中国药物警戒 ›› 2019, Vol. 16 ›› Issue (5): 270-276.

• 药物相关肝损伤研究专栏 • 上一篇    下一篇

何首乌相关肝损伤临床特征及用药合理性分析

涂灿1,2, 葛斐林1, 郭玉明1, 张雅铭1, 肖小河1, 王伽伯1,*   

  1. 1 解放军总医院第五医学中心/全军中医药研究所,北京 100039;
    2 成都中医药大学药学院,四川 成都 611137
  • 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: 王伽伯,男,博士,副研究员,中药安全性评价与风险防控。E-mail:pharm_sci@126.com
  • 作者简介:涂灿,男,在读博士,临床中药学。
  • 基金资助:
    国家自然科学基金重点项目(81630100): 基于临床病证的传统无毒中药肝毒性客观辨识及机制研究; 国家“重大新药创制”科技重大专项(2015ZX09501-004-001-008)：基于临床的中药何首乌肝毒性生物标记物研究; 公益性行业专项(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; 国家中药标准化项目(ZYBZH-Y-BJ-07): 何首乌和知母中药饮片标准化建设

Analysis of Clinical Characteristics and Medication Rationality of Polygonum Multiflorum Thunb. and Its Preparation-related Liver Injury

TU Can1,2, GE Feilin1, GUO Yuming1, ZHANG Yaming1, XIAO Xiaohe1, WANG Jiabo1,*   

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

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摘要： 目的 通过对何首乌及制剂相关肝损伤的临床特征及用药合理性的分析,探讨其肝损伤可能的风险因素,以期为其临床用药安全提供参考。方法 对2012~2016年何首乌相关肝损伤病例报告,分析何首乌相关肝损伤临床特征、用药合理性及可能的风险因素。结果 何首乌及制剂相关肝损伤病例女性多于男性,发病年龄跨度在8~93岁,中位数发病年龄是47岁（男、女性中位数发病年龄分别为40.5和51岁）;服药到发生肝损伤的时间跨度为1~376天,中位数为31天;服药日剂量为1~200 g,中位数为10 g。提示何首乌相关肝损伤具有典型的特异质属性。进一步探索其风险因素,发现患者存在自发用药（未在医师指导下）、生（制）何首乌混淆使用、非传统用药方式（膳食、泡酒、打粉、代茶饮等）、炮制不规范等不合理用药方式,是何首乌及制剂相关肝损伤的重要风险因素。此外,不恰当的联合用药、超药品说明书用药和临床重复用药等也可能是导致何首乌相关肝损伤的重要风险因素之一。结论 本文通过探索性分析何首乌及制剂致肝损伤相关安全风险因素,提示临床应用何首乌应高度重视其肝损伤风险,避免不合理用药,提高其安全用药水平。

关键词: 药品不良反应, 何首乌, 不合理用药, 风险因素

Abstract: Objective To investigate the clinical characteristics of liver injury related to Polygonum multiflorum Thunb.(PM) and its common preparations, and analyze their risk factors, so as to provide reference for rational drug use in clinic. Methods Based on the cases of PM and preparation-related liver injury for the past 5 years (2012~2016), the clinical characteristics of PM-related liver injury, the rationality of drug use and possible risk factors were analyzed. Results The incidence age ranged from 8 to 93 years, and the median age of onset was 47 years (the median age of onset was 40.5 for men and 51 for women, respectively). The time span from administration to liver injury was 1~376 days, with a median of 31 days. The daily dose was 1~200 g, with a median of 10 g, suggesting that PM-induced liver injury had idiosyncratic properties. The results from further exploration of the risk factors showed that some unreasonable drug uses were important risk factors for liver injury of PM, such as individual self-medication (not under the guidance of a physician), mixed use of crude and processed PM, unconventional drug use (diet, alcohol, powder and tea) and irregular processing, etc. In addition, clinical repeated drug use, exceeding the drug instructions and inappropriate combination therapy were also important risk factors for liver injury caused by PM. Conclusion This article explores the safety risk factors of liver injury caused by PM and its preparations, suggesting that the clinical application of PM should be paid great attention to the risk of liver injury, avoid irrational use of drugs, and improve the level of safe drug use.

Key words: adverse drug reaction, Polygonum multiflorum Thunb., irrational drug use, risk factors

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