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薬理と治療
Abstract
Background:In the previous open-label Phase 2 studies, the clinical efficacy and safety of Sigmart(nicorandil)were evaluated in patients with acute heart failure or acute exacerbation of chronic heart failure. Objectives To assess the clinically optimal dose of Sigmart for the treatment of acute heart failure or acute exacerbation of chronic heart failure, a multi-center, randomized double blind study was conducted. Methods Seventy two patients were randomly assigned into 3 treatment groups. Intravenous bolus injection of Sigmart at a dose of 200μg/kg was followed by a 6 hours infusion of Sigmart at rates of 50μg/kg/hr in group L(22 patients),100μg/kg/hr for group M(27 patients), and 200μg/kg/hr in group H(23 patients). Results Sigmart decreased pulmonary artery wedge pressure(PAWP)significantly in all groups, and increased cardiac index in group M. There were significant dose-dependent decreases in systolic pulmonary pressure and pressure rate product, while there was no significant change in other parameters. Percentage of patients with PAWP decrease over 30% tended to be the highest in group H. The reduction of PAWP after bolus injection was maintained throughout the infusion period in groups M and H, while it subsided rapidly in group L. The“usefulness rate”was 40.9%, 33.3% and 52.2% in groups L, M and H, respectively, which was not dose-dependent. There were 26 adverse reactions in 18 of 72 patients(25%). The incidences were 9.1%, 37.0% and 26.1% in the 3 groups from low to high dose, while did not show statistically significant dose-dependency. The most common adverse reactions were headache, increase in GOT(AST)and increase in GPT(ALT). The“safety ratio”was 90.9%, 59.3%, and 69.6% in each group. Conclusions These results suggest that optimal dose of Sigmart for the treatment of acute heart failure is a bolus injection of 200μg/kg followed by continuous infusion of 200μg/kg/hr.
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