Observation of the bone destruction of Qingre Huoxue Decoction in the treatment of active rheumatoid arthritis based on MRI evaluation: study protocol for a multicenter, randomized, double-blinded, controlled clinical trial

作者：Wei-Xiang Liu, Da Li, 唐晓颇 Tang, Xun Gong, Yanting Li, Yi Zhang, Chang Tian, Yue Ming, Jian Wang, Congmin Xia, Qiuwei Peng, Meng-ge Song, Fu-yuan Zhang, Jinzhi Guan, Yue Zhao, Xu Liu, Yong Wang, Yue Yue, Jiashu Yao, Weiqing Li, Jingjing Xie, Yubao Jiang, Xiaoya Liu, Zong Rui-kai, Bing Fan, Xi Wang, Chanyuan Wu, Qi Zhu, Yingying Qin, Yun-Ke Guo, Qingchun Huang, Quan Jiang · 发表于：Research Square · 年份：2022 · DOI：10.21203/rs.3.rs-2256219/v1 · 研究领域：Rheumatoid Arthritis Research and Therapies、Mycobacterium research and diagnosis、Infectious Diseases and Tuberculosis

Abstract Background: Bone destruction is the key and difficult point in the treatment of RA. Studies have found that the use of traditional Chinese medicine Qingre Huoxue Decoction (QRHXD) can effectively reduce disease activity and delay bone destruction. Magnetic resonance imaging (MRI) is one of the effective ways to evaluate bone destruction in RA in real time, which is helpful to the early evaluation and discovery of synovitis and bone destruction. Therefore, we designed a multicenter, randomized, double-blinded, controlled clinical trial to assess the improvement of the bone destruction of QRHXD in treating RA using MRI. Methods: This study aimed to assess the definitive evidence that the traditional Chinese medicine QRHXD slows bone destruction in RA using MRI. A total of 204 adult participants with RA will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be QRHXD plus MTX and the control intervention will be QRHXD placebo plus MTX for 24 weeks. The primary outcome measure will be RA MRI score at screening period and 24 weeks. Secondary outcome measures will include the ACR20, ACR50 and ACR70, DAS28, patient report outcome(PRO), health assessment questionnaire(HAQ) and X-ray sharp score of both hands. In addition, the vital signs and adverse reactions of the subjects will be recorded. Discussion: The purpose of this study is to use MRI to confirm that QRHXD can effectively slow the imaging progress of active RA. To provide evide...