左氧氟沙星600mg静脉注射治疗下呼吸道细菌性感染的疗效和安全性研究

Efficacy and safety of intravenous levofloxacin 600 mg in the treatment of lower respiratory tract infections

目的评价左氧氟沙星注射液600mg治疗下呼吸道感染的临床疗效与安全性。方法采用多中心、前瞻性、开放性试验。入组病例996例,因各种原因剔出后可评价病例847例,左氧氟沙星注射液600mg,每日1次静脉滴注,治疗下呼吸道感染患者,疗程为7～14d。记录观察期间出现的任何不良反应,评估治疗结束时的临床疗效、细菌学疗效及安全性。结果左氧氟沙星600mg静脉滴注治疗社区获得性肺炎、慢性支气管炎急性加重、支气管扩张并发感染的有效率分别为92.3%(477/517)、89.8%(203/226)、90.4%(94/104),总有效率为91.4%(774/847),总细菌清除率为83.9%。试验期间不良反应总发生率为6.2%(52/847),其中消化系统不良反应发生率为3.54%(30/847),中枢神经系统为1.7%(14/847),注射部位刺激为0.6%(5/847),皮肤反应为0.4%(3/847)。结论左氧氟沙星注射液600mg静脉滴注治疗下呼吸道感染具有良好的疗效和安全性。

Objective To evaluate the efficacy and safety of intravenous levofloxacin 600 mg in the treatment of lower respiratory tract infections caused by bacteria. Methods A multicenter, prospective and open label clinical trial was conducted. A total of 996 patients were included at the beginning, and only 847 were evaluable at the endpoint. The dosage was 600 mg, once daily injection. The duration of treatment was 7-14 days. Any unexpected symptoms and abnormal laboratory results were recorded during treatment and follow-up periods. The clinical and bacterial efficacy and safety were evaluated at the end of treatment. Results The response rate following treatment with intravenous levofloxacin 600 mg was 92.3% （477/517） for community acquired pneumonia, 89.8% （203/226） for acute exacerbation of chronic obstructive pulmonary disease, and 90.4% （94/104） for bronchiectasis, respectively. The overall response rate was 91.4% （7？4/847）. The bacterial clearance rate was 83.9%. The overall incidence of adverse events was 6.2% （52/847）. Digestive system disorders account for 3.54% （30/847）, central nervous system 1.7% （14/847）, injection site irritation 0.6% （5/847）, skin reactions 0.4% （3/847）. Conclusions Intravenous levofloxaein 600 mg is effective and safe in the treatment of lower respiratory tract infections.