慢性心衰中西医疗效评价指标的相关性研究
发布时间：2018-07-24 17:45
【摘要】：研究背景 慢性心力衰竭,简称慢性心衰,是心血管疾病发展的最终阶段。提高慢性心衰的临床疗效是21世纪医学界面临的重大课题,而中医药是否有疗效是核心问题,寻找合适替代指标成为中西医结合评价研究的关键。课题组前期研究成果——疾病特异性量表《慢性心衰中西医结合生存质量量表》,具有鲜明的中医药特色,能够为疗效评价提供了切实可靠的工具。 研究目的： 本研究在前期首都科技发展基金课题《慢性心衰中西医结合生存质量评价量表的研究》及国家行业科研专项《慢性心衰社区普适中医诊治方案》成果的基础上,研究生存质量量表及中医症状计分量表与现代医学理化指标及结局终点指标之间相关性,从而为慢性心衰中西医结合疗效评价体系的建立提供依据。 研究方法： (1)采用流行病学调查方法,于2013年2月至2014年2月,对北京市5家医院内符合纳入标准的211名慢性心力衰竭住院患者,在患者知情同意基础上进行中医症状计分、生存质量、理化检查指标、6MWT、心血管事件的调查与再调查,建立疗效评价指标的数据库。 (2)采用量表研制的方法,在国家中医药管理局行业科研专项《慢性心衰社区普适中医诊治方案》研究自制的症状计分表的基础上,采用离散趋势法、相关系数分析法、选项反应度分析法、克朗巴赫α系数法对56个初表条目进行筛选,研制《慢性心衰中医症状计分量表》,并对筛选出的量表进行信度、效度及反应度测评。 (3)采用pearson相关分析或spearmar湘关分析的方法,研究《慢性心衰中医症状计分量表》及《慢性心衰中西医结合生存质量量表》与现代医学公认的NT-proBNP、LVEF、心功能(NYHA)分级、6MWT步行距离4个指标相关性。 (4)按是否发生心血管事件(再住院、急性冠脉综合征、恶性心律失常、死亡)分组,采用两个独立样本t检验或秩和检验的方法及二分类的logistic回归分析,分析《慢性心衰中医症状计分量表》得分、《慢性心衰中西医结合生存质量量表》得分、NT-proBNP、LVEF、心功能(NYHA)分级、6MWT步行距离与心血管事件发生是否相关。 研究结果： (1)经筛选共有36个条目入选《慢性心衰中医症状计分量表》,经考评,《慢性心衰中医症状计分量表》各条目应答率均高于85%,克朗巴赫α系数为0.924,高于0.8；分半信度为0.897,高于0.7。慢性心衰中医症状计分量表转化分与心功能NYHA分级spearman相关系数为0.413,P值小于0.01,表明量表的标准效度较好；36个条目与本领域的相关系数均大于与其他领域的相关系数,且与本领域的相关系数均大于0.4,且除脾胃与腹部症状领域(E领域)外,其领域的克朗巴赫α系数大于本领域与其他领域的相关系数,说明该量表具有较好的内容效度；经主成分因子分析法分析,各条目中与9个公因子的因子载荷大于0.4的主成分分布与慢性心衰中医证候要素分布基本吻合,表明量表结构效度也较好。 (2)将患者治疗前后的LVEF、NT-proBNP、6分钟步行距离、中医症状计分量表得分及慢性心衰生存质量量表得分进行配对t检验或配对样本的秩和检验,结果显示：除LVEF外,其他4个疗效评价指标前后均值均有显著差异,将LVEF结果进行亚组分析,发现LVEF≤40%患者其LVEF在治疗前后有显著差异。 (3)将中医症状计分量表得分及慢性心衰生存质量量表得分与LVEF、NT-proBNP、6分钏步行距离、心功能NYHA分级进行相关性分析。结果显示：除LVEF与6MWT步行距离及中医症状计分量表得分这两组无显著相关性外,其余各指标之间均具有显著相关性。 (4)将中医症状计分量表得分及慢性心衰生存质量量表得分与LVEF、NT-proBNP、6分钟步行距离、心功能NYHA分级与6个月心血管事件(再住院、急性冠脉综合征、恶性心律失常、死亡)进行统计学分析,提示除6MWT步行距离外,其余指标与6个月心血管事件发生均相关。 研究结论： 《慢性心衰中医症状计分量表》具有较好的信度、效度和反应度,临床可操作性强,患者易于接受。《慢性心衰中医症状计分量表》及《慢性心衰中西医结合生存质量量表》与现代医学公认的LVEF、NT-proBNP、6分钟步行距离、心功能NYHA分级及心血管事件相关性较显著,可以作为慢性心衰中西医结合疗效评价的指标。
[Abstract]:Research background
Chronic heart failure, referred to as chronic heart failure, is the final stage of the development of cardiovascular disease. To improve the clinical efficacy of chronic heart failure is a major issue in the medical field in twenty-first Century, and whether the curative effect of traditional Chinese medicine is the core problem and the key to the study of integrated Chinese and Western medicine is the key to the study of the combination of traditional Chinese and Western medicine. The Disease Specificity Scale has distinct characteristics of traditional Chinese medicine and can provide a practical and reliable tool for the evaluation of curative effect.
The purpose of the study is:
