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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 sort out the safety incidents reports of tonic type Chinese Herbal Medicine Pieces and analyze the characteristics and causes of ADR / ADE, and put forward the drug caution and rational drug use suggestion. Methods: The literature of ADR / ADE was collected and sorted out in 79 literatures at home and abroad in the past 30 years. The safety of the samples was analyzed by retrospective study and statistical method. Results: A total of 261 reports of ADR / ADE were included in the literature, of which 932 cases were involved. There were 38 flavors of ADR / ADE, accounting for 48.10% of ADR / ADE. Analysis shows that the main influencing factors of ADR / ADE are the patients self-medication, overdose, long-term medication, individual differences, etc., and damage many organs and systems in the human body. Conclusion: The incidence of tonic type puncture is higher. Strengthen the tonic classics Pieces of drug safety and alert, to improve the safety of such Pieces of clinical medication is of great significance.