bluuebunny/crossref_metadata_2025_split huggingface dataset:
Antenatal Phenobarbital to Prevent or Minimize Intraventricular Hemorrhage in the Low-Birthweight Neonate
Authors: Barnes Eddilisa R. , Thompson Dennis F. 
Published: January 2017

OBJECTIVE: To review the evidence that antenatal phenobarbital can reduce the incidence or severity of periventricular-intraventricular hemorrhage (PIVH) in low-birthweight neonates. DATA SOURCES: MEDLINE searches were conducted with fan searches of all papers. STUDY SELECTION: Emphasis was placed on human data supplemented by relevant animal data. DATA SYNTHESIS: The barbiturates have been used to reduce hypoxic-ischemic cerebral events. Giving phenobarbital to high-risk pregnant women allows the drug to be in therapeutic concentrations during the critical period when PIVH occurs in low-birthweight infants. Current data suggest that antenatal phenobarbital can decrease the severity of PIVH; fewer data are available stating that it can decrease the incidence of PIVH. CONCLUSIONS: Evidence supports the hypothesis that antenatal phenobarbital is effective in decreasing the severity of PIVH in low-birthweight neonates. Further data are necessary regarding the incidence of low Apgar scores and respiratory depression in neonates given antenatal phenobarbital.
Venlafaxine: A Structurally Unique and Novel Antidepressant
Authors: Morton W Alexander , Sonne Susan C , Verga Michael A 
Published: January 2017

Objective: To introduce the new antidepressant venlafaxine. Basic pharmacokinetic data and clinical trials are reviewed, as well as adverse reactions, drug interactions, dosing guidelines, and therapeutic considerations. The article also discusses several pharmacotherapy issues and how venlafaxine compares with other available antidepressants. Data Sources: A MEDLINE search was used to identify pertinent literature, including reviews. Study Selection: As this is a relatively new agent, all available clinical trials were reviewed. Data Extraction: All clinical trials that were available prior to submission for publication were reviewed. Preliminary trials and unpublished reports were not reviewed. Data Synthesis: Venlafaxine hydrochloride is a structurally novel agent that has recently been approved in the US for the treatment of depression. This unique antidepressant blocks neuronal reuptake of norepinephrine, serotonin, and, to a lesser extent, dopamine. Venlafaxine and its major active metabolite, O—desmethylvenlafaxine, exhibit linear kinetics with an elimination half-life of 5 and 11 hours, respectively. Venlafaxine has been evaluated in 7 clinical trials for the treatment of depression. These have consisted of 2 open trials, 3 double-blind, placebo-controlled trials, and 2 double-blind trials where venlafaxine was compared with trazodone and imipramine. All 7 trials have established efficacy for venlafaxine using standard psychiatric rating scales to measure change of depressive symptoms. The usual daily dosage ranges from 75 to 225 mg/d in 2 to 3 divided doses, with a maximum daily dosage of 375 mg/d. The drug's adverse effect profile differs somewhat from other more specific serotonin reuptake inhibitors in that it appears to cause dry mouth, somnolence, and elevated blood pressure as well as nausea, headache, and dizziness. Conclusions: Although venlafaxine has recently become available for use as an antidepressant in the US, few clinical trials have been conducted to help the practitioner evaluate its place in the treatment of depression. There are no comparative trials of venlafaxine with the serotonin specific reuptake inhibitor antidepressants, which are rapidly becoming the newest comparative standard. The clinical place for venlafaxine in the treatment of depression has yet to be determined.
Bisoprolol: Is This Just Another Beta-Blocker for Hypertension or Angina?
Authors: Johns Thomas E , Lopez Larry M 
Published: January 2017

