【作者】 庞秋华；

【导师】 王小云；

【作者基本信息】 广州中医药大学 ， 中医妇科学， 2009， 博士

【摘要】 研究目的:本研究以绝经综合征为疾病载体进行中医药疗效评价方法学的探讨。在中医理论指导下,立足于中医学基本特点和优势,引入和应用内容分析法、心理测量学、临床流行病学和循证医学等科研方法,建立符合中医诊疗特色的绝经综合征病证评定量表,把不同证型模块整合到评定量表中,以期客观评价中医药的临床疗效。研究方法及内容:研究内容及方法:在国家科技部“十五”攻关项目研制的绝经综合征评定量表(CMRS)基础上针对绝经综合征病证特点,引入内容分析法,对绝经综合征中医辨证分型文献进行初步研究,归纳分析绝经综合征的主要证型,提取主症及次症等组成证型模块,将其整合到既往研究绝经综合征评定量表中,初步形成绝经综合征病证评定量表的条目池,形成具有辨证内涵的绝经综合征疗效评价量表的初步理论模型。选择小样本绝经综合征患者进行预调查,对调查结果采用条目分布考察法、相关分析法、t检验法、分辨力系数法等考察量表条目敏感性、重要性、代表性和区分性,使之能够更好地反应临床疗效。主要研究结果:1.基于内容分析法对绝经综合征证型研究(1)证型归纳的结果纳入研究的教材、专著、期刊文献共111篇。在所有的文献中初步采集到的各种按照不同术语表述的证型有74个。应用内容分析法,根据证候的命名和证候的分类原则,将证型本质相同而表述名称不同的证型合并后得到36个证型。对这36个证型在111篇文献中出现的频数和频率进行统计分析,频率大于25%的证型有6个:肾阳虚73.87%;肾阴虚65.77%,肾阴阳两虚46.85%,心肾不交36.64%,肝肾阴虚36.04%,脾肾阳虚28.83%。对以上的6个证型的证素的应用内容分析法进行定量统计分析。绝经综合征常因脏腑功能失调出现痰湿、瘀血、气郁等兼夹证,本研究中肝郁频率为21.62%,痰湿阻滞8.11%,气滞血瘀8.11%。(2)绝经综合征的证候模块在中医的理论中,人体是一个整体,阴阳是整体中的最基本的两个属性,阴阳平衡是健康的基本要求。绝经综合征出现率大于25%的6个证型中,可按照阴阳属性其分为三个证候模块。肾阴虚、肝肾阴虚、心肾不交具有阴虚的共性,组成阴虚模块;肾阳虚、脾肾阳虚具有阳虚的共性,组成阳虚模块,肾阴阳两虚为阴阳两虚模块。2.基于内容分析法对绝经综合征证素的研究(1)肾阳虚证111篇文献中,有65篇文献包括肾阳虚证的详细证素描述,共40个证素。频率大于50%的证素有9个,分别为畏寒肢冷(96.92%),舌淡(86.15%),小便清长或夜尿频多(86.15%),精神萎靡(78.46%),面浮肢肿(73.85%),便溏(70.77%),面色晦黯(69.23%),腰腹冷痛(61.54%),脉沉细无力(58.46%)。(2)肾阴虚证有62篇文献包括肾阴虚证素的详细描述,共35个证素。频率大于50%的证素有14个证素,分别为舌苔少(96.77%),潮热汗出(96.77%),舌质红(95.16%),头晕(93.55%),脉细数(91.94%),五心烦热(91.94%),耳鸣(90.32%),腰膝酸软(83.87%),经色鲜红(62.90%),大便干结(61.29%),口干(58.06%),皮肤干痒(56.45%),尿少色黄(53.23%),失眠多梦(51.61%)。心烦易怒(35.48%),阴部干涩(13,20.97%),健忘(8,12.90%)。(3)肾阴阳两虚证:共38篇文献包括肾阴阳两虚证素的详细描述,共38个证素。频率大于50%的证素共7个,分别为耳鸣(38,100.00%),头晕(38,100.00%),潮热汗出(27,71.05%),畏寒(25,65.79%),舌淡(23,60.53%),腰膝酸软(23,60.53%),苔薄(20,52.63%)。(4)心肾不交证:共34篇文献包括心肾不交证素的详细描述,分为34个证素。频率大于50%的证素共有10个,分别为失眠多梦(33,97.06%),舌红(31,91.18%),心悸怔忡(29,85.29%),脉细数(27,79.41%),烦躁易怒(27,79.41%),健忘易惊(25,73.53%),心烦不宁(22,64.71%),苔少(19,55.88%),腰膝酸软(18,52.94%),头晕耳鸣(17,50.00%)。(5)肝肾阴虚证:有23篇文献包括肝肾阴虚证素的详细描述,共38个证素。频率大于50%的证素共12个,分别为头晕(23,100.00%),舌红(22,95.65%),苔少(21,91.30%),耳鸣(19,82.61%),潮热汗出(18,78.26%),腰膝酸软(17,73.91%),五心烦热(17,73.91%),脉细数(14,60.87%),口干(14,60.87%),失眠多梦(13,56.52%),烦躁易怒(13,56.52%),便秘(12,52.17%)。(6)脾肾阳虚证有20篇文献包括脾肾阳虚证素的详细描述,共40个证素。频率大于50%的证素共有10个,分别为便溏(19,95.00%),纳呆(18,90.00%),面浮肢肿(16,80.00%),畏寒肢冷(14,70.00%),腰背冷痛(13,65.00%),神疲乏力(12,60.00%),脉沉细(10,50.00%),苔薄白(10,50.00%),舌淡胖有齿印(10,50.00%),夜尿频多(10,50.00%)。(7)肝郁证有17篇文献包括肝郁证证素的详细描述,共33个证素。频率大于50%的证素共有7个,分别为精神抑郁多愁易怒(17,100.00%),胁肋胀痛(16,94.12%),苔薄黄(11,64.71%),舌红(11,64.71%),潮热汗出(11,64.71%),胸闷叹息(11,64.71%),苔薄白(9,52.94%)。(8)气滞血瘀证有7篇文献包括气滞血瘀证素的详细描述,共29个证素。舌质紫黯或有瘀斑的出现率最高(5,71.43%),周身刺痛(3,42.86%)、胸胁刺痛(3,42.86%)、胸闷痹痛(3,42.86%)出现频率也较高。(9)痰湿阻滞证有5篇文献包括痰湿阻滞证素的详细描述,共20个证素。苔厚腻湿滑(5,60.00%)的出现率较高,颜面浮肿(5,100.00%)出现率高。不同证型的证素不尽相同,同一个证素可见于多个证型中,各证素对该证型的重要性都不同。本研究应用内容分析法对111篇绝经综合征文献的主要证型的证素进行了定性分析和定量统计,对各证型证素的频率进行排序,结合临床经验以及经过课题核心小组讨论后,主症主要提取自频率排前3位的证素中,次症主要提取自频率位于第4至第10位的证素中。3.绝经综合征主要证型及兼央证的主症和次症(1)肾阳虚证:主症3个,畏寒肢冷、小便清长或夜尿频多、精神萎靡;次症6个,面浮肢肿、便溏、腰腹冷痛、纳少、脘腹胀满、腰膝酸软。(2)肾阴虚证:主症有3个,潮热汗出、头晕、五心烦热;次症有7个,耳鸣、腰膝酸软、大便干结、口干、皮肤干痒、失眠多梦及心烦易怒。(3)肾阴阳两虚证:主症有3个,分别为耳鸣、头晕、潮热汗出;次症有4个,分别为畏寒、腰膝酸软、腰背冷痛和健忘。(4)心肾不交证:主症有3个,分别为失眠多梦、心悸、烦躁易怒;次症有5个,分别为健忘、腰膝酸软、头晕、耳鸣、潮热汗出。(5)肝肾阴虚证:主症有3个,分别为头晕、耳鸣、潮热汗出;次症有6个,分别为腰膝酸软、五心烦热、口干、失眠多梦、烦躁易怒、便秘。(6)脾肾阳虚证:主症有3个,分别为便溏、纳呆、面浮肢肿;次症有6个,分别为畏寒肢冷、神疲乏力、夜尿频多、脘腹胀满、头晕、腰膝酸软。(7)肝郁证:主症有2个,分别为精神抑郁多愁易怒和胁肋胀痛;次症有4个,分别为潮热汗出、胸闷叹息、失眠多梦、乳房胀痛。(8)气滞血瘀证:主症1个,为舌质紫黯或有瘀斑,次症2个,头胀痛、失眠多梦。(9)痰湿阻滞证:主症1个:颜面浮肿,次症4个,分别为潮热汗出、胸闷烦躁、头晕、苔厚腻湿滑。4.初步形成绝经综合征病证评定量表的模型该量表模型能体现中医证候类型及变化特点,能反映中医药治疗后患者自我感觉、生理功能、角色功能、心理健康等软指标的改变。结论:证候标准化和客观化,是建立客观规范的中医临床疗效评价体系的必要前提。对于中医药的疗效评价的研究,应该是在证候内涵的基础上进行。本研究通过结合既往流行性调查及绝经综合征证候文献研究结果,探索对绝经综合征证型的分类及证素的定性定量研究,对具有证候内涵的疗效评价量表条目进行更加规范化和科学化的研究,形成符合中医证候特点的绝经综合征病证评定量表模型。更多还原

