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心房颤动常见病理因素中西医结合诊断量表研制
Development of a Diagnostic Scale for Atrial Fibrillation Based on Common Pathological Factors in Integrated Traditional and Western Medicine

王啸轶1,方格2,刘建和3,胡志希1
Wang Xiaoyi1, Fang Ge2, Liu Jianhe3, Hu Zhixi1

1湖南中医药大学长沙 4102082湖南中医药高等专科学校,株洲 4120123湖南中医药大学第一附属医院长沙 410007
(1.Hunan University of Traditional Chinese Medicine,Changsha 410208;2.Hunan Higher Vocational College of Traditional Chinese Medicine, Zhuzhou 412012;3.First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410007)

摘要目的 研制心房颤动常见病理因素中西医结合诊断量表。方法 检索并筛选30知网、维普、万方、中国生物医学文献数据库收录的心房颤动辨证相关文献,提取相关病理因素及对应症状、体征、理化指标等诊断条目,并对条目进行规范化处理,确定条目池;使用德尔菲法筛选诊断条目,筛选指标为均数、满分比、变异系数;基于综合权重,结合条目均数、满分比、变异系数对筛选后条目赋权并确定诊断阈值形成心房颤动常见病理因素中西医结合诊断量表。结果 共检索文献6526篇,最终纳入115篇,提取血、气虚、阴虚、痰浊、阳虚、气滞共6常见病理因素,诊断条目共169个。基于德尔菲法专家问卷咨询,删除气滞病理因素,共筛选血、气虚、阴虚、痰浊、阳虚5个心房颤动常见病理因素的中西医结合诊断条目各1812111219拟定心房颤动常见病理因素中西医结合诊断量表结论 本研究筛选心房颤动常见病理因素,明确各病理因素诊断条目及其对应的权重与诊断阈值,研制心房颤动常见病理因素中西医结合诊断量表为心房颤动中西医结合临床诊断提供指导。
AbstractObjectiveTo develop a diagnostic scale for common pathological factors of atrial fibrillation based on a combination of traditional Chinese and Western medicine.MethodsLiterature from the past30years was searched andscreened from databases including CNKI, VIP, Wanfang, and Chinese Biomedical Literature Database, focusing on atrial fibrillation syndrome differentiation related literature, extracting relevant pathological factors and corresponding symptoms, signs, and physical and chemical indicators for diagnostic items, and standardizing these items, to determine the item pool; the Delphi method was used to screen diagnostic items, with screening criteria including mean, full score ratio, and coefficient of variation; based on comprehensive weight, the selected items were assigned weights and diagnostic thresholds were determined by combining item means, full score ratios, and coefficients of variation to form a diagnostic scale for common pathological factors of atrial fibrillation based on a combination of traditional Chinese and Western medicine.ResultsA total of6526 articles were retrieved, and finally115 articles were included, extracting a total of6 common pathological factors: blood stasis, qi deficiency, yin deficiency, phlegm turbidity, yang deficiency, and qi stagnation, with a total of169 diagnostic items.Based on the Delphi method expert questionnaireconsultation, the pathological factors of Qi stagnation were removed, and a total of bloodstasis, Qi deficiency, Yin deficiency, phlegm turbidity, and Yang deficiency5 common pathological factors of atrial fibrillation were screened, with combined Chinese and Western medicine diagnostic items of18,12,11,12,19 items,and a combined Chinese and Western medicine diagnostic scale for common pathological factors of atrial fibrillation was proposed.Conclusion This study screened common pathological factors of atrial fibrillation, clarified the diagnostic items of each pathological factor and their correspondingweights and diagnostic thresholds, and developed a combined Chinese and Western medicine diagnostic scale for common pathological factors of atrial fibrillation, providing guidance for the clinical diagnosis of atrial fibrillation using both Chinese and Western medicine.It seems there is no source text provided for translation. Please provide the text you would like to have translated

关键词:心房颤动;病理因素;中医药标准化;德尔菲法;诊断量表
Keywords:Atrial fibrillation; pathological factors;Traditional Chinese medicinestandardization;Delphi method;diagnosticscale

心房颤动(atrial fibrillationAF)简称房颤,是心律失常中最常见的一种类型,房颤本身不是一种致死性心律失常,但其可导致脑卒中、心肌梗死、心力衰竭、痴呆等严重并发症,对全人类的生命健康构成了巨大威胁,极大地加重了社会的医疗负担[1-2]长久以来,房颤的中西医结合诊断存在缺乏统一标准、主观性强、定量不足、与现代医学指标结合不足的弊端本研究以病理因素为切入点,经文献研究构建诊断条目池,再开展两轮德尔菲法专家问卷调查,筛选心房颤动不同病理因素诊断条目,再通过数理统计,最终形成心房颤动常见病理因素中西医结合诊断量表,为心房颤动中西医结合诊断提供指导,并探索中西医结合诊断研究的思路与方法。
Atrial fibrillation (atrialfibrillation,AF) is commonly referred to as AF, and it is the most common type of arrhythmia. Atrial fibrillation itself is not a lethal arrhythmia, but it can lead to serious complications such as stroke, myocardial infarction, heart failure, and dementia, posing a significant threat to the health and lives of people worldwide, greatly increasing the medical burden on society[1-2]. For a long time, the combined diagnosis of atrial fibrillation in traditional Chinese and Western medicine has suffered from a lack of unified standards, strong subjectivity, insufficient quantification, and inadequate integration with modern medical indicators. This study takes pathological factors as the entry point, constructs a diagnostic item pool through literature research, and then conducts two rounds of Delphi method expert questionnaire surveys to screen diagnostic items for different pathological factors of atrial fibrillation. Finally, through mathematical statistics, it forms a combined diagnostic scale for common pathological factors of atrial fibrillation in traditional Chinese and Western medicine, providing guidance for the combined diagnosis of atrial fibrillation and exploring ideas and methods for research in combined diagnosis.

