艾拉莫德治疗类风湿关节炎对骨代谢的影响及临床疗效

Clinical efficacy of iguratimod for rheumatoid arthritis and its impact on bone metabolism

目的探讨中重度类风湿关节炎(RA)患者艾拉莫德治疗24周前后骨代谢指标的变化、临床疗效及安全性。方法采用病例对照匹配的方法,按照入排标准选择研究组及基本资料匹配的对照组各27例。使用放免法测定2组之间治疗前后骨代谢中N-端骨钙素(N-MID)、总Ⅰ型前胶原氨基端延长肽(T-P1NP)、血清25羟维生素D3[25(OH)D]、Ⅰ型胶原降解产物(β-CTX)等反映骨代谢指标的变化以及研究组治疗前后C-反应蛋白(CRP)、红细胞沉降率(ESR)、关节肿痛数、28个关节的疾病活动度评分(DAS28)等评估疾病活动度指标的变化。结果1研究组治疗后骨代谢指标中N-MID、T-P1NP显著升高,与对照组比较差异均有统计学意义(P<0.01);β-CTX则明显降低,与对照组比较差异有统计学意义(P<0.01);但治疗后血清25(OH)D两组比较差异无统计学意义(P>0.05)。2研究组中经24周治疗后DAS28由基线的6.37±0.80降到3.36±1.08(P<0.01),44.45%的RA患者达到疾病缓解或低度活动状态。3研究组患者治疗后血沉(ESR)、C-反应蛋白(CRP)、压痛关节数(TJC)、肿胀关节数(SJC)显著低于治疗前(P<0.01)。结论艾拉莫德治疗RA能改善患者骨代谢状况,具有促进骨形成,抑制骨破坏的作用;能显著降低疾病活动度,改善关节症状,耐受性良好。

Objective To investigate the change of bone metabolism indicators in patients with active rheumatoid arthritis （RA） 24 weeks after the administration of iguratimod, and assess the clinical efficacy and safety of iguratimod. Methods Matched case-control study was conducted to selected 27 RA patients and 27 individuals meeting the criteria. The levels of N-terminal midfragment of osteocalcin（ N-MID）, total procollagen type I intact N-terminal propeptide （T-P1 NP）, serum 25-hydroxy-vitamin D [ 25 （OH）D] and 13-carboxy-terminal telopeptide of type I collage （13-CTX） before and after the treatment in both groups were determined by radioimmunoassay. The levels of C reactive protein（ CRP）, erythrocyte sedi- mentation rate（ ESR）, the number of joint tenderness and edema and DAS28 before and after the treatment in the study group were detected to evaluate the disease activity. Results （1）The levels of N-MID and T-P1NP in RA patients of study group were significantly increased after the treatment, while β-CTX decreased, differences between the two groups was statistically significant（P 〈 0.01 ）. However, the level of 25 （OH） D after the treatment was not significantly different between the two groups（P 〉0.05 ）. （2）After 24 weeks of treatment, the scores of DSA28 decreased from 6.37 ± 0.80 to 3.36 ± 1.08 （ P 〈 0.01 ）. 44.45% of RA patients achieved to remission or low disease active. （3）After the treatment, ESR, CRP, TJC and SJC of RA patient were significantly decreased （ P 〈 0. 01 ）. Conclusion Iguratimod can improve bone metabolism of RA patients and have the ability of promoting bone formation and inhibiting bone destruction. The treatment can decrease the disease activity ;improve joint symptom and the toleration of patients.