短期使用益赛普与来氟米特治疗强直性脊柱炎疗效观察

Clinical Study on Short-term Treatment with Recombinant Human Tumor Necrosis Factor-Α ReceptorⅡ:IgG Fc Fusion Protein and Leflunomide in Ankylosing Spondylitis

目的探讨短期使用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc益赛普)与来氟米特(LEF)联合治疗强直性脊柱炎(AS)的有效性和安全性。方法对36例患者随机分为实验组21例和对照组15例,实验组给予益赛普皮下注射治疗3个月,每周2次,每次25mg,同时给予LEF每日1次,每次20 mg。对照组给予LEF,剂量及方法同实验组,疗程3个月,随时观察并记录治疗过程中的任何不良事件,在0、2、4、8、12周监测血常规、红细胞沉降率(ESR)、肝肾功能。结果实验组和对照组的ACR20,ACR70,ESR、CRP指标均较入组时有明显改善,但两组间差异无统计学意义(P>0.05)。治疗12周后实验组停用益赛普时,两组的上述指标均进一步改善,两组间的不良反应率差异无统计学意义。结论短期益赛普与LEF联合治疗AS,可以减少益赛普的疗程,有效的缓解AS的症状,并不增加不良反应,具有较好的安全性。

Objective To evaluate the efficacy and safety of short -term treatment with recombinant human tumor necrosis factor - α receptor Ⅱ .IgG Fc fusion protein and leflunomide in ankylosing spondylitis. Methods 36 patients were divided into two groups： control group （n = 15）, experimental group （n = 21 ）. The patients in experimental group were treated with recombinant human tumor necrosis factor-α receptor Ⅱ ：IgG Fc fusion protein for 3 months（subcutaneous injection of 25mg, ,once a week）and Leflunomide was given orally （25mg once daily）. The control group was treated with Leflunomide the same dose as the experimental. The side effects were recorded. The blood routine, ESR, hepatic and renal function was checked at 0, 2.4.8,12 weeks. Results After the treatment, the ACR20, ACR70, ESR, CRP was improved in both groups but there was no significant difference between the two groups（P 〉0.05）. After withdrawal the recombinant human tumor necrosis factor - α receptor Ⅱ ：IgG Fc fusion protein; the above indexes were further improved. There was no significant difference about the occurrence rate of side effects （P 〉 0.05）. Conclusion Short - term treatment with Recombinant human tumor necrosis factors receptor Ⅱ ：IgG Fc fusion protein and leflunomide in ankylosing spondylitis is effective and safe.