Geroulanos S J
Department of Surgery, University Hospital, Zurich, Switzerland.
J Antimicrob Chemother. 1995 Jul;36 Suppl A:191-205. doi: 10.1093/jac/36.suppl_a.191.
In a multicentre, open, randomised study, the efficacy and tolerability of intravenous meropenem (1 g every 8 h, infusion or bolus) was compared with that of intravenous imipenem/cilastatin (1 g every 8 h, infusion) in 232 hospitalised patients with moderate to severe intra-abdominal infections. At the end of therapy, a satisfactory clinical response (cure or improvement) was seen in 79/82 (96%) evaluable meropenem patients and 83/88 (94%) imipenem/cilastatin patients; this was still seen at follow-up (57/63; 90% and 58/66; 88%, respectively). A satisfactory bacteriological response (elimination or presumed elimination) was seen in 69/82 (84%) meropenem patients and 71/88 (81%) imipenem/cilastatin patients at the end of therapy and in 52/62 (84%) and 55/70 (79%), respectively, at follow-up. There was a high level of clinical cure or improvement (95% for both treatment groups) in the 120 patients (60 in each group) who had polymicrobial infections. A similar incidence of adverse events was seen in each group: 45/116 patients in the meropenem group (72 events) and 42/116 patients in the imipenem/cilastatin group (65 events); the adverse event profiles were also similar, with injection site inflammation and elevated transaminases the most frequent in both groups. The results of this study indicate that monotherapy with meropenem was as effective and as well tolerated as the combination of imipenem/cilastatin in the treatment of moderate to severe intra-abdominal infections.
在一项多中心、开放、随机研究中，对232例中度至重度腹腔内感染的住院患者，比较了静脉注射美罗培南（每8小时1克，静脉滴注或推注）与静脉注射亚胺培南/西司他丁（每8小时1克，静脉滴注）的疗效和耐受性。治疗结束时，82例可评估的美罗培南患者中有79例（96%）、88例亚胺培南/西司他丁患者中有83例（94%）出现了满意的临床反应（治愈或改善）；随访时仍可见此结果（分别为57/63；90%和58/66；88%）。治疗结束时，82例美罗培南患者中有69例（84%）、88例亚胺培南/西司他丁患者中有71例（81%）出现了满意的细菌学反应（清除或假定清除），随访时分别为52/62（84%）和55/70（79%）。在120例（每组60例）患有多种微生物感染的患者中，临床治愈或改善水平较高（两个治疗组均为95%）。每组中不良事件的发生率相似：美罗培南组116例患者中有45例（72起事件），亚胺培南/西司他丁组116例患者中有42例（65起事件）；不良事件谱也相似，两组中最常见的是注射部位炎症和转氨酶升高。本研究结果表明，在治疗中度至重度腹腔内感染时，美罗培南单药治疗与亚胺培南/西司他丁联合治疗的疗效和耐受性相当。