On the basis of the previous capital science and technology development fund, the study of the quality of life assessment of chronic heart failure combined with the quality of life assessment of Chinese and Western medicine and the results of the national professional scientific research program of the community of chronic heart failure in the community of traditional Chinese medicine, the quality of life scale and the symptom score scale of traditional Chinese medicine and modern medical physicochemical indexes and endpoint end points were studied. The correlation between them provides the basis for the establishment of the evaluation system of the curative effect of integrated traditional Chinese and Western Medicine on chronic heart failure.
Research methods:
(1) from February 2013 to February 2014, 211 hospitalized patients with chronic heart failure in 5 hospitals in Beijing were selected by epidemiological investigation methods. On the basis of informed consent of the patients, the symptoms score, quality of life, physical and chemical examination index, 6MWT, the investigation and re investigation of cardiovascular events were carried out, and the evaluation index of the curative effect was established. Database.
(2) by using the method of scale development, on the basis of the national traditional Chinese Medicine Management Bureau of the State Administration of traditional Chinese medicine (TCM) for the diagnosis and treatment of chronic heart failure in the community of traditional Chinese medicine, the discrete trend method, the correlation coefficient analysis method, the option reactivity analysis method and the Chan bherh alpha coefficient method were used to screen the 56 initial items. The reliability, validity and responsiveness of the selected scale were evaluated.
(3) using the method of Pearson correlation analysis or spearmar Xiang Guan analysis, we studied the TCM symptom score scale of chronic heart failure and the quality of life of chronic heart failure combined with Chinese and Western medicine, and the classification of NT-proBNP, LVEF, cardiac function (NYHA) and 6MWT walking distance, and the correlation of the distance between 6MWT walking distance.
(4) according to the group of cardiovascular events (rehospitalization, acute coronary syndrome, malignant arrhythmia, death), two independent samples t test or rank sum test and two classification of logistic regression analysis were used to analyze the score of TCM symptom score scale for chronic heart failure, the score of quality of life for chronic heart failure combined with Chinese and Western medicine, NT-p RoBNP, LVEF, NYHA grading, and 6 MWT walking distance were associated with cardiovascular events.
