盐酸头孢吡肟注射液治疗急性细菌性感染的临床疗效

目的：评价国产盐酸头孢吡肟注射液治疗急性细菌性感染的有效性和安全性。方法：采用随机单盲，平行对照的多中心研究。共入选急性细菌性感染患者74例，分为两组。试验组（n=38）予国产盐酸头孢吡肟1.0～2．0g，bid；对照组（n=36）予进口盐酸头孢吡肟1．0～2．0g，bid，疗程均为7～10d。结果：试验组和对照组总痊愈率分别为50．0％和55．6％，有效率分别为89．5％和88．9％。两组细菌清除率分别为B7．0％和92．3％（P〉0．05）。两组不良反应发生率分别为10．5％与13．9％，主要表现为恶心、呕吐、转氨酶升高、皮疹，偶见白细胞、血红蛋白下降。结论：国产盐酸头孢吡肟注射液治疗急性细菌性感染临床疗效确切，安全性较好。

Efficacy of cefepime hydrochloride for injection in treatment of acute bacterial infections

Objective: To evaluate the efficacy and safety of domestic cefepime hydrochloride for injection in the treatment of acute bacterial infections. Methods: A randomized, single blind, parallel control and multi-centers clinical study enrolled 74 patients with acute bacterial infections, who were randomized intravenously to inject domestic cefepime hydrochloride (1.0 -2.0 g, n =38) twice a day or imported cefepime (1.0-2.0g, n=36) twice a day for 7 - 10 days. Results: The patients in domestic and imported cefepime group showed a total cure rate of 50. 0% versus 55. 6% , the effect rate of 89. 5% versus 88.9% , the bacterial eradication rate of 87.0% versus 92.3% ; the P values showed no statisti- cally difference between the two treatment groups (P >0.05). The incidence rate of adverse events was 10.5% versus 13.9%, dominating vomiting, nausea, abdominal discomfort, elevated transaminases, rash, leucopenia and erythropenia. Conclusion: The domestic cefepime hydrochloride for injection is therapeutically equivalent to the imported cefepime for patients with acute bacterial infections.