CAJ | 학술논문

目的：探讨中药与西药引发的药物性肝损伤（DILI）的临床特性。方法回顾性分析78例2008年7月至2014年7月江苏省中医院收治的DILI患者中、西药引发DILI的临床特点和实验室指标的差异性。结果发病人群以中老年患者为主，女性发病人数是男性的2倍以上，类型以肝细胞型（79.49%）最多见；中药引发的DILI患者占39.74%，西药引发的DILI患者占60.26%。中药与西药引发的DILI的人群发病年龄、性别、用药至发病时间、临床分型及免疫特性在临床表现上差异均无统计学意义（P均＞0.05），但两者临床疗效上差异均有统计学意义（P均＜0.05），即中药引发DILI的预后较差。初始发病时，中药引发DILI患者的TBil、ALT、AST、总胆汁酸（TBA）水平均高于西药引发患者（P均＜0.05），但两者总蛋白（TP）、白蛋白（ALB）、碱性磷酸酶（ALP）、谷氨酰转肽酶（GGT）及PT差异均无统计学意义（P均＞0.05）。中药或西医引发DILI患者治疗两周的肝功能均较治疗前有显著改善（P均＜0.05），PT变化均不大（P＞0.05），中药引发DILI患者的肝功能指标中，仅TBA显著高于西药引发患者（P＜0.05）。结论与西药相比，中药肝毒性更大且肝细胞坏死程度更重，其治疗恢复较慢，且预后较差。
목적：탐토중약여서약인발적약물성간손상（DILI）적림상특성。방법회고성분석78례2008년7월지2014년7월강소성중의원수치적DILI환자중、서약인발DILI적림상특점화실험실지표적차이성。결과발병인군이중노년환자위주，녀성발병인수시남성적2배이상，류형이간세포형（79.49%）최다견；중약인발적DILI환자점39.74%，서약인발적DILI환자점60.26%。중약여서약인발적DILI적인군발병년령、성별、용약지발병시간、림상분형급면역특성재림상표현상차이균무통계학의의（P균＞0.05），단량자림상료효상차이균유통계학의의（P균＜0.05），즉중약인발DILI적예후교차。초시발병시，중약인발DILI환자적TBil、ALT、AST、총담즙산（TBA）수평균고우서약인발환자（P균＜0.05），단량자총단백（TP）、백단백（ALB）、감성린산매（ALP）、곡안선전태매（GGT）급PT차이균무통계학의의（P균＞0.05）。중약혹서의인발DILI환자치료량주적간공능균교치료전유현저개선（P균＜0.05），PT변화균불대（P＞0.05），중약인발DILI환자적간공능지표중，부TBA현저고우서약인발환자（P＜0.05）。결론여서약상비，중약간독성경대차간세포배사정도경중，기치료회복교만，차예후교차。
Objective To investigate the clinical characteristics of drug-induced liver injury (DILI) caused by Traditional Chinese Medicine (TCM) or Western medicine.Methods Total of 78 cases with DILI were collected in Jiangsu Province Hospital of TCM during the period from 2008 July to 2014 July, then the clinical characteristics of DILI caused by TCM or Western medicine as well as the differences between the indexes of laboratory were analyzed retrospectively.Results The mainly patients were middle-aged and elder. The number of female patients was twice more than that of male ones, and the most common is liver cell type (about 74.49%). Further analysis found that DILI caused by TCM account for about 39.74%, while the Western medicine ones were about 60.26%. There were no differences in age, gender, the onset of disease, clinical classiifcation, and clinical immunological characteristics between DILI induced by TCM and Western medicine (P>0.05), but showed signiifcant statistical difference in clinical efifcacy between such two drug types (P<0.05), the prognosis was poor in TCM-induced compared to the Western medicine ones. During the initial onset time, hepatic function indexes such as the levels of TBil, ALT, AST, TBA of TCM-induced DILI were signiifcantly higher compared to the Western medicine ones (P<0.05). However, the levels of TP, ALB, ALP, GGT and PT induced by two types of drug showed no signiifcant differences (P>0.05). The hepatic function of TCM or Western medicine-induced DILI showed signiifcantly improved after treatment for two weeks compared to that of pre-treatment (P<0.05) except the level of PT (P>0.05). The results also showed that only TBA was higher in DILI patients induced by TCM compared to that of the Western medicine (P<0.05).Conclusions The hepatotoxicity and the degree of hepatocyte necrosis-induced by TCM is higher than that of the Western medicine, also its prognosis is worse and recovery is slower compared to the Western medicine ones.