苦碟子与单硝酸异山梨酯治疗慢性心力衰竭的疗效比较
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摘要
通过观察苦碟子注射液与单硝酸异山梨酯注射液治疗慢性心力衰竭的临床疗效,比较其在慢性心力衰竭治疗中的治疗效果。将62例住院及门诊慢性心力衰竭的患者随机分为两组,两组患者均进行常规的抗心衰治疗,包括卧床休息、低盐饮食,药物治疗如利尿剂、ACEI或ARB类药物、洋地黄或其他改善症状的正性肌力药等。有感染者选用敏感抗生素等药物联合治疗。治疗组在常规治疗的基础上加用苦碟子注射液(吉林通化华夏药业有限公司生产,国药准字Z20025450)40ml加入5%葡萄糖注射液250ml(糖尿病患者改为木糖醇)中静脉点滴,1次/日,疗程14天。对照组在常规治疗的基础上加用单硝酸异山梨酯注射液(山东鲁南制药厂生产)25mg,加入5%葡萄糖注射液250ml(糖尿病患者改为木糖醇)中静脉点滴,1次/日,疗程14天。观察患者胸闷、气短,呼吸困难,下肢水肿等症状的好转情况,按NYHA进行心功能分级,对治疗前后症状的好转情况及心功能分级变化进行疗效比较,通过治疗前后行心脏彩色多普勒超声检查,观察两组患者治疗前后心脏左室射血分数(EF),左心室舒张末期内径大小及二尖瓣返流情况的改善情况。结果显示治疗组及对照组在临床疗效、改善左室射血分数方面疗效相似,组间比较无显著性差异;两组对于左心室舒张末径均无明显影响,组内治疗前后比较左心室大小无显著性差异;苦碟子治疗组二尖瓣返流显著减少,在改善二尖瓣返流方面疗效优于对照组。说明苦碟子注射液与单硝酸异山梨酯注射液在慢性心力衰竭的辅助治疗中均有效,但苦碟子治疗组二尖瓣返流的改善优于单硝酸异山梨酯治疗组。
CHF is the final results on a variety of chronic cardiovascular diseases. It is very common and critical diseases harming to human health. Because of higher mutilation rate and poorer prognosis, it has become the main cause of the death and workless in patients with cardiovascular diseases. According to the survey of Epidemiology and Prevalence rate in Chinese adult population, which a total of 15 518 adults (ages from 35 to 74) were surveyed; the prevalence of CHF was 0.9 % for the general population and is becoming an important component of the public health problem in China. The mortality of the patients with CHF is related to the cardiac function (NYHA degree) and the clinical symptoms.①It has been established that the mortality in 5 years is 20% of the patients with cardiovascular diseases of cardiac function I.②the mortality in 2.5 years is 25% in patients with cardiac functionⅡorⅢ.③the mortality in 1 year is as high as 50% in patients with cardiac function IV. Improving the quality of life, prolonging life and preventing the progress of the clinical syndrome is the treatment aim of heart failure and must take long-term comprehensive measures such as the treatment of original disease and incentives, regulation of neurohumoral factors and improvement of ventricular function. The final aim is to improve exercise tolerance and quality of life, to prevent and delay the development of left ventricular enlargement, to correct hemodynamic abnormalities, alleviate the symptoms and decrease mortality and hospital admission rate. Nowadays, the strategy to deal with CHF has been radically changed from short-term haemodynamic and pharmacological way (such as Diuretics、Positive inotropic drugs and Vasodilator drugs) to long-term improvement of neurohormonal dysfunction and the remodelling of the ventricle. But improving the symptoms、reducing the cardiac load and pulmonary congestion is still a very important elements in the treatment of CHF. Nitrate drugs can expansion the peripheral venous、pulmonary artery and coronary artery directly on vascular smooth muscle. Therefore it is considered effective vasodilative drugs in the treatment of CHF. The active ingredients of Ixeris sonchifolia Hance injection which consisted of adenosine、flavonoids and isoflavones has been used in patients with ischemic cardiovascular and cerebrovascular disease. Adenosine, one of the active ingredients of the Ixeris sonchifolia hance injection, has shown a clear role not only in expanding coronary artery and peripheral vascular but also in improving myocardial and pulmonary blood supply. Inhibit the generation of oxygen free radicals and cellular calcium overload, Reduce oxygen free radicals and calcium overload- induced cardiomyocyte apoptosis, to reduce the decline of the number of myocardial cells. Adenosine also has the pharmacological effects such as promoting the generation of new capillary、restraining the proliferation and transfer of vascular smooth muscle cells、inhibiting the generation of extracellular matrix and the myocardial fibrosis, which may play a role in improving left ventricular remodeling. So far, clinical studies show that the Ixeris sonchifolia hance injection can significantly improve the dyspnea and heart function in patients with chronic pulmonary heart disease, and it also can improve the hemorrheology and microcirculation status of the patients with chronic pulmonary heart disease.
