TRIALS OF TRIALS IN ACUTE ISCHEMIC STROKE - THE HUMANA LECTURE
TRIALS OF TRIALS IN ACUTE ISCHEMIC STROKE - THE HUMANA LECTURE
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DOI：
10.1161/01.str.24.9.1410
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发表时间：
1993-09-01
期刊：
影响因子：
8.3
通讯作者：
ADAMS, HP
中科院分区：
文献类型：
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作者：
ADAMS, HP
由于中风是一种非常复杂的疾病，有许多临床变量，这些变量会使护理复杂化并影响结果，因此任何治疗都不太可能产生如此显著的反应，以至于医学界只根据轶事和不受控制的报告就接受任何治疗的益处。因此，需要一个精心组织的实验和临床研究计划来充分检查任何有希望的缺血性中风治疗方法。在过去的三十年里，许多研究已经检验了治疗中风的可能有效性，但他们的结果是不确定的。不幸的是，其中一些研究在设计上存在问题，这可能部分地解释了负面结果。我积极参与了几项中风临床研究的发展，犯了很多错误，我希望分享一些想法，可能有助于我们所有人未来的研究努力。一些建议可能会引起争议，但它们可以作为未来讨论的跳板。这些意见补充了前面的建议。目标应该是避免设计和操作上的问题，以免妨碍试验充分测试干预措施的能力。最近，Wardlaw和Warlow4表示：“急性中风治疗研究正在拒绝那些被认为能迅速产生治疗反应的化合物，因为它们可以被发明出来，但很少有充分的证据证明这一点，这种情况必须停止。”我同意，但遗憾的是，这种说法有局限性。相对较小的中风临床研究群体没有足够的资源（资金、患者、研究人员）来测试每一种可能有效的药物。我们应该抵制测试几种具有相同作用机制和假定在卒中治疗中相应有用性的药物。相反，研究应该集中在有限数量的化合物上，这些化合物要么有特殊的属性，要么没有
Because stroke is a very complex condition with a number of clinical variables that compound care and influence outcome, it is unlikely that any therapy will produce such a dramatic response that the medical community will accept the benefit of any treatment based only on anecdotal, uncontrolled reports. Thus, a carefully organized experimental and clinical research program is needed to adequately examine any promising therapy for ischemic stroke. 1~ 3 During the last three decades, a number ofstudies have examined the possi-ble usefulness of treatments for stroke, but their results are inconclusive. Unfortunately, some of these studies suffered from problems in design that may, in part, partially explain the negative results.? 2 Having been actively involved in the development of several clinical research studies in stroke and having made more than my fair share of mistakes, I wish to share some ideas that might help all of us in our future research endeav-ors. Somerecommendations may be controversial, but they might serve as a springboard for future discussion. These comments supplement previous suggestions. 1, 3 The goal should be to avoid problems in design and conduct that would hamper the trial's ability to adequately test the intervention. Recently, Wardlaw and Warlow4 stated that" Acute stroke treatment research is rejecting compounds thought to have therapeutic responseas fast as they can be invented, but with remarkably little good evidence to do so, and this must stop." I agree but, regrettably, this statement has limitations. The relatively small commu-nity of clinical researchers in stroke does not have the resources (money, patients, investigators) to test every drug that might be effective. We should resist testing several drugs that have equivalent mechanisms of action and presumed corresponding usefulness in stroke care. Rather, research should focus on a limited number of compounds that eitherhave special attributes or are