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减量探索.docVIP

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减量探索 　　【摘要】 目的 探索一种经济、有效、安全的强直性脊柱炎(AS)患者应用重组人Ⅱ型肿瘤坏死因子受体?抗体融合蛋白(益赛普)的减量方法。方法 对入选的48例活动期AS 患者随机分为A、B两组，进行1 年的疗效观察。两组患者均接受益赛普治疗，初始剂量为25 mg每周2次皮下注射，当疾病得到缓解(BASDAI＜2；ESR男＜15 mm/h，女＜20 mm/h；CRP0.8 mg/dl；PLT＜300×10??9?/L)，即将益赛普每隔2个月逐渐减量。如果减量使患者症状加重或ESR、CRP、PLT计数等炎性指标反弹至异常水平，则将益赛普重新调回前一个剂量，并于下次复查时评估以确定益赛普的剂量。A组患者同时接受柳氮磺吡啶(SSZ)口服治疗，初始剂量为0.25 tid，第2周增至0.5 bid，第3周增至0.75 bid，第4周增至1.0 bid维持至第24周。结果 两组患者前2个月均使用推荐剂量的益赛普即25 mg每周2次皮下注射，均取得令人满意的疗效，起效快，缓解率高，组间差别无统计学意义。病情获得缓解的病例从第3个月起减量至25 mg每周1次，至第4个月末评估疗效，达到ASAS20的百分数A组明显高于B组，且差异具有统计学意义(P0.05)。随着用药间隔逐渐延长，两组间的差距越来越大。当益赛普减量至25 mg每2周1次后，组间差别更是达到P0.01。结论 SSZ联合益赛普治疗AS可取得较高的疾病缓解率或低疾病活动状态，可明显延长益赛普的用药间隔。? 　　【关键词】 　　强直性脊柱炎；肿瘤坏死因子α；柳氮磺吡啶；治疗结果 　　?? 　　A study of how to taper the dosage of recombinant human tumor necrosis factor receptor?Fc fusion protein in the treatment of ankylosing spondylitis 　　 　　CHEN Mei?qing, CHEN Juan，SUN Hua?yu, et al.Department of Rheumatology，The First Hospital Attached to Xiamen University, Xiamen 361000,China 　　? 　　【Abstract】 Objective 　　To explore a economic and effective regimen of how to taper the dosage of recombinant human tumor necrosis factor receptor?Fc fusion protein(rhTNFR?Fc)in the treatment of ankylosing spondylitis (AS).Methods In a 1?year study，forty?eight patients with active AS were divided into A and B groups randomized.All of them received the treatment of injecting rhTNFR?Fc.Initially took 25 mg rhTNFR?Fc hypodermic injection twice a week. After the disease was well controlled［Bath ankylosing spondyltitis disease activity index2.0，erythrocyte sedimentation rate(ESR)male15 mm/h，female20 mm/h， and C?reactive protein(CRP)0.8 mg/dl,platelet300 10??9?/L］, rhTNFR?Fc dosage was gradually reduced in a 2?month step. The rhTNFR?Fc would come back to the former dosage if back pain，peripheral arthritis，extraarticular manifestations were aggravated or CRP or ESR or PLT were rebounded. And reassessedrhTNFR?Fc dosage after two monthes.Patients in group A took sulfasalazine c