普卢利沙星治疗急性细菌性感染的多中心双盲双模拟随机对照临床研究

A multicenter double blind double dummy randomized controlled clinical study of prulifloxacin versus levofloxacin in the treatment of acute bacterial infections

目的评价国产普卢利沙星治疗轻、中度急性细菌感染的临床疗效与安全性。方法采用多中心、双盲双模拟、平行随机对照试验设计，以左氧氟沙星为对照药，普卢利沙星组200rag，左氧氟沙星组200rag，每日两次，疗程均为7～10d。结果本研究共纳入278例，普卢利沙星组和左氧氟沙星组各有139例，其中普卢利沙星组FAS分析130例，PP分析123例；左氧氟沙星组进行FAS分析126例，PP分析119例。疗程结束时．FAS分析普卢利沙星组和左氧氟沙星组的痊愈率分别为53．85％和65．04％，PPS分析两组的痊愈率分别为55．56％和67．23％；FAS分析两组的有效率分别为86．92％和91．06％，PPS分析两组的有效率分别为89．68％和94．12％，两组细菌清除率分别为90．43％和87．10％。以上结果两组组间比较均无显著性差异。两组的不良反应发生率分别为5．15％和6．57％，主要表现为恶心、腹泻及血清转氨酶升高等。两组均未见严重不良事件发生。结论国产普卢利沙星注射液治疗轻、中度细菌感染疗效确切，安全性好。

Objective To evaluate the clinical efficacy and safety of prulifloxacin for the treatment of slight and moderate acute bacterial infections. Methods A muhicenter double blind double dummy randomized controlled clinical study was conducted to compare the efficacy and safety of prulifloxacin and levofloxacin. Both groups were administered at the dose of 200mg twice daily for 7 to 10 days. Results Two hundred and seventy eight patients were enrolled in the study, 139 in each groups. Due to some unexpected events, finally, there were only 130 cases in prulifloxacin group and 126 cases in levofloxacin group were assessable for clinical efficacy by full analysis set （FAS）, 123 cases in prulifloxacin group and 119 cases in levofloxacin group were assessable for clinical efficacy by per-protocol set （PPS） analysis. At the end of the treatment, in FAS analysis the total cure rats and effective rates were 53.85% and 86.92% in prulifloxacin group, 65.04% and 91.06% inlevofloxacin group; in PPS analysis the total cure rates and effective rates were 55.56% and 89. 68% in prulifloxacin group, 67. 23% and 94.12% in levofloxacin group. The bacterial resistance rates were 90.43% and 87.10% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 5. 15% and 6. 57% of patients in the two groups, mainly nausea, diarrhea and elevated transaminases. No serious adverse event was reported in any group. Conclusions Prulifloxacin is as effective and safe as levofloxacin in the treatment of slight and moderate acute bacterial infections.