【Abstract】 Purposes of Research:With the menopausalsyndrome to be a carrier,we try to explorate the methodology of the TCM evaluation of therapeutic efficiency.According to the theory of chinese medicine,basic on the characteristic and advantage of TCM, using content analysis method,psychometrics,clinical epidemiology and evidence based medicine,construct a rating scale of menopausal syndrome with disease and combinated syndrome which is consonant with the diagnosing and curate characteristics of TCM.we consider to bring different syndromes module to the rating scale,expect to evaluate the curative effect of TCM objectively.Research methods and content:Base on the Chinese Menopause Rating Scale(CMRS) which was construct in the "fifteenth" critical project of the National Science and Technology Development,we study the the Chinese Menopause syndromes literature with the TCM differentiation of symptoms and signs for classification of syndrome, using content analysis methods.Study Menopause syndromes literature which come from monograph,teaching material and medicine magazine with the differentation of every type syndromes of menopausal syndrome,sum up and analysis the main syndromes,extract the chief and secondary symptom to compose the symptom-complex module,and add them to the menopausal syndrome rating scale of disease and syndrom.The item pool of the rating scale is initial formation.The initial theory module of evaluate the TCM curative effect with differentiation of syndromes is constructed.We chose some menopausal syndrome patients to carry out the investigation in advance in the chinic.Inspect the senstinve,importantance,representation and distinguish using the surveying distribution of items methods,discrete method,correlational analysis method、t test method、resolving power coefficient method method and make it to reflect the curative effect well.Main results:1.Preliminary study on TCM literature relative to menopausal syndromes,using the content anylysis method.(1)The main syndromes of the menopausal syndrome.Totally 111 pieces of TCM literature relative to menopause syndrome were evolved in the study.There are 74 kinds of syndromes initially extract from all literatures.There are many syndromes which has the same essence but with different terminology name.According to the essence of the syndromes and the standard of differention of syndromes,we carry on the analysis of the 74 kinds syndromes and obtain 36 kinds of syndromes.We statistic the frequency of the 36 kinds of syndromes.There 6 syndromes whose frequency are higher than 25%.The kidney deficiency of yang syndrome appears 82 times(73.87%);73pieces literatures includ the kidney