摘要
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 appreciation the efficacy and safety of recombinant human tumor necrosis factor-Fc （rhTNFR： Fc, etanercept） in patients with ankylosing spondylitis. Methods Sixty patients who had active ankylosing spondylitis were randomized into two groups： the treatment group（30 eases） treated with etanercept and the control group（30 cases） with sulfasalazin. During the course of treatment, all subjects were assessed at week 0, 6, 14, 24 respectively. The observation items including proportion of ASAS20, ASAS50, ASAS70 and the bath ankylosing spondylitis disease activity inde （BASDAI）, rachiodynia VAS, the time of lumbodorsal morning stiffness,thoracic expansion, Schober, seoliolosis, intermalleolar distance as well as CRP, ESR. Results The observation items were all significantly improved after treatment in the treatment group （P〈0.05）,but in the control group improvement was only observed in the part items. There was more improvement of the items and less occurrence of adverse reation were observed in the treatment group than that in the control group （P〈0.05）. Conclusion The results had shown that etanercept could provide substantial benefits to patients with active AS by reducing clinical signs and improving range of motion as well as quality of life,and was well tolerated in the treatment of AS patients.
出处
《苏州大学学报（医学版）》
CAS
北大核心
2009年第3期518-520,523,共4页
Suzhou University Journal of Medical Science
关键词
强直性脊柱炎
肿瘤坏死因子Α
重组融合蛋白
ankylosing spondylitis
tumor necrosis factor-α
recombinant fusion protein