Objective: To review the pharmacology, pharmacokinetics, and clinical experience with bisoprolol and make recommendations regarding its potential clinical usefulness, as well as considerations for formulary inclusion. To review the clinical pharmacology of torsemide and to compare it with currently available loop diuretics, particularly furosemide. Data Sources: Reference citations were sought from Index Medicus and Science Citation Index. Data were collected from abstracts and articles describing experimental studies or blind clinical trials. Study Selection: Studies designed in a randomized, blind, and placebo-controlled manner were emphasized. Studies also were included if bisoprolol was evaluated comparatively with other agents in a randomized, blind fashion. Data Extraction: Data from human studies published in English were evaluated. Studies were assessed by sample size and the clarity of descriptions of methods and results. Data Synthesis: Bisoprolol reduces systolic and diastolic blood pressures in patients with hypertension for a 24-hour dosing interval and is associated with beneficial hemodynamic effects in patients with myocardial ischemia. It is devoid of intrinsic sympathomimetic activity and membrane-stabilizing effects at therapeutic dosages. In patients with hypertension, bisoprolol diminishes plasma renin activity, platelet aggregation, effective renal plasma flow, and creatinine clearance. Bisoprolol has minimal effects on glucose tolerance and plasma lipid profiles. Monotherapy with bisoprolol is as effective as with atenolol, nitrendipine, or nifedipine. Low-dose combination therapy with hydrochlorothiazide is at least as effective as either bisoprolol or hydrochlorothiazide alone. Preliminary experience in the management of angina pectoris suggests that bisoprolol is at least as efficacious as atenolol or verapamil. Thus far, reported adverse effects are similar to those of other beta-blockers. No clinically important drug interactions have been reported at this time. Conclusions: Bisoprolol, alone or in combination with hydrochlorothiazide, is safe and effective for the short-term management of hypertension. Its efficacy in the management of stable angina requires further investigation. There is little clinical evidence that distinguishes bisoprolol from other beta-blockers; therefore, its inclusion on an institutional formulary is not recommended.
Propofol Compatibility with other Intravenous Drug Products—Two New Methods of Evaluating IV Emulsion Compatibility
Authors: Michaels Michele R , Stauffer Gene L , Haas Daniel P 
Published: January 2017

OBJECTIVE: To determine the physical compatibility of propofol injection with 77 other drug products using two methods not previously reported. DESIGN: Each of 77 drug products were mixed with (1) an equal volume of propofol injection, (2) an equal volume of propofol injection with methylene blue added, and (3) an equal volume of the separated aqueous phase of propofol injection. The mixtures were observed for physical changes, and the turbidity of the aqueousphase mixtures was measured by nephelometry. SETTING: A university-affiliated urban teaching hospital. MAIN OUTCOME MEASURES: Observed physical changes or changes in turbidity. RESULTS: Of the 77 drugs tested, 69 showed immediate evidence of physical change, and the other 8 were found incompatible within 72 hours. CONCLUSIONS: Practitioners should not mix the immediately incompatible products with propofol by administering them in the same intravenous line. Caution should be used in simultaneous administration of the other drugs. The new methods were useful in detecting incompatibilities in emulsions.
Comparative Bioavailability and Safety of Two Intramuscular Ceftriaxone Formulations
Authors: Suárez Encarnación C , Grippi Jana R 
Published: January 2017

OBJECTIVE: To determine if two ceftriaxone solutions of different concentrations are bioequivalent when administered intramuscularly. DESIGN: Double-blind, single-dose, two-period, randomized crossover study. SETTING: A clinical research center. SUBJECTS: Seventeen healthy volunteers. INTERVENTION: Ceftriaxone 500 mg administered in either 2 or 1.4 mL of lidocaine 1% solution, with final ceftriaxone concentrations of 250 and 350 mg/mL, respectively. MAIN OUTCOME MEASURES: Blood samples were assayed for ceftriaxone concentrations with HPLC and pharmacokinetic parameters were calculated from the resulting plasma—concentration time profiles: maximum plasma concentration (Cmax) of ceftriaxone and areas under the concentration-time curve (AUC) from 0 to 36 h and 0 to infinity were the primary parameters considered in the determination of bioequivalence. RESULTS: The two solutions were generally well tolerated and had similar safety profiles. Administration of both solutions resulted in similar mean values for all pharmacokinetic parameters. Statistical analysis showed no significant differences between the two solutions in any pharmacokinetic parameter, indicating that the two solutions are statistically bioequivalent (p ≤ 0.05). The 90% CI for the ratio of the means for AUC0-36 (0.86 to 1.11), AUC0-∞. (0.89 to 1.14), and Cmax (0.84 to 1.12) are within the Food and Drug Administration range of bioequivalence (0.80 to 1.25). CONCLUSIONS: These results demonstrate that the more concentrated solution of ceftriaxone (350 mg/mL) is bioequivalent to the currently marketed solution of 250 mg/mL.
Sterility of Filgrastim (G-CSF) in Syringes
Authors: Jacobson Pamala A , West Nina J , Spadoni Virginia , Maksym Christopher J , Pierson Carl 
Published: January 2017

