补肾祛寒治尪汤联合甲氨蝶呤治疗类风湿关节炎肾虚寒凝证的临床疗效及安全性评价

[Treating rheumatoid arthritis patients of Shen deficiency and cold invading syndrome by bushen quhan zhiwang decoction combined methotrexate: an evaluation of clinical efficacy and safety].

作者信息

Wang Jian-Ming, Tao Qing-Wen, Zhang Ying-Ze, Xu Yuan, Yan Xiao-ping

机构信息

TCM Rheumatology, China-Japan Friendship Hospital, Beijing 100029, China.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2013 May;33(5):614-8.

PMID:23905378

Abstract

OBJECTIVE

To evaluate the clinical efficacy and safety of bushen quhan zhiwang decoction (BQZD) combined methotrexate (MTX) in treating rheumatoid arthritis (RA).

METHODS

A prospective, randomized controlled study was carried out. RA patients of Shen deficiency and cold invading syndrome in the treatment group (120 cases) were treated with BQZD and MTX (10 mg/week), while those in the control group (120 cases) were treated with MTX (10 mg/week) alone. The therapeutic course for all was 24 weeks. The efficacy and safety indices were evaluated at the baseline and 24 weeks after treatment, including clinical signs and symptoms, condition assessment, Health Assessment Questionnaire (HAQ), disease activity index 28 (DAS28), laboratory parameters of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), safety indicators, and Chinese medical syndrome integrals.

RESULTS

The total effective rate was 80. 0% in the treatment group, better than that of the control group (66.7%), showing statistical difference (P <0.01). In the two groups significant improvement of clinical signs and symptoms, ESR, CRP, visual analogue scale (VAS) by both physicians and patients, HAQ, DAS28, and Chinese medical syndrome integrals after treatment were shown (P <0.01). Better effects were obtained in the treatment group in lessening tender joint numbers and swollen joint numbers, VAS by both physicians and patients, DAS28, and Chinese medical syndrome integrals (P < 0.05). Besides, adverse reactions occurred less in the treatment group than in the control group (P < 0.05).

CONCLUSIONS

BQZD had roles in relieving symptoms, improving joint functions, signs, ESR, and CRP. It was an effective herb for RA patients of Shen deficiency and cold invading syndrome. It could enhance the efficacy and reduce adverse reactions of MTX through synergistic effects with MTX.

摘要

目的

评价补肾祛寒治尪汤（BQZD）联合甲氨蝶呤（MTX）治疗类风湿关节炎（RA）的临床疗效及安全性。

方法

进行一项前瞻性、随机对照研究。治疗组（120例）中属肾虚寒侵证的RA患者采用BQZD联合MTX（10mg/周）治疗，而对照组（120例）仅采用MTX（10mg/周）治疗。两组疗程均为24周。在基线及治疗24周后评估疗效和安全性指标，包括临床症状和体征、病情评估、健康评估问卷（HAQ）、28关节疾病活动指数（DAS28）、红细胞沉降率（ESR）和C反应蛋白（CRP）的实验室参数、安全性指标以及中医证候积分。

结果

治疗组总有效率为80.0%，优于对照组（66.7%），差异有统计学意义（P<0.01）。两组治疗后临床症状和体征、ESR、CRP、医生和患者视觉模拟评分（VAS）、HAQ、DAS28及中医证候积分均有显著改善（P<0.01）。治疗组在减少压痛关节数、肿胀关节数、医生和患者VAS、DAS28及中医证候积分方面效果更好（P<0.05）。此外，治疗组不良反应发生率低于对照组（P<0.05）。