拔毒化腐生肌类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for removing necrotic tissue and promoting tissue regeneration: Safety analysis and pharmacovigilance considerations

目的:通过系统梳理拔毒化腐生肌类中药饮片的安全事件报道,阐释并分析该类饮片引发不良反应/事件(ADR/ADE)的特点及原因,提出合理用药及药物警戒建议。方法:系统检索30年来国内外文献报道,收集和整理7味拔毒化腐生肌类饮片的ADR/ADE文献报道,采用回顾性研究和统计学方法对该类饮片引发的安全事件进行分析。结果:共纳入拔毒化腐生肌类饮片安全事件报道56篇,病例492例,涉及ADR/ADE的饮片共6味,占拔毒化腐生肌类饮片总数的85.71%。分析可见,拔毒化腐生肌类饮片ADR/ADE的临床表现涉及人体多个器官/系统,主要的影响因素为误用、剂量过大、长期用药、个体差异、给药途径不当等。结论:拔毒化腐生肌类饮片发生安全问题多见于硼砂、轻粉、砒石。加强拔毒化腐生肌类饮片的用药警戒,对提高该类饮片的安全合理应用具有重要意义。

Objective： 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 removing necrotic tissue and promoting regeneration. Methods： The literature reports of 7 kinds of Chinese materia medica for removing necrotic tissue and promoting regeneration 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 492 ADR/ADE cases were in 56 literature reports, in which 6 kinds of herbs were involved, accounting for about 85.71% of prepared slices of Chinese materia medica for removing necrotic tissue and promoting regeneration. According to the analysis, the included ADR/ADE cases generally affected multiple organs and systems. The main influence factors of ADR/ADE cases were misuse, overdosage, longterm use, individual differences, improper dosing way, and so on. Conclusion： The safety problems of prepared slices for removing necrotic tissue and promoting regeneration appear mainly in cases with Borax, Calomelas and Arsenicum sablimatum. Therefore, it is necessary to take pharmacovigilance actions to offer reference and guidance for clinical safe and rational use.