Rogalewski A, Schäbitz W-R
Klinik und Poliklinik für Neurologie, Universitätsklinikum, Albert-Schweitzer-Strasse 33, Münster, Germany.
Nervenarzt. 2008 Feb;79(2):218-24. doi: 10.1007/s00115-007-2386-x.
Stroke remains one of the most urgent medical problems of our times. The failure of most neuroprotective drugs in clinical trials led to the initiation of the Stroke Therapy Academic Industry Roundtable guidelines. Due to this improvement, the positive clinical trial results with the free radical scavenger NXY-059 (SAINT I) was encouraging. However, the subsequent SAINT II trial did not confirm these results. In this article we critically review the history of preclinical and clinical trials based on experience of NXY-059 development and present recommendations for potential future preclinical and clinical development of neuroprotective stroke therapy.
中风仍然是我们这个时代最紧迫的医学问题之一。大多数神经保护药物在临床试验中的失败促使了中风治疗学术产业圆桌会议指南的出台。由于这一改进，自由基清除剂NXY-059（SAINT I）的积极临床试验结果令人鼓舞。然而，随后的SAINT II试验并未证实这些结果。在本文中，我们基于NXY-059的研发经验，批判性地回顾了临床前和临床试验的历史，并针对神经保护性中风治疗未来潜在的临床前和临床开发提出建议。
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