Cadel A, Brusoni B, Pirelli P, Osculati G, Rovati A, Fanciulli R, Carati L, Valagussa F
Arzneimittelforschung. 1986 Feb;36(2A):376-9.
This study compares the effects of digoxin, placebo and ibopamine (SB-7505), the orally active 3,4-diisobutyryl ester of N-methyl-dopamine, on exercise tolerance and cardiac rhythm of 14 patients whose left ventricular heart failure (end-diastolic pressure, 26.3 +/- 5.9 mmHg; ejection fraction, 0.42 +/- 0.10%) depended on a previous myocardial infarction. Patients were admitted to the study while on chronic oral digoxin treatment (serum levels between 1.1 and 1.9 ng/ml). Placebo instead of digoxin was given for the following month. Thereafter ibopamine 50 mg t.i.d. for one month was given. A sequence of one-month treatments with digoxin, placebo and ibopamine was repeated, then ibopamine was administered continuously for the next two months. The concurrent treatment (diuretics in all patients, nitroderivates in twelve, calcium antagonists in two) remained unchanged during the observation period. Symptoms-limited exercise tests and 24-h Holter recordings were obtained at admission, at the end of each one-month treatment and at the end of the observation period. Two patients developed unstable angina without increase of serum creatine phosphokinase while on ibopamine and were withdrawn. Out of the 12 patients that concluded the trial, one required supplementary doses of diuretic at the end of the second period on placebo. The results obtained during the trial suggest that: a) therapeutic plasma levels of digoxin have no deleterious effect on cardiac rhythm nor significantly increase exercise tolerance as compared with placebo; b) diuretics and nitrates appear to sustain the clinical stability of these patients as a group.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究比较了地高辛、安慰剂和异波帕胺(SB - 7505,N - 甲基多巴胺的口服活性3,4 - 二异丁酰酯)对14例左心室心力衰竭(舒张末期压力为26.3±5.9 mmHg;射血分数为0.42±0.10%)且病因是既往心肌梗死患者的运动耐量和心律的影响。患者在接受慢性口服地高辛治疗(血清水平在1.1至1.9 ng/ml之间)时被纳入研究。接下来的一个月给予安慰剂而非地高辛。此后给予异波帕胺50 mg,每日三次,持续一个月。重复地高辛、安慰剂和异波帕胺各一个月的治疗序列,然后异波帕胺连续给药两个月。在观察期内,联合治疗(所有患者均使用利尿剂,12例使用硝基衍生物,2例使用钙拮抗剂)保持不变。在入院时、每个月治疗结束时以及观察期结束时进行症状限制性运动试验和24小时动态心电图记录。两名患者在服用异波帕胺期间出现不稳定型心绞痛且血清肌酸磷酸激酶未升高,随后退出研究。在完成试验的12例患者中,有1例在安慰剂治疗的第二个阶段结束时需要补充利尿剂剂量。试验期间获得的结果表明:a)与安慰剂相比,地高辛的治疗血浆水平对心律无有害影响,也未显著提高运动耐量;b)利尿剂和硝酸盐似乎可维持这些患者作为一个群体的临床稳定性。(摘要截断于250字)