Dobbs S M, Kenyon W I, Dobbs R J
Br Med J. 1977 Mar 19;1(6063):749-52. doi: 10.1136/bmj.1.6063.749.
The need for maintenance digoxin treatment was assessed in a double-blind, variable-dose, crossover comparison with placebo. Forty-six outpatients who had been prescribed the drug for heart failure were studied; 33 were in sinus rhythm and the remainder in atrial fibrillation. Mean serum digoxin concentrations in those with sinus rhythm averaged 1-33 nmol/l, but a lower concentration, averaging 0-97 nmol/l, was accepted in those with atrial fibrillation as six of them developed bradycardia. Sixteen of the 46 patients deteriorated on placebo, and eight completely recovered when digoxin was reintroduced; in the remainder additional diuretics were required temporarily. Spirometric values deteriorated on changing to placebo whether or not the patient showed clinical evidence of recurrence of heart failure. In a separate study of nine patients who showed no clinical evidence of deterioration on placebo, reintroduction of digoxin caused a shortening of left ventricular ejection time, which persisted for at least a month. This suggests that the inotropic response to digoxin is sustained during maintenance treatment.
通过与安慰剂进行双盲、可变剂量、交叉对照试验,评估了地高辛维持治疗的必要性。对46名因心力衰竭而服用该药的门诊患者进行了研究;其中33人处于窦性心律,其余患者为房颤。窦性心律患者的平均血清地高辛浓度为1 - 33 nmol/l,但房颤患者的平均浓度较低,为0 - 97 nmol/l,因为其中6人出现了心动过缓。46名患者中有16人在服用安慰剂时病情恶化,8人在重新服用地高辛后完全康复;其余患者需要临时增加利尿剂。无论患者是否有心力衰竭复发的临床证据,改用安慰剂后肺功能测定值都会恶化。在另一项针对9名在服用安慰剂时无临床恶化证据的患者的研究中,重新服用地高辛导致左心室射血时间缩短,这种情况持续了至少一个月。这表明在维持治疗期间,地高辛的正性肌力反应是持续存在的。