先天性心脏病围术期中医证侯的分布和演变规律
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摘要
研究目的
先天性心脏病是威胁儿童生命健康的重要疾病,手术是治疗先心病的主要方法。我院作为目前国内率先开展先天性心脏病手术的中医院,在临床应用当中发现中医辨证施治对患者围术期的康复非常有利,但是先心病围术期的中医证候分布和演变规律如何,如何利用临床客观指标来指导中医辨证,使中医辨证更加客观化、标准化,目前尚未有相关报道,本文首次对先心病围术期的中医证侯特点进行系统研究,通过对我院心脏中心2006年12月至2009年2月进行先天性心脏病手术的患者230例进行总结,探讨先心病围术期中医证型与临床客观指标和四诊信息的相关性,分析先心病围术期中医证侯症状、体征分布规律及其在中医证型诊断中的意义,为先心病围术期中医辨证分型规范化、客观化提供数理统计上的依据。同时,本文中采用的研究方法不仅能在先心病围术期的证候分析中应用,还可以用于其他疾病的中医证候分析,为探索证候研究的方法学提供了参考,同时也为进一步应用临床流行病学和数据挖掘的方法,进行定性与定量相结合,开展多中心、大样本、多时点的中医证候的前瞻性研究提供依据。
研究方法和内容
一、设计方案:
(一)设计临床观察表,对病人术前至术后1周的一般情况、四诊资料、围术期监测指标等进行采集,建立所有患者的个人信息及中医证候信息条目数据库
(二)将收集的四诊资料进行频数分析和聚类分析,根据中医病证诊断疗效标准和专家辨证确定聚类数目和不同的证候类型。
(三)对中医证候类型及临床客观指标进行Logistic回归分析,以探讨临床客观指标和先天性心脏病手术围术期中医证候的关系。
二、研究地点:
广东省中医院加州心脏中心
三、研究对象:
我院心脏中心2006年12月至2009年2月进行先天性心脏病手术的患者230例,其中男性121例(占52.6%),女性109例(占47.4%),年龄3.2±1.5岁,体重14±2.7KG,其中室间隔缺损(VSD)104例(45.2%),房间隔缺损(ASD)50例(21.7%),法乐氏四联征(TOF)28例(12.2%),肺动脉狭窄(PS)23例(10.0%),其他25例(10.9%)。术前心排指数(CI)为3.3±1.5(L/min/m~2),术前肺动脉压/主动脉压0.56±0.12,体外循环时间72±25min。所有患者均行气管插管全麻,开胸后体外循环下完成矫治手术,术后送监护室监护,监测心电、有创血压、呼吸、血氧(SPO2)、中心静脉压(CVP)、引流量、出入量等。
四、病例选择方法:
(一)纳入标准:
所有病例均有明确的病史、症状、体征;经心脏彩超、超高速CT或心脏造影明确诊断;年龄大于1月、小于15岁者。
(二)排除标准:
不符合纳入标准;肝、肾功能不全、精神病、不能配合研究者、资料不全等影响判定者。
五、研究方法:
(一)通过文献研究、专家咨询,进行中医四诊信息的筛选。
(二)制定临床调查表内容包括:患者基本情况;疾病史及相关危险因素;病人术前至术后1周的一般情况、四诊资料、围术期监测指标;填表说明。
(三)对证候调查人员进行培训,经考核合格后进入临床调查。
(四)分别于在手术前一天、术后第一天、术后第三天和术后第七天观察记录患者的证候,运用Epidata3.0统计软件,建立所有患者的个人信息及中医证候信息条目数据库。
六、诊断方法:
诊断标准参考《中西医结合外科学》、《中医诊断学》和专家辨证
七、统计分析:
对回收的调查表用Epidata3.0建立所有患者的个人信息及中医证候信息条目数据库,应用SPSS13.0统计软件对四诊资料进行频数分析和聚类分析,根据中医病证诊断疗效标准和专家辨证确定聚类数目和不同的证候类型。应用二值Logistic回归分析分析客观指标与证侯类型的关系。方法选用向前逐步法(Forward:wald)。计数资料的比较采用Crosstabs命令进行Chi-square检验,计量资料采用t检验。均数比较:若资料符合正态分布且方差齐用单因素方差分析,否则用非参数秩和检验。
结果
一、对所有症状、舌、脉进行频数统计分析,由于数据库中的变量数目太大,结合临床病例检验进行初筛,删除中医四诊信息指标中出现频率很小的指标,筛选出主要证候指标35个(Z1～Z35),次要证候指标25个(C1～C25),舌脉指标28个(S1～S28),形成主要临床症状和体征、舌脉象的频数分布表。
