Figulla H R, Gietzen F, Zeymer U, Raiber M, Hegselmann J, Soballa R, Hilgers R
Department of Cardiology and Pulmonology, Universitäts-Kliniken, Göttingen, Germany.
Circulation. 1996 Aug 1;94(3):346-52. doi: 10.1161/01.cir.94.3.346.
Evidence is arising that calcium antagonists in idiopathic dilated cardiomyopathy (IDC) may have beneficial effects on virus-induced cardiopathology, alcohol toxicity, micro-circulatory disorders, and impaired calcium cycling, all possibly involved in the pathogenesis of the disease. Thus, the effect of adjunct diltiazem (60 to 90 mg TID) on standard treatment was investigated.
The Diltiazem in Dilated Cardiomyopathy (DiDi) trial was a randomized, double-blind, placebo-controlled, multicenter trial of 186 patients (92 receiving diltiazem, 94 receiving placebo) with IDC diagnosed by coronary angiography, catheterization of the left side of the heart, and a left ventricular ejection fraction of < 0.50 (mean, 0.34 +/- 0.11). The effect of adjunct diltiazem treatment on transplant listing-free survival, hemodynamics, exercise capacity, and subjective status was investigated. During the 24-month study period, 33 patients dropped out of the study; 153 patients finished the study protocol. Twenty-seven patients died or had a listing for heart transplantation: 16 in the placebo group and 11 in the diltiazem group. The transplant listing-free survival rate was 85% for diltiazem and 80% for placebo recipients (P = .444). After 24 months, only diltiazem significantly increased cardiac index at rest (P = .01) and under a workload (P = .02), systolic and diastolic pressures (P = .003 and P = .004), stroke volume index (P = .003), and stroke work index (P = .000) and decreased both pulmonary artery pressure under workload (P = .007) and heart rate (P = .001). Diltiazem also increased exercise capacity (P = .002) and subjective well-being (P = .01). Adverse reactions were minor and evenly distributed in both groups, except for an increase in the PQ interval in the diltiazem group.
In patients with IDC, the adjunct therapy of diltiazem improves cardiac function, exercise capacity, and subjective status without deleterious effects on transplant listing-free survival.
有证据表明,钙拮抗剂对特发性扩张型心肌病(IDC)患者的病毒诱导性心脏病变、酒精毒性、微循环障碍及钙循环受损可能具有有益作用,而这些因素均可能参与了该疾病的发病机制。因此,本研究探讨了联用地尔硫䓬(每日三次,每次60至90毫克)对标准治疗的影响。
扩张型心肌病地尔硫䓬(DiDi)试验是一项随机、双盲、安慰剂对照、多中心试验,共纳入186例患者(92例接受地尔硫䓬治疗,94例接受安慰剂治疗),这些患者均经冠状动脉造影、左心导管检查确诊为IDC,且左心室射血分数<0.50(平均为0.34±0.11)。研究联用的地尔硫䓬治疗对无移植登记生存率、血流动力学、运动能力和主观状态的影响。在24个月的研究期间,33例患者退出研究;153例患者完成了研究方案。27例患者死亡或被列入心脏移植名单:安慰剂组16例,地尔硫䓬组11例。地尔硫䓬治疗组的无移植登记生存率为85%,安慰剂治疗组为80%(P = 0.444)。24个月后,仅地尔硫䓬显著增加了静息时(P = 0.01)和负荷状态下(P = 0.02)的心脏指数、收缩压和舒张压(P = 0.003和P = 0.004)、每搏量指数(P = 0.003)和每搏功指数(P = 0.000),并降低了负荷状态下的肺动脉压(P = 0.007)和心率(P = 0.001)。地尔硫䓬还提高了运动能力(P = 0.002)和主观幸福感(P = 0.01)。不良反应轻微,两组分布均匀,但地尔硫䓬组的PQ间期有所延长。
对于IDC患者,联用的地尔硫䓬治疗可改善心脏功能、运动能力和主观状态,且对无移植登记生存率无不良影响。