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哌拉西林/他唑巴坦与亚胺培南/西司他丁治疗腹腔内感染患者的随机对照比较

Randomized comparison of piperacillin/tazobactam versus imipenem/cilastatin in the treatment of patients with intra-abdominal infection.

作者信息

Erasmo Alex A, Crisostomo Armando C, Yan Lu-Nan, Hong Yun-Sik, Lee Kuhn-Uk, Lo Chung-Mau

机构信息

University of Santo Tomas Hospital, Manila, Philippines.

出版信息

Asian J Surg. 2004 Jul;27(3):227-35. doi: 10.1016/S1015-9584(09)60039-7.

Abstract

OBJECTIVES

Treatment of intra-abdominal infections remains a challenge because of their polymicrobial nature and associated mortality risk. Broad-spectrum empiric coverage is usually required. This randomized study compared the efficacy and safety of intravenous piperacillin/tazobactam with those of intravenous imipenem/cilastatin in the treatment of 293 hospitalized patients with intra-abdominal infection.

METHODS

A total of 149 patients received piperacillin/tazobactam 4 g/500 mg every 8 hours, and 144 patients received imipenem/cilastatin 500 mg/500 mg every 6 hours. Efficacy was evaluated by clinical and bacteriological response. Safety was evaluated by analysis of adverse events and physical and laboratory examinations.

RESULTS

Clinical and bacteriological responses in both evaluable treatment groups were equivalent. The clinical success was 97% (108/111) for piperacillin/tazobactam and 97% (100/103) for imipenem/cilastatin. Bacteriological success was 97% (67/69) for piperacillin/tazobactam and 95% (61/64) for imipenem/cilastatin. The most common pathogens were Escherichia coli, Klebsiella pneumoniae, Enterobacter species and Pseudomonas aeruginosa. The frequencies of treatment-related adverse events were similar (16 with piperacillin/tazobactam and 19 with imipenem/cilastatin).

CONCLUSIONS

These results suggest that the safety and efficacy of piperacillin/tazobactam administered every 8 hours are equivalent to those of imipenem/cilastatin administered every 6 hours for the treatment of intra-abdominal infections.

摘要

目的

由于腹腔内感染具有多种微生物的特性以及相关的死亡风险,其治疗仍然是一项挑战。通常需要进行广谱经验性覆盖治疗。这项随机研究比较了静脉注射哌拉西林/他唑巴坦与静脉注射亚胺培南/西司他丁在治疗293例住院腹腔内感染患者中的疗效和安全性。

方法

总共149例患者每8小时接受4 g/500 mg的哌拉西林/他唑巴坦静脉注射,144例患者每6小时接受500 mg/500 mg的亚胺培南/西司他丁静脉注射。通过临床和细菌学反应评估疗效。通过分析不良事件以及体格和实验室检查评估安全性。

结果

两个可评估治疗组的临床和细菌学反应相当。哌拉西林/他唑巴坦组的临床成功率为97%(108/111),亚胺培南/西司他丁组为97%(100/103)。哌拉西林/他唑巴坦组的细菌学成功率为97%(67/69),亚胺培南/西司他丁组为95%(61/64)。最常见的病原体为大肠埃希菌、肺炎克雷伯菌、肠杆菌属和铜绿假单胞菌。治疗相关不良事件的发生率相似(哌拉西林/他唑巴坦组16例,亚胺培南/西司他丁组19例)。

结论

这些结果表明,每8小时给药一次的哌拉西林/他唑巴坦在治疗腹腔内感染方面的安全性和疗效与每6小时给药一次的亚胺培南/西司他丁相当。

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