注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白剂量递减方案与标准剂量维持方案治疗强直性脊柱炎的疗效比较

Comparison of clinical effect between dose reduction scheme for hTNFR:Fc for injection and standard dose maintenance scheme in treatment of ankylosing spondylitis

目的观察并比较注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白(益塞普)剂量递减方案与标准剂量维持方案治疗强直性脊柱炎(AS)的疗效及安全性。方法选择2015年1月—2016年6月共18个月在我院治疗的80例AS患者为研究对象,随机分为两组,A组40例,给予益塞普递减方案治疗,B组40例,给予益塞普标准剂量维持方案治疗,比较两组的用药疗效及安全性。结果治疗后,两组的BASDAI、BASFI评分,腰背痛VAS评分,血清CRP、ESR水平均低于治疗前(P<0.05),但两组组间比较未见统计学意义(P>0.05);在治疗期间,A组与B组的不良反应发生率(32.50%、55.00%)及复发率(27.50%、22.50%)比较均无统计学意义(P>0.05);经统计,A组的年平均药物费用为(47 391±4 830)元,少于B组(82 038±5 127)元(P<0.05)。结论采用益塞普剂量递减方案治疗AS安全有效,能在短时间内控制疾病活动及改善临床症状,且花费更低,患者接受度更高。

Objective To observe and compare the clinical effect and safety of dose reduction scheme for recombinant human tumor necrosis factor receptor antibody fusion protein(hTNFR:Fc,etanercept)for injection and standard dose maintenance scheme in treatment of ankylosing spondylitis(AS).Methods 80 cases of patients with AS and who were treated in our hospital from January 2015 to June 2016 for 18 months were selected as the research objects,and were randomly divided into two groups.The group A of 40 cases were treated with etanercept of degressive scheme therapy,while the group B of 40 cases were treated with etanercept of standard dose maintenance therapy.Then,the clinical effect and safety of drug use of two groups were compared.Results The BASDAI,BASFI score,VAS score of low back pain,serum CRP and ESR levels of two groups after treatment were lower than those before the treatment(P<0.05),but there was no statistical significance between the two groups(P >0.05).During the treatment,there was no significant difference in the incidence of adverse reactions(32.50%,55%)and recurrence rate(27.50%,22.50%)between group A and group B(P >0.05).By statistics,the average annual drug cost in group A was RMB(47391±4830)yuan,which was less than that in group B of RMB(82038±5127)yuan(P<0.05).Conclusion The etanercept of degressive scheme therapy in treatment of AS are safe and effective,which may control disease activity and improve clinical symptoms in a short time,and low costs.The patient will receive higher degree of acceptance.