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循证医学与心肌保护——证据何在?

Evidence-based medicine and myocardial protection--where is the evidence?

作者信息

Ferguson Z G, Yarborough D E, Jarvis B L, Sistino J J

机构信息

Medical University of South Carolina, Charleston, USA.

Medical University of South Carolina, Charleston, USA

出版信息

Perfusion. 2015 Jul;30(5):415-22. doi: 10.1177/0267659114551856. Epub 2014 Oct 8.

DOI:10.1177/0267659114551856
PMID:25298053
Abstract

OBJECTIVE

Myocardial protection with cardioplegia is an integral component of most cardiac surgical procedures, providing protection of the heart by limiting metabolic activity and increasing the myocardium's capacity to withstand ischemia for prolonged periods of time. Cardioplegia has greatly affected the landscape of cardiothoracic surgery since its introduction in the 1960s, but, to this day, there continues to be a debate over what the ideal cardioplegic solution should be. The goal of this analysis is to describe current practices in cardioplegia and to point out the lack of quality human research and subsequent publications that prevent best practices from being utilized.

METHODS

This study is a systematic review of journal publications pertaining to the composition of commonly used cardioplegic solutions. Four main types of cardioplegia were assessed to give a narrower field of examination; specifically, microplegia, del Nido, Custodiol HTK, and 4:1 blood cardioplegia. Other combinations of cardioplegia, including St. Thomas's Solution and the University of Wisconsin (UW) Solution, were considered when applicable according to the context of the publication being reviewed. Factors being assessed consisted of scientific validity, nature of the test subject (isolated organ vs. animal vs. human studies), experimental setup (retrospective trials vs. randomized clinical trials) and patient outcomes.

RESULTS

There are very few randomized clinical trials with human subjects comparing commonly used cardioplegic solutions. Numerous retrospective studies exist, but often show similar intraoperative and postoperative outcomes between the solutions. Some solutions, del Nido cardioplegia in particular, were found to have few or no significant human trials to back the rigor required in such a highly specialized field as cardiovascular surgery. A wide variation in the types of surgeries and primary outcomes were included in the publications, so it is difficult to perform an accurate systematic review of the topic.

CONCLUSION

Uniform variables among different studies would be preferable for analysis of this topic; thus, it is the researchers' recommendation that the collection of multicenter data be undertaken in order to more fully answer this research question.Comparative effectiveness studies to associate commonly used solutions are needed. Without this research, surgeon preference remains the primary determining factor for deciding which cardioplegic solution to use. Cardioplegia selection should rely more on higher scientific research, using evidenced-based medicine and ranking of clinical studies.

摘要

目的

心脏停搏液心肌保护是大多数心脏手术不可或缺的一部分,通过限制代谢活动并增强心肌长时间耐受缺血的能力来保护心脏。自20世纪60年代引入以来,心脏停搏液极大地影响了心胸外科手术的格局,但时至今日,关于理想的心脏停搏液配方仍存在争议。本分析的目的是描述当前心脏停搏液的使用情况,并指出缺乏高质量的人体研究及后续出版物,从而阻碍了最佳实践的应用。

方法

本研究是对与常用心脏停搏液成分相关的期刊出版物进行的系统综述。评估了四种主要类型的心脏停搏液,以缩小研究范围;具体而言,微停搏液、德尔尼多停搏液、HTK液和4:1血液停搏液。根据所审查出版物的背景,在适用时考虑其他心脏停搏液组合,包括圣托马斯液和威斯康星大学(UW)液。评估的因素包括科学有效性、受试对象的性质(离体器官研究、动物研究或人体研究)、实验设置(回顾性试验或随机临床试验)以及患者结局。

结果

很少有针对常用心脏停搏液进行比较的人体随机临床试验。存在大量回顾性研究,但这些研究往往显示不同心脏停搏液在术中和术后的结局相似。一些停搏液,尤其是德尔尼多停搏液,几乎没有或没有重要的人体试验来支持心血管外科这一高度专业化领域所需的严谨性。出版物中纳入的手术类型和主要结局差异很大,因此难以对该主题进行准确的系统综述。

结论

不同研究间采用统一变量更有利于该主题的分析;因此,研究人员建议开展多中心数据收集,以便更全面地回答这一研究问题。需要进行比较有效性研究以关联常用的心脏停搏液。没有此类研究,外科医生的偏好仍是决定使用哪种心脏停搏液的主要因素。心脏停搏液的选择应更多地依赖更高水平的科学研究,采用循证医学和临床研究分级。

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