Clinical trial on levosimendan combined with nicorandil in the treatment of ischemic cardiomyopathy in the elderly patient
Objective To investigate the application effect of levosimendan combined with nicorandil in the treatment of elderly patients with ischemic cardiomyopathy(ICM).Methods Elderly patients with ICM were divided into the control group and the treatment group by cohort method.The control group was treated with levosimendan at 12 μg·kg-1.7 d later,and the treatment was carried out once again.On this basis,the treatment group was given oral administration of nicorandil,5 mg per dose,tid.Patients in two groups were treated for 3 months.The two groups were compared in terms of clinical efficacy,ventricular remodeling indicators[left ventricular posterior wall thickness(LVPWT),posterior wall end systolic thickness(PWS),interventricular septum thickness in systole(IVSS)and left ventricular mass index(LVMI)],cardiac function indicators[left ventricular ejection fraction(LVEF),left ventricular end systolic diameter(LVESD)and left ventricular end diastolic diameter(LVEDD)],myocardial injury markers[cardiac troponin Ⅰ(cTn Ⅰ)and N-terminal pro-brain natriuretic peptide(NT-proBNP)],and endocrine hormones[angiotensin Ⅱ(Ang Ⅱ)and aldosterone(ALD)].Safety was evaluated.Results There were 52 cases and 46 cases in the treatment group and the control group,respectively.After 3 months of treatment,the effective rates in the treatment group and the control group were 92.31％(48 cases/52 cases)and 78.26％(36 cases/46 cases),the difference was statistically significant(P＜0.05).After 3 months of treatment,LVPWT in the treatment group and the control group were(8.17±2.25)and(9.33±2.84)mm;PWS were(10.14±2.29)and(11.32±2.90)mm;IVSS were(11.19±1.74)and(12.04±1.85)mm;LVMI were(1.93±0.21)and(2.06±0.28)mg·g-1;LVEF were(52.74±8.67)％and(49.30±7.59)％;LVESD were(43.87±5.74)and(46.66±6.48)mm;LVEDD were(51.40±8.61)and(55.25±9.58)mm;cTn Ⅰlevels were(0.25±0.03)and(0.36±0.08)μg·L-1;NT-proBNP levels were(384.58±36.06)and(401.25±42.83)ng·L-1;Ang Ⅱ levels were(56.37±10.03)and(63.25±12.46)ng·L-1;ALD levels were(50.87±13.08)and(58.36±16.54)ng·L-1.The differences were statistically significant(all P＜0.05).The total incidence rates of adverse drug reactions in the treatment group and the control group were 7.69％(4 cases/52 cases)and 4.35％(2 cases/46 cases),without statistically significant difference(P＞0.05).Conclusion Levosimendan injection combined with nicorandil tablet can effectively inhibit ventricular remodeling and myocardial injury in elderly patients with ICM.Meanwhile,it can help to improve cardiac function and endocrine hormones in the patients,with good safety.
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