bluuebunny/crossref_metadata_2025_split huggingface dataset:
Placebo Response in Anxiety Disorders
Authors: Piercy Marlena A , Sramek John J , Kurtz Neil M , Cutler Neal R 
Published: January 2017

OBJECTIVE: To review literature on placebo response in anxiety, to discuss sources and levels of placebo response in various anxiety disorders, and to suggest methods to prevent high placebo response rates in clinical research trials. DATA SOURCE: Data from scientific literature were identified using a MEDLINE search, and were extracted and summarized for this review. STUDY SELECTION: Representative findings were selected from clinical and epidemiologic studies, review articles, letters to the editor, book chapters, and proceedings. DATA EXTRACTION: Data from English-language reports of studies on humans were included. Only the most representative conclusions drawn from review articles were used. DATA SYNTHESIS: Anxiety disorders in general are thought to be extremely susceptible to a variety of influences, including patient characteristics and environmental variables. Reported placebo response levels in clinical studies of anxiolytics for generalized anxiety disorder and panic disorder vary widely, with a tendency to be rather high, although studies in social phobia and obsessive-compulsive disorder appear to have consistently low placebo response rates. Comparisons of anxiety studies with studies of other indications, such as depression, show similar overall placebo response rates. To determine efficacy, drug response rates and placebo response rates must be clearly differentiated. CONCLUSIONS: Examination of the literature suggests that placebo response rates in studies of anxiolytics are influenced by a number of factors, including both endogenous and exogenous variables. High placebo response rates may mask true drug response rates and may result from poor study design or lack of procedural standardization. The use of certain design methods may help to prevent high placebo response rates in anxiolytic clinical trials.
Hypnotic Drug Use in Spain: A Cross-Sectional Study Based on a Network of Community Pharmacies
Authors: Rayón Pilar , Serrano-Castro Mariantonia , Barrio Horacio del , Alvarez Carmen , Montero Dolores , Madurga Mariano , Palop Ramón , De Abajo Francisco J. 
Published: January 2017

OBJECTIVE: To investigate how hypnotic drugs are used in Spain, specifically, (1) to characterize the user population in some simple demographic (e.g., sex, age) and clinical (e.g., type of insomnia, type of physician who prescribed the drug) variables; (2) to estimate the proportion of long-term users (>3 mo); (3) to determine the frequency of different administration schedules; (4) to determine whether the kind of hypnotic drug prescribed according to the duration of its effect correlates with the type of sleep disorder or patient age; and (5) to compare the dosage used by the elderly with that used by adults. DESIGN: Cross-sectional pharmacy-based study. SETTING: A network of 318 community pharmacies throughout Spain. SUBJECTS: Patients (n = 5324) requesting a hypnotic drug for insomnia who agreed to take part in the study. MAIN OUTCOME MEASURES: Distribution of the use of hypnotic drugs by age, sex, type of insomnia, type of physician, specific hypnotic drug, daily dosage, treatment schedule, and duration of treatment. RESULTS: Women (67%) and the elderly (58%) constituted the largest subgroups in the sample. Difficulties in sleep onset and in sleep maintenance as single disorders were reported by 38% and 37% of users, respectively. Prescriptions were written by general practitioners in 80% of cases. Daily use was reported by 88% and long-term use (>3 mo) by 72% of the users. Long-term treatment was two- to threefold more frequent in the elderly than in middle-aged subjects. Intermediate-action hypnotic drugs were used by 59% of subjects, short-action drugs by 24%, and long-action drugs by 17%. The type of hypnotic drug prescribed was not related to the kind of sleep disorder or the age of patients. Specialists prescribed long-action hypnotic drugs more often than did general practitioners. No relevant differences were observed between dosages used by the elderly and those used by adults. In both groups the dosage taken by most patients, regardless of the drug, corresponded to the available strength. Substitution drugs for triazolam belonged to the intermediate-action class in 53% of the cases. CONCLUSIONS: Recommendations on hypnotic drug use are largely not followed in Spain. Most patients are taking hypnotic drugs daily, over long time periods, and without an adequate dosage titration according to age. Measures should be taken to correct this situation.
Dirithromycin: A New Macrolide
Authors: Wintermeyer Susan M. , Abdel-Rahman Susan M. , Nahata Milap C. 
Published: January 2017

