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目的:评价国产加替沙星注射液治疗中、重度急性细菌性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,两组的用量、用法及疗程均为200 mg静脉滴注,每12小时1次,疗程7～10d。结果:本研究共纳入255例,加替沙星组和左氧氟沙星组分别为126例和129例,其中加替沙星组进行ITT分析123例,PP分析112例,左氧氟沙星组进行ITT分析120例,PP分析107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56.25％与55.14％和86.61％与82.24％,两组细菌清除率分别为94.85％和97.75％;治疗结束后7d随访,两组的总痊愈率和有效率分别为67.57％与69.23％和87.39％与90.38％,两组细菌清除率分别为94.79％和97.70％。以上结果两组间比较及疗程结束时与结束后7d比较,差异均无显著性。加替沙星组和左氧氟沙星组的不良反应发生率分别为17.89％和19.17％,均主要表现为轻度恶心、呕吐、头晕、失眠、局部刺激及转氨酶增高等。结论:国产加替沙星注射液治疗中、重度急性细菌性感染疗效确切,安全性较好。
Objective: To evaluate the clinical efficacy and safety of domestic gatifloxacin injection in the treatment of moderate and severe acute bacterial infections. Methods: A multicenter, double-blind and randomized controlled trial was designed. Levofloxacin injection was used as control. The dosage, usage and course of treatment were 200 mg intravenously every 12 hours for 7-10 days. Results: A total of 255 cases were enrolled in this study. Among them, 126 cases were treated with gatifloxacin and 129 cases were treated with levofloxacin. Among them, 123 cases were analyzed by ITT, 112 cases were analyzed by PP, 120 cases were treated by levofloxacin, PP analysis of 107 cases. At the end of treatment, the total cure rate and effective rate of gatifloxacin group and levofloxacin group were 56.25% and 55.14%, 86.61% and 82.24%, respectively. The bacterial clearance rates of the two groups were 94.85% and 97.75%, respectively. After 7 days of treatment, The total cure rate and effective rate of the two groups were 67.57% and 69.23% and 87.39% and 90.38% respectively. The bacterial clearance rates of the two groups were 94.79% and 97.70% respectively. The above results between the two groups compared with the end of treatment and 7d after the end of the comparison, the difference was not significant. Adverse reactions of gatifloxacin group and levofloxacin group were 17.89% and 19.17%, respectively, which were mainly mild nausea, vomiting, dizziness, insomnia, local irritation and elevated transaminases. Conclusion: Domestic gatifloxacin injection is effective and safe in the treatment of moderate and severe acute bacterial infections.