中国中西医结合杂志2025，Vol.45Issue(3)：277-282,6.DOI:10.7661/j.cjim.20250225.036
儿童紫癜性肾炎中西医临床研究核心结局指标集
Core Outcome Set of Clinical Research of Chinese and Western Medicine in Children with Henoch-Schönlein Purpura Nephritis
摘要
Abstract
Objective To construct a core outcome set(COS)of clinical research in children with Henoch-Schönlein purpura nephritis(HSPN)in Chinese and Western medicine,addressing the significant heterogeneity in selecting outcome measures for clinical studies and providing a basis for objective evaluation of the efficacy and safety of Chinese and Western medical treatments.Methods This study employed a systematic review and semi-structured individual in-depth interviews to initially construct a pool of outcome measures.The Delphi survey was used to rate the importance of each outcome measure,screening out key outcome measures for inclusion in a consensus meeting.An expert consensus meeting was then convened to reach agreement and construct the COS for HSPN clinical research in Chinese and Western medicine.Results Eight commonly used databases were searched through systematic review,and additional resources were retrieved from other platforms,resulting in 4 377 articles.After initial and secondary screening,148 articles were finally included,and 103 outcome measures were extracted.Through semi-structured individual in-depth interviews with 18 experts and combining the results of the systematic review,outcome measures were supplemented,merged,and their naming and classification were standardized.This resulted in an item pool containing 12 primary and 71 secondary outcome measures.After two rounds of Delphi surveys,18 important(Category A)outcome measures were selected for inclusion in the consensus meeting.Finally,a consensus meeting was held to discuss and determine the COS for HSPN clinical research in Chinese and Western medicine.The COS included five important and must-report(Category A1)outcome measures:urinary protein,24-hour urinary protein quantification,urinary red blood cell count,hematuria(gross hematuria),and serious adverse reactions.Additionally,there were three important but not must-report(Category A2)outcome measures:Chinese medicine syndrome therapeutic efficacy,urine microalbumin/creatinine ratio,and renal pathology biopsy.Conclusion The core outcome indices set of Chinese and Western medicine clinical studies of purpuric nephritis in children included five primary outcomes and three secondary outcomes.关键词
紫癜性肾炎/核心结局/指标集/儿童/中医证候/中西医结合/临床研究Key words
Henoch-Schönlein purpura nephritis/core outcomes/indices set/children/Chinese medicine syndromes/integrative medicine/clinical research引用本文复制引用
刘畅,杨燕,刘雅莉,王辉,梁琛,彭晓霞,王芳,董恒,佟静涵,柳静,胡艳..儿童紫癜性肾炎中西医临床研究核心结局指标集[J].中国中西医结合杂志,2025,45(3):277-282,6.基金项目
北京市研究型病房建设示范单位项目(No.BCRW202101) （No.BCRW202101）
