摘要
目的：
糖尿病在我国的发病率逐年升高,中医中药对糖尿病的治疗越来越受到人们的重视。中医辨证因症状繁多,且症状判定因周围环境、医生经验的不同而判断标准不一,造成临床辨证的不一致性。所以实现中医症状和证候的量化是中医现代化、标准化的首要任务。各种数学模型以其易量化、客观性、准确性等特点逐渐在中医量化领域受到广泛关注。因此本研究采用项目反应理论(IRT)与结构方程模型理论(SEM)对“动-定序贯八法”所提出的糖尿病证型进行核心症状的提取,并研究症状与证型以及证型间的关系,寻找糖尿病的核心病机,同时建立临床糖尿病患者的症状调查量表。
方法：
1.参照《中医临床诊疗术语——证候》部分所列举的征候,结合糖尿病患者的常见表现,建立“动-定序贯八法”症状调查量表进行临床病例搜集。
2.搜集广东省中医院自2012年2月至2013年1月内分泌门诊及病房的符合纳入标准的2型糖尿病患者,进行症状调查。
3.将搜集的症状资料运用EpiData3.1进行数据录入,运用经典测量理论(CTT)和项目反应理论(IRT)进行题目筛选,形成“动-定序贯八法”最终症状调查量表。并对量表进行信度、效度评价。
4.运用结构方程模型(SEM)对各证型最终保留题目进行验证性因素分析,寻找“动-定序贯八法”症状及证型间的结构关系,并对其关系进行量化。
成果：
1.本研究共搜集广东省中医院自2012年2月至2013年1月内分泌门诊及病房的符合纳入标准的2型糖尿病患者435例次,其中女性187例次,男性248例次。各证型分布规律为：肾虚证84例次,占19.3%；气阴两虚证299例次,占68.7%；肝气郁结证178例次,占40.9%；血分郁热证72例次,占16.6%；肺胃燥热证95例次,占21.8%；心神失养40例次,占9.2%；湿热内蕴证253例次,占58.2%；血脉瘀阻证187例次,43.0%。
2.运用CTT理论及IRT理论对题目进行删减,各证型最终保留题目为：肾虚证：健忘,耳鸣,腰膝酸软,尿频,小便淋漓不尽；气阴两虚证：疲倦、肢体乏力、自觉发热、自汗、盗汗、头晕、心悸、口干；肝气郁结证：情绪抑郁、喜叹息、胸胁或少腹胀闷窜痛、烦躁易怒；肺胃燥热证：自汗、口臭、牙龈肿痛、痰粘不易咯出、喉痒鼻燥、胃脘嘈杂、腹胀、胃脘隐隐灼痛、恶心反胃、嗳气；心神失养证：心悸、易惊；湿热内蕴证：身热不扬、头身沉重胀痛、胃／腹胀、恶心反胃、饥不欲食、胸闷不舒、腹泻,大便粘腻不爽；血脉瘀阻证：肢体麻木、月经血块、肢体疼痛。因血分郁热证内在一致性系数较低,测验信息特征曲线平缓,提示血分郁热证题目信度不高,无法对其证型进行量化。
3.运用SEM对各证型保留题目进行验证性因素分析,其CFI=0.711TLI=0.669SRMR=0.075RMSEA=0.08690%C.1=(0.081,0.090),显示假设模型与观察模型拟合度尚可。肾虚证各症状的因子负荷为：健忘(0.499),耳鸣(0.410),腰膝酸软(0.766),尿频(0.274),小便淋漓不尽(0.226),头部沉重胀痛(0.210)；气阴两虚证各症状的因子负荷为：疲倦(0.789)、肢体乏力(0.894)、自觉发热(0.246)、头晕(0.430)、口干(0.102)；肝气郁结证各症状的因子负荷为：情绪抑郁(0.552)、喜叹息(0.656)、胸胁或少腹胀闷窜痛(0.415)、烦躁易怒(0.429)、饥不欲食(0.256)、胸闷不舒(0.286)；肺胃燥热证各症状的因子负荷为：自汗(0.527)、口臭(0.518)、牙龈肿痛(0.462)、痰粘不易咯出(0.464)、喉痒鼻燥(0.575)、胃脘嘈杂(0.361),胃脘隐隐灼痛(0.214)；湿热内蕴证各症状的因子负荷为：身热不扬(0.350)、头身沉重胀痛(0.277)、口干(0.456)、饥不欲食(0.325)、胸闷不舒(0.175)、腹泻(0.331),大便粘腻不爽(0.423)；血脉瘀阻证各症状的因子负荷为：肢体麻木(1.000)、肢体疼痛(0.329)；心神失养与血分郁热因筛选后保留的题目较少未行SEM分析。
4.对最终形成的量表进行信度、效度评价。
信度分析方面：各证型的Cronbach's a系数为：肾虚证0.664；气阴两虚证0.720；肝气郁结证0.700；肺胃燥热证0.752；心神失养证0.682；湿热内蕴证0.693；血脉瘀阻证0.726。
