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原标题:|资讯|“公民的期望”瑞德西韦正式获FDA紧迫授权使用 5月1日,美国FDA依据“紧迫授权使用”(EUA)条款,正式同意了吉祥德公司研发的抗病毒药“瑞姆西韦”用于医治新冠病毒Covid-19感染患者(包含成人和儿童)。 正如业界专家评述“这是铁板钉钉的事儿了”。 无论如何,该药的安全性至少比羟氯喹要好得多。羟氯喹是上市用药,临床医治疟疾或风湿性关节炎等,但用于医治新冠肺炎或Covid-19感染患者总是让人心里不结壮。 但是, ,这其间的客观原因是什么? WHO有关负责人也对此药的临床效果,或可否使用于医治新冠肺炎/Covid-19病毒感染给出了 不知可否的答复 。 简略讲,相同标准的临床试验规划(随机、双盲安慰剂对照),假如临床效果评价结尾目标和该药使用紧迫状况(现在疫情急切困境)不同,也或许终究左右了FDA审评专家给出了【绿灯】“紧迫授权使用”。 FDA在其官方网站上宣布的声明如下: “FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” said HHS Secretary Alex Azar. “NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19. The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.” The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. “From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.” Based on evaluation of the emergency use authorization criteriaand the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use. The EUA also requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to health care providers and patients, including dosing instructions, potential side effects and drug interactions. 或许的不良反应 Possible side effects of remdesivir include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering. Following the declaration by the Secretary of HHS that circumstances exist justifying the emergency use of unapproved products, the FDA may issue an emergency use authorization to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threats when there are no adequate, approved, and available alternatives. The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency. The EUA was issued to Gilead Sciences Inc. The FDA previously allowed for study of the investigational drug under clinical trials, as well as expanded access use for individual patients and through a multi-patient expanded access program coordinated by Gilead. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 新版《医学印象中人工智能》(369页)概述了医学印象中AI使用,解析了AI技能对医学的影响,比如深度学习等;成像生物符号物AI使用程序开发和验证;大数据在印象学中的重要作用。要点介绍了AI对印象学和印象科、放射科医师的影响。该书是放射科医师、物理师,IT专家和印象信息人员参阅 祈求 · 光亮 回来搜狐,检查更多

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