows for faster step frequency selection , albeit dependent on prior experience . To test for both pre-programmed selection and direct optimization , we applied perturbations to treadmill walking to elicit transient changes in step frequency . We found that human step frequency adjustments ( n = 7 ) occurred with two components , the first dominating the response ( 66 ± 10 % of total amplitude change ; mean ± SD ) and occurring quite quickly ( 1.44 ± 1.14 s to complete 95 % of total change ) . The other component was of smaller amplitude ( 35 ± 10 % of total change ) and took tens of seconds ( 27.56 ± 16.18 s for 95 % completion ) . The fast process appeared to be too fast for direct optimization and more indicative of a pre-programmed response . It also persisted even with unusual closed-loop perturbations that conflicted with prior experience and rendered the response energetically suboptimal . The slow process was more consistent with the timing expected for direct optimization . Our interpretation of these results is that humans may rely heavily on pre-programmed gaits to rapidly select their preferred step frequency and then gradually fine-tune that selection with direct optimization .

perturbations to treadmill walking

human step frequency adjustments

human


A novel approach to the use of subgingival controlled-release chlorhexidine delivery in chronic periodontitis : a randomized clinical trial . BACKGROUND We aimed to analyze clinical , microbiologic , and serologic effects of chlorhexidine ( CHX ) chips used as a subgingival controlled-release delivery device before and immediately after scaling and root planing ( SRP ) . METHODS Twenty-four patients presenting with ≥12 teeth with probing depth ( PD ) ≥5 mm and bleeding on probing were assigned in test or control groups . After prophylaxis , CHX chips ( test ) or placebo chips ( control ) were placed in pockets with PD ≥5 mm . Ten days later , SRP was performed in all teeth with PD ≥4 mm in a single appointment . Immediately after SRP , new chips were inserted in all pockets with PD ≥5 mm . Parameters were assessed at baseline ; beginning of SRP ; and 1 , 3 , and 6 months after treatment . Subgingival samples were obtained at baseline ; beginning of SRP ; and at 1 month after treatment . Periodontal pathogens Aggregatibacter actinomycetemcomitans , Porphyromonas gingivalis , Prevotella intermedia , Tannerella forsythia , and Treponema denticola were analyzed . Serum levels of high sensitive C-reactive and lipopolysaccharide-binding proteins were measured . The changes of the parameters between and within the groups were tested by Mann-Whitney U test ( P < 0.05 ) . RESULTS All clinical and serologic parameters improved in both groups over time . There was a significant difference in clinical attachment level ( CAL ) gain from baseline to 6 months between groups ( 1.17 mm in the test group versus 0.79 mm in the placebo group ) ( P < 0.05 ) . The treatment with CHX chips showed a greater reduction of the microorganisms of the " red complex " after 1 month ( P = 0.02 ) . CONCLUSION The use of CHX chips before and immediately after SRP improved CAL and reduced the subgingival microorganisms of the red complex in the treatment of chronic periodontitis .

chlorhexidine

chlorhexidine ( CHX )

placebo

clinical

microbiologic

serologic effects

clinical attachment level ( CAL )

subgingival microorganisms of the red

chronic periodontitis :