效度分析方面：各证型预测准确率为肾虚证86%,气阴两虚证69.9%,肝气郁结证78.9%,肺胃燥热证81.8%,心神失养证91.0%,湿热内蕴证74.0%,血脉瘀阻证66.2%。SEM模型分析其CFI=0.711TLI=0.669SRMR=0.075RMSEA=0.08690%C.I=(0.081,0.090),提示结构效度尚可。
结论：
1.本研究参照《中医临床诊疗术语——证候》部分所列举的征候,结合糖尿病患者的常见表现,经过专家讨论,建立“动-定序贯八法”症状调查量表进行临床病例搜集,运用经典测量理论(CTT)和项目反应理论(IRT)进行题目筛选,形成最终量表。其最终量表的信度、效度较好。
2.运用结构方程模型(SEM)对症状与证型及各证型间的关系进行验证性因素分析,得出“动-定序贯八法”症状及证型间关系的结构模型,并对其关系进行量化。
3.结合CTT、IRT、SEM分析结果,得出“动-定序贯八法”所提出的八种证型的核心症状。(1)肾虚证型的核心症状为：腰膝酸软、健忘、耳鸣、尿频,淡红舌、薄白苔,脉沉、弱。(2)气阴两虚证型的核心症状为：肢体乏力、疲倦、头晕、自汗、舌红。(3)肝气郁结证型的核心症状为：喜叹息、情绪抑郁、胸胁或少腹胀闷窜痛、烦躁易怒,脉紧。(4)肺胃燥热证型的核心症状为：自汗、喉痒鼻燥、口臭、牙龈肿痛、痰粘不易咳出、胃脘嘈杂、苔薄黄。(5)心神失养证型的核心症状为：心悸、易惊。(6)湿热内蕴证型的核心症状为：身热不扬、口干、腹泻、大便粘腻、舌淡红,苔白腻、黄腻,脉滑。(7)血脉瘀阻证型的核心症状为：肢体麻木、月经血块、肢体疼痛,舌淡暗、偏暗、偏暗红、暗红,瘀斑。
4.依据SEM对“动-定序贯八法”所提出的八种证型分析可知,肾虚证与其他五个证型均有相关,肺胃燥热证与其他五个证型亦均有相关。肾虚与其他证型的相关度普遍高于肺胃燥热与其它证型的相关。。肾虚与肺胃燥热的相关最高,为0.767。6种证型间基本上均有相互影响,提示“动-定序贯八法”理论所提出的证型并非相互独立内在的,其之间亦有相互影响,相互联系,所以在运用该理论进行临床辨证时,要从整体出发,同时依据病人症状的严重程度及主要症状,判断其核心证候,从而把握其核心病机,依据核心病机,核心证候,进行临床药串配伍施治。
Objective
With the incidence of diabetes rising, the effect of traditional Chinese medicine in diabetes has great attention. But the variable symptoms and different diagnostic standards make the syndrome differentiation different. So the standartdization of syndrome differentiation of TCM is important. The characteristic of mathematical model is easy quantization, objectivity and accuracy, so it gets the extensive attention. The study uses Item Response Theory (IRT) and Structural Equation Model (SEM) to extract the key symptoms of the syndromes of diabetes, which proposed by dynamics-immobility-order-succession and eight therapies, to research the relation of symptoms and syndromes, to rsearch diabetic key pathogenesis, and to make the symptoms survey scale of diabetics in traditional chinese medicine.
