中成药致药物性肝损伤 159例回顾性分析

目的探讨中成药致药物性肝损伤( DILI)的发生原因、发生特征，以期规范中成药的使用，减少中成药相关不良反应。方法回顾性分析 2015年 1月至 2022年 12月苏州市中西医结合医院中成药致 DILI病人 159例，记录病人的基本情况(性别、年龄)、原发疾病、用药史、临床特征、实验室检查结果等。结果中成药致 DILI的发生与病人年龄分布和有无基础疾病有关，而与性别无关；涉及的中成药总共有 16种，主要用于治疗妇科及乳腺疾病、皮肤病、骨科疾病、心脑血管疾病以及肾脏疾病。使用骨康胶囊引发的药物性肝损病人有 31例，占比 19.50%；其次是仙灵骨葆胶囊，占比 11.95%；占比排名第三的是接骨七厘片/丸( 18例， 11.32%)；骨科疾病的病人服用相关中成药的时间较长。 159例确诊病人涵盖了药物性肝损伤的三种分型，包括肝细胞损伤型( 76例， 47.80%)、混合型( 51例， 32.08%)、胆汁淤积型( 32例， 20.13%)，肝细胞损伤型病人占比最高。其中，半数以上为轻度肝损伤( 81例， 50.94%)。结论在中医药理论指导下，严格遵循中医辨证施治的治疗原则，科学、规范应用中药，是提高用药安全性、减少中成药所致药物性肝损伤的重要措施。

The retrospective analysis of 159 cases with drug-induced liver injury caused by proprietary Chinese medicines

Objective To explore the causes and characteristics of drug-induced liver injury (DILI) caused by proprietary Chinesemedicines, in order to standardize the use of proprietary Chinese medicines and reduce the adverse reactions related to proprietary Chi-nese medicines.Methods The medical records of the 159 confirmed cases of DILI caused by proprietary Chinese medicines in Su-zhou Hospital of Integrated Traditional Chinese and Western Medicine from January 2015 to December 2022 were reviewed, and thebasic situation of patients, primary diseases, drug history, clinical features, laboratory test results were recorded.Results The occur- rence of DILI caused by proprietary Chinese medicines was related to the age distribution of patients and underlying diseases, but notto gender; There were a total of 16 kinds of proprietary Chinese medicines involved, which were mainly used to treat gynecological andbreast diseases, skin diseases, osteoarthrosis, cardiovascular and cerebrovascular diseases and kidney diseases. Thirty-one patients with drug-induced liver damage were caused by Gukang Jiaonang, accounting for 19.50%, followed by Xianlin Gubao Jiaonang, ac- counting for 11.95%, Jiegu Qili Pian ranked the third (18 cases, 11.32%). Patients with orthopaedic diseases take the relevant proprie-tary Chinese medicines for a longer period of time. The 159 confirmed patients covered the three types of DILI, including hepatocellu-lar injury (76 cases, 47.80%), mixed type (51 cases, 32.08%), and cholestatic type (32 cases, 20.13%). Among them, patients with hepa-tocellular liver injury accounted for the highest proportion. In addition, more than half of patients had moderate liver injury (81 cases,50.94%).Conclusion Under the guidance of Chinese medicine theory, strictly following the treatment principles of TCM differentia-tion and treatment, and scientifically and standardizing the application of Chinese medicine are important measures to improve the safe-ty of medication and reduce drug-induced liver injury caused by proprietary Chinese medicine.