来源：风湿病与关节炎,2018,7（6）:22-26.

注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白

对绝经后女性类风湿关节炎血清性激素水平的影响

（临床研究）

史丽璞，王　旭，郇　稳

　　【摘　要】目的：了解注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（以下简称益赛普）对绝经后女性类风湿关节炎（RA）患者血清性激素水平的影响，探讨性激素在绝经后女性RA中的临床意义。方法：选取绝经后女性RA患者65例作为RA组，健康体检者65例作为健康对照组。采用微粒子化学发光法测定2组血清睾酮（T）、雌二醇（E₂）水平，计算E₂/T比值，评估其与红细胞沉降率（ESR）、C-反应蛋白（CRP）、DAS28评分、健康评估问卷（HAQ）等指标的相关性。RA组给予皮下注射益赛普，每次25 mg，每周2次，1个疗程12周。比较治疗前后E₂、T水平，E₂/T比值及临床指标的变化。结果：RA组血清E₂水平及E₂/T比值显著高于健康对照组（P < 0.05）；2组血清T水平比较，差异无统计学意义（P > 0.05）。治疗前，RA患者E₂水平、E₂/T分别与ESR（r = 0.688，P = 0.000；r = 0.722，P = 0.000）、CRP（r = 0.499，P = 0.000；r = 0.505，P = 0.000）、DAS28（r = 0.756，P = 0.000；r = 0.413，P = 0.001）、HAQ（r = 0.603，P = 0.000；r = 0.416，P = 0.001）呈正相关性。RA组经益赛普治疗后，血清E₂水平、E₂/T比值显著低于治疗前（P < 0.05）。结论：血清性激素水平变化及雌雄激素比值失调可能参与了绝经后女性RA的发病，可能作为评估RA活动的指标。益赛普治疗可促进绝经后女性RA患者性激素水平及雌雄激素比值的恢复。

　　【关键词】　关节炎，类风湿；雌雄激素比值；重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白；疾病活动

Effect of Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ:IgG Fc Fusion Protein for Injection on Serum Sex Hormone Levels in Postmenopausal Women with Rheumatoid Arthritis

SHI Li-pu,WANG Xu,HUAN Wen

　　【ABSTRACT】Objective:To investigate the effect of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:Igg Fc Fusion Protein for Injection（Yi Sai Pu）on serum sex hormone levels in postmenopausal women with rheumatoid arthritis（RA）and to explore its clinical significance.Methods:The RA group was established by 65 cases of postmenopausal women with RA and the control group was composed of 65 healthy volunteers.The levels of estradiol（E₂）and testosterone（T）in serum were measured by microparticle chemiluminescence,and the ratio of E₂/T was calculated,whose correlation with ESR,CRP,DAS28 scores and HAQ indexes was evaluated.The RA group was given subcutaneous injection of 25 mg of Yi Sai Pu twice a week for 12 weeks.The changes of T and E₂ levels,E₂/T ratios and clinical indicators were compared before and after treatment.Results:The serum level of E₂ and the ratio of E₂/T in the RA group were significantly higher than those in the control group（P < 0.05）,and there was no significant difference in the level of serum T in the two groups（P > 0.05）.Before treatment,E₂ and E₂/T were positively correlated with ESR（r = 0.688,P = 0.000;r = 0.722,P = 0.000）,CRP（r = 0.499,P = 0.000;r = 0.505,P = 0.000）,DAS28（r = 0.756,P = 0.000;r = 0.413,P = 0.001）,HAQ（r = 0.603,P = 0.000;r = 0.416,P = 0.001）of the RA patients.After treatment with Yi Sai Pu,the E₂ level and E₂/T ratio in group RA were significantly lower than those before treatment（P < 0.05）.Conclusion:Changes of serum sex hormone levels and the imbalance of sex hormone ratio may be involved in the pathogenesis of RA in postmenopausal women,and may be used as an indicator of RA activity.Yi Sai Pu can promote the recovery of sex hormones and the ratio of sex hormones in postmenopausal women with RA.

　　【Keywords】 arthritis,rheumatoid;sex hormone ratio;Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for Injection;disease activity