肿瘤坏死因子α受体融合蛋白联合柳氮磺吡啶对活动性强直性脊柱炎的诱导与维持治疗初步探讨

Prelminary Study on Tumor Necrosis Factor-α Receptor Fusion Protein with Sulfasalazine in the Induction and Maintenance Therapy of Active Ankylosing Spondylitis

目的探讨肿瘤坏死因子α(TNF-α)受体融合蛋白联合柳氮磺吡啶对活动性强直性脊柱炎(AS)的疗效及其疗程和维持治疗的方法。方法采用临床开放性研究,对42例首诊或规范治疗3个月仍处于活动期的AS患者给予TNF-α受体融合蛋白与柳氮磺吡啶联合治疗。评价指标为2、8、16、24周达到AS疗效评价标准20、50、70(ASAS20)的患者百分比。结果 42例患者治疗后评价指标均较基线改善,24周达到ASAS20、ASAS50、ASAS70改善的患者分别为95.2%、78.6%、64.3%。急性期血中反应物水平在2周即出现明显改善(P<0.01)。结论 TNF-α受体融合蛋白联合柳氮磺吡啶治疗活动性AS,2周即可改善AS患者的症状、体征及AS患者的功能和活动范围,而这些改善在24周的疗程内均处于稳定的上升趋势。

Objective To investigate the treatment efficacy of tumor necrosis factor（TNF）-αreceptor fusion protein combined sulfasalazine for active ankylosing spondylitis（AS）with the.Methods Open-label clinical study was adopted,42 AS patients who were just diagnosed or still in active period after 3 months of standard treatment received TNF-α receptor fusion protein combined sulfasalazine therapy.Assessments indexes were the percentages of AS response criteria 20,50,70（ASAS20,ASAS50,ASAS70）at week 2,8,16 and 24.Results After treatment the assessment indexes of the 42 patients all improved from the baseline,at 24th week the number of patients with the efficacy achieving ASAS20,ASAS50,ASAS70 reached 95.2%,78.6%,and 64.3% respectively.Obvious improvement of acute phase reactant levels occurred at the 2nd week（P〈0.01）.Conclusion TNF-α receptor fusion protein combined sulfasalazine treating active AS sees obvious improvement of symptoms,features,function and activity scope at the 2nd week,which continues to stay in a stable up trend during the 24-week treatment.