Twenty-four

patients


Intervention to lower household wood smoke exposure in Guatemala reduces ST-segment depression on electrocardiograms . BACKGROUND A large body of evidence suggests that fine particulate matter ( PM ) air pollution is a cause of cardiovascular disease , but little is known in particular about the cardiovascular effects of indoor air pollution from household use of solid fuels in developing countries . RESPIRE ( Randomized Exposure Study of Pollution Indoors and Respiratory Effects ) was a randomized trial of a chimney woodstove that reduces wood smoke exposure . OBJECTIVES We tested the hypotheses that the stove intervention , compared with open fire use , would reduce ST-segment depression and increase heart rate variability ( HRV ) . METHODS We used two complementary study designs : a ) between-groups comparisons based on randomized stove assignment , and b ) before-and-after comparisons within control subjects who used open fires during the trial and received chimney stoves after the trial . Electrocardiogram sessions that lasted 20 hr were repeated up to three times among 49 intervention and 70 control women 38-84 years of age , and 55 control subjects were also assessed after receiving stoves . HRV and ST-segment values were assessed for each 30-min period . ST-segment depression was defined as an average value below -1.00 mm . Personal fine PM [ aerodynamic diameter ≤ 2.5 μm ( PM₂.₅ ] exposures were measured for 24 hr before each electrocardiogram . RESULTS PM₂.₅ exposure means were 266 and 102 μg/m³ during the trial period in the control and intervention groups , respectively . During the trial , the stove intervention was associated with an odds ratio of 0.26 ( 95 % confidence interval , 0.08-0.90 ) for ST-segment depression . We found similar associations with the before-and-after comparison . The intervention was not significantly associated with HRV . CONCLUSIONS The stove intervention was associated with reduced occurrence of nonspecific ST-segment depression , suggesting that household wood smoke exposures affect ventricular repolarization and potentially cardiovascular health .

chimney woodstove

stove intervention

open fire

stove

open fires

chimney stoves

stoves .

ST-segment depression

ST-segment depression

heart rate variability ( HRV ) .

HRV and ST-segment values

ST-segment depression

38-84 years of age


Insulin pump therapy started at the time of diagnosis : effects on glycemic control and pancreatic β-cell function in type 1 diabetes . BACKGROUND In the interest of preserving residual insulin secretory capacity present at the time of diagnosis with type 1 diabetes ( T1D ) , we compared the efficacy of starting insulin pump therapy at diagnosis with standard multiple daily insulin injections ( MDIs ) . METHODS We conducted a prospective , randomized , pilot trial comparing MDI therapy with continuous subcutaneous insulin therapy ( pump therapy ) in 24 patients , 8-18 years old , with newly diagnosed T1D . Subjects were evaluated at enrollment and 1 , 3 , 6 , 9 , and 12 months after initial diagnosis of T1D . Preservation of insulin secretion , measured by mixed-meal-stimulated C-peptide secretion , was compared after 6 and 12 months of treatment . Between-group differences in glycosylated hemoglobin ( HbA1c ) , continuous glucose sensor data , insulin utilization , anthropometric measures , and patient satisfaction with therapy were also compared at multiple time points . RESULTS Initiation of pump therapy within 1 month of diagnosis resulted in consistently higher mixed-meal tolerance test-stimulated C-peptide values at all time points , although these differences were not statistically significant . Nonetheless , improved glycemic control was observed in insulin pump-treated subjects ( more time spent with normoglycemia , better mean HbA1c ) , and pump-treated subjects reported comparatively greater satisfaction with route of treatment administration . CONCLUSIONS Initiation of insulin pump therapy at diagnosis improved glycemic control , was well tolerated , and contributed to improved patient satisfaction with treatment . This study also suggests that earlier use of pump therapy might help to preserve residual β-cell function , although a larger clinical trial would be required to confirm this .

Insulin pump

insulin therapy ( pump therapy )

insulin pump therapy

glycemic control

pancreatic β-cell function

Preservation of insulin secretion

insulin utilization

, anthropometric measures , and

patient satisfaction

mixed-meal tolerance

C-peptide values

glycemic control

glycemic control

type 1 diabetes

type 1 diabetes ( T1D )

