大活络胶囊结合小剂量激素合甲氨蝶呤治疗早期类风湿性关节炎的疗效观察

Efficacy of Dahuoluo capsule combined with small dose of hormone and methotrexate on early rheumatoid arthritis

目的观察大活络胶囊结合小剂量激素合甲氨蝶呤治疗早期类风湿性关节炎的临床疗效。方法采用开放、随机、对照、前瞻性研究方法对收治的470例早期类风湿性关节炎患者进行临床观察。将2010年6月~2013年12月期间选取的470例患者按数字表法随机分为对照组和观察组各235例,对照组给予小剂量激素联合甲氨蝶呤治疗,观察组给予中药大活络胶囊结合小剂量激素联合甲氨蝶呤治疗,24周为1个疗程,1个疗程后对比2组完成率、疗效、安全性及临床症状、体征、实验检查等指标改善情况。结果 2组均入组235例,对照组完成率88.51%,观察组完成率91.06%,2组差异无统计学意义;观察组临床控制率43.93%,显著高于对照组的19.71%(P<0.05);2组治疗后关节疼痛数、关节压痛评分、肿胀评分、晨僵时间、20m步行时间、疾病活动度评分及红细胞沉降率、类风湿因子、肿瘤坏死因子-α,白细胞介素-1等血清水平均较治疗前显著下降(P<0.05),观察组上述指标治疗后均显著低于对照组,差异均有统计学意义(P<0.05);2组安全性差异无统计学意义。结论中药大活络胶囊结合小剂量激素合甲氨蝶呤治疗早期RA可抑制炎症反应,加快症状缓解,抑制病情进展,综合疗效较好,无明显不良反应。

Objective To observe the clinical curative effect of traditional Chinese medicine combined with small dose of hormone and methotrexate in the treatment of early rheumatoid arthritis. Methods 470 patients with early rheumatoid arthritis were selected in outpatient and inpatient department from June 2010 to December 2013 and observed by an open,randomized,controlled,prospective study method,of which were randomly divided into control group and observation group with 235 cases in each group. The control group were given small dose corticosteroids and methotrexate treatment,observation group were given Chinese medicine Dahuoluo capsule treatment combined with small dose of hormone and methotrexate. The completion rate,curative effect,safety and clinical symptoms,signs,laboratory examination and other indicators to improve the situation were compared between the two groups after 24 weeks of treatment. Results 235 cases in each group,completion rate of control group was 88. 51%,and the observation group was 91. 06%,and there was no significant difference between two groups; the clinical control rate was 43. 93% in observation group,which was significantly higher than 19. 71% in the control group( P < 0. 05); after treatment,joint pain,joint tenderness score,swelling score,morning stiffness 20 m walking time,disease activity score and erythrocyte sedimentation rate,rheumatoid factor,tumor necrosis factor alpha,interleukin-1 levels in serum in two groups were significantly decreased than those before treatment( P < 0. 05),the above index in the observation group after treatment were significantly lower than those in the control group,and the difference was statistically significant( P < 0. 05); there was no statistically significant difference in safety between two groups. Conclusion Traditional Chinese medicine combined with small dose of hormone Dahuoluo capsule and methotrexate can inhibit inflammatory reaction,relief the symptoms,inhibit disease progression in the treatment of early RA,which has comprehensive excellent effects with no obvious toxic side effects.