托舒沙星治疗细菌性感染的多中心临床试验

目的：评价国产托舒沙星片剂治疗细菌性感染的疗效与安全性。方法：托舒沙星与环丙沙星片剂非盲法随机对照治疗呼吸道感染及尿路感染208例，托舒沙星开放治疗细菌性感染213例。给药方案为，托舒沙星片每日450～600mg，环丙沙星片每日1～1．5g，均分2～3次口服。治疗单纯性尿路感染托舒沙星每日300mg，分2次口服，环丙沙星每日0．5～0．75g，分2～3次给药。结果：在对照试验中，托舒沙星和环丙沙星的有效率分别为90．6％(96／106)及89．2％(91／102)，细菌清除率均为88．4％(84／95及76／86)，不良反应发生率分别为7．5％(8／106)及6．7％(7／102)。上述两组的各项结果经统计学处理，差异均无显性。托舒沙星开放治疗细菌性感染213例的有效率为89．7％(191/213)，细菌清除率为91．3％(179／196)，不良反应发生率为6．6％(14／214)。结论：托舒沙星片剂治疗细菌性感染疗效确切，不良反应少见而轻微，其疗效及安全性与口服环丙沙星片相仿。

Multicenter clinical trial of tosufloxacin in the treatment of bacterial infections

Purpose:To evaluate the efficacy and safety of local made tosufloxacin tablet in the treatment of bacterial infections. Methods:A total of 208 patients with respiratory tract infections and urinary tract infections were randomly treated with tosufloxacin or ciprofloxacin (106 cases in tosufloxacin group, 102 in ciprofloxacin group)in a randomized comparative study. Another two hundred and thirteen patients with bacterial infections were treated with tosufloxacin simultaneously in an open study. Tosufloxacin was administered orally 450-600 mg per day, ciprofloxacin 1.0-1.5 g per day orally, divided to 2 or 3 times a day. Patients with uncomplicated lower urinary tract infections were treated with tosufloxacin or ciprofloxacin with a daily dosage of 300 mg or 500-750 mg, divided into 2 or 3 times. Results:In the randomized controlled study, the clinical efficacy rate of tosufloxacin and ciprofloxacin was 90.6% (96/106) and 89.2% (91/102),respectively, the bacterial elimination rate being 88.4%(84/95 and 76/86) in both groups. Adverse effects occurred in 7.5%(8/106) and 6.7% (7/102) of patients, respectively. There was no statistically significant difference between the two groups. The clinical efficacy rate and bacterial elimination rate of tosufloxacin in the open stndy of 213 patients were 89.7% (191/213) and 91.3%(179/196), respectively, the adverse effect rate being 6.6% (14/214). Conclusions:Tosufloxacin is effective and safe in the treatment of bacterial infections, the adverse effects are few and mild. The efficacy and safety of tosufloxacin is similar to ciprofloxacin in the treatment of respiratory tract and urinary tract infections.