OBJECTIVE: To review the clinical microbiology and therapeutic use of dirithromycin, emphasizing comparative data between dirithromycin and the standard macrolide erythromycin, as well as clarithromycin and azithromycin. DATA SOURCES: A MEDLINE search of English-language literature during the years 1966–1996, and an extensive review of journals were conducted to prepare this article. DATA EXTRACTION: The data on pharmacokinetics, adverse effects, and drug interactions were obtained from open and controlled studies. Controlled single- or double-blind studies were evaluated to assess the efficacy of dirithromycin in the treatment of various upper and lower respiratory tract infections, as well as skin and soft tissue infections. DATA SYNTHESIS: The spectrum of activity of dirithromycin is similar to that of erythromycin, clarithromycin, or azithromycin, with some notable exceptions. Dirithromycin was more active in vitro against Campylobacter jejuni and Borrelia burgdorferi than was erythromycin or clarithromycin, but in general demonstrated less activity than erythromycin, clarithromycin, or azithromycin against a majority of microorganisms. The pharmacokinetic profile of dirithromycin offers the advantages of once-daily dosing and high and prolonged tissue concentrations; dosing adjustments are not needed in the elderly or in patients with renal or mild hepatic impairment. Clinical efficacy and bacteriologic eradication rates with dirithromycin and erythromycin are comparable for the treatment of respiratory and skin and soft tissue infections due to susceptible pathogens. Dirithromycin appears to have adverse effect profiles similar to those of the other macrolides, with reported problems most often related to the gastrointestinal tract. Dirithromycin does not seem to cause clinically important interactions with drugs such as theophylline, oral contraceptives, cyclosporine, or terfenadine. CONCLUSIONS: Dirithromycin offers some attractive pharmacokinetic properties. The long elimination half-life of dirithromycin allows once-daily dosing and higher and more prolonged tissue concentrations than are achievable with erythromycin. The spectrum of activity, adverse effect profile, clinical efficacy, and bacteriologic eradication rate of dirithromycin may be similar to those of erythromycin. No significant drug interactions with dirithromycin have been reported. Based on available data, dirithromycin may not offer any unique clinical advantage over clarithromycin or azithromycin. Future clinical trials may reveal a special role for dirithromycin in patient care.
Topical Antimicrobial Prophylaxis in Minor Wounds
Authors: Langford Jane H , Artemi Phillip , Benrimoj Shalom I 
Published: January 2017

OBJECTIVE: To evaluate the ability of a novel topical antimicrobial gel containing cetrimide, bacitracin, and polymyxin B sulfate to prevent infections of minor wounds. DESIGN: A clinical trial compared the test preparation with placebo and a povidone iodine antiseptic cream. SETTING: Five primary schools in Sydney, Australia, participated in the study over a 6-week spring/summer school term. SUBJECTS: Children aged 5–12 years with parental consent were eligible for study participation. Accidental injuries occurring at school were treated in a standardized manner by nurses at each site. OUTCOME MEASURES: Wounds were evaluated by the medical practitioner after 3 days of topical treatment. The clinical outcome was classified as resolution or suspected infection. If a clinical infection was suspected, the injury was swabbed for microbiologic evaluation. Growth of a dominant microorganism was classified as a microbiologic infection. RESULTS: Of the 177 injuries treated, there were nine clinical infections. A comparison of these showed a significant difference among treatment groups (p < 0.05). This difference was associated with the test preparation and placebo; the test preparation reduced the incidence of clinical infection from 12.5% to 1.6% (p < 0.05; 95% CI, 0.011 to 0.207). A comparison of microbiologic infections showed no significant differences among treatment groups (p > 0.05). CONCLUSIONS: The novel gel preparation containing cetrimide, bacitracin, and polymyxin B sulfate showed therapeutic action and reduced the incidence of clinical infections in minor accidental wounds. It may be a suitable product for first aid prophylaxis.
Nitroprusside Treatment of Erythromelalgia in an Adolescent Female
Authors: Stone Jonathan D , Rivey Michael P , Allington Douglas R 
Published: January 2017

