重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白对强直性脊柱炎外周血细胞的影响

Influence of a recombinant human tumor necrosis factor-Fc fusion protein on peripheral blood cells in patients with ankylosing spondylitis

目的评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(商品名:益赛普)治疗强直性脊柱炎(AS)对患者外周血细胞的影响。方法本研究前6周为随机、双盲、安慰剂对照临床试验,52例AS患者随机接受6周的每周2次益赛普(25 mg)或安慰剂皮下注射;后6周均接受益赛普治疗,于第0、1、2、4、6、7、8、10、12周进行血常规检查及临床疗效评价,分析白细胞总数、中性粒细胞、淋巴细胞、血红蛋白和血小板的变化规律。结果益赛普治疗后第1周,AS患者外周血白细胞总数即较基线时下降(P<0.05),并且有11例患者出现白细胞减少,进一步分析显示益赛普治疗使AS患者中性粒细胞减少、淋巴细胞增多、中性粒细胞减少的程度要高于淋巴细胞增加的程度。临床分析表明白细胞减少与益赛普的疗效无关。同时还发现益赛普治疗可改善AS患者的贫血状态,降低异常升高的血小板。结论益赛普治疗AS在一定程度上可引起患者血液系统的变化,有必要在今后的治疗过程中定期监测血常规。

Objective To evaluate the influence of a recombinant human tumor necosis factor-Fc fusion protein （etanercept） on peripheral blood cells in patients with ankylosing spondylitis（AS）. Methods The study was designed as a randomized,double-blind,placebo-controlled trial in the first 6 weeks followed by another 6 weeks of open label trial. Fifty-two AS patients were randomly assigned to receive twice-weekly subcutaneous injections of etanercept （25 mg） or placebo for 6 weeks. The blood routine examination was checked at weeks 0,1,2,4,6,7,8,10 and 12 and the changes of white blood cell （WBC）, neutrophil, lymphocyte, platelet and hemoglobin were analyzed. Meanwhile, the clinical efficacy of etanercept on AS patients was evaluated. Results The quantity of WBC was decreased at the first week after.the treatment with etanercept （P〈0.05,compared to the baseline）,and there were 11 cases of leukopenia. The analysis showed that etanercept decreased the quantity of neutrophil, increased the quantity of lymphocyte, improved the anemia and decreased the elevated platelet count. There was no correlation between the leukopenia and clinical efficacy of etanercept. Conclusion Etanercept affects the peripheral blood cells in patients with AS. It is suggested that patients receiving etanercept should be followed regularly for blood counts along with other efficacy and side effects.