雷公藤制剂相关肝损伤分析

Analysis of Liver Injury Associated with Preparations Containing Tripterygium Wilfordii

目的通过对雷公藤制剂相关药物性肝损伤(DILI)病例的分析,探讨其临床特征及用药特点,为雷公藤制剂的临床合理用药和安全性评价提供参考。方法对2012年1月~2016年12月雷公藤制剂相关DILI病例进行临床特征及用药特点的分析与再评价。结果5年期间共收集到雷公藤制剂相关DILI报告251例;年龄为6~89岁,41~60岁之间人数居多。对153例单用雷公藤制剂病例的用药原因分析发现,雷公藤制剂主要用于泌尿系统疾病、皮肤病、风湿性疾病等;服药到发生肝损伤的时间跨度为0~1793天,中位数为12天;服药日剂量为6~180mg,中位数为60mg。用药合理性分析发现,雷公藤制剂存在25例超疗程服药,3例禁忌人群用药,9例超剂量用药。结论雷公藤制剂对于泌尿系统、风湿免疫类疾病疗效确切,但在保证合理用药的前提下,仍然应重视其毒-效双重性和风险-获益评估,定期监测患者肝功能,警戒其肝损伤风险,以提高临床安全用药水平。

Objective Through analyzing drug-induced liver injury (DILI) case reports associated with preparations containing Tripterygium Wilfordii (Lei Gong Teng,LGT),to investigate its characteristics of clinic and medication,and to provide reference for the rational drug use and safety evaluation on preparations containing LGT in clinical application.Methods To analyze and reevaluate characteristics of clinic and medication of preparations containing LGT reported between January 2012 and December 2016.Results A total of 251 DILI case reports associated with preparations containing LGT were collected during 5 years,whose age range was from 6 to 89 years old,with the concentrating distribution of age group from 41 to 60.Preparations containing LGT were mainly used for urinary system diseases,skin diseases,rheumatic diseases,etc,by analyzing the reasons for medication of 153 cases.The period of taking the preparations containing LGT until DILI occurring was from 0 to 1 793 days with the median of 12 days,and the range of daily dose was from 6 to 180 mg,with the median of 60 mg.From the analysis of rational drug use,we found that there were 25 cases with the prolonged treatment beyond prescribed course,3 cases belonging to contraindication in people,and 9 cases with overdose respectively.Conclusion Preparations containing LGT were effective for urinary system and rheumatic immune diseases.However,under the premise of rational drug use,we should pay more attention to its duality of toxicity and effect and risk-benefit assessment while remind patients to detect their liver biochemical indexes regularly,which could guard against the risk of DILI,as well as improve the level of safe drug use in clinical application.