FDA宣布常用鼻塞药无效(中)

Yeah, exactly. So, more products started using phenylephrine.

是, 没错。更多的产品开始使用苯肾上腺素。

Basically they were using it as a substitute?

基本上他们把苯肾上腺素作为替代？

Yep. Phenylephrine was actually approved in the 1970s, so it had been around a while.

是的。苯肾上腺素实际上是在20世纪70年代获批的，所以它已经存在了一段时间了。

But even back then, the FDA said it wasn’t very effective as a decongestant.

但即使在当时，美国食品和药品管理局（FDA）也表示它作为减充血剂效果并不显著。

There was a cough and cold panel in 1972, in which the panel specifically noted that the data were not strongly indicative of efficacy. So this goes back quite a number of years.

1972年，一个研究咳嗽和感冒的小组特别指出，这些数据并不能强有力地表明疗效。这可以追溯到很多年前。

That’s Jennifer Le, a professor at the pharmacy school at the University of California San Diego.

詹妮弗·勒是加州大学圣地亚哥分校药学院的教授。

She was on the recent FDA advisory panel earlier this month that made the decision that phenylephrine wasn’t effective.

她是本月早些时候做出苯肾上腺素无效决定的FDA顾问小组的专家。

Back in the 1970s, the FDA was more concerned with safety than effectiveness.

早在20世纪70年代，FDA更关心安全性而非有效性。

So first and foremost, at the dose that's currently approved, 10 milligram for nasal congestion, it does not appear to provide any safety concerns, except in a very small population who has high blood pressure.

首先，目前获批的用于治疗鼻塞的剂量--10毫克，似乎没有任何安全问题，一小部分高血压患者除外。

Then, in 2007, an FDA advisory panel reviewed the data.

2007年，FDA的一个顾问小组重新审查了这些数据。

And in reviewing the data they thought that efficacy was maybe suggestive at higher doses, and so the recommendation at that time was to obtain more clinical data.

在重新审查数据时，他们认为高剂量的药效可能具有暗示性，所以当时的建议是获取更多的临床数据。

And the committee who reviewed it withdrew approval for those less than 12 years of age.

审查委员会撤回了对12岁以下儿童的的批准。

Fast-forward to today, when another FDA panel—the one Le was one—reviewed the drug’s effectiveness again.

快进到今天，FDA的另一个小组(詹妮弗·勒所在的小组)重新审查了这种药物的有效性。

They looked at more recent data on both how the drug is metabolized and how well it works in people.

他们对药物代谢方式及其在人体内的效果的最新数据进行了研究。

And the pharmacologic data side indicated that when you take oral phenylephrine, most of it is metabolized to inactive forms, so very little of the active drug—in fact, one percent, based on FDA data—actually gets into the blood.

药理学方面的数据表明，当口服苯肾上腺素时，大部分都被代谢成了非活性形式，因此，只有很少的活性药物--实际上，根据FDA的数据，只有1%的活性药物会进入血液。

So, most of the drug isn’t even making it to the nose, in other words.

也就是说，大部分药物甚至都没有进入鼻内。

Exactly. In addition to that, three trials of oral phenylephrine showed it was no better than a placebo at relieving congestion.

确实如此。除此之外，口服苯肾上腺素的三项试验表明，这种成分在缓解充血方面并不比安慰剂好。

So, the committee voted unanimously that oral phenylephrine is basically useless.

因此，委员会一致认为口服苯肾上腺素并无缓解鼻塞的功效。

The FDA panel only reviewed forms of the drug that come in capsules, tablets and syrups, though.

然而，FDA小组只审查了胶囊、片剂和糖浆形式的药物。

So what about things like nasal sprays?

那么像鼻腔喷雾剂这样的东西呢?

They didn’t review phenylephrine nasal sprays. Those might still be effective since they are going right into your nose.

他们没有审查苯肾上腺素鼻腔喷雾剂的功效。这些成分可能仍然有效，因为它们直接进入了鼻腔。

But the oral pills won’t do much.

但是口服药片没有多大功效。