氯唑西林和普那霉素治疗浅表型脓皮病的随机、开放、非干预研究

作     者：Chosidow O Bernard P Berbis P 惠海英 

作者机构：Department of Internal Medicine H pital Pitié-Salpêtrière UniversitéParis-VI 47-83 boulevard de I'H pital.FR-75013 Paris Cedex 13 France.Prof 

出 版 物：《世界核心医学期刊文摘（皮肤病学分册）》 (Digest of the World Core Medical JOurnals:Dermatology)

年 卷 期：2005年第1卷第10期

页      面：58-59页

学科分类：1002[医学-临床医学] 100206[医学-皮肤病与性病学] 10[医学] 

主　　题：脓皮病 氯唑西林 普那霉素 苯唑西林 干预试验 试验设计 于非 设计分析 

摘      要：Background:Superficial pyodermas may require systemic antibiotics. In a previous open-label trial, oxacillin and pristinamycin achieved similar cure rates, but its design was not truly that of a non-inferiority study. Objectives:To assess the efficacy and safety of oral cloxacillin versus pristinamycin (both 2 g/day) to treat superficial pyodermas. Methods:Multi-centre, parallel-group, open-label, randomized non-inferiority trial. Results:French general practitioners in private practice included 334 out-patients (mean age:42 years). At the follow-up (day 14), the cure rates (primary efficacy end point) for the intent-to-treat populations were 80.7%(138/171) for cloxacillin and 82.8%(135/163) for pristinamycin. The observed difference between cure rates was-2.1%, with the lower limit of the two-sided 95%confidence interval higher than the non-inferiority threshold of-15%. The per-protocol analysis yielded similar results. Therapy was discontinued for 10 patients (cloxacillin:1, pristinamycin:9; P=0.01). Conclusion:Cloxacillin could be an alternative to pristinamycin in out-patients with superficial pyodermas.