目的 本研究探讨补肾养骨口服液对强直性脊柱炎的疗效及其安全性。方法 本研究为随机对照试验,研究了补肾养骨口服液+塞来昔布胶囊对比单纯用塞来昔布胶囊治疗强直性脊柱炎的效果,观察指标有腰臀痛程度、僵硬持续时间、红细胞沉降率(erythrocyte sedimentation rate,ESR)、C-反应蛋白(C-reactive protein,CRP)、ASAS 20改善标准,观察时间点为第1和第12周。在整个研究过程中,通过血液、肝脏和肾功能测试来监测安全性,并记录不良反应。结果 有60名患者参加了此次试验。①两组治疗均有效:补肾养骨口服液+塞来昔布胶囊组30例(80.3%),塞来昔布组30例(60.8%),两组的ASAS 20都达到改善标准;但补肾养骨口服液+塞来昔布胶囊组效果好于塞来昔布组(P＜0.05)。②两组监测指标(腰臀痛程度、僵硬持续时间、ESR、CRP)对比,治疗后改善显著,而且补肾养骨口服液+塞来昔布胶囊组比塞来昔布组改善更明显。③两组治疗前后血常规、肝肾功能未见异常,但补肾养骨口服液+塞来昔布胶囊组不良反应发生率12.5%,而塞来昔布组为52.5%,两组差异具有统计学意义(P＜0.05)。结论 本研究说明了补肾养骨口服液在治疗强直性脊柱炎中具有疗效,且较安全。

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 （47 391±4 830） yuan,which was less than that in group B of RMB （82 038±5 127） 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.