摘要
目的深入挖掘各类损伤、中毒等不良事件(adverse events,AEs)和中草药及其提取物的关联,总结AEs特征,为中草药的临床安全应用与风险预警提供依据。方法基于美国FDA AEs报告系统(FDA Adverse Event Reporting System,FAERS)数据库,检索2004年第1季度至2025年第2季度(2004年1月1日至2025年6月30日)中草药相关AEs报告,采用报告比值比(Reporting Odds Ratio,ROR)法、英国药品和保健产品管理局(British Medicine and Healthcare Products Administration,MHRA)综合标准法、贝叶斯可信区间递进神经网络(Bayesian Confidence Interval Progressive Neural Network,BCPNN)法以及多项式伽马泊松分布缩减(Muti-item Gamma Poisson Shrinker,MGPS)法进行信号挖掘,并对药物的AEs发病时间进行分析。结果共筛选出中草药85种,共提取以中草药为主要怀疑对象的AEs报告2822份。其中,男性856例(30.33%),女性1470例(52.09%);报告国家以美国为主971份(34.41%),报告年龄主要集中在≥18~<65岁人群(46.03%)。上报的AEs主要集中于死亡、住院时间延长、其他严重后果等方面。信号强度最高的首选术语(preferred term,PT)包括金鸡纳中毒、金属中毒、镇静并发症,ROR值分别为869.94(95%CI:425.26~1779.62)、26.11(95%CI:15.88~42.94)、23.1(95%CI:17.72~30.13),各种制剂毒性的报告数量最多,为502份。AEs发生时间的中位数为47d,53%的AEs发生于用药后2个月内,风险随着时间的推移而降低(早期失败型)。结论在使用中草药及其提取物时,应重点关注金鸡纳中毒、金属中毒、镇静并发症、术后深静脉血栓形成等AEs,针对可能会出现的的AEs进行重点监测,特别是在女性和成年人群体中,保障患者用药安全。
Objective To deeply explore the adverse events(AEs)related to injuries and poisoning in Chinese herbal medicine and their extracts,summarize the characteristics of AEs,and provide a basis for the clinical safe application and risk warning of Chinese herbal medicines.Method Based on the FDA Adverse Event Reporting System(FAERS)database,the reports of AEs related to Chinese herbal medicine were retrieved from the first quarter of 2004 to the second quarter of 2025(2004.1.1-2025.6.30).The risk signals were mined by the Reporting Odds Ratio(ROR)method,the comprehensive standard method of the British Medicine and Healthcare Products Administration(MHRA),the Bayesian Confidence Interval Progressive Neural Network(BCPNN)method and the Muti-item Gamma Poisson Shrinker(MGPS)method,and the onset time of AEs was analyzed.Result A total of 85 kinds of Chinese herbal medicine were screened,and 2822 adverse events with Chinese herbal medicine as the main suspect were extracted.Among them,856(30.33%)were reported by men and 1470(52.09%)were reported by women.The reporting countries were mainly the United States(34.41%),and the reporting age was mainly concentrated in≥18-65 years old(46.03%).The AEs were mainly focused on death,prolonged hospitalization,and other serious consequences.The preferred term(PT)with the highest signal intensity included cinchona poisoning,metal poisoning,and sedative complications.The ROR values were 869.94(95%CI:425.26-1779.62),26.11(95%CI:15.88-42.94),and 23.1(95%CI:17.72-30.13),respectively.The number of reports of toxicity of various preparations was the largest,with 502 cases.The median time of AEs was 47 days,and 53%of AEs occurred within 2 months after medication.The risk was considered to decrease over time(early failure type).Conclusion In the use of Chinese herbal medicine and its extracts,we should focus on AEs such as cinchona poisoning,metal poisoning,sedative complications,postoperative deep vein thrombosis,and focus on monitoring the possible AEs,especially in women and adults,to ensure medication safety.
作者
黄莎莎
林欣慧
李景琳
王凌
Huang Shasha;Lin Xinhui;Li Jinglin;Wang Ling(School of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,Fujian,China;School of Pharmacy,Fujian Medical University,Fuzhou 350108,Fujian,China)
出处
《创伤与急诊电子杂志》
2025年第3期173-181,共9页
Journal of Trauma and Emergency(Electronic Version)
基金
福建省自然科学基金项目(2024J011032)。
关键词
中草药
美国FDA不良事件报告系统
不良事件
信号挖掘
时序
Chinese herbal medicines
FDA Adverse Event Reporting System
Adverse events
Signal mining
Timing
