Dart Allison B, Mutter Thomas C, Ruth Chelsea A, Taback Shayne P
Department of Pediatrics and Child Health, University of Manitoba, FE-009 840 Sherbrook St, Winnipeg, Manitoba, Canada, R3A 1S1.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD007594. doi: 10.1002/14651858.CD007594.pub2.
Hydroxyethyl starches (HES) are synthetic colloids commonly used for fluid resuscitation, yet controversy exists about their impact on kidney function.
To examine the effects of HES on kidney function compared to other fluid resuscitation therapies in different patient populations.
We searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library), MEDLINE, EMBASE, MetaRegister and reference lists of articles.
Randomised controlled trials (RCTs) and quasi-RCTs in which HES was compared to an alternate fluid therapy for the prevention or treatment of effective intravascular volume depletion. Primary outcomes were renal replacement therapy (RRT), author-defined kidney failure and acute kidney injury (AKI) as defined by the RIFLE criteria. Secondary outcomes included serum creatinine and creatinine clearance.
Screening, selection, data extraction and quality assessments for each retrieved article were carried out by two authors using standardised forms. Authors were contacted when published data were incomplete. Preplanned sensitivity and subgroup analyses were performed after data were analysed with a random effects model.
The review included 34 studies (2607 patients). Overall, the RR of author-defined kidney failure was 1.50 (95% CI 1.20 to 1.87; n = 1199) and 1.38 for requiring RRT (95% CI 0.89 to 2.16; n = 1236) in HES treated individuals compared with other fluid therapies. Subgroup analyses suggested increased risk in septic patients compared to non-septic (surgical/trauma) patients. Non-septic patient studies were smaller and had lower event rates, so subgroup differences may have been due to lack of statistical power in these studies. Only limited data was obtained for analysis of kidney outcomes by the RIFLE criteria. Overall, methodological quality of studies was good but subjective outcomes were potentially biased because most studies were unblinded.
AUTHORS' CONCLUSIONS: Potential for increased risk of AKI should be considered when weighing the risks and benefits of HES for volume resuscitation, particularly in septic patients. Large studies with adequate follow-up are required to evaluate the renal safety of HES products in non-septic patient populations. RIFLE criteria should be applied to evaluate kidney function in future studies of HES and, where data is available, to re-analyse those studies already published. There is inadequate clinical data to address the claim that safety differences exist between different HES products.
羟乙基淀粉(HES)是常用于液体复苏的合成胶体,但关于其对肾功能的影响存在争议。
在不同患者群体中,比较HES与其他液体复苏疗法对肾功能的影响。
我们检索了Cochrane肾脏组的专业注册库、Cochrane对照试验中心注册库(CENTRAL,收录于Cochrane图书馆)、MEDLINE、EMBASE、MetaRegister以及文章的参考文献列表。
随机对照试验(RCT)和半随机对照试验,其中将HES与另一种液体疗法进行比较,以预防或治疗有效血管内容量不足。主要结局为肾脏替代治疗(RRT)、作者定义的肾衰竭以及根据RIFLE标准定义的急性肾损伤(AKI)。次要结局包括血清肌酐和肌酐清除率。
两名作者使用标准化表格对每篇检索到的文章进行筛选、选择、数据提取和质量评估。当发表的数据不完整时,会与作者联系。在使用随机效应模型分析数据后,进行预先计划的敏感性和亚组分析。
该综述纳入了34项研究(2607例患者)。总体而言,与其他液体疗法相比,接受HES治疗的个体中,作者定义的肾衰竭相对危险度(RR)为1.50(95%可信区间[CI] 1.20至1.87;n = 1199),需要进行RRT的RR为1.38(95% CI 0.89至2.16;n = 1236)。亚组分析表明,与非脓毒症(手术/创伤)患者相比,脓毒症患者的风险增加。非脓毒症患者的研究规模较小且事件发生率较低,因此亚组差异可能是由于这些研究缺乏统计学效力。仅获得了有限的数据用于按照RIFLE标准分析肾脏结局。总体而言,研究的方法学质量良好,但由于大多数研究未设盲,主观结局可能存在偏倚。
在权衡HES用于容量复苏的风险和益处时,应考虑AKI风险增加的可能性,尤其是在脓毒症患者中。需要进行大规模且有充分随访的研究,以评估HES产品在非脓毒症患者群体中的肾脏安全性。在未来HES的研究中应应用RIFLE标准评估肾功能,并且在有数据可用时,对已发表的研究进行重新分析。目前尚无足够的临床数据来证实不同HES产品之间存在安全性差异这一说法。