FDA批準(zhǔn)第一種治療兒童花生過(guò)敏的藥物

FDA批準(zhǔn)第一種治療兒童花生過(guò)敏的藥物

The US Food and Drug Administration approved the first drug to treat peanut allergies in children on Friday, following an advisory committee vote of approval in September.

美國(guó)食品和藥物管理局(FDA)周五批準(zhǔn)了第一種治療兒童花生過(guò)敏的藥物，此前咨詢委員會(huì)在9月份進(jìn)行了投票批準(zhǔn)。

The drug, Palforzia, can be used for children between 4 and 17 years old. It's designed to minimize the incidence and severity of a child's allergic reaction to peanuts, as even a small amount of exposure can be harmful to children with the allergy.

這種名為Palforzia的藥物可用于4至17歲的兒童。它的目的是盡量減少兒童對(duì)花生過(guò)敏反應(yīng)的發(fā)生率和嚴(yán)重程度，因?yàn)榧词故巧倭康慕佑|也可能對(duì)過(guò)敏兒童有害。

Children are left attempting to avoid exposure to peanuts to avoid reactions. Though that will continue to be necessary with Palforzia, the risk of a reaction will be lessened, says Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement.

孩子們?cè)噲D避免接觸花生以避免過(guò)敏反應(yīng)。FDA生物制品評(píng)估與研究中心主任彼得馬克博士在一份聲明中說(shuō)，盡管這對(duì)Palforzia來(lái)說(shuō)仍然是必要的，但反應(yīng)的風(fēng)險(xiǎn)將會(huì)降低。

"When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy," he said.

他說(shuō)：“在避免食用花生的同時(shí)，Palforzia提供了FDA批準(zhǔn)的治療選項(xiàng)，以幫助降低花生過(guò)敏兒童發(fā)生這些過(guò)敏反應(yīng)的風(fēng)險(xiǎn)。”

More than 2.5% of all American children are allergic to peanuts, according to The American College of Allergy, Asthma and Immunology. It's one of the most common food allergies in the country.

美國(guó)過(guò)敏、哮喘和免疫學(xué)學(xué)院的數(shù)據(jù)顯示，超過(guò)2.5%的美國(guó)兒童對(duì)花生過(guò)敏。這是美國(guó)最常見(jiàn)的食物過(guò)敏之一。

For those allergic, exposure to peanuts can result in symptoms like cramping, indigestion, hives, swelling and even fainting or dizziness.

對(duì)那些過(guò)敏的人來(lái)說(shuō)，接觸花生會(huì)導(dǎo)致痙攣、消化不良、蕁麻疹、腫脹甚至?xí)炑５劝Y狀。

How it works

(藥物)如何發(fā)揮作用?

The new treatment essentially works by exposing children to controlled dosages of peanut protein until they've reached a maintenance level.

這種新的治療方法基本上是通過(guò)讓兒童接觸受控劑量的花生蛋白，直到他們達(dá)到維持水平。

In a trial submitted by Aimmune Therapeutics, the manufacturers of the drug, two-thirds of children were able to eat the equivalent of two peanuts with no allergic symptoms after the months-long treatment.

在該藥物制造商美國(guó)免疫治療公司提交的一項(xiàng)試驗(yàn)中，三分之二的兒童在經(jīng)過(guò)長(zhǎng)達(dá)數(shù)月的治療后，能夠吃下相當(dāng)于兩顆花生的食物，沒(méi)有過(guò)敏癥狀。

Patients may be required to take the therapy for six months or longer, and about 9% of the children dosed with the drug had to stop treatment because their allergic reactions were so severe.

患者可能需要接受6個(gè)月或更長(zhǎng)時(shí)間的治療，大約9%的兒童因過(guò)敏反應(yīng)嚴(yán)重而不得不停止治療。

Anaphylaxis can occur any time with Palforzia, but patients are at highest risk during and after initial dose escalation and the first dose of each up-dosing level; both are administered under supervision in a health care setting so providers can monitor for reactions.

Palforzia可隨時(shí)發(fā)生過(guò)敏反應(yīng)，但在初始劑量增加期間和之后以及每次增加劑量的第一次劑量時(shí)，患者的風(fēng)險(xiǎn)最高;這兩種劑量都是在醫(yī)療機(jī)構(gòu)的監(jiān)督下使用的，這樣醫(yī)生就可以監(jiān)測(cè)病人的反應(yīng)。

If a patient tolerates the first dose of an increased level, the patient can continue it daily at home. Palforzia comes in a powder form that is made from actual peanuts, and should be mixed with semi-solid food like yogurt or applesauce.

如果患者耐受第一次劑量增加，患者可以在家里每天繼續(xù)。Palforzia是一種由花生制成的粉末，應(yīng)該與酸奶或蘋(píng)果醬等半固體食物混合。

Providers will also have to counsel patients or their caregivers to have an injectable epinephrine drug with them that can be ready to be used at all times.

提供者還必須建議患者或其護(hù)理人員隨身攜帶可隨時(shí)使用的注射用腎上腺素藥物。