加替沙星注射液治疗急性细菌性感染临床评价

Clinical evaluation of injectable gatifloxacin in the treatment of acute bacterial infections

目的:评价加替沙星注射液治疗急性下呼吸道及泌尿道细菌性感染的安全性及有效性。方法:以左旋氧氟沙星为对照药,采用多中心、随机、平行对照试验方法。试验组:静脉滴注加替沙星注射液400mg/d,疗程7～14d;对照组:静脉滴注左旋氧氟沙星注射液400mg/d,疗程7～14d。结果:共入选病例209例,其中加替沙星组102例,因不良反应中途退出1例,临床疗效评价病例101例;左旋氧氟沙星组107例,因不良反应中途退出1例,临床疗效评价病例106例。试验组和对照组下呼吸道感染痊愈率分别为73.1%、71.7%,有效率分别为90.4%、92.5%;泌尿道感染痊愈率分别为83.7%、77.4%,有效率均为98.1%;总痊愈率分别为78.2%、74.5%,总有效率分别为94.1%,95.3%,两组差异均无统计学意义(P均>0.05)。两组细菌清除率分别为98.9%、100%,两组差异无统计学意义(P>0.05);加替沙星组、左旋氧氟沙星组不良反应率分别为3.9%、10.3%,两组差异无统计学意义(P>0.05)。结论:加替沙星注射液治疗急性下呼吸道、泌尿道细菌感染安全、有效。

Objective: To evaluate the clinical safety and efficacy of gatifloxacin in the treatment of acute bacterial infections. Methods: Two hundred and nine patients with lower respiratoy tract infection or urinary tract infection were enrolled into a randomized controlled multicenter clinical trial,and 400 mg gatifloxacin was given to each of 102 patients and 400mg levofloxacin as control to each of the other 107 by intravenous drip once a day for 7 to 14 days. Results: In gatifloxacin group 102 patients were assessable for safety and 101 for efficacy. In levofloxacin group,107 were assessable for safety and 106 for efficacy. The following were the results of gatifloxacin and levofloxacin groups: the clinical cure rate for lower respiratory tract infection,73.1% and 71.7%; efficacy rate for lower respiratory tract infection,90.4% and 92.5%; clinical cure rate for urinary tract infection,83.7% and 77.4%; efficacy rate for urinary tract infection,98.1% and 98.1%; total clinical cure rate,78.2% and 74.5%; total efficacy rate,94.1% and 95.3%; bacterial clearance rate,98.9% and 100%; and adverse occurance rate,3.9% and 10.3%. All above indicators had no significant difference between the two groups (P>0.05). Conclusion: Gatifloxacin is effective and safe in the treatment of acute bacterial infection of respiratory and urinary tracts.