基于整合证据链的白鲜皮粉末致肝损伤病例实验研究  

Dictamni Cortex powder-induced liver injury based on integrated evidence chain

作　　者：黄奕雪 郭玉明[2] 周永峰[2] 章从恩[2] 景静[3] 刘士敬[3] 张娜娜[4] 宋经元[4] 肖小河[3] 王伽伯[2] HUANG Yi-xue GUO Yu-ming ZHOU Yong-feng ZHANG Cong-en JING Jing LIU Shi-jing ZHANG Na-na SONGJlng-yuan XIAO Xiao-he WANG Jia-bo(Chengde Medical College, Chengde 067000, China China Military Institute of Chinese Materia Medica, 302 Military Hospital, Beijing 100039, China Integrated Traditional Chinese and Western Medicines Diagnosis, Treatment and Research Center, 302 Military Hospital, Beifing 100039, China Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100193, China)

机构地区：[1]承德医学院,河北承德067000 [2]中国人民解放军第302医院全军中医药研究所,北京100039 [3]中国人民解放军第302医院中西医结合肝病诊疗与研究中心,北京100039 [4]中国医学科学院北京协和医学院药用植物研究所,北京100193

出　　处：《中国中药杂志》2017年第3期600-606,共7页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2015ZX09501-004-001-008);国家公益性行业专项(201507004-04)

摘　　要：针对白鲜皮可能导致肝损伤的问题,该文对1例典型的单独服食白鲜皮粉末导致肝损伤病例进行临床和实验室系统研究。按照《中草药相关肝损伤临床诊疗指南》推荐的整合证据链方法对该病例进行诊断研究。通过临床病史、生化学和影像学等检查,排除基础疾病以及病毒性、自身免疫性、酒精性等易混淆肝病对诊断的影响;通过服药史调查,排除其他药物对诊断的影响,该患者仅服食1种药物,怀疑该患者为"白鲜皮粉末"导致药物性肝损伤。进一步按照《中国药典》对患者服食药物进行质量检查,符合白鲜皮项下规定;采用DNA条形码鉴定,ITS2序列BLAST比对,与植物白鲜Dictamnus dasycarpus相似度为100%;检测外源性有害物质,重金属、农残、微生物毒素均未超过相关标准的规定;采用液相高分辨质谱联用仪及Agilent Fake TCM-Drugs数据库检查,未发现化学药物添加。综上,确定该病例为单独服用白鲜皮粉末(15 g/日,超过药典规定用量)导致药物性肝损伤。该文按照《中草药相关肝损伤临床诊疗指南》,从临床到实验室系统检查,确认了1例单独服食白鲜皮粉末致药物性肝损伤的典型病例,为后续研究白鲜皮及其相关制剂的肝损伤风险提供了直接和可靠证据。A typical clinical case of taking Dictamni Cortex（ Baixianpi） powder was analyzed to study liver damage caused by Dictamni Cortex. Liver damage was diagnosed according to the integrated evidence chain method recommended by the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury. By analyzing clinical history and biochemistry and imaging examinations,underlying diseases,such as viral hepatitis,autoimmune liver disease and alcoholic liver disease,were excluded. Through the investigation of medication history,we made it clear that the patient only took Dictamni Cortex powder during the period,and thus suspected that the liver injury was induced by Dictamni Cortex. Furthermore,the quality of the drug was tested,and the results showed it was consistent with the quality standard of Chinese Pharmacopoeia. DNA barcoding showed that the drug was 100% similar with Dictamnus dasycarpus. Moreover,exogenous harmful substances and chemical drug additions were tested,and the results showed that the content of heavy metal,pesticide residues and microbial toxin were consistent with the required standards,and no chemical drug additions were found in Agilent Fake TCM-Drugs database. In summary,we confirmed that the clinical case of drug-induced liver injury was induced by D. dasycarpus with the dose of 15 g · d^（-1）,which exceeded the prescribed amount of Chinese Pharmacopoeia. According to the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury,the case of drug-induced liver injury induced by D. dasycarpus was confirmed,which provided a direct and reliable evidence for the study of risk of liver injury induced by D. dasycarpus and its relevant preparations.

关 键 词：中草药 肝损伤 白鲜皮 整合证据链 生药学鉴定 

分 类 号：R575[医药卫生—消化系统]