注射用盐酸头孢甲肟治疗急性细菌性感染的有效性和安全性

目的：评价国产注射用盐酸头孢甲肟治疗急性细菌性感染的有效性和安全性。方法：在呼吸系统和泌尿系统感染患者中，以日本产注射用盐酸头孢甲肟（商品名：倍司特克）作对照药进行多中心随机对照研究。试验药和对照药的用法均为每次1．0g，静脉滴注，每日2次，疗程7—10d。试验组和对照组可供意向性治疗（intention-to-treat，ITT）分析的病例分别为71例、68例，可供符合方案数据（perprotocol population，PP）分析的病例分别为68例、64例。结果：ITT人群中，试验组和对照组的有效率分别为88.7％和86．8％，不良反应发生率分别为5.6％和7．4％；PP人群中，试验组和对照组的有效率分别为92．7％和92．2％，细菌清除率分别为96．7％和94．6％。两组数据比较均无统计学差异（P〉0，05）。ITT分析与PP分析结果一致。结论：国产注射用盐酸头孢甲肟与日本产注射用头孢甲肟同是治疗临床常见细菌性感染的安全、有效的药物。

Randomized controlled multicenter clinical trial of cefmenoxime hydrochloride for injection in treatment of acute bacterial infections

AIM: To evaluate the clinical efficacy and safety of domestic cefmenoxime hydrochloride for injection in the treatment of acute bacterial infections. METHODS: A randomized, comparative, single-blind, multicenter clinical trial of domestic cefmenoxime hydrochloride injection (test) and cefmenoxime hydrochloride injection (Bestcall) made in Japan (control) in the treatment of respiratory and urinary tract infections were conducted. The test drug and control drug were administrated intravenously at a dose of 1.0 g bid for 7 to 10 days, respectively. Among ITT (intention-to-treat) population, 71 patients were enrolled in test group and 68 patients in control group. Among PP (per-protocol) population, 68 patients were evaluated in test group and 64 patients in control group. RESULTS: All the results were analyzed on the basis of ITT and PP population. The clinical efficacy rates for test and control group were separately 88.7 %(ITT), 92.7 %(PP) and 86.8 %(ITT), 92.2 %(PP). The bacterial eradication rates were 96.7 % and 94.6 %, respectively. The incidences of adverse reaction were 5.6 % and 7.4 %, respectively. There were no significant differences between the two groups (P> 0.05 ). ITT and PP analysis revealed similar result. CONCLUSION: The domestic cefmenoxime hydrochloride injection has an excellent clinical efficacy and good safety profile in treating patients with acute bacterial infection as the control drug.