急性冠脉综合征患者介入治疗后中医证候要素与预后的相关性研究
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摘要
1研究目的
研究急性冠脉综合征(Acute Coronary Syndrome, ACS)患者介入治疗后中医证候要素的分布规律；筛选与终点事件有关的危险证候要素,客观评价中医证候要素与预后结局的相关性。
2方法
本研究为多中心纵向观察性研究,对北京地区4家三级医院符合入选标准的120例患者进行入组时及入组后3、6、12个月进行随访。随访方式为门诊随访或电话随访,随访期一年。记录相关四诊信息、冠脉造影结果、终点事件等,若患者出现终点事件结束随访。通过对四诊信息进行辨证,将证候要素分解为病性证候要素及病位证候要素,分别分析入组时病性及病位证候要素分布规律,并与12个月随访结束时终点事件情况进行Logistic回归分析,筛选与终点事件相关的危险证候要素。并结合Gensini积分评价所筛选出的危险因素。
3结果
3.1横断面研究
3.1.1主要病性证候要素及其组合
120例ACS患者提取出7个病性证候要素,前三位分别是：血瘀(81.7%)、气虚(51.6%)、阴虚(42.5%),最少的为气滞(1.6%),表明血瘀和气虚是ACS患者的主要证候要素,在不同组合形式中两证素组合最多,占52.2%。所有患者中实性病性证素组合中血瘀+痰浊占34.17%,虚实组合中血瘀+气虚占44.17%,虚虚组合气虚+阴虚占26.67%。
3.1.2主要病位证候要素及其组合
120例ACS患者提取出9个病位证候要素,依据出现的比例多少排序是心(70.8%)>肾(40%)>胃(30.8%)>大肠(25.8%)>肺(21.7%)>小肠(10.8%)>脾(10%)>肝(1.7%)>胆(0.8%),反映了ACS患者主病位在心。病位组合方面,在组合形式上以2病位组合和3病位组合最常见,分别占26.7%和19.2%。病位相兼的组合中以心+肾为常见,占20.1%。
3.1.3终点事件
本研究随访12个月发生终点事件7例,终点事件发生率5.8%。按临床分型分组,终点事件有6例发生在不稳定性心绞痛(Unstable Angina Pectoris,UA)患者群中,按血管病变支数分组,其中1支血管病变组发生1例终点事件,2支血管病变组2例,3支血管病变组4例。
3.2证候要素与终点事件相关性
以病性证素作为自变量,终点事件作为因变量,应用Forward：LR方法进行Logistic回归分析,进入模型的变量“阴虚”回归系数检验的P=0.997,OR=0.00,各病性证候要素与终点事件的相关性无统计学意义。
以病位要素作为自变量,终点事件作为因变量,应用Forward：LR方法进行Logistic回归分析,共进行了2步,先后选入了两个变量,病位分别为“胃”和“脾”,第二步模型参数检验显示“脾”组P=0.068,OR=7.079,95%可信区间(0.863,58.054)无统计学意义,“胃”组P=0.009,OR=20.183,95%可信区间(2.099,194.053),有统计学意义。
3.3Gensini积分对相关证候要素的评价
首先进行了Gensini积分与本研究数据拟合度的检验,在不同临床分型的组间比较显示不稳定性心绞痛组与ST段抬高心肌梗死组之间有显著差异(P=0.016),95%可信区间(-17.74,-1.40)。在不同血管病变支数组间比较显示与1支血管病变组比较,2支血管病变和3支血管病变组均有显著差异(P=0.00和P=0.00)；同时组间均值比较的95%可信区间分别为(-30.62,-10.01)和(-24.57,-14.04)。Gensini积分与本研究数据拟合度较好。
不同的病性证侯要素组合Gensini积分均数的比较,F检验的结果F=0.311,P=0.817,组间均数无差异。不同病位证素组合组间进行Gensini积分均数的比较,基于方差不齐的的近似F检验Welch法和Brown-Forsythe法显示概率分别为P=0.364和P=0.363,组间差别无统计学意义。病位“胃”组和非病位“胃”组,两组间Gensini积分F检验的结果F=0.926,P=0.338,组间差别无统计学意义。
4结论
4.1血瘀、气虚是ACS的主要病性证候要素,气虚血瘀是两证候要素组合中主要组合形式；
4.2心、肾为ACS患者主要病位证候要素,病位相兼的组合中以心+肾为常见；
4.3病位“胃”与终点事件发生相关；
4.4辨证病位“胃”组和病位非“胃”组比较Gensini积分无明显差别。
1 Objectives
To study the distribution regularity of syndrome elements of the disease property and location in ACS patients with PCI, and make extraction of risk syndrome elements in relation to endpoint events. Furthermore, to explore possible objective evidence of modern medicine.
