温阳方对心衰心阳虚证RAAS系统干预作用的临床研究
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摘要
研究背景
     充血性心力衰竭是在临床上非常多见的各种心脏疾病导致心功能不全的综合征,是大多数心血管疾病的最终归宿,也是最主要的死亡原因。尽管医学诊疗技术不断进步,心衰的发生率反而有逐年增高的趋势。
     当代对心力衰竭生理病理机制的不断深入的研究发现,神经内分泌细胞因子系统的长期、慢性激活促进心肌重塑,加重心肌损伤和功能变化,是心力衰竭发生的基本机制。故现代治疗心力衰竭的关键在于阻断相关神经内分泌系统,防止心肌重塑,以延缓心力衰竭的发展。
     近年来肾素一血管紧张素一醛固酮系统(RAAS)在心力衰竭的生理病理机制上的作用已得到肯定。故西医治疗多采用血管紧张素转化酶抑制剂等治疗心衰,1987年应用血管紧张素转换酶抑制剂(ACEI)治疗心衰的临床试验,更是奠定了RAAS系统抑制剂治疗心衰的基础。
     祖国传统医学认为,心衰,病位主要在心,为本虚标实之证,本虚以气虚、阳虚为主,标实以瘀血、痰饮居多。本虚(心气阳亏虚)是心衰发病的关键,是心衰发作的初始因素,并贯穿整个心衰的病理过程,而且是导致水肿的主要原因。故大多数医家认为气虚阳虚是心衰中医辨证的纲领,而治疗上多采用温阳益气的治疗原则。
     我国著名老中医颜德馨教授在长期的心衰治疗的临床实践中,认为阳为一生之主宰,得之则明,失之则不彰;心体阴而用阳,心之气阳虚衰即为心功能的衰退;心衰为本虚标实之证,其病机关键点为心气阳虚,“有一分阳气,便有一分生机”。颜德馨教授在临床上制定出温阳方治疗心衰,通过大规模的临床试验证实,温阳方能明显改善患者的心衰症状和心功能,但尚未能明确其具体作用机制。
     研究目的
     系统分析温阳方干预心衰心阳虚证患者前的中医症状、舌、脉的情况及干预前患者RAAS系统指标,并分析温阳方干预心衰心阳虚证患者后患者的中医症状、舌、脉及RAAS系统指标的变化情况,观察温阳方的临床疗效,尝试寻找温阳方治疗心衰的可能机制和作用靶点。
     研究方法
     按标准选取心衰心阳虚证患者70例,采用随机对照的原则分为治疗组(西医基础治疗+温阳方)和对照组(西医基础治疗),其中治疗组服用温阳方,每日1次,持续服用1个月。主要观察指标为前后心功能、心衰计分、中医症状、舌、脉及RAAS系统指标:肾素(PRA)、血管紧张素Ⅱ(AngⅡ)、醛固酮(ALD)。以血、尿、大便常规、肝肾功能、血气分析、血生化及胸片、EKG、BNP等作为安全指标。
     研究结果
     1.本研究纳入病例70例,脱落病例5例,最后获得治疗组33例和对照组32例,两组患者在入院一般临床资料对比无明显差异,其心功能分级、心衰计分、中医症候计分等方面并无显著性差异(P>0.05),两组具有组间可比性;
     2.治疗组和对照组经过治疗后相比较,治疗组的肾素(PRA)、血管紧张素Ⅱ(AngⅡ)、醛固酮(ALD)下降水平明显优于对照组(P<0.05),提示温阳方可以有效地调节心衰心阳虚型患者RAAS系统内分泌因子,具有统计学意义;
     3.两组治疗后进行心衰计分疗效相比较,其差异具有统计学意义(P<0.05),治疗组总有效率明显优于对照组;两组治疗后心功能疗效相比较,其差异具有统计学意义,治疗组总有效率亦明显高于对照组;
     4.两组治疗后的的中医症候积分疗效相比较,其差异具有显著统计学意义(P<0.05),提示加用温阳方的治疗组总有效率明显高于对照组。
     研究结论
     本研究通过温阳方对心衰心阳虚型患者进行干预的疗效观察,提示阳虚型心衰患者运用中西医结合治疗(西医基础治疗+温阳方)后,可以更为有效地改善患者的心功能和心衰症状,以及降低患者的心衰计分,从而提高患者的生存质量。温阳方可显著地降低阳虚型心衰患者RASS系统肾素、管紧张素Ⅱ、醛固酮水平,其可能对于患者RAAS系统起调节作用,提示即为温阳方治疗心衰的可能机制和可能作用靶点。根据安全指标提示温阳方具有良好的安全性,未见明显或严重不良反应。
Background
     Congestive heart failure is very common in clinical heart disease led to a variety of cardiac dysfunction syndrome,cardiovascular disease,the majority of the final destination,but also the most important cause of death. Despite the continuing technical progress in medical clinics,the incidence of heart failure but have increased year-on-year trend.
