胃肠道出血:暂停输血改善存活


  【24drs.com】根据发表于1月3日新英格兰医学期刊的研究,暂停输血直到血红素值低于7%而非9%,可改善急性上胃肠道(GI)出血患者的整体存活达45%。
  
  美国耶鲁大学医学院VA Connecticut Healthcare System的Loren Laine医师在编辑评论中声明,这篇研究提供了期待已久的证据,可为上胃肠道出血处置调整现行建议与指引实务。
  
  Laine医师写道,之前的统合分析大部份包括了宽松输血策略的潜在效益,但只有不到1%包括了急性GI出血的病患。
  
  为了检视缩减使用范围的可能效益,西班牙巴塞隆纳肝脏和消化系统疾病暨生物医学研究中心、Autonomous大学de Sant Pau医院胃肠科胃肠道出血小组Candid Villanueva医师等研究者共纳入921名急性GI出血病患,指定他们依据不同输血策略接受红血球输血,分别是严格(血色素<7 g/dL)或宽松(血色素<9 g/dL)策略;两组病患在开始时的血色素值相当(分别是9.6 ± 2.2 g/dL和9.4 ± 2.4 g/dL;P = .45)。
  
  结果发现,严格的输血方式使45天死亡率整体降低55%(95% vs 91%;95%信心区间[CI],33% - 92%;P = .02),主要是无法成功控制的出血导致死亡数减少(分别是3人[0.7%]vs 14人[3.1%];P = .01)。
  
  其它效益包括输血减少(49% vs 86%;P < .001),减少后续出血可能性(10% vs 16%;风险比[HR],0.62;95%信心区间[CI],0.43 - 0.91;P =.01),整体副作用较少(40% vs 48%;HR,0.73;95% CI,0.56 - 0.95;P = .02)。
  
  次组分析发现,肝硬化病患的死亡率降低43%(HR,0.57;95% CI,0.30 - 1.08;P = .08),存活率的改善特别可归因于Child–Pugh类别A或B之疾病(HR,0.30;95% CI,0.11 - 0.85;P = .02);在更严重的类别C疾病则未发现这项效益(HR,1.04;95% CI,0.45 - 2.37;P = .91)。
  
  后续出血风险方面也观察到类似的模式,分别是:一般肝硬化患者(12% vs 22%;HR,0.49;95% CI,0.27 - 0.90;P = .02),Child–Pugh类别A或B者(11% vs 21%;HR,0.53;95% CI,0.27 - 0.94;P = .04),类别C疾病者(15% vs 28%;HR,0.58;95% CI,0.15 - 1.95;P = .33)。
  
  虽然担心门脉压反弹增加、门脉高压之肝硬化患者的相关出血风险等,严格策略组的病患从开始到第2或3天,门脉压力梯度并无改变,而宽松策略组则观察到显著增加(20.5 ± 3.1 mm Hg到21.4 ± 4.3 mm Hg;P = .03)。
  
  指定到严格组的肝硬化病患,整体上比较不需要气球充填加压止血或经颈静脉肝内门体静脉分流术(分别是2% vs 8% [ P = .03]与4% vs 11% [ P = .04])。
  
  静脉曲张和消化道溃疡相关出血的病患中,严格输血策略显示趋向比宽松方式更可改善存活率(分别是HR,0.58 [95% CI,0.27 -1.27;P = .18]与HR,0.70 [95% CI,0.26 - 1.25;P = .26]),后续出血可能性也是改善(分别是11% vs 22% [HR,0.50;95% CI,0.23 - 0.99;P = .05]和10% vs 16% [HR,0.63;95% CI,0.37 - 1.07;P = .09])。
  
  Laine医师写道,之前根据的大多是动物研究结果,严格输血策略通常用在静脉曲张出血病患,以预防门脉压的反弹上升,研究作者虽认为是在门脉高压病患观察到严格输血策略的主要效果,而非无门脉高压者,但是并未提供正式的关联检测。
  
  Laine医师指出,再者,后续出血和死亡的风险比,在各组整体和肝硬化、食道静脉曲张、消化性溃疡等次组皆相似,信心区间几乎重迭。
  
  不过,Laine医师认为,该研究显示,在胃肠道出血病患进行严格输血策略所发现的效益超过其它族群所观察的结果,显示出血和死亡率是关键结果的重要性。
  
  Laine医师结论指出,该研究对指引临床实务提供了重要证据,建议多数上胃肠道出血病患,不论有无门脉高压都先暂停输血,直到他们的血色素值低于7 g/dL。
  
  资料来源:http://www.24drs.com/professional/list/content.asp?x_idno=6974&x_classno=0&x_chkdelpoint=Y
  

GI Bleeds: Withholding Transfusions Boosts Survival

By Yael Waknine
Medscape Medical News

Withholding transfusions until hemoglobin levels are lower than 7%, rather than 9%, improves overall survival by 45% in patients with acute upper gastrointestinal (GI) bleeding, according to a study published in the January 3 issue of the New England Journal of Medicine.