OBJECTIVE: To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment. DESIGN: The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0,24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity. SETTING: A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100 000 clean room. MAIN OUTCOME MEASURES: The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity. RESULTS: Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days. CONCLUSIONS: Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.
Management of Otitis Media with Effusion in Young Children
Authors: Paap Christopher M 
Published: January 2017

OBJECTIVE: To summarize and critique the Agency for Health Care Policy and Research (AHCPR) Clinical Practice Guideline for the management of otitis media with effusion (OME) in children. DATA SOURCES: The AHCPR Clinical Practice Guideline, Otitis Media with Effusion in Young Children; the Quick Reference Guide for Clinicians, Managing Otitis Media with Effusion in Young Children; and the Parent Guide, Middle Ear Fluid in Young Children, were the primary data sources. The AHCPR developed the Guideline based on a comprehensive literature review from multiple bibliographic databases, including the National Library of Medicine. Data were also collected during open hearings and from unpublished sources derived from a call in the Federal Register. Additional citations from the biomedical literature were used for supporting evidence. STUDY SELECTION: Peer-reviewed reports of controlled, randomized studies were preferred, but other study designs were considered. Over 3000 abstracts were identified, of which 378 articles were used for data extraction, and an additional 100 articles were included from bibliography review and panel recommendations. An expert panel reviewed the data and incorporated clinical expertise into the development of consensus statements. DATA EXTRACTION: Data were extracted to apply to a base case with OME to narrow the scope of the Guideline. The base case was defined as a child who is 1–3 years old, is otherwise healthy, and has no underlying craniofacial, neurologic, or sensory conditions. Multiple meta-analyses were done to help the panel come to conclusions on several issues. DATA SYNTHESIS: The Guideline documents carefully outlined treatment algorithms for the management of OME in otherwise healthy children. The main areas that need to be further clarified are the role of more aggressive identification of causative pathogens, when antimicrobial therapy should be initiated, and which antimicrobial agents are preferred for the treatment of OME. There are many vague areas in the Guideline that allow for multiple interpretations. Data regarding the use of corticosteroids were influenced heavily by the expert opinion of the panel rather than the literature-based evidence and potential cost implications. The Guideline provided specific recommendations for the surgical management of OME. Confounding patient factors that would affect decisions on management of OME, such as underlying disease states and physical or mental abnormalities, were not addressed in the Guideline. CONCLUSIONS: The documents were well organized and provide detailed explanation of the recommendations. The Guideline provides specific criteria for the surgical management of OME, but is vague in its recommendations on the medical management of OME with antibiotics, corticosteroids, and the use of invasive tympanocentesis in the evaluation of OME in otherwise healthy children.
Combining Microfractures, Autologous Bone Graft, and Autologous Matrix-Induced Chondrogenesis for the Treatment of Juvenile Osteochondral Talar Lesions
Authors: D’Ambrosi Riccardo , Maccario Camilla , Ursino Chiara , Serra Nicola , Usuelli Federico Giuseppe 
Published: January 2017