资料与方法
Materials and Methods

文献研究
LiteratureResearch

文献检索
Literature search

计算机检索近30年(1990-2020年)中国知网(CNKI)、万方数据平台(WANFANG DATA)、维普中文期刊服务平台(VIP)、中国生物医学文献数据库(SinoMed)收录的心房颤动相关文献。检索词为:心房颤动、房颤、心房颤、心悸、怔忡、病理因素、气虚、血虚、阴虚、阳虚、气滞、血、痰浊、中医、诊断、中西医结合、证候、证型、辨证、证素,以“AND”、“OR”逻辑运算符连接。
A computer search was conducted for literature related to atrial fibrillation indexed in the China National Knowledge Infrastructure (CNKI), Wanfang Data Platform, VIP Chinese Journal Service Platform, and SinoMed Biomedical Literature Database over the past 30 years (1990-2020). The search terms included: atrial fibrillation, AF, atrial flutter, palpitations, arrhythmia, pathological factors, qi deficiency, blood deficiency, yin deficiency, yang deficiency, qi stagnation, blood stasis, phlegm turbidity, traditional Chinese medicine, diagnosis, integrated traditional and Western medicine, syndromes, syndrome types, syndrome differentiation, and syndrome elements, connected by "AND" and "OR" logical operators.

文献纳入标准
LiteratureInclusion Criteria

1包含明确心房颤动中医证型及相对应的症状、体征和/或理化指标的文献;(2)有明确的中医和/或西医诊断标准的文献。
1Literature that includes clear Traditional Chinese Medicine (TCM) syndromes of atrial fibrillation and corresponding symptoms, signs, and/or physical and chemical indicators;(2Literature with clear TCM and/or Western medicine diagnostic criteria.

文献排除标准
Exclusion criteria for literature

1)重复发表的论文或重复使用研究数据的文献(只保留发表刊物级别较高的文献);(2)非CN期刊收录的文献;(3只有证名而无辨证相关条目的文献;(4)无证型相关诊断标准的文献;(5)动物实验研究、个案报道、临床经验、综述。
1)Papers that are published repeatedly or literature that reuses research data (only retaining literature from higher-level publications);(2)Literature not included in CN journals;(3Literature that only has evidence but no relevant dialectical entries;(4)Literature without evidence-based diagnostic criteria;(5)Animal experimental studies, case reports, clinical experiences, reviews.

文献筛选与数据提取
Literature Screeningand Data Extraction

将下载的文献题录导入NoteExpress 3.2.0.7629软件,根据纳入及排除标准阅读每一篇文献的题目、摘要进行初筛,再逐篇阅读全文进行复筛。使用Microsoft Excel软件建立文献资料提取表,将最终纳入的文献进行数据录入、校对和清理,提取内容为:作者姓名、发表年份、文献标题、文献来源、证型、症状、体征、主要理化检查结果及相关中西医诊断标准。参照GB/T 16751.2-1997《中医临床诊疗术语 证候部分》[3]、《中医诊断学》(第9版)[4],对证名、症状、体征的表达进行规范处理;参照《内科学》(第8版)[5]、《心房颤动:目前的认识和治疗的建议-2018[1]对西医理化指标的表达进行规范处理;将临床意义相近的条目进行同义合并,将复合条目进行拆分处理
Import the downloaded literature citations intoNoteExpress3.2.0.7629 software, read the title and abstract of each literature according to the inclusion and exclusion criteria for initial screening, and then read each article in full for re-screening. UseMicrosoftExcel software to create a literature data extraction table, enter, proofread, and clean the data of the final included literature, extracting the following content: author name, publication year, literature title, literature source, evidence type, symptoms, signs, main physicochemical examination results, and relevant Chinese and Western medicine diagnostic criteria. Refer toGB/T16751.2-1997“Terminology of Clinical Diagnosis and Treatment in Traditional Chinese MedicineSymptom Section”[3], “Diagnosis in Traditional Chinese Medicine” (9thEdition)[4], standardizing the expression of disease names, symptoms, and signs; referring to “Internal Medicine” (8thEdition)[5], “Atrial Fibrillation: Current Understanding and Treatment Recommendations-2018[1] standardizing the expression of Western medical physical and chemical indicators; merging entries with similar clinical significance, splitting composite entries for processing.It seems there is no source text provided for translation. Please provide the text you would like to have translated

德尔菲法专家问卷咨询
Delphi Method Expert Questionnaire Consultation

确定条目池
Determine the entry pool

通过前期文献系统评价与研究小组研讨,选择频次2的条目纳入条目池。
Through the preliminary literature systematic review andresearch groupdiscussions, entries with a frequency2were included in the entry pool.

问卷设计
Questionnaire Design

在前述文献研究提取不同病理因素诊断条目池的基础上,开展研究团队研讨会,进一步补充和确定诊断条目,并制定专家咨询问卷。咨询问卷包括研究者声明、研究背景介绍、专家基本信息表、问卷填写说明、待筛选诊断条目重要性评价、熟悉程度、判断依据、修改建议、补充意见等。其中条目重要性评价采用Likert 5级评分法(4分-非常重要、3分-比较重要、2分-一般重要、1分-比较不重要、0分-极不重要)专家熟悉程度分为很熟悉(1分)、较为熟悉(0.8分)、一般熟悉(0.6分)、不太熟悉(0.4分)、不熟悉(0.2分);专家判断依据分别为临床经验(0.8分)、理论分析(0.6分)、参考国内外资料(0.4分)、直觉(0.2分)。
Based on the extraction of different pathological factors from the aforementioned literature research to form a pool of diagnostic entries, a research team seminar was held to further supplement and confirm the diagnostic entries, and to develop an expert consultation questionnaire. The consultation questionnaire includes a researcher statement, research backgroundintroduction, expert basic information form, questionnaire filling instructions, importance evaluation of the diagnostic entries to be screened,familiarity level,judgment basis, modification suggestions, and additionalcomments. Among them, the importance evaluation of the entries uses theLikert5level scoring method (4points - very important,3points - relatively important,2points - generally important,1point - relatively unimportant,0points - extremely unimportant); the expert familiarity level is divided into very familiar (1point), relatively familiar (0.8points), generally familiar (0.6points), not very familiar (0.4points), and unfamiliar (0.2points); the expert judgment basis includes clinical experience (0.8points), theoretical analysis (0.6points), reference to domestic and international materials (0.4points), intuition (0.2points).It seems there is no source text provided for translation. Please provide the text you would like to have translated

