加替沙星序贯给药治疗下呼吸道细菌性感染

Clinical randomized controlled trials of Gatifloxacin in the treatment of lower respiratory tract bacterial infections using introvenous to oral step down therapy

目的 :评价加替 (Gatifloxacin)沙星先静脉、后口服序贯给药治疗社区获得性肺炎 (CAP)为主的下呼吸道感染的疗效与安全性。 方法 :采用随机对照盲法平行试验设计 ,入选并完成病例 5 2例 ,其中CAP 5 1例 ,慢性支气管炎急性发作 (AECB) 1例。试验组 (2 6例 )给予加替沙星注射液 4 0 0mg ,每天 1次静脉滴注 ,共 3～ 5天 ,继以加替沙星片 4 0 0mg ,每天 1次口服 ;对照组 (2 6例 )给予左旋氧氟沙星注射液 4 0 0mg/d ,分 2次静脉滴注 ,共 3～ 5天 ,继续以每天左旋氧氟沙星片 4 0 0mg/d ,分 2次服用 ,总疗程均为 7～ 1 4天。 结果 :试验组和对照组临床可评价的病例均为 2 6例 ,有效率分别为 1 0 0 % (2 6 /2 6 )和 96 .2 % (2 5 /2 6 )。痊愈率分别为 76 .9% (2 0 /2 6 )和 6 5 .4 % (1 7/2 6 ) ,差异均不显著 (P >0 .0 5 )。试验组和对照组可作细菌学评价病例分别为 1 8例和 1 9例 ,细菌清除率分别为 94 .4 %(1 7/1 8)和 6 8.4 % (1 3/1 9) (P >0 .0 5 )。试验组和对照组不良反应发生率分别为 30 .8% (8/2 6 )和 1 1 .5 % (3/6 ) ,(P>0 .0 5 )。实验室检查异常发生率各为 4 2 .3% (1 2 /2 6 )和 2 6 .9% (7/2 6 ) (P >0 .0 5 ) ,均系轻度 ,并呈一过性 ,无需处理。 结论 :本研究结果显示 。

Objectives: To evaluate the efficacy and safety of Gatifloxacin compared with Levofloxacin in the treatment of lower respiratory tract bacterial infections using introvenous to oral step down therapy. Methods: A total of 52 patients (51 with community acquired pneumonia and 1 with acute exacerbation of chronic bronchitis)were included in this study, 26 cases treated with Gatifloxacin were compared with 26 cases treated with Levofloxacin. Drugs were first administered intravenously at a dose of 400 mg of Gatifloxacin,once a day or 200 mg of Levofloxacin, q 12 h for 3～5 days,then taked orally at a dose of 400 mg of Gatifloxacin,once a day or 400 mg of Levofloxacin, q 12 h ,the total period of treatment was 7～14 days. Results: The overall clinical efficacious rates and cure rates of Gatifloxacin was 100%, 96.2 % and 76.9%,65.4% in Levofloxacin group,There was no significant difference( P >0.05)between two group in the clinical efficacy rates and cure rates. There was also no significant difference( 94.4% to 68.4 %, P >0.05)between Gatifloxacin and Levofloxacin in the bacterial clearance rates. The incidence of adverse drug reactions(30.8%)for Gatifloxacin was low, and no severe adverse drug reactions was found. Conclusions: Gatifloxacin is an effective and safe antibiotics for the treatment of lower respiratory tract bacterial infection in introvenous to oral step down therapy.