2 Methods
This study was a multi-center longitudinal observational study. According to the provisions of the protocol,120 patients from 4 hospitals were enrolled and clinic visit were performed 3,6,12 months after the enrollment, by follow-up of telephone calls and outpatients, and the follow-up lasted 1 year. The relative four diagnostic information, coronary angiography results and endpoint events during follow-up were recorded. The follow-up was ended when endpoint events happened. Syndrome elements were divided into syndrome elements of the disease property and location, we analyzed their distribution regularity respectively. We used Logistic regression analysis to analyzed the correlation between disease property location and endpoint events during the period of follow-up and made extraction of risk syndrome elements. The Gensini score was used to evaluate the risk syndrome elements, furthermore objective evidence would be explored.
3 Results
3.1. Cross-sectional study:
3.1.1 Major syndrome elements of the disease property and their combination of 120 ACS cases.
Seven syndrome elements of the disease property were extracted totally. Blood stasis(81.7%), qi deficiency(51.6%), yin deficiency(42.5%) were in the top three,and qi stagnation(1.6%) was the fewest. It indicated that the blood stasis and qi deficiency were the major syndrome elements. The two syndrome elements combination(52.2%) was the major form in the different combinations. Blood stasis and phlegm syndrome elements accounted for 34.17% of excess syndrome elements, blood stasis and qi deficiency accounted for 44.17% of deficiency-excess mixing syndrome elements, qi deficiency and yin deficiency accounted for 26.67% of deficiency syndrome elements.
3.1.2 Major syndrome elements of the disease location and their combination analysis
Nine syndrome elements of the disease location were extracted totally. According to the proportion, heart(70.8%)> kidney(40%)> stomach(30.8%)> large intestine (25.8%)> lung(21.7%)> small intestine (10.8%)>spleen(10%)> liver(1.7%)>gall bladder(0.8%). It reflected that the major disease location of ACS was in the heart. Of the combination of the disease location,2 or 3 disease location combined form were the most commom style, they accounted for 26.7% and 19.2%. Of the combined disease locations form, heart combined kidney was the most common type, accounting for 20.1%.
3.1.3 Endpoint events analysis
During the period of 1 year follow-up,7 cases of cardiovascular endpoint event occurred in, and the incidence was 5.8%. In different clinical classification groups,6 cases occurred in UA patients. In different criminal vessel groups,1 case who occurred endpoint had single criminal vessel,2 cases had two criminal vessels,4 cases had three criminal vessels.
3.2 The correlation of syndrome elements and endpoint events analysis
The syndrome elements of the disease property were named independent variable, endpoint events were named dependent variable. Using Forward:LR method for Logistic regression analysis. The independent variable of yin deficiency was in regression and coefficient test, P=0.997,OR=0.00. The conclusion indicated that syndrome elements and endpoint events had no significant correlation.
The syndrome elements of the disease location were named independent variable, endpoint events were named dependent variable. Using Forward:LR method for Logistic regression analysis.2 locations were choosed as variables, they were stomach and spleen. Of the spleen, model parameter test was used to made analysis, P=0.068,OR=7.079,95%CI(0.863,58.054), showed no significant difference. Of stomach, P=0.009,OR=20.183,95%CI(2.099,194.053), showed significant differences.
3.3 Using Gensini score to evaluate the relative syndromes elements.
First, test of goodness for fit about Gensini score about the test data was performed. There was significant difference between groups of unstable angina and st-segment elevation myocardial infarction. The difference had statistical significance (P=0.016),95% CI (-17.74-1.40). There was significant difference between single vessel group and two vessels group(P=0.00),95%CI (-30.62,-10.01);there was significant difference between single lesion group and three lesions group(P=0.00), 95%CI (-24.57,-14.04).
Comparison was made about the mean of Gensini score in different combination of syndrome elements of the disease property, the results of F test is F=0.311,P=0.817. The means between groups had no differences. About the desease location comparion, the results of Welch test was P=0.364,and Brown-Forsythe test was P=0.363. The means between groups had no differences. Gensini scores between the group stomach location and non-stomach location had no differences by F test, the result was F=0.926,P=0.338.
4 Conclusions
4.1 Blood stasis and qi deficiency are main disease properties of syndrome elements of ACS. The combination of Qi deficiency and Blood stasis is the main combined syndrome factors types.
4.2 Disease location of Heart and kidney are the main syndrome factors of disease location of ACS. the combination of heart+kidney is the common type of combined disease locations syndrome elements.
4.3 Disease location of "stomach" is relative to endpoint events occurring.
4.4 There was no significant difference in Gensini score between group with disease location of "stomach" and "non-stomach".
