涌吐类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for emetic: Safety analysis and pharmacovigilance considerations

目的:梳理涌吐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,提出涌吐类中药饮片的合理用药与药物警戒建议。方法:系统检索30余年来国内外文献报道,收集和整理4味涌吐类中药饮片的安全事件报道,采用回顾性研究和统计学方法分析该类中药饮片的不良反应特点及原因。结果:共收集到4味涌吐类中药饮片安全问题的文献报道23篇,案例35篇。其ADR/ADE的临床表现主要为A型不良反应,以毒副反应较为常见;主要影响因素为超剂量用药、误用滥用等。结论:涌吐类中药饮片均具有毒性,容易发生ADR/ADE且后果严重,临床上应对其可能发生安全问题的因素加以警戒,从而提高临床安全合理用药水平。

Objective： To analyze the characteristics and reasons of adverse drug reactions/adverse drug events（ADR/ADE）, and to provide suggestions for the pharmacovigilance and the rational use of prepared slices of Chinese material medica for emetic. Methods： The literature reports of 4 kinds of Chinese material medica for emetic over last 30 years were reviewed, and then ADR/ADE characteristics and reasons by retrospective study and statistical methods were analyzed. Results： The total of 35 ADR/ADE cases were in 23 literature reports, in which all 4 kinds of herbs were involved. According to the analysis, the main type of ADR/ADE was type A, and the toxic effect was the most common manifestations. The main influence factors were over dosage, misuse, self-medication, and so on. Conclusion： Due to all the Chinese material medica for emetic are toxic, and easily cause serious ADR/ADE, it is necessary to make pharmacovigilance suggestions to offer reference and guidance for clinical safe and rational use.