Ishikawa K, Nakai S, Takenaka T, Kanamasa K, Hama J, Ogawa I, Yamamoto T, Oyaizu M, Kimura A, Yamamoto K, Yabushita H, Katori R
Kinki University, School of Medicine, Osaka, Japan.
Circulation. 1997 May 20;95(10):2368-73. doi: 10.1161/01.cir.95.10.2368.
The administration of calcium antagonists to patients with healed myocardial infarction is a controversial treatment. This study was conducted to elucidate the effect of short-acting nifedipine and diltiazem on cardiac events in patients with healed myocardial infarction.
A controlled clinical open trial of 1115 patients with healed myocardial infarction was carried out between 1986 and 1994. The patients included 595 who received no calcium antagonist, 341 who received short-acting nifedipine 30 mg/d, and 179 who received short-acting diltiazem 90 mg/d. The primary end points were cardiac events, which were defined as fatal or nonfatal recurrent myocardial infarction; death from congestive heart failure; sudden death; and hospitalization because of worsening angina, congestive heart failure, or premature ventricular contractions. Cardiac events occurred in 51 patients (8.6%) in the no-calcium-antagonist group and 54 (10.4%) in the calcium-antagonist group (odds ratio, 1.24; 95% CI, 0.83 to 1.85), demonstrating that the calcium antagonists did not reduce the incidence of cardiac events. Subgroup analysis revealed no beneficial effects of these drugs for reducing cardiac events in patients with such complications as hypertension or angina pectoris.
This study showed that use of short-acting nifedipine and diltiazem in this postmyocardial infarction population was associated with a 24% higher cardiac event rate, but this strong adverse trend did not reach statistical significance.
对心肌梗死已愈合的患者使用钙拮抗剂是一种有争议的治疗方法。本研究旨在阐明短效硝苯地平和地尔硫䓬对心肌梗死已愈合患者心脏事件的影响。
1986年至1994年间对1115例心肌梗死已愈合的患者进行了一项对照临床开放试验。患者包括595例未接受钙拮抗剂治疗的患者、341例接受30mg/d短效硝苯地平治疗的患者和179例接受90mg/d短效地尔硫䓬治疗的患者。主要终点是心脏事件,定义为致命或非致命性复发性心肌梗死、充血性心力衰竭死亡、猝死以及因心绞痛恶化、充血性心力衰竭或室性早搏住院。未接受钙拮抗剂治疗组有51例患者(8.6%)发生心脏事件,钙拮抗剂治疗组有54例患者(10.4%)发生心脏事件(优势比,1.24;95%置信区间,0.83至1.85),表明钙拮抗剂并未降低心脏事件的发生率。亚组分析显示,这些药物对患有高血压或心绞痛等并发症的患者减少心脏事件并无益处。
本研究表明,在此心肌梗死后人群中使用短效硝苯地平和地尔硫䓬与心脏事件发生率高24%相关,但这种强烈的不良趋势未达到统计学显著性。