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

Double-blind,double-dummy,randomized-controlled clinical trial on erythromycin A cyclic 11,12-carbonate versus roxithromycin

目的 评价红霉素环 11,12 碳酸酯治疗呼吸系统和皮肤软组织细菌性感染的安全性和有效性。方法 以罗红霉素为对照 ,进行多中心、区组随机、双盲双模拟对照试验。红霉素环 11,12 碳酸酯片 2 5 0～5 0 0mg/次 ,每日 2次 ,口服 ,疗程 5～ 10d。罗红霉素片 15 0～ 3 0 0mg/次 ,每日 2次 ,疗程 5～ 10d。结果 试验组、对照组各病种的临床有效率分别为 90 0 0 %与 77 2 7% ;不同细菌感染者的临床有效率分别为 89 47%与76 19% ;细菌清除率分别为 10 0 % (19/19)与 95 2 4% (2 0 /2 1) ,试验组与对照组各对应指标差异无统计学意义 (P >0 .0 5 ) ;不良反应结果显示 ,红霉素环 11,12 碳酸酯可引起轻微消化道症状 ,及实验室肝功能的异常 ,其不良反应发生率为 12 .0 0 % ,罗红霉素可引起轻微肝功能异常 ,无需处理可自行缓解 ,不良反应发生率为3 85 % ,两组指标差异无统计学显著性 (P >0 0 5 ) ,试验期间未出现严重不良反应。结论 红霉素环 11,12 碳酸酯作为一种新型大环内酯类抗菌药物 ,抗菌活性较强 ,使用方便 ,可安全有效地治疗由敏感菌引起的轻、中度感染 。

Objective To evaluate the efficacy and safety of domestic erythromycin A cyclic 11,12 carbonate. Method A double blind, double dummy randomized controlled clinical trial was conducted in the treatment of acute respiratory tract and skin soft tissue infections. The patients were given erythromycin A cyclic 11,12 carbonate tablet 250～500mg, twice a day for 5～10 days or roxithromycin tablet 150～300mg, twice a day for 5～10 days. Result A total of 42 patients were enrolled (20 in trial group, 22 in control group ). Clinical effective rate was 90 00% (18/20) in trial group and 77 27% (17/22) in control groups at the end of treatment ( P =0.269). Among the pathogens isolated at pre treatment, 19 of 19(100%) in the trial group were eradicated at the end of treatment, as were 21 of 22(95 24%) in the control group. There was no statistic significance between two groups ( P >0 05). Side effects were reported for 3 patients in the trial group and 1 patient in control group. Most patients developed mild abnormalities in gastro intestinal tract. Conclusion Results suggested that erythromycin A cyclic 11,12 carbonate was an effective and safe antibacterial agent in treatment of mild to moderate acute bacterial infections.