2种头孢吡肟治疗急性细菌性感染的多中心随机对照试验

目的：比较2种头孢吡肟治疗急性细菌性感染的有效性和安全性。方法：采用多中心、单盲、平行随机对照研究方法,试验组给予国产注射用头孢吡肟,对照组给予进口注射用头孢吡肟。2药的剂量均为1.0～2.0 g,bid,疗程7～10 d。研究共纳入221例病人,试验组114例,男性55例,女性59例,年龄(43±s 14)a；对照组107例,男性54例,女性53例,年龄(43±14)a。结果：试验组总痊愈率和有效率分别为54.4%和89.5%；对照组分别为54.2%和86.9%,2组细菌清除率分别为96%与90%,2组比较差异均无显著意义(P＞0.05)。2组不良反应发生率分别为5.0%与5.1%,主要表现以消化道反应为多见,一般勿需特殊处理。结论：2种头孢吡肟治疗急性细菌性感染临床均疗效确切、安全性较好,且疗效相当。

A randomized multi-center clinical study of cefepime in treatment of acute bacterial infections

AIM:To evaluate the clinical efficacy and safety of 2 kinds of cefepime in the treatment of a- cute bacterial infections.METHODS:A randomized multi-center single-blind clinical study was conducted for comparing the domestic with imported cefepime for injection.Both of them were administered intravenously at a dose of 1.0-2.0 g twice daily for 7 to 10 d.Altogether,241 patients were enrolled in the study,among them 221 patients were eligible for clinical efficacy analysis including 114(M 55,F 59;age(43±s 14)a)in domes- tic group and 107(M 54,F 53;age(43±14)a)in imported group.RESULTS:The cure rates,effective rates, and bacterial clearance rates were 54.4%,89.5%,and 96% in domestic group;and 54.2%,86.9%,and 90% in imported group,respectively.There was no statistically significant difference between the two treatment groups. Adverse reactions were 5.0% and 5.1% respectively for patients in the same forementioned two groups,domi- nating with thirsty,nausea,abdominal discomfort,and elevated transaminases.CONCLUSION:Domestic ce- fepime is as effective and safe as imported one in the treatment of acute bacterial infections.