阿奇霉素与乳糖酸红霉素随机对照及开放治疗急性下呼吸道感染70例临床验证

A randomized controlled clinical study on azithromycin versus erythromycin and open trial on azityromycin in the treatment of acute lower respiratory tract infection

目的 临床验证观察注射用阿奇霉素治疗急性下呼吸道感染的安全性和有效性。方法 国产注射用阿奇霉素与乳糖酸红霉素随机对照开放治疗急性轻、中度下呼吸道感染 70例 ,其中随机对照组 40例 ,试验组 2 0例应用阿奇霉素粉针剂 ,第 1天 ,每次 2 5 0mg ,每日 2次 ,以后每次 2 5 0mg ,每日 1次 ,疗程 5～ 7d ;对照组 2 0例应用乳糖酸红霉素粉针剂 ,每次 60 0mg ,每日 2次 ,疗程 7d。另用阿奇霉素进行开放试验治疗 3 0例急性下呼吸道感染患者 ,阿奇霉素用法同前。结果 试验组与对照组临床有效率分别为 85 %和 80 % ,细菌清除率分别为 10 0 %和 93 .7% ,不良反应发生率分别为 10 %和 2 5 % ,以上结果经统计学处理差异无显著性。开放试验组临床有效率为 86.7% ,细菌清除率为 95 .7% ,不良反应发生率为 6.7%。结论 阿奇霉素每次 2 5 0mg ,每日 1次静脉滴注 ,首次剂量加倍 ,对于敏感致病菌所引起的急性轻。

Objective To evaluate the efficacy and safety of azithromycin in the treatment of acute lower respiratory tract infection.Methods A randomized controlled clinical study on azithromycin versus erythromycin was conducted in the treatment of 40 cases of lower respiratory tract infection,20 patients received azithromycin intravenously at the doses of 250 mg twice daily for the first day and 250 mg per day for the following days,with a treatment course of 5～7 days.20 patients received erythromycin intravenously at the doses of 600 mg twice daily for 7 days.30 patients were enrolled in the open trial study on azithromycin and were given azithromycin at the same dose and treatment course.Results In the randomized controlled study the clinical effective rate was 85% in azithomycin group and 80% in erythromycin group.Bacterial clearance rates of the two groups were 100% and 93.7% respectively. Drug adverse reaction rates were 10% and 25% respectively. In open trial group the clinical effective rate was 86.7%,bacterial clearance rate was 95.7% and drug adverse reaction rate was 6.7%.Conclusion Intravenous azithromycin at the dose of 250 mg daily (first day 250mg twice daily)is effective and safe in the treatment of lower respiratory tract infection.