二、使用SPSS 13.0软件对包括临床症状、体征、舌象和脉象在内的88个变量进行4～6类的聚类分析,从所得3种分类结果来看,聚为7类使得四诊信息的分散性较好,证型分布清晰,根据专家意见分别将这7类证候命名为:包括:单证——气虚、阳虚、血虚、血瘀、痰浊,兼证——气阴两虚、气虚痰瘀。聚类分析所得出的相关系数平方(R~2)是指与同类变量之间的相关程度,同类内R~2越大越应该划分在同一类中去,因此,可以将R~2作为证候指标的权重来看,某一具体指标(症状、体征或舌脉象)的权重越大,则其对所对应的证候诊断的贡献度就越大。根据证候四诊合参指标权重并结合临床确定先心病围术期7种证候诊断要点。
三、先心病围术期中医证侯的统计分析显示围手术期不同时间点(术前1天,术后第1天,术后第3天,术后第7天)中医证型分布不同,不同先心病(VSD、ASD、TOF、PS、其他)术后第一天证型的分布有差异性:TOF术后发生阳虚、血瘀、痰浊机会较高(P＜0.01);VSD术后发生阳虚机会较高(P＜0.01);ASD术后出现气阴两虚证比例显著高于其他先心病(P＜0.01),PS术后发生痰浊、气虚痰瘀证机会较高。中医证型和一些重要临床指标(年龄、体重、体外循环时间、Pp/Ps、CI)存在相关性:阳虚组年龄、体重显著低于其他证侯组,Pp/Ps、CI显著高于其他证侯组(P＜0.01);阳虚、血虚组体外循环时间显著长于其他证侯组(P＜0.01);,而痰浊、气虚痰瘀组Pp/Ps显著低于其他证侯组(P＜0.01)。术后早期常见并发症与术后第一天证型的关系:低心排的证型分布是阳虚＞气虚痰瘀＞其他;肺高压的证型分布是阳虚＞痰浊=血瘀＞其他;急性肾功能不全的证型分布是阳虚＞气虚痰瘀=气阴两虚＞其他;凝血功能障碍的证型分布是血虚＞血瘀＞其他。围术期中晚期并发症与术后第三天中医证型的关系:肺部感染的证型分布为痰浊＞气虚痰瘀＞其他;胃肠功能紊乱的证型分布为气虚＞痰浊＞其他。
四、先心病围术期中医证侯影响因素的Logistic回归分析显示不同先心病类型与各中医证型之间存在相关性:ASD最重要的证候是气虚和气阴两虚,TOF者为:阳虚和血瘀,PS为:痰浊和气虚痰瘀。重要临床指标与各中医证型之间存在相关性:年龄、体重、CI越小,发生阳虚的机会越大,体外循环时间越长,Pp/Ps越高,发生阳虚的机会越大。体循时间延长,出现血虚证的风险增加。肺动脉压越高,CI越低,出现气虚痰瘀证的风险越高。术后早期并发症与中医证侯存在相关性:低心排、肺高压、急性肾功能不全最重要的证候是阳虚,凝血功能障碍最常见的证型为血虚和血瘀证。术后中晚期并发症与中医证侯的相关性:痰浊和气虚痰瘀是肺部感染最重要的证候;胃肠功能紊乱最重要的证候是气虚、痰浊证。
结论
先天性心脏病手术围手术期主要包括7种证型:单证——气虚、阳虚、血虚、血瘀、痰浊,兼证——气阴两虚、气虚痰瘀。在不同时点中医证侯分布和演变有其规律性。各客观指标(病种、年龄、体重、体外循环时间、Pp/Ps、CI)与中医证型之间有相关性。术后早期和中晚期并发症中医证侯分布不同。利用多元统计方法,可以实现对相关证候信息资料的全面而有效的分析处理。利用临床客观指标来指导中医辨证,可以实现中医辨证的微观化、标准化、定量化。
Study Objective
Congenital heart disease(CHD) is a serious disease threatening children health.Surgery is the most important method to treat CHD.TCM has been proved beneficial to patients undergoing congenital heart disease(CHD) surgery.How is the distribution and evolution discipline of TCM syndromes in the perioperation ? No experience has been offered before.As the first TCM hospital conducted CHD surgery in our country,by reviewing the 230 cases undergone CHD surgery,we intend to reveal the distribution and evolution characteristics of TCM syndromes in perioperation of CHD,and the relationship between the TCM syndromes and clinical objective indexes.We also hope to find a efficient way to carry forward research on TCM syndromes.
Design
1.Design survey table,collect the data about patients' basic information, the manifestation of TCM syndromes and clinical objective indexes on the time as:the day before operation,the first day after operation,the third day after operation,and the seventh day after operation.Establish the database.
2.Frequency analysis and Cluster Analysis are used to deal with the data and conclude the main TCM syndrome types in perioperation of CHD,refered to TCM diagnosed standard and expertise.
3.Logistic Analysis is used to deal with the data,discuss the relationship of TCM syndromes types and clinical objective indexes.
Setting
California Heart Center in Guang Dong Province Hospital of TCM.
Patients
230 patients who had accepted CHD operation in our center from December,2006 to February,2009,with 121 males(52..6%),109 females(47.4%),age 3.2±1.5 years,weight 14±2.7KG,CHD types include VSD 104(45.2%),ASD 50(21.7 %),TOF 28(12.2%),PS 23(10.0%),others 25(10.9%).The clinical objective indexes include:CI 3.3±1.5(L/min/m2),Pp/Ps 56±0.12,Cardiopulmonary bypass time 72±25min.All patients received operations under the conditions of tracheal intubation anesthesia and cardiopulmonary bypass.After the operations,they were send to ICU,The monitored indexes included ECG,invasive blood pressure,breath,SPO2,CVP,drainage,fluid amount.
Patient choosed methods
1.iddmission standard
All patients have difinite illness histroy,syndrome,sign of CHD,diagnosed by echocardiogram,ultra-velocity CT or cardiography.Age ranges from 1 month to 15 years.
2 Excluding standard
Unsuitable for addmission standard;With liver or kidney desfunction,mental disorder,uncapable of accommodation,defective material.
Approach
1.Choose the TCM information by the way of literature learning and expertise requiry.
2.Design survey table,including the general information,illness history and relative risk factors,TCM materials,surveillance index in perioperation.
3.Ttrain the surveyors,qualified to survey after passing exams.
4.Gather the data about the individual characteristics,operation records, cardiopulmonary bypass,ICU surveillance indexes and differentiation of TCM syndromes.Record the TCM materials on the day before operation,the first day after operation,the third day after operation,the seventh day after operation.Establish the data base about the patients' individual information and TCM information using the statistical software SPSS 13.0 for Windows.
Diagnosed method
The diagnosed standand referred to《Intergrated Chinese and Western medicine for surgery》,《TCN diagnose》,as well as expertise differetiation of TCM syndrome.
Statistical method
Establish the data base about the patients' individual information and TCM information using Epidata 3.0 statistical soft,Frequency analysis and Cluster analysis are used to deal with the data and find the main TCM syndrome types in perioperation of CHD,refered to TCM diagnosed standard and expertise. Logistic Analysis is used to deal with the data,discussing the relationship between TCM syndromes types and clinical objective indexes.
Main Results
1.Frequency analysis is used to deal with the indexes including all the signs, tough,pulse.Cancel the low frequent indexes,filter and gain the main sign indexes(Z1~Z35),minor sign indexes(C11~C25),tough and pulse indexes (S1~S28),form the frequency distribution table.
2.Cluster Analysis is used to deal with the 88 indexes,and under the instruction of famous professors,we conclude the most frequent 7 TCM syndrome types,which can be divided into 2 groups:the simple TCM syndrome group including TCM syndrome Deficiency of Heart-Qi,Lost of Heart-Yang,Lost of Blood,Blood Stasis,Stagnation of Phlegm,the double TCM syndromes group includes TCM syndrome Deficiency of Heart-Qi and Heart -Yin,Deficiency of Qi and Stagnation of Phlegm.Calculate the R2 of each index,which can refrect the contribution degree of each index to the TCM syndrome,and according to R2,we can identify the diagnosing factors for these 7 TCM syndromes.
3.Statistical analysis shows that diversity exists in the TCM syndromes at different time of perioperation(the day before operation,the first day after operation,the third day after operation,the seventh day after operation), so do in different CHD types(VSD,ASD,TOF,PS,others).Age and weight are the important correlative factor of the TCM syndromes type Deficiency of Heart- Yang.CI(Cardiac Index) decreases and more syndrome type Deficiency of Heart- Yang occur.Cardiopulmonary bypass cross-clamping time is the important correlative factor of TCM types Deficiency of Heart- Yang and Lost of Blood.Pp/Ps is negative correlative with syndrome type Stagnation of Phlegm.Deficiency of Heart- Yang is the most common TCM type in the complications such as low heart output,pulmonary hypertension,and acute renal failure,the blood coagulation dysfunction is most manifested as the TCM type Lost of Blood;Stagnation of Phlegm is the common TCM type for lung infection.Gasointestinal dysfunction is most manifested as the TCM type Deficiency of Heart-Qi
4.Logistic Analysis on the affecting factors of TCM syndrome in the CHD perioperation shows that the correlationship between TCM syndromes and different kinds of CHD(VSD,ASD,TOF,PS,others):ASD is most manifested as the TCM type Deficiency of Heart-Qi,TOF is most manifested as Deficiency of Heart- Yang and Blood Stasis,PS is most manifested as Stagnation of Phlegm,Deficiency of Qi and Stagnation of Phlegm.Correlationship exists between objective index(Age,weight,Cardiopulmonary bypass cross-clamping time,Pp/Ps,CI) and TCM syndromes:Age and weight are negative relative with TCM syndromes type Deficiency of Heart- Yang.CI(Cardiac Index) decreases and more syndrome type Deficiency of Heart- Yang occur.Cardiopulmonary bypass cross-clamping time and Pp/Ps are positive relative with TCM types Deficiency of Heart- Yang,More Cardiopulmonary bypass cross-clamping time will lead to more TCM syndrome Lost of Blood.Pp/Ps is positive relative with syndrome type Deficiency of Heart-Qi and Stagnation of Phlegm.Deficiency of Heart- Yang is the most common TCM type in the complications such as low heart output, pulmonary hypertension,and acute renal failure,the blood coagulation dysfunction is most manifested as the TCM type Lost of Blood;Stagnation of Phlegm is the common TCM type for lung infection.Gasointestinal dysfunction is most manifested as the TCM type Deficiency of Heart-Qi
Conclusion
Disciplines exist in the distribution and evolution of TCM syndromes in perioperation of CHD.Objective index can be used to instruct differentiation of TCM syndromes and contribute to reveal the disciplines.The main TCM syndrome types in the perioperation of CHD include Deficiency of Heart-Qi,Lost of Heart-Yang,Lost of Blood,Blood Stasis,Stagnation of Phlegm,the double syndrome group includes TCM syndromes as:Deficiency of Heart-Qi and Heart -Yin,Deficiency of Qi and Stagnation of Phlegm.Diversity exists in the TCM syndromes at different time of perioperation(the day before operation,the first day after operation,the third day after operation,the seventh day after operation).Correlation exists between objective index(Age,weight, Cardiopulmonary bypass cross-clamping time,Pp/Ps,CI) and TCM syndromes. Different TCM syndromes exist in different complications after operation.The TCM syndrome materials can be thoroughly and efficiently analyzed by the way of multiplex statistical method.Objective index can be used to instruct differentiation of TCM syndromes,which can help to realize the objectization, standard and quantitization of TCM syndrome differentiation.
先天性心脏病是威胁儿童生命健康的重要疾病,手术是治疗先心病的主要方法。我院作为目前国内率先开展先天性心脏病手术的中医院,在临床应用当中发现中医辨证施治对患者围术期的康复非常有利,但是先心病围术期的中医证候分布和演变规律如何,如何利用临床客观指标来指导中医辨证,使中医辨证更加客观化、标准化,目前尚未有相关报道,本文首次对先心病围术期的中医证侯特点进行系统研究,通过对我院心脏中心2006年12月至2009年2月进行先天性心脏病手术的患者230例进行总结,探讨先心病围术期中医证型与临床客观指标和四诊信息的相关性,分析先心病围术期中医证侯症状、体征分布规律及其在中医证型诊断中的意义,为先心病围术期中医辨证分型规范化、客观化提供数理统计上的依据。同时,本文中采用的研究方法不仅能在先心病围术期的证候分析中应用,还可以用于其他疾病的中医证候分析,为探索证候研究的方法学提供了参考,同时也为进一步应用临床流行病学和数据挖掘的方法,进行定性与定量相结合,开展多中心、大样本、多时点的中医证候的前瞻性研究提供依据。
研究方法和内容
一、设计方案:
(一)设计临床观察表,对病人术前至术后1周的一般情况、四诊资料、围术期监测指标等进行采集,建立所有患者的个人信息及中医证候信息条目数据库
(二)将收集的四诊资料进行频数分析和聚类分析,根据中医病证诊断疗效标准和专家辨证确定聚类数目和不同的证候类型。
(三)对中医证候类型及临床客观指标进行Logistic回归分析,以探讨临床客观指标和先天性心脏病手术围术期中医证候的关系。
二、研究地点:
广东省中医院加州心脏中心
三、研究对象:
我院心脏中心2006年12月至2009年2月进行先天性心脏病手术的患者230例,其中男性121例(占52.6%),女性109例(占47.4%),年龄3.2±1.5岁,体重14±2.7KG,其中室间隔缺损(VSD)104例(45.2%),房间隔缺损(ASD)50例(21.7%),法乐氏四联征(TOF)28例(12.2%),肺动脉狭窄(PS)23例(10.0%),其他25例(10.9%)。术前心排指数(CI)为3.3±1.5(L/min/m~2),术前肺动脉压/主动脉压0.56±0.12,体外循环时间72±25min。所有患者均行气管插管全麻,开胸后体外循环下完成矫治手术,术后送监护室监护,监测心电、有创血压、呼吸、血氧(SPO2)、中心静脉压(CVP)、引流量、出入量等。
四、病例选择方法:
(一)纳入标准:
所有病例均有明确的病史、症状、体征;经心脏彩超、超高速CT或心脏造影明确诊断;年龄大于1月、小于15岁者。
(二)排除标准:
不符合纳入标准;肝、肾功能不全、精神病、不能配合研究者、资料不全等影响判定者。
五、研究方法:
(一)通过文献研究、专家咨询,进行中医四诊信息的筛选。
(二)制定临床调查表内容包括:患者基本情况;疾病史及相关危险因素;病人术前至术后1周的一般情况、四诊资料、围术期监测指标;填表说明。
(三)对证候调查人员进行培训,经考核合格后进入临床调查。
(四)分别于在手术前一天、术后第一天、术后第三天和术后第七天观察记录患者的证候,运用Epidata3.0统计软件,建立所有患者的个人信息及中医证候信息条目数据库。
六、诊断方法:
诊断标准参考《中西医结合外科学》、《中医诊断学》和专家辨证
七、统计分析:
对回收的调查表用Epidata3.0建立所有患者的个人信息及中医证候信息条目数据库,应用SPSS13.0统计软件对四诊资料进行频数分析和聚类分析,根据中医病证诊断疗效标准和专家辨证确定聚类数目和不同的证候类型。应用二值Logistic回归分析分析客观指标与证侯类型的关系。方法选用向前逐步法(Forward:wald)。计数资料的比较采用Crosstabs命令进行Chi-square检验,计量资料采用t检验。均数比较:若资料符合正态分布且方差齐用单因素方差分析,否则用非参数秩和检验。
结果
一、对所有症状、舌、脉进行频数统计分析,由于数据库中的变量数目太大,结合临床病例检验进行初筛,删除中医四诊信息指标中出现频率很小的指标,筛选出主要证候指标35个(Z1～Z35),次要证候指标25个(C1～C25),舌脉指标28个(S1～S28),形成主要临床症状和体征、舌脉象的频数分布表。
二、使用SPSS 13.0软件对包括临床症状、体征、舌象和脉象在内的88个变量进行4～6类的聚类分析,从所得3种分类结果来看,聚为7类使得四诊信息的分散性较好,证型分布清晰,根据专家意见分别将这7类证候命名为:包括:单证——气虚、阳虚、血虚、血瘀、痰浊,兼证——气阴两虚、气虚痰瘀。聚类分析所得出的相关系数平方(R~2)是指与同类变量之间的相关程度,同类内R~2越大越应该划分在同一类中去,因此,可以将R~2作为证候指标的权重来看,某一具体指标(症状、体征或舌脉象)的权重越大,则其对所对应的证候诊断的贡献度就越大。根据证候四诊合参指标权重并结合临床确定先心病围术期7种证候诊断要点。
