% 0期刊文章%一个Luca Massacesi %艾琳Tramacere %玛丽亚毕讷德提Donata %格拉Filippini %一个Loredana Lamantia %一个亚历山德拉·索拉里%萨尔瓦多Amoroso %一个马里奥•巴塔利亚% Gioacchino泰德%克拉拉米兰% T咪唑硫嘌呤和β干扰素疗效的直接比较多发性硬化症(P01.200) % D J神经病学2013% % P P01.200-P01.200 % V 80% N % X 7补充目的:比较疗效和安全性的咪唑硫嘌呤(阿扎)目前干扰素的临床和MRI结果复发缓和多发性硬化症(MS)的措施,通过多中心随机对照试验(RCT)。首页背景:批准后β干扰素(IFN)多发性硬化症(MS)、硫唑嘌呤(AZA)主要被用来作为二线治疗,尽管这些药物的直接比较从未执行。设计/方法:符合条件的患者(n = 150;复发缓和多发性硬化症;> 2复发在过去2年)被随机分配给阿扎或干扰素,随访2年。主要结果在复发率功效。关键二次结果是一些新的大脑病变,以通过T2加权MRI序列。MRI评价包括122名患者。这些治疗方法的疗效比较运用non-inferiority设计根据出版的指南。结果:基线特征,生成的随机比较组(n = 77和73年)。临床评价表明,年复发率低的阿扎比干扰素组和non-inferiority分析表明,阿扎施加在这个测量结果至少同样的效果的干扰素(0.67%,单侧95% C.I.= 0.96;p = 0.03)。新的T2病灶数量分析在97例,两组相似,表明阿扎也保持这个结果至少73%的干扰素疗效(p = 0.05)。 Number of patients with adverse events (AE) and patients who discontinued treatment for AEs were similar in both the treatment groups although total AE number was higher in the AZA treated group.CONCLUSIONS: These data indicate for the first time, that in relapsing remitting MS AZA is at least as effective as IFNs on clinical outcome measures and that its efficacy on suppressing new brain lesions is equivalent to that of the IFNs.Supported by: Italian Medicines Agency(Agenzia Italiana del Farmaco; AIFA).Disclosure: Dr. Massacesi has received personal compensation for activities with Biogen Idec, Merk-Serono, Sanofi-Aventis, Novartis, and the European Medicine Agency. Dr. Tramacere has nothing to disclose. Dr. Benedetti has nothing to disclose. Dr. Filippini has nothing to disclose. Dr. Lamantia has nothing to disclose. Dr. Solari was a board member for Novartis, Biogenidec and Merck Serono, and has received speaker honoraria from Sanofi-Aventis. Dr. Amoroso has nothing to disclose. Dr. Battaglia has nothing to disclose. Dr. Tedeschi has received research support from Biogen-Idec, Merk-Serono, Sanofi-Aventis and Novartis. Dr. Milanese has nothing to disclose.Monday, March 18 2013, 2:00 pm-6:30 pm %U

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