哌拉西林钠／舒巴坦钠(4:1)治疗急性细菌性感染多中心随机单盲对照临床研究

Multicenter single-blind randomized clinical trial of parenteral piperacillin-sulbactam(4:1) in the treatment of acute bacterial infections

目的 评价国产注射用哌拉西林钠／舒巴坦钠治疗中、重度急性细菌性感染 的疗效与安全性。方法用多中心单盲随机对照实验设计,哌拉西林钠／舒巴坦 钠(试验组)和哌拉西林钠／他唑巴坦(对照组)分别为107和108例。2组的用 量、用法、疗程相同,q8h静脉滴注,疗程5-10天,重症患者可延长至14天。 结果疗程结束时,试验组与对照组总痊愈率和有效率分别为77．67％与 93．20％和75．47％与93．40％,2组细菌清除率分别为95．0％和97．59％(P> 0．05);药物不良反应发生率分别为7．69％和8．33％。结论 国产注射用哌拉西 林钠／舒巴坦钠治疗中、重度急性细菌性感染疗效确切,安全性较好。

Objective To evaluate the clinical efficacy and safety of domestic injectable piperacillin - sulbactam for the treatment of acute moderate and severe bacterial infections. Methods A muhicenter, single- blind, randomized clinical trial was carried. Piperacillin -sulbactam （trial） was administered intravenously at a dose of 5 g thrice daily for 5 to 10 days. And piperacillin- tazobactam （control） was administered intravenously at a dose of 4. 5 g thrice daily for 5 to 10 days. A total of 215 patients （107trial, 108 control） with respiratory or urinary tract infections were enrolled in the study Results At the end of the treatment, the cure rate and effective rate were 77.67% and 93.20% in trail; while 75.47% and 93.40% in control. The bacterial eradication rates were 95.0% and 97.59% , respectively. There was no statistical difference between the two groups （ P 〉 0. 05 ）. Adverse reactions were observed in 7.69% and 8.33% of patients in the two groups. Conclusion Domestic injectable piperacillin -sulbactam is effective and safe for the treatment of acute moderate and severe bacterial infections.