口服法罗培南钠片治疗急性盆腔炎多中心随机对照临床的研究.docVIP

口服法罗培南钠片治疗急性盆腔炎多中心随机对照临床的研究 　　[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（P0.05）；总有效率分别为95.45%和95.38%，差异无统计学意义（P0.05）；细菌根除率分别为92.42%和92.31%，差异无统计学意义（P0.05）；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（P0.05）。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 and 0.5g， respectively， qd） as the control group. The treatment durations for both groups were 7 to 14 days. Results In the trial and control group， the cure rates were 77.27% versus 78.46%， and the total effective rates were 95.45% versus 95.38%. The bacterial eradication rates were 92.42% in trial group and 92.31% in control group. The incidences of drug adverse reaction were 12.68% and 13.89%，respectively，and the P values showed no significant difference （P0.05）. Conclusion Faropenem