Mracek Jan
Lékarská fakulta, Neurochirurgické oddelení FN, Univerzita Karlova v Plzni.
Cas Lek Cesk. 2010;149(12):586-90.
The aim of neuroprotection is to rescue ischemic tissue and improve functional outcome by intervention on ischemic cascade. A lot of experimental trials demonstrated that neuroprotection is effective in infarction volume reduction. Unfortunately most of the effective agents in preclinical studies failed in clinical trials. None of tested neuroprotective agents have shown to improve outcome in clinical trial phase III up to now. The main reasons that may have caused the failure of past clinical trials are: extended therapeutic window, heterogeneous population of stroke patients, low dose administration, inadequate endpoints, discrepancies on outcome assessments in experimental and clinical trials, irregular study design and inadequate statistical evaluation. Future of neuroprotection is seen in concentration on the subgroup with existing penumbra, the combination of neuroprotection and thrombolysis and in prophylactic neuroprotection. The unification of the design in experimental and clinical trials is the main prerequisite for potential success in the clinical testing.
神经保护的目的是通过干预缺血级联反应来挽救缺血组织并改善功能预后。许多实验性试验表明，神经保护在减少梗死体积方面是有效的。不幸的是，大多数临床前研究中的有效药物在临床试验中失败了。到目前为止，在III期临床试验中，没有一种经过测试的神经保护药物显示能改善预后。过去临床试验失败的主要原因可能是：治疗窗延长、中风患者群体异质性、低剂量给药、终点不充分、实验和临床试验中结局评估存在差异、研究设计不规则以及统计评估不充分。神经保护的未来在于关注存在半暗带的亚组、神经保护与溶栓的联合以及预防性神经保护。实验和临床试验设计的统一是临床测试潜在成功的主要前提。
