加替沙星注射液治疗急性下呼吸道感染的多中心双盲随机对照临床研究

A multicenter double-blind randomized controlled clinical study of parenteral gatifloxacin versus levofloxacin in the treatment of acute lower respiratory tract infections

目的 评价国产加替沙星注射液治疗急性下呼吸道感染的临床疗效与安全性。方法 采用多中心、双盲、随机对照试验设计 ,以左氧氟沙星注射液为对照药 ,两组均为 2 0 0 mg静脉滴注 ,Q12 h,疗程 7～ 10 d。结果 本研究共纳入 16 2例 ,加替沙星组和左氧氟沙星组分别为 82例和 80例 ,其中加替沙星组进行 ITT分析 80例 ,PP分析 70例 ,左氧氟沙星组进行 ITT分析 75例 ,PP分析 6 6例。疗程结束时加替沙星组与左氧氟沙星组的总痊愈率和有效率分别为 4 8.5 7%与 37.88%和 81.4 3%与 72 .73% ,两组细菌清除率分别为98.36 %和 98.2 8% ;治疗结束后 7d随访 ,两组的总痊愈率和有效率分别为 6 6 .6 4 %与 6 0 .6 0 %和 86 .92 %与89.39%。以上结果两组间比较及疗程结束时与结束后 7d比较 ,均无统计学差异。加替沙星组和左氧氟沙星组的不良反应发生率分别为 2 2 .5 0 %和 2 5 .33% ,均主要表现为轻度恶心、呕吐、头晕、失眠、局部刺激及肝功转氨酶增高等。结论 国产加替沙星注射液治疗急性下呼吸道感染疗效确切 ,安全性较好。

Objective To evaluate the clinical efficacy and safety of domestic parenteral gatifloxacin for the treatment of acute lower respiratory tract infections. Methods A multicenter double-blind randomized controlled clinical study was conducted comparing the efficacy and safety with levofloxacin. Both gatifloxacin and levofloxacin were administered intravenously at a dosage of 200mg twice daily for 7 to 10 days. Results One hundred and sixty-two patients were enrolled in this study, 82 were in gatifloxacin group and 80 in levofloxacin group respectively. 80 patients were enrolled in ITT analysis and 70 patients were eligible for PP analysis in gatifloxacin group, while 75 patients were enrolled in ITT analysis and 66 patients were eligible for PP analysis in levofloxacin group. At the end of the treatment, the cure rates and effective rates were 48.57% and 81.43% in the gatifloxacin group, and 37.88% and 72.73% in the lexofloxacin group respectively. The bacterial eradication rates of the two groups were 98.36% and 98.28% respectively. After 7 days termination, the cure rates and effective rates were 66.64% and 86.92% in the gatifloxacin group, and 60.60% and 89.39% in the lexofloxacin group respectively. The bacterial eradication rates of the two groups were 98.36% and 98.28% respectively. There were no significant statistic differences between two groups. In two groups, 22.50% and 25.33% of patients′ adverse reactions were observed, dominated by mild nausea, vomiting, dizzy, insomnia, local site reaction and elevated transaminases. Conclusion Domestic parenteral gatifloxacin is effective and safe for the treatment of acute lower respiratory tract infections.