加替沙星治疗社区获得性下呼吸道感染

Clinical Trial on Treatment of Acquired Lower Respiratory Tract Infection with Oral Gatifloxacin Once Daily in Community

目的 评价加替沙星治疗社区获得性下呼吸道感染的疗效和安全性。方法 前瞻性、非对照、开放性Ⅳ期药物临床试验。加替沙星400mg／d口服，疗程7～14d。结果 2004年2月-2005年2月，共入选36例下呼吸道感染患者，其中失访2例，中途停药2例，剔除1例。安全性可评价病例34例；治疗效果可评价病例31例，其中男7例，女24例，年龄23～69岁，平均44．8岁；肺炎18例，慢性支气管炎急性发作13例；治愈28例，显效1例，进步2例，有效率93．5％。筛选痰培养细菌15株，阳性率44％，治疗结束全部清除，清除率100％。4例出现不良事件，表现为输液局部发痒、口服药物后出现呼吸困难、胃肠道反应和失眠，不良反应发生率11．8％。结论 加替沙星口服每日1次给药，治疗社区获得性下呼吸道感染疗效确凿，安全性高。

Objective To evaluate the efficacy and safety of gatifloxacin in the treatment of acquired lower respiratory tract infection in community. Methods A prospective, non-comparator control, open-label drug clinical trial of phase Ⅳ was conducted. The dosage of gatifloxacin was 400 mg, once daily orally. The duration of treatment was 7-14 d. Results Totally 36 cases with community acquired lower respiratory tract infection were enrolled in Beijing Tiantan hospital from February 2004 to February 2005. 34 patients were assessable for safety and 31 patients assessable for efficacy. The mean age of the patients was 44.8 years old （23-69 years）. There were 18 patients with pneumonia and 13 patients with chronic bronchitis. The results showed that the overall efficacy rate was 93. 5%, whereas the bacterial clearance rate was 100%. The rate of adverse drug reaction was 11.8%. Conclusion It is both effective and safe with oral gatifloxacin once daily to treat community acquired lower respiratory tract infection.