中药配方颗粒不良反应监测评价方法探讨

Discussion on Monitoring and Evaluation Methods of Adverse Reaction of Traditional Chinese Medicine Formula Granules

目的分析中药配方颗粒不良反应文献报道的特点与规律,为开展中药配方颗粒不良反应监测工作提供参考依据。方法检索2001年12月—2022年10月中国知网、万方、维普和PubMed等数据库,对中药配方颗粒不良反应相关文献报道进行统计和描述性分析;同时对黑龙江省9家医疗机构中药配方颗粒临床应用情况进行实地调研。结果筛选相关文献44篇,涉及中药配方颗粒不良反应/事件1580例(n=26780)。其临床多以组方(加减)配伍使用;不良反应主要累及胃肠系统损害(42.6%)、皮肤及其附件损害(24.5%)及心血管系统一般损害(21.3%)等。多数临床医师、药师认同开展中药配方颗粒不良反应监测工作,但目前缺乏上报途径和评价方法。结论临床应关注配方颗粒不良反应发生规律特点,加强不良反应监测机制研究,科学建立中药配方颗粒及中药饮片安全性评价方法,确保患者用药安全有效。

OBJECTIVE To analyze the characteristics and regularity of the adverse reaction(ADR)induced by traditional Chinese medicine(TCM)formula granules and provide a reference for monitoring the ADR of TCM formula granules.METHODS Relevant literature from CNKI,Wanfang,VIP,and PubMed from December 2001 to October 2022 were retrieved for ADRs induced by TCM formula granules for further statistical and descriptive analysis.In addition,the clinical application of TCM formula granules in 9 medical institutions in Heilongjiang Province was investigated.RESULTS Forty-four studies were selected,involving 1580 cases(n=26780)of ADRs of TCM formula granules.Its clinical application was mostly based on the combination(addition or subtraction)of prescriptions.ADR primarily involved the gastrointestinal system(42.6%),skin and its appendages(24.5%)and cardiovascular system(21.3%).Most clinicians and pharmacists agreed to monitor the ADR of TCM formulations,but there was a lack of reporting and assessment methods.CONCLUSION In clinical practice,attention should be paid to the characteristics of the occurrence of adverse reactions of formula granules,strengthen the research on the monitoring mechanism of adverse reactions,and establish a scientific method for the safety evaluation of formula granules and TCM tablets to ensure the safe and effective use of medicines by patients.