Remy K E, Sun J, Wang D, Welsh J, Solomon S B, Klein H G, Natanson C, Cortés-Puch I
Critical Care Medicine Department, Clinical Center, NIH, Bethesda, MD, USA.
NIH Library, NIH, Bethesda, MD, USA.
Vox Sang. 2016 Jul;111(1):43-54. doi: 10.1111/vox.12380. Epub 2016 Feb 5.
Preclinical studies generated the hypothesis that older stored red blood cells (RBCs) can increase transfusion risks. To examine the most updated and complete clinical evidence and compare results between two trial designs, we assessed both observational studies and randomized controlled trials (RCTs) studying the effect of RBC storage age on mortality.
Five databases were searched through December 2014 for studies comparing mortality using transfused RBCs having longer and shorter storage times.
Analysis of six RCTs found no significant differences in survival comparing current practice (average storage age of 2 to 3 weeks) to transfusion of 1- to 10-day-old RBCs (OR 0·91, 95% CI 0·77-1·07). RBC storage age was lower in RCTs vs. observational studies (P = 0·01). The 31 observational studies found an increased risk of death (OR 1·13, 95% CI 1·03-1·24) (P = 0·01) with increasing age of RBCs, a different mortality effect than RCTs (P = 0·02).
RCTs established that transfusion of 1- to 10-day-old stored RBCs is not superior to current practice. The apparent discrepancy in mortality between analyses of RCTs and observational studies may in part relate to differences in hypotheses tested and ages of stored RBCs studied. Further trials investigating 1- to 10-day-old stored RBC benefits would seem of lower priority than studies to determine whether 4- to 6-week stored units have safety and efficacy equivalent to the 2- to 3-week-old stored RBCs commonly transfused today.
临床前研究提出了这样的假设,即储存时间较长的老龄红细胞(RBC)会增加输血风险。为了检验最新且完整的临床证据,并比较两种试验设计的结果,我们评估了观察性研究和随机对照试验(RCT),这些研究探讨了RBC储存时间对死亡率的影响。
检索了五个数据库,截至2014年12月,查找比较使用储存时间长短不同的RBC进行输血时死亡率的研究。
对六项RCT的分析发现,将当前做法(平均储存时间为2至3周)与输注1至10日龄的RBC进行比较时,生存率无显著差异(OR 0.91,95%CI 0.77 - 1.07)。与观察性研究相比,RCT中的RBC储存时间更短(P = 0.01)。31项观察性研究发现,随着RBC年龄增加,死亡风险升高(OR 1.13,95%CI 1.03 - 1.24)(P = 0.01),这与RCT的死亡率效应不同(P = 0.02)。
RCT证实,输注1至10日龄的储存RBC并不优于当前做法。RCT分析与观察性研究在死亡率方面的明显差异可能部分与所检验的假设以及所研究的储存RBC年龄差异有关。进一步研究1至10日龄储存RBC益处的试验,其优先级似乎低于确定4至6周储存单位是否具有与当今常用的2至3周龄储存RBC相当的安全性和有效性的研究。