黄芪注射液治疗气虚型慢性心力衰竭急性失代偿患者的随机对照临床研究
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摘要
第一部分文献研究
综述了以下内容:1心力衰竭的药物治疗现状。2心力衰竭相关血清蛋白标志物:心力衰竭标志物(BNP)、心血管炎症标志物(hsCRP)、心肌细胞损伤标志物(cTnI)、以及与心室重构有关的基质金属蛋白酶-9(MMP-9)。3评价心功能的又一指标:TEI指数。4黄芪注射液治疗心力衰竭的研究进展。
第二部分试验研究
目的
1评价黄芪注射液治疗气虚型慢性心力衰竭急性失代偿患者(DCHF)的疗效;2探讨黄芪注射液对DCHF的血浆蛋白标志物的影响及不同血浆蛋白标志物与DCHF的相关性;3研究黄芪注射液对气虚型DCHF患者中医症状及证型的影响。
方法
将118例气虚类(含气阴两虚及气阳虚)DCHF患者随机分为试验组60例,对照组58例,试验组予以黄芪注射液结合西医常规治疗,对照组予以西医常规治疗,观察7天,评价两组在超声心动图、BNP、心功能分级、临床表现、血浆蛋白标志物、中医症状和证候等方面的变化。
结果
1试验组对于LVEF(P=.003)、呼吸困难程度(P=.002)、心功能分级改善程度(P=0.044)和Tei指数(P=0.035)的改善优于对照组。疗效评价结果显示试验组疗效优于对照组,黄芪注射液结合西医常规药物治疗DCHF效果优于单纯西医常规药物治疗,黄芪注射液治疗DCHF有效。2在中医症状的改善方面,试验组对于心悸的改善优于对照组(P=0.003),提示除呼吸困难外,黄芪注射液尚可改善慢性心力衰竭急性失代偿的其他多种症状。3试验组对cTnI值的改善优于对照组(P=.041),提示黄芪注射液对于心力衰竭的心肌有保护作用,可以减轻心力衰竭心肌细胞的损伤。4回归分析结果表明MMP-9与心功能分级(P=.001)和BNP(P=.026)均有良好的相关性,表明MMP-9与心力衰竭相关。经药物治疗后心力衰竭患者MMP-9较用药前下降(P＜0.01),提示心室重构的程度经过药物干预是可以好转的。5心力衰竭气虚证、气阴两虚证、气阳虚证有不同特点:扩张性心肌病患者辨证多为气阳虚;气虚证、气阴两虚证、气阳虚证心力衰竭严重程度不同,气阳虚证患者心力衰竭程度最严重。6用药后较基线气虚证和气阳虚证有变化,部分气虚证患者转变为气阴两虚证,部分气阳虚证患者转变为气虚证,证候变化情况在试验组和对照组之间的差异无统计学意义(P＞0.5)。7试验组全部受试者未发生不良事件和药物不良反应。提示黄芪注射液治疗慢性心力衰竭急性失代偿安全性好。
结论
1本试验比较黄芪注射液与5%葡萄糖注射液结合西医常规治疗对DCHF的疗效,结果显示黄芪注射液治疗DCHF有效,可以应用于DCHF及其他急性心力衰竭的治疗。2本试验比较黄芪注射液与5%葡萄糖注射液治疗DCHF的安全性,结果全部受试者未发生不良反应,提示黄芪注射液安全性好。3 MMP-9与心力衰竭相关,是心力衰竭的又一准确性高的血浆蛋白标志物。药物治疗可使心力衰竭患者MMP-9下降,提示心室重构的程度经过药物干预是可以减轻的。4除呼吸困难外,黄芪注射液尚可改善慢性心力衰竭急性失代偿的其他症状如心悸。5心力衰竭气虚证、气阴两虚证、气阳虚证在原发疾病和心力衰竭病情程度上有不同特点:扩张性心肌病患者辨证多为气阳虚;气阳虚证患者心力衰竭程度最严重。6药物治疗后心力衰竭患者的阳虚表现可以得到改善甚至完全缓解,转变为气虚;药物治疗对于心力衰竭患者有伤阴之弊。
The first part-documentation study
This paper provides an overview of the following aspects:1 The current Situation of medication in heart failure.2 Serum Protein Markers correlated to heart failure:BNP、hsCRP、cTnI、MMP-9.3 Another heart function index -TEI index.4 The study progress about Astragalus injection used in heart failure.
