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目的评价加替沙星片治疗临床常见急性细菌性感染的安全性和有效性。方法本项多中心临床试验以左氧氟沙星为对照药,用随机双盲对照的试验方法。两药剂量均为200mg,每日口服2次,疗程7-14天。共入选病例280例,其中加替沙星组143例,临床疗效评价病例114例,安全性评价例数116例;左氧氟沙星组137例,临床疗效评价病例110例,安全性评价病例112例。结果两组临床总有效率分别为95.6%和91.8%,细菌清除率分别为96.1%和92.3%,药物不良反应发生率分别为10.3%与9.8%。结论加替沙星与左氧氟沙星治疗临床常见急性细菌性感染安全、有效。
Objective To evaluate the safety and efficacy of gatifloxacin tablets in the treatment of common acute bacterial infections in clinical practice. Methods This multicentre clinical trial levofloxacin as a control drug, a randomized double-blind control test. The two doses are 200mg, 2 times daily oral, treatment 7-14 days. A total of 280 cases were enrolled, of which 143 were gatifloxacin group, 114 cases were clinical efficacy evaluation, 116 cases were safety evaluation; 137 cases were levofloxacin, 110 cases were clinical efficacy evaluation and 112 cases were safety evaluation. Results The total effective rates of the two groups were 95.6% and 91.8% respectively, the bacterial clearance rates were 96.1% and 92.3% respectively, and the adverse drug reactions were 10.3% and 9.8% respectively. Conclusion Gatifloxacin and levofloxacin are safe and effective in the treatment of common acute bacterial infections.