Hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis.
Hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis.
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DOI：
10.1136/bmj.f839
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发表时间：
2013-02-15
期刊：
影响因子：
--
通讯作者：
Wetterslev J
中科院分区：
文献类型：
--
作者：
Haase N;Perner A;Hennings LI;Siegemund M;Lauridsen B;Wetterslev M;Wetterslev J
目的评价羟乙基淀粉130/0.38-0.45与晶体或白蛋白相比对脓毒症患者死亡率、肾损伤、出血和严重不良事件的影响。设计随机临床试验的荟萃分析和试验序贯分析的系统评价。数据来源：科克伦图书馆、Medline、Embase、Biosis Previews、Science Citation Index Expanded、CINAHL、Current Controlled Trials、Clinicaltrials.gov和Centerwatch，截至2012年9月;手动检索参考文献列表和其他系统性综述;联系作者和相关制药公司。研究选择合格试验是比较羟乙基淀粉130/0. 38 - 0. 45与晶体或人血白蛋白在脓毒症患者中的随机临床试验。纳入已发表和未发表的试验，不考虑语言和预先确定的结局。数据提取两名评审员独立评估纳入研究，并提取有关方法，干预措施，结局和偏倚风险的数据。风险比和95%置信区间的平均差异估计与固定和随机效应模型。结果纳入了9项试验，随机分配了3456例脓毒症患者。总的来说，羟乙基淀粉130/0.38-0.45与晶体或白蛋白相比不影响死亡的相对风险（1.04，95%置信区间0.89至1.22，3414例患者，8项试验），但在预定义的低偏倚风险试验分析中，死亡的相对风险为1.11（1.00至1.23，试验序贯分析（TSA）调整95%置信区间0.95至1.29，3016例患者，4项试验）。羟乙基淀粉组中，肾脏替代治疗使用较多（1.36，1.08至1.72，TSA调整1.03至1.80，1311例患者，5项试验），急性肾损伤的相对风险为1.18（0.99至1.40，TSA调整0.90至1.54，994例患者，4项试验）。羟乙基淀粉组中更多的患者输注红细胞（1.29，1.13至1.48，TSA调整1.10至1.51，973例患者，3项试验），更多的患者发生严重不良事件（1.30，1.02至1.67，TSA调整0.93至1.83，1069例患者，4项试验）。两组之间的红细胞输注量没有差异（平均差异65 mL，95%置信区间-20至149 mL，3项试验）。结论在包括近期试验数据的常规荟萃分析中，与晶体或白蛋白相比，羟乙基淀粉130/0.38-0.45增加了脓毒症患者肾脏替代治疗和红细胞输注的使用，并导致更严重的不良事件。羟乙基淀粉130/0.38-0.45似乎不太可能为脓毒症患者提供总体临床获益。
Objective To assess the effects of fluid therapy with hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin on mortality, kidney injury, bleeding, and serious adverse events in patients with sepsis. Design Systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources Cochrane Library, Medline, Embase, Biosis Previews, Science Citation Index Expanded, CINAHL, Current Controlled Trials, Clinicaltrials.gov, and Centerwatch to September 2012; hand search of reference lists and other systematic reviews; contact with authors and relevant pharmaceutical companies. Study selection Eligible trials were randomised clinical trials comparing hydroxyethyl starch 130/0.38-0.45 with either crystalloid or human albumin in patients with sepsis. Published and unpublished trials were included irrespective of language and predefined outcomes. Data extraction Two reviewers independently assessed studies for inclusion and extracted data on methods, interventions, outcomes, and risk of bias. Risk ratios and mean differences with 95% confidence intervals were estimated with fixed and random effects models. Results Nine trials that randomised 3456 patients with sepsis were included. Overall, hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin did not affect the relative risk of death (1.04, 95% confidence interval 0.89 to 1.22, 3414 patients, eight trials), but in the predefined analysis of trials with low risk of bias the relative risk of death was 1.11 (1.00 to 1.23, trial sequential analysis (TSA) adjusted 95% confidence interval 0.95 to 1.29, 3016 patients, four trials). In the hydroxyethyl starch group, renal replacement therapy was used more (1.36, 1.08 to 1.72, TSA adjusted 1.03 to 1.80, 1311 patients, five trials), and the relative risk of acute kidney injury was 1.18 (0.99 to 1.40, TSA adjusted 0.90 to 1.54, 994 patients, four trials). More patients in the hydroxyethyl starch group were transfused with red blood cells (1.29, 1.13 to 1.48, TSA adjusted 1.10 to 1.51, 973 patients, three trials), and more patients had serious adverse events (1.30, 1.02 to 1.67, TSA adjusted 0.93 to 1.83, 1069 patients, four trials). The transfused volume of red blood cells did not differ between the groups (mean difference 65 mL, 95% confidence interval −20 to 149 mL, three trials). Conclusion In conventional meta-analyses including recent trial data, hydroxyethyl starch 130/0.38-0.45 versus crystalloid or albumin increased the use of renal replacement therapy and transfusion with red blood cells, and resulted in more serious adverse events in patients with sepsis. It seems unlikely that hydroxyethyl starch 130/0.38-0.45 provides overall clinical benefit for patients with sepsis.
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