甲氨蝶呤单用及与白芍总苷联用治疗幼年类风湿性关节炎的临床疗效比较

Comparative study on clinical efficacy of using methotrexate singly or combined with total glucosides of paeony in treating juvenile rheumatoid arthritis

目的探讨甲氨蝶呤(MTX)和白芍总苷(TGP)联合治疗幼年类风湿性关节炎的疗效及其安全性。方法 51例幼年类风湿性关节炎(JRA),随机分为MTX组25例及MTX+TGP组26例,各自接受相应药物治疗26周。参与疗效评估的指标有晨僵时间、关节压痛数、关节压痛指数、关节肿胀数、关节肿胀指数、血沉、C-反应蛋白,并以总改善百分率对疗效进行综合评估。参与安全性评估的指标有皮肤粘膜损害、胃肠反应、神经系统反应、血象、肝、肾功能。结果 MTX+TGP组治疗12、26周后的总有效率分别为80.8%、100%,而MTX组分别为24%、84%,两组比较有显著性差异(P<0.01);而两组的不良反应发生率分别为15%及20%,差异无显著性(P>0.05)。结论甲氨蝶呤和白芍总苷联合治疗幼年类风湿性关节炎的临床疗效显著优于单独使用甲氨蝶呤,且其不良反应未相应增加。

Objective： To evaluate the efficacy and safety of the combined therapy with methotrexate（MTX） and total glucosides of paeony（TGP） in the patients with juvenile rheumatoid arthritis （JRA）. Methods： Fiftyone patients with active polyarthritis JRA were divided into 2 groups, 25 patients in the MTX group were only administered orally with MTX, while 26 patients in the combined treated group were treated with MTX plus TGP, the therapeutic course for both groups was 26 weeks. The clinical assessments included morning stiffness time ,the number of tender and swollen joints, tender articular index, swollen articular index, erythrocyte sedimentation rate, serum C - reactive protein; safety was assessed by observing the reaction of skin and mucous membrane, gastrointestinal tract, nervous system, hematologic changes, liver and renal function. Results ： Efficacy and safety were assessed at 12th and 26th week. The total effective rates of MTX plus TGP group at 12th week and 26th week were respectively 80. 8% and 100% ;while those of MTX group were 24% and 84%, there was significant difference between the two groups （P 〈 0.01 ）. While,there was no significant difference （15% v 20% ） in occurrence rate of side effects between the two groups. Conclusion： The effect of the MTX and TGP therapy in patients with active JRA is better than MTX alone. The combination therapy with MTX and TGP is safe and well tolerated.