加替沙星片治疗急性细菌性感染随机双盲对照研究

A Randomized Double-blind Controlled Trial on Gatifloxacin Tablet in the Treatment of Acute Bacterial Infections

目的 :评价加替沙星治疗急性细菌性感染的安全性和有效性。方法 :采用多中心、随机双盲、阳性药平行对照方法 ,对临床确诊为轻、中度急性呼吸系统或泌尿系统感染的患者 2 2 0例 ,试验组、对照组各 1 1 0例 ,分别口服加替沙星、氧氟沙星 2 0 0mg ,bid ,疗程 7～ 1 4d。结果 :试验组 1 0 3例、对照组 1 0 0例完成试验。试验组和对照组痊愈率分别为 76 .7%和 71 .0 % ,有效率分别为 93 .2 %和 85 .0 % ,细菌清除率分别为 96 .7%和 93 .8% ,两组间差异均无统计学意义。不良反应发生率分别为 1 6 .4 %和 1 8.2 %。试验组和对照组分别有 5例 (4.55 % )和 9例(8.1 8% )出现ALT、AST轻度升高 ,停药 1 0d后复查恢复正常。结论 :加替沙星抗菌谱广 ,抗菌活性强 ,能安全有效地治疗轻。

Objective: To evaluate the clinical safety and efficacy of gatifloxacin tablets in the treatment of acute bacterial infections.Method: By the randomized, double blind and active parallel controlled means, 220 patients with mild to moderate acute infections of the respiratory and urinary systems were divided into two groups. 110 patients were treated ;with gatifloxacin tablets, 0.2 g, po, bid ; 7 14 days, the other 110 patients were treated with ofloxacin tablets, 0.2 g, po, bid for 7 14 days.Result: 203 patients have completed the trial, 103 in the gatifloxacin group and 100 in the ofloxacin group. In the per protocol analysis, the clinical cure rates of the gatifloxacin group and the ofloxacin group were 76.7% and 71.0% ; the total effective rates being 93.2% ; and 85.0% . The bacterial clearance rates were 96.7% and 93.8% respectively. In the intent to treat analysis, the adverse reaction rates were 16.4% and 18.2% , respectively. There were respectively 5 ( 4.55% ) and 9 ( 8.18% ) abnormality of laboratory examinations of the ALT or AST associated with gatifloxacin group and ofloxacin group. All of these adverse reactions were mild, and they were recovered 10 days after stopping the drugs.Conclusion: Gatifloxacin is a potent antibiotic agent and can be recommended to treat the mild to moderate a cute infections of the respiratory and urinary systems.