科學(xué)家發(fā)現(xiàn)了一種新的花生過敏治療法

科學(xué)家發(fā)現(xiàn)了一種新的花生過敏治療法

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

一種備受關(guān)注但飽受爭議的花生過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，美國食品和藥品管理局的一個咨詢委員會以7票贊成、2票反對的結(jié)果通過了一項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歲的患者減少對花生的過敏反應(yīng)。這種療法是由制藥公司美國免疫治療公司開發(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·費內(nèi)戈爾德博士說，“我投了‘贊成’票，因為我認(rèn)為數(shù)據(jù)相當(dāng)清晰，而且我實際上會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.

該委員會的投票結(jié)果可能成為解決花生過敏問題的一個里程碑。目前，美國食品和藥品監(jiān)督管理局還沒有批準(zhǔn)花生過敏的治療方案，導(dǎo)致過敏人群別無選擇，只能不食用花生。美國食品和藥品管理局通常遵循咨詢委員會的建議。預(yù)計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，這種療法可能會導(dǎo)致更多的過敏反應(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)過敏反應(yīng)的風(fēng)險更低，但我認(rèn)為，從我們提供給我們的數(shù)據(jù)來看，安全性和有效性都沒有得到證明，”圣地亞哥斯克里普斯診所的過敏專家約翰凱爾索博士說。

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，對花生過敏的人越來越多。據(jù)估計，目前美國有2.2%的兒童對花生過敏。口服免疫療法并不能治愈這些過敏癥狀，但對一些患者來說，它可以更容易控制過敏。

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)過幾個月的研究，它已經(jīng)被證明可以降低許多患者對少量花生過敏反應(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.

該委員會還以8票贊成、1票反對的結(jié)果通過了一項風(fēng)險評估和緩解戰(zhàn)略，其中包括制藥商確?；颊甙踩枰扇〉牟襟E。

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

美國免疫治療公司的科學(xué)家們展示了一項關(guān)于帕爾福齊亞的研究成果，這是以AR101的名義開發(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.

在第三階段的試驗中，許多診所對帕爾福齊亞的安全性和有效性進(jìn)行了測試， 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.

一項關(guān)于口服免疫療法的獨立研究發(fā)現(xiàn)，接受該療法的兒童發(fā)生過敏反應(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。