基于三维混合研究方法构建中医药治疗肾阳虚证的疗效评价指标  

Constructing efficacy evaluation index of TCM in treating kidney-yang deficiency syndrome based on three-dimensional hybrid method

作　　者：何健 蔡琳琳[2] 代欣玥 孙明月[3] 高蕊 He Jian;Cai Linlin;Dai Xinyue;Sun Mingyue;Gao Rui(GCP Center,Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Department of Oncology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Institute of Clinical Pharmacology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院广安门医院GCP办公室,北京100053 [2]中国中医科学院西苑医院肿瘤科,北京100091 [3]中国中医科学院西苑医院临床药理研究所,北京100091

出　　处：《国际中医中药杂志》2025年第3期318-326,共9页International Journal of Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程(CI2021A04708)。

摘　　要：目的基于三维度混合研究方法构建中医药治疗肾阳虚证的疗效评价指标。方法采用文献研究、问卷调查、专家访谈的方法,初步构建肾阳虚证结局指标清单;通过德尔菲法问卷调查筛选核心指标,召开专家共识会议确定肾阳虚证的核心指标。结果获得夜尿频多、腰部酸痛、性欲低下、畏寒、乏力、五更泻、精神萎靡7个肾阳虚证中医症状条目;生活质量评分(量表形式)、性生活水平(性生活自我满意度、性生活日志等)2个肾阳虚证疾病相关核心指标条目。疾病相关指标用于疗效评价时,可结合临床研究涉及的相关疾病,作为疗效指标的补充;作为推荐内容,不作为肾阳虚证候疗效评价的主体内容。结论本研究通过“定性定量研究方法结合”“主客观指标结合”“医患共评结合”3个维度的混合研究方法,形成肾阳虚证疗效评价核心指标,为《肾阳虚证疗效评价标准》的制定提供前期研究基础,为证候类疗效评价研究提供思路与方法。Objective Constructing efficacy evaluation index of TCM in treating kidney-yang deficiency syndrome based on three-dimensional hybrid method.Methods The outcome index list of kidney-yang deficiency syndrome was preliminarily constructed through literature research,questionnaire survey and expert interview.The core indicators of kidney-yang deficiency syndrome were screened by Delphi questionnaire,and the expert consensus meeting was held to determine the core outcome of kidney-yang deficiency syndrome.Results The TCM symptoms of kidney-yang deficiency syndrome:7 items:frequent urination at night,waist pain,low libido,chills,fatigue,diarrhea and mental malaise.Related core indicators of kidney-yang deficiency syndrome:Level quality of life score(scale),sex life level(sexual self satisfaction,sexual life log,etc.)two entries,objective indicators in the core index and stronger correlation disease,curative effect evaluation,can be combined with clinical research involves the related diseases,used to supplement the curative effect,as recommendations,not as the main body of kidney-yang deficiency syndrome curative effect evaluation content.Conclusion This study refers to the clinical trial of the TCM core outcome to develop technical specifications,in the development process and methods,through the"combination of qualitative and quantitative research methods""combination of subjective and objective indicators""combination of doctor-patient evaluation"three dimensions of mixed research methods,formation of kidney-yang deficiency syndrome curative effect evaluation of the core outcome,for the kidney-yang deficiency syndrome curative effect evaluation standard of prophase research foundation,to provide ideas and methods for the evaluation of curative effect of syndrome.

关 键 词：肾阳虚 三维混合方法研究 证候疗效评价 核心指标 

分 类 号：R25[医药卫生—中医内科学]