运动疗法联合重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗强直性脊柱炎的临床疗效

Clinical Effect of Exercise Therapy Combined with Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ:IgG Fc Fusion Protein Therapy on Ankylosing Spondylitis Patients

【目的】通过综合国内外相关的运动疗法,建立一套方便强直性脊柱炎(AS)病人简单易行有效运动疗法;并探讨重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白联合该运动疗法治疗AS的有效性和价值。【方法】本研究共纳入符合1984修订的纽约诊断标准活动性AS患者60例,随机分配到研究组(n=30)和对照组(n=30),两组患者均予每周一次50 mg重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白皮下注射,用药时间12周,研究组同时联合运动治疗。观察并记录治疗前和治疗后第0、2、6和12周患者ASAS20、BASFI、BASDAI、ASDAS3、BASMI、患者总体评价、ASQo L、CRP、ESR等指标,对比研究组与对照组间疗效差异。【结果】研究组,ASAS20改善达到80.67%,BASFI、BASDAI、ASDAS2、BASMI、患者总体评价、ASQo L、CRP和ESR在治疗后3个月均得到显著的改善(P<0.05)。对照组,ASAS20改善达到80.67%,其余指标除BASMI(P=0.681)、Schober(P=0.578)和胸廓活动度(P=0.161)外,改善差异均有统计学意义(分别P<0.05)。研究组与对照组比较,实验组BASMI、Schober、扩胸度及ASQo L比对照组改善明显,差异有统计学意义(P皆<0.05)。【结论】此运动疗法联合重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗AS较之单独使用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗,在活动度患者生活质量方面均具有显著的疗效,且对患者的脊椎活动度、胸廓活动度和机体功能改善更显著。

【Objectives】 To detect the effect of the exercise therapy combined biological agents（Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ ：IgG Fc Fusion Protein） in AS patients,and assess the clinical value of exercise therapy.【Methods】Sixty patients with AS were included in this study.The patients were divided into two groups.Patients in group I（n = 30） received the biological agents（Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ：IgG Fc Fusion Protein,50 mg every week,im） and an exercise program.Group II（n = 30） patients were given the same biological agents（Recombinant Human Tumor Necrosis Factor-αReceptorⅡ：IgG Fc Fusion Protein,50 mg every week,im） but not the exercise therapy.All patients were evaluated before（T0） and at the end of the treatments（T1）.Evaluation parameters were the ASAS20,Bath AS Disease Activity Index（BASDAI）,Bath AS Functional Index（BASFI）,Bath AS Metrology Index（BASMI）,the Bath AS Patient Global Score（BAS-G）,AS Quality of Life（ASQo L）,Schober,change in thoracic activity C reaction protin（CRP） and erythrocyte sedimentation rate（ESR）.【Result】 In both groups,a significant improvement was determined in all clinical outcomes between T0 and T1 except for BASMI Schober and change in thoracic activity in group II.Comparison of the groups showed that group I got the better effect of BASMI,Schober change in thoracic activity,and ASQo L（P〈0.05）.【Conclusion】 Combined with the exercise therapy showed more beneficial effects in spinal mobility,change in thoracic activity,and quality of life in AS patients than used the Recombinant Human Tumor Necrosis Factor-αReceptorⅡ：IgG Fc Fusion Protein therapy only.