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急性缺血中风“阴阳类证”临床辨证思维模式的初建与评价
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摘要
研究背景
     中风病严重危害人类健康,而缺血中风作为卒中的主要类型,是其高发病率、高死亡率、高致残率使其成为世界范围危害极大、亟待攻克的一种疾病。既往研究结果表明中医药可以明显降低急性中风患者的病死率和致残率,其独特优势在国际上也逐渐产生了一定的影响。但由于中风病因病机复杂,临床分型意见颇不一致,缺乏统一的辨证分型标准。因此,探求中风病辨证规律并对其进行规范化和标准化研究对中风病的治疗和研究有非常现实的意义。
     研究目的
     总结导师刘茂才教授以“阴阳类证”辨治中风病的学术思想。初步建立急性缺血中风“阴阳类证”临床辨证思维模式,使之更加符合缺血中风的临床实际,并在多中心大样本横断面证候调查中对其进行评价。
     研究方法
     1本临床研究部分分两个阶段完成,第一阶段横断面调查研究为证候规范部分前期研究,目的是初步构建急性缺血中风证候四诊采集表,并以八五攻关量化标准的六证型为金标准,并验证两者的符合率及一致性,为证候规范的进一步临床研究提供依据。第二阶段为扩大样本含量横断面调查研究,根据证候规范前期1252例研究统计分析结果,针对初稿中与专家经验不太符合或有歧义的部分,再次进行文献调研和专家咨询。对《缺血中风辨证规范(初稿)》四诊采集表内条目进行合并、补充、删除,编制《缺血中风辨证规范》四诊采集表,初步建立及评价急性缺血中风“阴阳类证”临床辨证思维模式。
     2第一阶段将缺血中风病急性期1252例患者按照“阴阳类证”临床辨证思维模式进行辨证,所有数据都采取了Access文档保存,此调查表可在计算机上实现,在进行软件开发时赋予了查询功能,并将“八五量表”的中风证型诊断分值赋予了此调查表中的条目,在完成数据的采集后可以直接查询各个证型的诊断结果,并且可以按照不同分级程度进行查询,如可查询风证≥7分的病例(≥7分可诊断)。并将阴虚阳亢、火热证归入阳类证,其中出现阴虚阳亢者归入阳类虚证,出现火热证但无阴虚阳亢者归入阳类实证;其他证型归入阴类证,其中有气虚证者归入阴类虚证,无气虚证者归入阴类实证,与“阴阳类证”临床辨证思维模式辨证四型辨证相比较,计算两者诊断的符合率及Kappa值。
     3第二阶段采用前瞻性横断面调查的方法,运用病症结合的中风病证候采集表对4077例缺血中风急性期患者进行中风病证候四诊信息采集,建立缺血中风病急性期数据库。以医学专业思维为先导,初步建立及评价中风病急性期“阴阳类证”临床辨证思维模式。
     研究结果
     1在证候规范部分前期研究中,全部患者1252例急性中风患者均按“阴阳类证”临床辨证思维模式辨证标准进行辨证(辨为阳类虚证、阳类实证、阴类虚证、阴类实证),并以八五攻关量化标准的六证型为金标准,分析得出聚类分析的结果表明,阳类证的诊断符合率为85.5%,阴类证的诊断符合率为91.5%。提示两种辨证方法具有较高的一致率,临床上按本课题提出的“阴阳类证”临床辨证思维模式辨证标准进行辨证具有较高的准确性。通过“八五量表”规范赋值后得出的诊断为阳类虚证患者(占30.5%)明显高于根据四诊信息采集平台采集后规范得到的结果(占19.1%);相反,通过前者诊断为“阳类实证”患者(占15.4%)明显低于后者(占24.8%);但两种诊断相加后诊断为“阳类证”的患者,前后两种方法得到的结果分别为45.9%、43.9%,基本上一致。而诊断为“阴类证”的结果前后两种方法对比(分别占52.7%和56.1%)也基本上一致。也进一步说明了根据四诊信息采集平台采集后规范辨证的结果是有相当的准确性的。
     2第一阶段证型探索分析:三个路标(火热证、阴虚证、气虚证)四诊指标与专家经验相比,总体符合率较高,但亦有不太一致者。如舌红、苔黄在诊断阳类证热象中权重最高符合经验诊断,但脉数在热象中权重较低,并出现舌偏斜、肢体迟纵不收、偏身麻木、口渴喜热饮等与热象关联不大或无关联的四诊指标。分析原因,其中舌偏斜、肢体迟纵不收、偏身麻木均为辨病四诊指标,故在四诊中出现频数较高,故而会影响统计结果,而有些指标如口渴喜热饮的出现可能与中风病证型复杂,临床多复合证为主,少见单证独立存在有关。有些热象四诊指标权重较轻,临床以气虚证、痰证、血瘀证为主,但按“阴阳类证”临床辨证思维模式辨证有热象者归入阳类证范畴均纳入阳类证。