The second part-experiment study
OBJECTIVES
1 To observe the clinical efficacy of Astragalus injection in treating acute decompensated chronic heart failure(DCHF).2 To discuss the influence of Astragalus injection to the Serum Protein Markers correlated to heart failure and the correlation of the Serum Protein Markers and DCHF.3 To observe the influence of Astragalus injection to the traditional Chinese Medicine(TCM) symptoms and syndromes of DCHF patients with Qi Deficiency.
METHODS
118 cases with DCHF and Qi Deficiency were randomly assigned to receive conventional therapy(control group)or conventional therapy plus Astragalus injection(treatment group).After 7 days observations,The therapeutic efficacy and adverse reactions were compared between the two groups.
RESULTS
1 There were significant differences between 2 groups in LVEF(P=.003), dyspnea situation(P=.002),cardiac function grade improvement(P=0.044) and Tel index(P=0.035) In treatment group showed better improvement than in control group.2 About the improvement of TCM symptoms,There were significant differences between 2 groups in cardiopalmus(P=.003).In treatment group showed better improvement than in control group.3 There were significant differences between 2 groups in cTnI(P=.041).In treatment group showed better improvement than in control group.That means Astragalus injection afect myocardium of patients with heart failure protectively.So Astragalus injection can help relief damnification of myocardium cells in patients with heart failure.4 Results of regression analysis show that MMP-9 is corelated with classification of heart function(P=.001) and BNP (P=.026).That means MMP-9 is corelated with heart failure.After medication, MMP-9 in patients with heart failure declined(P＜0.01),which means the degree of ventricular remodeling could be improved by medication.5 the different characteristic of Qi Deficiency syndrome、Qi-Yin Deficiency Syndrome、Qi-Yang Deficiency Syndrome in DCHF patients include the following aspects:dilated cardiomyopathy patients always have Qi-Yang Deficiency Syndrome.ln the three syndromes,the degree of heart failure is most serous in Qi-Yang Deficiency Syndrome.6 After medication,Qi Deficiency syndrome and Qi-Yang Deficiency Syndrome changed,some subjects with Qi Deficiency Syndrome turned to with Qi-Yin Deficiency Syndrome,some subjects with Qi-Yang Deficiency Syndrome turned to with Qi Deficiency Syndrome,There were no significant differences between 2 groups in changes of Syndrome(P＞0.5).7 There was no adverse Event and adverse reactions to drug happened.
Conclusions
1 In this examination,we compared Astragalus injection with 5%glucose injection in the efect to DCHF,the result showed that Astragalus injection can effectively improve heart function in DCHF patients.2 In the examination,we compared Astragalus injection with 5%glucose injection in the security,the result was no Adverse Event happened,which showes that Astragalus injection has good security.3 MMP-9 is corelated with heart failure.MMP-9 in in patients with heart failure declined after medication,which means the degree of ventricular remodeling could be improved by medication.4 except for dyspnea,Astragalus injection also can help improve other symptom of DCHF such as cardiopalmus.5 In Qi Deficiency Syndrome、Qi-Yin Deficiency Syndrome and Qi-Yang Deficiency Syndrome.dilated cardiomyopathy patients always have Qi-Yang Deficiency Syndrome.In the three syndromes,the degree of heart failure is most serous in Qi-Yang Deficiency Syndrome.6 After medication,Yang Deficiency Syndrome may be improved even completly remissed and turned to Qi Deficiency Syndrome;After medication,Yin may be injured in DCHF patients.
