中国中药杂志2026，Vol.51Issue(9)：2689-2698,10.DOI:10.19540/j.cnki.cjcmm.20260123.501
男性不育症肾阳虚证诊断标准
Diagnostic criteria for kidney Yang deficiency syndrome in male infertility
摘要
Abstract
This study aimed to establish Diagnostic criteria for kidney Yang deficiency syndrome in male infertility(referred to as"this criteria").A preliminary questionnaire item pool was constructed through literature retrieval,in combination with male infertility-related textbooks,existing national standards,guidelines,and expert consensus documents,as well as expert interviews and group discussions.Two rounds of questionnaire surveys were conducted using the Delphi method to standardize the diagnostic criteria item pool and complete item supplementation and screening.Expert questionnaires were collected using the analytic hierarchy process(AHP)to statistically determine item weights and diagnostic thresholds.Finally,a diagnostic test was conducted by enrolling 105 participants to evaluate the diagnostic criteria,with sensitivity,specificity,accuracy,positive predictive value,negative predictive value,positive likelihood ratio,and negative likelihood ratio used as indicators of diagnostic efficacy at the established threshold.Based on the results of expert discussions,this criteria was established.After systematic literature screening,66 articles were included.By incorporating textbooks,national standards,and consensus documents,all items were summarized,merged,and classified,resulting in an initial diagnostic criteria item pool of 39 items.The first round of the Delphi method retained 29 important items,and the second round retained 18 important items.AHP identified three levels of item weights,i.e.,high,medium,and low.The primary symptoms for diagnosing kidney Yang deficiency syndrome in MI were finally determined as aversion to cold,soreness and weakness of the lower back and knees,a pale and swollen tongue,and a thin white tongue coating.The secondary symptoms were decreased libido,cold sensation in the lower abdomen or genital region,increased nocturnal urination,and a deep and weak pulse or a deep and slow pulse.Patients presenting all primary symptoms were diagnosed with this syndrome;patients presenting two primary symptoms together with any two manifestations from the secondary symptoms,physical signs,or pulse conditions were also diagnosed with this syndrome.After establishment of this criteria,105 MI patients from the Department of Andrology,Xiyuan Hospital of China Academy of Chinese Medical Sciences were enrolled.Eligible participants were diagnosed using both the evaluated this criteria and the reference diagnostic criteria.The diagnostic efficacy of this criteria showed a sensitivity of 0.91,specificity of 0.88,and accuracy of 0.89.This study established Diagnostic criteria for kidney Yang deficiency syndrome in male infertility and completed clinical validation,providing a reference basis for the clinical diagnosis of MI with kidney Yang deficiency syndrome.关键词
男性不育症/肾阳虚证/德尔菲法/层次分析法/诊断标准Key words
male infertility/kidney Yang deficiency syndrome/Delphi method/analytic hierarchy process/diagnostic criteria引用本文复制引用
赵子维,晏斌,郭军,郭俊,刘胜京,李纪新,吴霜,常洪源,于文晓,高庆和,王福..男性不育症肾阳虚证诊断标准[J].中国中药杂志,2026,51(9):2689-2698,10.基金项目
国家中医药管理局高水平中医药重点学科建设项目(zyyzdxk-2023238) （zyyzdxk-2023238）
中央级公益性科研院所基本科研业务费专项(ZZ15-YQ-012) （ZZ15-YQ-012）
中国中医科学院西苑医院能力提升项目(XYZX0405-31) （XYZX0405-31）
中国中医科学院科技创新工程项目(CI2021A02209) （CI2021A02209）
