摘要
目的系统评估儿童特应性皮炎(atopic dermatitis,AD)药物临床试验的设计要素,为不同试验结果的比较提供一定的可行性。方法系统检索Pub Med、Cochrane及EMbase数据库,纳入儿童AD的随机对照临床研究的英文文献。结果共收集994篇文献,最终纳入18篇文献。试验目的主要为控制皮损症状、减少/预防复发、缓解患者瘙痒症状或改善生活质量等;均采用随机、安慰剂对照;诊断标准中7项采用Hanifin&Rajka标准;干预措施中局部治疗5项,系统治疗13项;6项设计了导入期;9项设计了随访;主要评价指标中,联合皮肤病变范围、皮损严重程度、瘙痒程度和睡眠情况12项,次要评价指标中,联合皮损严重程度、瘙痒程度和睡眠情况5项、生活质量5项等。皮损严重程度评价量表中采用特应性皮炎积分指数(scoring of atopic dermatitis,SCORAD)量表12项、湿疹面积及严重程度指数(eczema area and severity index,EASI)量表4项、患者湿疹自我检查(patient oriented eczema measure,POEM)量表4项、研究者的整体评价法(investigator’s global assessment,IGA)5项;生活质量评价标准中主要为儿童皮肤病生活质量指数(children’s dermatology life quality index,CDLQI)量表,占6项;安全性评价中,13项有不良事件/不良反应观察设计。结论纳入研究的文献信息完善、质量较高,结果涵盖了儿童AD临床研究设计的基本要素,为药物治疗AD的临床试验设计及评价提供思路和方法。
Objective To systematically evaluate the design elements of clinical trials of children with atopic dermatitis(AD), and to provide a certain feasibility for the comparison of different trial results through standardized trial design. Methods The Pub Med, Cochrane and EMBASE databases were systematically searched, and English literatures of randomized controlled clinical studies on children with AD were included. Results A total of 994 articles were collected, and 18 articles were finally included. The purpose of all studies was to control skin lesion symptoms, reduce/prevent recurrence, relieve patients’ pruritus symptoms or improve quality of life, etc,randomized, placebo-controlled, 13 Use superiority test for 16 projects, double-blind design for 16 projects and seven of the diagnostic criteria were mostly Hanifin & Rajka criteria, five of the interventions included local treatment and 13 systemic treatment,6 were designed for the lead-in period,9 were designed for follow-up,among the main evaluation indicators, combined skin 12 items of lesion range, severity of skin lesions, degree of itching and sleep status, secondary evaluation refers to 5 items of combined skin lesion severity, degree of itching and sleep status, 6 items of certain laboratory examination indicators, five items of quality of life. In the damage severity evaluation scale, 12 items on the atopic dermatitis score index(SCORAD) scale, four items on the patient eczema self-examination scale(POEM) scale, 5 items on the investigator’s overall assessment method(IGA), eczema area and There are 4 Severity Index(EASI) scales, and the main quality of life evaluation standard is the CDLQI scale, accounting for 6 items;in the safety evaluation, 13 items have adverse events/adverse reaction observation designs, and 17 studies have passed the review of the ethics committee. Conclusion The literature information were perfect and high quality, which cover the basic elements of the AD clinical research design for children and provide ideas and methods for designing and evaluating for clinical trial of pediatric atopic dermatitis.
作者
晋黎
胡思源
朱中一
蔡秋晗
李梅芳
郦涵
蔡莉莉
JIN Li;HU Si-yuan;ZHU Zhong-yi;CAI Qiu-han;LI Mei-fang;LI Han;CAI Li-li(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)
出处
《中草药》
CAS
CSCD
北大核心
2022年第1期206-213,共8页
Chinese Traditional and Herbal Drugs
基金
国家科技部“十三五”重大新药创制项目“儿童中药新药临床评价技术示范性平台建设”课题(2020ZX09201-008)。
关键词
特应性皮炎
儿童
随机对照试验
试验设计
设计要素
atopic dermatitis
child patients
randomized controlled trials
trial design
design elements
作者简介
晋黎(1984-),女,博士研究生在读,主治医师,主要从事儿科临床及中药临床评价研究。E-mail:jinli95@126.com;通信作者:胡思源,教授,博士生导师,主要研究方向为中药临床评价方法学。Tel:(022)27986262,E-mail:husiyuan1963@sina.com。