综述了以下内容:1心力衰竭的药物治疗现状。2心力衰竭相关血清蛋白标志物:心力衰竭标志物(BNP)、心血管炎症标志物(hsCRP)、心肌细胞损伤标志物(cTnI)、以及与心室重构有关的基质金属蛋白酶-9(MMP-9)。3评价心功能的又一指标:TEI指数。4黄芪注射液治疗心力衰竭的研究进展。
第二部分试验研究
目的
1评价黄芪注射液治疗气虚型慢性心力衰竭急性失代偿患者(DCHF)的疗效;2探讨黄芪注射液对DCHF的血浆蛋白标志物的影响及不同血浆蛋白标志物与DCHF的相关性;3研究黄芪注射液对气虚型DCHF患者中医症状及证型的影响。
方法
将118例气虚类(含气阴两虚及气阳虚)DCHF患者随机分为试验组60例,对照组58例,试验组予以黄芪注射液结合西医常规治疗,对照组予以西医常规治疗,观察7天,评价两组在超声心动图、BNP、心功能分级、临床表现、血浆蛋白标志物、中医症状和证候等方面的变化。
结果
1试验组对于LVEF(P=.003)、呼吸困难程度(P=.002)、心功能分级改善程度(P=0.044)和Tei指数(P=0.035)的改善优于对照组。疗效评价结果显示试验组疗效优于对照组,黄芪注射液结合西医常规药物治疗DCHF效果优于单纯西医常规药物治疗,黄芪注射液治疗DCHF有效。2在中医症状的改善方面,试验组对于心悸的改善优于对照组(P=0.003),提示除呼吸困难外,黄芪注射液尚可改善慢性心力衰竭急性失代偿的其他多种症状。3试验组对cTnI值的改善优于对照组(P=.041),提示黄芪注射液对于心力衰竭的心肌有保护作用,可以减轻心力衰竭心肌细胞的损伤。4回归分析结果表明MMP-9与心功能分级(P=.001)和BNP(P=.026)均有良好的相关性,表明MMP-9与心力衰竭相关。经药物治疗后心力衰竭患者MMP-9较用药前下降(P＜0.01),提示心室重构的程度经过药物干预是可以好转的。5心力衰竭气虚证、气阴两虚证、气阳虚证有不同特点:扩张性心肌病患者辨证多为气阳虚;气虚证、气阴两虚证、气阳虚证心力衰竭严重程度不同,气阳虚证患者心力衰竭程度最严重。6用药后较基线气虚证和气阳虚证有变化,部分气虚证患者转变为气阴两虚证,部分气阳虚证患者转变为气虚证,证候变化情况在试验组和对照组之间的差异无统计学意义(P＞0.5)。7试验组全部受试者未发生不良事件和药物不良反应。提示黄芪注射液治疗慢性心力衰竭急性失代偿安全性好。
结论
1本试验比较黄芪注射液与5%葡萄糖注射液结合西医常规治疗对DCHF的疗效,结果显示黄芪注射液治疗DCHF有效,可以应用于DCHF及其他急性心力衰竭的治疗。2本试验比较黄芪注射液与5%葡萄糖注射液治疗DCHF的安全性,结果全部受试者未发生不良反应,提示黄芪注射液安全性好。3 MMP-9与心力衰竭相关,是心力衰竭的又一准确性高的血浆蛋白标志物。药物治疗可使心力衰竭患者MMP-9下降,提示心室重构的程度经过药物干预是可以减轻的。4除呼吸困难外,黄芪注射液尚可改善慢性心力衰竭急性失代偿的其他症状如心悸。5心力衰竭气虚证、气阴两虚证、气阳虚证在原发疾病和心力衰竭病情程度上有不同特点:扩张性心肌病患者辨证多为气阳虚;气阳虚证患者心力衰竭程度最严重。6药物治疗后心力衰竭患者的阳虚表现可以得到改善甚至完全缓解,转变为气虚;药物治疗对于心力衰竭患者有伤阴之弊。
The first part-documentation study
This paper provides an overview of the following aspects:1 The current Situation of medication in heart failure.2 Serum Protein Markers correlated to heart failure:BNP、hsCRP、cTnI、MMP-9.3 Another heart function index -TEI index.4 The study progress about Astragalus injection used in heart failure.
