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首页> 外文期刊>Anesthesia and Analgesia: Journal of the International Anesthesia Research Society >Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial.
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Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial.

机译：心脏外科手术患者的急性术后高血压的治疗：氯维地平评估其在心脏外科手术2（ESCAPE-2）中的术后降压作用的功效研究，这是一项随机，双盲，安慰剂对照试验。

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BACKGROUND: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients. METHODS: Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) >or=140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by >or=15% from baseline]. Patients received an infusion of either clevidipine (0.4-8.0 microg kg(-1) min(-1)) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by >or=15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation. RESULTS: Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4-7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups. CONCLUSIONS: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.
机译：背景：急性术后高血压是心脏手术的众所周知的并发症，并与术后发病率有关。 Clevidipine是一种超短效第三代二氢吡啶钙通道阻滞剂，可发挥血管选择性的，特定于动脉的血管舒张作用，以降低动脉血压，而不会对心功能产生负面影响。在这项双盲，安慰剂对照试验中，我们检查了氯维地平治疗心脏手术患者术后高血压的功效和安全性。方法：对206例接受心脏手术的患者进行术前随机分组。其中，有110项符合随机化后纳入研究的标准[入院后4小时内收缩压（SBP）>或= 140 mm Hg，并经临床评估认为需要将SBP降低至基线以上>或= 15％] 。除非治疗失败较早，否则患者将接受氯维地平（0.4-8.0 microg kg（-1）min（-1））或20％脂质乳剂（安慰剂）的输注，持续30分钟，最多1小时。主要终点是治疗失败的发生率，定义为无法从基线降低SBP≥15％或在​​开始研究药物后30分钟内以任何原因终止研究治疗。结果：克立地平治疗的患者治疗失败的发生率显着低于安慰剂患者[8.2％（61分中的5）对79.6％（39分中的39），P <0.0001]。 91.8％的氯维地平治疗患者获得了治疗成功。使用氯维地平达到SBP的中位时间为5.3分钟（95％置信区间为4-7分钟）。没有观察到从基线到心率的临床显着增加。两个治疗组的不良事件发生率相似。结论：克利夫地平可有效，安全地快速治疗心脏手术后的急性术后高血压。

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