Na Lin, Quan Jiang, Wei Liu, Jian Liu, Qing-Chun Huang, Kuan-Yu W U, Sheng-Hao T U, Zu-Shan Zhou, Wei-Heng Chen, Xiao-Xia L I, Yan-Qiong Zhang
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Beijing 100053, China.
Zhongguo Zhong Yao Za Zhi. 2020 Sep;45(17):4149-4153. doi: 10.19540/j.cnki.cjcmm.20200710.501.
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.
雷公藤（Tripterygium wilfordii Hook.f.，TwHF）是治疗类风湿关节炎最有效的传统中药之一。作为雷公藤的代表性制剂，雷公藤多苷片（TGT）和雷公藤片（TWT）被列入《2019年国家基本医疗保险、工伤保险和生育保险药品目录》甲类药品，TGT还被列入《2018年国家基本药物目录》和《2015年中国药典》。然而，TGT和TWT的具体临床应用难以把握，不良反应时有发生，患者疗效参差不齐，且TGT和TWT的药品说明书描述不够详细。为规范雷公藤制剂的临床应用，风湿免疫临床、药品监督管理、药学及循证医学研究领域的38家权威单位和48位知名专家共同制定了《雷公藤多苷片和雷公藤片用药指南》，供临床应用、教学及科研参考。该指南遵循“循证、共识、经验”原则，对有证据支持的形成“推荐意见”，对无证据支持的采用名义组法形成“共识建议”，从而对TGT和TWT的功能、用法用量、药物联用、注意事项、疗效、安全性等方面提供用药建议。本指南的应用有助于避免或减少雷公藤制剂的不良反应，提高疗效，降低用药成本，对提高中药合理使用水平具有一定的示范和推广价值。
