Friedrich Jacqueline, Lindauer Ute, Höllig Anke
Department of Neurosurgery, University Hospital RWTH Aachen, Aachen, Germany.
Front Neurol. 2022 May 30;13:834003. doi: 10.3389/fneur.2022.834003. eCollection 2022.
The translation of preclinical stroke research into successful human clinical trials remains a challenging task. The first Stroke Therapy Academic Industry Roundtable (STAIR) recommendations for preclinical research and several other guidelines were published to address these challenges. Most guidelines recommend the use of physiological monitoring to detect the occurrence of undesired pathologies such as subarachnoid hemorrhage and to limit the variability of the infarct volume and-therefore-homogenize the experimental result for complete reporting particularly with respect to transparency and methodological rigor. From the years 2009 and 2019, 100 published articles each using a rat stroke model were analyzed to quantify parameters related to anesthesia, physiological monitoring, stroke model type, ischemia verification, and overall study quality over time. No significant difference in the frequency of cerebral blood flow (CBF) measurements over time (28/34% for 2009/2019) was found. Notably, significantly fewer studies reported temperature, blood pressure, and blood gas monitoring data in 2019 compared to 2009. On the other hand, an increase in general study quality parameters (e.g., randomization, reporting of approval) was seen. In conclusion, the frequency of periinterventional monitoring has decreased over time. Some general methodological quality aspects, however, partially have increased. CBF measurement-the gold standard for ischemia verification-was applied rarely. Despite the growing recognition of current guidelines such as STAIR and ARRIVE (both widely approved in 2019) reporting, methods and procedures mostly do not follow these guidelines. These deficits may contribute to the translational failure of preclinical stroke research in search for neuroprotective therapies.
将临床前中风研究转化为成功的人体临床试验仍然是一项具有挑战性的任务。首次发布了中风治疗学术产业圆桌会议(STAIR)关于临床前研究的建议以及其他一些指南,以应对这些挑战。大多数指南建议使用生理监测来检测蛛网膜下腔出血等不良病理情况的发生,并限制梗死体积的变异性,从而使实验结果同质化,以便进行完整报告,特别是在透明度和方法严谨性方面。对2009年至2019年期间每年发表的各100篇使用大鼠中风模型的文章进行分析,以量化与麻醉、生理监测、中风模型类型、缺血验证和总体研究质量相关的参数随时间的变化。未发现随时间推移脑血流量(CBF)测量频率有显著差异(2009年/2019年分别为28%/34%)。值得注意的是,与2009年相比,2019年报告温度、血压和血气监测数据的研究显著减少。另一方面,总体研究质量参数(如随机化、批准报告)有所增加。总之,围手术期监测的频率随时间下降。然而,一些总体方法学质量方面部分有所提高。CBF测量——缺血验证的金标准——很少应用。尽管对STAIR和ARRIVE等当前指南(两者均于2019年广泛获批)的认可度不断提高,但报告的方法和程序大多未遵循这些指南。这些缺陷可能导致临床前中风研究在寻找神经保护疗法方面的转化失败。