加替沙星胶囊治疗呼吸系和泌尿生殖系急性细菌性感染109例

Gatifloxacin capsules in treating acute bacterial infection of respiratory tract and urinary-reproductive tract in 109 patients

目的 :评价加替沙星治疗轻、中度急性细菌性呼吸系统、泌尿生殖系统感染的安全性及疗效。方法 :采用随机、对照、双盲、双模拟、多中心试验设计方法。选择轻、中度急性细菌性呼吸系统、泌尿生殖系统感染病人 2 18例 ,可评价病例 2 15例 ,随机编入试验组或对照组。试验组 10 9例 ,给予加替沙星胶囊 ,4 0 0mg ,po ,qd ,疗程 7～ 14d ;对照组 10 6例 ,给予左氧氟沙星 ,2 0 0mg ,po ,bid ,疗程 7～ 14d。结果 :试验组、对照组有效率分别为 95 .4 % (10 4 /10 9)和 95 .3% (10 1/ 10 6 ) ;痊愈率分别为 84 .4 %(92 / 10 9)和 84 .9% (90 / 10 6 ) ;细菌清除率分别为10 0 %和 10 0 % ;细菌阴转率分别为 99%和 10 0 % ;不良反应发生率分别为 8.1% (9/ 111)和 7.5 %(8/ 10 7)。 2组间均无显著差异 (P >0 .0 5 )。结论 :加替沙星治疗轻、中度急性细菌性呼吸系统、泌尿生殖系统感染有效、安全。

AIM: To evaluate the safety and efficacy of gatifoxacin in treating mild and moderate acute bacterial infections of respiratory tract and urinary-reproductive tract. METHODS: The trial design was randomized, double blind,double modeling and multiple center. Two hundred and eighteen patients with mild and moderate acute bacterial infections of respiratory tract and urinary-reproductive tract were selected. Two hundred and fifteen patients that can be evaluated were randomly divided into test group or control group. The 109 patients in test group were given gatifloxacin capsule,400 mg,qd,7-14 d,while the 106 patients in control group were given levofloxacin capsule,200 mg,bid,7-14 d. RESULTS: The total effective rates of test and control group were 95.4 % (104/109) and 95.3 % (101/106). The recovery rates were 84.4 %(92/109)and 84.9 % (90/106) in two groups,respectively. The bacterial eradication rates were 100 % and 100%, respectively. The adverse reaction rates were 8.1 % (9/111) and 7.5 % (8/107), respectively. There was no significant statistical difference between the two groups( P >0.05). CONCLUSION: Gatifloxacin is effective and safe in treating mild and moderate acute infections of respiratory tract and urinary-reproductive tract.