科學(xué)家發(fā)現(xiàn)了一種新的花生過(guò)敏治療法

科學(xué)家發(fā)現(xiàn)了一種新的花生過(guò)敏治療法

A closely watched but controversial treatment for peanut allergies took a big step closer to becoming widely available.

一種備受關(guān)注但飽受爭(zhēng)議的花生過(guò)敏治療方法朝著廣泛應(yīng)用邁進(jìn)了一大步。

On Friday, an advisory committee of the U.S. Food and Drug Administration voted 7-2 to approve Palforzia, a standardized peanut powder product, to help reduce allergic reactions to peanuts for patients ages 4 to 17 as part of oral immunotherapy protocol. The treatment was developed by pharmaceutical company Aimmune Therapeutics.

上周五，美國(guó)食品和藥品管理局的一個(gè)咨詢委員會(huì)以7票贊成、2票反對(duì)的結(jié)果通過(guò)了一項(xiàng)名為帕爾福齊亞的標(biāo)準(zhǔn)化花生粉狀產(chǎn)品，作為口服免疫療法的一部分，幫助4至17歲的患者減少對(duì)花生的過(guò)敏反應(yīng)。這種療法是由制藥公司美國(guó)免疫治療公司開(kāi)發(fā)的。

"I voted 'yes' because I thought the data was quite clear, and I would actually compliment the sponsor on the extent and caliber of the studies," said Dr. Ira Finegold, a professor of medicine at Icahn School of Medicine at Mount Sinai in New York.

紐約西奈山伊坎醫(yī)學(xué)院的醫(yī)學(xué)教授艾拉·費(fèi)內(nèi)戈?duì)柕虏┦空f(shuō)，“我投了‘贊成’票，因?yàn)槲艺J(rèn)為數(shù)據(jù)相當(dāng)清晰，而且我實(shí)際上會(huì)真贊贊助商的研究的范圍和水平。”

The committee's vote could be a landmark in addressing peanut allergies, which currently have no FDA-approved treatment, leaving allergic people little choice but to avoid peanuts. The FDA usually follows the recommendations of its advisory committees. A final decision is expected early next year.

該委員會(huì)的投票結(jié)果可能成為解決花生過(guò)敏問(wèn)題的一個(gè)里程碑。目前，美國(guó)食品和藥品監(jiān)督管理局還沒(méi)有批準(zhǔn)花生過(guò)敏的治療方案，導(dǎo)致過(guò)敏人群別無(wú)選擇，只能不食用花生。美國(guó)食品和藥品管理局通常遵循咨詢委員會(huì)的建議。預(yù)計(jì)最終決定將于明年初做出。

The recommendation came despite concerns raised in some testimony that the treatment could actually lead to more allergic reactions, in some cases.

盡管有證據(jù)表明，在某些情況下，這種療法可能會(huì)導(dǎo)致更多的過(guò)敏反應(yīng)，但還是有人提出了這一建議。

"I also want my patients to have a lower risk of having reactions, but I think from the data that we have had presented to us that neither the safety nor efficacy have been demonstrated," said Dr. John Kelso, an allergy specialist at Scripps Clinic in San Diego.

“我也希望我的病人出現(xiàn)過(guò)敏反應(yīng)的風(fēng)險(xiǎn)更低，但我認(rèn)為，從我們提供給我們的數(shù)據(jù)來(lái)看，安全性和有效性都沒(méi)有得到證明，”圣地亞哥斯克里普斯診所的過(guò)敏專家約翰凱爾索博士說(shuō)。

Peanut allergies have been increasing in recent years. It's now estimated that 2.2% children in the U.S. are allergic to peanuts. Oral immunotherapy doesn't cure these allergies but for some patients can make them more manageable.

近年來(lái)，對(duì)花生過(guò)敏的人越來(lái)越多。據(jù)估計(jì)，目前美國(guó)有2.2%的兒童對(duì)花生過(guò)敏?？诜庖忒煼ú⒉荒苤斡@些過(guò)敏癥狀，但對(duì)一些患者來(lái)說(shuō)，它可以更容易控制過(guò)敏。

It is a regime of slowly increasing daily exposure to tiny amounts of peanut powder. Over the course of several months, it has been shown to reduce the incidence and severity of allergic reactions to small amounts of peanuts in many patients.

這是一種每天緩慢增加少量花生粉的方法。經(jīng)過(guò)幾個(gè)月的研究，它已經(jīng)被證明可以降低許多患者對(duì)少量花生過(guò)敏反應(yīng)的發(fā)生率和嚴(yán)重程度。

The committee also voted 8-1 to approve a Risk Evaluation and Mitigation Strategy, which includes steps the drugmakers would need to take to ensure patient safety.

該委員會(huì)還以8票贊成、1票反對(duì)的結(jié)果通過(guò)了一項(xiàng)風(fēng)險(xiǎn)評(píng)估和緩解戰(zhàn)略，其中包括制藥商確保患者安全需要采取的步驟。

Scientists from Aimmune Therapeutics presented research findings on Palforzia, which was developed under the name AR101.

美國(guó)免疫治療公司的科學(xué)家們展示了一項(xiàng)關(guān)于帕爾福齊亞的研究成果，這是以AR101的名義開(kāi)發(fā)的。

In a phase 3 trial, Palforzia's safety and efficacy were tested at numerous clinics , involving 551 participants from 4 to 55 years of age.

在第三階段的試驗(yàn)中，許多診所對(duì)帕爾福齊亞的安全性和有效性進(jìn)行了測(cè)試， 包括551名參與者，年齡從4歲到55歲不等。

While studies showed that oral immunotherapy using Palforzia can reduce reactions, researchers also said that the treatment carries side effects including nausea, itchiness in the throat and vomiting.

雖然研究表明，使用帕爾福齊亞口服免疫療法可以減少過(guò)敏反應(yīng)，但研究人員也表示，這種療法有副作用，包括惡心、喉嚨發(fā)癢和嘔吐。

An independent review of oral immunotherapy found that children doing the therapy had about a 20% chance of anaphylaxis, compared with about 7% avoiding peanuts.

一項(xiàng)關(guān)于口服免疫療法的獨(dú)立研究發(fā)現(xiàn)，接受該療法的兒童發(fā)生過(guò)敏反應(yīng)的幾率約為20%，而不吃花生的兒童只有7%。

The treatment needs further study.

這種療法有待進(jìn)一步的研究。