中国药物警戒 ›› 2019, Vol. 16 ›› Issue (5): 265-269.

• 药物相关肝损伤研究专栏 • 上一篇    下一篇

雷公藤制剂相关肝损伤分析

宋迪1,2, 葛斐林2, 张乐2, 王伽伯2, 秦旭华1,*, 郭玉明2,*   

  1. 1 成都中医药大学药学院,四川 成都 611137;
    2 中国人民解放军总医院第五医学中心/全军中医药研究所,北京100039
  • 收稿日期:2019-03-18 修回日期:2019-06-11 出版日期:2019-05-20 发布日期:2019-06-11
  • 通讯作者: 秦旭华,女,博士,教授·硕导,中药理论与应用研究。E-mail：1978537820@qq.com;郭玉明,女,博士,助理研究员,中医药临床评价。E-mail：guoyuming_0520@126.com
  • 作者简介:宋迪,女,硕士,中药理论与应用研究。
  • 基金资助:
    国家公益性行业专项课题（201507004-04）：基于免疫应激的何首乌肝损害易感人群筛查及风险防控对策研究

Analysis of Liver Injury Associated with Preparations Containing Tripterygium Wilfordii

SONG Di1,2, GE Feilin2, ZHANG Le2, WANG Jiabo2, QIN Xuhua1,*, GUO Yuming2,*   

  1. 1 College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Sichuan Chengdu 611137, China;
    2 China Military Institute of Chinese Medicine, the Fifth Medical Centre of Chinese People's Liberation Army General Hospital, Beijing 100039, China
  • Received:2019-03-18 Revised:2019-06-11 Online:2019-05-20 Published:2019-06-11

PDF (PC)

187

摘要： 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0~1 793天,中位数为12天;服药日剂量为6~180 mg,中位数为60 mg。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。

关键词: 雷公藤制剂, 药物性肝损伤, 临床特征, 合理用药

Abstract: 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.

Key words: preparations containing Tripterygium Wilfordii, drug-induced liver injury, clinical characteristic, rational drug use.

中图分类号: