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U.S., European Drug Officials Approve Inhaled InsulinA form. of insulin for people with di

U.S., European Drug Officials Approve Inhaled Insulin

A form. of insulin for people with diabetes to take by mouth is expected to be sold within a few months. The new medicine is called Exubera. The United States Food and Drug Administration: and the European Commission both recently approved it for adults. It could make life easier for many diabetics who require daily injections of insulin to control their blood sugar levels. But it will not replace all insulin injections. And it is not for everyone. People who smoke or have stopped smoking for less than six months should not take Exubera.(46)

Three drug companies -- Pfizer, Sanofi-Aventis and Nektar Therapeutics -- developed the inhaled insulin.(47)Experts say about fifteen percent of diabetics who need insulin do not take it. The treatment can involve several injections each day.

Insulin is a hormone that the body uses to change food into energy. Failure to control blood sugar levels can lead to serious problems, including blindness and loss of blood flow to the feet. It can also lead to heart disease, stroke and kidney failure4. Insulin has been sold as a drug since the nineteen twenties. This is the first new way to take it. Exubera uses a powder breathed into the lungs through a mouthpiece. Pfizer will study the long-term effects. It says some patients have reported a mild cough while using the inhaled insulin.(48).

Many people do not know they have diabetes. There are two forms. Most diabetics have the Type Two form. Their body does not make enough insulin or cannot effectively use the insulin it produces.(49)Most Type Two diabetics do not take insulin. Their medicines can be taken by mouth. Diet, exercise and weight control are also important. Type One diabetes often begins in childhood.(50).

Officials say diabetics with either type could use inhaled insulin, either before or after a meal. But Type One diabetics and some with Type Two would still need a longer-lasting injection at least once a day.

A. With this type the body is unable to produce insulin.

B. Pfizer recently bought the rights to sell it worldwide.

C. The control of their blood sugar levels is most important for patients with diabetes.

D. It is common in people who are overweight and not active.

E. Some patients with lung disease should not take it either.

F. People are advised to have their lungs examined before using Exubera, and at least once a year after that.

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更多“U.S., European Drug Officials Approve Inhaled InsulinA form. of insulin for people with di”相关的问题

第1题

Cancer Drug Trials Often Halted EarlyAn increasing number of clinical trials for new cance

Cancer Drug Trials Often Halted Early

An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.

The researchers looked at 25 randomized, controlled clinical trials that were stopped early because the treatments had started to show benefit to patients.

"When we analyzed 25 trials over a 10-year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials—more than 50 percent were stopped within the last three years", study co-author Giovanni Apolone said at a news conference Tuesday.

Of 14 trials halted early and published between 2005 and 2007, the researchers found that 11(79 percent) of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S. Food and Drug Administration.

"This suggests a strong commercial component in stopping trials prematurely. In fact, this strategy could guarantee quicker access to the market for companies. On the other hand, a quicker clinical drug development may lead to an ' immature' benefit/risk balance of new drugs", Apolone said.

He and his colleagues "are aware that trials stopped early because they are showing benefit may result in identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation".

It can take several years for the long-term benefits or harmful side effects of a new treatment to become apparent, Apolone noted, but the average duration(持续时间) of the 25 studies he and his colleagues analyzed was 30 months, with a range from 12 to 64 months.

They also found that at the time five of the studies were stopped, they'd enrolled less than 40 percent of the total number of patients planned for final analysis.

"Clinical trials need to stop early for superior benefit whenever there's proof beyond reasonable doubt that the new treatment really is superior. That would be an ethical obligation", Stuart Pocock, a professor of medical statistics at the London School of Hygiene and Tropical Medicine in the United Kingdom, said at the news conference. "However, too many trials are stopped early claiming efficacy(功效) without strong evidence being available".

The number of prematurely stopped clinical trials has increased recently.

A.Right

B.Wrong

C.Not mentioned

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第2题

How do propagandists argue for the U.S. drug pricing policy?A.Low prices will affect the q

How do propagandists argue for the U.S. drug pricing policy?

A.Low prices will affect the quality of medicines in America.

B.High prices are essential to funding research on new drugs.

C.Low prices will bring about the anger of drug manufacturers.

D.High-price drugs are indispensable in curing chronic diseases.

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第3题

The U.S. Food and Drug Administration has acted against similar contamination incidents li
ke that involving SV40 out of fear of a wider spread of AIDS.

A.Y

B.N

C.NG

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第4题

Compared with the U.S., most Western European nations______A.have higher infant death rate

Compared with the U.S., most Western European nations______

A.have higher infant death rates

B.do better on infant death rates

C.do more studies on Text4baby

D.pay less attention to Text4baby

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第5题

There are ______ custom tailors and dressmakers in the U.S. than in European countries.A.f

There are ______ custom tailors and dressmakers in the U.S. than in European countries.

A.far fewer

B.so fewer

C.very fewer

D.too fewer

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第6题

根据以下材料,回答题Cancer Drug Trials Often Halted EarlyAn increasing number of clinical t

根据以下材料,回答题

Cancer Drug Trials Often Halted Early

An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.

The researchers looked at 25 randomized, controlled clinical trials that were stopped early because the treatments had started to show benefit to patients.

"When we analyzed 25 trials over a 10-year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials——more than 50 percent were stopped within the last three years," study co-author Giovanni Apolone said at a news conference Tuesday.

Of 14 trials halted early and published between 2005 and 2007, the researchers found that 11(79 percent) of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S. Food and Drug Administration.

"This suggests a strong commercial component in stopping trials prematurely. In fact, this strategy could guarantee quicker access to the market for companies. On the other hand, a quicker clinical drug development may lead to an "immature" benefit/risk balance of new drugs,"Apolone said.

He and his colleagues "are aware that trials stopped early because they are showing benefit may result in identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confmnation."

It can take several years for the long-term benefits or harmful side effects of a new treatment to become apparent, Apolone noted, but the average duration (持续时间) of the 25 studies he and his colleagues analyzed was 30 months, with a range from 12 to 64 months.

They also found that at the time five of the studies were stopped, they"d enrolled less than 40 percent of the total number of patients planned for final analysis.

"Clinical trials need to stop early for superior benefit whenever there"s proof beyond reasonable doubt that the new treatment really is superior. That would be an ethical obligation,"Stuart Pocock, a professor of medical statistics at the London School of Hygiene and Tropical Medicine in the United Kingdom, said at the news conference. "However, too many trials are stopped early claiming efficacy (功效) without strong evidence being available."

The number of prematurely stopped clinical trials has increased recently. 查看材料

A.Right

B.Wrong

C.Not mentioned

点击查看答案

第7题

______ was not discovered until 1961, and the U.S. Food and Drug Administration has since
acted to ensure against similar contaminations.

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第8题

According to the writer, the advocators of New Towns in the U.S. ______.A.mainly have prof

According to the writer, the advocators of New Towns in the U.S. ______.

A.mainly have profit in mind

B.attach importance to social needs

C.hope to relieve pressures on existing cities

D.intend to follow the European example

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第9题

The Text4baby program is aimed at helping pregnancy women______.A.in the U.S.B.in poor cou

The Text4baby program is aimed at helping pregnancy women______.

A.in the U.S.

B.in poor countries

C.all over the world

D.in Western European nations

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第10题

Compared with the U.S.,most Western European nations. A)have higher infant death rates B)
do better on infant death rates C)do more studies on Text4baby D)pay less attention to Text4baby

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