补肾祛寒治尪汤联合甲氨喋呤治疗类风湿关节炎肾虚寒盛证的疗效与安全性评价

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

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DOI：10.7661/CJIM.2013.05.0614

中文关键词: 补肾祛寒治尪汤甲氨喋呤类风湿关节炎肾虚寒盛证

英文关键词:Bushen Quhan Zhiwang Decoction methotrexate rheumatoid arthritis Shen deficiency and cold invading syndrome

基金项目:中日友好医院重点学科建设项目（No. 2007－2012）

作者	单位	E-mail
王建明，陶庆文，张英泽
阎小萍	中日友好医院中医风湿病科（北京 100029）	yanxiaoping1688@126.com

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中文摘要:

目的评价补肾祛寒治尪汤联合甲氨喋呤（MTX）治疗类风湿关节炎（rheumatoid arthritis，RA）的临床疗效和安全性。方法采用前瞻性、随机对照研究，将240例RA肾虚寒盛证患者随机分为两组。治疗组（120例）予补肾祛寒治尪汤联合MTX（10 mg/周），对照组（120例）予MTX（10 mg/周），两组疗程均为24周。观察治疗前后临床症状体征、病情变化，健康状况评估（HAQ）、疾病活动指数（DAS28）、血沉（ESR）、C反应蛋白（CRP）、安全性指标、中医证候积分等改变，评估其疗效及安全性。结果治疗组总有效率80.0%，对照组总有效率66.7%，治疗组疗效优于对照组，差异有统计学意义（P<0.01）。两组治疗后在症状体征、ESR与CRP、患者对疾病评估（VAS）、医生对疾病评估（VAS）、HAQ、DAS28、中医证候积分等方面均有明显改善，差异有统计学意义（P<0.01）。治疗组在减少压痛关节数、肿胀关节数、患者对疾病评估（VAS）、医生对疾病评估（VAS）、DAS28、中医证候积分等方面均优于对照组，差异有统计学意义（P<0.05）。且不良反应明显少于对照组，差异有统计学意义（P<0.05）。结论补肾祛寒治尪汤对RA肾虚寒盛证患者具有缓解症状、改善关节功能活动、体征及ESR、CRP的作用，是治疗RA肾虚寒盛证的有效中药，与MTX联合用药具有协同作用，增加疗效，且能减少MTX的不良反应。

英文摘要:

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.

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