本文選自《經(jīng)濟學(xué)人》10月26日文章。阿爾茲海默病,,俗稱老年癡呆,,很多人認為它距自己很遠,實際上它與每個人都息息相關(guān)?,F(xiàn)在阿爾茲海默病已成為威脅人類尤其是老年人健康的主要病癥,,至今人類仍未揭開它的神秘面紗,更沒有有效藥物治療這種疾病,。近日Biogen(渤?。┖托l(wèi)材宣布,在與美國食藥品監(jiān)局(FDA)協(xié)商后,,計劃提交阿爾茨海默病治療藥物Aducanumab的生物制品許可上市申請,,如果獲得批準,Aducanumab將成為首個能改善阿爾茨海默病臨床癥狀的藥物,。Aducanumab曾因臨床數(shù)據(jù)呈現(xiàn)無效性被宣布終止,,但渤健對臨床數(shù)據(jù)進行細致分析后,將Aducanumab從死亡線上拉回來,,并宣布將向FDA提交上市申請,。本文認為,能治療阿爾茲海默癥的藥物對廣大患者來說是福音,,對生產(chǎn)藥企來說是搖錢樹,,在尚未確定其是否有效時,仍需謹慎對待,。 選文精講 Claims about a treatment for Alzheimer’s should be met with caution- Alzheimer's disease: 阿爾茨海默病,,簡稱AD,俗稱老年癡呆病
More trials would be a good ideaA DRUG THAT slowed the progress of Alzheimer’s disease would be both a boon to humanity and a cash cow for the firm that developed it. Hence the rollercoaster ride enjoyed by the shares of Biogen, a biotechnology company based in Cambridge, Massachusetts, which hopes to be the firm in question. The recent surge in its share price (see chart) followed its announcement, on October 22nd, that it would soon seek approval in America for aducanumab, a molecule it believes will fit the bill.一種能夠延緩阿爾茨海默病病情惡化的藥物,,對人類來說是福音,,對研發(fā)它的公司來說,也是搖錢樹,??偛课挥隈R薩諸塞州劍橋市的生物科技公司渤健有望成為這樣的公司,它的股價也因此經(jīng)歷了過山車式的波動,。10月22日,,該公司宣布將很快在美國申請對aducanumab(一種它認為能治療阿爾茨海默病的分子)的批準,其股價隨之飆升(見圖表),。 Aducanumab is a type of drug known as a monoclonal antibody. Antibodies are specialised protein molecules that form part of the immune system. They include so-called hypervariable regions, the exact chemistry of which differs from one type of antibody to another. The specifics of the hypervariable region cause it to bind with great fidelity to some other molecule, usually part of a pathogen, stopping that molecule working and marking it for destruction by other parts of the immune system.- monoclonal antibody: 單克隆抗體
- fidelity: 忠誠,、保真度,這里指緊密結(jié)合在一起
Aducanumab是一種被稱為單克隆抗體的藥物,??贵w是形成部分免疫系統(tǒng)的特殊蛋白質(zhì)分子,涉及所謂的高變區(qū),,其確切的化學(xué)性質(zhì)因抗體的不同而不同,。高變區(qū)的特性使其與其他分子(通常是病原體的一部分)緊密結(jié)合,讓這些細胞失效,,并標記其被免疫系統(tǒng)的其他部分破壞。 America’s Food and Drug Administration, which will decide whether to give aducanumab the go-ahead, will of course be aware of the conventions concerning statistical power, and will make its decision in light of that awareness. There must, though, be a temptation, given the magnitude of the problem of Alzheimer’s (in America alone there are almost 6m cases), and the absence of alternative treatments, to give a green light to something that might work, in the hope that it does work. Which will make heroes out of everyone involved if it turns out to be correct—and villains if it does not.美國食品藥品監(jiān)督管理局將決定是否批準aducanumab的使用,,當(dāng)然,它會弄明白有關(guān)統(tǒng)計強度的慣例,,并將根據(jù)這種認知做出決定,。然而,考慮到阿爾茨海默病的嚴重性(僅在美國就有近600萬病例),,以及缺乏替代療法,,肯定存在一些誘惑讓(FDA)給那些可能起作用的藥物開綠燈,寄希望于它真的奏效,。如果事實證明是正確的,,那么每個人都會成為英雄;如果不是,,那么每個人都會成為惡棍,。
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