| Objective:To evaluate the short-term clinical efficacy and safety of administration of levosimendan in patients with decompensated cardiac insufficiency.Methods:A total of120patients admitted due to heart failure (NYHA function class Ⅲ-Ⅳ or Killip Ⅲ) were randomly divided into levosimendan group(n=60)and control group (n=60)according to a computer-generated randomization schedule. The two groups were both given routinely diuretics, vasodilators, ACEI or ARB, beta-blockers, spironolactone, anticoagulants, antiplatele and statins. Levosimendan was administered as an initial loading dose of12ug/kg delivered over10min followed by a continuous infusion of0.1ug/kg/min for50min, and increased to0.2ug/kg/min for a further23h in levosimendan group.Dyspnoea were assessed at baseline and72h after the start of infusion. Echocardiography was performed to measure left ventricular ejection fraction (LVEF) and left ventricle end-diastolic diameter (LVDD) at baseline and24-48h after the start of infusion, and B-type natriuretic peptide (BNP) plasma level was analysed before and after treatment. NYHA class was assessed at baseline and1,3,5,9day after the start of infusion. Moreover, in-hospital mortality and hospitalization days of the both groups were recorded. The serum creatinine was monitored at baseline and1,5,9day after treatment. Observe and record the cases of arrhythias, and hypotension during treatment. The readmission rate, mortality and the incidence of the combined end point of the two groups were compared during3months following-up.Results:(1) The improvement of dyspnoea of levosimendan group was superior to that of control group:the probability of achieving the effective grade or better in levosimendan group was2.489times (95%CI:1.3152-4.7162, P=0.005) than that of control group.(2) The LVEF in levosimendan group after treatment had significantly more increased than that before treatment [(31.82±6.32)%vs.(28.68±6.39)%, P＜0.001]. Removing the effects of LVEF before treatment (LVEF before treatment as covariates, F=157.54,P＜0.001), the improvement of LVEF in levosimendan group was obviously superior to that of control group after treatment[(31.82±6.32)%vs.(31.3±5.51)%, F=7.10, P=0.009].The LVDD after treatment in two groups was no difference compared with that of before treatment (P>0.05).(3) The BNP decreased obviously (P＜0.001) in both groups compared with before treatment, and it decreased more remarkably after treatment in levosimendan group compared with control group (P＜0.001).(4) The improvement of NYHA class of levosimendan group after treatment was superior to that of control group:the probability of achieving the effective grade or better in levosimendan group was2.058times (95%CI:1.3266-3.1734, P=0.001) than that of control group. The improvement of NYHA class after treatment was more and more obvious in both groups with the extension of time. The probability of achieving the effective grade or better in levosimendan group respectively was2.122,2.433,2.837times (P=0.006,P=0.002,P=0.001) than that of control group at3,5,9days.(5) There was no difference between two groups in hospitalization (P=0.612), with similar hospital mortality which reduced by15.6%in levosimendan group compared with that of control group. Compared with control group, The mortality and readmission rate in levosimendan group respectively reduced by25.0%and26.7%during3months, though without statistical differences between two groups (P=0.160, P=0.149). However, the combine end point events(death or readmission) of levosimendan group was significantly less than that of control group (51.2%vs70.0%).(6) Safety aassessment:The serum creatinine were increased after treatment in both groups, but no statistically significant difference between the groups (P>0.05); The incidence of hypotension and arrhythmias of levosimendan group respectively increased by58.7%and66.7%compared with control group. There were no statistical differences, however, in incidence of hypotension and arrhythmiasbut between two groups (P=0385,P=0.114).Conclusion:(1) The improvement of dyspnoea is more marked with levosimendan than with traditional therapy in patients with decompensated cardiac insufficiency.(2) There is a more effective improvement in NYHA class or Killips with levosimendan than with traditional therapy in patients with decompensated cardiac insufficiency.(3) Administration of levosimendan shows a greater decrease in combine end point events(death or readmission) during a three-month period.(4)There is a trend of increasing arrhythmias with levosimendan compared with traditional therapy. |
PDF Full Text Request