羟乙基淀粉容量复苏试验中的报告偏倚。
Reporting bias in trials of volume resuscitation with hydroxyethyl starch.
作者信息
Wiedermann Christian J
机构信息
Academic Teaching Department of Internal Medicine, Central Hospital of Bozen/Bolzano, Lorenz-Böhler-Street 5, 39100, Bozen/Bolzano (BZ), Italy,
出版信息
Wien Klin Wochenschr. 2014 Apr;126(7-8):189-94. doi: 10.1007/s00508-014-0503-y. Epub 2014 Mar 5.
Abstract
The possibility of renal damage by hydroxyethyl starch has become the focus of intensive dispute based on the findings of published large trials. The aim of this narrative review is to analyze outcome reporting bias in the literature on volume resuscitation, focusing on selective outcome reporting in published randomized and observational trials with "modern" hydroxyethyl starch as therapeutic intervention. Three recent publications claimed to confirm renal safety of hydroxyethyl starch 130/0.4 for indications in severe sepsis, trauma, and critical illness, respectively. Selective outcome reporting was identified in these studies including underreporting of side effects and change of primary study outcomes. In conclusion, selective outcome reporting bias is identified in recent publications of clinical trials on volume resuscitation with HES.
摘要
基于已发表的大型试验结果，羟乙基淀粉导致肾损伤的可能性已成为激烈争论的焦点。本叙述性综述的目的是分析容量复苏文献中的结果报告偏倚，重点关注以“现代”羟乙基淀粉作为治疗干预措施的已发表随机试验和观察性试验中的选择性结果报告。最近有三篇出版物分别声称证实了羟乙基淀粉130/0.4在严重脓毒症、创伤和危重病适应症中的肾脏安全性。在这些研究中发现了选择性结果报告，包括副作用报告不足和主要研究结果的改变。总之，在最近关于使用羟乙基淀粉进行容量复苏的临床试验出版物中发现了选择性结果报告偏倚。
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本文引用的文献
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2
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3
[Limited applications for hydroxyethyl starch : background and alternative concepts].[羟乙基淀粉的应用受限：背景及替代概念]
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