摘要
目的:通过系统梳理祛风湿类中药饮片安全事件报道,分析其发生不良反应/事件(ADR/ADE)的特点及原因,提出祛风湿类中药饮片的药物警戒与合理用药建议。方法:系统检索30年来国内外文献中关于48味祛风湿类中药饮片的ADR/ADE报道,采用回顾性研究和统计学方法对该类中药饮片的安全事件进行分析。结果:纳入祛风湿类中药饮片ADR/ADE文献报道459篇,案例3 370例,涉及ADR/ADE的中药饮片为17味,占祛风湿类饮片数的35.42%。分析可见,祛风湿类饮片涉及的不良反应以A型、B型为常见,亦可见C型、D型,损害人体多个器官及系统。导致ADR/ADE的主要原因有过量、患者自行用药、服用方法不当等。结论:祛风湿类中药饮片发生安全事件相对较多,主要因素为自行用药。加强祛风湿类中药饮片的用药警戒,对提高该类饮片的安全合理应用具有重要意义。
Objective： Analyze the characteristics and reasons of adverse drug reactions/adverse drug events（ADR/ADE）, and provide suggestions for the pharmacovigilance and the rational use of prepared slices of Chinese materia medica for rheumatism. Methods： The literature reports of 48 kinds of Chinese materia medica for rheumatism over last 30 years were reviewed, and then the characteristics and reasons of ADR/ADE were analyzed by retrospective study and statistic methods. Results： The total of 3 370 ADR/ADE cases were in 459 literature reports, in which 17 kinds of herbs were involved, accounting for about 35.42% of prepared slices of Chinese materia medica. According to the analysis, the clinical manifestations of the above ADR/ADE cases were mainly type A and B, and less type C and D also. The above ADR/ADE cases usually damaged human multiple organs and systems. And the main influence factors were overdose, self-medication, unsuitable way of taking, and so on. Conclusion： There were a lot ADR/ADE reports of prepared slices of Chinese materia medica for rheumatism, which mainly led by self-medication. It is important to take pharmacovigilance actions so as to improve the safe and rational use.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2016年第10期4117-4123,共7页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
北京中医药大学"重点学科"开放课题(No.2013-ZDXKKF-19)
北京中医药大学科研创新团队(No.2011-CXTD-014)
北京中医药大学研究生自主选题(No.2016-JYB-XS123)
教育部高等学校博士学科点专项科研基金(No.20130013120001
No.20120013130002)
药品评价中心项目(基于中医药典籍数据挖掘的乌头属中药药物警戒思想研究)~~
关键词
祛风湿类
中药饮片
不良反应
安全问题
合理用药
用药警戒
Rheumatism
Prepared slices of Chinese materia medica
Adverse drug reaction
Safety problems
Rational use of Chinese medicine
Pharmacovigilance