专家遴选
Expert Selection

为保证研究质量,确定专家遴选原则为:1具备副高级及以上职称;(2从事房颤临床诊疗或中医证候标准化工作不少于10
To ensure the quality of the research, the criteria for selecting experts are as follows:1Must have a title of associate senior or above;(2Engaged inAtrial Fibrillationclinical diagnosis and treatment or traditional Chinese medicinestandardization workfor no less than10years

匿名处理
Anonymous processing

为了避免专家之间互相影响或权威专家意见对其他专家的干扰,保证各位专家意见的平等性、独立性与真实性,本研究中调查专家在招募阶段与调查阶段均互相匿名,独立参与调查
In order to avoid mutual influence among experts or interference from authoritative experts' opinions on other experts, and to ensure the equality, independence, and authenticity of each expert's opinion, this study conducted the survey with experts remaining anonymous during both the recruitment and survey phases, participating independently in the investigation

统计分析
Statistical analysis

基于问卷结果,使用Microsoft Excel软件计算专家积极系数、权威程度、集中程度、协调程度、综合权重[6]。专家积极系数即问卷的有效回收率(%权威程度通常采用权威系数(Q)表示,权威系数(Q=熟悉程度+判断依据/2集中程度包括均数(满分比(%)(K),其中均数(=x1+ x2+xn/nn为专家人数, xnn位专家对条目的重要性评分;满分比(K=n(x=4)/N×100%N为专家人数n(x=4)为对条目的重要性评分为非常重要的专家人数。协调程度采用变异系数(CV)表示,变异系数(CV=SD/SD为条目重要性评分的标准差。综合权重反映纳入诊断量表的条目的重要性占比综合权重=条目二轮总评分/所有条目二轮总评分。
Based on the questionnaire results, usingMicrosoftExcelsoftware to calculate the expert positivity coefficient, authority level, concentration level, coordination level, comprehensive weight[6]. The expert positivity coefficient is the effective recovery rate of the questionnaire (%).The authority level is usually represented by the authority coefficient (Q), the authority coefficient (Q)=Familiarity level+Judgment basis/2.The degree of concentration includes the mean (and the full score ratio (%)(K),where the mean (=x1+x2+xn/nn is the number of experts, xn is the nth expert's score of importance for the item; the full score ratio (K=n(x=4)/N×<100%N is the number of expertsn(x=4) is the number of experts who rated the importance of the item as very important. The degree of coordination is represented by the coefficient of variation (CV), the coefficient of variation (CV)=SD/SD is the standard deviation of the importance ratings of the items. The comprehensive weight reflects the proportion of importance of the items included in the diagnostic scale the comprehensive weight= total score of the second round of items/ total score of all items in the second round.It seems there is no source text provided for translation. Please provide the text you would like to have translated

诊断量表拟定
Drafting of diagnostic scales

综合权重等比扩大100四舍五入得到整数权重,基于条目整数权重及研究小组研讨,结合条目均数、满分比、变异系数进行调整,最终确定各病理因素不同诊断条目权及诊断阈值,从而得出诊断量表。
Comprehensive weight is expanded proportionally100timesafterrounding to obtain integer weights, based on the integer weights of the items and discussions within the research group, adjustments are made in conjunction with the item mean, full score ratio, and coefficient of variation, ultimately determining the different diagnostic weightsof pathological factorsand diagnostic thresholds, thus deriving the diagnostic scale.

结果
Result

文献研究
Literature research

文献筛选结果
Literature screening results

一共检索到文献6526篇,其中CNKI 2598篇(软件自动除重后剩余1683篇),SinoMed 1928篇(软件自动除重后剩余1925篇),WANFANG DATA 1112篇(软件自动除重后剩余1101篇),VIP 896篇(软件自动除重后剩余895篇)。合并后得到文献共5604篇,再次进行数据库间除重后,纳入文献3554篇进行初筛。初筛剔除文献3032篇,剩余522篇进入复筛。复筛剔除文献共407篇,最终纳入文献115
A total of6526documents were retrieved, among whichCNKI2598documents (after automatic deduplication by the software, remaining1683documents),SinoMed1928documents (after automatic deduplication by the software, remaining1925documents),WANFANGDATA1112documents (after automatic deduplication by the software, remaining1101documents),VIP896documents (after automatic deduplication by the software, remaining895documents).After merging,the total number of documents is5604documents. After further deduplication between databases,3554documents were included for initial screening. The initial screening excluded3032documents, leaving522documents forfurther screening.The further screening excluded a total of407documents, and finally115documents were included.

条目池确定
Entry pool determined

选择频次2的条目纳入条目池,条目按频次降序排列。
Selection frequency2entries are included in the entry pool, and entries are sorted in descending order by frequency.