三、先心病围术期中医证侯的统计分析显示围手术期不同时间点(术前1天,术后第1天,术后第3天,术后第7天)中医证型分布不同,不同先心病(VSD、ASD、TOF、PS、其他)术后第一天证型的分布有差异性:TOF术后发生阳虚、血瘀、痰浊机会较高(P＜0.01);VSD术后发生阳虚机会较高(P＜0.01);ASD术后出现气阴两虚证比例显著高于其他先心病(P＜0.01),PS术后发生痰浊、气虚痰瘀证机会较高。中医证型和一些重要临床指标(年龄、体重、体外循环时间、Pp/Ps、CI)存在相关性:阳虚组年龄、体重显著低于其他证侯组,Pp/Ps、CI显著高于其他证侯组(P＜0.01);阳虚、血虚组体外循环时间显著长于其他证侯组(P＜0.01);,而痰浊、气虚痰瘀组Pp/Ps显著低于其他证侯组(P＜0.01)。术后早期常见并发症与术后第一天证型的关系:低心排的证型分布是阳虚＞气虚痰瘀＞其他;肺高压的证型分布是阳虚＞痰浊=血瘀＞其他;急性肾功能不全的证型分布是阳虚＞气虚痰瘀=气阴两虚＞其他;凝血功能障碍的证型分布是血虚＞血瘀＞其他。围术期中晚期并发症与术后第三天中医证型的关系:肺部感染的证型分布为痰浊＞气虚痰瘀＞其他;胃肠功能紊乱的证型分布为气虚＞痰浊＞其他。
四、先心病围术期中医证侯影响因素的Logistic回归分析显示不同先心病类型与各中医证型之间存在相关性:ASD最重要的证候是气虚和气阴两虚,TOF者为:阳虚和血瘀,PS为:痰浊和气虚痰瘀。重要临床指标与各中医证型之间存在相关性:年龄、体重、CI越小,发生阳虚的机会越大,体外循环时间越长,Pp/Ps越高,发生阳虚的机会越大。体循时间延长,出现血虚证的风险增加。肺动脉压越高,CI越低,出现气虚痰瘀证的风险越高。术后早期并发症与中医证侯存在相关性:低心排、肺高压、急性肾功能不全最重要的证候是阳虚,凝血功能障碍最常见的证型为血虚和血瘀证。术后中晚期并发症与中医证侯的相关性:痰浊和气虚痰瘀是肺部感染最重要的证候;胃肠功能紊乱最重要的证候是气虚、痰浊证。
结论
先天性心脏病手术围手术期主要包括7种证型:单证——气虚、阳虚、血虚、血瘀、痰浊,兼证——气阴两虚、气虚痰瘀。在不同时点中医证侯分布和演变有其规律性。各客观指标(病种、年龄、体重、体外循环时间、Pp/Ps、CI)与中医证型之间有相关性。术后早期和中晚期并发症中医证侯分布不同。利用多元统计方法,可以实现对相关证候信息资料的全面而有效的分析处理。利用临床客观指标来指导中医辨证,可以实现中医辨证的微观化、标准化、定量化。
Study Objective
Congenital heart disease(CHD) is a serious disease threatening children health.Surgery is the most important method to treat CHD.TCM has been proved beneficial to patients undergoing congenital heart disease(CHD) surgery.How is the distribution and evolution discipline of TCM syndromes in the perioperation ? No experience has been offered before.As the first TCM hospital conducted CHD surgery in our country,by reviewing the 230 cases undergone CHD surgery,we intend to reveal the distribution and evolution characteristics of TCM syndromes in perioperation of CHD,and the relationship between the TCM syndromes and clinical objective indexes.We also hope to find a efficient way to carry forward research on TCM syndromes.
