Wang Yi-Ru, Liu Li, Wang Xiao-Yun, Wang Qiong, Yao Min, Cui Xue-Jun, Mao Jian-Chun, Liu Jian, Gu Xiao-Hua, Chen Yong-Li, Yu Xiang, Shi Qi, Liang Qian-Qian, Wang Yong-Jun
Longhua Hospital, Shanghai University of Traditional Chinese Medicine.
Institute of Spine, Shanghai University of Traditional Chinese Medicine.
Medicine (Baltimore). 2019 Feb;98(6):e14424. doi: 10.1097/MD.0000000000014424.
Rheumatoid arthritis (RA) is a chronic systemic and autoimmune inflammatory disease ending with the destruction of joints. Current therapies can relieve RA symptoms, but some also bring severe adverse events. Therefore, an effective and safe therapeutic strategy remains to be created to benefit patients with RA by large. Jia Wei Niu Bang Zi granule (NBZG) consisting of RA-fighting Chinese herbals has been used in Longhua Hospital in the last several decades. NBZG has potential therapeutic effect on RA, which should be evaluated by larger sample clinical trial.
A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine the efficiency of NBZG in pain relief and joint protection. A total of 120 patients with active RA will be enrolled, and treated with NBZG or placebo for 12 weeks. The primary outcome measurements include rate of American College of Rheumatology (ACR) 50 at 12 weeks' treatment. The 2nd outcome measurements include rate change of ACR20, ACR70, the disease activity score (DAS) 28, 36-item Short-Form Health Survey Questionnaire, Health Assessment Questionnaire - Disability Index, score changes of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, and the Athens insomnia scale at the same time points.
Although NBZG has shown efficacy in treating RA in Longhua Hospital for decades, the universality of this efficacy needs evaluated. The results of this trial will provide a convincing evidence about NBZG's efficacy in treating active RA in a large population.
ClinicalTrials.gov ID: NCT03173040 (registered on May 30, 2017).
类风湿关节炎（RA）是一种慢性全身性自身免疫性炎症疾病，最终会导致关节破坏。目前的治疗方法可以缓解类风湿关节炎的症状，但有些也会带来严重的不良事件。因此，仍有待制定一种有效且安全的治疗策略，以使广大类风湿关节炎患者受益。加味牛蒡子颗粒（NBZG）由具有抗类风湿作用的中草药组成，在过去几十年中一直在龙华医院使用。NBZG对类风湿关节炎具有潜在的治疗作用，应通过更大样本的临床试验进行评估。
将进行一项多中心、随机、双盲、安慰剂对照的临床试验，以确定NBZG在缓解疼痛和保护关节方面的疗效。总共将招募120例活动性类风湿关节炎患者，并用NBZG或安慰剂治疗12周。主要结局指标包括治疗12周时美国风湿病学会（ACR）50达标率。次要结局指标包括ACR20、ACR70的达标率变化、疾病活动评分（DAS）28、36项简明健康调查问卷、健康评估问卷-残疾指数、患者关节炎疼痛评估、患者对关节炎的整体评估以及同一时间点的雅典失眠量表评分变化。
尽管几十年来NBZG在龙华医院治疗类风湿关节炎方面已显示出疗效，但这种疗效的普遍性需要评估。该试验的结果将为NBZG在大量人群中治疗活动性类风湿关节炎的疗效提供令人信服的证据。
ClinicalTrials.gov标识符：NCT03173040（于2017年5月30日注册）。