8-18 years old

newly diagnosed T1D


[ Clinical study on treatment of endometriosis-related infertility patients by laparoscopic surgery in combination of quyu jiedu recipe ] . OBJECTIVE To study the clinical efficacy of the laparoscopic surgery in combination of Quyu Jiedu Recipe ( QYJDR ) on endometriosis ( EMs ) -related infertility patients . METHODS 130 EMs-related infertility patients of blood stasis and toxin accumulation syndrome diagnosed and treated by laparoscopic surgery were randomly assigned to two groups , i.e. , the test group ( 75 cases ) and the control group ( 55 cases ) . All patients received routine progesterone treatment after laparoscopic surgery . QYJDR was given to patients in the test group after laparoscopic surgery , lasting for twelve months . The pregnancy rate within one year after laparoscopic surgery were compared between the two groups . The Chinese medicine syndrome integrals , serum endometrium antibody ( EMAb ) and cancer antigen 125 ( CA125 ) levels were compared between before drug therapy and three months after drug therapy . RESULTS The pregnancy rate within one year after laparoscopic surgery was higher in the test group than in the control group [ 61.33 % ( 46/75 ) vs 45.45 % ( 25/55 ) ] , showing significant difference ( P < 0.05 ) . The Chinese medicine syndrome integral was ( 16.07 +/- 6.77 ) score and ( 7.25 +/- 3.27 ) score before and 3 months after drug therapy in the test group , while it was ( 15.92 +/- 7.51 ) score and ( 12.73 +/- 6.12 ) score in the control group . The Chinese medicine syndrome integral after drug therapy was lower than that before drug therapy in the same group . Besides , the integral difference between before and after drug therapy was higher in the test group than in the control group [ ( 9.12 +/- 6.16 ) score vs ( 3.48 +/- 2.06 ) score ) ] , showing statistical difference ( P < 0.05 ) . After three-month drug therapy , the serum EMAb negative conversion rate was obviously higher in the test group than in the control group ( 44.44 % vs 15.62 % ) , showing statistical difference ( P < 0.05 ) . The serum CA125 level was ( 31.88 +/- 15.78 ) U/mL before drug therapy and ( 18.82 +/- 10.08 ) U/mL three months after drug therapy in the test group , while it was ( 30.63 +/- 19.28 ) U/mL and ( 18.05 +/- 11.20 ) U/mL respectively in the control group . It was lowered after drug therapy in the two groups with statistical difference ( P < 0.05 ) . There was no statistical difference between the two groups after drug therapy ( P > 0.05 ) . CONCLUSIONS The laparoscopic surgery in combination of QYJDR could effectively improve clinical symptoms of EMs patients of blood stasis and toxin accumulation syndrome , promote negative conversion of EMAb , lower serum CA125 levels , and elevate the clinical pregnancy rate . QYJDR is an effective formula in treatment of EMs-related infertility .

laparoscopic surgery

quyu jiedu recipe ]

laparoscopic surgery

Quyu Jiedu Recipe ( QYJDR )

progesterone

QYJDR

laparoscopic surgery

laparoscopic surgery

QYJDR

QYJDR

clinical efficacy

pregnancy rate

pregnancy rate

Chinese medicine syndrome integral

Chinese medicine syndrome integral

serum EMAb

serum CA125 level

blood stasis

toxin accumulation syndrome

negative conversion of EMAb

serum CA125 levels

clinical pregnancy rate .

EMs-related infertility patients


Chronic vasodilator therapy with flosequinan in congestive heart failure . This study was conducted to determine the long-term effect of flosequinan , a new orally administered arterial and venous dilator , on the clinical course of patients with moderate to severe congestive heart failure . Seventeen patients on chronic digitalis and diuretic therapy were randomized to receive either flosequinan ( n = 9 ) or placebo ( n = 8 ) in a double-blind fashion . Changes in symptomatology , exercise performance , and left ventricular function were assessed serially during the two-month treatment period . During the course of therapy , a modest improvement in the symptom scores and functional classification of the flosequinan-treated patients was observed . Flosequinan evoked a significant increase in maximal exercise capacity . While long-term flosequinan administration also effected a progressive increase in resting heart rate , it did not consistently improve indices of left ventricular systolic function . The addition of chronic vasodilator therapy with flosequinan to standard digitalis-diuretic regimens is capable of inducing clinical improvement in patients with moderate to severe chronic heart failure . Trials involving larger patient populations will be necessary to confirm the results of this preliminary study and to determine the extent of clinical improvement , subpopulations benefited , role in heart failure therapeutics , and so forth .

flosequinan

flosequinan

flosequinan

placebo

Flosequinan

flosequinan

flosequinan

long-term effect

symptomatology

exercise performance

left ventricular function

symptom scores

functional classification

maximal exercise capacity .

resting heart rate

left ventricular systolic function .

congestive heart failure .

