地红霉素治疗急性细菌性呼吸道感染142例多中心随机对照临床研究

目的评价地红霉素片治疗急性细菌性呼吸道感染的疗效和安全性。方法采用多中心、随机、双盲、双模拟和平行对照临床研究方法，将确诊为急性呼吸道感染的患随机分为2组。试验组口服地红霉素片，500mg每日1次，疗程7d；对照组口服阿奇霉素片，500mg，每日1次，疗程5d。结果地红霉素组69例，有效率为88．4％(61／69)，痊愈率为33．3％(23／69)；阿奇霉素组73例，有效率为86．3％(63／73)，痊愈率为39．7％(29／73)；2组细菌清除率分别为85．1％(40／47)和90．7％(49／54)；不良反应发生率分别为14．5％(10／69)和5．5％(4／73)，以上指标2组之间统计学处理差异无显性。结论地红霉素片可以安全有效地用于治疗急性细菌性呼吸道感染。

A multi-centre randomized double-blind controlled clinical trial of dirithromycin in 142 patients with acute bacterial respiratory tract infection

Objective This study was designed to evaluate the efficacy and safety of dirithromycin in patients with acute bacterial respiratory tract infection (RTI). Methods Patients with RTI were randomized into two groups according to the design of a multi-centre controlled, double-blind, double-dummy clinical trial. Patients in the treatment group were administered with dirithromycin 500 mg, qd for 7 days compared with patients in control group receiving azithromycin 500 mg, qd for 5 days. Results Sixty-nine cases were treated with dirithromycin. The response rate was 88.4% (61/69) and cure rate was 33.3% (23/69). Seventy-three cases were treated with azithromycin. The response rate was 86.3% (63/73) and cure rate was 39.7% (29/73). The bacteriological eradication rate of the two groups was 85.1% (40/47) and 90.7% (49/54) respectively. The incidence of adverse event was 14.5% (10/69) and 5.5% (4/73) respectively. No statistically significant difference was found between the two groups in terms of the comparisons above (P>0.05). Conclusions Dirithromycin is effective and safe for patients with acute bacterial RTI.