摘要
该研究构建了中医药治疗呼吸道病毒感染早期寒包火证核心指标集(core outcome set,COS),为相关临床研究选择疗效评价指标提供参考。采用文献调研法收集随机对照试验、系统评价、指南和临床试验注册方案中报告的,中医药治疗呼吸道病毒感染早期寒包火证相关的结局指标,补充检索高水平期刊发表的西医治疗呼吸道病毒感染疾病系统评价,以及国家药品监督管理局药品审评中心和美国食品药品监督管理局官网,构建初始结局指标条目池。通过2轮德尔菲法,采用Likert 9级评分法调研结局指标重要性。最后通过面对面专家共识会议,确定最终纳入的指标。结果共纳入临床研究31篇、系统评价5篇、指南2篇、临床试验注册方案5篇、新药指导原则8篇,通过规范合并结局指标,构建了包含34个结局指标的指标池。2轮德尔菲咨询后初步纳入17个结局指标,召开专家共识会议进一步对指标进行讨论和凝练,最终确定10个核心结局指标,包括转重率、主要症状改善时间、所有症状消失时间、解热镇痛药物用量、不良事件发生率、病毒转阴时间、病死率、生活质量、住院时间、体温复常时间。
This study constructed a core outcome set(COS)for traditional Chinese medicine(TCM)treatment of early-stage external cold and internal heat syndrome in respiratory viral infections,aiming to provide a reference for selecting outcomes in related clinical studies.A literature review was conducted to collect outcomes related to the early-stage external cold and internal heat syndrome in respiratory viral infections under TCM treatment from randomized controlled trials,systematic reviews,guidelines,and registered clinical trial protocols.Supplementary searches were performed in high-impact journals for systematic reviews on conventional medicine treatments for respiratory viral infections,as well as on the official websites of the Center for Drug Evaluation of the National Medical Products Administration and the US Food and Drug Administration,to develop the initial outcome pool.Two rounds of the Delphi surveys using a 9-point Likert scale were conducted to evaluate the importance of outcomes.The final outcomes were determined through a face-to-face expert consensus meeting.A total of 31 clinical studies,five systematic reviews,two guidelines,five registered clinical trial protocols,and eight new drug evaluation guidelines were included.After standardizing and sorting the outcomes,a pool of 34 outcomes was established.After two rounds of Delphi surveys,17 outcomes were initially included.After the expert consensus meeting,10 core outcome indicators were finally determined,including rate of progression to severe cases,time to major symptom improvement,time to resolution of all symptoms,dosage of antipyretic and analgesic medications,incidence of adverse events,time to viral clearance,mortality rate,quality of life,length of hospital stay,and time to normalization of body temperature.
作者
高卓
田晨
卢婷婷
石嘉恒
赵昕
齐文升
刘杰
葛龙
GAO Zhuo;TIAN Chen;LU Ting-ting;SHI Jia-heng;ZHAO Xin;QI Wen-sheng;LIU Jie;GE Long(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;School of Nursing,Gansu University of Chinese Medicine,Lanzhou 730000,China;Department of Health Policy and Management,School of Public Health,Lanzhou University,Lanzhou 730000,China;Key Laboratory of Evidence-based Medicine,Gansu Province,Lanzhou 730000,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国中药杂志》
北大核心
2025年第22期6497-6504,共8页
China Journal of Chinese Materia Medica
基金
中央高水平中医医院临床研究和成果转化能力提升项目———中医药临床循证研究专项(HLCMHPP2023090)
呼吸道传染疾病应急防控专项(HLCMHPP2023091)。
关键词
中医药
呼吸道病毒感染
寒包火证
核心指标集
traditional Chinese medicine
respiratory viral infection
external cold and internal heat syndrome
core outcome set
