中国药物警戒 ›› 2021, Vol. 18 ›› Issue (3): 235-239.
DOI: 10.19803/j.1672-8629.2021.03.06

• 何首乌肝毒性研究专栏 • 上一篇    下一篇

口服何首乌制剂用药前后肝功能变化分析

周明1, 费占洋1,△, 赵久丽2, 薛丹2, 李明2, 李登科1, 王子建1, 李轶群1, 唐雪春2,*, 孙震晓1,#   

  1. 1北京中医药大学生命科学学院,北京 102488;
    2北京中医药大学东直门医院,北京 100700
  • 出版日期:2021-03-15 发布日期:2021-04-06
  • 通讯作者: *唐雪春,女,博士,主任医师,硕导,中医临床研究。E-mail：tangxuechun@yeah.net ＃共同通信作者。
  • 作者简介:周明,男,博士,中药分子细胞药理学与毒理学。△并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（81473418）：肝细胞色素P450酶表达低下致何首乌特异质肝毒性机制研究

Changes of Liver Function in 35 Patients Orally Taking Polygoin Multiflori Radix Preparations

ZHOU Ming1, FEI Zhanyang1,△, ZHAO Jiuli2, XUE Dan2, LI Ming2, LI Dengke1, Wang Zijian1, LI Yiqun1, TANG Xuechun2,*, SUN Zhenxiao1,#   

  1. 1School of Life Sciences, Beijing University of Chinese Medicine, Beijing 100029, China;
    2Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • Online:2021-03-15 Published:2021-04-06

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摘要： 目的 研究临床常规使用含何首乌汤剂及中成药患者用药前后肝功能指标变化,分析其临床应用的肝损伤风险。方法 收集35例临床使用含何首乌汤剂或中成药患者的一般资料,并对患者用药前后谷丙转氨酶（ALT）、门冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、谷氨酰转肽酶（GGT）、总胆红素（TBIL）、直接胆红素（DBIL）和间接胆红素（IBIL）等指标进行检测,根据用药前7项肝功能检测指标正常与否将患者分为2组,分析用药前后2组别患者有无肝功能损伤。结果 用药前7项肝功能检测指标正常组患者,用药后AST、ALP、GGT、TBIL、DBIL和IBIL均值变化差异无统计学意义（P>0.05）,ALT均值变化差异有统计学意义（P<0.05）,但均在正常值范围内;用药前7项肝功能检测指标不正常组患者,用药后ALP、GGT、TBIL和IBIL均值变化差异无统计学意义（P>0.05）,但用药后部分肝功能指标均值有所下降。结论 临床常规服用含何首乌汤剂或中成药较为安全,肝损伤风险较小。

关键词: 含何首乌制剂, 不良事件, 肝功能, 肝损伤

Abstract: Objective To analyze the post-treatment changes of liver function in patients taking a conventional dosage of decoction and Chinese patent medicine containing Polygoni Multiflori Radix(PMR), and to determine the risk of liver injury in clinical application. Methods The clinical data on 35 cases who used decoction and Chinese patent medicine containing PMR was collected. Their liver function indexes, such as alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP),γ-glutamyl transpeptadase (GGT), total bilirubin(TBIL), direct bilirubin(DBIL) and indirect bilirubin(IBIL) , were detected. The patients were divided into two groups according to the normality of their liver function indexes before treatment and the incidence of liver injury after treatment was analyzed. Results There was no significant difference in levels of AST, ALP, GGT, TBIL, DBIL or IBIL after treatment（P>0.05）in patients who had normal liver function before treatment, but there was significant difference in ALT（P<0.05）that was in the normal range. Among patients who had abnormal liver function before treatment, there was also no significant difference in levels of ALP, GGT, TBIL or IBIL after treatment（P>0.05）, but some of their liver function indexes decreased after treatment. Conclusion Taking orally a conventional dosage of decoction and Chinese patent medicine containing PMR is relatively safe and has lower clinical risk of liver injury.

Key words: Polygoni Multiflori Radix, adverse event, liver function, liver injury

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