新英格兰医学报导——骨科大手术后不提倡积极输血

蓝鱼o_0

Liberal or Restrictive Transfusion in High-Risk Patients after Hip Surgery

Jeffrey L. Carson, M.D., Michael L. Terrin, M.D., M.P.H., Helaine Noveck, M.P.H., David W. Sanders, M.D., Bernard R. Chaitman, M.D., George G. Rhoads, M.D., M.P.H., George Nemo, Ph.D., Karen Dragert, R.N., Lauren Beaupre, P.T., Ph.D., Kevin Hildebrand, M.D., William Macaulay, M.D., Courtland Lewis, M.D., Donald Richard Cook, B.M.Sc., M.D., Gwendolyn Dobbin, C.C.R.P., Khwaja J. Zakriya, M.D., Fred S. Apple, Ph.D., Rebecca A. Horney, B.A., and Jay Magaziner, Ph.D., M.S.Hyg. for the FOCUS Investigators

N Engl J Med 2011;  365:2453-2462December 29, 2011

Background The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture.


Methods We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up.


Results A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, &#8722;3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, &#8722;0.9%; 99% CI, &#8722;3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, &#8722;1.9 to 4.0). The rates of other complications were similar in the two groups.


Conclusions A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.)


Supported in part by grants from the National Heart, Lung, and Blood Institute (U01 HL073958 and U01 HL074815).
Dr. Carson reports receiving grant support to his institution from Amgen; Dr. Lewis, receiving a salary from the Orthopaedic Associates of Hartford, receiving a stipend for serving as president of the Hartford County Medical Association, and providing expert testimony representing the American Academy of Orthopaedic Surgery on the Medicare Evidence Development and Coverage Advisory Committee; Dr. Apple, serving as a scientific advisory board member for Abbott Laboratories, Alere, Beckman Coulter, Ortho Clinical Diagnostics, and Instrumentation Laboratories, receiving consulting fees from Abbott Diagnostics, Ortho Clinical Diagnostics, and Instrumentation Laboratories, receiving grant support to his institution from Abbott Diagnostics, Siemens, Ortho Clinical Diagnostics, Roche Diagnostics, BioRad, Response Biomedical, Radiometer, and BRAHMS, and receiving lecture fees and travel expenses from Abbott Diagnostics and Alere; Dr. Magazine, serving as a board member for Amgen, Novartis, and GlaxoSmithKline and receiving consulting fees from Eli Lily, Sanofi-Aventis, and Amgen, grant support to his institution from Novartis, Merck, and Eli Lilly, and lecture fees from Novartis.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
No other potential conflict of interest relevant to this article was reported.
This article (10.1056/NEJMoa1012452) was published on December 14, 2011, at NEJM.org.
Source InformationThe authors' affiliations are listed in the Appendix.
Address reprint requests to Dr. Carson at the Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, 125 Paterson St., New Brunswick, NJ 08903, or at carson@umdnj.edu.
  Investigators in the Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) are listed in the Supplementary Appendix, available at NEJM.org.


Appendix The authors' affiliations are as follows: the Division of General Internal Medicine, Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick (J.L.C., H.N., K.D.); the Department of Epidemiology and Public Health, University of Maryland School of Medicine (M.L.T., J.M.); and Johns Hopkins Bayview Medical Center (K.J.Z.) — both in Baltimore; the Division of Orthopaedic Surgery, University of Western Ontario, London (D.W.S.); the Department of Physical Therapy and Surgery and the Division of Orthopaedic Surgery (L.B.), University of Alberta, Edmonton; the Division of Orthopedic Surgery (K.H.) and Department of Medicine (D.R.C.), University of Calgary, Calgary, AB; and the Department of Orthopedic Surgery, QEII Health Sciences Centre, Halifax, NS (G.D.) — all in Canada; the Department of Medicine, Saint Louis University School of Medicine, St. Louis (B.R.C.); the Department of Epidemiology, University of Medicine and Dentistry of New Jersey–School of Public Health, Piscataway (G.G.R.); the Transfusion Medicine and Cellular Therapeutics Branch, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, Bethesda (G.N.); and the Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, Perry Point (R.A.H.) — both in Maryland; the Department of Orthopedic Surgery, New York–Presbyterian Hospital at Columbia University, New York (W.M.); Hartford Hospital, Hartford, CT (C.L.); and Minneapolis Medical Research Foundation of Hennepin County Medical Center and University of Minnesota School of Medicine, Minneapolis (F.S.A.).

蓝鱼o_0

输血技术是医学史上的一座里程碑。由于骨科人工关节置换术常伴有大量出血，所以骨科医生常对贫血或高龄患者有针对性地进行术后输血。然而术后输血指征究竟应当从严还是从宽，却一直是个有争议的话题。为了探究该问题，美国多家医学院联合开展了一项多中心临床试验——髋部骨折手术重建后输血触发试验的患者心血管功能结局(FOCUS)研究，并将该研究的最新结果发表在了 N Engl J Med 上。
FOCUS试验由美国心肺血液研究所资助（NCT00071032），其主要目的在于观察有心血管风险的患者，所以入选标准为：年龄50岁以上，因髋部骨折首次手术，既往有心血管危险因素且术后3日内血红蛋白低于10g/dl。在FOCUS试验中，宽松的输血指征为：血红蛋白低于10g/dl时开始输红细胞，最少1U，直至血红蛋白恢复至10g/dl以上；严格的输血指征为：存在贫血症状或体征，或在血红蛋白低于8g/dl的情况下以谨慎原则进行处理。
由于对输血疗效及安全性的评估涉及范围非常广泛，所以FOCUS试验设置了三个观察终点，首要观察终点：患者死亡或随访60日仍不能独立行走10英尺以上；第二观察终点：院内发作心肌梗死、不稳定型心绞痛以及任何原因引起的死亡，并且每种结局均进行独立评估；第三观察终点：随机分组后30日内院内发生肺炎、伤口感染、血栓栓塞、卒中或短暂性缺血发作，以及临床可以观察到的心肌梗死等。
从2004年1月至2009年2月，FOCUS试验共在47个临床中心纳入了2016例患者，随机分为两组，分别观察宽松输血指征和严格输血指征的疗效差异。遵照不同的指征，宽松输血组患者平均输血接近2U，而严格输血组接近0U，其中59.0%的患者未接受任何输血治疗。结果发现，两组间患者三个观察终点均无明显差异，积极输血的意义极其有限。
研究者称，FOCUS试验入选的患者在以往均被认为是高危患者，其平均年龄高达81岁，而且均为心血管疾病高危人群。研究结果证实积极输血以维持血红蛋白在10g/dl以上，其临床结局并不优于8g/dl以下组，所以，积极输血的意义可能仅仅体现在改善患者的体能状态，以便尽早进行功能锻炼上。
研究者称，在FOCUS试验中，严格输血组用血量比宽松组低约65%，并且一半以上患者未接受输血，这是一个非常重要的发现。这意味着，严格掌握输血指征可以节约一半以上宝贵的血液。

——转自DXY。

盛夏的果实

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放飞梦想

不仅是大型骨科手术，从已有的文献资料来看对于所有手术均不提倡积极输血。如必须输血，也是提倡成分输血，尤其是滤除白细胞的红细胞。