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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: To systematically sort out the safety incidents reported on the decoction-producing saprophytic muscle slices of traditional Chinese medicine and explain the characteristics and causes of ADR / ADE caused by such decoctions, and put forward the suggestion of rational use and caution. Methods: The literature of ADR / ADE was collected and collated in the literature of the past 30 years. The ADR / ADE samples of 7 kinds of poisoned saprophytic muscle slices were collected and analyzed. The safety events caused by these kinds of slices were analyzed retrospectively and statistically. Results: A total of 56 safety cases were reported involving 492 cases of appendicitis, and 492 cases were involved in ADR / ADE, accounting for 85.71% of the total. The analysis shows that the clinical manifestations of ADR / ADE are related to multiple organs / systems of the human body. The main influencing factors are misuse, overdosage, long-term medication, individual differences, improper route of administration and so on. Conclusions: The safety problems of poisoning decoction of myogenic muscle slices are more common in borax, light powder, and limestone. Strengthening the extraction of poisonous saprophytic muscle Pieces medication alert, to improve the safe and rational use of such Pieces is of great significance.