药物性肝损伤相关医疗损害案例分析  

Case Analysis of Medical Damage Related to Drug-induced Liver Injury

作　　者：刘秀兰 李为 郭敏[1] 杜金凤 刘东[1] 李娟[1] Liu Xiulan;Li Wei;Guo Min;Du Jinfeng;Liu Dong;Li Juan(Department of Pliarmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Beijing Yingke Law Firm)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030 [2]北京盈科律师事务所

出　　处：《药物流行病学杂志》2021年第11期729-734,共6页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:分析药物性肝损伤(drug-induced liver injury, DILI)导致的相关医疗纠纷的规律及特点,为临床合理用药提供参考。方法:对2010年8月~2020年11月录入北京盈科律师事务所法律文书数据库的DILI相关医疗损害责任纠纷案例的裁判文书进行分析,建立数据库,汇总分析相关纠纷的原因并制定较为全面的处方审核策略。结果:共检索到判决书88例,纳入裁判文书39例,案例例数呈现逐年递增的趋势。导致肝损伤药物排名前三分别是中药汤剂(13例,27.66%)、抗结核药(9例,19.15%)及中成药(8例,17.02%)。约1/4的案例法院判决医方因DILI存在医疗过错,需承担60%~100%的赔偿责任;类似医疗纠纷案件在各级医院都有发生,以三级医院发生比例最高(20例,51.28%)。判罚缘由主要为医方对患者的用药指征把握不严格,用药风险预见不足,防范监测不到位,告知义务履行不严格。结论:医疗机构应健全并落实药品不良反应监测管理制度,重视DILI,加强临床合理用药、用药监护及处方审核,可利用处方审核软件降低DILI发生风险,发挥药师在处方审核与药学服务中的作用。Objective:To analyze the regularity and characteristics of the medical damage liability related to drug-induced liver injury(DILI), and to provide references for clinical rational use of drugs.Methods:Medical damage liability disputes cases caused by DILI retrieved by legal documents database of Beijing Yingke Law Firm from August 2010 to November 2020 were analyzed. We established a database, analyzed the causes and formulated a comprehensive prevention and prescription review strategy. Results:A total of 88 judgments were retrieved and 39 were included in the judgment document. The number of cases showed an increasing trend year by year. The top three drugs that caused liver damage were traditional Chinese medicine(13 cases 27.66%), anti-tuberculosis drugs(9 cases 19.15%) and Chinese patent medicines(8 cases 17.02%). Approximately one-quarter of the case courts ruled that the doctor had medical fault due to DILI and was required to bear 60%-100% of the compensation liability;this medical dispute case occurred in all levels of hospitals, with the highest proportion in tertiary hospitals(51.28% of 20 cases). The main reasons for the punishment were that the doctors were not strict with the patient’s medication indications, the medication risks were not foreseeable, the prevention monitoring was not in place, and the notification obligation was not strictly fulfilled. Conclusion:Medical institutions can use prescription review software to reduce the risk of DILI, and play the role of pharmacists in prescription review and pharmaceutical care. Physicians should pay attention to DILI, earnestly inquire, strengthen medication education and monitoring, reduce the life safety threats and related medication disputes caused by the adverse reactions to patients.

关 键 词：药物性肝损伤 医疗纠纷 侵权责任 处方审核 药品不良反应 

分 类 号：R595.3[医药卫生—内科学]