OBJECTIVE: TO report a case of erythromelalgia in an adolescent patient successfully treated with nitroprusside. CASE SUMMARY: A 15-year-old girl with erythromelalgia resistant to aspirin therapy received an infusion of nitroprusside. The response of the erythromelalgia to nitroprusside was dramatic, with complete pain resolution within 17 hours after the start of therapy. No relapse of erythromelalgia was seen when nitroprusside was discontinued and the patient remained well after 6 months. DISCUSSION: This case adds to existing literature substantiating the benefit of nitroprusside for the treatment of erythromelalgia in pediatric patients. Erythromelalgia in children may represent a different disease entity than that seen in adults, which is commonly responsive to aspirin therapy. The pathogenesis of erythromelalgia is unclear and precludes formulating a proposed mechanism by which nitroprusside has benefit in children. CONCLUSIONS: Nitroprusside is valuable for erythromelalgia resistant to aspirin therapy in pediatric patients. Because of unanswered questions regarding the disease, aspirin remains the agent of first choice in all patients with this rare disease.
Acute Asthma Associated with Sustained-Release Verapamil
Authors: Ben-Noun Liubov 
Published: January 2017

OBJECTIVE: TO describe a patient with asymptomatic bronchial asthma and hypertension who developed an acute asthma attack after receiving sustained-release verapamil. CASE SUMMARY: A 66-year-old white woman with a 10-year history of hypertension and bronchial asthma was switched from immediate-release verapamil hydrocloride 40 mg tid to sustained-release verapamil 240 mg/d po for better hypertension control. After taking the first tablet, she developed dyspnea, cough, and wheezing. Antiasthmatic medications were prescribed, but the asthma symptoms did not improve. She continued taking verapamil for 6 months, then, on her own, stopped all medications including the sustained-release verapamil, and her asthma symptoms disappeared. On rechallenge she developed severe dyspnea, cough, and wheezing 20 minutes after administration. The asthma resolved within 24 hours following three albuterol inhalations. The next day similar symptoms developed with rechallenge of the same brand of sustained-release verapamil in a 120-mg formulation, and verapamil was discontinued. Six months later she was again prescribed sustained-release verapamil 240 mg in another clinic where the physician was unaware of her previous reaction. Once again, severe dyspnea, cough, and wheezing developed. DISCUSSION: On four separate occasions the patient was challenged, advertently or inadvertently, with sustained-release verapamil. Similar symptoms developed after each challenge and resolved after discontinuing this preparation. Although dyspnea associated with verapamil administration has been reported, this is the first report of an elderly asymptomatic asthmatic patient with hypertension who developed an acute asthma attack following sustained-release verapamil administration. CONCLUSIONS: Sustained-release verapamil is thought to be the cause of the asthma attack in this patient because she was not taking any other preparations; the symptoms started with the administration of sustained-release verapamil and were relieved after its discontinuation.
Consensus Guidelines for Coordinated Outpatient Oral Anticoagulation Therapy Management
Authors: Ansell Jack E , Buttaro Marissa L , Thomas Orsula Voltis , Knowlton Calvin H ,   Anticoagulation Guidelines Task Force
Published: January 2017

