慢性心衰中西醫(yī)療效評(píng)價(jià)指標(biāo)的相關(guān)性研究
發(fā)布時(shí)間：2018-07-24 17:45
【摘要】：研究背景 慢性心力衰竭,簡稱慢性心衰,是心血管疾病發(fā)展的最終階段。提高慢性心衰的臨床療效是21世紀(jì)醫(yī)學(xué)界面臨的重大課題,而中醫(yī)藥是否有療效是核心問題,尋找合適替代指標(biāo)成為中西醫(yī)結(jié)合評(píng)價(jià)研究的關(guān)鍵。課題組前期研究成果——疾病特異性量表《慢性心衰中西醫(yī)結(jié)合生存質(zhì)量量表》,具有鮮明的中醫(yī)藥特色,能夠?yàn)榀熜гu(píng)價(jià)提供了切實(shí)可靠的工具。 研究目的： 本研究在前期首都科技發(fā)展基金課題《慢性心衰中西醫(yī)結(jié)合生存質(zhì)量評(píng)價(jià)量表的研究》及國家行業(yè)科研專項(xiàng)《慢性心衰社區(qū)普適中醫(yī)診治方案》成果的基礎(chǔ)上,研究生存質(zhì)量量表及中醫(yī)癥狀計(jì)分量表與現(xiàn)代醫(yī)學(xué)理化指標(biāo)及結(jié)局終點(diǎn)指標(biāo)之間相關(guān)性,從而為慢性心衰中西醫(yī)結(jié)合療效評(píng)價(jià)體系的建立提供依據(jù)。 研究方法： (1)采用流行病學(xué)調(diào)查方法,于2013年2月至2014年2月,對(duì)北京市5家醫(yī)院內(nèi)符合納入標(biāo)準(zhǔn)的211名慢性心力衰竭住院患者,在患者知情同意基礎(chǔ)上進(jìn)行中醫(yī)癥狀計(jì)分、生存質(zhì)量、理化檢查指標(biāo)、6MWT、心血管事件的調(diào)查與再調(diào)查,建立療效評(píng)價(jià)指標(biāo)的數(shù)據(jù)庫。 (2)采用量表研制的方法,在國家中醫(yī)藥管理局行業(yè)科研專項(xiàng)《慢性心衰社區(qū)普適中醫(yī)診治方案》研究自制的癥狀計(jì)分表的基礎(chǔ)上,采用離散趨勢(shì)法、相關(guān)系數(shù)分析法、選項(xiàng)反應(yīng)度分析法、克朗巴赫α系數(shù)法對(duì)56個(gè)初表?xiàng)l目進(jìn)行篩選,研制《慢性心衰中醫(yī)癥狀計(jì)分量表》,并對(duì)篩選出的量表進(jìn)行信度、效度及反應(yīng)度測(cè)評(píng)。 (3)采用pearson相關(guān)分析或spearmar湘關(guān)分析的方法,研究《慢性心衰中醫(yī)癥狀計(jì)分量表》及《慢性心衰中西醫(yī)結(jié)合生存質(zhì)量量表》與現(xiàn)代醫(yī)學(xué)公認(rèn)的NT-proBNP、LVEF、心功能(NYHA)分級(jí)、6MWT步行距離4個(gè)指標(biāo)相關(guān)性。 (4)按是否發(fā)生心血管事件(再住院、急性冠脈綜合征、惡性心律失常、死亡)分組,采用兩個(gè)獨(dú)立樣本t檢驗(yàn)或秩和檢驗(yàn)的方法及二分類的logistic回歸分析,分析《慢性心衰中醫(yī)癥狀計(jì)分量表》得分、《慢性心衰中西醫(yī)結(jié)合生存質(zhì)量量表》得分、NT-proBNP、LVEF、心功能(NYHA)分級(jí)、6MWT步行距離與心血管事件發(fā)生是否相關(guān)。 研究結(jié)果： (1)經(jīng)篩選共有36個(gè)條目入選《慢性心衰中醫(yī)癥狀計(jì)分量表》,經(jīng)考評(píng),《慢性心衰中醫(yī)癥狀計(jì)分量表》各條目應(yīng)答率均高于85%,克朗巴赫α系數(shù)為0.924,高于0.8；分半信度為0.897,高于0.7。慢性心衰中醫(yī)癥狀計(jì)分量表轉(zhuǎn)化分與心功能NYHA分級(jí)spearman相關(guān)系數(shù)為0.413,P值小于0.01,表明量表的標(biāo)準(zhǔn)效度較好；36個(gè)條目與本領(lǐng)域的相關(guān)系數(shù)均大于與其他領(lǐng)域的相關(guān)系數(shù),且與本領(lǐng)域的相關(guān)系數(shù)均大于0.4,且除脾胃與腹部癥狀領(lǐng)域(E領(lǐng)域)外,其領(lǐng)域的克朗巴赫α系數(shù)大于本領(lǐng)域與其他領(lǐng)域的相關(guān)系數(shù),說明該量表具有較好的內(nèi)容效度；經(jīng)主成分因子分析法分析,各條目中與9個(gè)公因子的因子載荷大于0.4的主成分分布與慢性心衰中醫(yī)證候要素分布基本吻合,表明量表結(jié)構(gòu)效度也較好。 (2)將患者治療前后的LVEF、NT-proBNP、6分鐘步行距離、中醫(yī)癥狀計(jì)分量表得分及慢性心衰生存質(zhì)量量表得分進(jìn)行配對(duì)t檢驗(yàn)或配對(duì)樣本的秩和檢驗(yàn),結(jié)果顯示：除LVEF外,其他4個(gè)療效評(píng)價(jià)指標(biāo)前后均值均有顯著差異,將LVEF結(jié)果進(jìn)行亞組分析,發(fā)現(xiàn)LVEF≤40%患者其LVEF在治療前后有顯著差異。 (3)將中醫(yī)癥狀計(jì)分量表得分及慢性心衰生存質(zhì)量量表得分與LVEF、NT-proBNP、6分釧步行距離、心功能NYHA分級(jí)進(jìn)行相關(guān)性分析。結(jié)果顯示：除LVEF與6MWT步行距離及中醫(yī)癥狀計(jì)分量表得分這兩組無顯著相關(guān)性外,其余各指標(biāo)之間均具有顯著相關(guān)性。 (4)將中醫(yī)癥狀計(jì)分量表得分及慢性心衰生存質(zhì)量量表得分與LVEF、NT-proBNP、6分鐘步行距離、心功能NYHA分級(jí)與6個(gè)月心血管事件(再住院、急性冠脈綜合征、惡性心律失常、死亡)進(jìn)行統(tǒng)計(jì)學(xué)分析,提示除6MWT步行距離外,其余指標(biāo)與6個(gè)月心血管事件發(fā)生均相關(guān)。 研究結(jié)論： 《慢性心衰中醫(yī)癥狀計(jì)分量表》具有較好的信度、效度和反應(yīng)度,臨床可操作性強(qiáng),患者易于接受�！堵孕乃ブ嗅t(yī)癥狀計(jì)分量表》及《慢性心衰中西醫(yī)結(jié)合生存質(zhì)量量表》與現(xiàn)代醫(yī)學(xué)公認(rèn)的LVEF、NT-proBNP、6分鐘步行距離、心功能NYHA分級(jí)及心血管事件相關(guān)性較顯著,可以作為慢性心衰中西醫(yī)結(jié)合療效評(píng)價(jià)的指標(biāo)。
[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.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2014
【分類號(hào)】：R541.6
本文編號(hào)：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.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2014
【分類號(hào)】：R541.6
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