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-Sch?nlein Purpura Nephritis

作　　者：刘畅[1] 王辉[2] 梁琛 彭晓霞[1] 王芳[4] 董恒 佟静涵 柳静 胡艳[6] 杨燕[6] 刘雅莉 LIU Chang;WANG Hui;LIANG Chen;PENG Xiao-xia;WANG Fang;DONG Heng;TONG Jing-han;LIU Jing;HU Yan;YANG Yan;LIU Ya-li(Center for Clinical Epidemiology and Evidence-based Medicine,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045;Nephropathy Department,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045;Pediatric Medicine,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045;Department of Nephrology,Peking University First Hospital,Beijing 100034;Pediatric Surgery,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045;Traditional Chinese Medicine Department,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045)

机构地区：[1]国家儿童医学中心,首都医科大学北京儿童医院,临床流行病学与循证医学中心,北京100045 [2]国家儿童医学中心,首都医科大学北京儿童医院肾病科,北京100045 [3]国家儿童医学中心,首都医科大学北京儿童医院儿内科,北京100045 [4]北京大学第一医院肾内科,北京100034 [5]国家儿童医学中心,首都医科大学北京儿童医院儿外科,北京100045 [6]国家儿童医学中心,首都医科大学北京儿童医院中医科,北京100045

出　　处：《中国中西医结合杂志》2025年第3期277-282,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：北京市研究型病房建设示范单位项目(No.BCRW202101)。

摘　　要：目的构建儿童紫癜性肾炎中西医临床研究的核心结局指标集,解决临床研究中选取结局指标时显著异质性问题,为中西医疗效与安全性的客观评估提供依据。方法采用系统评价和半结构式深度访谈初步构建结局指标条目池;通过德尔菲问卷调查对各结局指标的重要性进行评分,筛选出纳入共识会议的重要结局指标;并通过专家共识会议达成共识,构建紫癜性肾炎中西医临床研究的核心结局指标集。结果通过系统评价的方法检索8个常用数据库并补充检索其他平台资源,共获取4377篇文献,经过初筛、复筛,最终纳入148篇文献,提取到103个结局指标。通过与18名专家进行半结构式深度访谈,结合系统评价结果,补充、合并结局指标,并规范其命名和分类,最终形成包含12个一级指标、71个二级结局指标的条目池。经过两轮德尔菲问卷调查,筛选出18个重要(A类)结局指标纳入共识会议的结局指标。最后通过共识会议,讨论并确定了紫癜性肾炎中西医临床研究核心结局指标集,包括5个重要且必须报告(A1类)结局指标——尿蛋白、24 h尿蛋白定量、尿红细胞计数、血尿(肉眼血尿)、严重不良反应,以及3个重要但非必须报告(A2类)结局指标——中医证候疗效、尿微量白蛋白/肌酐比值、肾病理活检。结论儿童紫癜性肾炎中西医临床研究的核心结局指标集包含5种重要结局和3种次要结局。Objective To construct a core outcome set(COS)of clinical research in children with Henoch-Sch?nlein 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 4377 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 pa

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 

分 类 号：R272[医药卫生—中医儿科学]