The results of the study:
(1) after screening a total of 36 entries in the "TCM symptom score scale of chronic heart failure", after evaluation, the response rate of each item in the TCM symptom score scale of chronic heart failure was higher than 85%, the alpha coefficient of Cronbach was 0.924, higher than 0.8, and the half reliability was 0.897, higher than the 0.7. classification of the symptom score scale of the chronic heart failure and the NYHA classification of heart function spearma The N correlation coefficient is 0.413 and the P value is less than 0.01, indicating that the standard validity of the scale is better. The correlation coefficient between the 36 items and this field is greater than that in other fields, and the correlation coefficient of the field is greater than 0.4, and the Krone Bach alpha coefficient in the field is greater than that in the field and other collar except for the spleen and stomach and the abdominal symptom field (E field). The correlation coefficient of the domain shows that the scale has good content validity, and the principal component analysis by the principal component factor analysis shows that the principal component distribution of each item and the factor load of 9 common factors more than 0.4 is basically consistent with the distribution of TCM syndrome factors in chronic heart failure, which indicates that the structure validity of the scale is also better.
(2) the LVEF, NT-proBNP, 6 minute walking distance, TCM symptom score scale score and the score of chronic heart failure quality of life were tested by paired t test or paired sample test before and after the treatment. The results showed that there were significant differences in the mean values before and after the other 4 evaluation indexes except LVEF, and the subgroup analysis of the LVEF results was carried out. It was found that the LVEF of patients with LVEF < 40% had significant difference before and after treatment.
(3) the correlation analysis between the score of TCM symptom score scale and the score of chronic heart failure quality of life and the walking distance of LVEF, NT-proBNP, 6 kchuan and the NYHA classification of cardiac function was analyzed. The results showed that there was a significant phase between the two groups except the distance between the walking distance of LVEF and 6MWT and the score of the TCM symptom score scale. Customs.
(4) the score of TCM symptom score scale and the scores of chronic heart failure quality of life scale and LVEF, NT-proBNP, 6 minute walking distance, cardiac function NYHA classification and 6 month cardiovascular events (rehospitalization, acute coronary syndrome, malignant arrhythmia, death) were analyzed statistically, indicating that the other indexes and 6 month cardiovascular events except the 6MWT walking distance. The events were all related.
The conclusions are as follows:
"TCM symptom score scale for chronic heart failure" has good reliability, validity and responsiveness, strong clinical operability, patients easy to accept. < chronic heart failure TCM symptom score scale > and < chronic heart failure with Chinese and Western medicine combined quality scale > LVEF, NT-proBNP, 6 minute walk distance, NYHA classification and cardiovascular function of heart function Event correlation is more significant, and can be used as an indicator for evaluating the efficacy of integrated traditional Chinese and Western medicine for chronic heart failure.
【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R541.6
本文编号：2142160
[Abstract]:Research background
Chronic heart failure, referred to as chronic heart failure, is the final stage of the development of cardiovascular disease. To improve the clinical efficacy of chronic heart failure is a major issue in the medical field in twenty-first Century, and whether the curative effect of traditional Chinese medicine is the core problem and the key to the study of integrated Chinese and Western medicine is the key to the study of the combination of traditional Chinese and Western medicine. The Disease Specificity Scale
The purpose of the study is:
On the basis of the previous capital science and technology development fund, the study of the quality of life assessment of chronic heart failure combined with the quality of life assessment of Chinese and Western medicine and the results of the national professional scientific research program of the community of chronic heart failure in the community of traditional Chinese medicine, the quality of life scale and the symptom score scale of traditional Chinese medicine and modern medical physicochemical indexes and endpoint end points were studied. The correlation between them provides the basis for the establishment of the evaluation system of the curative effect of integrated traditional Chinese and Western Medicine on chronic heart failure.
Research methods:
(1) from February 2013 to February 2014, 211 hospitalized patients with chronic heart failure in 5 hospitals in Beijing were selected by epidemiological investigation methods. On the basis of informed consent of the patients, the symptoms score, quality of life, physical and chemical examination index, 6MWT, the investigation and re investigation of cardiovascular events were carried out, and the evaluation index of the curative effect was established. Database.
