【目的】基于德尔菲法及层次分析法构建乳腺癌肝郁证的中医证候诊断标准专家共识。【方法】在前期文献研究构建的 乳腺癌肝郁证症状条目池的基础上，进行三轮德尔菲法专家咨询，以确定条目指标，采用均数、满分比、标准差、变异系 数进行条目筛选，以层次分析法计算得到的比重作为条目权重，形成乳腺癌肝郁证的诊断量表，并在此诊断量表基础上开 展临床前瞻性验证研究以评估该诊断标准的诊断效能。【结果】通过文献研究，共纳入298 条证候条目，包括160 条乳腺癌肝 郁证的四诊信息。在三轮德尔菲法调查中，共29 名专家全程参与，专家积极系数为96.67%，专家权威系数大于0.8。基于德 尔菲法及层次分析法，共筛选得到12 条条目，具体为：乳房肿块、乳房肿块坚实、乳房肿块边界不清、情志抑郁、易怒、 心烦、性急、烦躁、善太息、胸胁胀痛、病情随情绪变化而增减、脉弦。层次分析法得到二级指标的权重由高到低排名居 前5 位的分别是：病情随情绪变化而增减、性急、脉弦、胸胁胀痛、善太息。最终通过三轮专家咨询形成乳腺癌肝郁证的证 候诊断标准，即具备“性急或善太息”“胸胁胀痛”“病情随情绪变化而增减”“脉弦”这4 项主症中的任意两项，并具备 “乳房肿块，或乳房肿块坚实，或乳房肿块边界不清”“情志抑郁，或易怒，或心烦，或烦躁”这2 项次症的任意一项，即可 判断为乳腺癌肝郁证。诊断性试验的各项真实性和临床实用价值指标（灵敏度、特异度、准确度、阳性似然比、阴性似然比、 阳性预测值、阴性预测值）均较好，诊断符合率为87.23%，Kappa 值为0.733。【结论】本研究明确了乳腺癌肝郁证的主次症及 诊断条件，形成了中医证候诊断标准专家共识，可为乳腺癌肝郁证的精准诊断提供依据，为后续乳腺癌的中医药疗效评价 奠定基础。

Objective To establish an expert consensus on the traditional Chinese medicine（TCM）syndrome diagnostic criteria for liver depression syndrome in breast cancer using the Delphi method and analytic hierarchy process（AHP）. Methods Based on a preliminary item pool of symptoms associated with liver depression syndrome in breast cancer derived from prior literature research，three rounds of Delphi expert consultation were conducted to refine the symptom indicators. Items were screened using mean scores，full score ratio，standard deviation， and coefficient of variation. The weight of the indicators calculated with AHP was used for the criteria of the item constructing the diagnostic scale for liver depression syndrome in breast cancer. And then a prospective clinical validation study was conducted to evaluate the performance of the established diagnostic criteria. Results Through the retrieval of the literature，a total of 298 syndrome manifestation items were included，comprising 160 items of four-examination information related to liver depression syndrome in breast cancer. During the three rounds of Delphi consultation，29 experts participated the whole consultation，with a positive coefficient of 96.67% and an authority coefficient exceeding 0.8. After the Delphi consultation and AHP，a total of 12 items were ultimately defined，and they were breast mass，solid breast mass，poorly-defined breast mass margins，emotional depression，irritability，vexation，impatience，dysphoria，preference of deep sighing，distending pain in the chest and hypochondrium，symptom exacerbation or alleviation with emotional changes，and wiry pulse. The leading five secondary indicators ranked by AHP-derived weight in descending order were symptom exacerbation or alleviation with emotional changes，impatience，wiry pulse，distending pain in the chest and hypochondrium， and preference of deep sighing. Following three rounds of expert consultation，the diagnostic criteria for liver depression syndrome in breast cancer were established as follows：presence of any two of the four primary symptoms：impatience or preference of deep sighing，distending pain in the chest and hypochondrium，symptom exacerbation or alleviation with emotional changes，and wiry pulse；and accompanied by any one of the two secondary symptoms：breast mass or solid breast mass or poorly-defined breast mass margins，and emotional depression or irritability or vexation or dysphoria. The diagnostic test demonstrated favorable results in the parameters assessing validity and clinical utility（sensitivity，specificity，accuracy，positive likelihood ratio， negative likelihood ratio，positive predictive value，and negative predictive value），with a diagnostic consistency rate of 87.23% and a Kappa value of 0.733. Conclusion The primary and secondary symptoms and the diagnostic criteria for liver depression syndrome in breast cancer have been clarified，and an expert consensus on TCM syndrome diagnostic criterion has been formulated. This consensus provides a foundation for the precise diagnosis of liver depression syndrome in breast cancer and lays a basis for subsequent evaluation of TCM therapeutic efficacy in breast cancer.

R273.79

国家自然科学基金项目（编号：82274513，82405608，82474504）；羊城中医药创新人才团队建设项目（编号：2026RC002）； 广州市科技计划项目（编号：SL2023A03J01120、SL2025A04J4201）；中医证候全国重点实验室项目（编号：QZ2023ZZ 13、SKLKY2024B0017）； 中医药广东省实验室培育项目（编号：HQL2024PZ023）；广东省中医院中医药科学技术研究专项（编号：YN2022QN01）；广东省中医证候临床研 究重点实验室项目（编号：YN2023ZH 10）；广州中医药大学与中山市中医院高水平医院共建项目学科建设专项（编号：GZYZS2024XKG05）； 中医药广东省实验室2024 年第二批产业化项目（编号：HQL2025CY003）；北京科创医学发展基金会项目（编号：2022KT 1333/KC2021-ZZ- 0010-9）；广州市国医大师传承创新工程项目（穗卫中医[2025]2 号）；中华中医药学会青托项目（编号：2025-QNRC2-B41）