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目的评价重组人Ⅱ型肿瘤坏死因子受体Fc抗体融合蛋白(益赛普)治疗强直性脊柱炎(AS)的疗效和安全性。方法60例活动性AS患者随机分为治疗组(30例)和对照组(30例),分别应用益赛普、柳氮磺胺吡啶治疗24周,分别在第0、6、14、24周评价两组的临床疗效和安全性。观察指标为ASAS20、ASAS50、ASAS70、AS活动指数(BASDAI)、脊柱痛、晨僵时间、胸廓扩张度、Schober、脊柱侧弯、踝间距以及C反应蛋白(CRP)、红细胞沉降率(ESR)等。结果治疗组患者治疗后BASDAI、脊柱痛、胸廓扩张度、Schober、脊柱侧弯、踝间距及CRP、ESR等指标较治疗前均明显改善,差异均有统计学意义(均P<0.05)。对照组患者治疗后BASDAI、脊柱痛、晨僵时间及CRP、ESR均较治疗前明显改善,差异均有统计学意义(均P<0.05),但胸廓扩张度、Schober、脊柱侧弯、踝间距治疗前后的差异无统计学意义。两组间比较,治疗组各项观察指标改善程度明显优于对照组,差异有统计学意义(P<0.05)。治疗组不良反应发生率(13.3%)明显低于对照组(40.0%),差异有统计学意义(P<0.05)。结论益赛普治疗活动性AS疗效显著,能改善AS患者的症状、体征、关节功能和生活质量,并具有良好的安全性。
Objective To evaluate the efficacy and safety of recombinant human type Ⅱ tumor necrosis factor receptor Fc antibody fusion protein (Isphaset) in the treatment of ankylosing spondylitis (AS). Methods Sixty patients with active AS were randomly divided into treatment group (n = 30) and control group (n = 30). The patients were treated with ipsapin and sulfasalazine for 24 weeks, respectively, at weeks 0, Clinical efficacy and safety in both groups. The observation indexes included ASAS20, ASAS50, ASAS70, BASDAI, spinal pain, morning stiffness, thoracic dilatation, Schober, scoliosis, C-reactive protein and erythrocyte sedimentation rate (ESR) . Results The scores of BASDAI, spine pain, thoracic dilatation, Schober, scoliosis, ankle, CRP and ESR in treatment group were significantly improved after treatment (all P <0.05). BASDAI, spine pain, morning stiffness, CRP and ESR in the control group were significantly improved after treatment compared with those before treatment (all P <0.05), but the thoracic dilatation, Schober, scoliosis, ankle spacing Before and after treatment, the difference was not statistically significant. The comparison between the two groups showed that the improvement of various observation indexes in the treatment group was obviously better than that in the control group (P <0.05). The incidence of adverse reactions in the treatment group (13.3%) was significantly lower than that in the control group (40.0%), the difference was statistically significant (P <0.05). Conclusion Yi-Saipu treatment of active AS significant effect, can improve the symptoms of AS patients, signs, joint function and quality of life, and has good safety.