Objective: To evaluate the clinical efficacy and safety of domestic faropenem in the treatment of acute bacterial infections. Methods: A multicenter, randomized, double blind and double simulation clinical study was conducted to compare the efficacy and safety of faropenem and cefaclor in the treatment of acute bacterial infection. Patients in trial group(n = 122) were given faropenem 250 mg，and in control group (n = 118) were given cefaclor 200 mg，3 times daily for 7 to 10 days. Results: The clinical cure rates were 33.61% and 27.12% in trail and control groups respectively and the clinical effective rates were 87.70% and 83.05% respectively. There was no significant difference in terms of clinical effectiveness between the two groups（P > 0.05）. The adverse reaction rates were 7.32% in trial group and 3.36% in control group（P > 0.05）. The adverse reaction of the trial group was mainly exaltation of aminotransferase, which did not affect the therapy. No severe adverse reaction was found. Conclusion: Domestic faropenem is effective and safe for the treatment of bacterial respiratory tract and urinary tract infections.%目的:评价国产法罗培南钠片治疗急性细菌感染的临床疗效和安全性.方法:采用多中心、随机对照、双盲双模拟试验,以头孢克洛片为对照药,选择急性细菌感染患者,试验组每次口服法罗培南钠200 mg,共122例;对照组每次口服头孢克洛250 mg,共118例;2组均为每天3次,疗程7～10 d.结果:试验组和对照组的痊愈率分别为33.61%和27.12%;有效率分别为87.70% 和83.05%;试验组和对照组的细菌清除率分别为96.15%和91.92%,2组差异无统计学意义(均P > 0.05);试验组和对照组的不良反应发生率分别为7.32%和3.36%,2组差异无统计学意义(P > 0.05),试验药物的不良反应主要为转氨酶轻度升高,但不影响治疗,未见严重不良反应.结论:国产法罗培南钠片治疗呼吸系统和泌尿系统感染的临床疗效确切、安全性较好.
展开▼