Yin deficient(65.77%);52 pieces literatures includ the kidney Yin and Yang deficiency(46.85%);44 pieces literatures includ type of failure of the heart and kidney integrating syndromes(36.64%);40 pieces literatures includ hepatic and renal yin deficiency(36.04%);32 pieces literatures includ the spleen kidney deficiency of yang(28.83%).We statistic the syndrome elements of the above syndromes using the content analysis,including the quantitative analysis and qualitative analysis.The menopause syndrome usually has companying with syndromes because the malfunction of zangfu organs.The main companying with syndromes are stagnation of liver-QI(21.62%),type of stagnation of phlegm-damp(8.11%)、qi-stagnancy and blood stasis(8.11%)。(2) the syndrom module of menopause syndromeThe general idea is the basic in TCM theory and the human body is a whole.Yin and Yang are the two basic attributes in the whole body.a balance of Yin and Yang is the basic request of the body health,we split the main 6 sundromes of menopause syndrome according to the Yin and Yang attributes. Deficiency of kidney-YIN、hepatic and renal yin deficiency and failure of the heart and kidney integrating make up of the Yin deficiency module;The kidney deficiency of yang、the spleen kidney deficiency of yang make up of the Yang deficiency module;the kidney Yin and Yang deficiency is in the Yin and Yang deficiency module.2.Study the syndrome elements of all kinds syndromes of MS using the content analysis method.(1) Kidney deficiency of yangThere are 65literatures describe the kidney deficiency of yang’ s syndrome elements,altogether 40 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,such as fear cold and member cold(96.92%);pale tongue(86.15%);clear abundant urineand Frequent urination at night(86.15%);listlessness(78.46%);swollenface and limbs(73.85%); loose stool(70.77%);laepcumx complexion(69.23%);waist abdomen cold pain (61.54%);deep or thready weak pulse(58.46%).(2) Deficiency of kidney-YINThere are 62 literatures describe the kidney Yin deficient’ s syndrome elements,altogether 35 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,14 syndrome elements in total, such as tongue coating few(96.77%);hectic fever and perspiration(96.77%); red tongue(95.16%);dizzy(93.55%);thready and rapid pulse(91.94%);burning sensation of five centres(91.94%);sibilismus aurium(90.32%);waist and knee acidum weak(83.87%);menses blood colour bright red(62.90%);constipation (61.29%);Dry mouth(58.06%);the skin itches dryly(56.45%).(3) The kidney Yin and Yang deficiencyThere are 38 literatures describe the kidney Yin and Yang deficiency’ s syndrome elements,altogether 38 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,7 syndrome elements in total, such assibilismus aurium(100.00%);dizzy(100.00%);hectic fever and perspiration(71.05%);hot and cold by turns(65.79%);pale tongue(60.53 %);waist and knee acidum weak(60.53%);tongue coating thinness(52.63 %)。