Seventeen


A physiotherapy service to an emergency extended care unit does not decrease admission rates to hospital : a randomised trial . BACKGROUND One of the reasons physiotherapy services are provided to emergency departments ( EDs ) and emergency extended care units ( EECUs ) is to review patients ' mobility to ensure they are safe to be discharged home . AIM To investigate whether a physiotherapy service to an EECU altered the rate of hospital admission , rate of re-presentation to the ED , visits to community healthcare practitioners , return to usual work/home/leisure activities and patient satisfaction . METHODS A randomised trial with concealed allocation , assessor blinding and intention-to-treat analysis was undertaken in an EECU . The sample comprised 186 patients ( mean age 70 years , 123 ( 66 % ) female patients , 130 ( 70 % ) trauma ) who were referred for physiotherapy assessment/intervention . Referral occurred at any stage of the patients ' EECU admission . All participants received medical/nursing care as required . The physiotherapy group also received physiotherapy assessment/intervention . RESULTS The physiotherapy group had a 4 % ( 95 % CI -18 % to 9 % ) lower rate of admission to hospital than the control group and a 4 % ( 95 % CI -6 % to 13 % ) higher rate of re-presentation to the ED , which were statistically non-significant ( p≥0.45 ) . Differences between groups for use of community healthcare resources , return to usual work/home/leisure activities and satisfaction with their EECU care were small and not significant . CONCLUSION A physiotherapy service for EECU patients , as provided in this study , did not reduce the rate of hospital admission , rate of re-presentation to the ED , use of community healthcare resources , or improve the rate of return to usual work/home/leisure activities or patient satisfaction . Trial registration number ANZCTRN12609000106235 .

physiotherapy service

physiotherapy

physiotherapy service

physiotherapy assessment/intervention

physiotherapy

physiotherapy assessment/intervention

physiotherapy

physiotherapy

admission rates to hospital

rate of hospital admission

rate of re-presentation to the ED

patient satisfaction

rate of admission to hospital

rate of re-presentation to the ED

mean age 70 years

female

trauma


Cancer information and anxiety : applying the extended parallel process model . There is concern that public education about testicular cancer ( TC ) may cause unnecessary anxiety . Psychological theory suggests that if threat ( eg , TC ) information is accompanied with threat control strategies ( eg , testicular self-examination ; TSE ) anxiety is less likely . Male students ( N=443 ) were randomized to either a TC or TC +TSE information group or a no information control group , and assessed at three time points . Anxiety levels did not differ between the groups and exposure to TC+TSE resulted in greater perceived message benefit , increased intention to self-examine and lower message denigration . This suggests TC information is not anxiogenic , but inclusion of TSE information may improve acceptance of disease awareness information .

testicular self-examination ;

TC

TC

+TSE

TC

anxiety :

Anxiety levels

perceived message benefit

intention to self-examine

message denigration .

Male

students


Quality of individual INR control and the risk of stroke and bleeding events in atrial fibrillation patients : a nested case control analysis of the ACTIVE W study . INTRODUCTION Time in therapeutic range ( TTR ) for international normalized ratio ( INR ) is an accepted quality measure of anticoagulation control in patient populations , but its usefulness for predicting stroke and bleeding in individuals is not well understood . MATERIALS AND METHODS In a nested case control analysis among ACTIVE W study patients , cases with stroke and cases with bleeding were separately matched with controls . Several anticoagulation quality measures were compared , overall and in a time-dependent manner . RESULTS 32 cases with ischemic stroke and 234 cases with bleeding in the analysis were matched in a 4:1 ratio to 122 and 865 controls , respectively . Follow-up duration was 257±154days for the stroke analysis and 222±146days for the bleeding analysis . Compared with their respective controls , the study mean TTR of both stroke cases ( 53.9 % ±25.1 vs 63.4 % ±24.8 ; p=0.055 ) and bleeding cases ( 56.2 % ±25.4 vs 63.4 % ±26.8 ; p < 0.001 ) was lower . Time below range for stroke and time above range for bleeding were only greater in the last month leading up to the event , not over the entire study period . Rather , over the entire study period bleeding cases spent more time below range than controls ( 26.8 % ±25.9 vs 20.8 % ±24.0 ; p=0.001 ) . CONCLUSIONS TTR was lower in individual AF patients with stroke or bleeding compared with matched controls in ACTIVE W. Maintaining a high TTR , with equal importance to avoid low and high INRs , is a relevant goal of individual patient treatment to prevent stroke and bleeding .

