濕疹是兒科臨床常見的皮膚病,特應(yīng)性皮炎是其中最常見的一種。《兒童濕疹/特應(yīng)性皮炎中藥臨床試驗(yàn)設(shè)計(jì)與評(píng)價(jià)技術(shù)指南》已正式發(fā)布,其中提到濕疹/特應(yīng)性皮炎臨床試驗(yàn)的核心指標(biāo)集,包括客觀體征、主觀癥狀、生活質(zhì)量和長期控制4個(gè)核心領(lǐng)域,并參考核心指標(biāo)集所述,制定了療效評(píng)價(jià)指標(biāo)。綜述國內(nèi)外濕疹/特應(yīng)性皮炎臨床試驗(yàn)中關(guān)于上述4個(gè)核心領(lǐng)域以及中醫(yī)證候療效評(píng)價(jià)指標(biāo)進(jìn)展,并探討了療效評(píng)價(jià)指標(biāo)相關(guān)問題,以期為臨床和科研工作者開展兒童濕疹/特應(yīng)性皮炎中藥臨床研究時(shí)選擇合適的療效評(píng)價(jià)指標(biāo)提供指導(dǎo)。

Eczema is a common skin disease in pediatrics, of which atopic dermatitis is the most. Guideline on Design And Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases: Eczema/ Atopic Dermatitis has been officially published, which refers to the core index set of eczema/atopic dermatitis clinical trials, including four core areas: signs, subjective symptoms, quality of life, and long-term control of eczema, and consults the core index set to formulate the efficacy evaluation index. Therefore, this paper reviews the progress of the above four core areas and traditional Chinese medicine syndrome efficacy evaluation index in eczema/atopic dermatitis clinical trials at home and abroad, and discusses the related problems of efficacy evaluation index, in order to provide guidance for clinical and scientific researchers to select appropriate efficacy evaluation indices when carrying out clinical research on childhood eczema / atopic dermatitis.

R985

國家科技重大專項(xiàng)(民口)重大新藥創(chuàng)制專項(xiàng)(2020ZX09201-008)