"[This study] provides long-awaited evidence to guide practice and justify current recommendations for the management of upper gastrointestinal bleeding," asserts Loren Laine, MD, from the Yale University School of Medicine in New Haven and the VA Connecticut Healthcare System in West Haven, in an accompanying editorial.

Although prior meta-analyses have largely excluded the potential for benefit with a liberal transfusion strategy, only 1% or less of included patients had acute GI bleeds, Dr. Laine writes.

To examine the potential benefit of a more narrow approach, Candid Villanueva, MD, from the Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Autonomous University, and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas, Barcelona, Spain, and colleagues consecutively enrolled 921 patients presenting with acute GI bleeds, assigning them to receive red blood cell transfusions according to a restrictive (hemoglobin level, <7 g/dL) or liberal (hemoglobin level, <9 g/dL) strategy. Baseline hemoglobin levels were comparable for the 2 groups of patients (9.6 ± 2.2 g/dL and 9.4 ± 2.4 g/dL, respectively; P = .45).

Results revealed that a restrictive approach to transfusions led to an overall 55% reduction in 45-day mortality rate (95% vs 91%; 95% confidence interval [CI], 33% - 92%; P = .02), which was primarily attributed to fewer deaths from bleeding that could not be successfully controlled (3 [0.7%] patients vs 14 [3.1%] patients; P = .01).

Other benefits included fewer transfusions (49% vs 86%; P < .001), a decreased likelihood of further bleeding (10% vs 16%; hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.43 - 0.91; P = .01), and fewer adverse events overall (40% vs 48%; HR, 0.73; 95% CI, 0.56 - 0.95; P = .02).

Subgroup Analyses

Subgroup analyses revealed that there was a 43% decrease in mortality among patients with cirrhosis (HR, 0.57; 95% CI, 0.30 - 1.08; P = .08), and that improved survival rate was particularly driven by those with Child–Pugh class A or B disease (HR, 0.30; 95% CI, 0.11 - 0.85; P = .02). No such benefit was observed among those with more severe class C disease (HR, 1.04; 95% CI, 0.45 - 2.37; P = .91).

A similar pattern was observed with respect to the risk for further bleeding among patients with cirrhosis in general (12% vs 22%; HR, 0.49; 95% CI, 0.27 - 0.90; P = .02), those with Child–Pugh class A or B disease (11% vs 21%; HR, 0.53; 95% CI, 0.27 - 0.94; P = .04), and patients with class C disease (15% vs 28%; HR, 0.58; 95% CI, 0.15 - 1.95; P = .33).

Although concerns have been raised regarding the risk for rebound increases in portal pressure and related bleeding in patients with cirrhosis who have portal hypertension, patients in the restrictive strategy group experienced no change in the portal pressure gradient from baseline to days 2 or 3, whereas a significant increase was observed among those in the liberal strategy group (20.5 ± 3.1 mm Hg to 21.4 ± 4.3 mm Hg; P = .03).

Patients with cirrhosis who were assigned to the restrictive strategy group were less likely overall to require balloon tamponade or a transjugular intrahepatic portosystemic shunt (2% vs 8% [ P = .03] and 4% vs 11% [ P = .04]), respectively.

Among patients with variceal and peptic ulcer–related bleeding, the restrictive transfusion strategy showed a trend toward improved survival rates relative to the liberal approach (HR, 0.58 [95% CI, 0.27 -1.27; P = .18] and HR, 0.70 [95% CI, 0.26 - 1.25; P = .26], respectively), as well as toward the likelihood of further bleeding (11% vs 22% [HR, 0.50; 95% CI, 0.23 - 0.99; P = .05] and 10% vs 16% [HR, 0.63; 95% CI, 0.37 - 1.07; P = .09]).

"Largely on the basis of results from studies in animals, a restrictive transfusion strategy is commonly used for patients with variceal bleeding to prevent rebound increases in portal pressure," Dr. Laine writes, noting that although the study authors suggest that the restrictive transfusion strategy's main benefit was observed among patients with rather than without portal hypertension, no formal test of interaction was provided.

Furthermore, hazard ratios for further bleeding and for death were similar in the overall group and in subgroups with cirrhosis, esophageal varices, or peptic ulcer, with closely overlapping confidence intervals, Dr. Laine points out.

However, the study shows merit in it that it reveals benefits for a restrictive transfusion strategy in patients with gastrointestinal bleeding that exceeds that observed in other populations, Dr. Laine suggests, noting the importance of bleeding and mortality as key outcomes.

"[The study] provides important evidence to guide clinical practice," Dr. Laine concludes, advising that most patients with upper GI bleeding, with or without portal hypertension, have blood transfusions withheld until their hemoglobin levels drop below 7 g/dL.

The study was funded in part by the Fundacio Investigacio Sant Pau. One coauthor reports receiving consulting fees from Sequana Medical. The other authors and the editorialist have disclosed no relevant financial relationships.

N Engl J Med. 2013;368:11-21, 75-76.

    
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