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使用Celsior或圣托马斯2号溶液进行择期心脏手术:一项前瞻性、单中心、随机对照试验研究。

Elective cardiac surgery using Celsior or St. Thomas No. 2 solution: a prospective, single-center, randomized pilot study.

作者信息

Pereda Daniel, Castella Manuel, Pomar Jose-Luis, Cartaña Ramon, Josa Miguel, Barriuso Clemente, Roman Javier, Mulet Jaime

机构信息

Department of Cardiovascular Surgery, Thorax Institute, Hospital Clinic of Barcelona, University of Barcelona, Villarroel 170, 08036 Barcelona, Spain.

出版信息

Eur J Cardiothorac Surg. 2007 Sep;32(3):501-6. doi: 10.1016/j.ejcts.2007.05.021. Epub 2007 Jul 2.

DOI:10.1016/j.ejcts.2007.05.021
PMID:17604178
Abstract

OBJECTIVE

Celsior is a crystalloid solution specifically designed for solid-organ transplantation. Due to its advanced combination of solutes, we wanted to evaluate its safety, efficacy, and possible benefits when used as blood cardioplegia in elective cardiac surgery in a single-center, randomized, controlled clinical trial, comparing its performance with a well-established cardioplegic solution.

METHODS

Patients programmed for aortic valve replacement were randomized to receive either St. Thomas No. 2 or Celsior as blood cardioplegia with the same administration protocol. Intraoperative and postoperative variables concerning myocardial protection were registered and compared.

RESULTS

A total of 60 patients were enrolled and randomized (Celsior, 30; St. Thomas, 30). There were no significant differences in baseline and preoperative variables. Volume of cardioplegic solution, number of administrations needed and the amount of potassium added were similar in both groups. Patients in the Celsior group showed a higher incidence of spontaneous sinus rhythm after myocardial ischemia (77% vs 40%, p=0.004) and fewer patients required defibrillation (17% vs 43%, p=0.024) for ventricular reperfusion arrhythmias. Postoperatively, there were no significant differences in troponin I release, inotropic and vasopressor drug support, ICU stay, and postoperative evolution. There were no deaths in the study.

CONCLUSIONS

Celsior solution used as blood cardioplegia is effective and seems to be safe in elective aortic valve replacement when compared in this pilot study with a standard cardioplegic solution used worldwide. Fast return to sinus rhythm and lower incidence of reperfusion arrhythmias in the Celsior group may reflect a better myocardial protection during cardioplegic arrest. More investigation is needed to elucidate its performance in elective surgery.

摘要

目的

赛尔西奥(Celsior)是一种专门为实体器官移植设计的晶体溶液。由于其溶质的先进组合,我们希望在一项单中心、随机、对照临床试验中评估其在择期心脏手术中用作血液停搏液时的安全性、有效性和可能的益处,并将其性能与一种成熟的停搏液进行比较。

方法

计划进行主动脉瓣置换的患者被随机分配接受圣托马斯2号(St. Thomas No. 2)或赛尔西奥作为血液停搏液,采用相同的给药方案。记录并比较有关心肌保护的术中和术后变量。

结果

总共60例患者入组并随机分组(赛尔西奥组30例;圣托马斯组30例)。基线和术前变量无显著差异。两组的停搏液体积、所需给药次数和添加的钾量相似。赛尔西奥组患者心肌缺血后自发窦性心律的发生率较高(77%对40%,p = 0.004),因心室再灌注心律失常需要除颤的患者较少(17%对43%,p = 0.024)。术后,肌钙蛋白I释放、正性肌力药和血管升压药支持、重症监护病房停留时间及术后病情演变方面无显著差异。研究中无死亡病例。

结论

在这项初步研究中,与全球使用的标准停搏液相比,赛尔西奥溶液用作血液停搏液在择期主动脉瓣置换中是有效的且似乎是安全的。赛尔西奥组窦性心律恢复快和再灌注心律失常发生率较低可能反映了停搏期间更好的心肌保护。需要更多研究来阐明其在择期手术中的性能。

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