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减量探索

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25mg每周2次皮下注射,当疾病得到缓解(BASDAI<2;ESR男<15mm/h,女<20mm/h;CRP<0.8mg/dl;PLT<300×109/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0.25tid,第2周增至0.5bid,第3周增至0.75bid,第4周增至1.0bid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25mg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25mg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(P<0.05)。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25mg每2周1次后,组间差别更是达到P<0.01。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。

A study of how to taper the dosage of recombinant human tumor necrosis factor receptor-Fc fusion protein in the treatment of ankylosing spondylitis

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 controlledBath ankylosing spondyltitis disease ...