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一種花生過敏藥已經(jīng)被FDA批準(zhǔn)

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2020年02月04日

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A Peanut Allergy Drug Has Been Approved By The FDA

一種花生過敏藥已經(jīng)被FDA批準(zhǔn)

The Food and Drug Administration (FDA) has for the first time given the green light for the use of a drug to treat peanut allergies in children in the US. Known as Palforzia, the medication does not cure allergies but is intended to lessen the risk of a major reaction in the event of accidental exposure to peanuts.

美國(guó)食品和藥物管理局(FDA)首次批準(zhǔn)使用一種治療美國(guó)兒童花生過敏的藥物。這種被稱為Palforzia的藥物并不能治愈過敏,但它的目的是降低在意外接觸花生時(shí)發(fā)生重大反應(yīng)的風(fēng)險(xiǎn)。

Ben Taub

It is thought that at least 3 million Americans suffer from peanut and tree nut allergies, with avoidance being the only form of protection currently available. For some, however, even tiny particles of a nut can cause potentially fatal anaphylactic reactions, which makes certain environments – such as airplanes – highly dangerous.

據(jù)認(rèn)為,至少有300萬(wàn)美國(guó)人患有花生和樹堅(jiān)果過敏,目前唯一有效的保護(hù)措施就是避免過敏。然而,對(duì)一些人來(lái)說(shuō),即使是堅(jiān)果的微小顆粒也可能導(dǎo)致致命的過敏反應(yīng),這使得某些環(huán)境(如飛機(jī))非常危險(xiǎn)。

Palforzia – which has been approved for children between the ages of four and 17 – uses oral immunotherapy, whereby minuscule amounts of peanut protein are ingested in order to stimulate the body’s immune system to create the necessary antibodies to prevent an allergic reaction. Unlike vaccines, which often only need to be applied once in order to provide lasting protection, Palforzia will need to be taken every day for its effect to be maintained, and discontinuing its use will eliminate any peanut tolerance.

Palforzia已經(jīng)被批準(zhǔn)用于4到17歲的兒童,它使用口服免疫療法,通過攝入極少量的花生蛋白來(lái)刺激身體的免疫系統(tǒng)產(chǎn)生必要的抗體來(lái)防止過敏反應(yīng)。與疫苗不同的是,為了提供持久的保護(hù),通常只需要使用一次,Palforzia將需要每天服用,以保持其效果,停止使用將消除任何花生耐受性。

During the first six months of treatment, children will be administered small but increasing doses of the drug under a doctor’s supervision, before being allowed to continue taking it at home in the form of a powder that can be sprinkled on food. Research published last year revealed that when immunotherapy is stopped, cells that had previously been susceptible to peanut proteins continue to react in the same way as they did before treatment began. In other words, this type of therapy provides no lasting protection whatsoever and should be seen as a prevention rather than a cure.

在治療的前6個(gè)月,在醫(yī)生的監(jiān)督下,兒童將接受小劑量但逐漸增加的藥物治療,然后允許他們?cè)诩依锢^續(xù)服用,可以撒在食物的粉末上。去年發(fā)表的研究表明,當(dāng)免疫療法停止時(shí),那些先前對(duì)花生蛋白敏感的細(xì)胞會(huì)繼續(xù)以治療開始前的方式反應(yīng)。換句話說(shuō),這種類型的治療不能提供任何持久的保護(hù),應(yīng)該被視為一種預(yù)防而不是治愈。

Patients will also have to continue avoiding peanuts, though the drug should at least enable them to tolerate small amounts if they do accidentally come into contact with them.

患者還必須繼續(xù)避免食用花生,不過,如果他們不小心接觸到花生,這種藥物至少應(yīng)該能讓他們耐受少量的花生。

While Palforzia is set to become available in the US, other countries are yet to follow suit, with many question marks remaining over the effectiveness of oral immunotherapy for allergies. A recent paper in The Lancet found that while peanut tolerance is generally enhanced by oral immunotherapy, the number of anaphylactic events experienced by patients actually tends to increase after beginning treatmen.

盡管Palforzia將在美國(guó)上市,但其他國(guó)家仍未跟進(jìn),對(duì)于口服免疫療法治療過敏的有效性仍存在許多疑問。最近發(fā)表在《柳葉刀》雜志上的一篇論文發(fā)現(xiàn),雖然口服免疫療法通常可以增強(qiáng)花生耐受性,但患者在開始接受治療后發(fā)生過敏事件的數(shù)量實(shí)際上往往會(huì)增加。

The study authors say this finding reveals how unpredictable allergic reactions are and how many uncontrollable factors may influence them, meaning that even when this new treatment becomes available, users should still be as careful as ever not to come into contact with peanuts.

這項(xiàng)研究的作者說(shuō),這一發(fā)現(xiàn)揭示了過敏反應(yīng)是多么不可預(yù)測(cè),有多少無(wú)法控制的因素可能會(huì)影響它們,這意味著即使有了這種新的治療方法,使用者仍然應(yīng)該像以往一樣小心,不要接觸花生。


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