注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白减量治疗强直性脊柱炎的疗效分析

Efficacy of Yisaipu tapering in the treatment of ankylosing spondylitis

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（益赛普）减量治疗强直性脊柱炎（AS）的有效性。方法回顾性分析2013年2月至2017年4月在广东省第二人民医院采用益赛普及塞来昔布治疗87例AS患者的临床资料。所有患者均接受为期12周足量益赛普及塞来昔布治疗。在第13～24周，足量组患者继续方案治疗，减量组患者益赛普剂量减半。通过AS疾病活动性评分（ASDAS）、Bath AS功能指数（BASFI）、骶髂关节核磁共振（MR）评分等指标比较减量与足量使用益赛普治疗AS疗效的差异，并记录不良反应的发生情况。结果第24周减量组ASDAS与BASFI分别为1.1±0.7及1.3±1.1，足量组为1.0±0.7及1.1±1.0，组间差异均无统计学意义（均P〉0.05）。减量组与足量组患者在治疗前骶髂关节MR评分分别为8±7及8±6，第24周均较前显著下降（4±4及4±3，P〈0.05），但组间差异无统计学意义（P〉0.05）。结论益赛普减量皮下注射可维持AS病情及功能稳定，与足量使用益赛普无差异。

Objective To assess the efficacy of Yisaipu tapering in patients with ankylosing spondylitis （AS）. Methods A total of 87 cases of AS patients from Guangdong Second Provincial General Hospital who were treated with Yisaipu and celecoxib were retrospectively analyzed from February 2013 to April 2017. All patients received full dose Yisaipu and celecoxib in the initial 12 weeks. After that, the patients in the full dose group maintained Yisaipu （50 mg/w） treatment from the 13rd to 24th week, while tapering group received Yisaipu 50 mg subcutaneous injection once every other week. By using AS disease activity score （ASDAS）, Bath AS functional index （BASFI） and magnetic resonance （MR） score of sacroiliac joint （SIJ） plus recording adverse events, differences of efficacy and safety between groups were compared. Results ASDAS and BASFI of tapering group were 1. 1 ± 0. 7 and 1.3 ± 1.1, while those of full dose group were 1.0 ± 0. 7 and 1.1 ± 1.0, respectively. No significant difference of ASDAS or BASFI was found between groups. Besides, the MR scores of tapering and full dose groups were 8 ± 7 and 8 ± 6 respectively before therapy, while they were significantly lower in the 24th week （4 ± 4 and 4 ± 3, P 〈 0. 05 ）. However, changes of MR score between groups were similar （ P 〉 0.05 ）. Conclusion Dose tapering of Yisaipu subcutaneous injection might be effective for keeping stable of disease activity and function in patients with AS. Its efficacy is similar to those of full dose Yisaipu.