Objective In this study we observe the curative effect of Ixeris sonchifolia Hance injection in the treatment of chronic heart failure by comparing with Isosorbide mononitrate injection.
Methods 62 patients from the in-patient and the out-patient were randomly divided into curative group and conventional group. The conventional treatment of CHF were gived in both groups, including bed rest、low-salt diet and some drugs such as diuretics、ACEI or ARB drugs、digitalis and so on. 40ml of Ixeris sonchifolia Hance injection which was dissolved in 250ml of 5% glucose or xylitol or 25mg of isosorbide mononitrate injection which was dissolved in 250ml of 5% glucose or xylitol, were respectively gived in curative group or conventional group, once a day for ten or fourteen days. Clinical symptoms such as chest distress、shortness of breath、dyspnea and edema of both lower extremities were observed and the cardiac function of all patients in pre- and post-treatment was evaluated, according to the NYHA classification. Left ventricular ejection fraction、left ventricular end-diastolic diameter and mitral regurgitation were measured in pre- and post-treatmen by the Color Doppler ultrasonography.
Result Compared pre-treatment with post-treatment in LVEF of both groups, there were significant differences (p<0.01). The LVEF of Ixeris sonchifolia Hance injection group was from 28.73±9.72% to 37.35±10.81% and Isosorbide mononitrate injection group was from 28.32±8.87 % to 35.06±10.09%. But no significant difference between groups(P>0.05). LVEDD of Ixeris sonchifolia Hance injection group was not obvious in both groups (p>0.05). Decreased from 64.42±8.13 (mm) to 64.00±7.70 (mm) (p>0.05), And Isosorbide mononitrate injection group decreased from 67.06±8.42 (mm) to 66.32±8.27 (mm) (p>0.05). There is a marked improvement in Ixeris sonchifolia Hance injection group, the mitral regurgitation decreased from 9.00±4.37(cm2)to 5.56±3.88(cm2) (P<0.01), But in conventional group the MR decreased from8.98±5.60(cm2)to 7.68±6.71(cm2)(P>0.05). And there was difference between two groups (P<0.05).
Conclusion First, Both Ixeris sonchifolia Hance injection and Isosorbide mononitrate injection are effective in the treatment of chronic heart failure. There are obviously improvement on clinical symptoms and cardiac function classification. Second, LVEF of two groups was markedly improved from pre-treatment to post-treatment, but there was no difference between groups. However, the mitral regurgitation was obviously improved in Ixeris sonchifolia Hance injection group. Third, as Ixeris sonchifolia Hance injection, it is mitigative and fewer adverse reactions.Thus, it can be used as a substitude for Isosorbide mononitrate injection, when its side effects or contraindication is not underwent by patient.
