红霉素环11,12-碳酸酯与罗红霉素双盲双模拟随机对照治疗细菌性感染的临床及细菌学评价

A randomized,double-blinded,double-modelling and controlled clinical and bacteriological evaluation of erythromycin cyclic 11,12-carbonate in the treatment of bacterial infection compared with roxithromycin

目的 评价红霉素环 11,12 碳酸酯治疗呼吸系统和皮肤细菌性感染的安全性与有效性。方法采用多中心、区组随机化、双盲双模拟对照试验设计 ,选用罗红霉素作对照药。试验药 :红霉素环 11,12 碳酸酯片剂 ,2 5 0～ 5 0 0mg/次 ,每日 2次。对照药 :罗红霉素片剂 ,15 0～ 3 0 0mg/次 ,每日 2次 ,疗程均为 5～ 10d。结果 实验组 2 8例 (呼吸系统感染 17例 ,皮肤软组织感染 11例 )与对照组 2 9例 (呼吸系统感染 17例 ,皮肤软组织感染 12例 )临床总有效率分别为 85 71%与 82 76% ,细菌清除率分别为 76%与 83 3 3 % ,细菌敏感百分率分别为 89 3 6%与 72 3 4% ,不良反应发生率分别为 12 1%与 12 5 % ,两组比较无统计学差异。结论 红霉素环 11,12 碳酸酯治疗细菌性感染安全有效。

Objective To evaluate the efficacy and safety of erythromycin cyclic 11,12-carbonate in the treatment of bacterial infection of respiratory system and skin. Methods A multi-centered, randomized, double-blinded, double-modelling and controlled clinical trial were adopted with roxithromycin as control. Erythromycin cyclic 11,12-carbonate tablets: 250～500mg twice daily; Roxithromycin tablets: 150～300mg twice daily. The duration was 5～10 days. Results The overall clinical effective rates of experimental group (28 cases) and controlled group (29 cases) were 85.71% and 82.76% respectively; the bacterial clearance rates were 76% and 83.33%; the bacterial sensitivity rates were 89.36% and 72.34%; adverse reaction rates were 12.1% and 12.5%. No statistical difference between the two groups showed. Conclusion Erythromycin cyclic 11,12-carbonate was effective and well tolerated in the treatment of acute bacterial infection.