缺血性中风不同时点神经功能缺损程度、证候特征与预后相关性的研究
摘要
中风病患者的临床疗效评价多采用公认的西医量表,从“病”的角度予以评价,中医药干预治疗中风历史悠久、疗效确切,主要是通过干预证候达到治疗或改善症状的目的,单独引用针对“病”的疗效指标并不能全面、客观、有效地评价中医药治疗中风的疗效,病证结合临床疗效评价模式则有机的结合了两者,力图对患者做出全面、科学、客观、准确的评价。研究目的
本研究通过仅从“病”的角度和从“病证结合”的角度进行与缺血性中风结局预后的相关性研究,来评价证候状态对疾病结局预后影响,从而为从病证结合角度进行疗效评价提供依据。研究方法
本研究是“显示中医药疗效优势的中药临床药效评价关键技术研究”(课题编号：2009ZX09502-028)的一部分,根据研究目的,对疾病的评价选用使用最为广泛的NIHSS量表,对证候的判断使用《缺血性中风证候要素诊断量表》,以公认的BI量表为结局指标(残疾与否),使用前期973课题数据,经数据清洗与转化,纳入研究病例755例,从中提取患者一般资料变量18个,不同时点神经科量表测评指标(NIHSS、BI)6个,中医四诊信息变量196个,证候要素变量6个
结果
1不同时点统计方法的优选
使用clementine12.0软件二元分类器依据研究目的选择最大使用参考变量及最大曲线下面积作为方法优选条件排序,自动对不同时点不同统计方法的建模能力优劣进行了优选,可见在不同时点Logistic回归分析方法优于贝叶斯网络、决策树及判别分析等。
2中风病发病90天预后不良因素初筛
随机提取数据库70%的病例作为训练集,采用logistic回归分析方法提取与缺血性中风发病90天预后的相关因素。结果表明与预后相关因素包括年龄、既往是否有中风史、OCSP分型、NIHSS评分及分级、证候要素。其中不同时点有不同的证候要素进入指标的初筛,发病第3天气虚证、发病第7天痰湿证和气虚证、发病第14天气虚证、发病28天内火证和气虚证、发病第90天内风证、内火证、痰湿证、血瘀证、气虚证均进入变量的初筛,提示不同时点的证候要素对观测预后的重要性不一样。同时发现气虚证均进入不同时点的指标初筛,提示气虚证与预后关系显著。
3病和病证结合与预后的相关性研究
构建不同时点NIHSS与残疾的模型方程,研究提示不同时点的NIHSS评分均与残疾密切相关,是残疾预测的独立相关因素,提示围绕“病”的概念去判断疾病的变化与转归的确具有很重要的临床意义。
构建不同时点NIHSS、证候要素与残疾的模型方程,研究发现气虚证在发病第3天、7天、14天均进入了病证结合评价模式模型方程,内火证和阴虚证则在发病第90天进入了该方程模型,分别成为发病90天残疾预测的独立危险因素,说明对证候状态的评价应该进入中风病疗效评价中,中风病疗效评价模式应该采用病证结合模式。
验证不同时点NIHSS与残疾的模型方程以及不同时点NIHSS、证候要素与残疾的模型方程,研究发现,纵向比较2个模型对残疾的预测能力均可,AUC曲线下面积均>0.7,且对结局的预测能力随病程延长总体上呈上升的趋势。横向比较2个模型AUC曲线下面积、敏感度、特异度、Youden指数并无明显的差异,两者相比无统计学意义。
4随时间演变单证候动态改变预后不同
研究显示发病3天和14天的单个证候要素前后比较：内火证、痰湿证证候消失组较证候不变组、证候新增组预后佳,提示在中风病的急性期病程阶段影响病情轻重及近期预后的核心证候主要是内火证与痰湿证。发病14天和28天的单个证候要素前后比较：阴虚证证候新增组较证候消失组预后差,余证候演变与预后无关,提示在恢复早期阴虚证较其他证候更易影响中风病患者的近期预后。发病28天和90天的单个证候要素前后比较：内风证证候新增组较证候不变组预后差；内火证、气虚证证候消失组较证候不变组预后佳；血瘀证证候新增组较较证候不变组、证候消失组预后差。提示到了中风病的恢复后期,若出现内风证不利于患者的近期预后,在治疗干预上则更应重视对内火证、气虚证及血瘀证候的干预。提示对证候状态的评价是建立中药疗效评价的核心,在评价中注意证候动态时空性这一特点。
结论
中风病起病急骤,临床表现多样,病情在不同时点具有不同的特点和不同证候特征,目前评价方法注重对疾病的评价,忽视了对证候的评价,难以显示出中药干预中风病独特的疗效优势。本研究结果提示：对患者进行“病”的评价基础上,更要注意对患者“证”的评价,在“证”评价中要注重其动态时空特点,中风临床疗效评价体系构建应以证候动态时空性特点为核心,将疾病评价与证候状态评价紧密结合。
Accepted western scales are usually used to evaluate the curative effect of patients with stroke in term of "disease" itself. However, with a long therapeutic history and definitely curative effect, the Chinese traditional medicine focuses on the "syndrome" to treat patients and improve their symptoms. It can not be comprehensive, objective and effective to evaluate the curative effect of Chinese medicine to treat stroke only based on "disease" itself. Therefore, combinating of disease and syndrome would be a comprehensive, scientific, objective and accurate method to evaluate the outcomes of patients with stroke.
Objective
In the present study, by comparing the predictive abilities of scales to evaluate the outcomes of patients with ischemic stroke in term of only the "disease" and the combination of "disease and syndrome", to evaluate the effect of syndrome on the outcomes of stroke, and to provide the evidence for evaluation of curative effect in term of combination of disease and syndrome.
Methods
