FDA批準第一種治療兒童花生過敏的藥物

FDA批準第一種治療兒童花生過敏的藥物

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.

美國食品和藥物管理局(FDA)周五批準了第一種治療兒童花生過敏的藥物，此前咨詢委員會在9月份進行了投票批準。

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花生過敏反應的發(fā)生率和嚴重程度，因為即使是少量的接觸也可能對過敏兒童有害。

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.

孩子們試圖避免接觸花生以避免過敏反應。FDA生物制品評估與研究中心主任彼得馬克博士在一份聲明中說，盡管這對Palforzia來說仍然是必要的，但反應的風險將會降低。

"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：“在避免食用花生的同時，Palforzia提供了FDA批準的治療選項，以幫助降低花生過敏兒童發(fā)生這些過敏反應的風險。”

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.

美國過敏、哮喘和免疫學學院的數(shù)據(jù)顯示，超過2.5%的美國兒童對花生過敏。這是美國最常見的食物過敏之一。

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

對那些過敏的人來說，接觸花生會導致痙攣、消化不良、蕁麻疹、腫脹甚至暈眩等癥狀。

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讓兒童接觸受控劑量的花生蛋白，直到他們達到維持水平。

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免疫治療公司提交的一項試驗中，三分之二的兒童在經(jīng)過長達數(shù)月的治療后，能夠吃下相當于兩顆花生的食物，沒有過敏癥狀。

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個月或更長時間的治療，大約9%的兒童因過敏反應嚴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可隨時發(fā)生過敏反應，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，患者的風險最高;這兩種劑量都是在醫(yī)療機構的監(jiān)督下使用的，這樣醫(yī)生就可以監(jiān)測病人的反應。

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，應該與酸奶或蘋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理人員隨身攜帶可隨時使用的注射用腎上腺素藥物。