来源：风湿病与关节炎,2018,7（8）:15-19.

甲氨蝶呤联合艾拉莫德治疗中医不同证型类风湿关节炎疗效比较研究（临床研究）

吕新亮，刘禹全

　　【摘　要】目的：观察甲氨蝶呤联合艾拉莫德治疗中医不同证型类风湿关节炎的临床疗效及安全性。方法：选取类风湿关节炎患者108例，对随访了12周的100例患者进行观察。根据《中药新药临床研究指导原则（试行）》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，每组20例。给予口服甲氨蝶呤联合艾拉莫德治疗，观察周期12周。观察并记录治疗前及治疗后6，12周的红细胞沉降率、类风湿因子、超敏C-反应蛋白、肿胀关节数、压痛关节数、晨僵时间、患者对疾病状况的总体评价（VAS评分），计算DAS28评分。结果：治疗6，12周后，各组类风湿因子、红细胞沉降率、超敏C-反应蛋白、肿胀关节数、压痛关节数、VAS评分较治疗前有所降低，差异有统计学意义（P < 0.05）。治疗6，12周后，湿热痹阻证组、寒湿痹阻证组、寒热错杂证组晨僵时间较治疗前均缩短，差异有统计学意义（P < 0.05）。治疗12周后，湿热痹阻证组、寒湿痹阻证组、寒热错杂证组DAS28有效应答率均明显高于痰瘀互结证组和肝肾亏虚证组，差异有统计学意义（P < 0.05）。无患者发生严重不良事件，偶有消化系统不良反应如恶心呕吐、食欲减退等，经对症处理调整用药时间后均好转。结论：甲氨蝶呤联合艾拉莫德治疗类风湿关节炎疗效确切，无明显不良反应，湿热痹阻证、寒湿痹阻证、寒热错杂证疗效明显优于痰瘀互结证和肝肾亏虚证。

　　【关键词】　关节炎，类风湿；甲氨蝶呤；艾拉莫德；辨证论治；临床疗效

Comparative Study of Treating Rheumatoid Arthritis of Different Syndromes with Methotrexate and Iguratimo

LYU Xin-liang,LIU Yu-quan

　　【ABSTRACT】Objective:To observe the clinical efficacy and safety of methotrexate combined with iguratimo in the treatment of rheumatoid arthritis with different syndromes.Methods:One hundred and eight patients with rheumatoid arthritis were selected and one hundred of them followed up for 12 weeks were observed.According to Guidelines for Clinical Research on New Chinese Medicine（Trial）,there are five syndrome types:dampness-heat obstruction syndrome,cold-dampness obstruction syndrome,cold-heat mixed syndrome,phlegm-stasis syndrome,and liver and kidney deficiency syndrome.There were 20 cases in each syndrome.They were orally given methotrexate combined with iguratimo and observed for 12 weeks.The erythrocyte sedimentation rate,rheumatoid factor,hypersensitive C-reactive protein,swollen joints count,tender joints count,morning stiffness time,patients' visual analogue score（VAS score）were observed and recorded before treatment and 6,12 weeks after treatment,and DAS28 score was calculated.Results:After 6,12 weeks of treatment,rheumatoid factor,erythrocyte sedimentation rate,hypersensitive C-reactive protein,swollen joints count,tender joints count and VAS score were lower in each group than those before treatment（P < 0.05）.After 6,12 weeks of treatment,the morning stiffness time of dampness-heat obstruction syndrome group,cold-dampness obstruction syndrome group and cold-heat mixed syndrome group was shorter than that before treatment,and the difference was statistically significant（P < 0.05）.After 12 weeks of treatment,the effective response rate of DAS28 in the dampness-heat obstruction syndrome group,cold-dampness obstruction syndrome group,and cold-heat mixed syndrome group was significantly higher than that in the phlegm-stasis syndrome group and liver-kidney deficiency syndrome group,and the difference was statistically significant（P < 0.05）.No serious adverse events occurred,and occasional digestive system adverse reactions such as nausea,vomiting,and anorexia occurred,which were improved after adjusting the medication time.Conclusion:Methotrexate combined with iguratimo has a definite effect on rheumatoid arthritis without obvious adverse reactions.The curative effect of dampness-heat obstruction syndrome,cold-dampness obstruction syndrome and cold-heat mixed syndrome is superior to that of phlegm-stasis syndrome and liver and kidney deficiency syndrome.

　　【Keywords】 arthritis,rheumatoid;methotrexate;iguratimo;treatment with syndrome differentiation;clinical efficacy