Erbel R, Meyer J, Diefenbach C, Delorme G, Bourdarias J P, Vernant P, Lellouche D, Mattioli G, Barbieri A, Installe E
Am J Cardiol. 1987 Aug 14;60(5):31C-36C. doi: 10.1016/0002-9149(87)90522-4.
Previous clinical studies with intravenous enoximone have used cumulative dosing to quantify enoximone's hemodynamic effects. The magnitude and duration of the hemodynamic effects of single intravenous doses of enoximone were evaluated in patients with congestive heart failure. Sixty patients, who were in New York Heart Association functional classes III and IV, received single intravenous doses of enoximone, either 0.25 (12 patients), 0.5 (13 patients), 1 (14 patients), 1.5 (10 patients) or 2 mg/kg (11 patients). Cardiac index was increased by 20% with the 0.25 mg/kg dose and by 48% and 42% with the 1.5 and 2 mg/kg doses, respectively. These increases were statistically significant (Student's paired t test with Bonferroni's correction, p less than 0.007) for 1 hour after 0.25 and 0.5 mg/kg, for 2 hours after 1 mg/kg and for 4 hours after 1.5 and 2 mg/kg. Enoximone also reduced pulmonary artery diastolic pressure by 19% with 0.25 mg/kg and by 29% with 2 mg/kg. The duration of effect varied from 1 hour with 0.25 mg/kg to 4 hours with 2 mg/kg. Enoximone produced no consistent or dose-related effects on heart rate or blood pressure. Eighteen adverse reactions were reported by 15 patients, of which 11 were minor and transient (vein pain, flushes, nausea). In 5 patients ventricular or supraventricular arrhythmias were observed, including nonsustained ventricular tachycardia and extrasystoles; 3 of these patients had evidence of arrhythmias before enoximone. Laboratory studies before and after treatment showed no drug-related effects. Dose-related effects on the magnitude and duration of hemodynamic responses to intravenous enoximone were evident within the dose range of 0.25 to 2 mg/kg.(ABSTRACT TRUNCATED AT 250 WORDS)
既往使用静脉注射依诺昔酮的临床研究采用累积给药来量化依诺昔酮的血流动力学效应。在充血性心力衰竭患者中评估了单次静脉注射依诺昔酮的血流动力学效应的强度和持续时间。60例纽约心脏协会心功能分级为Ⅲ级和Ⅳ级的患者接受了单次静脉注射依诺昔酮,剂量分别为0.25mg/kg(12例患者)、0.5mg/kg(13例患者)、1mg/kg(14例患者)、1.5mg/kg(10例患者)或2mg/kg(11例患者)。0.25mg/kg剂量使心脏指数增加20%,1.5mg/kg和2mg/kg剂量分别使其增加48%和42%。在注射0.25mg/kg和0.5mg/kg后1小时、1mg/kg后2小时、1.5mg/kg和2mg/kg后4小时,这些增加具有统计学意义(采用Bonferroni校正的Student配对t检验,p<0.007)。依诺昔酮还使肺动脉舒张压在0.25mg/kg时降低19%,在2mg/kg时降低29%。效应持续时间从0.25mg/kg时的1小时到2mg/kg时的4小时不等。依诺昔酮对心率或血压未产生一致的或剂量相关的影响。15例患者报告了18例不良反应,其中11例为轻微且短暂的(静脉疼痛、潮红、恶心)。5例患者观察到室性或室上性心律失常,包括非持续性室性心动过速和期前收缩;其中3例患者在使用依诺昔酮前就有心律失常证据。治疗前后的实验室研究未显示与药物相关的影响。在0.25至2mg/kg的剂量范围内,静脉注射依诺昔酮对血流动力学反应的强度和持续时间存在剂量相关效应。(摘要截短至250字)