蚁参蠲痹胶囊治疗类风湿关节炎的临床研究

目的：观察和评价蚁参蠲痹胶囊治疗类风湿关节炎的疗效和安全性。方法：将439例类风湿关节炎（证属肾脾两虚、寒湿瘀阻）患者分成两组，治疗组329例采用蚁参蠲痹胶囊治疗，对照组110例采用通痹胶囊＋安慰剂治疗，两组每次服用4粒（通痹胶囊含3粒安慰剂），早、中、晚各1次，连服2月。治疗前及用药后每2周进行疗效评价，以主要症状、体征整体改善率、血沉（ESR）及C反应蛋白（CRP）的改善情况为判定标准评价疾病疗效，并以中医临床症状、体征改善情况及证候积分减少程度为判定标准评价中医证候疗效。同时对患者进行用药前后的三大常规、心、肝、肾功能、精液、脾脏等安全性检查，观察以上安全性指标的变化。结果：治疗后，试验组和对照组的症状、体征及相关理化指标均有明显改善，其中试验组对疾病的有效率达86．7％、对中医证候的有效率达87．3％、中医症状总积分较疗前明显降低，且与对照组比较有显著性差异。蚁参蠲痹胶囊治疗组末见明显的不良反应。结论：通过两组治疗对比观察，发现蚁参蠲痹胶囊具有行气活血，通络止痛之功效，是一种治疗肾脾两虚、寒湿瘀阻类风湿关节炎的理想制剂，且用药安全。

Clinical research of YiShenJuanBi Capsules in the Treatment of Rheumatoid Arthritis

Objective：To observe and appraise the efficacy and Safety of YiShenJuanBi capsules in the treatment of rheumatoid arthritis. Methods：439 patients（renal spleen deficiency and cold dampness Stagnation syndrome ） with rheumatoid arthritis were treated,in which 329 patients used the YiShenJuanBi capsules （as therapeutic group）and the others used Tong bi capsules and placebo （as control group）, they were treated with capsules respectively, 2 each time（Tongbi capsules con-tains 3 capsules of simulative preparations）, 3 times a day, and for 2 months. Calculating rate of improvement in major symptoms and Signs, improvement of ESR and CRP,evaluated the efficacy before and after treatment fortnightly. Duringthese periods, probing the improvement Of TCM clinical symptoms and integral Syndrome judged the TCM efficacy. Meanwhile, carring out security examination such as three routines,functions of heart, liver and kidney, semen and spleen ob served the change of the security index. Results： After the treatment , the two groups both were obviously improved the symptoms and signs. The efficiency of therapeutic group was 86.7% in the efficacy and 87.3% in the TCM efficacy. The total TCM clinical symptoms and integral Syndrome were dramaticaly improved, and there was significant difference between therapeutic group and control group. No Adverse Reactions had been found in our therapeutic group. Conclusion： YiShenJuanBi capsules has the effect of promoting qi to activate blood and activating meridians to stop pain in our research.It is an ideal medicine in treating the rheumatoid arthritis that is caused by renal spleen deficiency and cold dampness Stagnation.