银杏内酯注射液临床使用合理性与安全性再评价研究

Research on the clinical rationality and safety of Ginkgolid injections in certain hospital:An integrated approach

目的探讨银杏内酯注射液临床使用合理性与安全性再评价问题。方法本研究分层随机抽取某医院2014年1月至2014年12月临床使用银杏内酯注射液住院病历120份,采用药品说明书推荐评价、药物利用研究及药品不良反应/事件(ADR/ADE)监测综合方法,初步探讨银杏内酯注射液临床使用合理性与安全性再评价问题。结果药品说明书推荐评价指标合理性百分率以西医辨病(36.67%)、中医辨病(22.50%)、中医辨证(22.50%)、给药剂量(3.33%)、给药浓度(39.17%)相对偏低,8项指标总得分百分率波动幅度与平均值基本保持一致(50.83%);药物利用研究提示银杏内酯注射液临床使用平均用药频度(a DDDs/a DDCs)和药物利用指数(d DUI/c DUI)均不高(a DDDs/a DDCs=3.40/6.63,d DUI/c DUI=0.32/0.62);此外,该医院2014年未见银杏内酯注射液药物不良反应/事件(ADR/ADE)报告,而中文数据库亦未见有关银杏内酯注射液ADR/ADE及配伍禁忌文献报道,但是有同类银杏叶注射制剂ADR/ADE及配伍禁忌文献报道。结论应加强该医院银杏内酯注射液临床监测工作,同时应关注银杏叶注射制剂ADR/ADE及配伍禁忌文献报道,并避免出现中药注射剂联合配伍现象。

Objective To re-evaluate the clinical rationality and safety of the traditional Chinese medicine injections（ TCMIs）,Ginkgolid injections.Methods In this study,120 medical records from the certain hospital,which contained Ginkgolid injections prescription during 2014,were selected randomly and evaluated by criteria according to drug information leaflets,drug utilization index for dose /concentration（ dDUI /cDUI） and average defined daily dose /concentration（ a DDDs /a DDCs）,and adverse drug action /event（ ADR /ADE） monitoring.Results There were poor clinical rationality and safety for Ginkgolid injections,such as in aspects of the disease differentiation of western medicine,disease and syndrome differentiation of traditional Chinese medicine,the administration dose and concentration,and especially in under-dosage and inferior-concentration administration.No ADR /ADE and compatibility taboo cases about Ginkgolid injections were reported both in hospital during 2014,and in Chinese database.Conclusion In brief,it should strengthen the monitoring of Ginkgolid injections in the hospital,especially on the ADR /ADE and compatibility taboo cases about Ginkgo biloba extract injections in the databases,so as to avoid the phenomena of combination of traditional Chinese medicine injections with others.