儿童湿疹/特应性皮炎药物临床试验评价指标的研究进展

Research progress in the efficacy indicators of drug clinical trials on eczema/atopic dermatitis in children

湿疹是儿科临床常见的皮肤病,特应性皮炎是其中最常见的一种。《儿童湿疹/特应性皮炎中药临床试验设计与评价技术指南》已正式发布,其中提到湿疹/特应性皮炎临床试验的核心指标集,包括客观体征、主观症状、生活质量和长期控制4个核心领域,并参考核心指标集所述,制定了疗效评价指标。综述国内外湿疹/特应性皮炎临床试验中关于上述4个核心领域以及中医证候疗效评价指标进展,并探讨了疗效评价指标相关问题,以期为临床和科研工作者开展儿童湿疹/特应性皮炎中药临床研究时选择合适的疗效评价指标提供指导。

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:objective 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.