【作者】 林楚华；

【导师】 刘凤斌；

【作者基本信息】 广州中医药大学 ， 中医学， 2011， 博士

【摘要】 【目的】运用结构方程及项目反应理论研制基于辨证的中医功能性胃肠病量表。【方法】使用中医功能性胃肠病初量表收集临床病例,包括301例患者和61例健康人。通过文献复习,结合医家临床实践经验及诊疗规范意见,以中医基础理论及中医诊断学为指导,提出中医功能性胃肠病辨证的理论模型。模型将证型细化为9个证型：脾胃气虚证,肝郁证,气滞证,气逆证,寒证,湿证,热证,阴虚证,阳虚证,同时包括5条路径：肝郁气滞,脾虚湿阻,湿阻气滞,阴虚发热,阳虚则寒。因样本量较少,主要对脾胃气虚证,肝郁证,气滞证,湿证这4个证型进行分析。运用结构方程模型及项目反应理论筛选条目,筛选原则为：若条目的因子负荷及鉴别度低下,试题信息函数低平,则参考中医理论后可删除。运用结构方程模型对筛选后的辨证模型进行重新拟合,分析症状及证型的关系,证型及证型的关系；运用项目反应理论对各证型进行项目分析,得出各填表人的证型能力值(包括健康人,患者),及证型能力值和标准估计误的平均值,对能力值进行独立样本t检验,以考核其区分效度。[结果]通过结构方程模型及项目反应理论分析后,最终删除条目15条,包括：肝郁证的脉弦,湿证的苔腻,脉滑,苔滑,脾胃气虚证的自汗,喜按,舌齿痕,舌胖大,苔薄,白苔,脉细,淡红舌,脉缓,大便时干时烂,气滞证的拒按,共删除了37.5%的条目,最终模型拟合度良好(x2/DF=1.82,GFI=0.88,RMSEA=0.052),测验信息函数改变不大,达到了简化模型的目的。根据各症状的负荷值及鉴别度得出各证型的主症和次症,肝郁证主症：心情不好病情加重,消极感受,次症：胁部不适；湿证主症：身重、头重,次症：苔厚,腹泻；脾胃气虚证主症：体乏,懒言,口淡,饮食不慎加重病情,隐痛,次症：纳呆食少,易累,早饱,吐痰涎,大便先干后烂,便溏,气滞证主症：腹中重坠感,胀闷,便后不尽感,次症：排便不畅,胀痛,痛即欲泻,胸闷。结构方程模型的分析结果提示了功能性胃肠病疾病发展过程中证型转化的方向：郁证与气滞证、脾胃气虚证与湿证,湿证与气滞证之间的关系为直接效应,即前者证型程度越严重则后者证型程度将更严重。脾胃气虚证与气滞证之间的关系为间接效应,主要通过脾胃气虚导致湿证,湿证再影响气机导致气滞。湿证导致脾胃气虚并不明显,主要以脾胃气虚不能运化水湿致使湿阻为患,湿证未能反过来导致脾胃气虚。健康人及患者人群,在四个证型的证型能力值的均数t检验均为P<0.05,得分差别具有统计学意义,表明本模型有区分不同属性人群的能力,区分度良好。四个证型的估计标准误均值范围为0.0—0.4,四个证型的测验均具有良好的精确性。【结论】本量表是以功能性胃肠病的认识及临床经验为基础进行设计的,其条目分为主观条目(患者自评)及客观条目(医生评价),对临床症状的收集更全面,通过分析简化模型后量表更简洁全面。根据分析结果得到了各证型的主症及次症,证型转化关系,并形成了诊断规则,可更好地指导临床。中医辨证模型的拟合度良好,符合中医理论,证型程度能区分健康人及患者。中医功能性胃肠病辨证量表是具有良好的区分效度的疾病特异性量表,简单明了,易于接受,易于理解和实施,便于分析,可作为临床中医功能性胃肠病辨证分型的工具。更多还原

【Abstract】 ObjectiveThis study was designed to develop FGID-scale based on syndrome differentiation by using structural equation model (SEM) and item response theory (IRT) methods.MethodsData were collected by the primary scale functional gastrointestinal disorders scale (FGID-scale), which were from 301 FGID patients and 61 healthy people.The hypothetical model was constructed based on presented papers, clinical experience, diagnostic and treatment guide, basic theory of traditional Chinese medicine, clinical diagnosis of Chinese medicine, and so on. The model includes nine syndrome(qi deficiency, liver depression, qi stagnation, qi upward flow, cold syndrome, dampness syndrome, heat syndrome, yin deficiency, yang deficiengcy) and five paths (Stagnation of Qi due to depression of the liver, spleen deficiency with dampness retention, retention of dampness due to stagnation of QI, yin deficiency generating interior heat, yang deficiency leading to cold).SEM and IRT were used to shorten FGID-scale. Two criteria were used to filter items for shortening scales. One is factor loadings value, the other is item discrimination parameter value. If both values are low, the item information function curve is low and flat, the item can be deleted refer to basic theory of traditional Chinese medicine. SEM is used to analyze the shortened FGID-scale model, the relationship between symptoms and syndromes, and the relationship between syndromes and syndromes. IRT was used to analyze the syndromes, to predict the abilities(include patients and healthy people), the mean of the abilities and standard error of estimation. Analysis of abilities with t-test is used to evaluate the discriminant validity.Result15 items were delected in the end, including wiry pulse, dense tongue coating, slippery tongue coating, slippery pulse, spontaneous sweating, like push, like to be press, teeth-marked tongue, bulgy, thin coating, white coating, veinlet, pink tongue, infrequent pulse, dry and sloppy stool from time to time, dislike of press. The shortened FGID-scale model had a good fit(x2/DF=1.82, GFI=0.88, RMSEA=0.052). The test information function does not change much. The shortend model is simpler than the first one.According to the item’s factor loadings and the item discrimination parameter, the syndromes’s primary symptom and secondary symptom can be distinguished. For liver depression, primary symptom indicates that the worse the mood, the more serious the illness becomes, while the secondary symptom is the pain of hypochondrium. For dampness syndrom, primary symptom is heaviness sensation of the head and body, while the secondary symptom is thick coating and diarrhea. For qi deficiency, primary symptom includes lassitude, distinclination to talk, tasteless and insipid. Inadvertent dining results in worse illness, dull pain. Its secondary symptom includes anorexia, fatigue, easy to feel full, spit. Stool is dry and then sloppy, and chance to be loose. For qi stagnation, primary symptom marked includes abdominal heaviness, fullness, and stool tenesmus, while the secondary symptom includes difficult elimination, bursting, pain-leading diarrhea and chest distress.The more manifested the livers depressed is, the more stagnate the qi is. The more deficient the qi is, the more stagnate it is. The more manifested the dampness syndrome is, the more deficient the qi is. Deficient of qi results in manifestated dampness syndrome, and then influences the activities of qi, and qi stagnates. However, dampness syndrome cannot cause qi deficient.Analyzed the mean of patients and healthy people’s syndrome ability with t-test (P<0.05), the mean is statistically significant difference. It indicate the model have the ability to discriminate the patients and healthy people. The discriminant validity is good.ConclusionThe Traditional Chinese Medicine based on syndrome differentiation model has a good fit, conform the basic theory of traditional Chinese medicine the syndrome ability can discriminate the patients and healthy people. Traditional Chinese Medicine based on syndrome differentiation is a valid disease-specific instrument used for measuring the Traditional Chinese medicine curative effect.更多还原