研究急性冠脉综合征(Acute Coronary Syndrome, ACS)患者介入治疗后中医证候要素的分布规律；筛选与终点事件有关的危险证候要素,客观评价中医证候要素与预后结局的相关性。
2方法
本研究为多中心纵向观察性研究,对北京地区4家三级医院符合入选标准的120例患者进行入组时及入组后3、6、12个月进行随访。随访方式为门诊随访或电话随访,随访期一年。记录相关四诊信息、冠脉造影结果、终点事件等,若患者出现终点事件结束随访。通过对四诊信息进行辨证,将证候要素分解为病性证候要素及病位证候要素,分别分析入组时病性及病位证候要素分布规律,并与12个月随访结束时终点事件情况进行Logistic回归分析,筛选与终点事件相关的危险证候要素。并结合Gensini积分评价所筛选出的危险因素。
3结果
3.1横断面研究
3.1.1主要病性证候要素及其组合
120例ACS患者提取出7个病性证候要素,前三位分别是：血瘀(81.7%)、气虚(51.6%)、阴虚(42.5%),最少的为气滞(1.6%),表明血瘀和气虚是ACS患者的主要证候要素,在不同组合形式中两证素组合最多,占52.2%。所有患者中实性病性证素组合中血瘀+痰浊占34.17%,虚实组合中血瘀+气虚占44.17%,虚虚组合气虚+阴虚占26.67%。
3.1.2主要病位证候要素及其组合
120例ACS患者提取出9个病位证候要素,依据出现的比例多少排序是心(70.8%)>肾(40%)>胃(30.8%)>大肠(25.8%)>肺(21.7%)>小肠(10.8%)>脾(10%)>肝(1.7%)>胆(0.8%),反映了ACS患者主病位在心。病位组合方面,在组合形式上以2病位组合和3病位组合最常见,分别占26.7%和19.2%。病位相兼的组合中以心+肾为常见,占20.1%。
3.1.3终点事件
本研究随访12个月发生终点事件7例,终点事件发生率5.8%。按临床分型分组,终点事件有6例发生在不稳定性心绞痛(Unstable Angina Pectoris,UA)患者群中,按血管病变支数分组,其中1支血管病变组发生1例终点事件,2支血管病变组2例,3支血管病变组4例。
3.2证候要素与终点事件相关性
以病性证素作为自变量,终点事件作为因变量,应用Forward：LR方法进行Logistic回归分析,进入模型的变量“阴虚”回归系数检验的P=0.997,OR=0.00,各病性证候要素与终点事件的相关性无统计学意义。
以病位要素作为自变量,终点事件作为因变量,应用Forward：LR方法进行Logistic回归分析,共进行了2步,先后选入了两个变量,病位分别为“胃”和“脾”,第二步模型参数检验显示“脾”组P=0.068,OR=7.079,95%可信区间(0.863,58.054)无统计学意义,“胃”组P=0.009,OR=20.183,95%可信区间(2.099,194.053),有统计学意义。
3.3Gensini积分对相关证候要素的评价
首先进行了Gensini积分与本研究数据拟合度的检验,在不同临床分型的组间比较显示不稳定性心绞痛组与ST段抬高心肌梗死组之间有显著差异(P=0.016),95%可信区间(-17.74,-1.40)。在不同血管病变支数组间比较显示与1支血管病变组比较,2支血管病变和3支血管病变组均有显著差异(P=0.00和P=0.00)；同时组间均值比较的95%可信区间分别为(-30.62,-10.01)和(-24.57,-14.04)。Gensini积分与本研究数据拟合度较好。
不同的病性证侯要素组合Gensini积分均数的比较,F检验的结果F=0.311,P=0.817,组间均数无差异。不同病位证素组合组间进行Gensini积分均数的比较,基于方差不齐的的近似F检验Welch法和Brown-Forsythe法显示概率分别为P=0.364和P=0.363,组间差别无统计学意义。病位“胃”组和非病位“胃”组,两组间Gensini积分F检验的结果F=0.926,P=0.338,组间差别无统计学意义。
4结论
4.1血瘀、气虚是ACS的主要病性证候要素,气虚血瘀是两证候要素组合中主要组合形式；
4.2心、肾为ACS患者主要病位证候要素,病位相兼的组合中以心+肾为常见；
4.3病位“胃”与终点事件发生相关；
4.4辨证病位“胃”组和病位非“胃”组比较Gensini积分无明显差别。
1 Objectives
To study the distribution regularity of syndrome elements of the disease property and location in ACS patients with PCI, and make extraction of risk syndrome elements in relation to endpoint events. Furthermore, to explore possible objective evidence of modern medicine.
