目的评价国产头孢吡肟治疗急性细菌性下呼吸道感染的有效性与安全性。方法采用多中心随机单盲对照试验,对照组为进口头孢吡肟,用法均为中度感染1g/次,重度感染2g/次,每日两次静滴,疗程7～10d。结果共入选123例,可评价疗效病例113例,试验组55例,对照组58例,试验组和对照组痊愈率分别为45.45%和31.03%,有效率分别为92.73%和81.03%;两组细菌清除率分别为95.35%和97.50%,药物不良反应发生率分别为8.06%和8.20%,两组比较差异均无统计学意义(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安全、有效。 Objective To evaluate the efficacy and safety of domestic cefepime in the treatment of acute bacterial lower respiratory tract infection. Methods A multicentre randomized single-blind controlled trial was used. The control group was imported cefepime. The patients were moderately infected with 1g / time and severe infections were 2g / time intravenously twice daily for 7-10 days. Results A total of 123 patients were enrolled in this study. 113 cases were evaluated for curative effect, 55 cases in trial group and 58 cases in control group. The cure rates of trial group and control group were 45.45% and 31.03%, respectively, and the effective rates were 92.73% and 81.03% The rates of bacterial clearance were 95.35% and 97.50%, respectively. The incidences of adverse drug reactions were 8.06% and 8.20% respectively. There was no significant difference between the two groups (P> 0.05). Conclusion Domestic cefepime injection is safe and effective in the treatment of acute bacterial lower respiratory tract infection.