ECLIPSE研究：氯维地平与硝酸甘油、硝普钠、尼卡地平治疗心外手术患者急性高血压的对比研究

背景心外手术过程中的高血压常难以控制，并进而影响手术疗效。氯维地平是一种新型的2-氢吡啶L型钙通道阻滞剂，可有效降低动脉压，起效迅速，且半衰期极短。氯维地平治疗围手术期高血压的安全性事件评估研究（evaluation of clevidipine in the perioperative treatment of hypertension assessing safety events trial, ECLIPSE）旨在比较氯维地平（CLV）与硝酸甘油（NTG）、硝普钠（SNP）、尼卡地平（NIC）治疗心外手术患者急性高血压的疗效与安全性。方法我们分析了3项前瞻性、随机、开放性平行对照研究的资料，这些研究由61家医疗中心参与完成，比较了氯维地平与硝酸甘油、硝普钠、尼卡地平在心外手术患者的围手术期应用情况。共选择1964例患者，1512例按临床标准需紧急治疗高血压，符合随机化纳入标准。这些患者按1：1比例随机编入3个平行的对比治疗组。主要结局为30天内的死亡事件、心肌梗死、中风和肾功能不全，次要结局为血压控制的充分性与精确度的评估报告。结果氯维地平组与其他治疗组相比，心肌梗死、中风和肾功能不全的发生率均无显著差异。硝普钠治疗组与氯维地平组相比，死亡例数显著增加（P=0．04）。与硝酸甘油（P=0．0006）和硝普钠（P=0．003）相比，氯维地平能更有效地把血压控制在预定范围内。在控制血压于一个预定范围方面氯维地平与尼卡地平等效，但当预定血压控制范围较窄时，氯维地平较尼卡地平超出范围的幅度更小。结论氯维地平用于治疗心外手术患者的急性高血压安全有效。

BACKGROUND： Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure （BP）. The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial （ECLIPSE） was performed to compare the safety and efficacy of clevidipine （CLV） with nitroglycerin （NTG）, sodium nitroprusside （SNP）, and nicardipine （NIC） in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery. METHODS： We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1 ： 1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome. RESULTS： There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients （P = 0. 04）. CLV was more effective compared with NTG （P =0. 0006） or SNP （P = 0. 003） in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC. CONCLUSIONS： CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.