Background: The purpose of this study was to evaluate the clinical and radiologic outcomes of patients younger than 20 years, treated with the arthroscopic-talus autologous matrix-induced chondrogenesis (AT-AMIC) technique and autologous bone graft for osteochondral lesion of the talus (OLT). Methods: Eleven patients under 20 years (range 13.3-20.0) underwent the AT-AMIC procedure and autologous bone graft for OLTs. Patients were evaluated preoperatively (T0) and at 6 (T1), 12 (T2), and 24 (T3) months postoperatively, using the American Orthopaedic Foot & Ankle Society Ankle and Hindfoot (AOFAS) score, the visual analog scale and the SF-12 respectively in its Mental and Physical Component Scores. Radiologic assessment included computed tomographic (CT) scan, magnetic resonance imaging (MRI) and intraoperative measurement of the lesion. A multivariate statistical analysis was performed. Results: Mean lesion size measured during surgery was 1.1 cm3 ± 0.5 cm3. We found a significant difference in clinical and radiologic parameters with analysis of variance for repeated measures ( P < .001). All clinical scores significantly improved ( P < .05) from T0 to T3. Lesion area significantly reduced from 119.1 ± 29.1 mm2 preoperatively to 77.9 ± 15.8 mm2 ( P < .05) at final follow-up as assessed by CT, and from 132.2 ± 31.3 mm2 to 85.3 ± 14.5 mm2 ( P < .05) as assessed by MRI. Moreover, we noted an important correlation between intraoperative size of the lesion and body mass index (BMI) ( P = .011). Conclusions: The technique can be considered safe and effective with early good results in young patients. Moreover, we demonstrated a significant correlation between BMI and lesion size and a significant impact of OLTs on quality of life. Level of Evidence: Level IV, retrospective case series.
Extended infusion compared to standard infusion cefepime as empiric treatment of febrile neutropenia
Authors: Wrenn Rebekah H , Cluck David , Kennedy LeAnne , Ohl Christopher , Williamson John C 
Published: January 2017

Background Extended infusion (EI) dosing provides a longer time above the minimum inhibitory concentration, which is important for the clinical success of β-lactam antibiotics, especially for patients with impaired immunity. The aim of this study was to determine the feasibility and clinical impact of administering cefepime by EI as treatment of febrile neutropenia. Methods This was a prospective, randomized, comparative pilot study. All patients received cefepime 2 g IV every 8 h, with the first dose administered using a 30-min infusion. After the first dose, patients were randomized to receive cefepime over 30 min as a standard infusion (SI) or 3 h (EI). Patients were >18 years old with febrile neutropenia (neutrophil count <500 cells/mm3 and temperature >38.0ºC) and received chemotherapy or stem cell transplant as treatment for malignancy. Patients were excluded for the following: allergy to a cephalosporin, creatinine clearance (CrCl) < 50 mL/min, receipt of concurrent Gram-negative antimicrobial, sepsis, or solid tumor malignancy. The primary outcome was defervescence by 72 h. Secondary outcomes included time to defervescence, clinical success, in-hospital mortality, hospital length of stay, and need for additional antimicrobials. Main results Sixty-three patients were enrolled: 33 in the SI arm and 30 in the EI arm. The groups were similar with regard to age, gender, weight, estimated creatinine clearance, and duration of neutropenia. None of the patients in the EI arm withdrew due to practical complications of receiving EI cefepime. Twenty-three patients in the SI arm and 20 patients in the EI arm defervesced by 72 h ( p = 0.99). There were no differences in secondary outcome measures; however, patients in the EI arm appeared to have defervesced more rapidly (median 19 vs. 41 h, p = 0.305). Conclusion Administration of cefepime by EI for the treatment of febrile neutropenia is feasible. Larger clinical trials are necessary to determine if EI cefepime imparts a clinical benefit in the treatment of febrile neutropenia.
Baxter elastomeric pumps: Weighing as an alternative to visual inspection
Authors: Cusano Ellen L , Ali Raafi , Sawyer Michael B , Chambers Carole R , Tang Patricia A 
Published: January 2017

