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一种花生过敏药已经被FDA批准

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2020年02月04日

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A Peanut Allergy Drug Has Been Approved By The FDA

一种花生过敏药已经被FDA批准

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.

美国食品和药物管理局(FDA)首次批准使用一种治疗美国儿童花生过敏的药物。这种被称为Palforzia的药物并不能治愈过敏,但它的目的是降低在意外接触花生时发生重大反应的风险。

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.

据认为,至少有300万美国人患有花生和树坚果过敏,目前唯一有效的保护措施就是避免过敏。然而,对一些人来说,即使是坚果的微小颗粒也可能导致致命的过敏反应,这使得某些环境(如飞机)非常危险。

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已经被批准用于4到17岁的儿童,它使用口服免疫疗法,通过摄入极少量的花生蛋白来刺激身体的免疫系统产生必要的抗体来防止过敏反应。与疫苗不同的是,为了提供持久的保护,通常只需要使用一次,Palforzia将需要每天服用,以保持其效果,停止使用将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.

在治疗的前6个月,在医生的监督下,儿童将接受小剂量但逐渐增加的药物治疗,然后允许他们在家里继续服用,可以撒在食物的粉末上。去年发表的研究表明,当免疫疗法停止时,那些先前对花生蛋白敏感的细胞会继续以治疗开始前的方式反应。换句话说,这种类型的治疗不能提供任何持久的保护,应该被视为一种预防而不是治愈。

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.

患者还必须继续避免食用花生,不过,如果他们不小心接触到花生,这种药物至少应该能让他们耐受少量的花生。

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.

尽管Palforzia将在美国上市,但其他国家仍未跟进,对于口服免疫疗法治疗过敏的有效性仍存在许多疑问。最近发表在《柳叶刀》杂志上的一篇论文发现,虽然口服免疫疗法通常可以增强花生耐受性,但患者在开始接受治疗后发生过敏事件的数量实际上往往会增加。

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.

这项研究的作者说,这一发现揭示了过敏反应是多么不可预测,有多少无法控制的因素可能会影响它们,这意味着即使有了这种新的治疗方法,使用者仍然应该像以往一样小心,不要接触花生。


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