中药与西药源性药物性肝损害的临床特点分析

Drug-induced liver injury:clinical characteristics analysis of traditional Chinese medicine and western medicine induced liver injury

目的探讨中、西药药物性肝损害(DILI)的发病特点,为临床合理用药、规避药物引起肝损害提供依据。方法对第一诊断为"药物性肝炎/药物性肝损害"的328例患者进行RUCAM评分,将≥6分的274例患者纳入研究,比较中、西药DILI的发生情况、临床特征及风险因素。结果中、西药DILI的发生比率为1∶2.22,男女比率分别为1∶1.74和1∶0.77,抗结核药和何首乌分别是导致DILI最主要的西药和中药。中药引起DILI的患者中ALT、TBil、AST、GGT和ALP均高于西药组,其中ALT和TBil的差异有统计学意义(P<0.01,P<0.018);住院天数、ALT、AST和ALP为DILI预后的影响因素。HBV感染是严重型DILI的危险因素(P=0.022)。结论中药使用过程中DILI发生率之高,甚至可引起比较严重的肝损害,需引起重视。初发病时的ALT、AST和ALP水平对预后有一定的预测意义。

Objective To explore the different clinical features of liver injury induced by traditional Chinese medicine and western medicine,and to provide evidences for promoting clinical rational drug use and avoiding drug-induced liver injury（DILI）.Methods Three hundred and twenty-eight patients with primary diagnosis of DILI were assessed by Roussel Claf causality assessment methodRoussel Uclaf Causality Assessment Method（RUCAM）rating system,274 of which with scores≥6 were enrolled in this study for comparison of occurrence,clinical features and risk factors between traditional Chinese medicines and western medicine induced liver injury.Results Ratio of traditional Chinese medicine and western medicine induced liver injury was 1∶2.22,in which male/female ratio was 1∶1.74 and 1∶0.77,respectively.Besides,main drugs of western and traditional Chinese medicine due to DILI were anti-tuberculosis drugs and polygonum multiflorum,respectively.Levels of alanine aminotransferase（ALT）,total bilirubin（TBiL）,aspartate transaminase（AST）,gamma-glutamyl transpeptidase（GGT）and alkaline phosphatase（ALP）in traditional Chinese group were much higher than those in western medicine group.Furthermore,levels of ALT and TBiL showed statistically significant difference（P〈0.0001,P〈0.018,respectively）between the 2 groups.The prognosis of DILI was related to hospitalization days and levels of ALT,AST and ALP.In addition,hepatitis B virus（HBV）infection was a risk factor of severe DILI（P=0.022）.Conclusion Traditional Chinese drug induces liver injury more frequently than western medicine does,even causes serious liver damage,which should be paid more attention to.Levels of ALT,AST and ALP at first diagnosis are significant predictors for prognosis.