Design
1.Design survey table,collect the data about patients' basic information, the manifestation of TCM syndromes and clinical objective indexes on the time as:the day before operation,the first day after operation,the third day after operation,and the seventh day after operation.Establish the database.
2.Frequency analysis and Cluster Analysis are used to deal with the data and conclude the main TCM syndrome types in perioperation of CHD,refered to TCM diagnosed standard and expertise.
3.Logistic Analysis is used to deal with the data,discuss the relationship of TCM syndromes types and clinical objective indexes.
Setting
California Heart Center in Guang Dong Province Hospital of TCM.
Patients
230 patients who had accepted CHD operation in our center from December,2006 to February,2009,with 121 males(52..6%),109 females(47.4%),age 3.2±1.5 years,weight 14±2.7KG,CHD types include VSD 104(45.2%),ASD 50(21.7 %),TOF 28(12.2%),PS 23(10.0%),others 25(10.9%).The clinical objective indexes include:CI 3.3±1.5(L/min/m2),Pp/Ps 56±0.12,Cardiopulmonary bypass time 72±25min.All patients received operations under the conditions of tracheal intubation anesthesia and cardiopulmonary bypass.After the operations,they were send to ICU,The monitored indexes included ECG,invasive blood pressure,breath,SPO2,CVP,drainage,fluid amount.
Patient choosed methods
1.iddmission standard
All patients have difinite illness histroy,syndrome,sign of CHD,diagnosed by echocardiogram,ultra-velocity CT or cardiography.Age ranges from 1 month to 15 years.
2 Excluding standard
Unsuitable for addmission standard;With liver or kidney desfunction,mental disorder,uncapable of accommodation,defective material.
Approach
1.Choose the TCM information by the way of literature learning and expertise requiry.
2.Design survey table,including the general information,illness history and relative risk factors,TCM materials,surveillance index in perioperation.
3.Ttrain the surveyors,qualified to survey after passing exams.
4.Gather the data about the individual characteristics,operation records, cardiopulmonary bypass,ICU surveillance indexes and differentiation of TCM syndromes.Record the TCM materials on the day before operation,the first day after operation,the third day after operation,the seventh day after operation.Establish the data base about the patients' individual information and TCM information using the statistical software SPSS 13.0 for Windows.
Diagnosed method
The diagnosed standand referred to《Intergrated Chinese and Western medicine for surgery》,《TCN diagnose》,as well as expertise differetiation of TCM syndrome.
Statistical method
Establish the data base about the patients' individual information and TCM information using Epidata 3.0 statistical soft,Frequency analysis and Cluster analysis are used to deal with the data and find the main TCM syndrome types in perioperation of CHD,refered to TCM diagnosed standard and expertise. Logistic Analysis is used to deal with the data,discussing the relationship between TCM syndromes types and clinical objective indexes.
Main Results
1.Frequency analysis is used to deal with the indexes including all the signs, tough,pulse.Cancel the low frequent indexes,filter and gain the main sign indexes(Z1~Z35),minor sign indexes(C11~C25),tough and pulse indexes (S1~S28),form the frequency distribution table.
