摘要
目的:分析我国近年来中药不良反应/事件(ADR/ADE)的监测情况,为减少中药ADR/ADE的发生提供参考。方法:收集2016~2020年《国家药品不良反应监测年度报告》,对中药监测情况进行统计分析。结果:统计显示,2016~2020年药品ADR/ADE报告涉及怀疑药品例数中中药数量在20~25万例次左右,中药严重ADR/ADE报告增长水平明显高于总体增长水平;女性患者略多于男性;老年患者所占比例逐年上升;注射给药所占比例较高,口服给药呈现逐年增长的态势,2019年口服给药比例首次超过了注射给药;主要涉及活血化瘀类、清热解毒类、益气养阴类等药品;主要累及皮肤及其附件损害、胃肠损害、全身性损害。结论:通过分析中药监测情况并探讨中药发生ADR/ADE的原因,建议加强对高风险药品及特殊人群的风险管理,并继续加强中药生产、流通、使用、研发等各个环节的监督管理,从而减少中药ADR/ADE发生,促进中药的用药安全。
Objective:Analyze the monitoring situation of ADR/ADE in traditional Chinese medicine in recent years,and provide references for reducing the incidence of ADR/ADE in Chinese medicine.Methods:Collect the"National Adverse Drug Reaction Monitoring annual Report"from 2016 to 2020,and conduct statistical analysis on the monitoring of traditional Chinese medicine.Results:The number of suspected drug cases of traditional Chinese medicine was about 200,000 to 250,000 in the report of adverse reactions/events from 2016 to 2020.The increasing levels of reports of serious ADR/ADE in Chinese medicine was significantly higher than the overall growth level;Slightly more female patients than male;The proportion of elderly patients increasd year by year;The higher proportion was injections,The proportion of oral medications increasd year by year,In 2019,for the first time,the proportion of oral administration exceeded that of injections;The main categories of drugs involved are activating blood circulation and removing blood stasis,clearing heat and detoxifying,nourishing qi and nourishing Yin,etc.It mainly involves skin and its accessories damage,gastrointestinal damage,systemic damage.Conclusion:By analyzing the monitoring of traditional Chinese medicine and exploring the causes of ADR/ADE in traditional Chinese medicine,proposal to strengthen risk management of high-risk drugs and special populations.And continue to strengthen the supervision and management of Production,distribution,use,research and development of traditional Chinese medicine,reducing the incidence of ADR/ADE in Chinese medicine,to promote the safety of traditional Chinese medicine.
作者
冯祝婷
钟金萍
吕凌丽
罗才荣
凡标
Feng Zhuting;Zhong Jinping;Lyu Lingli;Luo Cairong;Fan Biao(Guzhou College of Health Prodessions,Tongren 554300,China;Tongren Municipal People's Hospital,Tongren 554300,China)
出处
《山东化工》
CAS
2022年第10期165-167,共3页
Shandong Chemical Industry
基金
铜仁市科技局基础科学研究专项基金项目(铜仁市科研(2019)125号)。
关键词
中药
不良反应
不良事件
风险管理
安全用药
Chinese medicine
adverse reactions
adverse events
risk management
safe medication
