鱼腥草注射液临床不合理用药不良事件分析  

Analysis of Adverse Events Caused by Irrational Application of Houttuynia Injection

作　　者：崔小花[1] 王莉[1] 成岚[1] 袁强[1] 李廷谦[2] 李幼平[1] 邓绍林[2] 商洪才[3] 张伯礼[3] 卞兆祥[4] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西医院,成都610041 [3]天津中医药大学,天津300193 [4]香港浸会大学

出　　处：《中国中西医结合杂志》2011年第3期407-412,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的分析鱼腥草注射液临床不合理用药情况及发生不良事件(adverseevent,AE)的风险,为其上市后再评价和临床合理使用提供参考依据。方法 检索PubMed、EMBASE、CBM、CNKI、VIP等数据库(截至2010年6月),纳入病例报告、横断面研究、临床对照研究。结果 共纳入鱼腥草注射液不合理用药文献342篇416例AE。包括:(1)132篇禁忌用药人群发生294例AE(其中儿童290例AE),48例过敏性休克。(2)超量使用9篇文献报告57例AE,高危联合用药6例。(3)195篇报告16种不合理给药方式,其中7种发生59例AE(腔内推注20例,雾化吸入13例,冲洗10例,口服8例,灌肠、穴位注射、直肠给药各1例),其余10种报道未发生AE。结论 鱼腥草注射液临床使用中存在擅自改变给药方式,并存在超剂量用药、高危联合用药和禁忌人群使用等不合理用药问题,增加了AE发生风险。Objective To analyze irrational clinical application of Houttuynia Injection（HI） and the risk of adverse event（AE） occurrence,thus providing references for after-sales reevaluation and rational clinical application of HI.Methods Literatures concerning unreasonable application of HI were searched（terminated by June 2010） from PubMed,EMBASE,Chinese Biomedical Disc（CBMdisc）,Chinese National Knowledge Infrastructure（CNKI）,Chinese Science and Technology Journal Full-text Database（VIP）,and etc.for case report,cross-sectional study,and clinical control study.Results A total of 342 papers with a total of 416 AE cases were retrieved.Of them,AE happened to 294 cases（including 290 children） of the 132 papers concerning contraindications,and 48 with allergic shock;AE happened to 57 cases in 9 papers reporting over-dose,and 6 with high risk combined medication.Sixteen irrational administration ways were reported in 195 papers.Of them,AE happened to 59 cases of seven administration ways（twenty cases by intracavitary injection,thirteen by aerosol inhalation,ten by rinse,eight by oral administration,one by enema,one by acupoint injection,and one by rectal administering）.AE was not reported in the rest ten reports.Conclusion The risk of AE occurrence was increased by changing clinical administration ways of HI without authorization,over-dose medication,high risk combined medication,and application in people with contraindications.

关 键 词：鱼腥草注射液 不合理用药 不良事件 风险 

分 类 号：R286[医药卫生—中药学]