Asanoi H, Sasayama S, Sakurai T, Lee J D, Kinoshita M, Ishimura T, Yoshikawa J, Mitsudo K, Sato H, Morioka S
Toyama Medical and Pharmaceutical University.
Cardiovasc Drugs Ther. 1995 Dec;9(6):791-7. doi: 10.1007/BF00879873.
Acute hemodynamic effects of intravenous infusion of dopexamine were evaluated by a placebo-controlled withdrawal study in patients with acute congestive heart failure. Twenty patients were enrolled at 10 centers in Japan. All patients had a pulmonary capillary or diastolic pressure of 15 mmHg or greater and a cardiac index of 2.5 l/min/m2 or less. Phase I: Intravenous dopexamine was introduced in a single-blind, uncontrolled fashion at the rate of 0.5 micrograms/kg/min and was titrated up to achieve a 30% or more increase in the cardiac index. Two patients withdrew from the study due to sinus tachycardia and ventricular ectopy or exacerbation of heart failure. Phase II: The remaining 18 responders who were free of limiting side effects were randomized in double-blind fashion to continue dopexamine or to switch to placebo for an additional 60 minutes. At the end of phase II, the hemodynamic improvement obtained in phase I of the study disappeared completely after substitution of placebo but was maintained in dopexamine-treated patients. Our findings suggest that dopexamine, when given in appropriate doses to selected patients, shows balanced vasodilator action suitable for the treatment of acute congestive heart failure.
通过一项安慰剂对照撤药研究，对急性充血性心力衰竭患者静脉输注多培沙明的急性血流动力学效应进行了评估。日本的10个中心招募了20名患者。所有患者的肺毛细血管压或舒张压均在15 mmHg及以上，心脏指数在2.5 l/min/m²及以下。第一阶段：以单盲、非对照方式开始静脉输注多培沙明，速率为0.5微克/千克/分钟，并进行滴定，以使心脏指数增加30%或更多。两名患者因窦性心动过速、室性早搏或心力衰竭加重而退出研究。第二阶段：其余18名无限制性副作用的反应者以双盲方式随机分组，继续使用多培沙明或改用安慰剂，持续60分钟。在第二阶段结束时，研究第一阶段获得的血流动力学改善在改用安慰剂后完全消失，但在接受多培沙明治疗的患者中得以维持。我们的研究结果表明，多培沙明给予选定患者适当剂量时，显示出适合治疗急性充血性心力衰竭的平衡血管舒张作用。
