甲氨蝶呤联合来氟米特治疗中医不同证型类风湿关节炎疗效比较研究

【目的】观察甲氨蝶呤（methotrexate，MTX）联合来氟米特（1eflunomide，LEF）治疗中医不同证型类风湿关节炎（rheumatoidarthritis，RA）的疗效有无差异。【方法】选取175例中重度RA患者，按照中医辨证标准分为湿热痹阻证、寒湿痹阻证、寒热错杂证、痰瘀互结证、肝肾亏虚证5个证型组，采用MTX联合LEF口服治疗，疗程12周，观察基线时和治疗12周后肿胀关节数、压痛关节数、晨僵时间、患者疼痛评分（VAS）、红细胞沉降率（ESR）、类风湿因子（RF）、C反应蛋白（CRP），计算DAS28评分，并观察ACR20、ACR50和ACR70的变化情况及不良反应，进行统计分析。【结果】与本组基线值比较，各组治疗12周后肿胀关节数、压痛关节数均减少，VAS、ESR、RF、CRP均降低，差异有统计学意义（P〈0．05）；除痰瘀互结证、肝肾亏虚证组外，其余各组关节晨僵时间均缩短，差异有统计学意义（P〈0．05）。湿热痹阻证、寒湿痹阻证、寒热错杂证组治疗后肿胀关节数、压痛关节数、晨僵时间、VAS、RF的改善情况及DAS28有效应答率、ACR20、ACR50、ACR70改善率均优于痰瘀互结证和肝。肾亏虚证组（P〈0．05），各组不良反应比较无差异（P〉0．05）。【结论】MTX联合LEF治疗中重度RA疗效确切，无明显不良反应，湿热痹阻证、寒湿痹阻证、寒热错杂证疗效优于痰瘀互结证和肝’肾亏虚证。

Comparative studies on the effect of methetremate combined with leflunomide in the treatment of different syndromes of rheumatoid arthritis according to Traditional Chinese Medicine

Objective] To compare methotrexate（MTX） combined with leflunomide（LEF） in the treatment of different syndromes of rheumatoid arthritis（RA） according to Traditional Chinese Medicine（TCM） syndrome differential standard and make sure whether the differences were significant. Method ] A total of 175 cases with moderate or severe RA according to TCM syndrome differential standard were divide into damp heat, cold dampness syndrome, syndrome of intermingled heat and cold, Phlegm each node syndrome, liver and kidney deficiency syndrome, five syndromes group. MTX combined with LEF oral treatment were given for 12 weeks. Baseline and swollen joint count, tenderness joint count, time of morning stiffness, pain score（VAS）, erythrocyte sedimentation rate（ESR）, rheumatoid factor（RF）, C reactive protein（CRP）, DAS28 score were observed after combined treatment for 12 weeks. Change of ACR20, ACR50 and ACR70 and adverse reactions after combined treatment were all observed and analyzed statistically. Results ] The number of swollen joints were reduced and VAS, ESR, RF, CRP were lowered in all treatment groups after 12 weeks, the differences were significant statistically（P 〈 0.05）. The time of morning joint stiffness was shortened in all groups except in phlegm each node syndrome group and liver and kidney deficiency group,the differences were significant statistically. The improvement of swollen joint count,tenderness joint point, time of morning stiffness, VAS, RF, DAS28, effective response rate, ACR20, ACRS0, ACR70 improvement rate of damp heat, cold dampness syndrom, syndrom of intermingled heat and cold group after treatment were better than that in Phlegm each node syndrome group and liver and kidney deficiency syndrome group（P 〈 0.05）. The adverse reactions in all treatment groups were better than baseline but no significant statistically（P 〉 0.05）. Oonclusion] MTX combined with LEF in the treatment of moderate to severe RA has definit efficacy, no significant adverse reactions.The curative effect on damp heat, cold dampness syndrome, cold syndrome is better than that of phlegm and blood stasis syndrome and liver and kidney deficiency syndrome.