百草妇炎清栓药学及临床研究综合评价  

Pharmaceutical and Clinical Comprehensive Evaluation of Baicaofuyanqing Suppository

作　　者：田文杨 翟烨[1] 

机构地区：[1]北京中医药大学东方医院,北京100078

出　　处：《中国药物警戒》2016年第11期686-690,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的对百草妇炎清栓药学研究及临床研究进行综合评价,为促进临床安全合理用药、提高疗效提供依据。方法使用中国生物医学文献数据库和中国期刊全文数据库对百草妇炎清栓进行检索,筛选符合要求的文献,从药学研究及临床有效性、安全性等方面进行相关文献的全面回顾与分析。结果百草妇炎清栓制剂有一定疗效且相对安全,但现有临床研究的方案设计、过程质控和证据级别有待提高。结论百草妇炎清栓具有一定疗效,且相对安全,但需要进一步开展设计良好的上市后临床研究以提高证据级别。Objective To provide evidence for promoting clinical safe and rational use of Baicaofuyanqing suppository andenhancing its efficacy by making a comprehensive review and analysis on the pharmaceutical researches and clinical studies.Methods We searched the researches of Baicaofuyanqing suppository in China Biology Medicine disc （CBMdisc） and ChineseJournal Full Text Database （CJFD）, selected the researches we needed and made a systematic review and analysis in termsof pharmacology, efficacy and safety. Results According to the researches,we found that the Baicaofuyanqing suppositoryhas certain therapeutic effectiveness and safety, but the level of evidence, quality control and the design of research should bestrengthened. Conclusion The Baicaofuyanqing suppository has certain therapeutic effectiveness and relative safety. It’s neededto enhance the level of evidence by developing more well-designed post-marketing clinical research.

关 键 词：百草妇炎清栓 再评价 上市后临床研究 安全性 有效性 

分 类 号：R969.3[医药卫生—药理学]