     3第二阶段证型探索分析:本研究结果表明,按“阴阳类证”临床辨证思维模式辨证方法进行辨证总体上是可行的,“阴阳类证”临床辨证思维模式的三个路标(一级路标火热证、二级路标阴虚证及气虚证)的四诊指标与专家经验相比有较好的符合率。但仍存在一些问题:如二级路标“阴虚证”四诊指标排在前十位的是舌红、便干、心烦易怒、面红、口唇干红、咽干、脉数、舌底脉络迂曲青紫、腰膝酸软、小便黄赤。其中多数与热象四诊指标重叠,特异性反映阴虚的四诊指标不多,与专家经验阴虚四诊指标(面色烘热、虚烦不得眠、盗汗、眩晕、耳鸣、舌红、苔少)相比,符合率较低。分析原因,可能与本次调查纳入的急性缺血性中风病患者存在偏倚有关:如本研究纳入的患者总体病情较轻、中医辨证阴类证占绝大多数、阳类虚证样本量偏少等。
     研究结论
     中医诊疗疾病的一大特色就是辨证论治,中医的疗效离不开正确规范的辨证,所以规范化、标准化是中医药发展及现代化的关键环节。本课题是在中医学关于证候的理论指导下,通过文献系统回顾、评价、专家咨询等,以“八五”《中风病病证诊断标准》为蓝本,定性与定量相结合,初步建立了急性缺血中风“阴阳类证”临床辨证思维模式,使之更加符合缺血中风的临床实际,并在多中心大样本横断面证候调查中对其进行评价。研究结果表明:本研究所确定的急性缺血中风“阴阳类证”临床辨证思维模式按三个路标辨证为四个证型是可行的,临床具有较高的实用性。其三个路标(火热证、阴虚证、气虚证)四诊指标与专家经验基本相符。同时,本研究结论也为今后进一步完善缺血性中风急性期综合治疗方案,探讨急性缺血中风临床疗效评价中医药干预的指标体系做好基础。
Background
     Stroke serious harm to human health,and ischemic stroke as the main types of stroke,it is the high incidence and high mortality,high morbidity worldwide to become great danger to be tackled by a disease.The results show that in the past Chinese medicine can be significantly reduced in patients with acute stroke mortality and morbidity,and it' s unique advantages in the international community have gradually produced a certain impact.But because of complex etiology and pathogenesis of stroke,it' s clinical type views rather inconsistent,and lack of unified standards-Syndrome.Therefore,to explore the rule of dialectical of stroke,and their standardization and standardized research on the treatment and research of stroke become very realistic significance.
     Objective
     To summury the academic thinking of "yin and yang" of treating stroke by my tutor,professor Liu Maocai.Initial set up acute ischemic stroke "yin and yang type Syndromes " clinical dialectical thinking mode to make it more in line with actual clinical ischemic stroke.And evaluate it in a large sample and multi-center cross-sectional survey.
