科学家发现了一种新的花生过敏治疗法

科学家发现了一种新的花生过敏治疗法

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

一种备受关注但饱受争议的花生过敏治疗方法朝着广泛应用迈进了一大步。

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，美国食品和药品管理局的一个咨询委员会以7票赞成、2票反对的结果通过了一项名为帕尔福齐亚的标准化花生粉状产品，作为口服免疫疗法的一部分，帮助4至17岁的患者减少对花生的过敏反应。这种疗法是由制药公司美国免疫治疗公司开发的。

"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.

纽约西奈山伊坎医学院的医学教授艾拉·费内戈尔德博士说，“我投了‘赞成’票，因为我认为数据相当清晰，而且我实际上会真赞赞助商的研究的范围和水平。”

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.

该委员会的投票结果可能成为解决花生过敏问题的一个里程碑。目前，美国食品和药品监督管理局还没有批准花生过敏的治疗方案，导致过敏人群别无选择，只能不食用花生。美国食品和药品管理局通常遵循咨询委员会的建议。预计最终决定将于明年初做出。

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

尽管有证据表明，在某些情况下，这种疗法可能会导致更多的过敏反应，但还是有人提出了这一建议。

"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现过敏反应的风险更低，但我认为，从我们提供给我们的数据来看，安全性和有效性都没有得到证明，”圣地亚哥斯克里普斯诊所的过敏专家约翰凯尔索博士说。

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.

近年来，对花生过敏的人越来越多。据估计，目前美国有2.2%的儿童对花生过敏。口服免疫疗法并不能治愈这些过敏症状，但对一些患者来说，它可以更容易控制过敏。

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.

这是一种每天缓慢增加少量花生粉的方法。经过几个月的研究，它已经被证明可以降低许多患者对少量花生过敏反应的发生率和严重程度。

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.

该委员会还以8票赞成、1票反对的结果通过了一项风险评估和缓解战略，其中包括制药商确保患者安全需要采取的步骤。

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

美国免疫治疗公司的科学家们展示了一项关于帕尔福齐亚的研究成果，这是以AR101的名义开发的。

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.

在第三阶段的试验中，许多诊所对帕尔福齐亚的安全性和有效性进行了测试， 包括551名参与者，年龄从4岁到55岁不等。

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.

虽然研究表明，使用帕尔福齐亚口服免疫疗法可以减少过敏反应，但研究人员也表示，这种疗法有副作用，包括恶心、喉咙发痒和呕吐。

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.

一项关于口服免疫疗法的独立研究发现，接受该疗法的儿童发生过敏反应的几率约为20%，而不吃花生的儿童只有7%。

The treatment needs further study.

这种疗法有待进一步的研究。