中药不良反应的现状分析及应对策略探讨

Current Situation Analysis and Countermeasure Exploration of Adverse Reactions of Traditional Chinese Medicine

目的:分析中药不良反应(adverse drug reaction,ADR)的现状及发生原因,提出应对策略。方法:查询近年中药不良反应的相关文献,结合临床实际经验进行归纳分析。结果:中药不良反应发生率呈逐年升高的趋势,涉及多个系统和器官,以皮肤及附件系统、消化系统和神经系统最为常见,主要由中药药物因素(如品种混乱、产地差异、污染等)、使用因素(炮制不规范、用法用量疗程不当、辨证错误或配伍不当等)和机体因素等造成。结论:应当重视中药不良反应,对中药材从生产到使用各环节严格进行质量控制和监管,建立完善警戒系统和补偿救济法律法规,加强临床合理科学用药,从医疗机构和临床药师、医生角度积极采取预防措施,最大限度减少或避免中药不良反应的发生。

Objective： To analyze the present situation and causes of adverse drug reactions （ADR） of traditional Chinese medieine （TCM） and put forward raasonable countermeasures to reduce the risk of ADR. Methods： The present situation and causes of ADR of TCM were analyzed and summarized by searching the literatures about ADR of TCM in recent years combining with the clinical practical experience. Results： The incidence of ADR of TCM showed a rising trend year by year, which involved multiple systems and organs such as skin and accessories system, digestive system and nervous system. The ADR was mainly caused by drug factors （ confused species, location difference, pollution and so on）, use factors （ irregular processing, improper usage and dosage, error syndrome differentiation and improper compatibility） and body factors. Conclusion： It is necessary to pay attention to the ADR of TCM. Quality control and supervision from production to application of herbs should be strengthened, warning system and law of compensation and relief should be established, and scientific and reasonable drug use should be enhanced in clinics. Effective countermeasures should be carried out from medical institutions, clinical pharmacist and clinician point of view to minimize or avoid the risk of ADR of TCM.