安神类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for tranquilization:Safety analysis and pharmacovigilance considerations

目的:旨在通过对安神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,提出安神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11味安神类中药饮片的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:收集安神类中药饮片ADR/ADE文献报道37篇,案例83例。涉及ADR/ADE的中药饮片为4味,占安神类饮片数的36.36%。其中,安神类饮片ADR/ADE的临床表现主要为A型不良反应,以中毒反应常见,损害人体多个器官及系统。安神类饮片发生ADR/ADE的主要原因有机体因素、饮片质量、过量使用和患者自行用药等。结论:安神类饮片发生安全问题多见于朱砂,加强安神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） of Chinese herbal pieces for tranquilization on the basis of systematic examination of reports about security incidents of Chinese herbal pieces for tranquilization, in order to provide suggestions for the pharmacovigilance and rational use of Chinese herbal pieces for tranquilization. Methods： The literatures at home and abroad in 30 years were retrieved systematically, and the ADR/ADE literatures of 11 kinds of Chinese herbal pieces for tranquilization were obtained. The untoward effects of this Chinese herbal piece were analyzed by using retrospective study and statistical methods. Results： A total of 83 ADR/ADE cases in 37 literatures were collected, which involved 4 kinds of Chinese herbal pieces accounting for 36.36% in Chinese herbal pieces for tranquilization. According to the analysis, the clinical manifestation of ADR/ADE was mainly type A untoward reaction with toxic reaction as the most common manifestation which might damage human organs and systems. The primary causes of ADR/ADE were individual differences, quality of Chinese herbal pieces, overdose, self-medication and so on. Conclusion： Chinese herbal pieces of Cinnabaris are the tranquilization drug with the most security problems. To strengthen the pharmacovigilance of Chinese herbal pieces for tranquilization is of great significance in improving the safety and reasonable application of this Chinese herbal piece.