Evidence for the efficacy of NXY-059 in experimental focal cerebral ischaemia is confounded by study quality

Evidence for the efficacy of NXY-059 in experimental focal cerebral ischaemia is confounded by study quality
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DOI：
10.1161/strokeaha.108.515957
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发表时间：
2008-10-01
期刊：
STROKE
影响因子：
8.3
通讯作者：
Donnan, Geoffrey A.
Donnan, Geoffrey A.
中科院分区：
医学1区
文献类型：
--
作者：
Macleod, Malcolm R.;van der Worp, H. Bart;Donnan, Geoffrey A.

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背景和目的-SAINT II试验的中性结果再次强调了将神经保护功效从实验室转化到临床的困难。动物研究容易受到研究质量偏倚的影响，这可能导致疗效的夸大。我们报告的影响，研究质量发表的估计疗效的NXY-059在动物models of stroke. Methods，我们进行了系统的审查和分层荟萃分析发表的研究描述的疗效NXY-059在实验性局灶性脑ischemia.Results-Overall，NXY-059改善梗死体积43.3%（95%CI，34.7至52.8）。9篇出版物中仅2篇报告了随机化、治疗分配隐藏和设盲结局评估。没有报告这些质量项目的研究提供了更高的估计比高质量的studies. Conclusions，报告的疗效NXY-059在动物模型中风是混淆低研究质量的疗效。SAINT II的失败凸显了在动物研究的设计、实施和报告方面的实质性改进的必要性;期刊可以通过采用类似于10年前临床试验的动物研究标准来发挥重要作用。
Background and Purpose-The neutral results of the SAINT II trial have again highlighted difficulties translating neuroprotective efficacy from bench to bedside. Animal studies are susceptible to study quality biases, which may lead to overstatement of efficacy. We report the impact of study quality on published estimates of the efficacy of NXY-059 in animal models of stroke.Methods-We conducted a systematic review and stratified meta-analysis of published studies describing the efficacy of NXY-059 in experimental focal cerebral ischemia.Results-Overall, NXY-059 improved infarct volume by 43.3% (95% CI, 34.7 to 52.8). Only 2 of 9 publications reported randomization, concealment of treatment allocation, and blinded outcome assessment. Studies not reporting these quality items gave substantially higher estimates of efficacy than did higher-quality studies.Conclusions-The reported efficacy of NXY-059 in animal models of stroke is confounded by low study quality. The failure of SAINT II highlights the need for substantial improvements in the design, conduct, and reporting of animal studies; journals can play an important role in this by adopting standards for animal studies similar to those agreed over 10 years ago for clinical trials.