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目的:通过对平肝息风类饮片安全事件报道的系统梳理,分析其发生不良反应/事件(ADR/ADE)的特点及原因,提出平肝息风类中药饮片的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17味平肝息风类中药饮片的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:纳入平肝息风类中药饮片ADR/ADE文献报道70篇,案例81例。涉及ADR/ADE的中药饮片10味,占平肝息风类饮片数的58.82%。分析可见,平肝息风类饮片ADR/ADE的临床表现主要为B型不良反应,涉及神经、循环及消化系统损害。平肝息风类饮片发生ADR/ADE的主要原因有机体因素、过量使用等。结论:平肝息风类饮片发生安全问题多见于动物类药材,加强平肝息风类中药饮片的用药警戒,对提高该类饮片的安全合理应用具有重要意义。
OBJECTIVE: To analyze the characteristics and causes of adverse reactions / events (ADR / ADE) of Pingfeng Zengfeng Tablets by systematically reviewing the reported safety events and put forward suggestions on alerting and rational use of Pingganzi Feng herbs. Methods: The literature of ADR / ADE was collected systematically and systematically from 30 years of domestic and foreign literatures. The ADR / ADE literature was collected and analyzed by using retrospective study and statistical method. Results: 70 cases were included in the literature of ADR / Chinese herbal pieces related to ADR / ADE 10 flavors, accounting for 58.82% of the number of flat liver flavor wind Pieces. Analysis shows that the main clinical manifestations of ADR / ADE of Pingganzi Fengcai Pieces are type B adverse reactions, involving nerve, circulatory and digestive system damage. The main reason for the occurrence of ADR / ADE of Pingganzi Fengcai Pieces is organism factor, excessive use and the like. Conclusion: The safety problems of Pingganzi Fengcai Pieces are more common in animal medicines. It is of great significance to improve the safety and rational application of Pingpizi Fengcai Pieces.