118例中药饮片和中药配方颗粒ADR报告分析与信号挖掘  

Adverse reactions in 118 cases of Chinese herbal pieces and formula granules:analysis and signal mining

作　　者：蔡权周 钱鑫 林占权 叶林虎 CAI Quanzhou;QIAN xin;LIN Zhanquan(Department of ADR Monitoring,Foshan Center for Food and Drug Control,Foshan 528000,China;不详)

机构地区：[1]佛山市食品药品检验检测中心不良反应监测室,广东佛山528000 [2]华南理工大学附属第六医院药学部,广东佛山528200

出　　处：《中国处方药》2025年第7期66-69,共4页Journal of China Prescription Drug

基　　金：广东省药品监督管理局2023年市县药品监管综合改革创新项目(ZG-DS-2023029)。

摘　　要：目的通过对中药不良反应进行分析和信号检测,评估中药使用中的安全性问题,为临床安全用药提供参考。方法对2012年1月1日~2023年12月31日佛山地区的中药饮片和中药配方颗粒不良反应监测数据进行综合分析,并采用报告比值比(ROR)和比例报告比(PRR)两种比例失衡算法对不良反应开展信号挖掘。结果在118例中药不良反应报告中,一般伤害92例,严重伤害26例,大部分病例好转(68.64%)或痊愈(27.12%)。不良反应报告频次从高到低排序,依次累及胃肠系统、皮肤及其附件、神经系统等,严重不良反应包括肝肾功能异常、心脏毒性和过敏性休克等。信号检测方面,检出蝉蜕、天花粉、苦杏仁、麻黄相关的瘙痒,款冬花、连翘、甘草、酸枣仁等相关的消化系统症状,炙甘草相关的乏力等潜在不良反应信号。结论中药饮片和中药配方颗粒在使用过程可能引发的不良反应涉及多个系统和器官,为确保用药安全,建议在使用中药前充分了解患者病史、过敏史等信息,用药过程中密切监测患者的不良反应情况。此外,应加强中药质量稳定性控制不良反应上报工作,为中药饮片及配方颗粒的安全使用奠定坚实基础。Objective To analyze and detect signals of adverse drug reactions(ADRs)associated with traditional Chinese medicine(TCM),evaluate safety issues in the use of TCM,and provide references for clinical safe medication practices.Methods A comprehensive analysis was conducted on the ADR monitoring data of Chinese herbal pieces and Chinese herbal formula granules in the Foshan region from January 1,2012 to December 31,2023.Signal detection for ADRs was performed using two disproportionality analysis methods:the Reporting Odds Ratio(ROR)and the Proportional Reporting Ratio(PRR).Results Among the 118 reported cases of TCM-related ADRs,92 cases were classified as general harm,while 26 cases were classified as severe harm.The majority of cases showed improvement(68.64%)or complete recovery(27.12%).The ADRs predominantly affected the gastrointestinal system,skin and appendages,and nervous system,in descending order of frequency.Severe ADRs included abnormal liver and kidney function,cardiotoxicity,and anaphylactic shock.In terms of signal detection,potential ADR signals were identified,such as itching associated with Cicadae Periostracum(Chantui),Trichosanthes Root(Tianhuafen),Bitter Almond(Kuxingren),and Ephedra(Mahuang);digestive system symptoms associated with Tussilago Farfara(Kuandonghua),Forsythia Suspensa(Lianqiao),Licorice Root(Gancao),and Spiny Jujube Seed(Suanzaoren);and fatigue associated with Honey-fried Licorice Root(Zhigancao).Conclusion Chinese herbal pieces and Chinese herbal formula granules may induce ADRs during use,involving multiple systems and organs.To ensure medication safety,it is recommended to thoroughly understand patients'medical history,allergy history,and other relevant information before administering TCM.Close monitoring of patients for ADRs during treatment is essential.Additionally,efforts should be strengthened to control the quality and stability of TCM and improve the reporting of ADRs,thereby providing a robust foundation for the safe use of Chinese herbal pieces and Chinese herbal form

关 键 词：中药饮片 中药配方颗粒 药物不良反应 比例失衡算法 信号检测 

分 类 号：R288[医药卫生—中药学]