收涩类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for astringent: Safety analysis and pharmacovigilance considerations

目的:通过对收涩类中药饮片安全事件报道的系统梳理,分析其引发不良反应/事件(ADR/ADE)的特点及原因,提出收涩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,收集和整理29味收涩类中药饮片的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:收集收涩类中药饮片ADR/ADE文献报道46篇,病例167例,涉及ADR/ADE的饮片为5味,占收涩类饮片数的17.24%。分析可知,收涩类饮片ADR/ADE的临床表现主要为A、B型不良反应,以毒副反应和过敏反应较为常见,其主要影响因素为超剂量用药、误用滥用、个体差异等。结论:引起ADR/ADE的收涩类中药饮片种类数量相对较少,集中于罂粟壳,故应对其可能发生安全问题的因素加以警戒,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 materia medica for astringent. Methods： The literature reports of 29 kinds of Chinese materia medica for 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 167 ADR/ADE cases were in 46 literature reports, in which 5 kinds of herbs were involved, accounting for about 17.24% 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, which were toxic and allergic reactions as the most common manifestations. And the main influencing factors were over dosage, misuse and abuse, individual differences, and so on. Conclusion： Although the included ADR/ADE reports of Chinese materia medica involved few kinds of prepared slices, which are mostly concentrated in Pericarpium Papaveris, it is necessary to take pharmacovigilance actions to improve the safe and rational use.