基于年龄校正的中西药肝脏不良反应监测大数据分析及中药皮肤用药风险警示  

Big Data Analysis of Liver Adverse Reactions Monitoring of Chinese and Western Medicines Based on Age Correction and Risk Warning for Dermatologic Drugs

作　　者：龙敏娟 赵旭 郭龙鑫 蔡煜涵 林丽 祝胜凯 刘文龙[1] 宋海波 肖小河[1,2] LONG Minjuan;ZHAO Xu;GUO Longxin;CAI Yuhan;LIN Li;ZHU Shengkai;LIU Wenlong;SONG Haibo;XIAO Xiaohe(School of Pharmacy,Hunan University of Chinese Medicine,Changsha Hunan 410208,China;China Military Institute of Chinese Materia,the Fifth Medical Centre,Chinese PLA General Hospital,Beijing 100039,China;The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine,Changsha Hunan 410208,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]湖南中医药大学药学院,湖南长沙410208 [2]解放军总医院第五医学中心,全军中医药研究所,北京100039 [3]湖南省中医药研究院附属医院,湖南长沙410208 [4]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076

出　　处：《中国药物警戒》2025年第3期271-275,共5页Chinese Journal of Pharmacovigilance

基　　金：中国工程院咨询项目基金(2023-XZ-88);国家自然科学基金资助项目(81721002、82230118、U23A20519)。

摘　　要：目的探索年龄与药物性肝损伤(DILI)发生风险之间的关系,分析年龄因素对中西药不良反应发生风险的影响,并基于“三因致毒”理论对特殊品种的肝损伤情况进行分析。方法对DILI相关的药品不良反应报告进行回顾性分析,基于人口普查数据对不良反应报告数进行人口学校正,分析DILI风险随年龄变化的总体趋势、类别药物趋势及特殊趋势品种风险特征。结果年龄校正后,中西药肝损伤的发生率均随着用药人群年龄的增加而升高,且西药发生率显著高于中药。按药物类别分析发现,除西药神经系统用药、中西皮肤用药外,DILI风险均随年龄增大而升高,其中皮肤用药中西药发生率接近且发生率呈抛物线形,这与总体趋势存在较大差异,进一步分析皮肤用药肝损伤情况发现,中药皮肤用药肝损伤引发的严重不良反应较西药更为频繁,其患者的基础疾病主要集中在白癜风、银屑病、脱发中,白鲜皮、何首乌、补骨脂等相关制剂是风险指数较高药物。结论发现对于大多数药物其DILI风险均与年龄呈正相关,进而证实年龄是影响DILI发生风险的重要因素,应对老年人肝损伤用药风险给予足够重视,同时应重视中药皮肤用药肝损伤发生风险,高度关注风险较高药味复方用药与患者状态,避免严重不良反应的发生。Objective To explore the relationship between age and the risk of drug-induced liver injury(DILI),and to study the impact of age on the risk of adverse reactions induced by Chinese and Western medicines.Methods Reports about adverse drug reactions related to DILI were retrospectively analyzed,and the number of ADR reports was adjusted demographically based on the data of a census.The way in which the risk of DILI changed with age,the usage of categorized drugs and the characteristics of drugs of special varieties were analyzed.Results After age correction,the incidence of liver injury was found to increase with the age of users of traditional Chinese medicines and Western medicines in particular.Analysis by drug category showed that the risk of DILI increased with age,except for Western medicines used for the nervous system,traditional Chinese medicines and Western medicines for skin diseases.DILI due to traditional Chinese medicines for dermatologic diseases caused a larger number of serious adverse reactions than Western medicines.The underlying diseases of patients were mostly vitiligo,psoriasis and alopecia.Preparations involving Dictamni cortex,Polygonum multiflorum,Psoralea corylifolia were high-risk drugs.Conclusion The risk of DILI is positively correlated with age for most drugs.The risk posed by drugs for DILI and by traditional Chinese medicines for skin diseases deserves more attention so as to prevent the occurrence of serious adverse reactions.

关 键 词：药品不良反应 药物性肝损伤 皮肤用药 风险信号 年龄 

分 类 号：R979.1[医药卫生—药品] R994.11[医药卫生—药学]