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目的 以左氧氟沙星氯化钠注射剂为对照 ,采用随机对照、多中心、平行开放的试验设计 ,评价加替沙星氯化钠注射剂治疗敏感菌引起的临床感染的有效性和安全性。方法 加替沙星氯化钠注射剂用法用量为 0 .4g/次 ,静脉滴注 ,1次 /日 ,左氧氟沙星氯化钠注射剂的用法用量为 0 .2 g/次 ,静脉滴注 ,2次 /日 ,两组的疗程均为 7～ 10天。加替沙星组临床可评价病例为 10 5例 ,细菌学评价例数为 93例 ,药物不良反应评价例数为 118例 ;左氧氟沙星组分别为 10 1例 ,82例和 111例。结果 试验组和对照组的临床有效率分别为 91.43 %、83 .17% ;细菌清除率分别为 92 .47%、96.3 4% ;药物不良反应发生率分别为 11.0 2 %、14 .41%。结论 加替沙星氯化钠注射剂是治疗细菌感染的安全有效的药物。
Objective To compare the efficacy and safety of levofloxacin sodium chloride injection with randomized controlled, multicenter and parallel open trial design to evaluate the efficacy and safety of gatifloxacin sodium chloride injection in the treatment of clinical infections caused by susceptible bacteria. Methods Gatifloxacin sodium chloride injection dosage of 0. 4g / times, intravenous infusion, 1 / day, the dosage of levofloxacin sodium chloride injection 0.2 g / intravenous infusion, 2 times / Day, the two groups of treatment are 7 to 10 days. There were 105 clinically evaluable cases in gatifloxacin group, 93 cases in bacteriological evaluation, 118 cases in adverse drug reactions and 101 cases in levofloxacin group and 82 cases in 111 cases. Results The clinical effective rates of the experimental group and the control group were 91.43% and 83.17% respectively. The bacterial clearance rate was 92.47% and 96.3% respectively. The incidence of adverse drug reactions was 11.0 2% and 14.41% respectively. Conclusion Gatifloxacin sodium chloride injection is a safe and effective drug for the treatment of bacterial infection.