摘要
目的从西药肝损伤和中药肝损伤2个维度对目前诊断药物性肝损伤的3种常用诊断方法进行临床适用性分析,并比较其特征及差异。方法前瞻性队列研究纳入2015年1月—2020年12月入住解放军总医院第五医学中心的非中西药联合应用的急性药物性肝损伤住院患者289例为研究对象,其中,中药肝损伤187例,西药肝损伤102例。分别应用整合证据链(IEC)、Roussel Uclaf因果关系评价法(RUCAM)、结构化专家观点程序(SEOP)3种诊断方法对289例患者进行诊断,收集患者急性起病时的一般资料、潜伏期、详细服药情况、实验室指标ALT、AST、GGT、ALP、TBil等。统计分析3种诊断方法分别对西药肝损伤和中药肝损伤病例诊断结果评定的一致性和各自适用性。计量资料组间比较采用Kruskal-Wallis H检验,计数资料组间比较采用χ^(2)检验。结果西药肝损伤与中药肝损伤的临床肝损伤类型均以肝细胞型为主(81.4%、74.3%),实验室指标表现为有更高的ALT和AST水平。应用IEC、RUCAM、SEOP分别对西药肝损伤病例进行诊断,临床诊断率依次为65.7%、100%、63.7%;西药肝损伤构成比依次是23.2%、35.3%和22.5%。再依次对中药肝损伤病例进行诊断,临床诊断率分别为47.6%、100%、29.9%;中药肝损伤构成比分别为30.8%、64.7%、19.4%。一致性检验结果显示,在诊断西药肝损伤病例时,除IEC与SEOP评价结果存在一致性外(Kappa=0.785,P<0.05),RUCAM vs IEC(Kappa=0.149,P>0.05)和RUCAM vs SEOP(Kappa=0.117,P>0.05)的一致性评定结果均较差。在诊断中药肝损伤时,RUCAM vs SEOP(Kappa=0.066,P>0.05)的一致性评定结果较差,而RUCAM vs IEC(Kappa=0.026,P<0.05)和IEC vs SEOP(Kappa=0.437,P<0.05)评价结果存在一致性。结论IEC对西药肝损伤和中药肝损伤均有较好的适用性,IEC与SEOP在诊断西药肝损伤时存在一致性,虽然在诊断中药肝损伤病例结果间也存在一致性,但一致性水平较低。RUCAM与另2种诊断方法评定结果的一致性均较差。临床对药物性肝损伤患者进行诊断时,应综合运用IEC、RUCAM和SEOP,以便更准确地判断药物与肝损伤之间因果关系。
Objective To investigate the clinical applicability and different characteristics of three commonly used diagnostic methods for drug-induced liver injury from the two aspects of liver injury induced by Western medicine and liver injury induced by traditional Chinese medicine.Methods A prospective cohort study was performed for 289 hospitalized patients with acute drug-induced liver injury who were admitted to The Fifth Medical Center of Chinese PLA General Hospital from January 2015 to December 2020 and did not receive integrated traditional Chinese and Western medicine therapy,among whom 187 patients had herb-induced liver injury and 102 had Western medicine-induced liver injury.The 289 patients were diagnosed by the integrated evidence chain(IEC),Roussel Uclaf Causality Assessment Method(RUCAM),and the Structured Expert Opinion Process(SEOP)method,and related data at acute onset were collected,including general information,latency period,detailed medication,and laboratory markers such as alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transpeptidase,alkaline phosphatase,and total bilirubin.A statistical analysis was performed to investigate the consistency between IEC,RUCAM,and SEOP in the diagnosis of Western medicine-induced liver injury and herb-induced liver injury and their own applicability.The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data;the chi-square was used for comparison of categorical data.Results The hepatocellular type was the main type of clinical liver injury in both Western medicine-induced liver injury and herb-induced liver injury,accounting for 81.4%and 74.3%,respectively,and laboratory examination showed higher levels of ALT and AST.Western medicine-induced liver injury cases were diagnosed by IEC,RUCAM,and SEOP,with a clinical diagnosis rate of 65.7%,100%,and 63.7%,respectively,and the constituent ratio of Western medicine-induced liver injury was 23.2%,35.3%,and 22.5%,respectively.Herb-induced liver injury cases were diagnosed by these three methods,with a clinical diagnosis rate of 47.6%,100%,and 29.9%,respectively,and the constituent ratio of herb-induced liver injury was 30.8%,64.7%,and 19.4%,respectively.The consistency test of the three diagnostic methods showed that in the diagnosis of Western medicine-induced liver injury cases,there was good consistency between IEC and SEOP(Kappa=0.785,P<0.05),while there was poor consistency between RUCAM and IEC(Kappa=0.149,P>0.05)and between RUCAM and SEOP(Kappa=0.117,P>0.05);in the diagnosis of herb-induced liver injury cases,there was poor consistency between RUCAM and SEOP(Kappa=0.066,P>0.05),while there was good consistency between RUCAM and IEC(Kappa=0.026,P<0.05)and between IEC and SEOP(Kappa=0.437,P<0.05).Conclusion The IEC method shows good applicability for both Western medicine-induced liver injury and herb-induced liver injury,and there is good consistency between IEC and SEOP in the diagnosis of Western medicine-induced liver injury cases,while there is a relatively low level of consistency between IEC and SEOP in the diagnosis of herb-induced liver injury.There is poor consistency between RUCAM and the other two methods.In the clinical diagnosis of Western medicine-induced liver injury,IEC,RUCAM,and SEOP should be used in combination to accurately judge the causal relationship between drugs and liver injury.
作者
何婷婷
梁庆升
王丽苹
梁龙鑫
李筱涵
崔延飞
景婧
柏兆方
宫嫚
王睿林
HE Tingting;LIANG Qingsheng;WANG Liping;LIANG Longxin;LI Xiaohan;CUI Yanfei;JING Jing;BAI Zhaofang;GONG Man;WANG Ruilin(Department of Traditional Chinese Medicine Hepatology of Department of Liver Disease,The Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;.The Fifth Ward of Department of Liver Disease,The Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;Institute of Liver Diseases,The Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;Department of Clinical Laboratory,The Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;College of Pharmacy,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;PLA Institute of Traditional Chinese Medicine,Beijing 100039,China)
出处
《临床肝胆病杂志》
CAS
北大核心
2022年第1期141-147,共7页
Journal of Clinical Hepatology
基金
重大科学攻关问题和医药技术难题科研课题(2020KTY001)
国家科技重大专项(2018ZX10303502-002-019,2018ZX10725506-002)
国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202005)。
关键词
化学性与药物性肝损伤
诊断
疾病特征
Chemical and Drug Induced Liver Injury
Diagnosis
Disease Attributes