Purpose Elastomeric pumps are used to administer 46-hour infusions of 5-fluorouracil (5FU). Baxter suggests patients visually monitor their pumps to ensure that infusions are proceeding correctly. This can be confusing and lead to concerns about under- or over-dosing. Baxter has not considered weighing pumps as a validated method for monitoring. This study aims to validate weighing as a more accurate method for patients and healthcare professionals, and describe real life Baxter Infusor™ variability. Methods Patients who had been started on a 46-hour 5FU infusion returned to the clinic approximately 24 h after starting treatment. The pump was weighed on a StarFrit kitchen scale, and date, time, and weights recorded. Patients were asked if they had a preference for weighing or visually inspecting their pump. Results Pumps ( n = 103) were weighed between 17.25 and 27.5 h after connection. The average weight of a pump was 189 g. Of 103 pumps weighed, 99 weighed less than expected, corresponding to average flow rates of 5.69 mL/h over the elapsed time. The expected flow rate is 5 mL/h with 10% variability. Average flow rates within the 17.25- to 27.5-hour window were 4.561 mL/h, which is 8.78% slower than expected, but within the 10% known variability. Forty-seven percent of patients didn’t have a preference for either method, but for those who did have a preference, more than twice as many preferred weighing. Conclusion With proper education, weighing Baxter Infusors at home with kitchen scales can be an accepted and objective alternative to the current recommendation of visual inspection.
Processing speed test: Validation of a self-administered, iPad®-based tool for screening cognitive dysfunction in a clinic setting
Authors: Rao Stephen M , Losinski Genna , Mourany Lyla , Schindler David , Mamone Bernadett , Reece Christine , Kemeny Danielle , Narayanan Sridar , Miller Deborah M , Bethoux Francois , Bermel Robert A , Rudick Richard , Alberts Jay 
Published: January 2017

Background: Cognitive dysfunction is common in multiple sclerosis (MS) patients and has important consequences for daily activities, yet, unlike motor function, is not routinely assessed in the clinic setting. We developed the Processing Speed Test (PST), a self-administered iPad®-based tool to measure MS-related deficits in processing speed. Objective: To determine whether the PST is valid for screening cognitive dysfunction by comparing it to the paper-and-pencil Symbol Digit Modalities Test (SDMT). Methods: We assessed PST test–retest reliability, sensitivity of PST and SDMT in discriminating MS patients from healthy controls (HC), convergent validity between PST and SDMT, correlations between T2 lesion load and PST and SDMT, and PST performance with and without technician present during administration. Results: PST had excellent test–retest reliability, was highly correlated with SDMT, was slightly more sensitive than SDMT in discriminating MS from HC groups, and correlated better with cerebral T2 lesion load than did SDMT. Finally, PST performance was no different with or without a technician in the testing environment. Conclusion: PST has advantages over SDMT because of its efficient administration, scoring, and potential for medical record or research database integration. PST is a practical tool for routine screening of processing speed deficits in the MS clinic.
Microvascular Changes in Arterial Occlusive Disease: Target for Pharmacotherapy
Authors: Bollinger Alfred , Hoffmann Ulrich , Franzeck Ulrich K 
Published: January 2017

The main techniques which have been used to study skin microcirculation in patients with peripheral arterial occlusive disease include intravital microscopy with and without the use of fluorescent dyes, laser Doppler fluxmetry and transcutaneous oximetry. In patients with severe ischaemia (rest pain or incipient gangrene) the number of perfused skin capillaries is reduced. Parallel to the decreased number of microvessels containing blood, transcutaneous oxygen tension is low or even approaches the zero level. The tendency to oedema formation is documented by increased leakage of intravenously injected sodium fluorescein at the capillary apex of foot skin (‘candlelight phenomenon’). Laser Doppler flux at rest may still be within the normal range even in advanced disease, since the sample volume of these instruments also contains non-nutritive shunt vessels. However, reactive hyperaemia after arterial occlusion is decreased and delayed in peripheral ischaemia. Whereas rhythmic low-frequency vasomotion is significantly enhanced in patients with intermittent claudication, vasoparalysis with no flux fluctuations prevails in patients with critical ischaemia.