Methods
1. By referencing and combining the usually symptoms of diabetes, making the scale of dynamics-immobility-order-succession and eight therapies.
2. The investigation proceeds in the type2diabetes which was the patients of endocrinology department of Guangdong province hospital of TCM from Feb2012to Jan2013.
3. Inputting the data by EpiData3.1, using CTT and IRT to screen the items, then making the final scale of dynamics-immobility-order-succession and eight therapies. Evaluating the reliability and validity of scale.
4. Using the confirmatory factor analysis of SEM analyses the final items, to research and quantitate the relation of symptoms and syndromes.
Result
1. the number of sample is435. In the sample, the number of females is187, male is248, the pattern of deficiency kidney is84(19.3%), the pattern of deficiency qi and yin is299(68.7%), the pattern of constrained liver qi is178(40.9%),the pattern of hot blood is72(16.6%), the pattern of dry-heat clogging the lung and stomach is95(21.8%),the pattern of deficiency nourishment heart is40(9.2%), the pattern of damp heat collecting inside is253(58.2%), the pattern of congealed blood is187(43.0%).
2. Screening the items by CTT and IRT. For the low Cronbach's a and smooth TCC, the pattern of hot blood can not be quantitated. The items of others as follow.the pattern of deficiency kidney is consist of forgetfulness, tinnitus, soreness and weakness of waist and knees, frequent micturition,urine leaching;the pattern of deficiency qi and yin is consist of tired, hypodynamia of limbs, feeling heating,spontaneous sweating, night sweating,dizziness, palpitation, dryness in the mouth;the pattern of constrained liver qi is consist of depression, sigh,fullness and pain in the hypochondrium or lateral lower abdomen, being irritable;the pattern of dry-heat clogging the lung and stomach is consist of spontaneous sweating, bad breath, swelling and aching of gum, sticky phlegm, dry itchy nose and pharynx, gastric noisy, abdominal distension,gastral dull burn pain, nausea, belching;the pattern of deficiency nourishment heart is consist of palpitation, being easily scared; the pattern of damp heat collecting inside is consist of hiding fever, headache and heavy,abdominal distension, nausea, hunger without desire to eat, chest tightness, diarrhea,watery faeces;the pattern of congealed blood is consist of numb limbs,gores in the menses, limb pain.
3. Analyzing the items by confirmatory factor analysis of SEM. The result is CFI=0.711TLI=0.669SRMR=0.075RMSEA=0.08690%C. I=(0.081,0.090). It confirms that the hypothetic model has a mediocre fit. The factors loading of the pattern of deficiency kidney are forgetfulness(0.499), tinnitus(0.410), soreness and weakness of waist and knees (0.766), frequent micturition(0.274),urine leaching(0.226), headache and heavy (0.210);The factors loading of the pattern of deficiency qi and yin are tired(0.789), hypodynamia of limbs(0.894), feeling heating(0.246), dizziness(0.430), dryness in the mouth(0.102);The factors loading of the pattern of constrained liver qi are depression(0.552), sigh(0.656),fullness and pain in the hypochondrium or lateral lower abdomen (0.415), being irritable(0.429), hunger without desire to eat (0.256), chest tightness (0.286);The factors loading of the pattern of dry-heat clogging the lung and stomach are bad breath(0.518), swelling and aching of gum(0.462), sticky phlegm(0.464), dry itchy nose and pharynx(0.575), gastric noisy(0.361), spontaneous sweating (0.527), gastral dull burn pain(0.214);The factors loading of the pattern of damp heat collecting inside are hiding fever(0.350), headache and heavy(0.277), dryness in the mouth (0.456).hunger without desire to eat(0.325), chest tightness(0.175), diarrhea (0.331),watery faeces (0.423); The factors loading of the pattern of congealed blood are numb limbs (1.000), limb pain (0.329). The pattern of hot blood and the pattern of deficiency nourishment heart don not make SEM analysis, for the small amount of items.
