The Efficacy、Safety And Its Prognosis Of Recombinant Human Brain Natriuretic Peptide Alone Or In Combination With Sodium Nitroprusside On Acute Decompensated Heart Failure Patients

Background:As the acceleration of the aging population in our country and the change of people’s life-style, diet structure, the prevalence of hypertension, coronary heart disease and other cardiovascular diseases are increasing year by year. Accordingly, heart failure, as the final stage of cardiovascular continuum, also has become much common. Statistics has shown a high morbidity and high mortality of acute decompensated heart failure (ADHF) without satisfactory therapeutic efficacy. So, it is of importance to take effective measures to improve the prognosis and reduce mortality. Sodium nitroprusside(SNP), as a treatment drugs for ADHF, has advantages of functioning quickly and Metabolising fast with a cheap price, now is widely applied to clinical administration. But it has various side effects such as nausea, vomiting, mental restlessness, muscle spasms, headache, skin rashes, sweating, fever, etc. While used continuously at large dosage on patients with hepatic and/or renal dysfunction, it may cause cyanides and thiocyanide accumulation and lead to poisoning. rhBNP, as a new agent of ADHF drugs, its curative efficacy has been broadly confirmed. However, its safety concern remaining uncertain, together with its high expense, limits its clinical application. So, it is meaningful to analyze rhBNP’s therapeutic effect, safety, to find a optimal way to combine with other vaso-dilating agents hence to reduce the cost, and finally to improve the prognosis of patients with ADHF.Objective:To observe the efficacy, safety and short-term prognosis of recombinant human brain natriuretic peptide (rhBNP) on ADHF by using alone or in combination with sodium nitroprusside.Methods:68patients with ADHF admitted to Hunan provincial hospital from October2010to October2011were randomly divided into3groups according to the vasodilating regimen used:Sodium nitroprusside (SNP) group (A group, N=25), rhBNP group (B group,N=20); and Combination group(rhBNP in combination with SNP, C group,N=23).72hours of continuous treatment, followed up one month after discharge. The study is stratified and matched up pre-and after treatment among three groups.(1)Clinical symptoms, heart function classification, serum NT-proBNP, blood pressure, aldosterone and electrolyte level were observed pre-and after treatment, separately. Meanwhile,24、48and72hours urine volumn were recorded, separately.(2)In all the43patients treated with rhBNP(both in rhBNP group and combination group),9patients with normal baseline renal function,34patients with renal dysfunction; in25patients treated with sodium nitroprusside alone,5patients with normal baseline renal function,20patients with renal dysfunction, subgroups hence were divided according to their baseline endogenous creatinine clearance rate and their value of endogenous creatinine clearance pre-and after treatment were observed, separately:①between the normal baseline renal function subgroup with rhBNP and SNP, endogenous creatinine clearance rate pre-and after treatment were compared;②between the baseline renal dysfunction subgroup with rhBNP and SNP, endogenous creatinine clearance rate pre-and after treatment were compared;③within all the patients treated with rhBNP(both in rhBNP group and combination group), endogenous creatinine clearance rate were observed pre-and after treatment with normal baseline and renal function, separately.(3) length of hospital stay,30days of readmission or mortality were observed pre-and after treatment, separately.Results:1.rhBNP is markedly superior to SNP in improving dysponea and symptoms in ADHF patients, and there was a statistically significant trend toward greater improvement in dysponea with rhBNP. The efficacy rate of SNP group was45%(8/25cases), the total response rate was64%(16/25cases). In rhBNP group efficacy rate was45%(9/20cases), the total response rate was85%(17/20cases). In Combination group efficacy rate was47.83%(11/23cases), the total response rate was91.3%(21/23cases). There were no significant differences among the three groups.2.Both clinical symptoms and NT-proBNP level were improved in all three groups after treatment. Among3grouops, there was no statistically significance in the changes of NT-proBNP level pre-and after treatment between rhBNP group and Combination group, but significant difference was observed if compared with that of SNP group (P<0.01)3.After72hours treatment, Systolic blood pressure and heart rate in the3groups were significantly lower than those of baselines (P<0.05) There were no significant differences among the three groups. Among3groups, there was statistically significance in the changes of diastolic blood pressure pre-and after treatment between B and C group. There were also no significant differences among the three groups.4.Aldosterone levels in the C group were significantly lower than those of baselines (P<0.05). But aldosterone levels in the A group were not significantly lower than baselines (P>0.05). There was statistically significance in the changes of aldosterone level pre-and after treatment between A and C group.(53.77±57.02vs9.03±23.47pg/ml,P<0.01).5.Potassium levels in the B and C group were slightly lower than those of baselines (P>0.05). Potassium level in the A group were slightly higher than baselines (P>0.05). There were no significant differences of potassium and sodium among the three groups. After treatment,24h,48h,72h urine volume were not statistically differences among the three groups (P>0.05).6.But the dosage of diuretic use were statistically differences among the three groups, with A group more than the other two groups, statistically significant difference was observed.(206.20±101.25vs130.13±64.82mg,206.20±101.25vs82.61±61.68mg,P<0.05); There were no significant differences between the other two groups.(130.13±64.82vs82.61±61.68mg,P=0.055)7.In all the patients treated with rhBNP(both in rhBNP group and combination group), Patients with baseline normal renal function or renal dysfunction had no statistically significance of pre-and after treatment endogenous creatinine clearance rate change (7.95±12.09vs5.27±9.10ml/min,P>0.05). The change value of endogenous creatinine clearance rate pre-and after treatment in all rhBNP patients(including normal renal function and renal dysfunction) was (7.95±12.09or5.27±9.10) ml/min, which was no significant different if compared with that of B group (P>0.05).8.There were no significant differences of length of hospital stay and mortality among the three groups. Among3groups, there was statistically significance about30days readmission between A and C group.(P=0.013)Conclusion:1.Compared with sodium nitroprusside, rhBNP group and Combination group can further improve clinical symptoms NT-proBNP、aldosterone level on acute decompensated heart failure patients, no impact on blood pressure、heart rate and electrolyte level were observed.2.Compared with sodium nitroprusside, rhBNP treatment in combination with SNP did not increased urine output, but the usage of diuretics were more reduced.3.Based on the protocol of titrating IV vaso-dilating agents according to BP in this study, rhBNP did not deteriorate the renal function, the safety of its combination with SNP is similar to that of SNP using alone. To the patients with baseline renal dysfunction, rhBNP can even improve the renal function to some extent.4.Compared with SNP, rhBNP group and Combination group did not deteriorate the short-term clinical outcome, meanwhile rhBNP in combination with SNP can decrease30days readmission.