温里类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for warming interior: Safety analysis and pharmacovigilance considerations

目的:通过对温里类饮片安全事件报道的系统梳理,分析其发生不良反应/事件(ADR/ADE)的特点及原因,提出温里类中药饮片的警戒与合理用药建议。方法:系统检索30年来国内外文献,收集和整理14味温里类中药饮片的ADR/ADE文献,采用回顾性研究和统计学方法对该类中药饮片的不良反应进行分析。结果:收集温里类中药饮片ADR/ADE文献报道57篇,案例164例。涉及ADR/ADE的中药饮片7味,占温里类饮片数的50%。分析可见,温里类饮片ADR/ADE的临床表现主要为A型不良反应,毒副反应较为突出,主要损害神经、循环及消化系统。温里类饮片发生ADR/ADE的主要原因有用药不当和患者自行用药等。结论:温里类饮片发生安全问题多为用药因素,加强温里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： To 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 Chinese herbal pieces for warming interior. Methods： The literature reports of 14 kinds of Chinese herbal pieces for warming interior over the last 30 years were reviewed, and then analyzed the characteristics and reasons of ADR/ADE by retrospective study and statistical methods. Results： A total of 57 literature reports and 164 ADR/ADE cases were collected, which involved 7 kinds of herbs, accounting for about 50% of Chinese herbal pieces for warming interior. According to the analysis, the type of ADR/ADE was type A, and the toxic effect was the most common manifestations. The above ADR/ADE involved nervous, cardiovascular and digestive system. The main influence factors were individual improper preparation method, self-medication and so on. Conclusion： The security issues of Chinese herbal pieces for warming interior are mostly caused by inappropriate and irrational use of medicines. It is necessary to make pharmacovigilance suggestions to offer reference and guidance for the safe and rational use.