然降多吉胶囊治疗活动性类风湿性关节炎(湿痹/寒湿阻络证)Ⅲ期临床研究

Clinical Study(phase III) of Ranjiangduoji Capsule in Treating Patients with Active Rheumatoid Arthritis(Stagnancy of Cold-dampness in Collaterals)

目的:在Ⅱ期临床试验基础上进一步观察然降多吉胶囊的安全性及不良反应;进一步评价该药治疗活动性类风湿性关节炎、藏医辨证为湿痹(寒湿阻络证)者的疗效。方法:符合活动性类风湿性关节炎(湿痹/寒湿阻络证)患者共478例进入临床试验,采用多中心、分层区组随机、双盲双模拟、平行对照临床试验设计方法,4周为一疗程。结果:然降多吉胶囊治疗组有效率为71.7%;对照组有效率为64.3%,两组比较无显著性差异(P>0.05),但然降多吉胶囊对治疗类风湿关节炎的体征疗效,即关节压痛数、关节肿胀数与对照药复方雪莲胶囊相比有显著性差异(P<0.05),治疗药然降多吉胶囊明显优于对照药。结论:然降多吉胶囊具有散寒除湿,消肿止痛功效,能显著减轻活动性类风湿性关节炎患者关节疼痛及关节肿胀、缩短晨僵时间,临床使用是安全有效的。

Objective： To assess the efficacy and safety of Ranjiangduoji Capsule （RJDJC） in treating active rheumatoid arthritis （RA） differentiated as stagnancy of cold-dampness in collaterals with traditional Tibetan medicine based on previous clinical study （phase Ⅱ ） and especially to evaluate the curative effects in odynolysis and detumescence and fix the clinical dosage. Methods： Four hundred and seventy-eight patients were enrolled according the criteria of active RA （stagnancy of cold--dampness in collaterals） in the study which was multi-centered, double-blinded, randomized and parallel controlled. All subjects were randomly divided into treatment group （n= 359, RJDJC, 2 capsules per time and twice a day） and control group （n=l19, Fufangxuelian Capsule, 2 capsules per time and twice a day）. The duration lasted 4 weeks. Main indexes were effective rate, erythrocyte sedimentation rate （ESR）, C-reactive protein （CRP）, etc. Results.. The effective rate of treatment group and control group was 71.7 % and 64.3% respectively, and there was no significant difference between them （P〉0.05）. For improvement on arthralgia and arthroncus, treatment group showed better effect, and there was significant difference between the two groups （P〈0.05） after treatment. No serious adverse effects were detected. Conclusion.. RJDJC was considered to possess the functions of dispelling cold and removing dampness, and removing edema to relieve pain. It could remarkably alleviate active RA patients＇ joint pain and shorten morning stiffness duration with strong safety.