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WASHINGTON, Dec. 21 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved Isentress for the treatment of HIV-1 infection for children and adolescents.The drug is part of a class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. It was first approved for use in adult patients in October 2007, under FDA's accelerated approval program."Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.Isentress is a pill that can be taken twice daily, with or without food. The pill is also available in a chewable form. As the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.A single, multi-center clinical trial of 96 children and adolescents aged 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.According to the FDA, the most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping and headache. The frequency of these side effects is similar for children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash.
WASHINGTON, Nov. 18 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday revoked its approval of Avastin for treating the breast cancer after concluding that the drug has not been shown to be safe and effective for that use.Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer."After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," FDA Commissioner Margaret Hamburg said in a statement. "Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life. "Avastin's risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone -- not enough to outweigh the risk of taking the drug.FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.Genentech did not agree with the Center's evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center's withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, included recommendations from the FDA 's Oncologic Drugs Advisory Committee, voting 6-0 in favor of withdrawing approval of Avastin's breast cancer indication.

NEW YORK, Dec. 1 (Xinhua) -- New York City Mayor Michael Bloomberg announced on Thursday a new recommendation that doctors offer every person with an HIV diagnosis antiretroviral treatment to help them live longer and prevent transmission.This marks a change from the current practice that treatment only be offered to those who show signs of damage to their immune systems, said the mayor during the annual World AIDS Day commemorative ceremony at Gracie Mansion. "Over the past ten years HIV diagnoses and deaths in New York City have seen a dramatic decline," said Mayor Bloomberg. "Steady progress in our fight against HIV has turned what used to be a death sentence into a disease that can be prevented and, with antiretroviral therapy, managed.The annual death toll from HIV in the city is down by more than a third: 933 deaths in 2009Despite this progress, however, more than 110,000 people in New York City are infected with HIV, more than in any other U.S. city and about 75 percent of all cases in the New York State.Figures from the New York City Health and Hospitals Corporation (HHC) showed that HHC has tested more than one million New Yorkers for HIV since 2005 when the public hospitals and health centers began offering HIV screening as a routine part of medical care for patients aged 13 to 64.
WASHINGTON, Dec. 21 (Xinhua) -- New research suggests that, in people who don't currently have memory problems, those with smaller regions of the brain's cortex may be more likely to develop symptoms consistent with very early Alzheimer's disease.The study was published Wednesday in the online issue of Neurology, the medical journal of the American Academy of Neurology.For the study, researchers used brain scans to measure the thickness of regions of the brain's cortex in 159 people free of dementia with an average age of 76. The brain regions were chosen based on prior studies showing that they shrink in patients with Alzheimer's dementia.Of the 159 people, 19 were classified as at high risk for having early Alzheimer's disease due to smaller size of particular regions known to be vulnerable to Alzheimer's in the brain's cortex, 116 were classified as average risk and 24 as low risk. At the beginning of the study, participants were also given tests that measured memory, problem solving and ability to plan and pay attention. The tests will go on over the next three yearsThe study found that 21 percent of those at high risk experienced cognitive decline during three years of follow-up after the MRI scan, compared to seven percent of those at average risk and none of those at low risk."Further research is needed on how using MRI scans to measure the size of different brain regions in combination with other tests may help identify people at the greatest risk of developing early Alzheimer's as early as possible," said study author Bradford Dickerson, of Massachusetts General Hospital in Boston and a member of the American Academy of Neurology.
WASHINGTON, Nov. 25 (Xinhua) -- In the United States, the AIDS epidemic has plateaued, but it is still at "unacceptable high" level, a U.S. expert said ahead of the World AIDS Day."The situation is stable in the United States, stable in an unacceptable high level for at least 10 years and has not gone down. It's still a serious problem," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), told Xinhua in an exclusive interview.According to Fauci, there are about 1.1 million people infected with HIV in the U.S., of which about 20 percent do not know they are infected. Those are the ones that more likely will infect other people. Since the world's first AIDS case was reported 30 years ago, the U.S. has seen close to 600,000 AIDS-related death. And among the 65,000 new infections each year in the U.S, about 50 percent are African Americans. In the United States, about 12 percent of the population is African American."Our new approach to prevention is to try and get access at community level, to people at most risk, to seek out to voluntarily test, to link them to care, and to automatically get them treatment," said Fauci. "When you get someone on treatment, it is extremely unlikely that they will infect their sexual partner."Fauci thought the international community's battle against the HIV/AIDS has gotten better over the last 30 years.Early on, when the disease was inaccurately thought to be a disease of developed world. There was a denial in many countries in Asia, in Southern Africa, South America and Caribbean, that this will turn out to be an extraordinary problem in those countries. As the years went by, it was clear that it was not a disease of gay men in the United States and the developed world. It was a disease mostly in the developing world when 90 percent of new infections occur in low- and middle-income countries and 67 percent of the cases are in Southern Africa."The response of the global community first was denial and not full appreciation of the potential impact of the pandemic. As the years have gone by, the response has been better and better," said Fauci, an immunologist that has made substantial contributions to research in the areas of AIDS and other immunodeficiencies, both as a scientist and as the head of NIAID.The advance in the arena of therapy with drugs has been " spectacular" and "very impressive", he said.In the early 1980 before there were any drugs, the median survival period of people in the United States who was infected with HIV, was about six to eight months. "Today in 2010, if someone was newly infected with HIV and he's 20-25 years old, and you put them on therapy, you can predict mathematically that they will live additional 50 years," said Fauci.Over the last couple of years, there has been "significant but slow" advances with vaccines against HIV. For example, there was a trial that was conducted in Thailand in which there was a modest degree of efficacy, about 31 percent of protection."That's not enough to have a vaccine available for widespread use but give us some important clues into what next generation of vaccines would be," said Fauci.As to the "three zeros" target adopted by the United Nations this year, Fauci said that it's "aspirational but not gonna be easy.""It is good to set very high goals for the future. I don't think that we realistically are gonna get to zero new infections, zero new discrimination, zero (AIDS-related) death in the next few years," said Fauci. "I think it will take several years to get there. I believe that if more countries and the international community are engaged to play a role in trying to stop HIV, to prevent and treat and care for HIV-infected individuals, that we will automatically achieve that objective."
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