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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 2 0 8例 ,托舒沙星开放治疗细菌性感染 2 1 3例。给药方案为 ,托舒沙星片每日 45 0～ 60 0mg ,环丙沙星片每日 1～ 1 .5 g ,均分 2～ 3次口服。治疗单纯性尿路感染托舒沙星每日 30 0mg ,分 2次口服 ,环丙沙星每日 0 .5～ 0 .75 g ,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% ( 96/1 0 6)及 89.2 % ( 91 /1 0 2 ) ,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 % ( 8/1 0 6)及 6.7% ( 7/1 0 2 )。上述两组的各项结果经统计学处理 ,差异均无显著性。托舒沙星开放治疗细菌性感染 2 1 3例的有效率为 89.7% ( 1 91 /2 1 3) ,细菌清除率为 91 .3% ( 1 79/1 96) ,不良反应发生率为 6.6% ( 1 4/2 1 4)。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
Objective: To evaluate the efficacy and safety of domestic tosufloxacin tablets in the treatment of bacterial infections. Methods: Totally 268 cases of respiratory tract infection and urinary tract infection were treated with tosufloxacin and ciprofloxacin tablets in a non-blinded fashion. Toxarsacin was used to treat 213 cases of bacterial infection. Dosage regimen, tosacsulfate daily 45 0 ~ 60 0mg, ciprofloxacin tablets 1 ~ 1 .5 g daily, divided into 2 or 3 times orally. Treatment of simple urinary tract infection of tosufloxacin 30mg daily, 2 times orally, ciprofloxacin 0.5 ~ 0.75 g daily, divided into 2 or 3 times. Results: In the control trial, the effective rates of tosufloxacin and ciprofloxacin were 90.6% (96/1 0 6) and 89.2% (91/102), respectively. The bacterial clearance rate was 88.4% (84/95 and 76/86). The incidence of adverse reactions were 7.5% (8/1 0 6) and 6.7% (7/1 0 2), respectively. The results of the two groups were statistically processed, the difference was not significant. The effective rate of tosufloxacin in the treatment of bacterial infection was 89.7% (91 1/2 1 3), the bacterial clearance rate was 91.3% (1 79/1 96), and the incidence of adverse reactions was 6.6 % (1 4/2 1 4). Conclusion: Toxsacatin tablets are effective in treating bacterial infections with rare and mild adverse reactions. Their efficacy and safety are similar to oral ciprofloxacin tablets