摘要
目的了解河南中医药大学第五临床医学院/郑州人民医院2021年中药注射剂药品不良反应(ADR)和药品不良事件(ADE)发生的特点及规律,分析其发生原因并制定预防措施,为临床合理安全用药提供参考。方法通过“国家药品不良反应监测系统”抽取2021年全年上报的54例中药注射剂ADR/ADE作为研究对象,采用回顾性分析方法对发生情况和原因进行评价。结果ADR/ADE报告中,>50岁报告40例,占比达74.07%,男女性别比为1.25∶1;主要涉及神经系统类和心血管系统类药物;累及器官/系统损害以皮肤及附件(37例次)和消化系统损害(10例次)为主,3例患者出现严重ADR/ADE;发生原因包括医护因素所致33例,药物本身原因或患者自身体质因素所致21例。结论50岁以上的中老年人发生ADR/ADE的占比较大,以皮肤及附件、消化系统损害为主,医护因素是导致ADR/ADE发生的主要原因,应积极采取有效的预防对策和措施,并加大药物不良反应监测力度,为中药注射剂合理安全用药提供保障。
Objective To understand the characteristics and regularity of adverse drug reaction(ADR)and adverse drug event(ADE)of traditional Chinese medicine injections in the Fifth Clinical Medical College of Henan University of Traditional Chinese Medicine/Zhengzhou People’s Hospital in 2021,analyze the causes of occurrence and formulate preventive measures,so as to provide reference for rational and safe clinical drug use.Methods A total of 54 cases of traditional Chinese medicine injection ADR/ADE reported in 2021 were selected as research objects through the“National ADR Monitoring System”,and the occurrence and causes were evaluated by retrospective analysis method.Results In ADR/ADE reports,40 cases of>50 years old were reported,accounting for 74.07%,and the male-female ratio was 1.25∶1.It mainly involves drugs of nervous system and cardiovascular system.The organ/system damage was mainly caused by skin and accessories(37 cases)and digestive system damage(10 cases),and 3 cases were serious ADR/ADE.The causes included 33 cases caused by medical and nursing factors,21 cases caused by drugs or patients’own physical factors.Conclusion The incidence of ADR/ADE in middle-aged and elderly people>50 years old is relatively large,mainly caused by skin,accessories and digestive system damage.Medical factors are the main causes of ADR/ADE.Effective preventive measures should be taken actively,and adverse drug reaction monitoring should be strengthened to ensure the rational and safe use of traditional Chinese medicine injection.
作者
贾美云
张艳
JIA Meiyun;ZHANG Yan(Department of Nursing,the Fifth Clinical Medical College of Henan University of Traditional Chinese Medicine/Zhengzhou People’s Hospital,Zhengzhou 450000,China;Department of Pharmacy,the Fifth Clinical Medical College of Henan University of Traditional Chinese Medicine/Zhengzhou People’s Hospital,Zhengzhou 450000,China)
出处
《河南医学研究》
CAS
2023年第17期3103-3107,共5页
Henan Medical Research
基金
河南省中医药科学研究专题基金项目(2019ZY3013)。
关键词
中药注射剂
药品不良反应
药品不良事件
发生情况
措施
traditional Chinese medicine injection
adverse drug reaction
adverse drug event
occurrence situation
measure