1病理因素诊断条目池
(1)BloodStasisPathologicalFactorsDiagnosis Item Pool

中医诊断条目:心悸、舌质紫暗、心胸疼痛、胸闷、脉结、脉涩、舌有瘀斑瘀点、唇甲青紫、脉代、脉弦、痛有定处、痛引肩背内臂、面色黧黑、心痛如刺、心烦、面色晦暗、脉细、舌下络脉曲张、皮下瘀斑、肌肤甲错、病程日久、入夜尤甚。理化指标:心电图诊断、纤维蛋白原升高、PT异常、D-二聚体升高、APTT异常、CRP升高、同型半胱氨酸升高、血小板计数异常、CHA2DS2-VASc评分4分、AT3异常、INR2HAS-BLED评分3分、血栓弹力图提示高凝状态。
Traditional Chinese Medicine diagnostic items: palpitations, dark purple tongue, chest pain, chest tightness, pulse knotty, pulse rough, tongue with ecchymosis and spots, lips and nails cyanotic, pulse alternate, pulse string-like, pain with a fixed location, pain radiating to shoulder, back, and inner arm, dark complexion, stabbing heart pain, irritability, dull complexion, fine pulse, sublingual collateral veins distended, subcutaneous ecchymosis, skin and nails abnormal, long course of disease, worse at night.Electrocardiogram diagnosis, elevated fibrinogen,PTabnormal,D-dimer elevated,APTTabnormal,CRPelevated, homocysteine elevated, abnormal platelet count,CHA2DS2-VAScscore4points,AT3abnormal,INR2,HAS-BLEDscore3points, thromboelastography suggests a hypercoagulable state.

2气虚病理因素诊断条目池
(2)Qi DeficiencyPathologicalFactor Diagnosis Item Pool

中医诊断条目:心悸不安、气短、神疲乏力、胸闷、脉结、自汗、脉细、脉代、脉弱、头晕、苔白、舌淡、脉虚、面白、少气懒言、舌有齿痕、动则加重、心胸隐痛。理化指标:心电图诊断、LVEF值正常、左心房内径正常、BNP正常、CHA2DS2-VASc评分2分、HAS-BLED评分2分。
Traditional Chinese Medicine diagnostic items: palpitations, shortness of breath, fatigue, chest tightness, pulse knotting, spontaneous sweating, thin pulse, pulse replacement, weak pulse, dizziness, white tongue coating, pale tongue, deficient pulse, pale face, little speech, tongue with tooth marks, worsens with movement, hidden chest pain. Physical and chemical indicators: electrocardiogram diagnosis,LVEF value normal, left atrial diameter normal,BNP normal,CHA2DS2-VASc score2 points,HAS-BLED score2 points.

3阴虚病理因素诊断条目池
(3)Diagnosis Item Pool for Yin Deficiency Pathological Factors

中医诊断条目:心悸、脉细、舌红、少苔、口干、盗汗、胸闷、脉数、潮热或五心烦热、失眠、头晕、心烦、多梦、脉结、脉代、脉促、红、耳鸣、腰膝酸软、大便干、心胸隐痛、形体消瘦。理化指标:心电图诊断、静息心室率110bpm、全血粘度升高、甲状腺功能异常。
Traditional Chinese Medicine diagnostic items: palpitations, thin pulse, red tongue, little coating, dry mouth, night sweats, chest tightness, rapid pulse, tidal fever or five hearts heat, insomnia, dizziness, irritability, vivid dreams, knotty pulse, intermittent pulse, rapid pulse,red cheeks, tinnitus, soreness in the lower back and knees, dry stool, hidden pain in the chest, and emaciation. Physical and chemical indicators: electrocardiogram diagnosis, resting ventricular rate110bpm, increased whole blood viscosity, abnormal thyroid function.

4痰浊病理因素诊断条目池
(4)Diagnosis of pathological factors for phlegm-dampness

中医诊断条目:心悸、苔腻、脉滑、多痰、苔白、胸闷如、脉弦、精神疲倦、心烦、失眠、脉结、头晕、口干、口苦、苔滑、身体困重、脘痞或腹胀、体胖、恶心、呕吐痰涎、纳呆。理化指标:心电图诊断、甘油三酯升高、低密度脂蛋白胆固醇升高、高密度脂蛋白胆固醇降低、总胆固醇升高、全血粘度升高。
Traditional Chinese Medicine diagnostic items: palpitations, greasy tongue, slippery pulse, excessive phlegm, white tongue, chest tightness like suffocation, string-like pulse, mental fatigue, irritability, insomnia, knotty pulse, dizziness, dry mouth, bitter mouth, slippery tongue, heavy body, epigastric distension or abdominal bloating, obesity, nausea, vomiting phlegm and saliva, poor appetite. Physical and chemical indicators: electrocardiogram diagnosis, elevated triglycerides, elevated low-density lipoprotein cholesterol, decreased high-density lipoprotein cholesterol, elevated total cholesterol, increased whole blood viscosity.

5阳虚病理因素诊断条目池
(5)Yang DeficiencyPathologicalFactor Diagnosis Entry Pool

中医诊断条目:心悸怔忡、畏冷肢凉、气短、胸闷、脉沉、脉弱、舌淡、浮肿、面色㿠白、苔白、脉细、舌胖大、脉结、小便短少、脉代、神疲乏力、舌质紫暗、大便、小便清长、面唇青紫、自汗、恶心呕吐、苔滑、喘息或不能平卧、遇寒加重、动则加重、舌有齿痕。理化指标:心电图诊断、LVEF值降低、左心房内径增大、左心室舒张末期内径增大、FS值降低、BNP升高、E/A降低、TNF-α升高、IL-6升高。
Traditional Chinese Medicine diagnostic items: palpitations, cold intolerance with cold limbs, shortness of breath, chest tightness, deep pulse, weak pulse, pale tongue, edema, pale complexion, white coating, thin pulse, enlarged tongue, knotted pulse, scanty urination, intermittent pulse, fatigue, dark purple tongue, loose stools , clear and prolonged urination, cyanosis of the face and lips, spontaneous sweating, nausea and vomiting, slippery coating, wheezing or inability to lie flat, worsening with cold, worsening with movement, tongue with tooth marks. Physiological and chemical indicators: electrocardiogram diagnosis, LVEF value decreased, enlarged left atrial diameter, enlarged left ventricular end-diastolic diameter, FS value decreased, BNP elevated, E/A decreased, TNF-α elevated, IL-6 elevated.

