本资料中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。<\/i><\/p> \n

多发性硬化是一种以中枢神经系统炎性脱髓鞘病变为主要特点的免疫介导性疾病，其病因尚不明确，可能与遗传、环境、病毒感染等多种因素相关^{[1]<\/sup>。髓鞘损伤会干扰大脑与身体其他部位之间的通信，<\/span>最终导致神经退行性损害，这一过程目前尚不可逆^{[12]<\/sup>。<\/p> \n}}

复发型多发性硬化症包括临床孤立综合征、复发-缓解型疾病和活动性继发进展型疾病^{[13]<\/sup>。其中，复发-缓解型疾病是诊断时最常见的类型，80%-85%的患者初诊时被诊断为复发-缓解型疾病，其表现为明显的复发和缓解过程，每次发作后均基本恢复，不留或仅留下轻微后遗症^{[1]<\/sup>。约10%-15%的患者被诊断为进展型疾病^{[13]<\/sup>。<\/p> \n}}}

关于<\/u><\/b>SUNBEAM<\/u><\/b>和<\/u><\/b>RADIANCE<\/u><\/b>研究<\/u><\/b> <\/p> \n

SUNBEAM研究和RADIANCE研究均为全球多中心、随机、双盲、阳性药物平行对照的III期临床研究，旨在评估奥扎莫德两种口服剂量（0.92mg和0.46mg，每日一次）与干扰素β-1a相比，治疗成人复发型多发性硬化患者的疗效和安全性。前者共纳入1346例患者，为期12个月；后者共纳入1320例患者，为期24个月。<\/p> \n

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SUNBEAM<\/b>（<\/b>12<\/b>个月）及<\/b>RADIANCE<\/b>（<\/b>24<\/b>个月）主要研究结果数据汇总<\/b><\/span><\/p> <\/td> \n <\/tr> \n
研究终点<\/b><\/span><\/p> <\/td> \n
时间<\/b><\/span><\/p> <\/td> \n
奥扎莫德
<\/b>0.92mg<\/b>组<\/b><\/span><\/p> <\/td> \n
干扰素<\/b>β-1<\/b>组<\/b><\/span><\/p> <\/td> \n
降低百分比<\/i><\/b><\/span><\/p> <\/td> \n
对比对照药
物组的<\/b>P<\/b>值<\/b><\/span><\/p> <\/td> \n <\/tr> \n
年复发率（<\/span>ARR<\/span>）<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
0.18<\/span><\/p> <\/td> \n
0.35<\/span><\/p> <\/td> \n
-48 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
0.17<\/span><\/p> <\/td> \n
0.28<\/span><\/p> <\/td> \n
-38 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
T1<\/span>加权<\/span>GdE<\/span>病灶平
均数量<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
0.16<\/span><\/p> <\/td> \n
0.43<\/span><\/p> <\/td> \n
-63 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
0.18<\/span><\/p> <\/td> \n
0.37<\/span><\/p> <\/td> \n
-53 %<\/span><\/p> <\/td> \n
P=0.0006<\/span><\/p> <\/td> \n <\/tr> \n
新发<\/span>\/<\/span>扩大<\/span>T2<\/span>病灶平
均数量<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
1.47<\/span><\/p> <\/td> \n
2.84<\/span><\/p> <\/td> \n
-48 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
1.84<\/span><\/p> <\/td> \n
3.18<\/span><\/p> <\/td> \n
-42 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，全脑容
量平均百分比下降
（<\/span>%<\/span>）<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
-0.41<\/span><\/p> <\/td> \n
-0.61<\/span><\/p> <\/td> \n
-31 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
-0.71<\/span><\/p> <\/td> \n
-0.94<\/span><\/p> <\/td> \n
-26 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，皮层灰
质容量平均百分比下
降（<\/span>%<\/span>）<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
-0.16<\/span><\/p> <\/td> \n
-1.00<\/span><\/p> <\/td> \n
-84 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
-0.44<\/span><\/p> <\/td> \n
-1.11<\/span><\/p> <\/td> \n
-60 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
与基线相比，丘脑容
量平均百分比下降
（<\/span>%<\/span>）<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
-1.12<\/span><\/p> <\/td> \n
-1.72<\/span><\/p> <\/td> \n
-32 %<\/span><\/p> <\/td> \n
P<0.0001<\/span><\/p> <\/td> \n <\/tr> \n
24<\/span>个月<\/span><\/p> <\/td> \n
-1.40<\/span><\/p> <\/td> \n
-1.85<\/span><\/p> <\/td> \n
-27 %<\/span><\/p> <\/td> \n
P=0.0004<\/span><\/p> <\/td> \n <\/tr> \n
SDMT<\/span>评分有临床
意义改善的患者比例<\/span><\/p> <\/td> \n
12<\/span>个月<\/span><\/p> <\/td> \n
35.6 %<\/span><\/p> <\/td> \n
27.9 %<\/span><\/p> <\/td> \n
\/<\/span><\/p> <\/td> \n
P=0.0302<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
关于热珀西亚<\/u><\/b>^{®<\/sup><\/u><\/b>（盐酸奥扎莫德胶囊）<\/u><\/b><\/p> \n}
热珀西亚<\/i>是一种口服鞘氨醇1-磷酸（S1P）受体调节剂，可高亲和力结合S1P受体1和5（S1P_{1<\/sub>和S1P_{5<\/sub>）^{[11]<\/sup>。热珀西亚<\/i>可适度抑制淋巴细胞迁出，减少外周血中淋巴细胞数量^{[11]<\/sup>。热珀西亚<\/i>对多发性硬化发挥治疗作用的机制尚不完全明确，可能与减少淋巴细胞向中枢神经系统的迁移相关^{[11]<\/sup>。<\/p> \n}}}}}
热珀西亚<\/i>是全球首个同时获批复发型多发性硬化和溃疡性结肠炎这两项适应症的S1P受体调节剂：美国食品药品监督管理局（FDA）分别于2020年3月和2021年5月批准热珀西亚<\/i>用于治疗成人复发型多发性硬化症和中度至重度活动性溃疡性结肠炎成人患者；欧盟委员会（EC）则分别于2020年5月和2021年11月批准热珀西亚<\/i>用于治疗由临床或影像学特征定义的活动性复发缓解型多发性硬化症成人患者和对常规疗法或生物制剂应答不足、失应答或不耐受的中度至重度活动性溃疡性结肠炎成人患者。<\/p> \n
此外，针对热珀西亚<\/i>治疗克罗恩病的临床研究也正在全球范围内开展中。<\/p> \n
注：热珀西亚溃疡性结肠炎和克罗恩病适应症尚未在中国获批<\/i><\/p> \n
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[12] National Multiple Sclerosis Society. What Causes MS? www.nationalmssociety.org\/What-is-MS\/What-Causes-MS. Accessed March 25, 2020.<\/span><\/p> <\/td> \n <\/tr> \n
[13] National Multiple Sclerosis Society. Types of MS. www.nationalmssociety.org\/What-is-MS\/Types-of-MS. Accessed March 25, 2020.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
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