This study is one part of the project "the study of the key technologies in the therapeutic effect evaluation of Chinese herb showing the advantages of the therapeutic effect" (project number:2009ZX09502-028). According to the purpose of the study, NIHSS scale was chosen to evaluate the disease, syndrome factor of ischemic stroke diagnosis scale to evaluate the syndrome and Barthel Index (BI) to evaluate the outcomes(disabled or not). By using the retrospective data analysis method,755 patients were extracted from the data of former project 973 by screening and transforming the data. The variables of patients included general information(18 items), the scores of neurological evaluation scales at different time points (NIHSS, BI) (6 items), TCM four diagnostic factors (196 items) and syndrome factors (6 items).
Results
1 Optimization of statistical methods at different time points
The binary classifier in Clementine 12.0 software was used to evaluate the modeling capability of different statistic methodsbased on the maximum used of fields and the largest area under the curve and the results showed that Logistic regression analysis method was superior to Bayesian networks, decision trees, discriminant analysis.
2 Preliminary screening factors associated with poor outcome 90 days after onset of stroke
70% of cases from the database were extracted randomly as the training subset to screen the factors associated with poor outcome 90 days after onset of stroke by using logistic regression analysis. The results showed that these factors included age, history of stroke, OCSP type, NIHSS score and grading and syndrome factors. Different syndrome factors became preliminary screening factors at different time points. At day 3, it was qi deficiency, day 7 phlegm and damp syndrome and qi deficiency, day 14 qi deficiency, day 28 fire syndrome and qi deficiency, and day 90 wind syndrome, fire syndrome, phlegm and damp syndrome, blood stasis syndrome, qi deficiency, which indicating that different syndrome factors at different time points contribute to the prodiction of prognosis. We also found that qi deficiency has significant relationship with the prognosis.
3 The correlation of disease and disease-syndrome combination with prognosis
The disability model equations based on NIHSS scores at different time points showed that NIHSS scores at all time points were closely relevant to disability, and could be as an independent risk factor to predict disability, suggesting that the concept that used the "disease" to determine the changes and outcome of disease showed important clinical significance to some degree.
The disability model equations based on NIHSS scores and syndrome factors at different time points showed that qi deficiency entered into the disease-syndrome combination' equations at day 3, day 7, and day 14 and the fire syndrome and yin deficiency into the equation model as independent risk factors at day 90, suggesting that some syndromes could serve as independent risk factors to predict disability and the model of efficacy assessment should be based on the model of disease-syndrome combination.
