加替沙星氯化钠注射剂与左氧氟沙星氯化钠注射剂治疗细菌性感染随机对照临床研究

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。

A randomized comparative clinical study of Gatifloxacin in sodium chloride injection vs Levofloxacin in sodium chloride injection

Objective A randomized comparative open trial was conducted to evaluate the efficacy and safety of Gatifloxacin in sodium chloride injection by contrasting with Levofloxacin in sodium chloride injection. Methods The dose of Gatifloxacin iv was 0.2 g, qd and the duration of treatment was 7～10 days; the dose of Levofloxacin iv. was 0.2 g, bid for 7～10 days. The total number of final clinical evaluated subjects was 229, including 105 subjects in Gatifloxacin iv treatment group(G group) and 101 subjects in Levofloxacin iv. treatment group(L group). The bacterial evaluated subjects were 93 for G group and 82 for L group. Results Clinical efficacy rate and microbiologic eradication rate for G group were 91.43% and 92.74%, respectively;clinical efficacy rate and microbiologic eradication rate for L group were 83.17% and 96.34%. The incidence of adverse reaction were 11.02% for G group and 14.41% for L group. Conclusion It was concluded that Gatifloxacin had an excellent clinical efficacvy and good safety in patients with bacterial infections.