Lanas F, Standen D, Steinmann W C, Montecinos A, Stockins B
Unidad de Cardiología, Factultad de Medicina, Universidad de La Frontera, Temuco, Chile.
Rev Med Chil. 1994 Oct;122(10):1147-52.
Due to differences in treatment effect in studies on the effectiveness of digoxin in patients with congestive heart failure in sinus rhythm, a cross-over placebo-controlled, randomized double blind clinical trial was performed. Thirty one patients, without previous treatment with digoxin, in New York Heart Association (NYHA) functional class II to IV, with a dilated left ventricle and/or ventricular systolic dysfunction were included. Patients received digoxin, adjusted for blood levels, or placebo, during an 8 week period, prior to crossing over to the other treatment for another 8 weeks. The order of treatments was randomly allocated. Outcome measurement were performed at the end of each 8 week period. Digoxin, compared with placebo, improved NYHA class, 6.9% vs 41.4% (p = 0.013) and increased the treadmill exercise time, 406 +/- 204 s vs 484 +/- 185 s (p = 0.003). During the digoxin treatment the left ventricular and systolic diameter was reduced from 52.9 +/- 8.9 to 50.1 +/- 9.7 mm (p = 0.016) and the shortening fraction increased from 21.4 +/- 8.3 to 24.8 +/- 8.1% (p = 0.009). No significant difference was observed in the left ventricular end diastolic diameter (LVED) of the left ventricle and in a estimation of quality of life. In conclusion, digoxin treatment produced a significant improvement in functional capacity, exercise time, and left ventricular performance.
由于在窦性心律的充血性心力衰竭患者中,关于地高辛有效性的研究存在治疗效果差异,因此进行了一项交叉安慰剂对照、随机双盲临床试验。纳入了31例未接受过地高辛治疗、纽约心脏协会(NYHA)心功能分级为II至IV级、左心室扩张和/或心室收缩功能障碍的患者。患者在8周期间接受根据血药浓度调整剂量的地高辛或安慰剂治疗,之后交叉接受另一种治疗8周。治疗顺序随机分配。在每个8周治疗期结束时进行结果测量。与安慰剂相比,地高辛改善了NYHA分级,改善率分别为6.9%和41.4%(p = 0.013),并增加了跑步机运动时间,分别为406±204秒和484±185秒(p = 0.003)。在地高辛治疗期间,左心室收缩直径从52.9±8.9毫米降至50.1±9.7毫米(p = 0.016),缩短分数从21.4±8.3%增加至24.8±8.1%(p = 0.009)。左心室舒张末期内径(LVED)和生活质量评估方面未观察到显著差异。总之,地高辛治疗在功能能力、运动时间和左心室功能方面产生了显著改善。