Objective To evaluate the applicability and advantage of diagnostic method for herb-induced liver injury (HILI) based on the integrated evidence chain (iEC) with an exemplification by Polygonum multiflorum (PM). Methods A total of 145 HILI patients implicated with PM and its preparation before onset were enrolled from 302 Military Hospital of China from January 2007 to December 2016. The diagnostic efficiency for HILI and the reliability of causality were compared between iEC and Roussel-Uclaf causality assessment method (RUCAM). Results Among 145 HILI patients assessed by RUCAM scale, 74 cases were diagnosed as probable population, which was predominant (51.0%). Among patients diagnosed with probable HILI based on RUCAM score, 5 cases were qualified for confirmed diagnosis, 54 cases for clinical diagnosis and 15 cases for suspected diagnosis after evidence chain was constructed by using iEC method, proportions of cases with confirmed diagnosis, clinical diagnosis and suspected diagnosis were 71.4%, 53.5% and 74.1% assessed by iEC, respectively. Seven patients were diagnosed with confirmed HILI by use of iEC method, whereas those were considered probable (n=5) and possible (n=2) based on RUCAM scale. Chronic liver diseases had no effect on the diagnostic efficiency of iEC method in HILI patients (P > 0.05), but it could obviously reduce the scores of RUCAM scale in HILI patients compared with HILI patients without chronic liver diseases (P<0.001). Conclusions Both iEC method and RUCAM scale have a good consistency. iEC method can be appropriate for the diagnosis and causality assessment of HILI due to clinical complicated factors of herbal medicines, especially in patients with chronic liver diseases.%目的 以何首乌为例,解读中草药相关肝损伤(herb-induced liver injury, HILI)客观诊断整合证据链(integrated evidence chain, iEC)法的适用性和优势.方法 以2007年1月—2016年12月解放军第三〇二医院收治的145例发病前有何首乌及其制剂服用史的HILI患者为研究对象,对比新建立的iEC法和常规应用的罗素优克福因果关系评估方法(Roussel-Uclaf causality assessment method, RUCAM)的诊断效能和因果关系判断的异同.结果 145例HILI患者的RUCAM相关性评分以"很可能"为主(n=74, 51.0%).而这些RUCAM相关性评分为"很可能"的患者中,经iEC法构建证据链后, 5例达到"确定诊断",54例达到"临床诊断",15例为"疑似诊断",分别占iEC法相同诊断级别HILI患者的71.4%、53.5%和40.5%.RUCAM相关性评分仅为"很可能"(5例)和"可能"(2例)级别的7例患者,通过iEC法构建证据链可达到"确定诊断".经iEC法客观辨识后,无慢性肝病(chronic liver diseases, CLDs)基础和有CLDs基础的HILI患者的诊断级别变化不大(P>0.05),而有CLDs基础HILI患者的RUCAM相关性评分级别较无CLDs基础HILI患者明显下降(P<0.001).结论 iEC法与RUCAM法的总体一致性较好,iEC法是适用于临床影响因素较为复杂的HILI诊断和因果关系评价,对有基础肝病的药物性肝损伤患者仍有较好的适用性.
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