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亚胺培南/西司他丁(每日1.5克)与美罗培南(每日3.0克)治疗腹腔内感染患者的前瞻性、随机、多中心试验结果

Imipenem/cilastatin (1.5 g daily) versus meropenem (3.0 g daily) in patients with intra-abdominal infections: results of a prospective, randomized, multicentre trial.

作者信息

Basoli A, Meli E Z, Mazzocchi P, Speranza V

机构信息

Department of Surgery, Università degli Studi La Sapienza, Policlinico Umberto I., Rome, Italy.

出版信息

Scand J Infect Dis. 1997;29(5):503-8. doi: 10.3109/00365549709011863.

Abstract

An open-label prospective, randomized, parallel multicentre study was undertaken to compare the efficacy and tolerability of 1.5 g/day intravenous imipenem/cilastatin with 3 g/day intravenous meropenem in the treatment of intra-abdominal infections. A total of 287 patients were enrolled: 201 patients, divided between the 2 treatment groups, were evaluable. Clinical outcome, bacteriological outcome, untoward microbiological effects, and clinical and laboratory adverse experiences were evaluated. 98% of patients receiving imipenem/cilastatin therapy were cured, with 96% showing eradication of infection. 95% of those on meropenem were cured, with 98% showing eradication. These differences in clinical and bacteriological outcome between the 2 treatments were not statistically significant. Two patients receiving imipenem/cilastatin and 5 receiving meropenem had untoward microbiological effects. There was a 0.7% frequency (1/139 patients) of possibly or probably drug-related clinical or laboratory adverse experiences with imipenem/cilastatin and a 2.7% frequency (4/148) with meropenem. The mean time to defervescence was significantly less for patients in the imipenem/cilastatin treatment group than for those receiving meropenem. This study shows that 1.5 g/day of imipenem/cilastatin is equivalent to 3.0 g/day meropenem in clinical and bacteriological outcome, as well as in incidence of side effects.

摘要

开展了一项开放标签的前瞻性、随机、平行多中心研究,以比较每日1.5克静脉注射亚胺培南/西司他丁与每日3克静脉注射美罗培南治疗腹腔内感染的疗效和耐受性。共纳入287例患者:201例患者分为2个治疗组,可进行评估。评估了临床结局、细菌学结局、不良微生物学效应以及临床和实验室不良事件。接受亚胺培南/西司他丁治疗的患者中有98%治愈,96%显示感染根除。接受美罗培南治疗的患者中有95%治愈,98%显示根除。两种治疗在临床和细菌学结局上的这些差异无统计学意义。2例接受亚胺培南/西司他丁治疗的患者和5例接受美罗培南治疗的患者出现不良微生物学效应。亚胺培南/西司他丁可能或很可能与药物相关的临床或实验室不良事件发生率为0.7%(1/139例患者),美罗培南为2.7%(4/148例)。亚胺培南/西司他丁治疗组患者的平均退热时间显著短于接受美罗培南治疗的患者。本研究表明,每日剂量1.5克的亚胺培南/西司他丁在临床和细菌学结局以及副作用发生率方面与每日剂量3.0克的美罗培南相当。

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