Time in therapeutic range ( TTR )

TTR

Time in therapeutic range ( TTR )

Time below range for stroke

time above range for bleeding

atrial fibrillation patients :

cases with ischemic stroke

cases with bleeding


Use of hormonal contraceptives and risk of HIV-1 transmission : a prospective cohort study . BACKGROUND Hormonal contraceptives are used widely but their effects on HIV-1 risk are unclear . We aimed to assess the association between hormonal contraceptive use and risk of HIV-1 acquisition by women and HIV-1 transmission from HIV-1-infected women to their male partners . METHODS In this prospective study , we followed up 3790 heterosexual HIV-1-serodiscordant couples participating in two longitudinal studies of HIV-1 incidence in seven African countries . Among injectable and oral hormonal contraceptive users and non-users , we compared rates of HIV-1 acquisition by women and HIV-1 transmission from women to men . The primary outcome measure was HIV-1 seroconversion . We used Cox proportional hazards regression and marginal structural modelling to assess the effect of contraceptive use on HIV-1 risk . FINDINGS Among 1314 couples in which the HIV-1-seronegative partner was female ( median follow-up 18·0 [ IQR 12·6-24·2 ] months ) , rates of HIV-1 acquisition were 6·61 per 100 person-years in women who used hormonal contraception and 3·78 per 100 person-years in those who did not ( adjusted hazard ratio 1·98 , 95 % CI 1·06-3·68 , p=0·03 ) . Among 2476 couples in which the HIV-1-seronegative partner was male ( median follow-up 18·7 [ IQR 12·8-24·2 ] months ) , rates of HIV-1 transmission from women to men were 2·61 per 100 person-years in couples in which women used hormonal contraception and 1·51 per 100 person-years in couples in which women did not use hormonal contraception ( adjusted hazard ratio 1·97 , 95 % CI 1·12-3·45 , p=0·02 ) . Marginal structural model analyses generated much the same results to the Cox proportional hazards regression . INTERPRETATION Women should be counselled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception , especially injectable methods , and about the importance of dual protection with condoms to decrease HIV-1 risk . Non-hormonal or low-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1 . FUNDING US National Institutes of Health and the Bill & Melinda Gates Foundation .

hormonal contraceptives

Hormonal contraceptives

hormonal contraceptive

hormonal contraceptive

HIV-1 acquisition

HIV-1 transmission

risk of HIV-1 acquisition

female


A double-blind , randomized , controlled , multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction . BACKGROUND We sought to determine the safety and preliminary efficacy of transcatheter intramyocardial administration of myoblasts in patients with heart failure ( HF ) . METHODS MARVEL is a randomized placebo-controlled trial of image-guided , catheter-based intramyocardial injection of placebo or myoblasts ( 400 or 800 million ) in patients with class II to IV HF and ejection fraction < 35 % . Primary end points were frequency of serious adverse events ( safety ) and changes in 6-minute walk test and Minnesota Living With HF score ( efficacy ) . Of 330 patients intended for enrollment , 23 were randomized ( MARVEL-1 ) before stopping the study for financial reasons . RESULTS At 6 months , similar numbers of events occurred in each group : 8 ( placebo ) , 7 ( low dose ) , and 8 ( high dose ) , without deaths . Ventricular tachycardia responsive to amiodarone was more frequent in myoblast-treated patients : 1 ( placebo ) , 3 ( low dose ) , and 4 ( high dose ) . A trend toward improvement in functional capacity was noted in myoblast-treated groups ( Δ6-minute walk test of -3.6 vs +95.6 vs +85.5 m [ placebo vs low dose vs high dose ; P = .50 ] ) without significant changes in Minnesota Living With HF scores . CONCLUSIONS In HF patients with chronic postinfarction cardiomyopathy , transcatheter administration of myoblasts in doses of 400 to 800 million cells is feasible and may lead to important clinical benefits . Ventricular tachycardia may be provoked by myoblast injection but appears to be a transient and treatable problem . A large-scale outcome trial of myoblast administration in HF patients with postinfarction cardiomyopathy is feasible and warranted .

