中国医院用药评价与分析2025，Vol.25Issue(7)：791-794,800,5.DOI:10.14009/j.issn.1672-2124.2025.07.004
基于数据挖掘探讨含雄黄成方制剂相关不良反应的特点与用药规律
Adverse Drug Reaction Characteristics and Medication Patterns of Traditional Chinese Medicine Formulations with Realgar Based on Data Mining
摘要
Abstract
OBJECTIVE:To analyze medication patterns and adverse drug reactions/events(ADR/ADE)characteristics associated with traditional Chinese medicine(TCM)formulations with realgar through data mining,and to provide reference for clinical pharmacovigilance and safe medication.METHODS:TCM formulations with realgar were identified from the 2020 edition of Pharmacopoeia of the People's Republic of China:Part Ⅰ(hereinafter referred to as"Chinese Pharmacopoeia"),including varieties,dosage forms,components,and dosages.Characteristics of adverse reactions were discussed based on the case reports of ADR/ADE in Chinese and English literature databases.Association rule analysis was implemented to assess the link between various drug combinations and adverse reactions.RESULTS:Analysis of the Chinese Pharmacopoeia revealed 38 kinds of TCM formulations with realgar,comprising 163 herbal components,24 of which were toxic.In 42.11％(16 kinds)of these formulations,daily realgar intake exceeded the recommended maximum of 0.1 g in Chinese Pharmacopoeia.There were 112 ADR/ADE cases involving 12 kinds of Chinese patent medicines with confirmed causality.Patients' age ranged from 11 d to 82 years,with 68.75％(77 cases)experiencing reactions within 5 d,and 38.39％(43 cases)receiving doses beyond advised limits.Adverse reactions mainly manifested as symptoms in the skin and its appendages,nervous system and digestive system.The prognosis of the vast majority of patients was favorable.Notably,apart from realgar,formulations with cinnabar-musk and bufexag-camphor combinations exhibited higher support degrees in adverse reactions,while those without adverse reports,such as camphor-cinnabar/artificial bufexag/scutellaria/licorice/rhubarb and cinnabar-scutellaria had higher support degrees,possibly mitigating realgar toxicity.Subsequent analysis indicated minor variances in system-specific adverse reactions according to drug combinations.CONCLUSIONS:The research highlights the significant risks of off-label dosages of prepared formulations containing realgar in clinical settings,especially concerning safety in pediatric and geriatric populations.Meanwhile,public education on medication safety should be strengthened to prevent its improper use.关键词
雄黄/成方制剂/不良反应/用药规律/数据挖掘Key words
Realgar/Formulated preparations/Adverse reactions/Medication patterns/Data mining分类
医药卫生引用本文复制引用
张田,徐文峰,郭思瑞,李婷,王月,金鹏飞..基于数据挖掘探讨含雄黄成方制剂相关不良反应的特点与用药规律[J].中国医院用药评价与分析,2025,25(7):791-794,800,5.基金项目
北京市卫生健康委员会首都卫生发展科研专项(No.首发2024-1-4052) （No.首发2024-1-4052）
