阿齐霉素治疗呼吸、泌尿生殖系统细菌感染的临床随机对照研究

Clinical randomized controlled trials of azithromycin injection in the treatment of bacterial infection

目的 :评价国产阿齐霉素 (Azithromycin)粉针剂对呼吸、泌尿生殖系统感染的临床疗效及安全性。 方法 :患者 1 6 0例 ,分为试验组 (阿齐霉素 ) 6 0例、对照组 (克拉霉素 ) 6 0例、非对照试验组 (阿齐霉素 ) 4 0例。给药方法为阿齐霉素 0 .5 g,每天 1次 ,静滴 ;克拉霉素 0 .5 g,每天 2次 ,静滴 ;疗程均为 5～ 7天。 结果 :1 0 0例应用阿齐霉素治疗的急性细菌性感染患者 ,总有效率为 92 .0 %。呼吸系统感染随机对照研究显示 ,试验组的痊愈率为 6 3.3%、有效率为 86 .7% ,略高于对照组的痊愈率 (5 5 .0 % )、有效率 (85 .0 % ) ,但在统计学上并无显著差异 (P>0 .0 5 ) ;非对照试验组 (泌尿生殖系统感染、化脓性扁桃体炎、皮肤软组织感染等 )的痊愈率为 97.5 % ,有效率为 1 0 0 .0 %。试验组患者感染菌清除率为 96 .7% ,略高于对照组清除率 93.3% ,统计学分析无显著差异。应用阿齐霉素的患者总不良反应发生率为1 3.0 % ,其中试验组为 1 5 .0 % ,明显低于对照组 (45 .0 % ,P<0 .0 1 )。 结论 :阿齐霉素粉针剂对呼吸系统、泌尿生殖系统、化脓性扁桃体炎、皮肤软组织感染不仅有很好的疗效 ,而且安全。

Objectives:To evaluate the efficacy and safety of azithromycin injection compared with clarithromycin in the treatment of acute bacterial infections. Methods: A total of 160 patients were included in this study, 60 cases of respiratory infections treated with azithromycin were compared with 60 cases treated with clarithromycin, 40 cases of other tissue infections were treated with azithromycin. Drugs were administered intravenously once daily (for azithromycin) or twice daily (for clarithromycin) for 5～7 days, at a daily dose of 0.5 g of azithromycin or 1.0 g of clarithromycin. Results: The overall clinical efficacious rates of azithromycin was 92.0%. There was no significant difference（P>0.05） between azithromycin and clarithromycin in the clinical efficacy and bacterial clearance rates. The incidence of adverse drug reactions for azithromycin （15%）was lower than that for clarithromycin（45.0%，P<0.05）． Conclusions: Azithromycin injection is an effective and safe antibiotics for the treatment of bacterial infection．