skeletal myoblast implantation

myoblasts

placebo

myoblasts

( placebo )

myoblast-treated

( placebo )

myoblast-treated

myoblasts

safety

cardiovascular effects

safety

efficacy

frequency of serious adverse events (

safety

changes in 6-minute walk test

Minnesota Living With HF score

efficacy

Ventricular tachycardia responsive

functional capacity

patients with heart failure ( HF ) .


Safety , tolerability , and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age . BACKGROUND Incidence and severity of herpes zoster ( HZ ) and postherpetic neuralgia increase with age , associated with age-related decrease in immunity to varicella-zoster virus ( VZV ) . One dose of zoster vaccine ( ZV ) has demonstrated substantial protection against HZ ; this study examined impact of a second dose of ZV . METHODS Randomized , double-blind , multicenter study with 210 subjects ≥60 years old compared immunity and safety profiles after one and two doses of ZV , separated by 6 weeks , vs. placebo . Immunogenicity was evaluated using VZV interferon-gamma ( IFN-γ ) enzyme-linked immunospot ( ELISPOT ) assay and VZV glycoprotein enzyme-linked immunosorbent antibody ( gpELISA ) assay . Adverse experiences ( AEs ) were recorded on a standardized Vaccination Report Card . RESULTS No serious vaccine-related AEs occurred . VZV IFN-γ ELISPOT geometric mean count ( GMC ) of spot-forming cells per 10 ( 6 ) peripheral blood mononuclear cells increased in the ZV group from 16.9 prevaccination to 49.5 and 32.8 at 2 and 6 weeks postdose 1 , respectively . Two weeks , 6 weeks and 6 months postdose 2 , GMC was 44.3 , 42.9 , and 36.5 , respectively . GMC in the placebo group did not change during the study . The peak ELISPOT response occurred ∼2 weeks after each ZV dose . The gpELISA geometric mean titers ( GMTs ) in the ZV group were higher than in the placebo group at 6 weeks after each dose . Correlation between the IFN-γ ELISPOT and gpELISA assays was poor . CONCLUSIONS ZV was generally well-tolerated and immunogenic in adults ≥60 years old . A second dose of ZV was generally safe , but did not boost VZV-specific immunity beyond levels achieved postdose 1 .

zoster vaccine

zoster vaccine ( ZV )

placebo

placebo

Safety

tolerability

immunogenicity

immunity

safety

Immunogenicity

Adverse experiences ( AEs )

serious vaccine-related

healthy

adults ≥60 years of age

≥60 years


Effect of different rates of infusion of propofol for induction of anaesthesia in elderly patients . The effect of changing the rate of infusion of propofol for induction of anaesthesia was studied in 60 elderly patients . Propofol was administered at 300 , 600 or 1200 ml h-1 until loss of consciousness ( as judged by loss of verbal contact with the patient ) had been achieved . The duration of induction was significantly longer ( P less than 0.001 ) with the slower infusion rates ( 104 , 68 and 51 s ) , but the total dose used was significantly less ( P less than 0.001 ) in these patients ( 1.2 , 1.6 and 2.5 mg kg-1 , respectively ) . The decrease in systolic and diastolic arterial pressure was significantly less in the 300-ml h-1 group at the end of induction and immediately after induction ( P less than 0.01 ) . The incidence of apnoea was also significantly less in the slower infusion group .

propofol

propofol

Propofol

loss of consciousness

duration of induction

incidence of apnoea

elderly patients .

elderly patients