2 Methods
This study was a multi-center longitudinal observational study. According to the provisions of the protocol,120 patients from 4 hospitals were enrolled and clinic visit were performed 3,6,12 months after the enrollment, by follow-up of telephone calls and outpatients, and the follow-up lasted 1 year. The relative four diagnostic information, coronary angiography results and endpoint events during follow-up were recorded. The follow-up was ended when endpoint events happened. Syndrome elements were divided into syndrome elements of the disease property and location, we analyzed their distribution regularity respectively. We used Logistic regression analysis to analyzed the correlation between disease property location and endpoint events during the period of follow-up and made extraction of risk syndrome elements. The Gensini score was used to evaluate the risk syndrome elements, furthermore objective evidence would be explored.
3 Results
3.1. Cross-sectional study:
3.1.1 Major syndrome elements of the disease property and their combination of 120 ACS cases.
Seven syndrome elements of the disease property were extracted totally. Blood stasis(81.7%), qi deficiency(51.6%), yin deficiency(42.5%) were in the top three,and qi stagnation(1.6%) was the fewest. It indicated that the blood stasis and qi deficiency were the major syndrome elements. The two syndrome elements combination(52.2%) was the major form in the different combinations. Blood stasis and phlegm syndrome elements accounted for 34.17% of excess syndrome elements, blood stasis and qi deficiency accounted for 44.17% of deficiency-excess mixing syndrome elements, qi deficiency and yin deficiency accounted for 26.67% of deficiency syndrome elements.
3.1.2 Major syndrome elements of the disease location and their combination analysis
Nine syndrome elements of the disease location were extracted totally. According to the proportion, heart(70.8%)> kidney(40%)> stomach(30.8%)> large intestine (25.8%)> lung(21.7%)> small intestine (10.8%)>spleen(10%)> liver(1.7%)>gall bladder(0.8%). It reflected that the major disease location of ACS was in the heart. Of the combination of the disease location,2 or 3 disease location combined form were the most commom style, they accounted for 26.7% and 19.2%. Of the combined disease locations form, heart combined kidney was the most common type, accounting for 20.1%.
3.1.3 Endpoint events analysis
During the period of 1 year follow-up,7 cases of cardiovascular endpoint event occurred in, and the incidence was 5.8%. In different clinical classification groups,6 cases occurred in UA patients. In different criminal vessel groups,1 case who occurred endpoint had single criminal vessel,2 cases had two criminal vessels,4 cases had three criminal vessels.
3.2 The correlation of syndrome elements and endpoint events analysis
The syndrome elements of the disease property were named independent variable, endpoint events were named dependent variable. Using Forward:LR method for Logistic regression analysis. The independent variable of yin deficiency was in regression and coefficient test, P=0.997,OR=0.00. The conclusion indicated that syndrome elements and endpoint events had no significant correlation.
The syndrome elements of the disease location were named independent variable, endpoint events were named dependent variable. Using Forward:LR method for Logistic regression analysis.2 locations were choosed as variables, they were stomach and spleen. Of the spleen, model parameter test was used to made analysis, P=0.068,OR=7.079,95%CI(0.863,58.054), showed no significant difference. Of stomach, P=0.009,OR=20.183,95%CI(2.099,194.053), showed significant differences.
3.3 Using Gensini score to evaluate the relative syndromes elements.
First, test of goodness for fit about Gensini score about the test data was performed. There was significant difference between groups of unstable angina and st-segment elevation myocardial infarction. The difference had statistical significance (P=0.016),95% CI (-17.74-1.40). There was significant difference between single vessel group and two vessels group(P=0.00),95%CI (-30.62,-10.01);there was significant difference between single lesion group and three lesions group(P=0.00), 95%CI (-24.57,-14.04).
Comparison was made about the mean of Gensini score in different combination of syndrome elements of the disease property, the results of F test is F=0.311,P=0.817. The means between groups had no differences. About the desease location comparion, the results of Welch test was P=0.364,and Brown-Forsythe test was P=0.363. The means between groups had no differences. Gensini scores between the group stomach location and non-stomach location had no differences by F test, the result was F=0.926,P=0.338.
4 Conclusions
4.1 Blood stasis and qi deficiency are main disease properties of syndrome elements of ACS. The combination of Qi deficiency and Blood stasis is the main combined syndrome factors types.
4.2 Disease location of Heart and kidney are the main syndrome factors of disease location of ACS. the combination of heart+kidney is the common type of combined disease locations syndrome elements.
4.3 Disease location of "stomach" is relative to endpoint events occurring.
4.4 There was no significant difference in Gensini score between group with disease location of "stomach" and "non-stomach".
引文
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