(2) by using the method of scale development, on the basis of the national traditional Chinese Medicine Management Bureau of the State Administration of traditional Chinese medicine (TCM) for the diagnosis and treatment of chronic heart failure in the community of traditional Chinese medicine, the discrete trend method, the correlation coefficient analysis method, the option reactivity analysis method and the Chan bherh alpha coefficient method were used to screen the 56 initial items. The reliability, validity and responsiveness of the selected scale were evaluated.
(3) using the method of Pearson correlation analysis or spearmar Xiang Guan analysis, we studied the TCM symptom score scale of chronic heart failure and the quality of life of chronic heart failure combined with Chinese and Western medicine, and the classification of NT-proBNP, LVEF, cardiac function (NYHA) and 6MWT walking distance, and the correlation of the distance between 6MWT walking distance.
(4) according to the group of cardiovascular events (rehospitalization, acute coronary syndrome, malignant arrhythmia, death), two independent samples t test or rank sum test and two classification of logistic regression analysis were used to analyze the score of TCM symptom score scale for chronic heart failure, the score of quality of life for chronic heart failure combined with Chinese and Western medicine, NT-p RoBNP, LVEF, NYHA grading, and 6 MWT walking distance were associated with cardiovascular events.
The results of the study:
(1) after screening a total of 36 entries in the "TCM symptom score scale of chronic heart failure", after evaluation, the response rate of each item in the TCM symptom score scale of chronic heart failure was higher than 85%, the alpha coefficient of Cronbach was 0.924, higher than 0.8, and the half reliability was 0.897, higher than the 0.7. classification of the symptom score scale of the chronic heart failure and the NYHA classification of heart function spearma The N correlation coefficient is 0.413 and the P value is less than 0.01, indicating that the standard validity of the scale is better. The correlation coefficient between the 36 items and this field is greater than that in other fields, and the correlation coefficient of the field is greater than 0.4, and the Krone Bach alpha coefficient in the field is greater than that in the field and other collar except for the spleen and stomach and the abdominal symptom field (E field). The correlation coefficient of the domain shows that the scale has good content validity, and the principal component analysis by the principal component factor analysis shows that the principal component distribution of each item and the factor load of 9 common factors more than 0.4 is basically consistent with the distribution of TCM syndrome factors in chronic heart failure, which indicates that the structure validity of the scale is also better.
(2) the LVEF, NT-proBNP, 6 minute walking distance, TCM symptom score scale score and the score of chronic heart failure quality of life were tested by paired t test or paired sample test before and after the treatment. The results showed that there were significant differences in the mean values before and after the other 4 evaluation indexes except LVEF, and the subgroup analysis of the LVEF results was carried out. It was found that the LVEF of patients with LVEF < 40% had significant difference before and after treatment.
(3) the correlation analysis between the score of TCM symptom score scale and the score of chronic heart failure quality of life and the walking distance of LVEF, NT-proBNP, 6 kchuan and the NYHA classification of cardiac function was analyzed. The results showed that there was a significant phase between the two groups except the distance between the walking distance of LVEF and 6MWT and the score of the TCM symptom score scale. Customs.
(4) the score of TCM symptom score scale and the scores of chronic heart failure quality of life scale and LVEF, NT-proBNP, 6 minute walking distance, cardiac function NYHA classification and 6 month cardiovascular events (rehospitalization, acute coronary syndrome, malignant arrhythmia, death) were analyzed statistically, indicating that the other indexes and 6 month cardiovascular events except the 6MWT walking distance. The events were all related.
The conclusions are as follows:
"TCM symptom score scale for chronic heart failure" has good reliability, validity and responsiveness, strong clinical operability, patients easy to accept. < chronic heart failure TCM symptom score scale > and < chronic heart failure with Chinese and Western medicine combined quality scale > LVEF, NT-proBNP, 6 minute walk distance, NYHA classification and cardiovascular function of heart function Event correlation is more significant, and can be used as an indicator for evaluating the efficacy of integrated traditional Chinese and Western medicine for chronic heart failure.
【学位授予单位】：北京中医药大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R541.6
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