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用于危重症患者复苏和容量扩充的人血白蛋白溶液。

Human albumin solution for resuscitation and volume expansion in critically ill patients.

机构信息

Cochrane Injuries Group, London School of Hygiene & Tropical Medicine, North Courtyard, Keppel Street, London, UK, WC1E 7HT.

出版信息

Cochrane Database Syst Rev. 2011 Oct 5(10):CD001208. doi: 10.1002/14651858.CD001208.pub3.

Abstract

BACKGROUND

Human albumin solutions are used for 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, such as in burns and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids.

OBJECTIVES

To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients.

SEARCH STRATEGY

We searched the Cochrane Injuries Group Specialised Register (searched 31 May 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), MEDLINE (Ovid) (1948 to week 3 May 2011), EMBASE (Ovid) (1980 to Week 21 2011), CINAHL (EBSCO) (1982 to May 2011), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) (1970 to May 2011), ISI Web of Science: Conference Proceedings Citation Index - Science (CPCI-S) (1990 to May 2011), PubMed (www.ncbi.nlm.nih.gov/sites/entrez/) (searched 10 June 2011, limit: last 60 days). Reference lists of trials and review articles were checked, and authors of identified trials were contacted.

SELECTION CRITERIA

Randomised controlled trials comparing albumin or PPF with no albumin or PPF or with a crystalloid solution in critically ill patients with hypovolaemia, burns or hypoalbuminaemia.

DATA COLLECTION AND ANALYSIS

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.

MAIN RESULTS

We found 38 trials meeting the inclusion criteria and reporting death as an outcome. There were 1,958 deaths among 10,842 trial participants.For hypovolaemia, the relative risk of death following albumin administration was 1.02 (95% confidence interval (CI) 0.92 to 1.13). This estimate was heavily influenced by the results of the SAFE trial, which contributed 75.2% of the information (based on the weights in the meta-analysis). For burns, the relative risk was 2.93 (95% CI 1.28 to 6.72) and for hypoalbuminaemia the relative risk was 1.26 (95% CI 0.84 to 1.88). There was no substantial heterogeneity between the trials in the various categories (Chi(2) = 26.66, df = 31, P = 0.69). The pooled relative risk of death with albumin administration was 1.05 (95% CI 0.95 to 1.16).

AUTHORS' CONCLUSIONS: For patients with hypovolaemia, there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trials.

摘要

背景

人血白蛋白溶液用于一系列医学和外科问题。其获批适应症为休克的紧急治疗以及其他急需恢复血容量的情况,如烧伤和低蛋白血症。人血白蛋白溶液比其他胶体溶液和晶体溶液更昂贵。

目的

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。

检索策略

我们检索了Cochrane损伤组专业注册库(检索时间为2011年5月31日)、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2011年第2期)、MEDLINE(Ovid)(1948年至2011年5月第3周)、EMBASE(Ovid)(1980年至2011年第21周)、CINAHL(EBSCO)(1982年至2011年5月)、ISI科学网:科学引文索引扩展版(SCI-EXPANDED)(1970年至2011年5月)、ISI科学网:会议论文引文索引 - 科学版(CPCI-S)(1990年至2011年5月)、PubMed(www.ncbi.nlm.nih.gov/sites/entrez/)(检索时间为2011年6月10日,限制:过去60天)。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。

入选标准

比较白蛋白或PPF与无白蛋白或PPF或与晶体溶液在低血容量、烧伤或低白蛋白血症的危重症患者中的随机对照试验。

数据收集与分析

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。

主要结果

我们发现38项试验符合纳入标准并将死亡作为一项结局进行报告。10842名试验参与者中有1958人死亡。对于低血容量患者,给予白蛋白后死亡的相对风险为1.02(95%置信区间(CI)0.92至1.13)。这一估计受到SAFE试验结果的严重影响,该试验贡献了75.2%的信息(基于荟萃分析中的权重)。对于烧伤患者,相对风险为2.93(95%CI 1.28至6.72),对于低白蛋白血症患者,相对风险为1.26(95%CI 0.84至1.88)。各类别试验之间没有实质性异质性(卡方 = 26.66,自由度 = 31,P = 0.69)。给予白蛋白时合并的死亡相对风险为1.05(95%CI 0.95至1.16)。

作者结论

对于低血容量患者,与生理盐水等更便宜的替代方案相比,没有证据表明白蛋白能降低死亡率。没有证据表明白蛋白能降低烧伤和低白蛋白血症危重症患者的死亡率。在某些高度特定的危重症患者群体中白蛋白可能适用这一可能性仍存在疑问。然而,鉴于缺乏白蛋白能带来死亡率益处的证据,且与生理盐水等替代方案相比白蛋白成本增加,白蛋白仅应在分配隐藏良好且样本量充足的随机对照试验背景下使用似乎是合理的。

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