The second part-experiment study
OBJECTIVES
1 To observe the clinical efficacy of Astragalus injection in treating acute decompensated chronic heart failure(DCHF).2 To discuss the influence of Astragalus injection to the Serum Protein Markers correlated to heart failure and the correlation of the Serum Protein Markers and DCHF.3 To observe the influence of Astragalus injection to the traditional Chinese Medicine(TCM) symptoms and syndromes of DCHF patients with Qi Deficiency.
METHODS
118 cases with DCHF and Qi Deficiency were randomly assigned to receive conventional therapy(control group)or conventional therapy plus Astragalus injection(treatment group).After 7 days observations,The therapeutic efficacy and adverse reactions were compared between the two groups.
RESULTS
1 There were significant differences between 2 groups in LVEF(P=.003), dyspnea situation(P=.002),cardiac function grade improvement(P=0.044) and Tel index(P=0.035) In treatment group showed better improvement than in control group.2 About the improvement of TCM symptoms,There were significant differences between 2 groups in cardiopalmus(P=.003).In treatment group showed better improvement than in control group.3 There were significant differences between 2 groups in cTnI(P=.041).In treatment group showed better improvement than in control group.That means Astragalus injection afect myocardium of patients with heart failure protectively.So Astragalus injection can help relief damnification of myocardium cells in patients with heart failure.4 Results of regression analysis show that MMP-9 is corelated with classification of heart function(P=.001) and BNP (P=.026).That means MMP-9 is corelated with heart failure.After medication, MMP-9 in patients with heart failure declined(P＜0.01),which means the degree of ventricular remodeling could be improved by medication.5 the different characteristic of Qi Deficiency syndrome、Qi-Yin Deficiency Syndrome、Qi-Yang Deficiency Syndrome in DCHF patients include the following aspects:dilated cardiomyopathy patients always have Qi-Yang Deficiency Syndrome.ln the three syndromes,the degree of heart failure is most serous in Qi-Yang Deficiency Syndrome.6 After medication,Qi Deficiency syndrome and Qi-Yang Deficiency Syndrome changed,some subjects with Qi Deficiency Syndrome turned to with Qi-Yin Deficiency Syndrome,some subjects with Qi-Yang Deficiency Syndrome turned to with Qi Deficiency Syndrome,There were no significant differences between 2 groups in changes of Syndrome(P＞0.5).7 There was no adverse Event and adverse reactions to drug happened.
Conclusions
1 In this examination,we compared Astragalus injection with 5%glucose injection in the efect to DCHF,the result showed that Astragalus injection can effectively improve heart function in DCHF patients.2 In the examination,we compared Astragalus injection with 5%glucose injection in the security,the result was no Adverse Event happened,which showes that Astragalus injection has good security.3 MMP-9 is corelated with heart failure.MMP-9 in in patients with heart failure declined after medication,which means the degree of ventricular remodeling could be improved by medication.4 except for dyspnea,Astragalus injection also can help improve other symptom of DCHF such as cardiopalmus.5 In Qi Deficiency Syndrome、Qi-Yin Deficiency Syndrome and Qi-Yang Deficiency Syndrome.dilated cardiomyopathy patients always have Qi-Yang Deficiency Syndrome.In the three syndromes,the degree of heart failure is most serous in Qi-Yang Deficiency Syndrome.6 After medication,Yang Deficiency Syndrome may be improved even completly remissed and turned to Qi Deficiency Syndrome;After medication,Yin may be injured in DCHF patients.
引文
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