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薬理と治療
Abstract
Objectives A multicenter, open-label, dose escalation study was conducted to evaluate the safety, efficacy and pharmacokinetics of a bolus injection with the following continuous infusion of Sigmart(nicorandil)in acute heart failure or acute exacerbation of chronic heart failure. Methods Sigmart was administered intravenously with a bolus injection of 200μg/kg followed by continuous infusion of A)50μg/kg/hr, B)100μg/kg/hr, C)150μg/kg/hr, D) 200μg/kg/hr, or E)250μg/kg/hr in 51 patients. Administration of Sigmart was continued for 6 hours, and permitted to prolong to 24 hours. Results Pulmonary artery wedge pressure(PAWP)decreased by 21.0%, 18.4%, 33.5% and 31.0% at the end of study period in groups of B, C, D and E, respectively, with all of the changes being statistically significant. Cardiac index increased in group D and E, though not statistically significant. There was a dose-dependent increase in global improvement rate, the percentage of“improved”or better, being over 70% in group D and E. Adverse reactions, one headache in group B and one flush in group C, were observed, while both reactions were mild and the infusion of Sigmart was allowed to be completed. Twelve abnormal changes in clinical laboratory values were observed in 6 patients, while none of them were clinically significant. Conclusions These results suggest that Sigmart is safely administered and improves the hemodynamics in patients with acute heart failure or acute exacerbation of chronic heart failure. In addition, the clinical optimal dose of Sigmart is considered to be a bolus injection of 200μg/kg followed by a continuous infusion at a rate of 200μg/kg/hr.
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