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SSS 2010-01-01

时间:2010-05-20 01:08来源:互联网 提供网友:mark@li   字体: [ ]
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    (单词翻译:双击或拖选)

We like to think that medical equipment implanted in our bodies undergoes rigorous testing before it’s put inside a person. That’s not always the case, at least for cardiovascular devices. That’s according to an article in the Journal of the American Medical Association.

Researchers evaluated the FDA pre-market approval process for 78 high-risk devices, such as pacemakers, stents and implanted defibrillators. They had assumed that these types of devices should and would be subject to random1 double-blinded studies with controls over an appropriate time-frame to investigate safety and efficacy.

But for 51 of the devices—65 percent—approval was based on a single study. Only 27 percent of studies were randomized, and only 14 percent were blinded. Only half of the devices were compared with controls.

The authors recognize the tension between sufficient testing and the need to get new drugs and devices to the public. But, they say, “The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can. In addition, although devices can be lifesaving, they also have great potential for risk and adverse2 events.”
 


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1 random HT9xd     
adj.随机的;任意的;n.偶然的(或随便的)行动
参考例句:
  • The list is arranged in a random order.名单排列不分先后。
  • On random inspection the meat was found to be bad.经抽查,发现肉变质了。
2 adverse 5xBzs     
adj.不利的;有害的;敌对的,不友好的
参考例句:
  • He is adverse to going abroad.他反对出国。
  • The improper use of medicine could lead to severe adverse reactions.用药不当会产生严重的不良反应。
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TAG标签:   SSS  defibrillator
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