摘要
目的基于对药源性肝损伤(DILI)住院病例用药资料的详尽调查、核实及其肝生化检测数据的分析,探讨本地区DILI发生的原因与规律性特征,进而对DILI,特别是中药DILI的报告提出规范性建议。方法自2012年1月—2015年12月在复旦大学金山医院消化科住院的60例DILI病例,逐一详尽调查用药资料及其肝生化资料,进行分类、分析、总结,报告DILI的相关药物及影响因素,判断DILI的依据包括因果关系的明确、时间顺序关系的合理:即用药时出现临床症状、肝酶指标的异常升高或肝功能的恶化,停药后病情好转或正常。结果 DILI病例有肝酶指标的异常升高,平均年龄63.1岁。除DILI外,患1种以上疾病者60例,患2种以上疾病者56例,例均患病3.3种。例均用药5.7种,在致DILI的主药中,解热镇痛药27例,占45.0%;确定为纯中药相关者2例,占3.3%。DILI患者血白蛋白低于正常平均值者55例,占91.7%;前白蛋白低于正常平均值者58例,占96.7%;纤维蛋白原低于正常平均值者30例,占50.0%;血红蛋白低于正常平均值者53例,占88.3%;抗凝血酶活性共测45例,低于正常平均值者30例,占66.7%。结论 DILI病例以长期用多种药物的老年病例为主,大多数有以白蛋白水平降低为代表的慢性肝功能损害、有前白蛋白降低代表的新近肝功能损害,说明DILI的大多数是在有慢性肝损伤基础上产生的新近肝损伤。DILI的主要病因是解热镇痛药,而不是中药。报告DILI时,尤其是中药DILI,必需提供药物的生产厂家、批号,若是中药材必需提供足够的鉴定信息或来源证明。
Objective To summarize the causes and characteristics of drug-induced liver injury(DILI) and thus propose the principles for DILI reports,esp.,of Chinese herbs based on comprehensive investigation of drug administration data.Methods From January 2012 to December 2015,we exhaustively investigated the complete medication data of 60 DILI inpatients one by one,and the culprit-drugs of DILI were identified.The medication data before hospitalization and the data of liver function and liver chemistries tested were sorted,analyzed and summarized.In this way the factors for DILI,and its characterization were reported.The DILI drugs was determined by the time relationship between incident of DILI and the time of culprit-drug administration:the elevation of liver enzymes or worsening of liver function,and abnormal symptoms following drug administration;and liver enzymes lowered and abnormal symptoms relieved after discontinuation of the drugs.Results The average age of DILI patients was 63.1 years old.After excluding DILI itself,60(100%) patients had ≥1 diseases,56(93.3%) patients had ≥2 diseases.The average number of diseases per patient was 3.3.The average number of drugs administered per patient was 5.7.In the major causes of DILI,there were 27 cases due to NSAIDs,accounting for 45.0%,as the first cause of DILI;and there were 2 cases due to Chinese herbal monotherapy,accounting for 3.3%.In all DILI patients,there were 55,accounting for 91.7% with albumin below the average normal level;there were 58,accounting for 96.7% with prealbumin below the average normal level;there were 30,accounting for 50% with fibrinogen below the average normal level;and there were 53,accounting for 88.3% with hemoglobin below the average normal level.Antithrombin activity was tested in 45 patients,there were 30,accounting for 66.7% with antithrombin activity below the average normal level.Conclusion NSAIDs are the first cause of DILI.DILI patients were mostly the elderly population with multiple diseases and had a long-term administration of multiple drugs,and had asymptomatic potential liver injury.The majority were with chronic liver injury presented by lowered albumin level,and with recent liver injury by lowered prealbumin level.In view of background complexity and the multi-drug use history in DILI patients,the surveying,analysis and attribution of DILI causes must be cautious to confirm the real causative drugs.We propose to strengthen the normative of DILI reports.DILI.It is necessary to provide the exact information of pharmaceuticals:the usage of the pharmaceuticals,the formal manufacturer and the batch numbers,and etc.The results of this study suggest that in reporting DILI,we must be careful in drug source checking,surveying,and attribution,especially for Traditional Chinese Medicine.If it is for the toxicity of medicinal plants,sufficient professional identification information,or the source of the Chinese herbs must be presented for verification.
作者
蒋淼
方忠宏
刘玉娟
姜玲海
任伟芳
Jiang Miao;Fang zhonghong;Liu Yujuan;Jiang Linghai;Ren Weifang(Gastrointestinal Department,Jinshan Hospital,Fudan University ,Shanghai 201508,China;Department of Pharmacy ,Jinshan Hospital,Fudan University ,Shanghai 201508,China)
出处
《北京中医药大学学报》
CAS
CSCD
北大核心
2019年第2期149-159,共11页
Journal of Beijing University of Traditional Chinese Medicine
关键词
药源性疾病
解热镇痛药
非甾体抗炎药
药源性肝损伤
中药
白蛋白
前白蛋白
肝功能
肝化学
Drug-induced diseases
non-steroidal anti-inflammatory drugs(NSAIDs)
drug-induced liver injury
Traditional Chinese Medicine
albumin
prealbumin
liver function
liver chemistry
