| Objective:1. To observe the effect of the long-term arotinolol hydrochloride on the heart function of the dilated cardiomyopathy(DCM) patients with congestive heart failure(CHF). 2.To observe the relativity of the Echocardiography and the Radionuclide angiocardiography in evaluating RVEF. 3.To evaluate the safety of the arotinolol hydrochloride on the DCM patients with CHF. Methods: To select 63 CHF patients with NAHY heart function II-IV, left ventricular end diastolic diameter(LVEDd) >60mm, left ventricular ejection fraction(LVEF)﹤50%, and still having the symptom after the standard medicine therapy of heart failure, all the patients subscribe the informed consent before the study. The study have two stages: The first stage lasted 1 week, all the patients accepted the standard medicine therapy of heart failure, including the Digoxin, Diuretics and the vasodilator drug ACEI, and complete all the examine after the hemodynamics was steady. The second stage lasted 12 months, all the patients was added the arotinolol hydrochloride in small dose on the basis of the standard medicine therapy of heart failure, the dose of the arotinolol hydrochloride was increased gradually by degree to the maximal tolerate dose. Results: 1. The effect of long-time therapy of arotinolol hydrochloride to the left ventricular function. 1.1 The CHF patients LVEF, stroke volume(SV) and Left Ventricular Cardiac Output(CO) were significantly increased after treament. Before treatment LVEF, SV and CO was respective 27.39%±7.94%,53.27ml±14.80ml and 4.49 L/min±1.32 L/min after treatment was respective 41.13%±9.45%,69.47ml±11.77ml and 4.97 L/min±1.01 L/min p<0.001. 1.2 The left ventricular function was improved after treatment, the significant efficacy rate was 4.76%, the efficacy rate was 50.79% and the whole efficiency was 55.56% on the base of NYHA heart function grade and LVEF.1.3 The ratio of X breadth of mind were significantly reduced after treatment. 1.4 The CHF patients' product of heart beat and systolic blood pressure was significantly decreased after treatment. 1.5 After treated with arotinolol hydrochloride 4 month-1year, the CHF patients' left ventricular end diastolic diameter(LVEDd), the left ventricular end systolic diameter (LVESd), the left ventricular end diastolic volume(LVEDV), the left ventricular end systolic volume(LVESV) and Left Ventricular Mass Index(LVMI) were significantly decreased. 2. The effect of long-time therapy of arotinolol hydrochloride to the right ventricular function. The congestive heart failure patients' RVEF was significant increased, before treatment was 36.88%±10.29%, after treatment was 45.76%±9.63%(P<0.001). The right ventricular diameter(RVD) was significant decreased, before treatment was 23.00mm±8.27mm, after treatment was 20.67mm±5.42mm(P=0.004). 3.The relativity analysis of the Radionuclide angiocardiography and the 2- dimension Echocardiography (2-DE) in evaluating RVEF. 3.1 The 2-DE adopted Simpson principle to calculate the RVEF, the Radionuclide angiocardiography adopted First Pass method. 3.2 The relativity analysis result indicated that the two methods had high correlation, the correlation coefficient is 0.933, P<0.001. 4. The safety evaluation of the arotinolol hydrochloride therapy. 4.1 During the study appear giddy 3 times, nausea 8 times, and all symptom disappear after treated, nobody was retreated from the study because of adverse event. 4.2 After treatment the patients hepatic function, renal function, blood sugar, blood serum potassium, sodium, chlorine, blood and urine general examine have no significant change (P>0.05). Conclusion: The primary clinical trial result indicated that arotinolol hydrochloride could improve the DCM patients' heart function. The whole efficiency were 55.56% and none was retreated from the study because of adverse event after treated with arotinolol hydrochloride which beginning with small dose then gradually increasing dose by degree to the maximal tolerate. |
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