对《现代药物是怎么开发出来的》的一点更正
“有时候，在临床试验过程中，一种药物被发现能够有效地治疗恶性疾病，会提前中止临床试验而直接用于治疗病人。例如，第一种治疗艾滋病的新药AZT的临床试验在只进行了106天之后，发现它能显著增加病人的存活率，美国食品药品管理局立即提前中止了该临床试验，并在批准其上市之前允许它被用于治疗4000多名艾滋病患者。”
有一个网友来函对文中介绍的AZT临床试验时间提出了怀疑。此处的确有误。上文“第一种治疗艾滋病的新药AZT 的临床试验在只进行了106天之后”一句应改为“第一种治疗艾滋病的新药AZT在还在做II期临床试验时”。
该例子依据的原文(见后)没有提到临床试验天数，在另一处有“Zidovudine was approved in 107 days”的说法，经仔细核对，天数(第107天，即106天后)应该指的是批准时间，而非临床试验时间。之所以出现这个误读，是因为以前读过颖河《认识药物》介绍的同一个例子提到临床试验只进行了106天，留下的印象导致先入为主的误读。实际上整个临床试验进行了大约一年，到II期临床试验时发现显著提高了艾滋病患者的存活率，即提前终止。
特此更正。
In any trial in which a possible effect on survival is being assessed, it’s important to monitor results as they emerge. That way, if a major effect is seen—positive or negative—the trial can be stopped. This happened in the first clinical study of the AIDS drug zidovudine (AZT), when a clear survival advantage for patients receiving zidovudine was seen well before the trial was scheduled to end. The trial was then ended early, and within a week FDA authorized a protocol allowing more than 4,000 patients to receive zidovudine before it was approved for marketing. ...These are examples of the ethical principle that if a lifesaving or life-extending treatment for a disease does exist, patients cannot be denied., http://www.100md.com(方舟子)
有一个网友来函对文中介绍的AZT临床试验时间提出了怀疑。此处的确有误。上文“第一种治疗艾滋病的新药AZT 的临床试验在只进行了106天之后”一句应改为“第一种治疗艾滋病的新药AZT在还在做II期临床试验时”。
该例子依据的原文(见后)没有提到临床试验天数，在另一处有“Zidovudine was approved in 107 days”的说法，经仔细核对，天数(第107天，即106天后)应该指的是批准时间，而非临床试验时间。之所以出现这个误读，是因为以前读过颖河《认识药物》介绍的同一个例子提到临床试验只进行了106天，留下的印象导致先入为主的误读。实际上整个临床试验进行了大约一年，到II期临床试验时发现显著提高了艾滋病患者的存活率，即提前终止。
特此更正。
In any trial in which a possible effect on survival is being assessed, it’s important to monitor results as they emerge. That way, if a major effect is seen—positive or negative—the trial can be stopped. This happened in the first clinical study of the AIDS drug zidovudine (AZT), when a clear survival advantage for patients receiving zidovudine was seen well before the trial was scheduled to end. The trial was then ended early, and within a week FDA authorized a protocol allowing more than 4,000 patients to receive zidovudine before it was approved for marketing. ...These are examples of the ethical principle that if a lifesaving or life-extending treatment for a disease does exist, patients cannot be denied., http://www.100md.com(方舟子)