国产哌拉西林钠/三唑巴坦钠治疗急性细菌感染性疾病的多中心临床研究

Multicentre clinical trial on efficacy and safety of domestic piperacillin/tazobactam for treatment of acute bacterial infections

目的 比较国产哌拉西林钠 /三唑巴坦钠与对照药特美汀治疗急性细菌感染性疾病的临床疗效和安全性。方法 采用多中心随机对照和开放试验方法。结果 试验组的痊愈率和有效率分别为 73.0 % (4 6 / 6 3)和 96 .8% (6 1/ 6 3) ,细菌清除率为 91.7% (5 5 / 6 0 ) ,对照组的痊愈率和有效率分别为 5 8.7% (37/ 6 3)和 90 .5 % (5 7/ 6 3) ,细菌清除率为 87.9% (5 1/ 5 8) ,2组差异无显著意义。开放组的痊愈率和有效率分别为 72 .7% (32 / 44 )和 97.7% (4 3/ 44 ) ,细菌清除率为 88.4% (38/ 43)。试验中未发现应用哌拉西林钠 /三唑巴坦钠的严重不良反应。结论 国产哌拉西林钠 /三唑巴坦钠对急性细菌性感染的临床疗效较好 。

Objective To compare the efficacy and safety of domestic piperacillin/tazobactam with those of Timentin in treatment of acute bacterial infections. Method A randomized controlled multicentre trial and an opening clinical trial were condusted in 4 hospitals in Beijing. Result The cure and efficacy rates in the test group were 73.0%(46/63) and 96 8%(61/63), respectively and the bacterial clearance rate was 91.7%(55/60). The cure and efficacy rates in the control group were 58.7%(37/63) and 97.7%(43/44) respectively, and the bacterial clearance rate was 87.9%(51/58). The differerence between the two groups was not statistically significant. The cure rate, efficacy rate and bacterial clearance rate in the opening group were 72.7%(32/44), 97.7%(43/44) and 88.4%(38/43) respectively. No serious adverse drug reaction was found during the treatment with piperacillin/tazobactam. Conclusion Domestic piperacillin/tazobactam is effective and safe for the treatment of acute bacterial infections.