6气滞病理因素诊断条目池
(6)Diagnosis Item Pool for Qi Stagnation Pathological Factors

中医诊断条目:心悸、心胸胀痛或窜痛、胸闷、情志抑郁、头晕、脉弦、急躁易怒、气短、颤抖、舌红、脉涩、脉结、苔黄、脉代、善太息、舌正常、随情志诱发或加重。理化指标:心电图诊断、甲状腺功能异常、生活质量评分降低、组织因子升高。
Traditional Chinese Medicine diagnostic items: palpitations, chest tightness or stabbing pain, chest oppression, emotional depression, dizziness, wiry pulse, irritability, shortness of breath, trembling, red tongue, rough pulse, knotted pulse, yellow coating, intermittent pulse, tendency to sigh, tongueappearancenormal, induced or worsened by emotions. Physical and chemical indicators: electrocardiogram diagnosis, thyroid function abnormalities, reduced quality of life scores, elevated tissue factor.

德尔菲专家问卷
Delphi Expert Questionnaire

专家基本情况
Basic Information of Experts

本研究进行了2轮问卷咨询,25位专家参与了咨询,分别来自湖南、广东、广西、江西、四川、安徽、上海、天津等8个省、自治区或直辖市,覆盖了华北、华东、中南、西南4个行政地理分区。咨询的专家均长期在临床和科研工作中从事房颤中西医结合诊疗与中医证候标准化工作专家构成情况见表1
This study conducted2 rounds of questionnaire consultations,25 experts participated in the consultations, coming from Hunan, Guangdong, Guangxi, Jiangxi, Sichuan, Anhui, Shanghai, Tianjin, and other8 provinces, autonomous regions, or municipalities, covering the North China, East China, Central South, Southwest4 administrative geographical divisions. The consulted experts have long been engaged in atrial fibrillation integrated traditional Chinese and Western medicine diagnosis and treatment and the standardization of traditional Chinese medicine syndrome criteria. The composition of experts is shown in Table 1.

1 专家构成情况
Table1Composition of Experts

轮次
Round

性别
Gender

年龄(岁)
Age (years)

职称
Title

专业
Professional

研究领域
Research Field

50
<50

50

副高级
Deputy Senior

高级
Advanced

中医诊断
Traditional Chinese Medicine Diagnosis

中医心血
Traditional Chinese Medicine Heart and Blood

管内科
Internal Medicine

中西医结合心血管内科
Integrative Traditional Chinese and Western Medicine Cardiology

临床
Clinical

科研
Scientific research

第一轮
First round

14

1

11

4

7

8

4

8

3

11

4

第二轮
Second round

8

2

9

1

7

3

1

8

1

9

1

专家积极系数
ExpertPositive Coefficient

第一轮问卷共发送15份,收回有效问卷15份,专家积极系数为100%;第二轮问卷共发送10份,收回有效问卷10份,专家积极系数为100%。二轮问卷的专家积极系数均为100%,说明专家对本研究的关注程度和积极性较高。
The first round of questionnaires sent15copies, with valid questionnaires returned15copies, and the expert engagement coefficient is100%; the second round of questionnaires sent10copies, with valid questionnaires returned10copies, and the expert engagement coefficient is100%. The expert engagement coefficient for the second round of questionnaires is100%, indicating a high level of attention and enthusiasm from the experts towards this research.

专家权威程度
Expert authority level

第一轮问卷熟悉程度=0.99判断依据=1.67权威系数(Q=1.33第二轮问卷熟悉程度=0.96判断依据=1.62权威系数(Q=1.29。二轮问卷的专家权威系数均在0.70以上,说明专家权威程度较高,对本领域较为熟悉,研究结果可靠性和权威度较高[7]
First Round QuestionnaireFamiliarity Level=0.99Basis for Judgment=1.67Authority Coefficient (Q)=1.33Second Round QuestionnaireFamiliarity Level=0.96Basis for Judgment=1.62Authority Coefficient (Q)=1.29. The expert authority coefficients of the second round questionnaire are all within0.70or above, indicating a high level of authority among experts, familiarity with the field, and a higher reliability and authority of the research results[7]。It seems there is no source text provided for translation. Please provide the text you would like to have translated

条目筛选
Entry Screening

本研究参考本领域相关文献[6,8],并结合研究实际,确定条目筛选标准。第一轮专家咨询的条目纳入标准如下:均数2.0、满分比25%、变异系数0.4。对全部符合以上3个标准的条目,直接纳入第二轮问卷调查;对上述3个标准只符合2个者:若满足均数2.0且满分25%,而变异系数>0.4的条目,认为虽然专家对此条目评价波动性较大,但总体对此条目做出较高评价,或给满分的专家比例较大,暂保留进入第二轮问卷调查;若满足均数2.0且变异系数0.4的条目,而满分比25%的条目,认为虽然给出满分的专家比例较小,条目相对重要性较大且专家意见较为统一,暂保留进入第二轮问卷调查;不满足上述条件的条目予以剔除
This study references relevant literature in this field[68], and based on the actual research, determines the criteria for item selection.The inclusion criteria for the first round of expertconsultation are as follows: mean2.0, full score ratio25%, and coefficient of variation0.4. For all items that meet the above3 criteria, they will be directly included in the second round of the questionnaire survey; for those that only meet2 of the above3 criteria: if the mean2.0 and the full score ratio25%, while the coefficient of variation >0.4 entries, it is believed that although the expert evaluations for this entry vary greatly, the overall evaluation is relatively high, or the proportion of experts giving full marks is large, and it will temporarily remain for the second round of the questionnaire survey; if the mean2.0 and the coefficient of variation0.4 for entries, while the proportion of full marks25% for entries, it is believed that although the proportion of experts giving full marks is small, the relative importance of the entry is large and the experts' opinions are relatively unified, it will temporarily remain for the second round of the questionnaire survey; entries that do not meet the above conditions will be excluded.It seems there is no source text provided for translation. Please provide the text you would like to have translated

