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MachineMakesPrescriptionDrugs‘OnDemand‘

By Amy Norton

HealthDay Reporter

THURSDAY, March 31, 2016 (HealthDay News) -- Scientists have created a compact machine that can churn out thousands of doses of prescription medication in a day -- putting the capabilities of a drug-manufacturing plant into a device the size of a kitchen refrigerator.

Experts said the advance could eventually allow on-the-spot drug production in special circumstances -- on the battlefield, during epidemics, after natural disasters, or in cases where a drug is needed for a rare medical condition, for instance.

The research, detailed in the April 1 issue of Science, took a new approach to producing prescription drugs -- which, right now, is often an inefficient, time-consuming process.

Chemical engineers at the Massachusetts Institute of Technology (MIT) used so-called "flow technology" to develop a compact machine that can automatically turn raw materials into a finished pharmaceutical-grade medication.

For now, the system is limited to making liquid versions of four common prescription drugs: the antidepressant fluoxetine (Prozac); diphenhydramine hydrochloride, an antihistamine that includes brand-names like Benadryl; the sedative diazepam (Valium); and lidocaine, a widely used local anesthetic.

But the researchers say that drug list can be expanded.

"We're also working on producing tablets, which are more complicated to manufacture than liquid drug formulations," said Klavs Jensen, a professor of chemical engineering at MIT who worked on the study.

Other technologies -- such as 3D "bioprinters" -- could help make that happen, according to Jensen.

Many drug companies are already looking into alternative processing methods -- ones that are "continuous" and can be done at one location, Jensen said.

The traditional way of drug-making is similar to cooking, according to Rainer Martin, a senior scientist with drug company Hoffmann-La Roche, in Basel, Switzerland.

Martin, who wrote an editorial published with the study, explained the process this way: Drugs are made in "batches," and the ingredients -- broad groups of chemicals known as reagents, catalysts and solvents -- are gradually added into a vat, stirred and heated. Then, the brew is analyzed to see if the chemical reactions are complete.

The problem, Jensen said, is that batch manufacturing has "little flexibility to respond to surges in demand" -- such as epidemics. Plus, he added, there can be "severe disruptions" in the drug supply if one plant has to shut down.

日期:2016年4月1日 - 来自[Health News]栏目
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Can You Trust Your Dietary Supplement?

Nov. 18, 2015 -- Seven federal agencies, including the Department of Justice and the FDA, held an extraordinary joint press conference Tuesday to announce the civil and criminal indictments of more than 100 makers and marketers of dietary supplements.

At the center of the action, called the Dietary Supplement Sweep, was an 11-count criminal indictment against Dallas-based USPlabs. The company made weight loss and bodybuilding supplements blamed for dozens of liver injuries -- some which required transplants -- and several fatal heart attacks in young, apparently healthy adults, authorities say.

“The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found -- practices that must be brought to the public’s attention so consumers know the serious health risks of untested products,” says the DOJ’s Principal Deputy Assistant Attorney General Benjamin Mizer in a press release.

The indictment offers a rare glimpse into the dangerous sell first, test later business practices embraced by the supplements industry and codified by a 1994 law called the Dietary Supplement Health and Education Act, or DSHEA. The law allows supplement manufacturers to self-certify that their products are safe and effective. The FDA can only step in once a problem comes to light.

Critics of the supplement industry applauded the indictments, but said they wouldn’t be enough to keep consumers safe in the long run until laws are changed.

“I’m glad to see enforcement actions taking place against companies that knowingly endanger or mislead American consumers. But, the bottom line is that a lack of consistent oversight makes the dietary supplement industry resemble the Wild West -- and until the government makes this a real priority, we will continue to see shelves stocked with products that could potentially harm American families,” U.S. Senator Claire McCaskill said in a press statement.

If the government wins its case against USPlabs, the company could face hundreds of millions of dollars in fines. Four company executives and a consultant face between 1 and 100 years in prison, depending on the individual charges against them.

“What worries me tremendously is that USPlabs is not alone in this practice,” says Pieter Cohen, MD, an assistant professor of medicine at Harvard who has published numerous studies questioning the safety of dietary supplements. “There are dozens of other companies doing the same thing today -- so consumers should understand that this is typical for the industry and reflects products sold at mainstream retailers.”

日期:2015年11月19日 - 来自[Health News]栏目

Ebola Doctor: ‘You Can’t Put Out 99% of a Fire’

Oct. 16, 2015 -- Though the numbers show we’ve reached a turning point in the Ebola outbreak, the threat of the virus is far from gone.

A nurse from Scotland is fighting for her life a second time after her Ebola infection apparently relapsed. And two new studies published Monday in TheNew England Journal of Medicine highlight a rare but real risk of men who've recovered spreading the disease through sex months after a blood test doesn't turn up signs of the virus.

The first study looks at a man who survived the disease and apparently passed it to his female partner more than 6 months after he recovered. A second study found traces of the virus in the semen of about 25% of tested male survivors at least 9 months after the onset of symptoms.