OBJECTIVE: TO provide primary and referring healthcare practitioners with guidelines for the provision of safe and effective anticoagulation management in any venue to standardize and improve quality of care and to permit negotiation for reimbursement from third-party payers. DATA EXTRACTION AND SYNTHESIS: Data on the current practice of anticoagulation providers and outcomes related to anticoagulation clinic care were obtained through the literature, interviews with anticoagulation providers, and a focus group meeting of anticoagulation clinic stakeholders. This information collation process revealed that an anticoagulation service consists of three separate areas for which guidelines should be developed. Based on the consensus opinions of the committee members, the literature review, and the current practice of anticoagulation services providers, a draft guideline was developed and reviewed by an independent multidisciplinary panel of anticoagulation services providers whose comments were incorporated into the final guideline. CONCLUSIONS: Systematic outpatient anticoagulation services are systems of care designed to coordinate and optimize the delivery of anticoagulation therapy by (1) evaluating patient-specific risks and benefits to determine the appropriateness of therapy; (2) facilitating the management of anticoagulation dosages and prescription pick up or delivery; (3) providing ongoing education of the patient and other caregivers about warfarin and the importance of self-care behavior leading to optimal outcomes; (4) providing continuous systematic monitoring of patients, international normalized ratio results, diet, concomitant drug therapy, and disease states; and (5) communicating with other healthcare practitioners involved in the care of the patient. To create a reproducible framework for the provision of these services, guidelines for structure, process, and outcomes of coordinated outpatient anticoagulation management services were developed. Guidelines for organization and management include (1) qualifications for personnel, (2) supervision, (3) care management and coordination, (4) communication and documentation, and (5) laboratory monitoring. Guidelines for the process of patient care include (6) patient selection and assessment, (7) initiation of therapy, (8) maintenance and management of therapy, (9) patient education, and (10) management and triage of therapy-related and unrelated problems. Guidelines for the evaluation of patient outcomes include (11) organizational components and (12) patient outcomes. The impact of these 12 guidelines on patient care and reimbursement procurement will depend on their implementation and the perceived value of their use.
Zolpidem: Distinct from Triazolam?
Authors: Lobo Bob L , Greene William L 
Published: January 2017

OBJECTIVE: TO review the literature that compares Zolpidem with triazolam, with an emphasis on efficacy and safety in humans. DATA SOURCES: Information was retrieved from a MEDLINE search (1983–1996) of the English-language literature using the terms triazolam and zolpidem. STUDY SELECTION: Reports of clinical trials comparing the safety and efficacy of zolpidem and triazolam were included in this review. DATA EXTRACTION: Data were evaluated according to study design, efficacy, and adverse effects. Pertinent information was selected and the data synthesized into a review format. DATA SYNTHESIS: Zolpidem and triazolam have similar pharmacokinetic and pharmacodynamic effects in humans. Clinical trials have shown that usually recommended, equipotent dosages of zolpidem and triazolam do not differ with respect to pharmacokinetics, efficacy, tolerability, residual effects, memory impairment, rebound insomnia, abuse potential, or other adverse effects. CONCLUSIONS: Zolpidem offers no distinct therapeutic advantage over triazolam for the treatment of insomnia.
The Effect of ICU Sedation Guidelines and Pharmacist Interventions on Clinical Outcomes and Drug Cost
Authors: Devlin John W , Holbrook Anne M , Fuller Hugh D 
Published: January 2017

OBJECTIVE: To measure the effect of evidence-based intensive care unit (ICU) sedation guidelines and interventions by a pharmacist to promote these guidelines on the weaning time from mechanical ventilation and sedation drug cost. DESIGN: Before-after study. SETTING: A 15-bed medical-surgical ICU at a tertiary-care teaching hospital. PATIENTS: 100 patients (2 groups of 50 consecutive patients) on mechanical ventilation (assist or pressure control mode for ≥6 h) who were successfully discharged from the ICU. METHODS: ICU sedation guidelines were developed through physician, nursing, and pharmacy consensus using a physician survey and literature overview as points of reference and were implemented into practice. Prospectively, data on the time required to wean patients from mechanical ventilation (successful trial of T-piece, pressure support, or intermittent mandatory ventilation leading to extubation) and total drug costs for sedation were measured and compared between groups. All prospective ICU pharmacist interventions pertaining to sedation were documented. RESULTS: New sedation guidelines promoted lorazepam use in preference to midazolam and suggested propofol for patients not successfully sedated with high-dose lorazepam, haloperidol, or morphine. Over the 2-month collection periods, there was no difference in the median weaning time between the pre- (16 h, range 2–607) and post- (18 h, range 1–284) guideline groups. Total sedation drug costs decreased from $4515 to $1152 ($US) (p = 0.081). Median sedation drug costs decreased from $ 11.27 (range $0–1340) to $3.55 (range $0–250), with the amount (mg) of midazolam and propofol used decreasing by 86% and 100%, respectively. The ICU pharmacist successfully recommended a change from midazolam to lorazepam in 12 of 50 patients, 5 of whom had received midazolam for more than 24 hours. CONCLUSIONS: High compliance with ICU sedation guidelines promoting lorazepam rather than midazolam or propofol in mechanically ventilated patients led to a 75% decrease in sedation drug costs and did not adversely affect the clinicians' ability to wean patients from mechanical ventilation.
Pancreatic Insufficiency Due to Antituberculous Therapy
Authors: Liu Barbara A , Knowles Sandra R , Cohen Lawrence B , Werb Marsha R , Shear Neil H 
Published: January 2017

