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FDA批准Eucrisa用于治疗湿疹

FDA approves Eucrisa for eczema
来源:FDA 2016-12-28 08:53点击次数:5341发表评论


The U.S. Food and Drug Administration approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.


美国食品药品管理局(FDA)批准了Eucrisa(crisaborole)软膏用于治疗2岁及2岁以上轻度至中度湿疹(异位性皮炎)。


Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as "eczema," which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, "weeping" clear fluid, and finally, coarsening and thickening of the skin.


异位性皮炎是一种慢性炎性皮肤疾病,通常被称为“湿疹”。湿疹是多种皮肤炎症的通称,异位性皮炎是众多湿疹中最常见的一种类型,通常初发于儿童期并可持续至成人期。特异性皮炎的发病原因涉及遗传、免疫及环境等诸多因素。异位性皮炎患者皮肤发红,呈鳞屑状和斑片状凸起,剧烈瘙痒。搔抓可导致肿胀、破裂、“滴出”透明液体,最终皮肤变得粗糙和肥厚。


"Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis," said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).


FDA药品评价与研究中心(CDER)药品评价三室副主任Amy Egan称:当今的批准为轻度至中度异位性皮炎患者提供了另外一种治疗选择。


Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.


Eucrisa局部外用,每日2次。Eucrisa属于磷酸二酯酶4(PDE-4)抑制剂,但其用于治疗异位性皮炎的具体作用机理尚不清楚。


The safety and efficacy of Eucrisa were established in two placebo-controlled trials with a total of 1,522 participants ranging in age from two years of age to 79 years of age, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment.


Eucrisa的安全性和有效性在2项安慰剂对照试验中得到证实。试验共计纳入1,522例年龄介于2-79岁之间轻度至中度异位性皮炎患者。总体上,Eucrisa治疗患者在治疗28天后达到皮肤清洁或几乎清洁,具有较高的应答率。


Serious side effects of Eucrisa include hypersensitivity reactions. Eucrisa should not be used in patients who have had a hypersensitivity reaction to Eucrisa’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.


Eucrisa严重的副作用包括超敏反应。Eucrisa禁用于对Eucrisa活性成分crisaborole有超敏反应的患者。Eucrisa最常见的副作用为用药皮肤疼痛,包括灼痛或刺痛。


Eucrisa is manufactured by Palo Alto, California-based Anacor Pharmaceuticals, Inc.


Eucrisa由位于加州帕洛阿尔托的Anacor制药公司生产。


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学科代码: 皮肤病学     关键词:Eucrisa crisaborole 异位性皮炎 新药 FDA ,新闻 爱思唯尔医学网, Elseviermed
来源: FDA
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