4. Evaluating the reliability and validity of scale.
Reliability:Cronbach's a of the pattern of deficiency kidney is0.664, the pattern of deficiency qi and yin is0.720, the pattern of constrained liver qi is0.700,the pattern of dry-heat clogging the lung and stomach is0.752, the pattern of deficiency nourishment heart is0.682, the pattern of damp heat collecting inside is0.693,the pattern of congealed blood is0.726.
Validity:forecasting accuracy of each patterns as follow:the pattern of deficiency kidney is86%, the pattern of deficiency qi and yin is69.9%,the pattern of constrained liver qi is78.9%, the pattern of dry-heat clogging the lung and stomach is81.8%, the pattern of deficiency nourishment heart is91.0%,the pattern of damp heat collecting inside is74.0%, the pattern of congealed blood is66.2%. the SEM result is CFI=0.711TLI=0.669SRMR=0.075RMSEA=0.08690%C.I=(0.081,0.090), which confirm the construct validity is mediocre
Conelusion
1. By referencing and combining the usually symptoms of diabetes, making the scale of dynamics-immobility-order-succession and eight therapies. After screening the items using CTT and IRT, making the final scale. The reliability and validity of scale are good.
2. Using the confirmatory factor analysis of SEM analyses the final items, to research and quantitate the relation of symptoms and syndromes.
3. Referencing the results of CTT, IRT and SEM, getting the key symptoms of the eight syndromes proposed by dynamics-immobility-order-succession and eight therapies.(1) The key symptoms of the pattern of deficiency kidney are soreness and weakness of waist and knees, forgetfulness, tinnitus, frequent micturition, pink tongue, thin and whitish tongue coating, deep or weak pulse.(2) The key symptoms of the pattern of deficiency qi and yin are hypodynamia of limbs, tired, dizziness, spontaneous sweating, and red tongue.(3) The key symptoms of the pattern of constrained liver qi are sigh, depression, fullness and pain in the hypochondrium or lateral lower abdomen, being irritable, tense pulse.(4) the key symptoms of the pattern of dry-heat clogging the lung and stomach are spontaneous sweating, dry itchy nose and pharynx, bad breath, swelling and aching of gum, sticky phlegm, gastric noisy, think and yellow tongue coating.(5) The key symptoms of the pattern of deficiency nourishment heart are palpitation, being easily scared.(6) The key symptoms of the pattern of damp heat collecting inside are hiding fever, dryness in the mouth, diarrhea, watery faeces, pink tongue, white or yellow and greasy tongue coating, slippery pulse.(7) the key symptoms of the pattern of congealed blood is consist of numb limbs, gores in the menses,limb pain, dinginess or litter darkness or dark red or litter dark red tongue, ecchymosis on tongue.
4. From the results of SEM, we can recognize that the pattern of deficiency kidney is related to other patterns, the pattern of damp heat collecting inside also. The degree of correlation in the pattern of deficiency kidney with others is higher than the pattern of damp heat collecting inside with others. The degree of correlation in the pattern of deficiency kidney with the pattern of damp heat collecting inside is the highest. The correlation in the six syndromes point that the syndromes are not independent proposed by dynamics-immobility-order-succession and eight therapies. So when using the theory, we should own the whole concept, hold the key syndrome and key pathogenesis.
引文
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