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糖尿病肾病的中医证候学研究
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摘要
目的
     为了探索糖尿病肾病(DiabeticNephropathy,DN)中医证候规律,以及不同证候和性别、年龄、实验室指标的相关性,对揭示中医证候的本质做有意义的工作。
     方法
     本研究是“973”国家重点基础研究发展计划课题—中医防治慢性肾功能衰竭临床方法的系统生物学研究(任务书编号:2005CB523503)的部分内容。
     本项研究由前瞻性研究、回顾性研究、专家问卷三部分构成。后两部分是辅助性部分,其研究的结果,是和文献研究、专家意见一起,为前瞻性研究的调查表制作、及证候学研究提供信息;前瞻性研究是主体部分,在制定调查表后,按照课题组统一制定的调查表对糖尿病肾病患者进行调查,采集北京中医药大学东直门医院等4家参研单位符合纳入标准的糖尿病肾病患者的一般情况、中医四诊信息以及相关的实验室检查结果。采用资料完整的病例。采用聚类分析、主成分分析和探索性因子分析对中医证型的分布规律进行分析和归纳;采用典型相关分析对多项实验室指标与多种中医证型的相关性进行研究和分析,探索确立公认的、科学的与中医证型相关的现代医学指标群。
     回顾性研究以东直门医院等三家单位,纳入标准的糖尿病肾病患者的一般情况、中医四诊信息,采用资料完整的病例,分析、归纳其中的中医症状,探索该病中医症状组成和证候的分布规律;专家问卷,由国内该领域的知名专家组成专家组,对问卷亲自填写,最后收集问卷对结果行分析,以补充回顾性的资料,为建立此次研究的调查表提供信息。
     结果
     我们对糖尿病肾病传统证候学研究时发现该病Ⅲ期患者以阴虚、气虚为主要表现;Ⅳ期患者证候以气虚、阴虚为主要表现;Ⅴ期患者则以气虚、阳虚为主要表现,可以看出阴虚、气虚到阳虚是糖尿病肾病的发展趋势,且三期均存在气、阴、阳虚的本虚证候,和痰湿和血瘀的标实证候。
     本次研究发现,该病单纯的虚证、单纯的实证极少,Ⅲ期中虚实夹杂66例,占86.4%,Ⅳ期虚实夹杂102例,占93.6%,Ⅴ期中虚实夹杂55例,占100%,其中主要是三证以上的虚实证型组合,体现了本病病情的复杂性。
     聚类分析、主成分分析和探索性因子分析结果基本符合证候调查表涉及的中医证候,由此从数理学角度反证了气、血、阴、阳虚证以及夹杂痰湿(湿浊)、血瘀证是糖尿病肾病重要因素。典型相关分析显示气虚证、阴虚证与和肌酐有密切关系。
     结论
     1.糖尿病肾病患者早期以气虚证、阴虚证为主要临床表现,而到了后期则主要以气虚、阳虚证、湿浊的临床表现为主了;作为标实证候的痰湿证和血瘀证则贯穿在整个疾病的发展过程中,这和传统认为的糖尿病及其并发证的病机是吻合的。该病病机复杂,证候虚实夹杂。由此也验证了吕仁和教授提出的以“正虚定证型,邪实定证候”的辨证思路和“活血化瘀,软坚散结”治法的科学性。
     2.通过采用聚类分析、主成分分析和探索性因子分析,从数理学角度验证了数位该病研究领域知名专家的临床经验。提示我们根据临床流行病学原理和方法,严格按DME进行设计的证候学研究,将专家经验作为对照的“金标准”进行临床验证是可行的。
     3.典型相关结果提示了该病“本虚标实”,“因虚致实”的病机特点,体现了吕仁和教授提出的糖尿病肾病“虚损、劳、衰”的病理进程。
     4.采用如聚类分析、探索性因子分析、典型相关分析等常见的降维统计学方法进行证候学研究具有一定的意义。
     5.前瞻性研究的结果与回顾性研究、专家问卷的结果是相符的,这说明回顾性研究、反复的征询专家意见是证候学研究的获得正确结果的基础,是证候学研究非常重要的部分,是制定调查表和证候学研究的必需。
Objective
     To discuss the TCM syndrome pattern of diabetic nephropathy, and the relativity ofdifferent TCM syndrome with sex, age and laboratory indices, so as to explore the characterofTCMsyndrome.
     Methods
     This research is part of program 973 grant (No.2005CB23503)from the Ministry ofScience and Technology to P.L—the systematic biology research of clinic methodology inpreventingandtreatingchronicrenalfailurebyTCM.