第二轮专家咨询的条目纳入标准如下:均数2.5、满分比30%、变异系数0.3。全部符合以上3个标准的条目予以保留,否则将条目剔除。
The second round of expertconsultation entry inclusion criteria are as follows: mean2.5, full score ratio30%, and coefficient of variation0.3. All entries that meet the above3 criteria will be retained; otherwise, the entries will be excluded.

值得说明的是,虽然理化指标“心电图诊断”在每一个病理因素中都得到较高的均分,但是部分专家给出0分,认为其对不同病理因素的诊断无特异性和区分度,且条目变异系数较大。故经研究小组商讨,决定去除“心电图诊断”,仅将其作为诊断心房颤动的必要前提。
It is worth noting that although the physical and chemical indicators“electrocardiogram diagnosis” received a high average score across all pathological factors, some experts gave it a0 score, believing that it lacks specificity and differentiation for different pathological factors, and that the coefficient of variation for the items is quite large. Therefore, after discussions among the research team, it was decided to remove“electrocardiogram diagnosis”, considering it only as a necessary prerequisite for diagnosing atrial fibrillation.

1病理因素诊断条目筛选结果
(1)Diagnosis of pathological factors for blood stasis

在第二轮咨询中,“心悸”条目变异系数0.3770.3,经研究小组研讨后,认为“心悸”为血病理因素临床常见条目,决定保留。经过两轮专家咨询,剔除的条目为:心电图诊断、面色晦暗、脉结、脉代、痛引肩背内臂、纤维蛋白原升高、血小板计数异常、APTT异常、PT异常、脉弦、AT3异常、INR2HAS-BLED评分≥3分、心烦、脉细、同型半胱氨酸升高、CRP升高;最终纳入诊断量表的条目为:心痛如刺、舌质紫暗、舌有瘀斑瘀点、舌下络脉曲张、痛有定处、脉涩、心悸、唇甲青紫、心胸疼痛、入夜尤甚、病程日久、胸闷、皮下瘀斑、肌肤甲错、面色黧黑、血栓弹力图提示高凝状态、D-二聚体升高、CHA2DS2-VASc评分≥4病理因素诊断条目筛选流程及结果见表2
In the second round of consultation, the coefficient of variation for the entry "palpitations" is 0.377 > 0.3, after discussion by the research group, it was concluded that "palpitations" is a clinically common entry for blood stasis pathological factors, and it was decided to retain it. After two rounds of expert consultation, the entries removed were: electrocardiogram diagnosis, dark complexion, pulse knot, pulse 代, pain radiating to shoulder and inner arm, elevated fibrinogen, abnormal platelet count, APTT abnormal, PT abnormal, pulse string, AT3 abnormal, INR < 2, HAS-BLED score ≥3 points, restlessness, thin pulse, elevated homocysteine, CRP elevated; the final entries included in the diagnostic scale were: stabbing chest pain, purple dark tongue, tongue with stasis spots, sublingual collateral veins varicosity, pain with a fixed location, rough pulse, palpitations, cyanosis of lips and nails, chest pain, worse at night, long course of disease, chest tightness, subcutaneous ecchymosis, skin and nail changes, dark complexion, thromboelastography suggesting a hypercoagulable state, D- dimer elevated, CHA2DS2-VASc score ≥4 points.BloodStasisPathological factor diagnosis entry screening process and results see Table2.It seems there is no source text provided for translation. Please provide the text you would like to have translated

2 病理因素诊断条目筛选结果
Table2BloodEcchymosisPathological Factors Diagnosis Entry Screening Results

条目
Entry

第一轮(15人)
First round (15people)

第二轮(10人)
Second round (10people)

是否纳入
Whether to include

综合权重
Comprehensive Weight

整数权重
Integer weight

均数
Average

满分比(%
Full score ratio (%

变异
Mutation

系数
Coefficient

均数
Average

满分比(%
Full score ratio (%)