     Methods
     1 Part of this clinical study completed in two phases,the first phase of cross-sectional survey research is the early research of the norms Syndrome, the purpose of the research is to preliminary set up the four consultation acquisition table of acute ischemic stroke syndromes.Six Syndromes of quantitative criteria of "Eighth-Five" key project as the gold standard,and verify the rate and consistency of the two standard Syndromes.And provide the basis for further clinical study of norm Syndromes.The second phase is the expansion of cross-sectional samples of investigations and studies, according to previous norms Syndrome 1,252 cases of statistical analysis on the results,in view of experience with experts in the draft or that there is a discrepancy is not in line with the part again literature research and expert advice.Merger,added,deleted the content of Four consultation acquisition table of the "Standardize differentiation of ischemic stroke(draft)",and preparation of the four consultation acquisition table of the " Standardize differentiation of ischemic stroke ",and initial set up and evaluate the acute ischemic stroke "yin and yang type Syndromes" clinical dialectical thinking mode.
     2 The first phase,the acute phase of ischemic stroke patients with 1,252 cases in accordance with "yin and yang type Syndromes" clinical dialectical thinking mode Syndrome,all data have taken Access document preservation,the survey forms can be achieved in the computer,software development when given in the query,and "Eighth-Five" key project scale stroke syndrome diagnosis percentile of the survey given in the table entries,and the completion of data collection can be directly for various syndromes diagnosis,and can be graded according to level of inquiries,if we can enquiries≧ 7 cases of Wind (≧ 7 can be diagnosed).We classified "yin deficiency and yang excess Syndrome" and "fiery-type Syndrome" into yang-type Syndrome category.The cases who have yin deficiency and yang excess Syndrome are classified in yang-deficiency Syndrome,those without yin deficiency and yang excess Syndrome but have fiery-type Syndrome are classified in yang-positive Syndrome. Those without such Syndromes are classified in yin-type Syndrome.The cases which have Qi-deficiency Syndrome are classified in yin-deficiency Syndrome category,and those without Qi-deficiency Syndrome are classified in yin-positive Syndrome category.Comparing the difference of the two dialectical standards,Calculation of the two standards of diagnostic rate and Kappa values.
     3 The second phase,we use the forward-looking and cross-sectional survey methods,and use the acquisition Table of stroke combined by disease and syndromes for four diagnostic information collection.We establish the acute phase of ischemic stroke database of 4,077 cases of acute ischemic stroke patients with stroke disease syndromes.To the medical profession thinking as the guide,we initial establish and evaluate the acute stroke "yin and yang type Syndromes" clinical dialectical thinking mode.
     Result
     1 In the early part of norms Syndrome study,1252 cases of all patients with acute stroke patients according to "Yin and Yang type Syndromes" clinical dialectical thinking mode of standards Syndrome(deficiency of Yang Syndrome, positive of Yang Syndrome,deficiency of Yin Syndrome,positive of Yin Syndrome).Six Syndromes of the " Eighth-Five science and technology research" quantitative criteria for the certification of gold standard,analyzed the results of cluster analysis indicate that the yang-type Syndrome diagnosis rate is 85.5%,yin-type Syndrome diagnosis rate is 91.5%.Suggesting that the dialectical method has a high rate of agreement,the clinical issues raised by "yin and yang type Syndromes" clinical dialectical thinking mode have higher standards of accuracy.
     Through the "Eighth-Five scale" norms that assignment after the diagnosis of Deficiency Yang Syndrome patients(30.5%)was significantly higher than that under the four diagnostic information collection platform acquisition norms after the results(19.1%);on the contrary,through The former diagnosis of "Positive Yang Syndrome" patients(15.4%)was significantly lower than the latter(24.8%),but the two combined diagnosis after diagnosis as "Yang-type Syndrome" of patients,both before and after the results were obtained 45.9% and 43.9%,which is basically the same.The diagnosis of "Yin-type Syndrome" before and after the results of the two methods comparison(52.7%and 56.1%) are basically the same.Note further consultation based on the four platforms collected information collection norms Syndrome is the result of considerable accuracy.