By using databaseⅡ, we validated the two disability model equations based on only NIHSS scores or both NIHSS scores and syndrome factors at different time points. By comparaing the two models longitudinally we found that both of them can predict disability with AUC>0.7, and this predictive ability was more powerful with the longer course of disease. By comparising the two models horizontally, we found that there were no statistically significant difference in AUC, sensitivity, specificity and Youden index.
4 The evolutionchange of single syndrome factorat different time points means different prognosis The results showed that at day 3 and day 14, the fire syndrome and phlegm and damp syndrome in group syndrome disappearing displayed better outcome than these in group syndrome non-change and sydrome plus, suggesting that at the acute phase of stroke, the condition of stroke and short-term prognosis were mainly influenced by the core syndrome of fire syndrome and phlegm and damp syndrome. At dayl4 and day 28, yin deficiency in group of sydrome plus showed poor prognosis than that in the group of syndrome disappearing, indicating that yin deficiency syndrome had more impact on short-term prognosis than other syndrome. At day 28 and day 90, the wind syndrome in group of sydrome plus showed poor prognosis than that in the group of non-change, and the fire syndrome and qi deficiency in group of sydrome disappearing had better outcome than these in group syndrome non-change; blood stasis syndrome in group of sydrome plus had poor prognosis than in the group non-change and disappearing. These findings suggested that during the late recovery of stroke, the wind syndrome meaned bad prognosis, and we should pay much attention to the treatment of fire syndrome, qi deficiency and blood stasis syndrome. So the state of syndrome should be the core of evaluation of traditional Chinese medicines, and we should pay attention to these dynamic features of syndormes.
Conclusions
Stroke is an acute disease with diverse clinical manifestation, and the conditions in different periods have different characteristics and syndrome features. Current evaluation methods usually focus on "disease" itself and ignore "syndrome", by using such methods it is difficult to make use of the efficacy of unique advantages of Chinese medicine. The results in this study suggest that during the process of evaluation of curative effect, except disease itself, we should pay much more attention to "syndrome" and their dynamic change characteristics in time and space. The system for clinical evaluation of stroke should be mainly based on syndromes and their dynamically spatial and temporal characteristics and combine the disease and the state of syndrome closely.
本研究通过仅从“病”的角度和从“病证结合”的角度进行与缺血性中风结局预后的相关性研究,来评价证候状态对疾病结局预后影响,从而为从病证结合角度进行疗效评价提供依据。研究方法
本研究是“显示中医药疗效优势的中药临床药效评价关键技术研究”(课题编号：2009ZX09502-028)的一部分,根据研究目的,对疾病的评价选用使用最为广泛的NIHSS量表,对证候的判断使用《缺血性中风证候要素诊断量表》,以公认的BI量表为结局指标(残疾与否),使用前期973课题数据,经数据清洗与转化,纳入研究病例755例,从中提取患者一般资料变量18个,不同时点神经科量表测评指标(NIHSS、BI)6个,中医四诊信息变量196个,证候要素变量6个
结果
1不同时点统计方法的优选
使用clementine12.0软件二元分类器依据研究目的选择最大使用参考变量及最大曲线下面积作为方法优选条件排序,自动对不同时点不同统计方法的建模能力优劣进行了优选,可见在不同时点Logistic回归分析方法优于贝叶斯网络、决策树及判别分析等。