变异
Mutation

系数
Coefficient

心悸*
Palpitations*

3.800

86.667

0.143

3.400

80.000

0.377

0.058

6

心痛如刺*
Heartache like a stab*

3.667

73.333

0.163

4.000

100.000

0.000

0.061

6

脉涩*
Pulse is thin*

3.667

66.667

0.129

3.700

70.000

0.124

0.059

6

心胸疼痛*
Chest pain*

3.600

66.667

0.170

3.600

60.000

0.136

0.058

6

痛有定处*
Pain has a definite place*

3.600

60.000

0.136

3.900

90.000

0.077

0.060

6

舌质紫暗*
Purple and dark tongue*

3.600

60.000

0.136

4.000

100.000

0.000

0.060

6

舌下络脉曲*
Sublingual collateral vein curveopen*

3.600

60.000

0.136

3.900

90.000

0.077

0.060

6

心电图诊断
Electrocardiogram Diagnosis

3.533

66.667

0.203

3.400

70.000

0.353

b
Nob

舌有瘀斑瘀点*
There are petechiae and ecchymosis on the tongue*

3.467

53.333

0.178

4.000

100.000

0.000

0.059

6

唇甲青紫*
Lips and nails are cyanotic*

3.400

46.667

0.180

3.600

70.000

0.184

0.058

6

病程日久*
Prolonged course of illness*

3.333

40.000

0.179

3.500

60.000

0.192

0.055

6

入夜尤甚*
Especially severe at night*

3.267

33.333

0.176

3.800

80.000

0.105

0.056

6

面色晦暗
Pale complexion

3.267

40.000

0.208

3.000

40.000

0.394

b
Nob

血栓弹力图提示高凝状态*
Thromboelastography indicates a hypercoagulable state*

3.267

46.667

0.236

3.600

70.000

0.184

0.055

6

胸闷*
Chest tightness*

3.200

53.333

0.346

3.500

70.000

0.230

0.053

5

肌肤甲错*
Skin armor error*

3.067

46.667

0.366

3.300

50.000

0.237

0.051

5

脉结
Pulse knot

3.067

33.333

0.325

2.700

30.000

0.440

b
Nob

D-二聚体升高*
D-dimer elevation*

3.067

40.000

0.346

3.400

60.000

0.235

0.051

5

皮下瘀斑*
Subcutaneous bruise*

3.000

40.000

0.365

3.500

60.000

0.192

0.051

5

脉代
Pulse deficit

2.933

26.667

0.340

2.500

30.000

0.573

b
Nob

CHA2DS2-VASc评分4*
CHA2DS2-VAScscore4points*

2.800

33.333

0.436

3.400

60.000

0.235

0.049

5

面色黧黑*
Dark complexion*

2.667

26.667

0.468

3.100

30.000

0.226

0.046

5

痛引肩背内臂
Pain radiatingshoulder, back, inner arm

2.600

20.000

0.440

/

/

/

a
Noa

纤维蛋白原升高
Fibrinogen elevation

2.333

33.333

0.676

3.000

50.000

0.422

b
Nob

血小板计数异常
Abnormal platelet count

1.933

26.667

0.789

/

/

/

a
Noa

APTT异常
APTTAbnormal

1.800

26.667

0.912

/

/

/

a
Noa

PT异常
PTAbnormal

1.800

26.667

0.912

/

/

/

a
Noa

脉弦
Pulse string

1.733

0.000

0.713

/

/

/

a
Noa

AT3异常
AT3Exception

1.600

20.000

0.963

/

/

/

a
Noa

INR2
INR<2

1.400

20.000

1.069

/

/

/

a
Noa

HAS-BLED评分3
HAS-BLEDRating3points

1.400

13.333

1.037

/

/

/

a
Noa

心烦
Distressed

1.267

0.000

0.887

/

/

/

a
Noa

脉细
Thin pulse

1.267

0.000

0.933

/

/

/

a
Noa

同型半胱氨酸升高
Elevated homocysteine levels

1.200

13.333

1.186

/

/

/

a
Noa

CRP升高
CRPincreased

1.200

13.333

1.147

/

/

/

a
Noa

注:*为最终纳入诊断量表的条目;a为第剔除的条目;b为第剔除的条目;/代表条目未进入此轮评分
Note:*Items included in the final diagnosis scale;a refers to items removed in the first round;b refers to items removed in the second round;/ represents items not included in this round of scoring.

2气虚病理因素诊断条目筛选结果
(2)Diagnosis entry screening results for Qi deficiency pathological factors

一轮问卷调查后剔除的理化指标“HAS-BLED评分≤2分”,第二轮专家重新给出了较高的评价,结合研究小组研讨,决定在第二轮继续咨询。经过两轮专家咨询,剔除的条目为:心电图诊断、脉细、舌有齿痕、胸闷、头晕、心胸隐痛、脉结、脉代、面白、BNP正常、LVEF值正常、左心房内径正常;最终纳入诊断量表的条目为:气短、神疲乏力、心悸不安、少气懒言、动则加重、脉弱、舌淡、自汗、脉虚、苔白、CHA2DS2-VASc评分≤2分、HAS-BLED评分≤2分。气虚病理因素诊断条目筛选流程及结果见表3
After the first round of the questionnaire survey, the eliminated physical and chemical indicators “HAS-BLED score ≤2 points,” in the second round the experts gave a higher evaluation again, and combined with the research group discussion, it was decided to continue consulting in the second round. After two rounds of expert consultation, the eliminated items were: electrocardiogram diagnosis, thin pulse, tongue with tooth marks, chest tightness, dizziness, chest pain, pulse knot, pulse replacement, pale face, BNP normal, LVEF value normal, left atrial diameter normal; the final items included in the diagnostic scale were: shortness of breath, fatigue, palpitations, reluctance to speak, worsening with activity, weak pulse, pale tongue, spontaneous sweating, weak pulse, white coating, CHA2DS2-VASc score ≤2 points, HAS-BLED score ≤2 points. The selection process and results of the diagnostic items for Qi deficiency pathological factors are shown in Table 3.

3 气虚病理因素诊断条目筛选结果
Table3Qi DeficiencyPathological Factors Diagnosis Entry Screening Results

条目
Entry

第一轮(15人)
First round (15people)

第二轮(10人)
Second round (10people)

是否纳入
Whether to include

综合权重
Comprehensive Weight

整数权重
Integer weight

均数
Average

满分比(%
Full score ratio (%)

变异
Mutation

系数
Coefficient

均数
Average

满分比(%
Full score ratio (%)

