目的：观察补肾通督胶囊治疗肾虚寒凝型类风湿关节炎的临床疗效。方法将71例类风湿关节炎患者随机分为治疗组(36例)和对照组(35例),治疗组口服补肾通督胶囊,对照组口服雷公藤多苷片,疗程均为12周。观察用药前后临床症状和体征、病情、实验室指标等改善情况。结果治疗组总有效率为72.22%(26/36),对照组总有效率为62.86%(22/35),2组比较差异无统计学意义(P＞0.05)。2组治疗后临床疾病活动指数、中医证候积分、压痛关节数、肿胀关节数、患者对疾病总体状况评价、医生对疾病总体状况评价、休息痛、晨僵时间、双手平均握力、20 m步行时间、健康状况问卷评分、C反应蛋白水平均明显改善,差异有统计学意义(P＜0.01,P＜0.05)。中医证候积分治疗组优于对照组,差异有统计学意义(P＜0.05)。结论补肾通督胶囊对于肾虚寒凝型类风湿关节炎有良好的临床疗效。%Objective To investigate the clinical efficacy of Bushen Tongdu Capsule for treating patients with rheumatoid arthritis (RA, TCM syndrome of kidney-deficiency with cold). Methods Totally 71 RA patients were randomly divided into treatment group (36 cases) that was treated with Bushen Tongdu Capsule and control group (35 cases) that was treated with tripterygium glycosides tablet. Both groups were treated for 12 weeks. The signs and symptoms, the state of illness, and laboratory index were observed before and after treatment. Results The total effective rate was 72.22% (26/36) in the treatment group, and 62.86% (22/35) in the control group, without statistical significance (P>0.05). After treatment, simplified disease activity index, TCM syndrome integrals, tender joint count, swollen joint count, overall evaluation from patients, overall disease evaluation from doctors, rest pain, morning stiffness time, average hands grip strength, 20 m walking time, healthy condition questionnaire score, and C-reactive protein were significantly improved in both groups (P<0.01, P<0.05). Compared with control group, TCM syndrome integrals changed more significantly, with statistical significance (P <0.05). Conclusion Bushen Tongdu Capsule can relieve symptoms and signs of RA patients (TCM syndrome of kidney-deficiency with cold) effectively.
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