简单来说,这个药物的原理,就是CD24这个蛋白可以对身体的炎症反应起抑制作用,而我们知道新冠的重症患者,通常是因为身体内出现了“免疫风暴”。相当于让身体的免疫系统出现防御过当的行为,致使身体组织遭受自身免疫系统破坏,导致器官损伤、衰竭、休克,甚至死亡。所以新冠真正让患者死亡的原因,本身并不是因为病毒,而是被病毒刺激而过度激化的免疫反应。而CD24蛋白恰好能对此起抑制作用。
那么这个药物就是通过向患者体内输入,经过人工改造的,能够高表达CD24蛋白的外泌体,从而起到抑制免疫风暴的作用[1]。
那既然II期的数据,目前尚不明晰,那不妨可以先看看I期的数据,当时显示,在35个入组患者中,有31人,在治疗后的3-5天内症状得到了较大的缓解。是不是感觉也不错?但其实这个结果在当时并没有显示出很强的说服力,原因有几个:
I. 入组人群太少,只有35个,不太具备统计学效应
II. 没有设计双盲和安慰剂组
III. 年龄组别上,没有青少年和老年组(18-85岁)
再来看看,II期新闻公布的有限信息,
The Israeli inventor of a “precision medicine” for COVID-19 is “very optimistic,” after an 88-person hospital trial entered its final day without a single patient ending up on a ventilator. The next phase of the drug trial will see a trial performed with some in a group given a placebo.
After a first trial in Israel, this trial, which will wrap up on Tuesday [last week], is taking place in Greece, sponsored by the government in Athens, involving moderate and serious patients aged up to 85. Almost 90 percent of them were released within five days, although some remain hospitalized.
Below is an updated list of 24 of the most-talked-about treatments for the coronavirus. While some are accumulating evidence that they’re-effective, most are still at early stages of research. We also included a warning about a few that are just bunk.
——再比如这篇:
Long COVID in a prospective cohort of home-isolated patients - Nature Medicinewww.nature.com/articles/s41591-021-01433-3作者调查了挪威第一波爆发期间卑尔根市共65位入院感染者和247位居家治疗感染者(四舍五入就对于轻症)。以上311位感染者占了第一波爆发期间卑尔根总感染者人数的82%,结果如下: