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目的 总结分析我国近5年来文献报道的药物性肝损伤(DILI)患者的临床特征.方法 检索2012年1月-2016年12月我国DILI相关原始病例报道,并从中纳入202篇相关文献,共计26015例DILI患者.总结DILI的性别、年龄及地域分布、致病药物、临床特征及预后情况.计数资料以率或构成比描述.结果 26015例DILI患者中,男12885例(49.53%),女13130例(50.47%),平均46.86岁.排列前5位的致病药物分别为中药(34.68%)、抗结核药(15.81%)、抗微生物药(12.04%)、抗肿瘤药(9.09%)、解热镇痛药(6.17%).临床表现主要为乏力(50.37%)、黄疸(52.68%)、纳差(43.59%).158篇文献记录了19994例患者DILl的分型,其中肝细胞型占58.84%、胆汁淤积型占21.79%、混合型占19.37%.肝活组织检查在诊断DILI中有一定价值.停用可疑药物,给予抗炎、保肝等综合治疗是DILI的主要治疗方式.179篇文献记录了22030例患者的预后信息,其中治愈11159例(50.65%)、好转8742例(39.68%)、无效1176例(5.34%)、死亡353例(1.60%).结论 国内文献报道DILI男女比例相当,中药引起的DILI最为常见,损伤类型以肝细胞型居多,治愈及好转率90.34%,患者大多预后良好.“,”Objective To investigate the clinical features of patients with drug-induced liver injury(DILI)in China in the last five years. Methods Related databases were searched for original case reports on DILI in China published from January 2012 to December 2017,and a total of 202 articles with 26 015 DILI patients were included in this analysis. Sex,age,geographical distribution,causative drugs,clinical features,and prognosis were summarized and analyzed. Categorical data were expressed as rate(%)or constituent ratio. Results Of all 26 015 patients,12 885(49.53%)were male and 13 130(50.47%)were female,with a mean age of 46.86 years. The five most common causative drugs were traditional Chinese medicine(TCM)(34. 68%),anti - tubercular agents(15. 81%),anti - microbial drugs (12.04%),antitumor drugs(9. 09%),and analgesic - antipyretic drugs(6. 17%). Major clinical manifestations included fatigue (50.37%),jaundice(52.68%),and poor appetite(43.59%). A total of 158 articles recorded the typing of 19994 DILI patients,among whom 58.84% had the hepatocellular type,21.79% had the cholestasis type,and 19.37% had the mixed type. Liver biopsy had a certain value in the diagnosis of DILI. Major therapies for DILI included withdrawal of suspected drugs,anti-inflammatory treatment,and liver protection. A total of 179 articles reported the prognosis of 22 030 patients,among whom 11 159(50.65%)were cured,8742(39.68%) were improved,1176(5.34%)had no response,and 353 patients(1.60%)died. Conclusion There is a similar incidence rate of DILI between male and female populations. TCM is the most common causative drugs for DILI. The hepatocellular type is the most common clini-cal type. The cured and improved rate is as high as 90.34%,and most patients have good prognosis.