     This research is composed of prospective study, retrospective study and specialistquestionnaire, of which the most principal is the prospective study. The results of theretrospective study and the specialist questionnaire, together with literature consultation andspecialist opinion, are the basic of the questionnaire and the TCM syndrome study.Theresearch proceeds with the questionnaire of diabetic nephropathy established according to taskgroup. The included DN patients were all from Dongzhimen Hospital affiliated to Beijinguniversityof Chinese Medicine and three other units of the study. The general conditions, fourdiagnostic information of TCM and relative laboratory indices of patients with completeinformationwerecollected.
     Themethodsofclusteringanalysis,principalcomponentanalysisandfactoranalysiswereadopted to analyse and sum up the distribution of TCM syndrome. The canonical correlationanalysis was adopted to analyse the relativity of the laboratory indices with different TCMsyndromes, so as toestablish agenerallyaccepted, scientificlaboratoryindices relatedtoTCMsyndrome.
     The retrospective study was conducted in Dongzhimen Hospital affiliated to Beijinguniversity of Chinese Medicine. The general conditions, four diagnostic information of TCMof enrolled patients with complete data were collected to analyse and sum up the TCMsyndrome and explore the general law of the distribution of symptomes and syndromes of DN.The questionnaires were filled up by twenty-seven well-known Chinese specialists in person.The results were collected to serve as a compensatory material for the retrospective study andtoprovideinformationfortheconstructionofthequestionaire.
     Results
     The main syndromes of the patients in stage III (Mogenson ) DN are deficiency of Yinand deficiency of Qi, the syndromes of patients with stage IV DN are deficiency of and Qideficiencyof Yin; while for the stage V syndromes are mainlydeficiencyof and Qi deficiencyof Yang. Phlegm and dampness, stagnation of blood stasis are evenly distributed in the threestages of DN. The tendency of progressing from deficiency of Yin to deficiency of Qi andfinallydificiencyofyangisthemainprocedureofDN.
     This research also disclosed that there are rarely pure deficiency syndrome or pureexcessivesyndrome.Thereare66cases(86.4%)inthethirdstageDNwithcombinedsyndromeofdeficiencyandexcessiveness,and102cases (93.6%)instage IVand55cases(100%)instage Vrespectively,mostofwhicharethecombinationofmorethanthreesyndromes.
     The results of clustering analysis, principal component analysis and factor analysis areapproximately inaccordencewiththe7groupsofTCMsyndromeinquestionary,andprovedthat deficiency of Qi, deficiency of Xue, deficiency of Yin, deficiency of Yang, phlegm anddampness,dampnessandturbid,stagnationofbloodstasisarebasicTCMsyndromeelementindiabetic nephropathy. The results of canonical correlation analysis displayed that there arepertinencebetweenthedeficiencyofQiandScr,deficiencyofYinandScr.
     Conclusion
     1.The main TCM syndrome of DN patients in the early stage are deficiency of Qi,deficiency of Yin, and in the forth and the fifth stage of diabetic nephropathy are mainlydeficiencyofYang.TheTCMsyndromeofphlegmanddampness, stagnationofbloodstasisare in the whole procedure of DN, in accordence with the traditional TCM pathogenesis. Andthe pathogenesis of this disease is complicated, deficiencysyndrome accompanied with excesssyndrome.Theresultsprovedprofessorlv’sciencestandpoint.
     2.The results of clustering analysis, principal component analysis and factor analysis alsomanifested the several well-known experts’clinical experience, and hint us that according tothe clinical Epidemiology principle methods, proceeding the strictly designation of the TCMsyndrome research,then theexpert experiencebywayofthe goldstandard that checkedbytheclinicalverificationisviable.
     3.Theresults ofcanonical correlationanalysis indicatethat standpoint ofdeficiencyoftheprimary and excessive of the secondary, that standpoint of deficiency causing excessive;alsoindicatethatprofessorLv’sstandpointthatpathologicaldevelopmenttrendis“XuShun、Lao、Shuai”inDN.
     4. The results of clustering analysis, canonical correlation analysis, principal componentsanalysisandfactoranalysishavedefinitesignificationinTCMsyndromeresearch.
     5.Theresultofprospective study is consistent with the resultof retrospective study and thespecialist questionnaire, showingthat retrospectivestudyandthespecialist questionnaireis thebasisforgainingrightresult,andisabsolutelyanecessarypartofTCMsyndromestudy.
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