OBJECTIVE: To describe a case of chronic pancreatic insufficiency related to antituberculous therapy. CASE SUMMARY: A 57-year-old man developed rash, fever, and hepatitis (aspartate aminotransferase 369 IU/L, alanine aminotransferase 506 IU/L), 6 weeks after starting isoniazid, rifampin, ethambutol, and pyrazinamide. He also developed severe metabolic acidosis secondary to diabetic ketoacidosis and lactic acidosis (serum bicarbonate 7 mEq/L, glucose 1778 mg/dL, and lactate 4.0 mEq/L). Acute pancreatitis was diagnosed on the basis of a mildly elevated amylase concentration (392 U/L) and radiologic evidence of pancreatic inflammation. He developed pancreatic insufficiency with steatorrhea and an abnormal secretin test. He continues to require pancreatic enzyme replacement and insulin therapy. Rechallenge was not performed. DISCUSSION: Hypersensitivity syndromes have been reported for various drug therapies, including antituberculous agents. Hypersensitivity syndrome reactions are characterized by fever, rash, and internal organ involvement. Rifampin has been reported to cause acute pancreatitis in up to 2.7% of patients. Drug-induced chronic pancreatitis, however, is reported to be extremely rare. This is the first reported case of chronic pancreatic insufficiency occurring in the setting of a hypersensitivity syndrome reaction to antituberculous drugs. CONCLUSIONS: Chronic pancreatic insufficiency should be considered as a possible long-term sequelae of a hypersensitivity syndrome reaction to antituberculous therapy.
Gentamicin and Tobramycin Pharmacokinetics in Pediatric Bone Marrow Transplant Patients
Authors: Jacobson Pamala A , West Nina J , Price Jessica , Hutchinson Raymond J 
Published: January 2017

OBJECTIVE: To describe the pharmacokinetic parameters of gentamicin and tobramycin in pediatric bone marrow transplant patients. DESIGN: Retrospective medical record review. Setting: Pediatric bone marrow transplant unit in a university teaching hospital. MAIN OUTCOME MEASURES: Pharmacokinetic parameters (apparent volume of distribution [Vd] in L/kg, half-life [t1/2] in h, elimination rate constant [ke] in h−1, clearance [Cl] in mL/min/1.73 m2 and mL/min/kg) calculated from serum concentrations. PATIENTS: Thirty-three patients aged 15 years or less who underwent bone marrow transplant and received gentamicin or tobramycin. RESULTS: Mean pharmacokinetic parameters were Vd 0.32 ± 0.07 L/kg, t1/2 2.32 ± 0.65 h, Cl 1.71 ± 0.53 mL/min/kg, and Cl 86.2 ± 24.5 mL/min/1.73 m2. Factors such as disease state, type of marrow graft, gender, or exposure to cyclosporine had no significant effect on pharmacokinetic parameters. Linear regression indicated a weak relationship between serum creatinine (SCr) and Cl in mL/min/kg (r = 0.59), but no relationship was found between SCr and Cl in mL/min/1.73 m2, between age and apparent Vd, or between SCr and apparent Vd. Models for estimating Cl and ke developed by multiple regression were somewhat predictive (r = 0.7). Required calculated maintenance dosages to obtain therapeutic concentrations were 8, 7, and 6 mg/kg/d in children 6 or younger, 7–12, and 13–15 years, respectively. CONCLUSIONS: The mean Cl and apparent Vd for all ages are similar to those reported in pediatric oncology patients who had not undergone marrow transplantation. Children 6 years or younger had lower than expected Cls and larger apparent Vds than did the older children. Dosages estimated to be necessary to achieve therapeutic concentrations were 6–8 mg/kg/d.