英夫利昔单抗治疗强直性脊柱炎的疗效观察

Curative Efficacy of Infliximab for Ankylosing Spondylitis

目的:探讨英夫利昔单抗治疗强直性脊柱炎(AS)的效果及安全性。方法:将60例确诊为AS并符合应用生物制剂的患者以随机抽样法分为对照组和观察组各30例,对照组患者在口服甲氨蝶呤的基础上应用柳氮磺胺吡啶等改善病情的药物;观察组患者在口服甲氨蝶呤的基础上联合应用英夫利昔单抗。观察2组患者治疗12周后的效果及治疗6、12周时的临床和实验室指标及不良反应发生情况。结果:治疗12周后,观察组患者疗效明显优于对照组(P<0.05)。治疗6、12周后,观察组患者的Bath强直性脊柱炎病情活动指数评分(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、脊柱痛、晨僵、胸廓扩张度、C反应蛋白(CRP)、细胞沉降率(ESR)、腰椎活动度试验(Schober)等指标均明显优于治疗前,且与对照组比较,差异具有统计学意义(P<0.05);治疗6周后,对照组患者晨僵、ESR、BASFI较治疗前有显著改善(P<0.05),治疗12周后,对照组患者除血小板计数(PLT)、白细胞计数(WBC)、心率(HR)等指标外,其他指标较治疗前有明显改善(P<0.05)。治疗6、12周后,2组患者的PLT、WBC下降,较治疗前均有显著差异(P<0.05),但2组间比较差异无统计学意义(P>0.05);2组患者治疗前后HR无明显变化(P>0.05);2组均未见明显不良反应。结论:英夫利昔单抗治疗AS,可以更早期地达到诱导、缓解病情的目的,较为安全、有效。

OBJECTIVE： To evaluate the efficacy and safety of infliximab for ankylosing spondylitis （AS）. METHODS： 60 patients confirmed as AS cases meeting the criteria for candidates receiving biological agents were randomly divided into control group and observation group, of 30 each. The control group received oral methotrexate plus sulfasalazine while the observation group received oral methotrexate in combination with infliximab. The curative efficacy in the two groups after treatment of 12 weeks, and the clinical and laboratory indexes and the adverse drug reactions at 6 and 12 week were evaluated. RESULTS： After 12 weeks of treatment, the observation group was significantly better curative efficacy than in the control group（P 〈 0. 05）; after treatment of 6 and 12 weeks, the observation group showed significant better improvement in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）, Bath AS functional index （BASFI）, spinal pain, morning stiffness, thoracic expansion, C-reaction protein（ CRP）, erythrocyte sediment rate（ESR）, range-of-motion test of lumbar（Schober） and other indicators, and compared with the control group, the differences were statistically significant （ P 〈 0. 05 ）. In the control group as compared with before treatment, significant improvement was noted in morning stiffness, ESR, BASFI after treatment of 6 weeks（P 〈 0. 05） and in all indicators except platelet count（PLT）, white blood count（WBC） and heart rate （HR） after treatment of 12 weeks （P 〈 0. 05 ）. After treatment of 6 and 12 weeks, PLT and WBC in both groups decreased significantly compared with before treatment（P 〈 0. 05 ）, yet the differences between the two groups were not statistically significant（P 〉0.05）. No significant adverse drug reactions were noted in either group. CONCLUSION： Infliximab treatment of AS resulted in early induction and remission and it is safe and effective.