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目的 :以甲磺酸加替沙星片和盐酸环丙沙星片随机对照治疗轻、中度急性泌尿道 /生殖道细菌感染 ,评价国产甲磺酸加替沙星片的疗效及安全性。方法 :试验组 2 4例患者接受甲磺酸加替沙星片 2 0 0mg口服 ,每日 2次 ;对照组 2 0例接受盐酸环丙沙星片 2 5 0mg ,每日 3次 ,疗程 7～ 14天。结果 :试验组和对照组痊愈率和有效率分别为 87.5 %、70 .0 % (P >0 .0 5 )与10 0 .0 %、90 .0 % (P >0 .0 5 )。两组的细菌阳性率、清除率分别为 87.5 %、80 .0 % (P >0 .0 5 )和 10 0 .0 %、87.5 % (P >0 .0 5 )。甲磺酸加替沙星的抗菌活性与环丙沙星、司氟沙星比较差异有显著性 (P <0 .0 5 ) ,但与左氧氟沙星、头孢噻肟及青霉素相比差异无显著性 (P >0 .0 5 )。两组不良反应发生率分别为 8.3%和 5 .0 % (P >0 .0 5 )。结论 :国产甲磺酸加替沙星片治疗轻、中度急性泌尿道 /生殖道细菌感染安全、高效
Objective: To evaluate the efficacy and safety of gatifloxacin mesylate tablets and ciprofloxacin tablets in the treatment of mild and moderate acute urinary tract / genital tract bacterial infections. METHODS: Twenty-four patients in the experimental group received 240 mg gatifloxacin tablets orally twice daily. In the control group, 20 received ciprofloxacin hydrochloride 250 mg three times a day for 7 ~ 14 days. Results: The cure rate and effective rate of the experimental group and the control group were 87.5%, 70.0% (P> 0.05) and 100.0%, 90.0% (P> 0.05) respectively. The positive rate and clearance rate of bacteria in the two groups were 87.5%, 80.0% (P> 0.05) and 100.0%, 87.5% (P> 0.05) respectively. The antibacterial activity of gatifloxacin mesylate was significantly different from that of ciprofloxacin and sparfloxacin (P <0.05), but no significant difference compared with levofloxacin, cefotaxime and penicillin P> 0 .0 5). The incidence of adverse reactions in both groups was 8.3% and 5.0% (P> 0.05). Conclusion: Gatifloxacin mesylate tablets are safe and effective in the treatment of mild and moderate acute urinary tract / genital tract bacterial infections