FDA批准第一种治疗儿童花生过敏的药物

FDA批准第一种治疗儿童花生过敏的药物

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.

美国食品和药物管理局(FDA)周五批准了第一种治疗儿童花生过敏的药物，此前咨询委员会在9月份进行了投票批准。

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.

这种名为Palforzia的药物可用于4至17岁的儿童。它的目的是尽量减少儿童对花生过敏反应的发生率和严重程度，因为即使是少量的接触也可能对过敏儿童有害。

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.

孩子们试图避免接触花生以避免过敏反应。FDA生物制品评估与研究中心主任彼得马克博士在一份声明中说，尽管这对Palforzia来说仍然是必要的，但反应的风险将会降低。

"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.

他说：“在避免食用花生的同时，Palforzia提供了FDA批准的治疗选项，以帮助降低花生过敏儿童发生这些过敏反应的风险。”

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.

美国过敏、哮喘和免疫学学院的数据显示，超过2.5%的美国儿童对花生过敏。这是美国最常见的食物过敏之一。

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

对那些过敏的人来说，接触花生会导致痉挛、消化不良、荨麻疹、肿胀甚至晕眩等症状。

How it works

(药物)如何发挥作用?

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

这种新的治疗方法基本上是通过让儿童接触受控剂量的花生蛋白，直到他们达到维持水平。

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.

在该药物制造商美国免疫治疗公司提交的一项试验中，三分之二的儿童在经过长达数月的治疗后，能够吃下相当于两颗花生的食物，没有过敏症状。

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个月或更长时间的治疗，大约9%的儿童因过敏反应严重而不得不停止治疗。

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可随时发生过敏反应，但在初始剂量增加期间和之后以及每次增加剂量的第一次剂量时，患者的风险最高;这两种剂量都是在医疗机构的监督下使用的，这样医生就可以监测病人的反应。

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剂量增加，患者可以在家里每天继续。Palforzia是一种由花生制成的粉末，应该与酸奶或苹果酱等半固体食物混合。

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.

提供者还必须建议患者或其护理人员随身携带可随时使用的注射用肾上腺素药物。