CHF is the final results on a variety of chronic cardiovascular diseases. It is very common and critical diseases harming to human health. Because of higher mutilation rate and poorer prognosis, it has become the main cause of the death and workless in patients with cardiovascular diseases. According to the survey of Epidemiology and Prevalence rate in Chinese adult population, which a total of 15 518 adults (ages from 35 to 74) were surveyed; the prevalence of CHF was 0.9 % for the general population and is becoming an important component of the public health problem in China. The mortality of the patients with CHF is related to the cardiac function (NYHA degree) and the clinical symptoms.①It has been established that the mortality in 5 years is 20% of the patients with cardiovascular diseases of cardiac function I.②the mortality in 2.5 years is 25% in patients with cardiac functionⅡorⅢ.③the mortality in 1 year is as high as 50% in patients with cardiac function IV. Improving the quality of life, prolonging life and preventing the progress of the clinical syndrome is the treatment aim of heart failure and must take long-term comprehensive measures such as the treatment of original disease and incentives, regulation of neurohumoral factors and improvement of ventricular function. The final aim is to improve exercise tolerance and quality of life, to prevent and delay the development of left ventricular enlargement, to correct hemodynamic abnormalities, alleviate the symptoms and decrease mortality and hospital admission rate. Nowadays, the strategy to deal with CHF has been radically changed from short-term haemodynamic and pharmacological way (such as Diuretics、Positive inotropic drugs and Vasodilator drugs) to long-term improvement of neurohormonal dysfunction and the remodelling of the ventricle. But improving the symptoms、reducing the cardiac load and pulmonary congestion is still a very important elements in the treatment of CHF. Nitrate drugs can expansion the peripheral venous、pulmonary artery and coronary artery directly on vascular smooth muscle. Therefore it is considered effective vasodilative drugs in the treatment of CHF. The active ingredients of Ixeris sonchifolia Hance injection which consisted of adenosine、flavonoids and isoflavones has been used in patients with ischemic cardiovascular and cerebrovascular disease. Adenosine, one of the active ingredients of the Ixeris sonchifolia hance injection, has shown a clear role not only in expanding coronary artery and peripheral vascular but also in improving myocardial and pulmonary blood supply. Inhibit the generation of oxygen free radicals and cellular calcium overload, Reduce oxygen free radicals and calcium overload- induced cardiomyocyte apoptosis, to reduce the decline of the number of myocardial cells. Adenosine also has the pharmacological effects such as promoting the generation of new capillary、restraining the proliferation and transfer of vascular smooth muscle cells、inhibiting the generation of extracellular matrix and the myocardial fibrosis, which may play a role in improving left ventricular remodeling. So far, clinical studies show that the Ixeris sonchifolia hance injection can significantly improve the dyspnea and heart function in patients with chronic pulmonary heart disease, and it also can improve the hemorrheology and microcirculation status of the patients with chronic pulmonary heart disease.
Objective In this study we observe the curative effect of Ixeris sonchifolia Hance injection in the treatment of chronic heart failure by comparing with Isosorbide mononitrate injection.
Methods 62 patients from the in-patient and the out-patient were randomly divided into curative group and conventional group. The conventional treatment of CHF were gived in both groups, including bed rest、low-salt diet and some drugs such as diuretics、ACEI or ARB drugs、digitalis and so on. 40ml of Ixeris sonchifolia Hance injection which was dissolved in 250ml of 5% glucose or xylitol or 25mg of isosorbide mononitrate injection which was dissolved in 250ml of 5% glucose or xylitol, were respectively gived in curative group or conventional group, once a day for ten or fourteen days. Clinical symptoms such as chest distress、shortness of breath、dyspnea and edema of both lower extremities were observed and the cardiac function of all patients in pre- and post-treatment was evaluated, according to the NYHA classification. Left ventricular ejection fraction、left ventricular end-diastolic diameter and mitral regurgitation were measured in pre- and post-treatmen by the Color Doppler ultrasonography.
Result Compared pre-treatment with post-treatment in LVEF of both groups, there were significant differences (p<0.01). The LVEF of Ixeris sonchifolia Hance injection group was from 28.73±9.72% to 37.35±10.81% and Isosorbide mononitrate injection group was from 28.32±8.87 % to 35.06±10.09%. But no significant difference between groups(P>0.05). LVEDD of Ixeris sonchifolia Hance injection group was not obvious in both groups (p>0.05). Decreased from 64.42±8.13 (mm) to 64.00±7.70 (mm) (p>0.05), And Isosorbide mononitrate injection group decreased from 67.06±8.42 (mm) to 66.32±8.27 (mm) (p>0.05). There is a marked improvement in Ixeris sonchifolia Hance injection group, the mitral regurgitation decreased from 9.00±4.37(cm2)to 5.56±3.88(cm2) (P<0.01), But in conventional group the MR decreased from8.98±5.60(cm2)to 7.68±6.71(cm2)(P>0.05). And there was difference between two groups (P<0.05).
Conclusion First, Both Ixeris sonchifolia Hance injection and Isosorbide mononitrate injection are effective in the treatment of chronic heart failure. There are obviously improvement on clinical symptoms and cardiac function classification. Second, LVEF of two groups was markedly improved from pre-treatment to post-treatment, but there was no difference between groups. However, the mitral regurgitation was obviously improved in Ixeris sonchifolia Hance injection group. Third, as Ixeris sonchifolia Hance injection, it is mitigative and fewer adverse reactions.Thus, it can be used as a substitude for Isosorbide mononitrate injection, when its side effects or contraindication is not underwent by patient.
引文
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