英夫利西单抗与改变病情的抗风湿药物治疗强直性脊柱炎的临床对比研究

Infliximab versus disease modifying antirheumatic drugs in the treatment of ankylosing spondylitis

目的 对单克隆抗体英夫利西单抗与传统改变病情的抗风湿药物（DMARDs）治疗强直性脊柱炎（AS）的临床疗效进行对比观察,以评价2种药物治疗AS的有效性和安全性.方法 60例确诊的活动期AS患者,随机分为治疗组及对照组,每组30例,治疗组分别于0、2、6、12周给予英夫利西单抗（5mg/kg）,对照组给予传统DMARDs（柳氮磺吡啶或来氟米特）,随访12周.观察主要疗效指标：治疗终点时达到AS疗效评价标准（ASAS）20的患者比例 次要疗效指标：治疗终点时达到ASAS 50的患者比例,不同时间点与基线值相比Bath AS疾病活动指数（BASDAI）、Bath AS功能指数（BASFI）、脊柱痛、脊柱炎症、患者总体评估指数（PGA）、目视模拟测试表（VAS）及红细胞沉降率（ESR）、C反应蛋白（CRP）变化的情况.计量资料采用t检验,计数资料采用x2检验.结果 2组患者在治疗第12周时与治疗前比较,ASAS 20（93%和47%）、ASAS 50（57%和27%）及BASDAI（2.8±0.4和4.9±1.2）、BASFI（2.8±0.9和4.0±1.1）、脊柱痛（2.5±1.0和3.9±1.2）、脊柱炎症（2.3±1.1和4.4±1.2）、PGA VAS（2.6±1.5和4.8±1.1）及ESR[（9±5）和（26±12）mm/1 h]、CRP[（5±3）和（19±12）mg/L]均改善,差异具有统计学意义（P〈0.05）.其中英夫利西单抗治疗组改善更为明显,优于传统DMARDs组（P〈0.05）.2组患者均无严重不良反应发生,最常见的不良反应为上呼吸道感染、胃肠道刺激症状及输液反应,英夫利西单抗组不良反应的发生率明显低于传统DMARDs组.结论 英夫利西单抗与传统DMARDs比较,能迅速减轻AS的症状与体征,并可改善AS患者的功能、活动范围和生活质量,具有良好的安全性和耐受性.

Objective To evaluate the efficacy and safety of infliximab and traditional disease modifying antirheumatic drugs （DMARDs） in the treatment of ankylosing spondylitis （AS）. Methods Sixty patients with definite AS were treated with infliximab 5 mg/kg infusion at 0, 2, 6, 12 weeks and were followed up for 12 weeks. The primary endpoint was proportion of ASAS 20 responders at week 12. The secondary endpoints were the proportion of ASAS 50, the change from baseline in Bath AS functional index （BASFI）.The improvement of signs and symptoms of AS and physical function were evaluated. The statistical treatments were used t-test andA2 test. Results The proportion of ASAS 20 responders at 2, 6, 12 week was 70%, 83% and 93% respectively. The proportion of ASAS50 responders at patients at 2, 6, 12 week was 13%, 37% and 57% respectively. Results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to patients with AS by reducing clinical signs and symptoms and improving range of motion, physical function and quality of life. Ten percent of the subjects reported treatment- related adverse events. The most frequently occurred were upper respiratory tract infection, followed by gastrointestinal adverse events and infusion reaction. Most treatment-related adverse events were mild to moderate in severity and disappeared after drug withdrawal. Conclusion Infliximab has been demonstrated to be effective and is well tolerated in the treatment of AS.