然降多吉胶囊治疗活动性类风湿性关节炎(寒湿阻络证)随机双盲安慰剂对照多中心Ⅱ期临床试验

Double-Blind Randomized Placebo Controlled Trial (Phase Ⅱ) on the Efficacy and Safety of Ranjiangduoji Capsule in the Treatment of Patients with Active Rheumatoid Arthritis (Rtention of Cold-damp in the Collaterals)

目的 评价然降多吉胶囊治疗活动性类风湿性关节炎(寒湿阻络证)的有效性和安全性。方法 选择活动性类风湿性关节炎,藏医辨证为寒湿阻络证患者240例进行随机、双盲、安慰剂对照、多中心Ⅱ期临床试验。试验组120例给予然降多吉胶囊,对照组120例给予然降多吉胶囊安慰剂,均为每次2粒,每日2次,口服,治疗4周。同时,两组均使用甲氨喋呤10mg,每周1次,口服,作为基础治疗。以主要症状疗效和血沉,C反应蛋白改变等为主要观察指标,评价其临床有效性和安全性。结果 试验组对活动性类风湿关节炎的总有效率为72 .0%,活动性类风湿关节炎藏医证候的总有效率为82. 2%,均明显优于对照组(P<0. 05 );在改善关节疼痛、肿胀方面,试验组也明显优于对照组(P<0. 05)。临床试验中未发现明显不良反应。结论 然降多吉胶囊治疗活动性类风湿关节炎(寒湿阻络证)安全有效,能明显减轻患者关节疼痛、肿胀等症状。

Objective To assess the efficacy and safety of Ranjiangduoji capsule in the treatment of the active rheumatoid arthritis (Retention of Cold-damp in the collaterals). Methods The double-blind, randomized and placebo controlled muti-central methods was adopted. Two hundred and forty patients were randomized to treatment group (n=120, Ranjiangduoji capsule, 2 capsules bid) and control group (n=120, placebo, 2 capsules bid). Both groups were treated with MTX (10 mg/week) as baseline treatment. The duration was 4 weeks. Main outcomes were effective rate, Erythrocyte Sedimentation Rate (ESR), C-reactive Protein (CRP), etc. Results The effective rate of treatment group was 72.0%, the effective rate of TCM syndrome was 82.2%, there was significant difference between the two groups (P<0.05). For improvement on arthralgia and arthroncus, there was also significant difference between the two groups (P<0.05) after 4 weeks duration. No obvious adverse effect was found in the observation. Conclusions Ranjiangduoji capsule has the clinical effect in treatment of the active rheumatoid arthritis, and has few side effects. Ranjiangduoji capsule can alleviate pain of joints.