對近5年來特應(yīng)性皮炎代表性新藥的國內(nèi)外批準(zhǔn)情況進(jìn)行介紹，總結(jié)了度普利尤單抗注射液、烏帕替尼緩釋片、迪高替尼乳膏、克立硼羅軟膏等4種不同作用機制、不同給藥途徑的特應(yīng)性皮炎治療藥物的申報資料中臨床藥理學(xué)研究主要內(nèi)容，以及國內(nèi)外監(jiān)管機構(gòu)對特應(yīng)性皮炎治療藥物的審評考量，旨在為特應(yīng)性皮炎新藥的早期臨床研發(fā)和評價提供參考依據(jù)。

In this review, the domestic and foreign approvals of representative new drugs for atopic dermatitis in recent five years are introduced, and the main contents of clinical pharmacology studies are summarized, which are in the application materials of four kinds of atopic dermatitis therapeutic drugs with different mechanisms of action and different routes of administration, such as dupilumab, upadacitinib, delgocitinib, crisaborole. Meanwhile, the consideration of domestic and foreign regulatory agencies for these drugs is summarized. The purpose of this review is to provide reference for the early clinical development and evaluation of new drugs for atopic dermatitis.

R285;R969.3