The disheartening news comes amid brighter news regarding the Ebola outbreak. The WHO this month marked 2 weeks without new cases in the hardest-hit West African countries -- Guinea, Sierra Leone, and Liberia -- before two new cases were reported in Guinea on Friday. The week of Oct. 4 was the first with no new reported cases since the outbreak was declared in March 2014, the WHO says.

The persistence of the virus continues to surprise infectious disease doctors and Ebola survivors, many of whom are still struggling with lingering after-effects of the disease.

“It’s not over even when it’s over, and that’s particularly going to be true for those who have survived the most severe disease,” says Ian Crozier, MD, an infectious disease expert who won a long battle against the virus, only to have it come back 2 months later to nearly blind one of his eyes.

We asked Crozier and another infectious disease expert, Philip Smith, MD, director of the biocontainment unit at the University of Nebraska Medical Center, about what the persistence of the virus means for ending the outbreak and for those who have survived.

WebMD: Dr. Smith, you treated two Ebola survivors -- Dr. Rick Sacra, a medical volunteer in Liberia who worked for the Christian organization SIM, and Ashoka Mukpo, a freelance cameraman for NBC. Do you continue to follow them? Do they continue to have health problems?

日期:2015年10月17日 - 来自[Health News]栏目
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Can This Test Predict Your Risk of Dying by 2020?

June 4, 2015 -- An online test may accurately predict your risk of dying before the end of this decade if you’re between 40 and 70 years old, the scientists who created it say. The research about it is published in The Lancet.

The exam is aimed at users in the United Kingdom, but you can access it here. Its accuracy for people in countries outside the U.K. is unknown, according to the web site.

Test-takers answer “a simple set of a dozen or so questions” with a click of the mouse and receive their chances of dying within the next 5 years, says study co-author Professor Erik Ingelsson from Uppsala University in Sweden.

The test gives the user their “Ubble age.” That's the age where the average risk of dying (if you’re living in the U.K.) most closely matches the estimated risk for the person taking the test. Ubble stands for UK Longevity Explorer, and the scientists who invented it claim it is 80% accurate.

This is the first study of its kind that is based on a very large number of people, Ingelsson says. But some experts are questioning how much of a useful tool the test really is.

How It Makes Its Predictions

To create a test-taker’s death risk score, Ingelsson and Dr. Andrea Ganna, from the Karolinska Institutet in Sweden, analyzed data collected between 2006 and 2010 from records in the UK Biobank of nearly half a million adults between the ages of 40 and 70.

They then calculated which health and lifestyle factors most accurately indicate the chances of dying in the short term.

They found that self-reported information, such as usual walking pace, illness, and injuries in the past 2 years, is generally more reliable at predicting the risk of death or survival than biological tests of things like pulse rate and blood pressure.

Walking pace, assessed as “slow,” “steady,” or “brisk,” is a stronger predictor of death risk in both men and women than smoking habits and other lifestyle measurements, the scientists says. How people rated their own health was the single most powerful predictor of death in men, while a previous cancer diagnosis was the strongest predictor in women. When the researchers excluded people with serious diseases or disorders, smoking habits emerged as the most reliable predictor of whether someone would die from any cause.

日期:2015年6月5日 - 来自[Health News]栏目

Clinical Trial Problems Can Go Unreported: Study

By Dennis Thompson

HealthDay Reporter

MONDAY, Feb. 9, 2015 (HealthDay News) -- Medical journals and the U.S. Food and Drug Administration rarely report violations of scientific conduct that federal regulators unearth during spot inspections of clinical trials, a new analysis shows.

In a study published in the Feb. 10 issue of JAMA Internal Medicine, a review of FDA inspection reports between 1998 and 2013 revealed nearly 60 clinical trials in which regulators had uncovered violations serious enough to earn the agency's most severe classification -- "official action indicated," or OAI, said study author Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University.

Seventy-eight articles were published based on data from these trials. But only three of them mentioned the violations that regulators found, Seife and a team of graduate students determined. The violations included fraud, incompetence or misconduct.

"Your physician makes decisions based upon what he knows from the peer-reviewed literature," Seife said. "If that literature is tainted in some way without the physician knowing, then the physician is making treatment decisions based upon bad data."

The good news is that such violations are rare, according to Seife. During the 2013 fiscal year, about 2 percent of the nearly 650 inspections the FDA carried out at clinical trial sites were classified as OAI, according to background information in the study.

But when these violations are uncovered, they can be serious enough to undermine the findings reported from the clinical trial:

  • A patient in a trial had a foot amputated two weeks after receiving stem cells to treat poor blood flow in a leg. Despite this, the article from the stem cell trial claimed that all of the patients reported improvement in their limbs.
  • The FDA deemed an entire trial devoted to the blood-thinning drug rivaroxaban unreliable, due to systematic and widespread scientific fraud. Despite this, the findings from the trial were published in a journal with no mention of the FDA's condemnation.
  • A patient died in a chemotherapy trial due to a researcher's falsification of documents, and the researcher ended up in prison after pleading guilty to fraud and criminally negligent homicide. None of the articles published from this clinical trial mention either the fraud or the subsequent homicide case.
日期:2015年2月11日 - 来自[Health News]栏目
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Measles FAQ

Jan. 20, 2015 -- At least 42 people have caught measles in an outbreak linked to Disneyland and Disney California Adventure Park over the Christmas holidays, health officials say.

