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心脏瓣膜手术患者的白细胞去除术

Leukodepletion for patients undergoing heart valve surgery.

作者信息

Spencer Sally, Tang Augustine, Khoshbin Espeed

机构信息

Faculty of Health and Medicine, Lancaster University, Lancaster, UK.

出版信息

Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD009507. doi: 10.1002/14651858.CD009507.pub2.

Abstract

BACKGROUND

There is some evidence for the benefits of leukodepletion in patients undergoing coronary artery surgery. Its effectiveness in higher risk patients, such as those undergoing heart valve surgery, particularly in terms of overall clinical outcomes, is currently unclear.

OBJECTIVES

To assess the beneficial and harmful effects of leukodepletion on clinical, patient-reported and economic outcomes in patients undergoing heart valve surgery.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 3 of 12) in The Cochrane Library, the NHS Economic Evaluations Database (1960 to April 2013), MEDLINE Ovid (1946 to April week 2 2013), EMBASE Ovid (1947 to Week 15 2013), CINAHL (1982 to April 2013) and Web of Science (1970 to 17 April 2013) on 19 April 2013. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), the US National Institutes of Health (NIH) clinical trials database and the International Standard Randomised Controlled Trial Number Register (ISRCTN) in April 2013 for ongoing studies. No language or time period restrictions were applied. We examined the reference lists of all included randomised controlled trials and contacted authors of identified trials. We searched the 'grey' literature at OpenGrey and handsearched relevant conference proceedings.

SELECTION CRITERIA

Randomised controlled trials comparing a leukocyte-depleting arterial line filter with a standard arterial line filter, on the arterial outflow of the heart-lung bypass circuit, in elective patients undergoing heart valve surgery.

DATA COLLECTION AND ANALYSIS

Data were collected on the study characteristics, three primary outcomes (1. post-operative in-hospital all-cause mortality within three months, 2. post-operative all-cause mortality excluding inpatient mortality < 30 days, 3. length of stay in hospital, 4. adverse events and serious adverse events) and seven secondary outcomes (1. tubular or glomerular kidney injury, 2. validated health-related quality of life scales, 3. validated renal injury scales, 4. use of continuous veno-venous haemo-filtration, 5. length of stay in intensive care, 6. costs of care). Data were extracted by one author and verified by a second author. Insufficient data were available to perform a meta-analysis or sensitivity analysis.

MAIN RESULTS

Eight studies were eligible for inclusion in the review but data on prespecified review outcomes were available from only one, modestly powered (24 participants) study (Hurst 1997). There were no differences between a leuko-depleting versus standard filter in length of stay in the intensive care unit (ICU) (mean difference (MD) 0.80 days; 95% confidence interval (CI) -0.24 to 1.84) or length of hospital stay (MD 0.20 days; 95% CI -1.78 to 2.18).

AUTHORS' CONCLUSIONS: There are currently insufficient good quality trials with valve surgery patients to inform recommendations for changes in clinical practice. A future National Institute for Health Research (NIHR)-funded feasibility study (recruiting mid-year 2013) comparing leukodepletion with a standard arterial line filter in patients undergoing elective heart valve surgery (the ROLO trial) will be the largest study to date and will make a significant contribution to future updates of this review.

摘要

背景

有证据表明,冠状动脉手术患者进行白细胞滤除有益。目前尚不清楚其在高风险患者(如接受心脏瓣膜手术的患者)中的有效性,特别是在总体临床结局方面。

目的

评估白细胞滤除对心脏瓣膜手术患者的临床、患者报告结局和经济结局的有益和有害影响。

检索方法

2013年4月19日,我们检索了Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)(2013年第3期,共12期)、英国国家医疗服务体系经济评估数据库(1960年至2013年4月)、MEDLINE Ovid(1946年至2013年4月第2周)、EMBASE Ovid(1947年至2013年第15周)、CINAHL(1982年至2013年4月)和科学引文索引(1970年至2013年4月17日)。我们还检索了世界卫生组织(WHO)国际临床试验注册平台(ICTRP)、美国国立卫生研究院(NIH)临床试验数据库以及国际标准随机对照试验编号注册库(ISRCTN),以查找正在进行的研究。未设置语言或时间限制。我们检查了所有纳入的随机对照试验的参考文献列表,并联系了已识别试验的作者。我们在OpenGrey上检索了“灰色”文献,并手工检索了相关会议记录。

选择标准

在接受择期心脏瓣膜手术的患者中,比较白细胞滤除动脉管路过滤器与标准动脉管路过滤器对体外循环回路动脉流出影响的随机对照试验。

数据收集与分析

收集了研究特征、三个主要结局(1. 术后三个月内院内全因死亡率;2. 术后全因死亡率,不包括住院30天内的死亡;3. 住院时间;4. 不良事件和严重不良事件)以及七个次要结局(1. 肾小管或肾小球肾损伤;2. 通过验证的健康相关生活质量量表;3. 通过验证的肾损伤量表;4. 持续静脉-静脉血液滤过的使用;5. 重症监护病房住院时间;6. 护理费用)的数据。数据由一位作者提取,并由另一位作者核实。现有数据不足,无法进行荟萃分析或敏感性分析。

主要结果

八项研究符合纳入本综述的条件,但仅一项样本量适中(24名参与者)的研究(Hurst 1997)提供了预设综述结局的数据。白细胞滤除过滤器与标准过滤器在重症监护病房(ICU)住院时间(平均差(MD)0.80天;95%置信区间(CI)-0.24至1.84)或住院时间(MD 0.20天;95%CI -1.78至2.18)方面无差异。

作者结论

目前针对瓣膜手术患者的高质量试验不足,无法为临床实践的改变提供建议。未来由英国国家卫生研究院(NIHR)资助的一项可行性研究(于2013年年中招募患者),比较择期心脏瓣膜手术患者使用白细胞滤除过滤器与标准动脉管路过滤器的效果(ROLO试验)将是迄今为止规模最大的研究,将为该综述的未来更新做出重大贡献。

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