中药药物性肝损伤报告中存在的问题及建议  

Problems in the Report of Traditional Chinese Medicine Drug-Induced Liver Injury and Recommondations

作　　者：冉姗 方忠宏[1] 黄海茵[2] 吕小群[1] 刘玉娟[1] RAN Shan;FANG Zhonghong;HUANG Haiyin;LYU Xiaoqun;LIU Yujuan(Jinshan Hospital of Fudan University,Shanghai,201508;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine)

机构地区：[1]复旦大学附属金山医院,上海市金山区201508 [2]上海中医药大学附属岳阳中西医结合医院

出　　处：《中医杂志》2021年第7期581-584,共4页Journal of Traditional Chinese Medicine

基　　金：上海市临床药学重点专科项目(2019-1229)。

摘　　要：目的评估国内报告的中药药物性肝损伤(DILI)文献,为中药DILI报告的标准操作规程提供建议。方法分别以"中药"并含"肝损伤"为关键词在中国知网进行检索,再以"药物"并含"肝损伤"为关键词检索,排除非DILI原始报告论文与无中药DILI文献后,逐篇查阅中药DILI相关报道的具体信息资料,对其疾病史、保健品史、饮酒史、中药史、西药史、药材来源及其鉴定信息等资料列表登记,整理、总结、报告中药DILI报告中存在的问题,并提出中药DILI报告的标准操作规范相关建议。结果以"中药"与"肝损伤"为关键词检索到文献220篇,纳入115篇。以"药物"与"肝损伤"为关键词检索到文献399篇,纳入212篇。共纳入分析327篇文献。在中药DILI报告中,报告多种疾病史者186篇(56.9%),说明多种药物用药史180篇(55.0%)、保健品应用史57篇(17.4%)、饮酒史110篇(33.6%)、中药用药史192篇(58.7%)、西药用药史171篇(52.3%),报告中药生产商21篇(6.4%)、批号15篇(4.6%)、用量用法95篇(29.1%)、用药持续时间253篇(77.4%)、药材来源9篇(2.8%),提供中药鉴定信息8篇(2.4%),说明DILI相关性140篇(42.8%)。在327篇中药DILI报告中,作者为诊疗者的69篇,查病历的研究257篇,借药物不良反应报告的研究1篇。结论在已有中药DILI报告中,作为药物不良反应/事件报告存在严重缺项,提示其研究结果可信度低。建议报告中药DILI需有相关中药的完整信息,给出中药DILI的因果论证,严格参照药物不良反应的报告规则,并经多学科专家进行判定。Objective To evaluate the papers reporting traditional Chinese medicine(TCM) drug-induced liver injury(DILI) in China, and to provide references for developing reporting standards of TCM DILI. Methods Terms including "Chinese herbal medicine(中药)", "drugs(药物)", and "liver damage(肝损伤)" were searched in CNKI for papers reporting TCM DILI. The basic characteristics regarding to the disease history, use of health-care products, drinking history, medications of both TCM and western medicine, source of Chinese medicinals and its identification were collected, and the problems in reporting TCM DILI were summarized. Results Totally, 327 reports on TCM DILI were included. The number of papers reporting history of multiple diseases was 186(56.9%), while that of history of multiple drugs, use of health-care products, drinking history, TCM medication history, use of western medicine drugs was 180(55.0%), 57(17.4%), 110(33.6%), 192(58.7%), and 171(52.3%), respectively. Information on manufacturers, batch numbers, dosage, duration, source of Chinese medicinals, and identification were reported in 21(6.4%), 15(4.6%), 95(29.1%), 253(77.4%), 9(2.8%) and 8(2.4%) papers respectively. One hundred and forty(42.8%) papers reported the correlation between TCM and DILI. Sixty nine papers were by clinical researchers, while 257 were retrospective studies based on medical records, and one was based on adverse drug reaction report(78.9%). Conclusion Current TCM DILI papers have not comprehensively reported both DILI-related patients′ information and TCM information, and mostly lacked the information on drug-related adverse reactions or adverse events, indicating a low reliability of the reporting. In future studies, full information on Chinese herbal medicine should be reported, confounding factors of western medicine should be excluded, and the standard procedures for reporting TCM DILI must be implemented.

关 键 词：药物性肝损伤 中药 药物不良反应 不良事件报告 

分 类 号：R285[医药卫生—中药学]