2中风病发病90天预后不良因素初筛
随机提取数据库70%的病例作为训练集,采用logistic回归分析方法提取与缺血性中风发病90天预后的相关因素。结果表明与预后相关因素包括年龄、既往是否有中风史、OCSP分型、NIHSS评分及分级、证候要素。其中不同时点有不同的证候要素进入指标的初筛,发病第3天气虚证、发病第7天痰湿证和气虚证、发病第14天气虚证、发病28天内火证和气虚证、发病第90天内风证、内火证、痰湿证、血瘀证、气虚证均进入变量的初筛,提示不同时点的证候要素对观测预后的重要性不一样。同时发现气虚证均进入不同时点的指标初筛,提示气虚证与预后关系显著。
3病和病证结合与预后的相关性研究
构建不同时点NIHSS与残疾的模型方程,研究提示不同时点的NIHSS评分均与残疾密切相关,是残疾预测的独立相关因素,提示围绕“病”的概念去判断疾病的变化与转归的确具有很重要的临床意义。
构建不同时点NIHSS、证候要素与残疾的模型方程,研究发现气虚证在发病第3天、7天、14天均进入了病证结合评价模式模型方程,内火证和阴虚证则在发病第90天进入了该方程模型,分别成为发病90天残疾预测的独立危险因素,说明对证候状态的评价应该进入中风病疗效评价中,中风病疗效评价模式应该采用病证结合模式。
验证不同时点NIHSS与残疾的模型方程以及不同时点NIHSS、证候要素与残疾的模型方程,研究发现,纵向比较2个模型对残疾的预测能力均可,AUC曲线下面积均>0.7,且对结局的预测能力随病程延长总体上呈上升的趋势。横向比较2个模型AUC曲线下面积、敏感度、特异度、Youden指数并无明显的差异,两者相比无统计学意义。
4随时间演变单证候动态改变预后不同
研究显示发病3天和14天的单个证候要素前后比较：内火证、痰湿证证候消失组较证候不变组、证候新增组预后佳,提示在中风病的急性期病程阶段影响病情轻重及近期预后的核心证候主要是内火证与痰湿证。发病14天和28天的单个证候要素前后比较：阴虚证证候新增组较证候消失组预后差,余证候演变与预后无关,提示在恢复早期阴虚证较其他证候更易影响中风病患者的近期预后。发病28天和90天的单个证候要素前后比较：内风证证候新增组较证候不变组预后差；内火证、气虚证证候消失组较证候不变组预后佳；血瘀证证候新增组较较证候不变组、证候消失组预后差。提示到了中风病的恢复后期,若出现内风证不利于患者的近期预后,在治疗干预上则更应重视对内火证、气虚证及血瘀证候的干预。提示对证候状态的评价是建立中药疗效评价的核心,在评价中注意证候动态时空性这一特点。
结论
中风病起病急骤,临床表现多样,病情在不同时点具有不同的特点和不同证候特征,目前评价方法注重对疾病的评价,忽视了对证候的评价,难以显示出中药干预中风病独特的疗效优势。本研究结果提示：对患者进行“病”的评价基础上,更要注意对患者“证”的评价,在“证”评价中要注重其动态时空特点,中风临床疗效评价体系构建应以证候动态时空性特点为核心,将疾病评价与证候状态评价紧密结合。
Accepted western scales are usually used to evaluate the curative effect of patients with stroke in term of "disease" itself. However, with a long therapeutic history and definitely curative effect, the Chinese traditional medicine focuses on the "syndrome" to treat patients and improve their symptoms. It can not be comprehensive, objective and effective to evaluate the curative effect of Chinese medicine to treat stroke only based on "disease" itself. Therefore, combinating of disease and syndrome would be a comprehensive, scientific, objective and accurate method to evaluate the outcomes of patients with stroke.
Objective
In the present study, by comparing the predictive abilities of scales to evaluate the outcomes of patients with ischemic stroke in term of only the "disease" and the combination of "disease and syndrome", to evaluate the effect of syndrome on the outcomes of stroke, and to provide the evidence for evaluation of curative effect in term of combination of disease and syndrome.
Methods
This study is one part of the project "the study of the key technologies in the therapeutic effect evaluation of Chinese herb showing the advantages of the therapeutic effect" (project number:2009ZX09502-028). According to the purpose of the study, NIHSS scale was chosen to evaluate the disease, syndrome factor of ischemic stroke diagnosis scale to evaluate the syndrome and Barthel Index (BI) to evaluate the outcomes(disabled or not). By using the retrospective data analysis method,755 patients were extracted from the data of former project 973 by screening and transforming the data. The variables of patients included general information(18 items), the scores of neurological evaluation scales at different time points (NIHSS, BI) (6 items), TCM four diagnostic factors (196 items) and syndrome factors (6 items).
