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目的探讨注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rh TNFR:Fc)对强直性脊柱炎(AS)继发骨质破坏及OPG/RANKL系统的影响。方法纳入门诊及住院确诊为AS病人60例,按数字表法随机均分为两组,治疗组:rh TNFR:Fc+甲氨蝶呤+柳氮磺吡啶;对照组:甲氨蝶呤+柳氮磺吡啶,疗程为24周,酶联免疫吸附法(ELISA)测定两组病人的骨钙素(OC)、C端肽(CTX)及细胞核因子κB受体活化子配基(RANKL)、骨保护素(OPG),比较两组上述指标的差异。AS病人骨盆片评分采用Bath AS放射学评分标准评估,选取治疗前与治疗24周后两个时间点,并进行安全性评估。结果治疗后两组病人OC均较治疗前表达升高,且治疗组表达要明显高于对照组(P<0.05),治疗后两组病人CTX均较治疗前表达下降(P<0.05),且治疗组表达要低于对照组(P<0.05);治疗后两组病人OPG均较治疗前表达有所提高(P<0.05),且治疗组表达要高于对照组(P<0.05),治疗后两组病人RANKL均较治疗前表达有下降(P<0.05),且治疗组表达要低于对照组(P<0.05);两组均未发现严重的不良反应。结论 rh TNFR:Fc治疗AS继发骨破坏可有效的降低骨代谢,促进骨形成,且不良反应少,疗效更佳。
Objective To investigate the effects of recombinant human TNF-α (TNFR) Fc injection on the secondary bone destruction and OPG / RANKL system in ankylosing spondylitis (AS). Methods Sixty patients with AS diagnosed as outpatients and inpatients were randomly divided into two groups according to the digital table method: treatment group: rh TNFR: Fc + methotrexate + sulfasalazine; control group: methotrexate + The therapeutic course was 24 weeks. The levels of osteocalcin (OC), C-terminal peptide (CTX) and activator of nuclear factor κB (RANKL) in the two groups were measured by enzyme-linked immunosorbent assay (OPG), the difference between the above two indicators was compared. The pelvic score of AS patients was assessed by Bath AS radiology score. Two points before and 24 weeks after treatment were selected and safety assessment was performed. Results After treatment, the OC in both groups increased compared with that before treatment, and the expression of OCX in the treatment group was significantly higher than that in the control group (P <0.05). After treatment, the CTX in both groups decreased compared with that before treatment (P <0.05) (P <0.05). After treatment, the expression of OPG in both groups was higher than that before treatment (P <0.05), and the expression of OPG in the treatment group was higher than that in the control group (P <0.05) The expression of RANKL in both groups was lower than that before treatment (P <0.05), and the expression of RANKL in treatment group was lower than that in control group (P <0.05). No serious adverse reaction was found in both groups. Conclusion rh TNFR: Fc treatment of AS secondary bone destruction can effectively reduce bone metabolism, promote bone formation, and fewer adverse reactions, better effect.