变异
Mutation

系数
Coefficient

气短*
Shortness of breath*

3.867

86.667

0.088

3.800

80.000

0.105

0.098

10

心悸不安*
Palpitations and restlessness*

3.667

80.000

0.191

3.400

60.000

0.235

0.091

9

神疲乏力*
Fatigue and exhaustion*

3.533

73.333

0.290

3.800

80.000

0.105

0.093

9

少气懒言*
Few words and lazy speech*

3.400

46.667

0.180

3.600

60.000

0.136

0.089

9

心电图诊断
Electrocardiogram Diagnosis

3.333

66.667

0.341

3.100

70.000

0.509

b
Nob

动则加重*
Increased weight when in motion*

3.200

60.000

0.415

3.600

60.000

0.136

0.086

9

自汗*
spontaneous sweating*

3.133

46.667

0.347

3.300

40.000

0.194

0.082

8

舌淡*
pale tongue*

3.133

33.333

0.229

3.400

40.000

0.144

0.083

8

脉弱*
Weak pulse*

3.067

40.000

0.346

3.500

50.000

0.143

0.083

8

脉虚*
Weak pulse*

3.000

46.667

0.439

3.300

50.000

0.237

0.080

8

脉细
Thin pulse

2.933

40.000

0.403

3.000

50.000

0.422

b
Nob

苔白*
Moss White*

2.867

20.000

0.334

3.200

30.000

0.188

0.077

8

舌有齿痕
The tongue has teeth marks

2.800

26.667

0.396

2.400

10.000

0.464

b
Nob

CHA2DS2-VASc评分2*
CHA2DS2-VASc score2 points*

2.667

40.000

0.524

3.100

30.000

0.268

0.073

7

胸闷
Chest tightness

2.600

26.667

0.462

2.900

40.000

0.360

b
Nob

头晕
Dizziness

2.200

13.333

0.580

/

/

/

a
Noa

HAS-BLED评分2*
HAS-BLEDRating2points*

2.133

20.000

0.637

3.000

30.000

0.298

0.064

6

心胸隐痛
Chest discomfort

2.067

6.667

0.624

/

/

/

a
Noa

脉结
Pulse knot

2.067

20.000

0.672

/

/

/

a
Noa

脉代
Pulse deficit

2.000

20.000

0.730

/

/

/

a
Noa

面白
Interesting

1.933

6.667

0.581

/

/

/

a
Noa

BNP正常
BNPNormal

1.333

6.667

1.049

/

/

/

a
Noa

LVEF值正常
LVEFvalue is normal

1.333

6.667

1.049

/

/

/

a
Noa

左心房内径正常
The left atrial diameter is normal

1.200

6.667

1.106

/

/

/

a
Noa

注:*为最终纳入诊断量表的条目;a为第剔除的条目;b为第剔除的条目;/代表条目未进入此轮评分
Note:*Items included in the final diagnosis scale;a refers to the first round of item removal;b refers to the second round of item removal;/ represents items not included in this round of scoring

3阴虚病理因素诊断条目筛选结果
(3)Diagnosis item screening results for Yin deficiency pathological factors

一轮问卷调查后剔除的理化指标“全血粘度升高”,第二轮专家重新给出了较高的评价,结合研究小组研讨,决定在第二轮继续咨询。经过两轮专家咨询,剔除的条目为:脉数、心电图诊断、多梦、失眠、形体消瘦、脉促、耳鸣、大便干、腰膝酸软、脉结、头晕、脉代、胸闷、心胸隐痛、甲状腺功能异常;最终纳入诊断量表的条目为:潮热或五心烦热、舌红、少苔、心悸、盗汗、脉细、口干、心烦、红、静息心室率≥110bpm、全血粘度升高阴虚病理因素诊断条目筛选流程及结果见表4
After the first round of the questionnaire survey, the physicochemical indicator “increased whole blood viscosity” was excluded, but in the second round the experts gave a higher evaluation again, and combined with the research group discussions, it was decided to continue consulting in the second round. After two rounds of expert consultation, the excluded items were: pulse rate, electrocardiogram diagnosis, vivid dreams, insomnia, weight loss, rapid pulse, tinnitus, dry stool, lower back and knee soreness, pulse knot, dizziness, pulse replacement, chest tightness, chest pain, thyroid dysfunction; the final items included in the diagnostic scale were: hot flashes or five hearts heat, red tongue, little coating, palpitations, night sweats, thin pulse, dry mouth, irritability, flushed cheeks, resting ventricular rate ≥110 bpm, increased whole blood viscosity. The screening process and results for the diagnostic items of Yin deficiency pathological factors are shown in Table 4.

4 阴虚病理因素诊断条目筛选结果
Table4Yin DeficiencyPathological Factors Diagnosis Entry Screening Results

条目
Entry

第一轮(15人)
First round (15people)

第二轮(10人)
Second round (10people)

是否纳入
Whether to include

综合权重
Comprehensive Weight

整数权重
Integer weight

均数
Average

满分比(%
Full score ratio (%

变异
Mutation

系数
Coefficient

均数
Average

满分比(%
Full score ratio (%)

变异
Mutation

系数
Coefficient

心悸*
Palpitations*

3.867

93.333

0.129

3.600

80.000

0.222

0.102

10

舌红*
Red tongue*

3.800

80.000

0.105

3.700

80.000

0.173

0.102

10

潮热或五心烦热*
Heat sensation or five heart heat*

3.733

86.667

0.182

3.900

90.000

0.077

0.103

10

少苔*
Less moss*

3.733

80.000

0.154

3.800

90.000

0.158

0.102

10

盗汗*
Night sweats*

3.667

73.333

0.163

3.600

60.000

0.136

0.098

10

口干*
Dry mouth*

3.467

66.667

0.295

3.400

50.000

0.195

0.093

9

脉细*
Thin pulse*

3.467

53.333

0.178

3.600

60.000

0.136

0.095

10

脉数
Pulse count

3.400

53.333

0.209

2.600

20.000

0.428

b
Nob

心烦*
Anxious*

3.333

46.667

0.210

3.300

30.000

0.139

0.090

9

心电图诊断
Electrocardiogram Diagnosis

3.200

60.000

0.382

2.900

50.000

0.522

b
Nob

多梦
Many dreams

3.067

53.333

0.403

3.000

40.000

0.333

b
Nob

失眠
Insomnia