重症医学阴性临床研究的意义何在?

Significance of negative clinical trials in the field of Critical Care Medicine

本文讨论了重症医学领域国际临床试验阴性结果的潜在原因,首要原因可能是这些以脓毒症与急性呼吸窘迫综合征为目标的研究入选患者的异质性。正因为如此,不可能存在一种疗法适合所有病情的情况,无论其医疗资源分布或地理位置如何;最后是研究主要终点,即病死率的设置,因其难以改善而成为研究者的梦魇。只有意识到以上局限性并加以解决,特别是脓毒症与急性呼吸窘迫综合征定义的不足,未来的研究才有可能成功。

In present brief review we discussed the underlying reasons for the negative results of international clinical trials in the field of Critical Care Medicine. Since there is a huge heterogeneity among the patients with sepsis or acute respiratory distress syndrome（ARDS） who are recruited in the studies, it is resonable that none of strategy could be fit to all condition no matter medical resource distribution and geographic location. Therefore, it becomes to be nightmare for the researchers as the primary outcome,mortality, is hard to be improved. Only when realizing and resloving above situation, especially the disadvantage of definition of Sepsis and ARDS, could the future large trial be successful.