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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 gatifloxacin injection in the treatment of acute lower respiratory tract infection. Methods A multicenter, double-blind, randomized controlled trial was designed. Levofloxacin injection was used as control. Both groups were given 200 mg intravenous drip for Q12 h for 7-10 days. Results A total of 162 cases were enrolled in this study. There were 82 cases in the gatifloxacin group and 80 cases in the levofloxacin group, 80 cases in the gatifloxacin group, 70 cases in the PP analysis group, 75 cases in the levofloxacin group by ITT analysis, PP analysis of 6 6 cases. The total cure rate and effective rate of gatifloxacin group and levofloxacin group at the end of treatment were 48.57% and 37.88%, 81.4 3% and 72.73%, respectively. The bacterial clearance rates of the two groups were 98.36% and 98.28% At 7 days after treatment, the total cure rate and effective rate were 66.46% and 60.0%, 86.92% and 89.39% respectively. The above results between the two groups and the end of treatment and after 7d compared, no significant difference. Adverse reactions of gatifloxacin group and levofloxacin group were 22.5% and 25.33%, respectively, which were mainly mild nausea, vomiting, dizziness, insomnia, local irritation and increase of liver transaminase . Conclusion Domestic gatifloxacin injection for the treatment of acute lower respiratory tract infection is effective and safe.