国产头孢吡肟治疗急性细菌性下呼吸道感染的随机对照临床试验

Domestic Cefepime Injection for Acute Bacterial Lower Respiratory Tract Infection: A Randomized Single-blind Controlled Clinical Trial

目的评价国产头孢吡肟注射剂治疗急性细菌性下呼吸道感染的有效性与安全性。方法采用随机、单盲(患者)、阳性药物平行对照试验设计,试验组用国产头孢吡肟,对照组用进口头孢吡肟,用法均为中度感染2g/d,重度感染4g/d,分两次静滴,疗程7～10天。结果共入选31例,可评价疗效病例30例,每组各15例,试验组和对照组痊愈率分别为40.00%和26.67%,有效率分别为80.00%和86.67%;两组细菌清除率分别为92.31%和100%,药物不良反应发生率分别为12.5%和13.33%,两组比较均无显著差异(P>0.05)。结论国产头孢吡肟注射剂治疗急性细菌性下呼吸道感染疗效确切,不良反应较少。

Objective To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A randomized, single-blind, controlled clinical trial was performed. The positive control was imported cefepime. The dosages of cefepime were lg for moderate infection and 2g for severe infection, twice a day intravenously. The duration of the treatment was 7-10 days. Results Thirty-one patients were enrolled in the trial, of whom 30 were evaluable （15 in the trial group and 15 in the control group）. No significant differences were observed between the trial group and the control group with respect to the cure rate （40% vs. 27%）, the effective rate （80% vs. 87%）, the bacterial clearance rate （92% vs. 100%）, and the incidence of adverse drug reactions （12.5% vs. 13%） （P〉0.05）. Conclusion Domestic cefepime injection is effective and safe in the treatment of acute bacterial lower respiratory tract infection.