Alderson P, Bunn F, Lefebvre C, Li Wan Po A, Li L, Roberts I, Schierhout G
Public Health Intervention Research Unit, London School of Hygiene & Tropical Medicine, 49-51 Bedford Square, London, UK, WC1B 3DP.
Cochrane Database Syst Rev. 2002(1):CD001208. doi: 10.1002/14651858.CD001208.
Human albumin solutions are used in a range of medical and surgical problems. Licensed indications are the emergency treatment of shock and other conditions where restoration of blood volume is urgent, burns, and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids.
To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients.
We searched the Cochrane Injuries Group trials register, Cochrane Controlled Trials Register, Medline, Embase and BIDS Index to Scientific and Technical Proceedings. Reference lists of trials and review articles were checked, and authors of identified trials were contacted. The search was last updated in November 2001.
Randomised controlled trials comparing albumin/PPF with no albumin/PPF, or with a crystalloid solution, in critically ill patients with hypovolaemia, burns or hypoalbuminaemia.
We collected data on the participants, albumin solution used, mortality at the end of follow up, and quality of allocation concealment. Analysis was stratified according to patient type.
We found 31 trials meeting the inclusion criteria and reporting death as an outcome. There were 177 deaths among 1519 trial participants. For each patient category the risk of death in the albumin treated group was higher than in the comparison group. For hypovolaemia the relative risk of death following albumin administration was 1.46 (95% confidence interval 0.97 to 2.22), for burns the relative risk was 2.40 (1.11 to 5.19), and for hypoalbuminaemia the relative risk was 1.38 (0.94 to 2.03). The pooled relative risk of death with albumin administration was 1.52 (1.17 to 1.99). Overall, the risk of death in patients receiving albumin was 14% compared to 9% in the control groups, an increase in the risk of death of 5% (2% to 8%). These data suggest that for every 20 critically ill patients treated with albumin there is one additional death.
REVIEWER'S CONCLUSIONS: There is no evidence that albumin administration reduces the risk of death in critically ill patients with hypovolaemia, burns or hypoalbuminaemia, and a strong suggestion that it may increase the risk of death. These data suggest that the use of human albumin in critically ill patients should be urgently reviewed and that it should not be used outside the context of a rigorously conducted randomised controlled trial.
人血白蛋白溶液用于一系列医学和外科问题。其许可适应证为休克的紧急治疗以及其他急需恢复血容量的情况、烧伤和低蛋白血症。人血白蛋白溶液比其他胶体和晶体溶液更昂贵。
量化在危重症患者管理中给予人血白蛋白和血浆蛋白组分(PPF)对死亡率的影响。
我们检索了Cochrane损伤组试验注册库、Cochrane对照试验注册库、Medline、Embase以及科学技术会议录的BIDS索引。检查了试验和综述文章的参考文献列表,并联系了已识别试验的作者。检索最后更新于2001年11月。
在患有低血容量、烧伤或低白蛋白血症的危重症患者中,比较白蛋白/PPF与不使用白蛋白/PPF或与晶体溶液的随机对照试验。
我们收集了关于参与者、使用的白蛋白溶液、随访结束时的死亡率以及分配隐藏质量的数据。分析根据患者类型进行分层。
我们发现31项试验符合纳入标准并将死亡作为一项结局进行报告。1519名试验参与者中有177人死亡。对于每一类患者,白蛋白治疗组的死亡风险高于对照组。对于低血容量,给予白蛋白后的相对死亡风险为1.46(95%置信区间0.97至2.22),对于烧伤,相对风险为2.40(1.11至5.19),对于低白蛋白血症,相对风险为1.38(0.94至2.03)。给予白蛋白后的合并相对死亡风险为1.52(1.17至1.99)。总体而言,接受白蛋白治疗的患者死亡风险为14%,而对照组为9%,死亡风险增加了5%(2%至8%)。这些数据表明,每20名接受白蛋白治疗的危重症患者中就会多出现1例死亡。
没有证据表明给予白蛋白可降低患有低血容量、烧伤或低白蛋白血症的危重症患者的死亡风险,且有强烈迹象表明其可能增加死亡风险。这些数据表明,应紧急审查在危重症患者中使用人血白蛋白的情况,且不应在严格进行的随机对照试验背景之外使用。