补虚类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for tonics: Safety analysis and pharmacovigilance considerations

目的:梳理补虚类中药饮片的安全事件报道,分析其引发不良反应/事件(ADR/ADE)的特点及原因,提出补虚类饮片的药物警戒与合理用药建议。方法:系统检索30年来国内外文献报道,收集和整理79味补虚类饮片的ADR/ADE文献,采用回顾性研究和统计学方法对该类饮片的安全事件进行分析。结果:共纳入补虚类饮片ADR/ADE的文献报道261篇,案例932例,涉及ADR/ADE的饮片有38味,占补虚类饮片数的48.10%。分析可见,补虚类饮片ADR/ADE的主要影响因素为患者自行用药、剂量过大、长期用药、个体差异等,且损害人体多个器官及系统。结论:补虚类饮片安全事件的发生率较高。加强补虚类饮片的用药安全和警戒,对提高该类饮片的临床安全合理用药具有重要意义。

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 prepared slices of Chinese materia medica for tonics. Methods: The literature reports of 79 kinds of Chinese materia medica for tonics over last 30 years were reviewed, and then the characteristics and reasons of ADR/ADE by retrospective study and statistical methods were analyzed. Results: The total of 932 ADR/ADE cases were in 261 literature reports, in which 38 kinds of herbs were involved, accounting for about 48.10% of prepared slices of Chinese materia medica for tonics. According to the analysis, the main influence factors of ADR/ADE cases were self-medication, overdosage, long-term use, individual differences, and so on. The included ADR/ADE cases usually affected multiple organs and systems. Conclusion: The incidence of safety events that led by Chinese materia medica for tonics is relatively high. Therefore, it is necessary to take pharmacovigilance actions to offer reference and guidance for clinical safe and rational use.