2.Cluster Analysis is used to deal with the 88 indexes,and under the instruction of famous professors,we conclude the most frequent 7 TCM syndrome types,which can be divided into 2 groups:the simple TCM syndrome group including TCM syndrome Deficiency of Heart-Qi,Lost of Heart-Yang,Lost of Blood,Blood Stasis,Stagnation of Phlegm,the double TCM syndromes group includes TCM syndrome Deficiency of Heart-Qi and Heart -Yin,Deficiency of Qi and Stagnation of Phlegm.Calculate the R2 of each index,which can refrect the contribution degree of each index to the TCM syndrome,and according to R2,we can identify the diagnosing factors for these 7 TCM syndromes.
3.Statistical analysis shows that diversity exists in the TCM syndromes at different time of perioperation(the day before operation,the first day after operation,the third day after operation,the seventh day after operation), so do in different CHD types(VSD,ASD,TOF,PS,others).Age and weight are the important correlative factor of the TCM syndromes type Deficiency of Heart- Yang.CI(Cardiac Index) decreases and more syndrome type Deficiency of Heart- Yang occur.Cardiopulmonary bypass cross-clamping time is the important correlative factor of TCM types Deficiency of Heart- Yang and Lost of Blood.Pp/Ps is negative correlative with syndrome type Stagnation of Phlegm.Deficiency of Heart- Yang is the most common TCM type in the complications such as low heart output,pulmonary hypertension,and acute renal failure,the blood coagulation dysfunction is most manifested as the TCM type Lost of Blood;Stagnation of Phlegm is the common TCM type for lung infection.Gasointestinal dysfunction is most manifested as the TCM type Deficiency of Heart-Qi
4.Logistic Analysis on the affecting factors of TCM syndrome in the CHD perioperation shows that the correlationship between TCM syndromes and different kinds of CHD(VSD,ASD,TOF,PS,others):ASD is most manifested as the TCM type Deficiency of Heart-Qi,TOF is most manifested as Deficiency of Heart- Yang and Blood Stasis,PS is most manifested as Stagnation of Phlegm,Deficiency of Qi and Stagnation of Phlegm.Correlationship exists between objective index(Age,weight,Cardiopulmonary bypass cross-clamping time,Pp/Ps,CI) and TCM syndromes:Age and weight are negative relative with TCM syndromes type Deficiency of Heart- Yang.CI(Cardiac Index) decreases and more syndrome type Deficiency of Heart- Yang occur.Cardiopulmonary bypass cross-clamping time and Pp/Ps are positive relative with TCM types Deficiency of Heart- Yang,More Cardiopulmonary bypass cross-clamping time will lead to more TCM syndrome Lost of Blood.Pp/Ps is positive relative with syndrome type Deficiency of Heart-Qi and Stagnation of Phlegm.Deficiency of Heart- Yang is the most common TCM type in the complications such as low heart output, pulmonary hypertension,and acute renal failure,the blood coagulation dysfunction is most manifested as the TCM type Lost of Blood;Stagnation of Phlegm is the common TCM type for lung infection.Gasointestinal dysfunction is most manifested as the TCM type Deficiency of Heart-Qi
Conclusion
Disciplines exist in the distribution and evolution of TCM syndromes in perioperation of CHD.Objective index can be used to instruct differentiation of TCM syndromes and contribute to reveal the disciplines.The main TCM syndrome types in the perioperation of CHD include Deficiency of Heart-Qi,Lost of Heart-Yang,Lost of Blood,Blood Stasis,Stagnation of Phlegm,the double syndrome group includes TCM syndromes as:Deficiency of Heart-Qi and Heart -Yin,Deficiency of Qi and Stagnation of Phlegm.Diversity exists in the TCM syndromes at different time of perioperation(the day before operation,the first day after operation,the third day after operation,the seventh day after operation).Correlation exists between objective index(Age,weight, Cardiopulmonary bypass cross-clamping time,Pp/Ps,CI) and TCM syndromes. Different TCM syndromes exist in different complications after operation.The TCM syndrome materials can be thoroughly and efficiently analyzed by the way of multiplex statistical method.Objective index can be used to instruct differentiation of TCM syndromes,which can help to realize the objectization, standard and quantitization of TCM syndrome differentiation.
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