昨日,FDA批准了新药Eucrisa软膏制剂,其适用于两岁或以上的轻度或是中度湿疹(特性皮炎)患者。
特性皮炎是一种皮肤长期慢性的炎症,通常被称为湿疹,是皮肤炎症的多种表现形式之一。湿疹通常发生在儿童时期并且能够持续到成年。引起湿疹的原因是多方面的,例如遗传因素、自身免疫和周围环境等。表现形式为发痒、皮肤变红、磷化和结成硬痂。由于发痒而导致的患者挠抓使皮肤脓肿、破裂、组织液外渗最终导致皮肤变厚。
Eucrisa适用于局部使用,每日两次但它的作用机制是未知的。参与实验者接受了28天的治疗,总的来说Eucrisa是效果显著地。这个药品的副作用是能够引起过敏反应。包括局部疼痛引起的发热和刺痛。
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
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.
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.
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.