摘要
背景中医药治疗甲状腺功能正常的桥本甲状腺炎疗效日益显著,在当前病证结合的诊疗模式下,中医证候疗效评价是最能体现中医药优势的评价指标,但目前大多数临床研究仍缺乏定量化、标准化的证候疗效评定方法。目的初步研制甲状腺功能正常的桥本甲状腺炎证候疗效评价量表。方法研究时间为2023年8—12月。依据国际量表的研制方法,以中医理论为指导,构建量表的理论框架,在文献检索和课题组前期临床调查的基础上建立量表初始条目池,采用主观筛选法中的德尔菲专家咨询法,结合客观筛选法中的条目分布考察法、离散趋势法、克朗巴赫α系数法和相关系数法,对条目进行筛选。结果两轮专家咨询均回收有效问卷22份,共44份,专家积极系数为95.83%、100.00%,专家权威系数为0.827、0.831,筛选得到重要性评分较高的8个证素及具有疗效评价属性的71个四诊信息条目。临床调查共回收有效问卷369份,综合4种数理统计方法结合专家小组讨论,删除气滞证5个条目,气虚证4个条目,痰证3个条目,阴虚证8个条目,血瘀证3个条目,阳虚证6个条目,火(热)证5个条目,血虚证2个条目,初步形成包含8个证素、51个四诊信息条目的甲状腺功能正常的桥本甲状腺炎证候疗效评价量表,其中气滞证9个条目,气虚证10个条目,痰证8个条目,阴虚证9个条目,血瘀证5个条目,阳虚证13个条目,火(热)证8个条目,血虚证8个条目。结论本研究初步研制出甲状腺功能正常的桥本甲状腺炎证候疗效评价量表,可为下一步条目的量化提供依据,并为此类量表的编制提供了可借鉴的方法。
Background The efficacy of traditional Chinese medicine(TCM)on the treatment of Hashimoto thyroiditis with normal thyroid function is increasingly pronounced.Under the current diagnosis and treatment mode combining both the disease itself and the relevant syndrome,TCM syndrome evaluation serves as an evaluation index that superiorly reflects the advantages of TCM.However,most clinical studies lack quantitative and standardized evaluation methods for the efficacy of TCM syndromes.Objective To preliminarily develop a TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function.Methods The study period was from August to December 2023.Guided by the TCM theory and international scale development methods,a theoretical framework for developing a TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function was established.An initial scale item pool was generated through literature review and preliminary clinical surveys by the research team.Items were refined using a combination analysis of subjective selection via the Delphi method and objective selection methods of item distribution,dispersion trends,Cronbach's alpha coefficient,and correlation coefficient analyses.Results A total of 22 valid questionnaires were collected in both rounds of expert consultation,making a total of 44 valid questionnaires,with the participation rate of 95.83%and 100.00%,respectively,and authority coefficient of 0.827 and 0.831,respectively.Eight key syndromes and 71 diagnostic information items associated with TCM syndrome evaluation were screened.A total of 369 valid questionnaires were collected from clinical surveys.Through the integration of four mathematical statistical methods and discussions with the expert panel,5 items for Qi stagnation syndrome,4 for Qi deficiency syndrome,3 for Phlegm syndrome,8 for Yin deficiency syndrome,3 for Blood stasis syndrome,6 for Yang deficiency syndrome,5 for Fire(Heat)syndrome,and 2 for Blood deficiency syndrome were removed.A preliminary formation of the TCM syndrome evaluation scale for Hashimoto's thyroiditis in patients with normal thyroid function was yielded,containing 51 diagnostic items in eight syndromes:9 items for Qi stagnation syndrome,10 for Qi deficiency syndrome,8 for Phlegm syndrome,9 for Yin deficiency syndrome,5 for Blood stasis syndrome,13 for Yang deficiency syndrome,8 for Fire(Heat)syndrome,and 8 for Blood deficiency syndrome.Conclusion This study has preliminarily developed a TCM syndrome evaluation scale for Hashimoto's thyroiditis with normal thyroid function,laying a foundation for the quantification of items and providing a methodological reference for the development of relevant scales.
作者
马文源
祁烁
商建伟
陈晓珩
李哲
李会龙
户蕊
李璐
司新颖
丁治国
MA Wenyuan;QI Shuo;SHANG Jianwei;CHEN Xiaoheng;LI Zhe;LI Huilong;HU Rui;LI Lu;SI Xinying;DING Zhiguo(Department of Thyroid,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Thyropathy Hospital,Sun Simiao Hospital,Beijing University of Chinese Medicine,Tongchuan 727100,China)
出处
《中国全科医学》
北大核心
2025年第28期3590-3600,共11页
Chinese General Practice
基金
陕西省中医药管理局双链融合项目(2022-SLRH-LJ-005)
陕西省中医药管理局项目(SZY-NLTL-2024-031,SZY-KJCYC-2023-074)
陕西省科技厅重点研发计划项目(2023-ZDLSF-56)。
关键词
桥本甲状腺炎
甲状腺疾病
甲状腺功能正常
症状体征和证候
证候疗效评价
疗效评价量表
专家咨询
条目筛选
Hashimoto's thyroiditis
Thyroid diseases
Normal thyroid function
Signs and TCM syndromes
Syndrome efficacy evaluation
Efficacy evaluation scale
Expert consultation
Item screening
