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多中心随机试验比较美罗培南(每日1.5克)与亚胺培南/西司他丁(每日2克)用于医院治疗社区获得性肺炎的疗效。

Multicenter randomized trial comparing meropenem (1.5 g daily) and imipenem/cilastatin (2 g daily) in the hospital treatment of community-acquired pneumonia.

作者信息

Bartoloni A, Strohmeyer M, Corti G, Buonomini M I, Franchino L, Romanelli G, Moretti A M, De Vizzi G B, Petraglia A, Mancini P, Atzeni R, Fogliani V, Giura R, Paradisi F

机构信息

Infectious Diseases Clinic, University of Florence, Italy.

出版信息

Drugs Exp Clin Res. 1999;25(6):243-52.

Abstract

An open, multicenter study with 144 patients, aged between 18 and 94 years, was performed to compare the efficacy and safety of meropenem with imipenem/cilastatin in the hospital treatment of community-acquired pneumonia. Patients were randomized to receive either intravenous meropenem (500 mg every 8 h) or intravenous imipenem/cilastatin (1,000 mg every 12 h). The primary end point was considered to be clinical efficacy and the secondary end points were bacteriological response and safety assessment. At the end of therapy, cure or improvement in signs and symptoms as a satisfactory clinical response was observed in 57 of 64 (89.1%) meropenem-treated patients and in 60 of 66 (90.9%) imipenem/cilastatin patients. The mean duration of treatment was 10 days for meropenem and 9.7 days for imipenem/cilastatin. In patients who were followed up for weeks 2-4, the response was satisfactory (100%) for both treatments. A satisfactory bacteriological response, defined as either presumed or confirmed eradication of all pathogens, was found in eight patients who had received meropenem and in 14 patients who had received imipenem/cilastatin. Response was considered satisfactory in 100% of the meropenem group and in 92.9% of the imipenem/cilastatin group and at follow-up, it was 100% for both treatments. Drug-related adverse events were reported in three (4.2%) meropenem-treated patients and in eight (11.0%) imipenem/cilastatin-treated patients. None of these events was classified as serious. The results of this study show that the clinical and bacteriological efficacy and tolerability of meropenem (500 mg every 8 h) are similar to that of imipenem/cilastatin (1,000 mg every 12 h) in the hospital treatment of community-acquired pneumonia.

摘要

一项针对144例年龄在18至94岁之间患者的开放性多中心研究开展,以比较美罗培南与亚胺培南/西司他丁在医院治疗社区获得性肺炎中的疗效和安全性。患者被随机分配接受静脉注射美罗培南(每8小时500毫克)或静脉注射亚胺培南/西司他丁(每12小时1000毫克)。主要终点被视为临床疗效,次要终点为细菌学反应和安全性评估。治疗结束时,在64例接受美罗培南治疗的患者中有57例(89.1%)观察到症状和体征治愈或改善,这被视为满意的临床反应;在66例接受亚胺培南/西司他丁治疗的患者中有60例(90.9%)观察到同样情况。美罗培南的平均治疗时长为10天,亚胺培南/西司他丁为9.7天。在第2至4周接受随访的患者中,两种治疗的反应均令人满意(100%)。在接受美罗培南治疗的8例患者和接受亚胺培南/西司他丁治疗的14例患者中发现了令人满意的细菌学反应,即所有病原体被假定或确认根除。美罗培南组100%的患者和亚胺培南/西司他丁组92.9%的患者反应被视为满意,在随访时,两种治疗的反应均为100%。在接受美罗培南治疗的3例(4.2%)患者和接受亚胺培南/西司他丁治疗的8例(11.0%)患者中报告了与药物相关的不良事件。这些事件均未被归类为严重事件。本研究结果表明,在医院治疗社区获得性肺炎中,美罗培南(每8小时500毫克)的临床和细菌学疗效及耐受性与亚胺培南/西司他丁(每12小时1000毫克)相似。

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