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JAMA:心脏手术时限制输血显示了可比性结果

来源:EurekAlert! 2010-10-18 16:51

据10月13日刊《美国医学会杂志》上的一项研究披露,在接受心脏手术的病人中,那些采纳了更为严格的红血球输入指导方针的病人与那些接受较多的输血患者相比,其死亡率和病情严重程度相似。本期《美国医学会杂志》上的另外一则研究对接受心脏手术患者的输血的变化程度进行了检查。

心脏手术与很高的输血率有关联。红细胞性输血的原理是根据所观察到的贫血是心脏手术后的病情严重程度与死亡有关的一个独立的风险因子。然而,根据文章的背景资料,输血与危重病人中的这些不良后果的高发生率有关;某些最近的研究证明,与心脏手术后没有输血的病人相比,那些接受输血的患者的临床后果更差。文章的作者写道:“在接受心脏手术的病人中缺乏有关最佳输血方式的证据。”

巴西圣保罗大学医学院临床医院的Ludhmila A. Hajjar, M.D., Ph.D.及其同事开展了一项心脏手术后的输血需求(TRACS)研究,旨在检验在接受选择性心脏手术的病人中采用一种红细胞输血的限制性策略是否与不受限制的输血策略同样安全。该随机性的临床试验是在2009年2月与2010年2月之间在一家巴西的大学医院的心脏外科转诊中心的加护病房(ICU)中开展的,该试验中包括有502名接受体外循环心脏手术的成年患者。这些患者被随机指派采用非限制性输血策略(以维持血球容积为30%或更高;血球容积是血球在全血中的容积百分比)或是采纳一种限制性输血策略(血球容积为24%或更高)。在加护病房中,非限制性输血策略组患者的总体平均血球容积值为31.8%,而在限制性输血策略组中,该数值为28.4%。

在非限制性输血策略组的总共253名患者中,有198人(占78%)接受了输血,而在249名限制性输血策略组的人中,有118人(占47%)接受了输血。研究人员发现,在手术后30天时所测定的发生主要的复合结果(如任何原因的死亡、心源性休克、急性呼吸窘迫综合症或需要做透析的急性肾损伤或在住院时需要进行血液滤过等)的病人在非限制性输血策略组中占10%,而在限制性输血策略组中则占11%。就发生在手术后30天时的临床并发症或死亡来说,红血球的输血单位数是与输血策略无关的独立风险因子。

心脏、呼吸系统、神经系统或感染性并发症或需要重新手术的严重出血的发生率在这两组人中没有明显的差别。在加护病房或医院的逗留时间长度上,这两组人也没有差别。

文章的作者提出,实行限制性输血策略的原理是基于许多证明非限制性输血策略缺乏益处以及同时这种做法会大大地增加与红细胞输血相关的成本及不良反应(包括病毒性和细菌性疾病的传播及输血相关性急性肺损伤)的研究。(生物谷Bioon.com)

生物谷推荐英文摘要:

JAMA. 2010;304(14):1559-1567. doi:10.1001/jama.2010.1446

Transfusion Requirements After Cardiac Surgery
The TRACS Randomized Controlled Trial

Ludhmila A. Hajjar, MD, PhD; Jean-Louis Vincent, MD, PhD; Filomena R. B. G. Galas, MD, PhD; Rosana E. Nakamura, MD; Carolina M. P. Silva, MD; Marilia H. Santos, MD, PhD; Julia Fukushima, MSc; Roberto Kalil Filho, MD, PhD; Denise B. Sierra, MD; Neuza H. Lopes, MD, PhD; Thais Mauad, MD, PhD; Aretusa C. Roquim, MD; Marcia R. Sundin, MD; Wanderson C. Le?o, MD; Juliano P. Almeida, MD; Pablo M. Pomerantzeff, MD, PhD; Luis O. Dallan, MD, PhD; Fabio B. Jatene, MD, PhD; Noedir A. G. Stolf, MD, PhD; Jose O. C. Auler Jr, MD, PhD

Context  Perioperative red blood cell transfusion is commonly used to address anemia, an independent risk factor for morbidity and mortality after cardiac operations; however, evidence regarding optimal blood transfusion practice in patients undergoing cardiac surgery is lacking.

Objective  To define whether a restrictive perioperative red blood cell transfusion strategy is as safe as a liberal strategy in patients undergoing elective cardiac surgery.

Design, Setting, and Patients  The Transfusion Requirements After Cardiac Surgery (TRACS) study, a prospective, randomized, controlled clinical noninferiority trial conducted between February 2009 and February 2010 in an intensive care unit at a university hospital cardiac surgery referral center in Brazil. Consecutive adult patients (n = 502) who underwent cardiac surgery with cardiopulmonary bypass were eligible; analysis was by intention-to-treat.

Intervention  Patients were randomly assigned to a liberal strategy of blood transfusion (to maintain a hematocrit 30%) or to a restrictive strategy (hematocrit 24%).

Main Outcome Measure  Composite end point of 30-day all-cause mortality and severe morbidity (cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration) occurring during the hospital stay. The noninferiority margin was predefined at –8% (ie, 8% minimal clinically important increase in occurrence of the composite end point).

Results  Hemoglobin concentrations were maintained at a mean of 10.5 g/dL (95% confidence interval [CI], 10.4-10.6) in the liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the restrictive-strategy group (P < .001). A total of 198 of 253 patients (78%) in the liberal-strategy group and 118 of 249 (47%) in the restrictive-strategy group received a blood transfusion (P < .001). Occurrence of the primary end point was similar between groups (10% liberal vs 11% restrictive; between-group difference, 1% [95% CI, –6% to 4%]; P = .85). Independent of transfusion strategy, the number of transfused red blood cell units was an independent risk factor for clinical complications or death at 30 days (hazard ratio for each additional unit transfused, 1.2 [95% CI, 1.1-1.4]; P = .002).

Conclusion  Among patients undergoing cardiac surgery, the use of a restrictive perioperative transfusion strategy compared with a more liberal strategy resulted in noninferior rates of the combined outcome of 30-day all-cause mortality and severe morbidity.

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