美洛培南与亚胺培南/西司他丁随机对照治疗细菌性感染的评价  

A randomized controlled trial on meropenem versus imipenem/cilastatin in the treatment of bacterial infection

作　　者：吕晓菊[1] 徐楠[1] 苗佳[1] 郑莉[1] 梁德荣[1] 邱敦功[1] 曹泽蓉[1] 俞汝佳[1] 宋春江[1] 周仲辉[1] 

机构地区：[1]华西医科大学附属第一医院,成都610041

出　　处：《中国抗生素杂志》2001年第2期118-122,共5页Chinese Journal of Antibiotics

摘　　要：以国产美洛培南为试验药 ,亚胺培南 /西司他丁 (1∶ 1)为对照药 ,通过随机对照治疗急性细菌性感染 ,评价前者的临床安全性和有效性。美洛培南每次 0 .5 g,q12 h或 q8h,静脉滴注 ,亚胺培南 /西司他丁每次1.0 g,q12 h或 q8h,静脉滴注 ,疗程 7～ 10 d。结果两组各完成合格病例 2 6例 ,其中呼吸系统感染 31例 ,泌尿系统感染 17例 ,皮肤软组织感染 3例。治疗结果显示 ,两组患者痊愈率分别为 73.0 8%与 6 5 .38% ,有效率为96 .15 %与 92 .31% ,细菌清除率为 10 0 %与 96 .15 % ,细菌产酶率为 6 0 .0 0 %与 5 7.6 9% ,不良反应发生率为11.5 4%与 7.6 9% ,两组各对应指标经统计学处理无显著性差异 (P>0 .0 5 )。美洛培南对本研究中分离的 5 1株常见致病菌抗菌活性强 ,对部分细菌所产 β-内酰胺酶稳定 ,其所致不良反应以胃肠道反应为主。结论 :美洛培南抗菌谱广 ,抗菌活性强 ,能安全有效地用于中、重度呼吸道、泌尿道及皮肤软组织等部位的感染。Objective: The safety and efficacy of meropenem versus imipenem/cilastatin were evaluated through a randomized controlled trial in the treatment of bacterial infection. Method: The regimen for meropenem was 0.5g intravenous q12 or q8, for imipenem/cilastatin (1∶1) was 1.0g intravenous q12 or q8 for 7~10 days. Results: Twenty six patients were enrolled in trial and control group respectively. The cured patients in two groups were 19 (73.08%) vs 17 (65.38%); effective responded patients were 25 (96.15%) vs 24 (92.31%); bacterial eradication rates were 100% vs 96.15%; bacterial β lactamase production rates were 60.00% vs 57.69%; adverse reaction rates were 11.54% vs 7.69% ( P >0.05). The adverse reactions were mild, mainly in gastrointestinal tract. Conclusion: Results suggested that meropenem is a potent antibacterial agent, can be recommended to treat moderate or severe bacterial infections.

关 键 词：美洛培南 亚胺培南/西司他丁 随机对照研究 细菌性感染 

分 类 号：R969.4[医药卫生—药理学]