Results
1 Optimization of statistical methods at different time points
The binary classifier in Clementine 12.0 software was used to evaluate the modeling capability of different statistic methodsbased on the maximum used of fields and the largest area under the curve and the results showed that Logistic regression analysis method was superior to Bayesian networks, decision trees, discriminant analysis.
2 Preliminary screening factors associated with poor outcome 90 days after onset of stroke
70% of cases from the database were extracted randomly as the training subset to screen the factors associated with poor outcome 90 days after onset of stroke by using logistic regression analysis. The results showed that these factors included age, history of stroke, OCSP type, NIHSS score and grading and syndrome factors. Different syndrome factors became preliminary screening factors at different time points. At day 3, it was qi deficiency, day 7 phlegm and damp syndrome and qi deficiency, day 14 qi deficiency, day 28 fire syndrome and qi deficiency, and day 90 wind syndrome, fire syndrome, phlegm and damp syndrome, blood stasis syndrome, qi deficiency, which indicating that different syndrome factors at different time points contribute to the prodiction of prognosis. We also found that qi deficiency has significant relationship with the prognosis.
3 The correlation of disease and disease-syndrome combination with prognosis
The disability model equations based on NIHSS scores at different time points showed that NIHSS scores at all time points were closely relevant to disability, and could be as an independent risk factor to predict disability, suggesting that the concept that used the "disease" to determine the changes and outcome of disease showed important clinical significance to some degree.
The disability model equations based on NIHSS scores and syndrome factors at different time points showed that qi deficiency entered into the disease-syndrome combination' equations at day 3, day 7, and day 14 and the fire syndrome and yin deficiency into the equation model as independent risk factors at day 90, suggesting that some syndromes could serve as independent risk factors to predict disability and the model of efficacy assessment should be based on the model of disease-syndrome combination.
By using databaseⅡ, we validated the two disability model equations based on only NIHSS scores or both NIHSS scores and syndrome factors at different time points. By comparaing the two models longitudinally we found that both of them can predict disability with AUC>0.7, and this predictive ability was more powerful with the longer course of disease. By comparising the two models horizontally, we found that there were no statistically significant difference in AUC, sensitivity, specificity and Youden index.
4 The evolutionchange of single syndrome factorat different time points means different prognosis The results showed that at day 3 and day 14, the fire syndrome and phlegm and damp syndrome in group syndrome disappearing displayed better outcome than these in group syndrome non-change and sydrome plus, suggesting that at the acute phase of stroke, the condition of stroke and short-term prognosis were mainly influenced by the core syndrome of fire syndrome and phlegm and damp syndrome. At dayl4 and day 28, yin deficiency in group of sydrome plus showed poor prognosis than that in the group of syndrome disappearing, indicating that yin deficiency syndrome had more impact on short-term prognosis than other syndrome. At day 28 and day 90, the wind syndrome in group of sydrome plus showed poor prognosis than that in the group of non-change, and the fire syndrome and qi deficiency in group of sydrome disappearing had better outcome than these in group syndrome non-change; blood stasis syndrome in group of sydrome plus had poor prognosis than in the group non-change and disappearing. These findings suggested that during the late recovery of stroke, the wind syndrome meaned bad prognosis, and we should pay much attention to the treatment of fire syndrome, qi deficiency and blood stasis syndrome. So the state of syndrome should be the core of evaluation of traditional Chinese medicines, and we should pay attention to these dynamic features of syndormes.
Conclusions
Stroke is an acute disease with diverse clinical manifestation, and the conditions in different periods have different characteristics and syndrome features. Current evaluation methods usually focus on "disease" itself and ignore "syndrome", by using such methods it is difficult to make use of the efficacy of unique advantages of Chinese medicine. The results in this study suggest that during the process of evaluation of curative effect, except disease itself, we should pay much more attention to "syndrome" and their dynamic change characteristics in time and space. The system for clinical evaluation of stroke should be mainly based on syndromes and their dynamically spatial and temporal characteristics and combine the disease and the state of syndrome closely.
引文
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