雷公藤多苷/雷公藤片治疗类风湿关节炎用药指南  

Clinical practice guideline for Tripterygium Glycosides/Tripterygium wilfordii Tablets in treatment of rheumatoid arthritis

作　　者：林娜[1] 姜泉[2] 刘维[3] 刘健[4] 黄清春[5] 吴宽裕[6] 涂胜豪[7] 周祖山 陈卫衡 李小霞[10] 张彦琼 代表编制组 LIN Na;JIANG Quan;LIU Wei;LIU Jian;HUANG Qing-chun;WU Kuan-yu;TU Sheng-hao;ZHOU Zu-shan;CHEN Wei-heng;LI Xiao-xia;ZHANG Yan-qiong;representing the preparation group(Institute of Chinese Materia Medico,China Academy of Chinese Medical Sciences,Beijing 100700,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230031,China;Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510020,China;the Second People's Hospital,Fujian University of Traditional Chinese Medicine,Fuzhou 350003,Chirui;Tongji Hospital Affiliated to Tongji Medical School,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Honghu,Hubei Province Hospital of Traditional Chinese Medicine,Honghu 433200,China;Third Affiliated Hospital,Beijing University of Chinese Medicine,Beijing 100029,China;Xuanwu Hospital,Capital Medical University,Beijing 100053,China;不详)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]中国中医科学院广安门医院,北京100053 [3]天津中医药大学第一附属医院,天津300381 [4]安徽中医药大学第一附属医院,安徽合肥230031 [5]广东省中医院,广东广州510020 [6]福建中医药大学附属第二人民医院,福建福州350003 [7]华中科技大学同济医学院附属同济医院,湖北武汉430030 [8]湖北省洪湖市中医院,湖北洪湖433200 [9]北京中医药大学第三附属医院,北京100029 [10]首都医科大学宣武医院,北京100053 [11]不详

出　　处：《中国中药杂志》2020年第17期4149-4153,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81974526,81974529,81974537,81873068);北京市自然科学基金项目(7192139);中央级公益性科研院所基本科研业务费专项(Z2017082,ZXKT19013)。

摘　　要：雷公藤是治疗类风湿关节炎疗效确切且应用最为广泛的中药之一,其代表制剂雷公藤多苷片和雷公藤片均为2019年版《国家基本医疗保险、工伤保险和生育保险药品目录》中的甲类药物,其中雷公藤多苷片还是2018年版《国家基本药物目录》的品种,且被2015年版《中国药典》纳入。由于雷公藤多苷片和雷公藤片在临床应用过程中常出现医生对用药指征难于准确把握、患者疗效参差不齐、毒副作用时有发生的情况,而现有药品说明书内容又过于简单和宽泛,为了规范雷公藤制剂的临床应用,国内风湿免疫临床、药物监督管理、药学和循证医学研究领域的38家权威单位和48位知名专家共同研制了《雷公藤多苷/雷公藤片治疗类风湿关节炎用药指南》,以供临床医疗应用及教学和科学研究参考。该指南在制作过程中遵循"循证为主、共识为辅、经验为鉴"的原则,通过名义组法对有证据支持的推荐建议形成"推荐意见",对无证据支持的推荐建议形成"共识建议",形成了雷公藤多苷片与雷公藤片在类风湿关节炎治疗中涉及功能主治、用法用量、合并用药、注意事项、疗效和安全性等方面的用药建议,其应用将有利于避免或减少雷公藤制剂的不良反应发生,增强疗效及降低医药费用,对提高中药合理用药水平也具有一定的示范推广价值。Tripterygium wilfordii Hook.f.(TwHF)is one of the most effective traditional Chinese herbal medicines against rheumatoid arthritis.As the representative agents of TwHF,Tripterygium Glycoside Tablets(TGT)and Tripterygium wilfordii Tablets(TWT)were included as Class A drugs in the 2019 edition of Medicine Catalogue for National Basic Medical Insurance,Injury Insurance and Maternity Insurance,and TGT was also included in 2018 edition of National Essential Drug List and 2015 edition of Chinese Pharmacopoeia.However,it is difficult to grasp the specific clinical applications of TGT and TWT.Side effects occur from time to time.The curative effect is uneven in patients.And the package inserts of TGT and TWT are not described in details.In order to standardize the clinical application of Tripterygium wilfordii preparations,38 authoritative units and 48 well-known experts in rheumatoid immunology clinical department,drug supervision and management,pharmacy and evidence-based medicine research fields jointly developed Tripterygium Glycoside Tablets and Tripterygium wilfordii Tablets Medication Guide for reference in clinical application,teaching and scientific research.The guideline followed the"evidence-based,consensus-assisted and experience-based"principles to form"recommendations"for the evidence supported ones,and form"consensus suggestions"for those without evidence support by using nominal group method.In this way,the medication recommendations on function,usage and dosage,drug combinations,precautions,efficacy,safety and other aspects of TGT and TWT can be provided.The application of this Guide will help to avoid or reduce the adverse reactions of T.wilfordii preparations,enhance the efficacy and reduce the cost of medicine,with certain demonstration and promotion values to improve the rational use level of traditional Chinese medicine.

关 键 词：雷公藤多苷片 雷公藤片 类风湿关节炎 临床用药指南 

分 类 号：R259[医药卫生—中西医结合]