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口服维拉帕米治疗静息性心绞痛的短期疗效。一项在冠心病监护病房患者中进行的双盲安慰剂对照试验。

Short-term efficacy of oral verapamil in rest angina. A double-blind placebo controlled trial in CCU patients.

作者信息

Mehta J, Pepine C J, Day M, Guerrero J R, Conti C R

出版信息

Am J Med. 1981 Dec;71(6):977-82. doi: 10.1016/0002-9343(81)90323-5.

DOI:10.1016/0002-9343(81)90323-5
PMID:7032291
Abstract

To determine the efficacy and safety of oral verapamil in patients with rest angina admitted to the Coronary Care Unit (CCU), a double-blind placebo-controlled trial was undertaken. Of the 65 patients with rest angina screened for the study, 15 met the inclusion criteria (at least two episodes of chest pain associated with ST-T segment changes per 24 hours) during single-blind placebo phase (Day 1). Patients were then randomized to receive either placebo or verapamil (80 mg every 6 hours) on Day 2. Protocol was designed such that those who did not respond to the placebo (nonresponders) received verapamil, 80 mg every 6 hours, whereas verapamil nonresponders received increased doses (120 mg every 6 hours) on Day 3. Those who did respond (responders) continued to receive their medication. Similar action was taken on Day 4, depending on chest pain frequency and clinical evaluation. The study drug was unblinded on Day 4. At the end of the four-day period, 13 patients were receiving verapamil (nine patients, 80 mg every 6 hours, and four patients, 120 mg every 6 hours) and all but one were responders. One patient received placebo all through the period of the study and was also considered to be a responder. In the remaining one patient evidence of myocardial necrosis developed after he received a single dose of verapamil (80 mg on Day 2). Except for the prolongation of PR interval in two patients while taking verapamil, no side effects from verapamil therapy were observed. These data demonstrate the efficacy of oral verapamil in reducing episodes of myocardial ischemia in the majority of all patients with rest angina.

摘要

为了确定口服维拉帕米对入住冠心病监护病房(CCU)的静息性心绞痛患者的疗效和安全性,进行了一项双盲安慰剂对照试验。在该研究筛选的65例静息性心绞痛患者中,有15例在单盲安慰剂阶段(第1天)符合纳入标准(每24小时至少有两次与ST-T段改变相关的胸痛发作)。然后,患者在第2天被随机分配接受安慰剂或维拉帕米(每6小时80毫克)。研究方案设计为,那些对安慰剂无反应者(无反应者)在第3天接受维拉帕米治疗,每6小时80毫克,而维拉帕米无反应者接受增加剂量(每6小时120毫克)。那些有反应者(反应者)继续接受他们的药物治疗。根据胸痛频率和临床评估,在第4天采取类似措施。研究药物在第4天揭盲。在四天研究期结束时,13例患者接受维拉帕米治疗(9例患者每6小时80毫克,4例患者每6小时120毫克),除1例患者外均为反应者。1例患者在整个研究期间一直接受安慰剂治疗,也被视为反应者。在其余1例患者中,在接受单剂量维拉帕米(第2天80毫克)后出现心肌坏死证据。除了2例患者在服用维拉帕米期间PR间期延长外,未观察到维拉帕米治疗的副作用。这些数据证明口服维拉帕米对大多数静息性心绞痛患者减少心肌缺血发作有效。

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