比例失衡法在中成药牛黄上清制剂风险信号挖掘与分析中的应用  

Application of proportional imbalance method in risk signal mining and analysis of Niuhuang Shangqing preparation

作　　者：李敏 谢彦军[2] 戚迎梅 于文雯 王丽 曹广生 李霞 Li Min;Xie Yanjun;Qi Yingmei;Yu Wenwen;Wang Li;Cao Guangsheng;Li Xia(Jinan Center for ADR and MDAE monitoring,Jinan 250102;Shandong ADR Monitoring Center,Jinan 250014)

机构地区：[1]济南市药品不良反应和医疗器械不良事件监测中心,山东济南250102 [2]山东省药品不良反应监测中心,山东济南250014

出　　处：《中国现代医药杂志》2025年第4期1-5,共5页Modern Medicine Journal of China

基　　金：山东省药品不良反应监测中心委托项目(编号:2023SDADRKY59)。

摘　　要：目的通过对牛黄上清制剂不良反应(ADR)的信号挖掘与分析,为临床合理用药和后续研究提供参考。方法利用报告比值比(ROR)法及比例报告比值比(PRR)法,对监测系统山东省2004年1月1日~2023年8月31日的牛黄上清制剂相关ADR报告进行数据分析和信号挖掘。结果采用ROR法和PRR法对筛选出的60个首选术语(PT)进行检测,共得到8个信号,两种方法所得的信号高度一致。同时通过对比78个牛黄上清制剂药品说明书,发现仅有3个药品说明书明确提示ADR。结论牛黄上清制剂发生的ADR信号集中在胃肠系统,与其组成成分的作用密切相关。建议临床用药时辨证施治,注意监测患者ADR,及时采取干预措施;建议相关企业完善药品说明书。Objective To provide reference for clinical rational and safe drug use by signal mining and analysis of adverse dug reactions(ADRs)associated with Niuhuang Shangqing preparation.Methods Reports of ADRs induced by Niuhuang Shangqing in Shandong province from Jan 1,2004 to Aug 31,2023,were analyzed,and signals were mined using the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.Results A total of 8 signals were indentified using the ROR method and PRR method,with high consistency between the two methods.Additionally,a comparison of the drug instruction of 78 Niuhuang Shangqing preparations revealed that only 3 drug instructions clearly indicated ADRs signals.Conclusion The ADRs of Niuhuang Shangqing preparation are mainly concentrated in the gastrointestinal system,which are closely related to the effects of its components.It is recommended to conduct syndrome-based treatment during clinical medication closely monitor patients for ADRs,and take timely intervention measures.Suggest relevant enterprises to improve dug inatructions.

关 键 词：牛黄上清 中成药 比例失衡法 报告比值比法 比例报告比值比法 不良反应 

分 类 号：R288[医药卫生—中药学]