加替沙星注射液治疗急性细菌性感染的多中心双盲随机对照研究  

A double-blind randomized multicenter clinical study of parenteral gatifloxacin versus levofloxacin in the treatment of acute bacterial infections

作　　者：苗佳[1] 梁德荣[1] 郑莉[1] 沈奇[1] 蔡永宁[1] 王霞[1] 文崇林[2] 杨斌[2] 江南[3] 林建梅[3] 

机构地区：[1]四川大学华西医院临床药理研究所,成都610041 [2]成都市第三人民医院 [3]四川省人民医院

出　　处：《中国抗感染化疗杂志》2004年第1期6-10,共5页Chinese Journal of Infection and Chemotherapy

摘　　要：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 injectable gatifloxacin for the treatment of acute moderate and severe bacterial infections. Methods: A double-blind randomized multicenter clinical study was conducted comparing the efficacy and safety of gatifloxacin with levofloxacin. Both gatifloxacin and levofloxacin were administered intravenously at a dose of 200 mg twice daily for 7 to 10 days. Results: Altogether, 255 patients were enrolled in the study, 126 were in gatifloxacin group and 129 in levofloxacin group. 123 patients were enrolled in ITT analysis and 112 patients were eligible for PP analysis in gatifloxacin group, while 120 patients were enrolled in ITT analysis and 107 patients were eligible for PP analysis in levofloxacin group. At the end of the treatment, the cure rates and effective rates were 56. 25% and 86. 61% in gatifloxacin group, and 55. 14% and 82. 24% in levofloxacin group respectively. The bacterial eradication rates were 94. 85% and 97. 75% respectively. Af day 7 of course of treatment, the cure rates and effective rates were 67. 57% and 87. 39% in gatifloxacin group, and 69. 23% and 90. 38% in levofloxacin group respectively. The bacterial eradication rates were 74. 79% and 97. 70% respectively. There were no statistically significant difference between the two treatment groups. Adverse reactions were observed in 17. 89% and 19. 17% of patients in the two groups, dominated by mild nausea, vomiting, dizziness, insomnia, local section and elevated transaminases. Conclusions: Domestic made injectable gatifloxacin is effective and safe for the treatment of acute moderate and severe bacterial infections.

关 键 词：加替沙星 左氧氟沙星 急性细菌性感染 双盲随机对照 多中心临床试验 

分 类 号：R515[医药卫生—内科学]