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目的 :评价美罗培南 (MEM)治疗重症细菌性感染的疗效和安全性。方法 :以亚胺培南 /西司他丁 (IPM/C)为对照药在肺部感染、腹腔和血行感染的住院患者中进行一项随机对照开放多中心临床研究 ,同时单以MEM治疗医院获得的化脓性脑膜炎病例。结果 :共有 114例可评价病例进入本项研究 ,包括肺部感染 5 4例 ,化脓性腹膜炎 16例、胆道感染 2 1例、败血症2 0例和化脓性脑膜炎 3例。其中接受MEM者 5 8例 (包括非对照研究的 3例化脓性脑膜炎患者 ) ,接受IPM/C者 5 6例。MEM与IPM /C随机对照研究结果 ,总有效率各为 87.3 % ( 4 8/ 5 5 )和 87.5 % ( 4 9/ 5 6) ,治愈率 70 .9% ( 3 9/ 5 5 )和 62 .5 % ( 3 5 /5 6)。细菌清除率MEM组 83 .9% ( 4 7/ 5 6) ,IPM /C组 87.9% ( 5 1/ 5 8)。两组患者的不良反应均少见而轻微 ,呈一过性 ,发生率各为 3 .1% (MEM组 )和 3 .3 % (IPM/C组 ) ;考虑为与药物有关的实验室异常者分别为 6.2 % (MEM组 )和 6.6% (IPM/C组 )。上述结果经统计学分析 ,其差别均无显著性。 3例化脓性脑膜炎患者经MEM治疗后痊愈 1例、显效 2例 ,未发生与药物有关的临床和实验室不良事件。结论 :美罗培南是治疗肺部、腹腔、血行感染重症患者的安全而有效的药物。本药治疗医院获得的化脓性脑膜炎的疗效值得进?
Objective: To evaluate the efficacy and safety of meropenem in the treatment of severe bacterial infections. Methods: A randomized open-label, multicenter, multicenter clinical trial was conducted in imipenem / cilastatin (IPM / C) as a reference drug in hospitalized patients with pulmonary infections, peritoneal and hematogenous infections, Obtained cases of purulent meningitis. RESULTS: A total of 114 evaluable cases were included in this study, including 54 cases of pulmonary infection, 16 cases of purulent peritonitis, 21 cases of biliary tract infection, 20 cases of sepsis and 3 cases of purulent meningitis. Fifty-eight patients (including 3 patients with purulent meningitis in a non-controlled study) who received MEM were enrolled in this study. Fifty-six patients underwent IPM / C. The results of randomized controlled study between MEM and IPM / C showed that the total effective rate was 87.3% (48/55) and 87.5% (49/56) respectively, and the cure rates were 70.9% (39/55) and 62 .5% (3 5/5 6). The bacterial clearance rate was 83.9% (47/56) in the MEM group and 87.9% (51/58) in the IPM / C group. Adverse reactions were rare and mild in both groups, with a transient incidence of 3.1% (MEM group) and 3.3% (IPM / C group), respectively; and those considered to be drug-related laboratory abnormalities 6.2% (MEM group) and 6.6% (IPM / C group), respectively. The above results by statistical analysis, the difference was not significant. Three cases of purulent meningitis recovered after treatment with MEM in 1 case, markedly effective in 2 cases, and no drug-related clinical and laboratory adverse events occurred. Conclusion: Meropenem is a safe and effective drug for the treatment of severe patients infected with lung, abdominal cavity and blood. The drug treatment of the hospital acquired purulent meningitis efficacy worth entering?