Tang Yujun, Li Haichang, Huang Lin, Wang Qiao, Han Yongmei, Wu Huaxiang, Su Xiao, Hou Xiujuan, Huang Chuanbing, Lin Changsong, Tao Qingwen, Tang Jinyang, Cao Wei, Xie Zhijun, Wen Chengping
College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China.
Department of Rheumatology, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, China.
Front Pharmacol. 2022 Feb 14;13:793394. doi: 10.3389/fphar.2022.793394. eCollection 2022.
Rheumatoid arthritis (RA) is an autoimmune disease characterized by progressive bone erosion on diarthrodial joints. RA patients usually experienced three stages before final diagnosis: the health period, the pre-clinical period (immune response exists without clinical symptoms), and the pre-RA period (immune response exists with mild inflammatory manifestation). Presently, there is seldom guidance referring to early intervention which is a benefit for stable disease conditions and low morbidity. Prophylactic treatment is a major feature of traditional Chinese medicine (TCM). In this present study, a multi-center, double-blind, placebo-controlled clinical trial is carried out to evaluate both efficacy and safety in preventing RA progression on Yunpi Qufeng Chushi formula (YQCF). The multi-center, double-blind, placebo-controlled clinical trial is conducted in 13 hospitals nationwide. A total of 390 patients ages between 18 and 70 will be recruited in the trial. They will be randomly assigned to the intervention group (YQCF) and placebo group. The follow-up visit will be taken every 3 months from baseline to 1 year. Diagnosis, disease activity scores, clinical disease activity index (CDAI), simplified disease activity index (SDAI), TCM syndrome scores, and safety assessments will be recorded at every visit. Joint color doppler ultrasound, health assessment questionnaire-disability index (HAQ-DI), and functional assessment of chronic illness therapy-fatigue (FACIT-F) will be recorded at baseline and the last visit. This work will provide evidence of YQCF in preventing RA progression. However, whether early intervention would benefit the controlling RA disease still needs a long-term follow-up. Protocol version 2 (201910-1). This research was approved by the medical ethics committee of Zhejiang Chinese Medical University (2019-045). Results will be published in a peer-reviewed academic journal. http://www.chictr.org.cn/index.aspx, ChiCTR1900024166.
类风湿关节炎（RA）是一种自身免疫性疾病，其特征为滑膜关节进行性骨质侵蚀。RA患者在最终确诊前通常经历三个阶段：健康期、临床前期（存在免疫反应但无临床症状）和类风湿关节炎前期（存在免疫反应且有轻度炎症表现）。目前，关于早期干预的指导很少，而早期干预有利于病情稳定和低发病率。预防性治疗是中医的一大特色。在本研究中，开展了一项多中心、双盲、安慰剂对照的临床试验，以评估运脾祛风除湿方（YQCF）预防RA进展的疗效和安全性。该多中心、双盲、安慰剂对照临床试验在全国13家医院进行。共招募390名年龄在18至70岁之间的患者参与试验。他们将被随机分配至干预组（YQCF）和安慰剂组。从基线到1年，每3个月进行一次随访。每次随访时记录诊断、疾病活动评分、临床疾病活动指数（CDAI）、简化疾病活动指数（SDAI）、中医证候评分和安全性评估。在基线和最后一次随访时记录关节彩色多普勒超声、健康评估问卷残疾指数（HAQ-DI）和慢性病治疗功能评估-疲劳量表（FACIT-F）。本研究将为YQCF预防RA进展提供证据。然而，早期干预是否有利于控制RA疾病仍需要长期随访。方案版本2（201910-1）。本研究已获浙江中医药大学医学伦理委员会批准（2019-045）。研究结果将发表在同行评审的学术期刊上。http://www.chictr.org.cn/index.aspx，ChiCTR1900024166 。
