口服法罗培南钠片治疗急性盆腔炎多中心随机对照临床研究
[摘要] 目的 探讨法罗培南钠片治疗急性盆腔炎的有效性和安全性。 方法 通过一项多中心、随机、平行对照研究设计,共有144例病例入组,对与方案集吻合的131例进行统计学分析,其中研究组(法罗培南钠组)66例,口服法罗培南钠,每次0.2 g,每天3次;对照组(头孢曲松钠联合甲硝唑组)65例,头孢曲松钠2.0 g联合甲硝唑0.5 g,静脉滴注,每天1次;平均治疗时间为7~14 d(最短不少于5天的时间)。结果 研究组与对照组临床治愈率分别为77.27%和78.46%,差异无统计学意义(P>0.05);总有效率分别为95.45%和95.38%,差异无统计学意义(P>0.05);细菌根除率分别为92.42%和92.31%,差异无统计学意义(P>0.05);药物不良反应(ADR)发生率分别为12.68%和13.89%,差异无统计学意义(P>0.05)。结论 法罗培南钠片治疗急性盆腔炎安全、有效,且患者服药方便、依从性好。
[关键词] 法罗培南钠;头孢曲松钠;甲硝唑;急性盆腔炎
[中图分类号] R711.3 [文献标识码] B [文章编号] 1673-9701(2014)31-0036-04
A multi-center, randomized and controlled clinical trial of faropenem sodium tablets in treatment of acute pelvic inflammatory disease
ZHANG Liping1 LONG Mei2
1.Department of Pharmacy,Zaozhuang Municipal Hospital in Shandong Province, Zaozhuang 277101,China;2.Department of Obstetrics and Gynaecology, Zaozhuang Downtown District Women and Children Health Care Hospital, Zaozhuang 277101,China
[Abstract] Objective To evaluate the effectiveness and safety of faropenem sodium tablets in the treatment of acute pelvic inflammatory disease. Methods A multi-center, randomized, parallel control clinical trial recruited 144 patients with acute pelvic inflammatory disease. The total number of subjects for per-protocol (PP) analysis was 131. They were randomly divided into two groups: 66 cases which received oral faropenem sodium (0.2 g,tid) the trial group and 65 cases which received intravenous injection of cefatriaxone sodium combined with metronidazole (2.0g a...
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