[Efficacy and safety of intravenous recombinant human brain natriuretic peptide in patients with severe heart failure: a prospective multicenter clinical study].

Objective: To explore the efficacy and safety of recombinant human brain natriuretic peptide (rhBNP) in the patients with severe heart failure (HF).

Methods: A prospective multicenter study was conducted. Patients whose age > 18 years old, and with the New York Heart Association (NYHA) cardiac function grade over III-IV, acute cardiac insufficiency and the acute exacerbation of chronic cardiac insufficiency admitted to intensive care unit/cardiovascular care unit (ICU/CCU) of 58 Hospitals in China were enrolled. On the basis of the conventional treatment, all patients would be given rhBNP (neo adjuvant) with a loading dose of 1.5 μg/kg for 3-5 minutes, and followed by a maintenance dose of 0.010-0.015 μg×kg×min for 3-7 days. Before the treatment and 1, 3, 7 days after treatment, researchers detected indexes of cardiac and renal function, the levels of N-terminal B-type natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), central venous pressure (CVP), urea nitrogen (BUN), serum creatinine (SCr), and urine output; the renal function index was re-evaluated at 30 days after administration, and the time entering ICU again, re-admission, cardiovascular events were recorded.

Results: 408 patients were enrolled, with 241 males and 167 females. Age range was 28-95 years, the average age was (63.0±15.8) years, and 50-70 years old accounted for 46.8%. Compared with the data before treatment, NT-proBNP, PCWP and CVP significantly decreased at 6 hours after treatment [NT-proBNP (μg×kg×min): 4 378.58±4 082.29 vs. 6 403.41±5 759.48, PCWP (mmHg, 1 mmHg = 0.133 kPa): 12.41±2.21 vs. 14.26±2.85 , CVP (mmHg): 10.63±2.62 vs. 11.45±3.45, all P < 0.05], and with the prolongation of injection, NT-proBNP, PCWP and CVP were gradually declined; CO 1 day after treatment (mL: 4.89±0.81 vs. 4.40±0.92) and LVEF 3 days after treatment (0.465±0.100 vs. 0.431±0.107) were significantly increased (both P < 0.05), and with the prolongation of injection, CO and LVEF were gradually increased. There were no obvious changes in BUN and SCr during the treatment, but 30 days after treatment, SCr was significantly lower than that pre-treatment (μmol/L: 110.98±47.40 vs. 132.62±75.60, P < 0.01). Compared with the data pre-treatment, urine output per hour was significantly increased at 3 hours after treatment (mL: 129.59±82.16 vs. 89.60±53.49, P = 0.000); urine output every 24 hours was significantly increased at day 1 and day 2 after administration (mL: 2 676.54±1 006.83, 2 678.74±975.97 vs. 2 150.36±283.76, both P < 0.01). In 7 days, the re-entry ICU rate was 2.7%, and the re-hospitalization rate was 2.88% within 30 days, re-cardiac failure rate was 1.43% in 30 days, and the overall fatality rate was 9.55% in 30 days.

Conclusions: The rhBNP can significantly improve heart function in patients with HF. And, it has a certain effect on renal function. The rhBNP is effective and safe for the treatment of cardiac insufficiency.