【摘要】 目的：了解何首乌与首乌藤及其制剂发生药物性肝损伤(DILI)的临床特征，探讨何首乌与首乌藤发生肝损伤的风险因素，为临床合理用药提供参考。方法：收集2018—2024年上海中医药大学附属曙光医院有何首乌、首乌藤及其制剂服药史，临床诊断为DILI的病例，记录患者的基本信息、服药原因、剂量、疗程及临床症状、生化指标、预后等，分析DILI的临床特征和可能的风险因素。结果：56例因服用何首乌和首乌藤及其制剂致DILI的患者中，服用何首乌及其制剂的有40例(占71.43%),服用首乌藤及其制剂的有16例(占28.57%);8例患者存在超剂量使用何首乌的现象；DILI的临床分型主要为肝细胞损伤型(46例，占82.14%),严重程度分级以轻度肝损伤为主(33例，占58.93%)。多因素分析结果显示，何首乌组的疗程(OR=1.164,95%CI=1.032～1.277,P=0.006)和首乌藤组的疗程(OR=1.439,95%CI=1.116～1.855,P=0.005)为风险因素。结论：首乌藤发生DILI的风险低于何首乌。何首乌引起DILI与药物使用的规范程度、疗程和患者基础疾病相关。应当正确评价中草药相关肝损伤，科学规范使用何首乌和首乌藤及其制剂。更多还原

【Abstract】 OBJECTIVE: To investigate the clinical characteristics and risk factors of drug-induced liver injury(DILI) caused by Polygonum multiflorum, Caulis polygoni multiflori and their preparations, so as to provide references for clinical rational medication. METHODS: Data of patients diagnosed with DILI and received Polygonum multiflorum, Caulis polygoni multiflori and their preparations in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from 2018 to 2024 were collected, patients’ basic information, reasons of medication, dosages, courses of treatment, clinical symptoms, biochemical indicators and prognoses were recorded to analyze the clinical characteristics and possible risk factors of DILI. RESULTS: Among the 56 patients with DILI caused by Polygonum multiflorum, Caulis polygoni multiflori and their preparations, 40 cases(71.43%) received Polygonum multiflorum and its preparations, 16 cases(28.57%) received Caulis polygoni multiflori and its preparations. There were 8 cases of off-label dose of Polygonum multiflorum; the clinical classification of DILI was mainly hepatocyte injury type(46 cases, 82.14%), and the severity grading was mainly mild liver injury(33 cases, 58.93%). Results of multivariate analysis showed that the treatment courses of the Polygonum multiflorum group(OR=1.164,95%CI=1.032-1.277,P=0.006) and the Caulis polygoni multiflori group(OR=1.439,95%CI=1.116-1.855,P=0.005) were risk factors. CONCLUSIONS: The risk of DILI caused by Caulis polygoni multiflori is lower than that of Polygonum multiflorum. DILI caused by Polygonum multiflorum is related to standard medication, treatment course and the patients’ underlying diseases. Liver injury related to traditional Chinese medicine should be correctly evaluated, Polygonum multiflorum, Caulis polygoni multiflori and their preparations should be used scientifically and in a standardized manner.更多还原