A randomized,controlled clinical trial on meropenem versus imipenem/cilastatin for the treatment of bacterial infections  

美罗培南与泰能随机对照治疗细菌性感染的临床评价(英文)

作　　者：侯芳[1] 李家泰[1] 吴国平[1] 郑波[1] 陈亦芳[1] 顾俊明[2] 王慧玲[2] 霍丽[2] 薛欣[2] 贾长绪[2] 尹永红[2] 田晓峰[2] 任双义[2] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]大连医科大学第二附属医院呼吸内科,大连116023

出　　处：《Chinese Medical Journal》2002年第12期1849-1854,共6页中华医学杂志（英文版）

摘　　要：Objective To evaluate the efficacy and safety of meropenem in Chinese patients, we conducted a study for the treatment of patients with lower respiratory tract infections, urinary tract infections and other infections Methods A total of 182 hospitalized patients were enrolled in the study 90 patients received 500 mg meropenem every 12 hours (or 1 g every 12 hours if necessary) and 92 patients received imipenem/cilastatin 500 mg/500 mg every 12 hours (or 1 g every 12 hours if necessary) by intravenous infusion The duration of treatment was 7-14 days for both groups Results Seventy of 90 cases receiving meropenem and 70 of 92 cases receiving imipenem/cilastatin were assessable for clinical efficacy The overall efficacy rates were 90% for the meropenem group and 87% for the imipenem/cilastatin group, and the bacterial eradication rates were 86% in both groups 93 (76%) of 123 strains isolated from patients produced β lactamases Adverse drug reactions were evaluated in 72 cases in the meropenem group and 70 cases in the imipenem/cilastatin group The adverse drug reaction rates were 9 7% and 8 6%, respectively The results showed that there were no statistical differences between these two groups ( P >0 05) Conclusion Meropenem is effective and safe for the treatment of bacterial infections caused mainly by beta lactamase producing strains目的　评价美罗培南的安全性和有效性。方法　共入选 182例 ,其中试验组 90例 ,疗效评价 70例 ,不良反应评价 72例 ;对照组 92例 ,疗效评价 70例 ,不良反应评价 70例。给药方法为美罗培南 5 0 0mg/次 ,Q12h (必要时 1g ,Q12h) ,静脉点滴 30分钟 ;泰能 (亚胺培南 /西司他丁 ,5 0 0mg/5 0 0mg) ,5 0 0mg/次 ,Q 12h(必要时 1g ,Q12h) ,静脉点滴 30分钟 ,疗程均为 7- 14天。结果　两药临床有效率分别为 90 %与 87% ,细菌清除率分别为 86% (5 5 /64)和 86% (5 7/66) ,76% (93/12 3)的临床分离致病菌进行株致病菌产β 内酰胺酶阳性。不良反应发生率分别为 9.7% (7/72 )与 8.6% (6/70 )。以上结果经统计学处理无显著差异 (P >0 .0 5 )。结论　美罗培南治疗细菌性感染 (包括酶菌感染 )安全有效。

关 键 词：meropenem·imipenem/cilastatin·infection 

分 类 号：R515[医药卫生—内科学]