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目的评价国产哌拉西林/三唑巴坦(4∶1)治疗急性细菌性呼吸道感染和尿路感染的有效性和安全性。方法采用随机、双盲、平行对照临床试验设计,试验组哌拉西林/三唑巴坦(4∶1)每次2.5g(2.0g/0.5g),对照组哌拉西林/三唑巴坦(8∶1),每次2.25g(2.0g/0.25g),用法均为每日2次静脉滴注,疗程均为5～14d。结果本试验共入选266例,纳入临床疗效FAS分析251例,试验组和对照组分别为124例和127例;纳入PPS分析248例,试验组和对照组分别为122例和126例,疗程结束时试验组和对照组的总痊愈率分别为61.48%和59.52%,有效率分别为87.70%和88.89%,两组总的细菌清除率分别为93.94%和92.10%;总的不良事件发生率分别为11.94%和12.88%,总的药物相关不良反应发生率分别为5.97%和9.09%。以上结果两组间比较无显著性差异(P>0.05)。结论国产哌拉西林/三唑巴坦(4∶1)治疗呼吸和泌尿系统急性细菌性感染的临床疗效确切,安全性较好。
Objective To evaluate the efficacy and safety of domestic piperacillin / tazobactam (4:1) in the treatment of acute bacterial respiratory tract infection and urinary tract infection. Methods A randomized, double-blind and parallel-controlled clinical trial was designed. The test group received piperacillin / tazobactam (4: 1) 2.5g (2.0g / 0.5g) (8: 1), each 2.25g (2.0g / 0.25g), usage are daily intravenous infusion, treatment are 5 ~ 14d. Results A total of 266 patients were enrolled in this study, and 251 patients were enrolled in the FAS analysis. There were 124 cases in the test group and 127 cases in the control group. 248 cases were included in the PPS analysis, 122 cases in the test group and 126 cases in the control group. The total cure rates of the experimental and control groups were 61.48% and 59.52%, the effective rates were 87.70% and 88.89% respectively. The total bacterial clearance rates of the two groups were 93.94% and 92.10% respectively. The total adverse event rates were For 11.94% and 12.88%, the total incidence of drug-related adverse reactions were 5.97% and 9.09%. The above results between the two groups showed no significant difference (P> 0.05). Conclusion Domestic piperacillin / tazobactam (4:1) is effective and safe in the treatment of respiratory and urinary bacterial acute bacterial infections.