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糖苷类片剂治疗类风湿关节炎临床实践指南

Clinical Practice Guideline for Glycosides/ Tablets in the Treatment of Rheumatoid Arthritis.

作者信息

Lin Na, Zhang Yan-Qiong, Jiang Quan, Liu Wei, Liu Jian, Huang Qing-Chun, Wu Kuan-Yu, Tu Sheng-Hao, Zhou Zu-Shan, Chen Wei-Heng, Li Xiao-Xia, Ding Ying, Fang Yong-Fei, Liu Jian-Ping, Li Zhen-Bin, He Dong-Yi, Chen Yao-Long, Lou Yu-Qian, Tao Qing-Wen, Wang Qing-Wen, Jin Ying-Hui, Liao Xing, Li Tai-Xian, Wang Xiao-Yue

机构信息

Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China.

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Front Pharmacol. 2021 Jan 14;11:608703. doi: 10.3389/fphar.2020.608703. eCollection 2020.

Abstract

Hook F (HF) is one of the most commonly used and effective traditional Chinese herbal medicines against rheumatoid arthritis (RA). Both Tripterygium Glycoside Tablets (TGT) and Tablets (TWT) are the representative HF-based agents enrolled into the 2019 edition of Medicine Catalog for National Basic Medical Insurance, Injury Insurance, and Maternity Insurance. However, individual differences in TGT/TWT response across patients usually exist in the process of treating RA, implying that the clinical application of the two agents may not be standardized leading to the ineffective treatment and the risk of side effects. Growing evidence show that the bioactive constituents of HF may often have toxicity, the package insert of TGT and TWT may not be described in detail, and the therapeutic windows of the two agents are narrow. Thus, it is an urgent task to develop a standardized clinical practice guideline for TGT and TWT in the treatment of RA. In the current study, a group of clinical experts of traditional Chinese medicine and Western medicine in the research field of rheumatism diseases, pharmacists, and methodologists of evidence-based medicine were invited to select the clinical questions, to determine the levels of the evidence and the strength of the recommendations, and to develop the recommendations and good practice points. The guideline is formed based on the combination of clinical research evidence and expert experience (evidence-based, consensus, supplemented by experience). The clinical problems which are supported by clinical evidence may form recommendations, and the clinical problems without clinical evidence may form experts' suggestions. Both recommendations and experts' suggestions in this guideline summarized the clinical indications, usage, dosage, combined medication, and safety of TGT and TWT against RA systematically and comprehensively, which may offer a professional guidance in the context of the clinical application of the two HF-based agents.

摘要

雷公藤(HF)是治疗类风湿性关节炎(RA)最常用且有效的传统中药之一。雷公藤多苷片(TGT)和雷公藤片(TWT)均为纳入2019年版国家基本医疗保险、工伤保险和生育保险药品目录的代表性雷公藤制剂。然而,在治疗RA的过程中,患者对TGT/TWT的反应通常存在个体差异,这意味着这两种制剂的临床应用可能未标准化,从而导致治疗无效和出现副作用的风险。越来越多的证据表明,HF的生物活性成分可能常常具有毒性,TGT和TWT的药品说明书可能未详细描述,且这两种制剂的治疗窗较窄。因此,制定TGT和TWT治疗RA的标准化临床实践指南是一项紧迫任务。在本研究中,邀请了一组风湿病研究领域的中西医临床专家、药剂师以及循证医学方法学家来选择临床问题、确定证据水平和推荐强度,并制定推荐意见和良好实践要点。该指南基于临床研究证据与专家经验相结合(循证、共识、经验补充)而形成。有临床证据支持的临床问题可形成推荐意见,无临床证据的临床问题可形成专家建议。本指南中的推荐意见和专家建议均系统、全面地总结了TGT和TWT治疗RA的临床适应证、用法、用量、联合用药及安全性,可为这两种雷公藤制剂的临床应用提供专业指导。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1b0/7845140/f2bdea2e282c/fphar-11-608703-g001.jpg

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