| Background:Chronic Congestive Heart Failure (CHF) is a complex clinical syndrome effecting human life quality obviously, which is the severe stage of various cardiac diseases. As the prolongation of life expectancy, the high rate of morbidity and mortality is increasingly the worldwide question, the survival rate of five years is similar to cancer. Recently, Heart Failure (HF) is becoming one of the most important cardiovascular diseases in 21st Century as its increasing morbidity. Modern medicine in treating HF has the disadvantage of evident side effects and limited clinical application although its great progress. Recently, a new concept is provided for treating HF as the rapid development of investigating Traditional Chinese Medicine(TCM) and its good effect. Many researchers claim that treating HF with combination of Western Medicine with TCM has evident effect, in that it is in accordance with the modern cognition on HF and show the advantage of TCM. Therefore, to deeply grub the experience especially the famous veteran doctors' experience in treating HF with TCM is one of the most important projects at present in order to promote TCM. Tongyanghuoxue Formula (TYHXF) is originally used to treat Sick Sinus Syndrome(SSS) and other bradycardia, it is based on the empirical formula of the famous TCM veteran doctor Liu zhiming in Guang'anmen Hospital, having the function of activating yang, tonifying qi and promoting blood flow. The safety and efficacy of the prescription is proved through lots of earlier multicenter randomized controlled clinical study. Based on the former investigation of the prescription, we will deeply study the safety, efficacy and the peculiarity of it on CHF identified with the yang deficiency and blood stasis in order to verify and understand the deep Chinese concept "the same treatment for the different diseases" and "treatment based on syndrome differentiation", to deeply grub famous veteran doctors'experience and enlarge its popularization and application, providing appropriate therapy for HF.Objective:To observe the effect of Tongyanghuoxue Formula on Chronic Congestive Heart Failure.Methods:Sixty CHF patients are randomly divided into two groups, the control group and the treatment group, with thirty cases in each. And the western convention treatment is applied to the patients in control group, while the combination of western convention treatment with Tongyanghuoxue Formula is applied to the patients in treatment group. Finally, the efficacy of the formula such as symptoms, syndromes, objective indicator and related quality of life scales and so on are contrasted before and after three weeks.Results:1 Comparison between two groups on total effect of TCM syndrome:About the total effect on HF, the total efficiency is 90% in the treatment group, while 76.67% in the control group, the treatment group is prior to the control group with statistical significance(P<0.05).2 Comparison between two groups on total scores of TCM syndrome:The total scores of TCM syndrome in two groups both decline significantly after treatment(P<0.01), and the treatment group is prior to the control group(P<0.05).3 Comparison between two groups on scores of single symptom:The scores of single symptom in two groups both decline significantly after treatment(P<0.01), and the treatment group is prior to the control group on palpitation, chest distress, shortness of breath, cold extremities, fatigue and spontaneous perspiration and so on(P<0.05), there is significant difference on cold extremities, fatigue and edema(P<0.01). However, there is no difference on dry mouth, expectoration and dysphoria(P>0.05).4 Comparison between two groups on total effect in cardiac function of NYHA classification:The total efficiency is 93.33% in the treatment group, while 76.67% in the control group, that suggests both groups can improve the cardiac function of HF patients, but there is no statistical significance on their difference(P>0.05).5 Comparison between two groups on total effect in Lee cardiac function:The total efficiency is 93.33% in the treatment group, while 70.00% in the control group, that suggests both groups can improve the Lee cardiac function of HF patients, and the treatment group is prior to the control group with statistical significance(P<0.05).6 Comparison between two groups on total scores of Lee cardiac function:The total scores of Lee cardiac function in two groups both decline significantly after treatment(P<0.01), and the treatment group is prior to the control group(P<0.01).7 Comparison between two groups on total effect of 6MWT:The total efficiency is 86.67% in the treatment group, while 66.67% in the control group, that suggests both groups can improve the exercise capacity of HF patients, and the treatment group is prior to the control group with statistical significance(P<0.05).8 Comparison between two groups on six minute walking distance:Both groups can increase the six-minute walking distance (P<0.01), and the treatment group is prior to the control group(P<0.01).9 Comparison between two groups on related indexes of ultrasound cardiogram:There is significant improvement on LVEF, FS, E point and A point in treatment group (P<0.01), on LVEF and FS in control group(P<0.01), and the treatment group is prior to the control group in LVEF improvement(P<0.05), no better than control group in FS improvement(P> 0.05), moreover, there is no evident improvement between control group in A point and treatment group in E point, A point and E/A (P>0.05).10 Comparison between two groups on the Brain Natriuretic Peptide (BNP) level in plasma:Both groups can decrease the BNP level in plasma (P<0.01), and the treatment group is prior to the control group(P<0.05).11 Comparison between two groups on total score of Minnesota Living with Heart Failure Questionnaire (MLHFQ):Both groups can decrease the score of MLHFQ(P<0.01), and the treatment group is prior to the control group(P<0.01).12 Comparison between two groups on total score of Medical Outcomes 36-Item Study Short-Form Health Survey (MOS SF-36):Both groups can increase the score of MOS SF-36(P<0.01), and the treatment group is prior to the control group(P<0.05).13 Observation on safety index and adverse reaction:There is no difference comparing pre-treatment with post-treatment in both groups on the index of safety examination(P>0.05), and there is no adverse reaction throughout the whole treatment, suggesting its safety.Conclusion:Tongyanghuoxue Formula can significantly improve CHF patients' symptoms and syndrome, improve cardiac function, increase patients' six-minute walking distance, decrease BNP level in plasma, improve patients'quality of life having good long-term outcome. Moreover, it has no side effects on patients, and is a formula with safety and efficacy. |
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