     Contemporary physiological and pathological mechanisms of heart failure the deepening of studies have found that neuro-endocrine system of long-term cytokines,chronic activation of the promotion of cardiac remodeling and increase the myocardial damage and functional changes occurred in the basic mechanisms of heart failure.Therefore,the key to the modern treatment of heart failure is related to the neuroendocrine system to block and prevent cardiac remodeling in order to delay the development of heart failure.
     In recent years,the renin-angiotensin-aldosterone system(RAAS) in heart failure of the physiological and pathological mechanisms have become established.Therefore,the use of Western medicine treatment of angiotensin-converting enzyme inhibitors,such as the treatment of heart failure,in 1987 the application of angiotensin-converting enzyme inhibitor (ACEI) treatment of heart failure clinical trials,but also laid the AAS system, the basis of inhibitor treatment of heart failure.
     Traditional Chinese medicine,heart failure,mainly heart disease, standard virtual reality-based card,the virtual to qi deficiency,yang deficiency mainly standard is to blood,phlegm most.The virtual(Heart Yang Deficiency gas) is the key to the pathogenesis of heart failure,heart attack is the initial factors and the pathology throughout the course of heart failure, but the main reason leading to edema.Therefore,most doctors believe is Yang Qi Deficiency Syndrome Differentiation of Heart Failure Program,and the treatment of the use of the treatment Onyang Yiqi.
     China's well-known Professor Yan Dexin old Chinese medicine in the long-term treatment of heart failure in clinical practice,that is the key to Yang for all their lives,to be shared is that the poor too;heart precursors and with Yin-Yang,Qi Yang Heart failure is decline of cardiac function;heart failure based on the virtual card is marked,and its key point of pathogenesis gas Heart Yang,"there is a yang,it is a life." Professor Yan Dexin developed in clinical treatment of heart failure Onyang side and capsules made by large-scale clinical trials confirm that Onyang patients can be significantly improved heart failure symptoms and heart function,but have not been able to clear its specific mechanism of action.
     Objective
     Onyang side analysis Yang intervention in patients with heart failure before symptoms of traditional Chinese medicine,tongue,pulse and the RAAS system in patients with pre-intervention indicators and analysis of Onyang party intervention in patients with heart failure after heart Yang of Chinese medicine in patients with symptoms,tongue,pulse and RAAS system changes in indicators to observe the clinical efficacy Onyang side,try to find the treatment of heart failure Onyang side mechanisms and the role of possible targets.
     Methods
     Selected in accordance with the standard heart failure patients with 70 cases of Yang,single-blind randomized into the treatment of the principle of the control group(Western medicine therapy + Onyang side capsules) and control group(Western medicine therapy),in which the treatment group was given capsules Onyang side,each 3,3 times a day,continued to take 1 month. MAIN OUTCOME MEASURES for the before and after the cardiac function,heart failure score,traditional Chinese medicine symptoms,tongue,pulse and RAAS system indicators:renin(PRA),angiotensinⅡ(AngⅡ),aldosterone(ALD). Blood,urine,stool routine,liver and kidney function,blood gas analysis, blood biochemistry and chest X-ray,EKG,BNP and other indicators as a security.
     The results
     1.In this study,70 cases into the case,five cases of loss of cases, the final treatment group received 33 cases and 32 cases of control group, two groups of patients admitted to the clinical data in general no significant differences in contrast,the cardiac function,heart failure score, classification of traditional Chinese medicine symptoms no significant difference(P>0.05) comparable with the group;
     2.Treatment group and control group after treatment compared to treatment group renin(PRA),angiotensinⅡ(AngⅡ),aldosterone(ALD) levels were significantly decreased compared with the control group(P<0.05),prompted Onyang capsule to be effective Yang regulate heart failure patients with cardiac RAAS system endocrine factor,with statistical significance;
     3.The treatment of heart failure after two hours of efficacy,compared with a statistically significant difference(P<0.05),the total effective rate in treatment group was superior to the control group;the two groups after treatment compared to effect cardiac function,the difference statistically significance,treatment group was significantly higher efficiency;
     4.Two groups of Chinese medicine treatment efficacy compared to symptom score,the difference was significant statistical significance(P<0.05),plus tips Onyang capsules side treatment group was significantly higher than the total effective rate.
     Conclusion of the study
     In this study,capsule side through Onyang Yang type of heart failure in patients with cardiac intervention effects observed in patients with heart failure prompted the use of Yang-based traditional Chinese and western medicine(TCM therapy capsules + Onyang side) can more effectively improve the patient's heart function and heart failure symptoms,as well as in patients with heart failure to reduce points,thereby enhancing the quality of life of patients.Onyang side capsule can be significantly reduced in patients with heart failure Yang RASS system type renin,angiotensinⅡ,aldosterone levels in patients with its role in the regulation of RAAS system,suggesting that Onyang side is the possibility of capsule in the treatment of heart failure mechanisms and the role of target.According to safety tips Onyang capsule has a good side of safety,no significant or serious adverse reactions.
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