     2 Certification of the first phase of exploration:the overall rate higher compared with the four diagnostic indicators of expertise and the 3 signs of this study(fiery Syndrome,yin-deficency Syndrome and Qi-deficency Syndrome), but some indicators such as red tongue,yellow tongue in fiery Syndrome are not consistent,they have higher weight meet the diagnosis of expertise,but rapid pulse has lower weight in fiery Syndrome,some indicators such as tongue skew,soft physical can not contraction,partial body numb,thirsty like to drink hot water etc have litter or no relationship with the fiery Syndrome. Analyze the reasons,some indicators such as tongue skew,soft physical can not contraction,partial body numb are all indicators dialectical for diseases, so they have higher frequency in four Diagnostic indicators and therefore will affect the statistical results.The emergence of some indicators such as thirsty like to drink hot water can he interpreted as the syndromes of the stroke are more complex,composite Syndrome more common than single syndrome, some indicators of fiery Syndrome have lower weight than other Syndromes. Qi-deficency Syndrome,sputum Syndrome and blood stasis Syndrome are more common than fiery Syndrome in clinical,but according to the "yin and yang type Syndromes" clinical dialectical thinking mode those who have fiery Syndrome are classified as yang-type Syndrome.
     3 The second phase of exploration permits analysis:The results of this study showed that,according to "Yin and Yang type Synddromes" clinical dialectical thinking mode differentiation Syndrome in general is feasible. Compared with the experience of experts and the four diagnostic indicators of the three "yin and yang type Syndromes" clinical dialectical thinking mode signs(The first-class road sign is fiery Syndrome,and the second-class road signs are yin-deficiency Syndrome and Qi-deficency Syndrome),they have a better rate.But there are still some problems:such as top ten four diagnostic indicators of "Yin deficiency Syndrome"(the second-class road signs)are red tongue,Dry stool,upset irritability,red looking,dry and red lips,dry throat,rapid pulse,meridian below the tongue Tortuous and cyanosis,soft and acid waist and knee,Yellow and Chise urine.Most indicators of the yin-deficiency Syndrome overlap the fiery Syndrome.The indicators specific reflect the yin-deficency Syndrome are not too much.The rates were lower compared with the four diagnostic indicators of expertise(Fever looking, virtual trouble can not sleep,night sweats,vertigo,tinnitus,red tongue, moss less).The reasons of this conclusion may be included in the survey of acute ischemic stroke patients with the existence of bias:If the patients included in this study generally less severe diseases,patients of Yin-type Syndrome account for the overwhelming majority,Yang-deficiency Syndrome samples collected in this study is not enough,etc.
     Conclusion
     Differential treatment is a major characteristic of Chinese medicine diagnosis and treatment.The efficacy of Chinese medicine can not do without the correct and standard differential treatment,Therefore,standardized,and standardization is the key link of the development and modernization of traditional Chinese medicine.The topic is under the guidance of the theory of the Chinese medcicine through literature review,evaluation,expert advice etc.We use the "Stroke Disease Diagnostic Criteria certification" of the "Eighth-Five " key project as a blueprint for the qualitative and quantitative analysis of the study.And initial set up the acute Ischemic stroke "yin and yang type Syndromes" clinical dialectical thinking mode to make it more in line with actual clinical ischemic stroke,and a large sample multi-center, cross-sectional survey Syndromes its evaluation.The results show that:the Institute of acute ischemic stroke identified "yin and yang type Syndromes" clinical dialectical thinking mode by three to four nodes Differentiation Syndrome is feasible,with higher clinical relevance.At the same time,the conclusion of the study for the future to further improve acute ischemic stroke treatment programmes,it also for acute ischemic stroke clinical efficacy of Chinese medicine evaluation index system to interfere with the foundation.
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