本資料中涉及的信息僅供參考，請遵從醫生或其他醫療衛生專業人士的意見或指導。<\/i><\/p> \n
關于多發性硬化<\/u><\/b> <\/p> \n
多發性硬化是一種以中樞神經系統炎性脫髓鞘病變為主要特點的免疫介導性疾病，其病因尚不明確，可能與遺傳、環境、病毒感染等多種因素相關[1]<\/sup>。髓鞘損傷會干擾大腦與身體其他部位之間的通信，<\/span>最終導致神經退行性損害，這一過程目前尚不可逆[12]<\/sup>。<\/p> \n 復發型多發性硬化癥包括臨床孤立綜合征、復發-緩解型疾病和活動性繼發進展型疾病[13]<\/sup>。其中，復發-緩解型疾病是診斷時最常見的類型，80%-85%的患者初診時被診斷為復發-緩解型疾病，其表現為明顯的復發和緩解過程，每次發作后均基本恢復，不留或僅留下輕微后遺癥[1]<\/sup>。約10%-15%的患者被診斷為進展型疾病[13]<\/sup>。<\/p> \n 關于<\/u><\/b>SUNBEAM<\/u><\/b>和<\/u><\/b>RADIANCE<\/u><\/b>研究<\/u><\/b> <\/p> \n SUNBEAM研究和RADIANCE研究均為全球多中心、隨機、雙盲、陽性藥物平行對照的III期臨床研究，旨在評估奧扎莫德兩種口服劑量（0.92mg和0.46mg，每日一次）與干擾素β-1a相比，治療成人復發型多發性硬化患者的療效和安全性。前者共納入1346例患者，為期12個月；后者共納入1320例患者，為期24個月。<\/p> \n SUNBEAM<\/b>（<\/b>12<\/b>個月）及<\/b>RADIANCE<\/b>（<\/b>24<\/b>個月）主要研究結果數據匯總<\/b><\/span><\/p> <\/td> \n <\/tr> \n 研究終點<\/b><\/span><\/p> <\/td> \n 時間<\/b><\/span><\/p> <\/td> \n 奧扎莫德 干擾素<\/b>β-1<\/b>組<\/b><\/span><\/p> <\/td> \n 降低百分比<\/i><\/b><\/span><\/p> <\/td> \n 對比對照藥 年復發率（<\/span>ARR<\/span>）<\/span><\/p> <\/td> \n 12<\/span>個月<\/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>個月<\/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>加權<\/span>GdE<\/span>病灶平 12<\/span>個月<\/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>個月<\/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 新發<\/span>\/<\/span>擴大<\/span>T2<\/span>病灶平 12<\/span>個月<\/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>個月<\/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 與基線相比，全腦容 12<\/span>個月<\/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>個月<\/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 與基線相比，皮層灰 12<\/span>個月<\/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>個月<\/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 與基線相比，丘腦容 12<\/span>個月<\/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>個月<\/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>評分有臨床 12<\/span>個月<\/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 關于熱珀西亞<\/u><\/b>®<\/sup><\/u><\/b>（鹽酸奧扎莫德膠囊）<\/u><\/b><\/p> \n 熱珀西亞<\/i>是一種口服鞘氨醇1-磷酸（S1P）受體調節劑，可高親和力結合S1P受體1和5（S1P1<\/sub>和S1P5<\/sub>）[11]<\/sup>。熱珀西亞<\/i>可適度抑制淋巴細胞遷出，減少外周血中淋巴細胞數量[11]<\/sup>。熱珀西亞<\/i>對多發性硬化發揮治療作用的機制尚不完全明確，可能與減少淋巴細胞向中樞神經系統的遷移相關[11]<\/sup>。<\/p> \n 熱珀西亞<\/i>是全球首個同時獲批復發型多發性硬化和潰瘍性結腸炎這兩項適應癥的S1P受體調節劑：美國食品藥品監督管理局（FDA）分別于2020年3月和2021年5月批準熱珀西亞<\/i>用于治療成人復發型多發性硬化癥和中度至重度活動性潰瘍性結腸炎成人患者；歐盟委員會（EC）則分別于2020年5月和2021年11月批準熱珀西亞<\/i>用于治療由臨床或影像學特征定義的活動性復發緩解型多發性硬化癥成人患者和對常規療法或生物制劑應答不足、失應答或不耐受的中度至重度活動性潰瘍性結腸炎成人患者。<\/p> \n 此外，針對熱珀西亞<\/i>治療克羅恩病的臨床研究也正在全球范圍內開展中。<\/p> \n 注：熱珀西亞潰瘍性結腸炎和克羅恩病適應癥尚未在中國獲批<\/i><\/p> \n [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 <\/p>"];
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<\/b>0.92mg<\/b>組<\/b><\/span><\/p> <\/td> \n
物組的<\/b>P<\/b>值<\/b><\/span><\/p> <\/td> \n <\/tr> \n \n \n \n
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量平均百分比下降
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質容量平均百分比下
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量平均百分比下降
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意義改善的患者比例<\/span><\/p> <\/td> \n \n \n
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