减少灰质萎缩患者复发多发性硬化症治疗Cladribine平板电脑(1946)

摘要目的:事后评价灰质(GM)和白质(WM)体积变化复发多发性硬化(MS)患者随机分为cladribine平板电脑3.5毫克/公斤体重(CT3.5;累积剂量超过2年)或安慰剂的清晰的研究。

背景:越来越明白的是,通用汽车萎缩与残疾有关发展和认知下降患者女士以前,我们表明,治疗与CT3.5清晰研究减少脑萎缩与安慰剂相比,与降低残疾的风险密切相关的进展[De斯特凡诺et al . MSJ 2018]。

设计/方法:图像pre-gadolinium t1加权磁共振成像扫描随机CT3.5或安慰剂的患者2年清晰使用SIENA-XL软件进行评估。图像- 6个月(CT3.5 n = 267;分析了安慰剂,n = 265)独立于图像从6日到24日个月(CT3.5 n = 184;安慰剂,n = 186)占pseudoatrophy的潜在影响。折合成年率的意思是改变比例的通用卷(PGMV)或WM卷(PWMV) CT3.5和安慰剂之间- 6日到24日个月比较用方差模型。

结果:CT3.5减少通用汽车和WM体积与安慰剂前6个月,与pseudoatrophy一致(PGMV变化:CT3.5安慰剂−−0.53和0.25 (p = 0.045);PWMV变化:CT3.5安慰剂−−0.49和0.34 (p = 0.137))。脑容量损失6日到24日个月减少患者随机分配到CT3.5通用CT3.5和安慰剂显著的区别(PGMV变化:CT3.5安慰剂−−0.90和1.27 (p = 0.026);PWMV变化:CT3.5安慰剂−−0.32和0.40 (p = 0.52))。

结论:在WM体积损失减少,特别是在通用汽车被指出从6日到24日个月CT3.5-treated病人安慰剂,经过一段时间的pseudoatrophy(0 - 6个月)。这些发现表明,CT3.5显著减少脑萎缩主要通用,产生影响,可能有助于降低残疾进展的风险。

披露:马可Battaglini没有披露。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围作为顾问生原体。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为罗氏公司担任顾问。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为赛诺菲担任顾问。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为默克公司担任顾问。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为Celgene公司担任顾问。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为诺华公司担任顾问。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为Geneuro担任顾问。玛丽亚Pia索尔已经收到个人薪酬在5000 - 9999美元的范围为在科学咨询服务或数据安全监测委员会Medday。玛丽亚Pia索尔已经收到个人薪酬在500 - 4999美元的范围为在科学咨询服务或数据安全监测委员会赛诺菲。 Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. L Luchetti has nothing to disclose. G Gentile has nothing to disclose. Rosa Cortese has nothing to disclose. Nektaria Alexandri has nothing to disclose. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Healthcare KGaA. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharma AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Serono S.p.A. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche S.p.A.. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Celgene International II Sàrl. The institution of Dr. De Stefano has received research support from Italian MS Society. The institution of Dr. De Stefano has received research support from Merck Healthcare KGaA.