加替沙星与左氧氟沙星随机对照治疗急性下呼吸道感染的临床评价

A randomized controlled trial on gatifloxacin vs levofloxacin in the treatment of acute lower respiratory tract infections

目的 :采用随机双盲平行对照方法评价加替沙星治疗急性下呼吸道感染的临床疗效和安全性。 方法 :经临床确诊为急性下呼吸道感染的患者 4 8例 ,其中治疗组 2 3例 ,口服加替沙星 0 .4g ,每天 1次 ;对照组 2 5例 ,口服左氧氟沙星 0 .2 g ,每天 2次 ,疗程均为 7～ 14天。 结果 :治疗组和对照组的痊愈率分别为 69.6% ( 16/ 2 3 )与72 .0 % ( 18/ 2 5 ) ,有效率分别为 10 0 %与 96.0 % (P >0 .0 5 )。两组细菌清除率分别为 10 0 %与 90 .0 % (P =0 .192 ) ,两组间临床和细菌学疗效差异不显著。不良事件发生率分别为 11.5 % ( 3 / 2 6)与 4 .0 % ( 1/ 2 5 ) ,均为消化道反应。两组分别有 8例 ( 3 0 .8% )和 9例 ( 3 6% )患者出现实验室检查异常 ,主要为转氨酶和淀粉酶轻度升高 ,但不影响治疗。 结论 :加替沙星抗菌谱广 ,抗菌活性强 。

Objectives:The safety and efficacy of gatifloxacin vs levofloxacin were evaluated by a randomized controlled trial in the treatment of acute lower respiratory tract infections. Methods:The regimen for gatifloxacin was 0.4 g oral qd and for levofloxacin was 0.2 g oral bid for 7～14 d. Results: Forty eight cases were divided and treated in two groups,23 in gatifloxacin group and 25 in levofloxacin group. The clinical cure rates in two groups were 69.6%(16/23) vs 72.0%(18/25); effective rates were 100% vs 96.0%, bacterial eradication rates were 100% vs 90.0%,adverse reaction rates were 11.5%(3/26) vs 4.0%(1/25). All of those adverse reactions were gastrointestinal tract reactions. There were respectively 9 and 13 abnormality of laboratory inspections associated with trial drugs, which happened to 8 and 9 patients in two groups. The reactions were mainly exaltation of aminotransferase and amylase. All of these adverse events were mild and reversible without affecting the therapy. Conclusions:Results suggested that gatifloxacin is a potent antibiotic agent and can be recommended to treat acute lower respiratory tract infection .