摘要
目的评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc;商品名:益塞普)联合甲氨蝶呤治疗银屑病关节炎(PsA)患者的临床疗效以及安全性。方法本研究为对照开放性试验,共纳入16例活动期脊柱病型PsA患者,至少服用甲氨蝶呤10～15mg/周联合非甾体抗炎药3个月临床未缓解。试验组加用rhTNFR:Fc每周50mg皮下注射,对照组加用其他改善病情抗风湿药(DMARDs)(来氟米特3例,沙利度胺3例,柳氮磺吡啶2例)。主要评价指标为2,4,8,12周达到强直性脊柱炎(AS)评价标准(ASAS)20改善的比例以及银屑病皮损面积和严重性指数(PSI75),次要评价指标包括上述时间达到ASAS50改善的比例以及PSI50,ASAS评分系统各单项指标的变化。并同时记录2组药物不良反应。计量资料比较采用t检验或Wilcoxon秩和检验,计数资料比较采用χ2检验。结果第2周对照组所有指标较基线均无明显改善,而试验组均明显改善(P<0.05)。至12周时试验组及对照组达到ASAS20改善的患者数分别为7例(7/8)及2例(2/8),2组比较差异有统计学意义(P<0.05)。试验组ASAS50、PSI75、PSI50均明显优于对照组。2组均未见严重不良反应发生。结论 rhTNFR:Fc治疗PsA能明显改善脊柱关节症状,减轻皮损,并且具有良好的安全性和耐受性。
Objective To evaluate the efficacy and safety profile of recombinant human tumor necrosis factor receptor：Fc fusion protein（rhTNFR：Fc） and methotrexate（MTX） in patients with psoriatic arthritis（PsA）.Method A 12-week,open-labeled controlled trial was conducted.Sixteen patients with active PsA of axial skeleton type who did not release after at least 3 months on MTX and nonsteroidal antiinflammatory drugs were randomised to rhTNFR：Fc（n= 8） or DMARDs（n=8,3 cases with leflunomide,3 cases with thalidomide,2 cases with sulfasalazine）.The primary outcomes were the percentage of patients achieving the ASAS 20 and psoriasis area and severity index scores（PSI）75 response at 2,4,8,12 weeks.The secondary outcomes include ASAS 50 and PSI 50 at 2,4,8,12 weeks and the change of single parameter in the ASAS core sets.The adverse events were also recorded.The metric data was estimated with the double t-test or Wilcoxon signed ranks test,and enumerative deta was estimated with χ2 test.Results At the second week,all parameters had no difference compared with the baseline in the DMARDs group.In the rhTNFR：Fc group,all parameters decreased significantly（P〈0.05）.The number of patients in the rhTNFR：Fc group achieving the ASAS 20 response at the twelfth week was 7,while the number was 2 in the DMARDs group,and singnificant difference was found between the two groups（P〈0.05）.After treated for 12 weeks,ASAS 50,PSI 75,PSI 50 of the rhTNFR：Fc group was better than the DMARDs group.There were no serious adverse reactions.Conclusion rhTNFR：Fc can relieve symptoms and skin lesion in PsA patients,and demonstrate good safty and toleration.
出处
《中国药物与临床》
CAS
2010年第10期1103-1105,共3页
Chinese Remedies & Clinics
