Ann Rheum Dis:阿达木单抗诱导治疗类风湿关节炎的临床和影像学结果

2015-10-27 candy 译 MedSci原创

目标:研究1年前经阿达木单抗诱导药治疗的早期类风湿关节炎病人的临床和影像学结局,另加以甲氨蝶呤和关节内糖皮质激素的针对性治疗策略。方法:早期类风湿关节炎病人以改变病情抗风湿药(DMARD)的甲氨蝶呤(20mg每周)与关节内糖皮质激素(20 mg/ml)治疗2年。另外,在第一年随机将他们分配到阿达木单抗诱导安慰剂组(予以单抗诱导安慰剂,n=91)和阿达木单抗诱导组(40 mg每隔一周)(予以阿达木单

目标:研究1年前经阿达木单抗诱导药治疗的早期类风湿关节炎病人的临床表现和影像学结局,另加以甲氨蝶呤和关节内糖皮质激素的针对性治疗策略。

方法:早期类风湿关节炎病人以抗风湿药(DMARD)甲氨蝶呤(20mg每周)与关节内糖皮质激素(20 mg/ml)治疗2年。另外,在第一年随机将他们分配到阿达木单抗诱导安慰剂组(予以单抗诱导安慰剂,n=91)和阿达木单抗诱导组(40 mg每隔一周)(予以阿达木单抗诱导安慰剂+阿达木单抗诱导剂,n=89)。如果3个月后存在疾病活动性,再加柳氮磺胺吡啶和羟氯喹等。在第二年里, 阿达木单抗诱导安慰剂组仍然继续。当病情再次明显存在活动性时,启用阿达木单抗诱导。评估临床反应、缓解、残疾、生活质量和影像学变化。

结果:阿达木单抗诱导撤退后1年,治疗情况与临床反应在组间无差异。在阿达木单抗诱导组与安慰剂组中,中位的2年甲氨蝶呤剂量都为20mg每周(P=0.45),发起三联DMARD疗法的病人分别为33、27例病人(P=0.49)。治疗目标(疾病活动评分,4个变量,C反应蛋白(DAS28CRP)≤3.2或DAS28 > 3.2,无关节肿胀)在两年后的所有随访病人中都实现了,占所有病人的85%;缓解率,DAS28 CRP < 2.6,两组的数据分别为:69 % /66%;临床疾病活动指数≤2.8,两组分别为:55%/57%;简化疾病活动指数<3.3,分别为:54%/49%;美国风湿学会/欧洲抗风湿联盟学院(28节):44%/45%(P=0.66–1.00)。影像学进展(Δ总Sharp分/年)是相似的1.31/0.53(P = 0.12)。侵蚀进展(Δ侵蚀评分(ES)/年),第一年:0.57/0.06(P = 0.02);第二年:0.38/0.05(P = 0.005)。无病情进展的患者比例(ΔES≤0),第一年:59 % / 76%(P = 0.03);第二年:64 % / 79%(P = 0.04)。

结论:依靠阿达木单抗诱导治疗,积极的曲安奈德和抗风湿药物治疗得到了极好的2年临床和影像学疾病控制效果。而在阿达木单抗诱导治疗过程中与治疗后,侵蚀评分进展略低。

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