(4) Failure of the heart and kidney integratingThere are 34 literatures describe the failure of the heart and kidney integratings syndrome elements,altogether 34 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,10 syndrome elements in total,such as insomnia and multi-dreams(97.06%);red tongue (91.18%);palpitation(85.29%);thready and rapid pulse(79.41%);perturbed and irritability(79.41%);loss of memory(73.5%);perturbed(64.71%),tongue coating few(55.88%),waist and knee acidum weak(52.94%),dizzy and sibilismus aurium(50.00%)。 (5) Hepatic and renal yin deficiencyThere are 23literatures describe hepatic and renal yin deficiency’ s syndrome elements,altogether 38 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,12 syndrome elements in total, such as dizzy(100.00%);red tongue(95.65%);tongue coating few(91.30 %);sibilismus aurium(82.61%);hectic fever and perspiration(78.26%); waist and knee acidum weak(73.91%);burning sensation of five centres(73.91 %);thready and rapid pulse(60.87%);Dry mouth(60.87%);insomnia and multi-dreams(56.52%);perturbed and irritability(56.52%);constipation (52.17%)。(6) The spleen and kidney deficiency of yangThere are 20 literatures describe the spleen kidney deficiency of yang’ s syndrome elements,altogether 40 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,loose stool(95.00%),bad appetite (90.00%),swollen face and limbs(80.00%);fear cold and member cold(70.00 %);weary and hypodynamia(60.00%);deep or thready pulse(50.00%);tongue coating thin and white(50.00%);pale tongue and imprints of the teeth(50.00 %);clear abundant urineand Frequent urination at night(50.00%)。(7) Syndrome of stagnation of liver-QIThere are 17 literatures describe stagnation of liver-QI’ s syndrome elements,altogether 33 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,deprementia or sensitivity sentimentality(100.00%);hypochondrium distending pain(94.12%);thin and yellow coating(64.71%);red tongue(64.71%);hectic fever and perspiration (64.71%).(8) Qi-stagnancy and blood stasisThere are 7 literatures describe qi-stagnancy and blood stasis’ s syndrome elements,altogether 29 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,1 syndrome elements in total, such aspurple toung or ecchymosis(71.43%).(9) Type of stagnation of phlegm-dampThere are 5 literatures describe type of stagnation of phlegm-damp’ s syndrome elements,altogether 20 syndrome elements.The syndrome elements whose frequency are bigger than 50%are as follows,2syndrome elements in total, such asthickly furred and Slippery Nipple(60.00%);swollen face and limbs (100.00%).Different syndroms’ element are different,a syndrome element may appear in many syndromes,every syndrome element has different importance to different syndromes.This research statistics the syndrome element using the qualitative analysis、quantitative analysis and the content analysis methods,sorting to every syndrome elements by the frequency of occurrence,according to the clinical experience,as well as after the topic core group discussion.Most chief symptomes come from the top three syndrome elements.Secondary symptomes come from the syndrome elements in the top ten.3.The chief symptomes and secondary symptomes of the main syndromes and accompanied with syndromes of the menopause syndromes.