The number includes 36 people in California and six from other states and Mexico, according to the California Department of Public Health.

While the contagious period is over, concerns about measles and future outbreaks remain.

Here, experts address what you need to know.

Q: How widespread is measles now?

The United States declared measles eliminated in 2000, according to the CDC. But outbreaks in recent years have been reported in Western Europe, Pakistan, Vietnam, and the Philippines. Travelers from those areas can bring the disease back to the U.S. when they visit.

U.S. measles cases in 2014 hit a record number since the 2000 declaration, according to the CDC -- 644 cases were reported in 27 states.?

Q: Who brought the measles to the amusement parks?

Public health experts haven't yet found the first patient, and doing so can be "almost impossible," says Aaron Glatt, MD. He's an infectious disease specialist and spokesperson for the Infectious Diseases Society of America.

Q: How is measles spread, and does it spread easily?

"You can catch it from anyone who has measles," Glatt says. The virus lives in the nose and throat mucus of the person affected, according to the CDC. When the infected person coughs or sneezes, the virus can be spread.

The virus is capable of living for up to 2 hours on a surface or in airspace, the CDC says. When others touch an infected surface, then touch their mouth, nose, or eyes -- or, when they breathe the air with the virus -- it can be spread and an infection can happen.

Measles is highly infectious. According to CDC estimates, 90% of those who aren't immune to the measles virus and are close to an infected person will also get measles.

Q: What are the first symptoms and how quickly do they usually show up?

Typically, people infected have a fever, cough, runny nose, and red eyes. Within a few days, the hallmark red rash usually appears, usually first on the face. It then can spread to the rest of the body.

日期:2015年1月21日 - 来自[Health News]栏目

Can Brain Training Give Athletes a Winning Edge?

Dec. 11, 2014 -- Luke Kunin plays hockey for the elite U.S. National Under-17 Team, so he knows his way around the ice. He’s been skating and taking slap shots almost as long as he’s been walking. He trains hard -- on the rink, in the gym, and in front of a computer.

The 16-year-old added a 30-minute, twice-weekly workout for his brain two seasons ago.

He uses the Hockey IntelliGym, a brain-training program. It’s a type of video game intended to help players develop “hockey sense” -- the ability to focus, make fast, accurate decisions, and to anticipate moves on the ice.

?“We get five or six different sessions in one lesson, based on different events you find on the ice, like power plays and penalty kills,” says Kunin, a native of St. Louis whose team is based in Ann Arbor, MI.

The program’s simplistic graphics are a far cry from hyper-realistic video games like the latest "Madden NFL" or "Call of Duty." But, its developers say, that stripped-down approach captures the essence of the game -- and teaches it.

Based on a program first used to enhance the skills of Israeli Air Force pilots, the Hockey IntelliGym has been used by USA Hockey since 2008. The organization’s web site claims the program boosts players’ goals and assists by an average of 42% in the first year.

“We see similar improvements to what we saw in the Air Force,” says Danny Dankner, CEO of Applied Cognitive Engineering, Inc. (ACE), the Israeli firm that developed the IntelliGym.

Kunin says he responds more quickly to situations on the ice since using the program. He sees and notices more.

“It’s helped me most with positioning in the defensive zone so that I’m facing the play and not just running around,” he says.

Beyond the Ice

At the University of California, Riverside, the baseball team tried a different brain-training program two seasons ago. Developed by psychology professor and researcher Aaron Seitz, PhD, and colleagues, the computer-based game was designed to sharpen batters’ vision. The team won four to five more games than expected in its 2013 season.

日期:2014年12月12日 - 来自[Health News]栏目
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FDAOKsArtificialArmThatDoesComplexTasks

By Robert Preidt

HealthDay Reporter

FRIDAY, May 9, 2014 (HealthDay News) -- The first artificial arm that can perform complex tasks was approved for sale May 9 in the United States.

The DEKA Arm System detects electrical signals in the muscles close to where the prosthetic is attached, which are then sent to a computer processor in the arm and translated into multiple movements, according to the U.S. Food and Drug Administration, which granted the marketing approval.

The agency's approval is based on clinical trials of the device, including one in which 36 military veterans tested the artificial arm in common household and self-care tasks.

Using the DEKA device, about 90 percent of the veterans were able to do things they couldn't do with their current artificial arm, including preparing food and feeding themselves, brushing and combing their hair, using keys and locks, and using zippers, the FDA said in an agency news release.

The DEKA prosthetic arm can be adapted to people who have limb loss at the shoulder joint, mid-upper arm or lower arm. It cannot be used for limb loss at the elbow or wrist joint.

"This innovative prosthesis provides a new option for people with certain kinds of arm amputations," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the news release.

"The DEKA Arm System may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm," she added.

The new prosthetic is made by DEKA Integrated Solutions in Manchester, N.H.

日期:2014年5月13日 - 来自[Health News]栏目
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