肝脏 ›› 2018, Vol. 23 ›› Issue (8): 666-669.

• 论著 • 上一篇    下一篇

187例中草药及其制剂导致肝损伤病例前瞻性临床研究

何婷婷, 钟学文, 张宁, 白云峰, 周坤, 周超, 王葽, 宫嫚   

  1. 100039 北京 解放军第三○二医院中西医结合诊疗与研究中心中西医结合科(何婷婷,张宁,白云峰,周坤,周超,王葽,宫嫚);航天中心医院中医科(钟学文)
  • 收稿日期:2018-02-27 发布日期:2020-04-24
  • 通讯作者: 宫嫚,Email:gongman302@163.com
  • 基金资助:
    国家中医药管理局专项课题(JDZX2015187)

Prospective clinical study of 187 cases with liver damage caused by Chinese herbal medicine and its preparations

HE Ting-ting, ZHONG Xue-wen, ZHANG Ning, BAI Yun-feng, ZHOU Kun, ZHOU Chao, WANG Yao, GONG Man   

  1. Integrative Department of Integrative Medicine Center for Liver Diseases Diagnosis and Treatment, 302 Military Hospital, Beijing 100039; TCM Department of Aerospace Central Hospital, Beijing 100049
  • Received:2018-02-27 Published:2020-04-24
  • Contact: GONG Man, Email:gongman302@163.com

摘要: 目的 观察中草药及其制剂导致肝损伤(herb-induced liver injury,HILI)的临床特征。方法 前瞻性分析2015年9月至2016年6月解放军第三○二医院187例HILI住院患者一般情况、用药史、生化指标、预后、三种诊断方法(整合证据链法iEC、结构化专家意见SEOP、因果关系评分RUCAM)诊断结果差异。结果 137例HILI患者为女性,年龄18~81岁,多发年龄段为40~59岁,中药开始应用至发生肝损伤的平均时间为60 d,139例(74.3%)临床分型为肝细胞损伤型;导致HILI的中药治疗疾病排在前5位的有:胃炎(8.0%)、椎间盘突出(5.3%)、失眠(4.8%)、脱发(4.8%)、银屑病(4.3%)。导致HILI中药汤剂及中成药的组方中,含既往有肝毒性报道的前5位中草药:何首乌(n=21)、延胡索(n=10)、大黄(n=9)、柴胡(n=8)、补骨脂(n=7)。29例(15.5%)发生肝硬化,30例(16.0%)形成慢性,死亡3例(1.6%)。187例HILI患者中,iEC法临床诊断率为47.6%,SEOP法临床诊断率为29.9%;HILI/DILI构成比方面,iEC法、RUCAM法及SEOP法结果分别为23.2%、48.7%、14.6%。结论 中草药及其制剂可导致肝损伤,应重视中药肝毒性,整合证据链法能够提高HILI临床诊断率,降低HILI/DILI构成比。

关键词: 中药肝损伤, 中药, 整合证据链, 临床特征, 预后

Abstract: Objective To observe clinical characteristics of herb-induced liver injury (HILI).Methods A total of 187 inpatients in our hospital between September 2015 and June 2016 were prospectively enrolled in the study, whose general condition, medical history, clinical manifestations, biochemical indices, prognosis and diagnosis differences using integrated evidence chain-based causality identification algorithm (iEC), structured expert opinion process (SEOP) and the Roussel Uclaf Causality Assessment Method (RUCAM) were analyzed.Results Among the patients, 137 (73.3%) were females aging from 18 to 81 years old, with majority in 40~59 years old. The median time from the application of Chinese herbs to the occurrence of liver injury was 60 days. Moreover, 139 cases (74.3%) were classified as hepatocellular injury. The most important 5 diseases, herbs for which were most likely to cause HILI, were gastritis (8.0%), disc herniation (5.3%), insomnia (4.8%), hair loss (4.8%), and psoriasis (4.3%). Among the Chinese herbs and traditional patent medicines that lead to HILI, the top 5 Chinese herbal with hepatotoxicity were Polygonum multiflorum (n=21), Corydalis Rhizome (n=10), Rhei Radix et Rhizome (n=9), Bupleuri Radix (n=8) and Psoraleae corylifolia (n=7). In the HILI patients, there were 29 (15.5%) with cirrhosis, 30 (16.0%) with chronicity and 3 (1.6%) died. The clinical diagnosis rates using iEC and SEOP were 47.6% and 29.9%, respectively. The ratio of HILI/DILI diagnosed with iEC, RUCAM and SEOP were 23.2%, 48.7% and 14.6%, respectively.Conclusion Attention should be paid to herbal hepatotoxicity. Our study suggests that iEC method could improve the clinical diagnosis rate of HILI and decrease the radio of HILI to DILI.

Key words: Herb-induced liver injury, Herbs, Integrated evidence chain-based causality identification algorithm, Clinical manifestations, Prognosis