(1) The kidney deficiency of yangChief symptomes:fear cold and member cold:clear abundant urine and frequent urination at night:listlessness,secondary symptomes:swollen face and limbs;loose stool;cold pain in back and abdomen,bad appetite,epigastric distension and depression,waist and knee acidum weak.(2) Deficiency of kidney-YINChief symptomes:hectic fever and perspiration;burning sensation of five centres;dizzy;secondary symptomes:sibilismus aurium;waist and knee acidum weak;constipation;the skin itches dryly;Dry mouth;insomnia and multi-dreams; perturbed and irritability。(3) The kidney Yin and Yang deficiencyChief symptomes:dizzy;sibilismus aurium;hectic fever and perspiration; secondary symptomes:fear cold and member cold;waist and knee acidum weak, loss of memory,waist and psychroalgia.(4) Failure of the heart and kidney integratingChief symptomes:insomnia and multi-dreams;palpitation;perturbed and irritability;secondary symptomes:loss of memory;waist and knee acidum weak; dizzy;sibilismus aurium;hectic fever and perspiration;(5) Hepatic and renal yin deficiencyChief symptomes:dizzy;sibilismus aurium;hectic fever and perspiration; secondary symptomes:waist and knee acidum weak;burning sensation of five centres.(6) Syndrome spleen and kidney deficiency of yangChief symptomes:bad appetite;loose stool;swollen face and limbs; secondary symptomes:fear cold and member cold;weary and hypodynamia; clear abundant urine and frequent urination at night;abdominal distension; dizzy;waist and knee acidum weak.(7) Stagnation of liver-QIChief symptomes:deprementia or sensitivity sentimentality;hypochondrium distending pain;secondary symptomes:hectic fever and perspiration;chest feels tight and sigh;insomnia and multi-dreams,breast distending pain.(8) Qi-stagnancy and blood stasisChief symptome:purple toung or ecchymosis;secondary symptomes:distention and pain of head;insomnia and dreamful sleep.(9)Type of stagnation of phlegm-dampChief symptomes:puffiness of face;secondary symptomes:hectic fever and perspiration;chest distress and restlessness;dizzy;thickly furred and Slippery Nipple.4.Initially construct a model of menopausal syndrome rating scale of disease and syndromeThe rating scale model can reflect the change of the pattern syndromes and the syndrome characteristic,it can reflect the change of the soft indicator such as sensation of oneself、physiologic function、role function and mental health and so on.Conclusion:The syndromes shoule have standardization and the objectification,the standardization and the objectification of the syndromes are the basic of establishing the Chinese medicine clinical curative effect system.We should study the clinical curative effect of TCM basic on the syndromes.This research summarizes the syndromes in many literatures,reference the formerly epidemic investigation result,and study syndromes classifieation and syndrome elements using qualitative and quantitate analysis.Study the item with syndrome connotation standardizedly and scientificly.Construct a menopausal syndrome rating scale of disease and syndrome model which is consonant with the characteristics of TCM.更多还原