化痰止咳平喘类中药饮片安全问题分析与用药警戒思考

Chinese materia medica for transforming phlegm and the treatment of cough and asthma: Safety analysis and pharmacovigilance considerations

目的:梳理化痰止咳平喘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,提出化痰止咳平喘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59味化痰止咳平喘类饮片的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:共收集化痰止咳平喘类饮片ADR/ADE的文献报道179篇839例。经筛选纳入文献156篇,案例573例,涉及ADR/ADE的饮片有22味,占化痰止咳平喘类饮片总数的37.29%。分析可见,化痰止咳平喘类饮片发生ADR/ADE的主要因素为患者自行用药及误用、剂量过大、长期用药、个体差异等,以及药物的贮藏、炮制、调剂过程中出现失误,其不良反应常累及人体多个器官系统。结论:化痰止咳平喘类饮片中药食两用药物安全事件多发,不良反应类型多样。加强化痰止咳平喘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： Analyze the characteristics and reasons of adverse drug reactions/adverse drug events（ADR/ADE）, and provide suggestions for the pharmacovigilance and rational use of prepared slices of Chinese materia medica for transforming phlegm and the treatment of cough and asthma. Methods： The literature reports of 59 kinds of these herbs were reviewed over last 30 years, and then the characteristics and reasons of ADR/ADE were analyzed by retrospective study and statistical methods. Results： The total of 573 ADR/ADE cases were in 156 literature reports, in which 22 kinds of herbs were involved, accounting for about 37.29% of these herbs. According to the analysis, the main factors of ADR/ADE cases were self-medication, overdosage, long-term use, individual body condition, and errors during drug storage, processing and dispensing. The ADR/ADE cases usually affected multiple organs and systems. Conclusion： There are more ADR/ADE cases reported in medicine and food dual-use drugs than the other herbs. To strengthen the pharmacovigilance of Chinese herbal pieces for transforming phlegm and the treatment of cough and asthma is of great significance in improving the safety and reasonable application of Chinese herbal piece.