【奥译言】美国FDA批准了一种新型一氧化碳中毒治疗设备

2019-03-18 09:59 阅读数：3558 标签：

3月14日，美国食品药品监督管理局（FDA）批准一种新型设备ClearMate的上市销售。ClearMate为一种急诊室设备，可以帮助治疗一氧化碳中毒患者。该设备采用一种新方法，通过提高患者的呼吸速率，快速去除其体内的一氧化碳。

“一氧化碳中毒会造成严重的后果，每年都会影响成千上万的人，”美国FDA器械和放射健康中心（CDRH）的眼耳鼻喉器械部主任Malvina Eydelman医学博士说。“虽然目前针对一氧化碳中毒有一种可以在任何地方进行的标准治疗，那就是通过面罩提供100%的氧气，但是一旦发生严重一氧化碳中毒事故，就必须进行高压氧治疗，此时情况就比较棘手了，因为在整个美国只有60个医疗中心拥有高压氧治疗装置。此外，这些医疗设施在农村地区很少见，因此在这些地区进行的治疗可能会因运输时间而大大延迟。此次获得FDA上市批准的ClearMate，为患者提供了一种简单但又能挽救宝贵生命的设备，可以最大限度地缩短患者接受重要治疗的时间，这一点对于严重一氧化碳中毒尤为重要。”

一氧化碳是一种毒性极强、无色无味的气体，几分钟内就能致人死亡。在美国，每年有近500人因意外接触一氧化碳而死亡，同时还有多达2万人因此进入急救室，而致人中毒的一氧化碳主要来自维护不善的供暖系统，或来自暴风雨期间供取暖或发电的煤气炉或燃气发电机。一氧化碳中毒最常见的症状包括：头痛、眩晕、乏力、胃部不适、呕吐、胸痛以及意识模糊。一氧化碳中毒是由于一氧化碳与血红蛋白结合的能力比氧强，所以当一氧化碳浓度较高时，一氧化碳就会与血液中的血红蛋白结合，阻碍了血红蛋白与氧的结合，从而减少了输送到大脑和其他组织的氧气量。

一氧化碳中毒的标准治疗方法是让患者通过面罩吸入100％的氧气。在一氧化碳中毒严重的情况下, 可以使用高压氧舱, 在高于正常气压的情况下输送氧气。

ClearMate是一种由气体混合器、阀门、仪表、呼吸回路、储氧器、面罩和软管组成的设备，其工作原理是可以加快一氧化碳从体内排出。该设备不但能给患者提供100%的氧气, 也能提供氧气和二氧化碳的混合物, 从而可以让患者呼吸加快。通过加快患者呼吸，可以缩短患者脱离一氧化碳气体的时间，确保正常量的氧气与血红蛋白结合，并输送到全身其他需要氧气的地方。

在授权ClearMate上市销售的过程中，FDA对多项临床研究的数据进行了审查，这些研究测试了该设备对100名患者的有效性。研究表明，该设备能有效去除一氧化碳。与单独使用100%的氧气治疗的方法相比，ClearMate中氧气和二氧化碳的结合可以更快除去一氧化碳，但还是没有高压氧治疗速度快。

在临床疗效研究和单独的设备安全性研究中，患者没有出现任何与设备相关的并发症。

FDA通过de novo上市前审查途径对ClearMate进行了审查，该途径是针对新型中低风险设备的监管途径。FDA的此次上市批准创建了一个新的监管分类，这意味着具有相同预期用途的同一类后续设备可以通过FDA 510(k)上市前审查途径进行审查，即该类设备一旦证明与其同品种设备实质性等同，就能获得上市销售许可。

FDA向Thornhill Research，Inc.授予了ClearMate的上市销售许可。

作为美国卫生及公共服务部（DHHS）的一个下属分支机构，FDA致力于通过保证人用药和兽药、疫苗和其它人用生物制品、以及医疗器械的安全性和有效性来保护公共卫生。此外，FDA还负责美国食品供应、化妆品、保健品和放射性产品的安全，并对烟草制品进行监管。

英文原文

FDA allows marketing of new device to help treat carbon monoxide poisoning

The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing.

“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning.”

Carbon monoxide is a colorless, odorless gas that is extremely poisonous and can kill within minutes. In the U.S. each year, nearly 500 people die while as many as 20,000 visit emergency rooms for unintended exposure to carbon monoxide, primarily from poorly-maintained heating systems, or gas stoves or gas-powered generators used for heat or power during storms. The most common symptoms of carbon monoxide poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion. Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues.

The standard form of treatment for carbon monoxide poisoning is to have the patient breathe 100 percent oxygen through a mask. In severe cases, a hyperbaric chamber may be used, which delivers oxygen under higher than normal pressure.

ClearMate—a device consisting of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses—works by speeding up the elimination of carbon monoxide from the body. It delivers both 100 percent oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. The increased breathing accelerates the rate at which the carbon monoxide leaves the patient’s body, allowing a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body.

In authorizing marketing of ClearMate, the FDA reviewed data from multiple clinical studies, which tested the effectiveness of the device on 100 patients. The studies demonstrated the device was effective at eliminating carbon monoxide. The combination of oxygen and carbon dioxide in the ClearMate resulted in a faster elimination of carbon monoxide than treatment with 100 percent oxygen alone but was not faster than hyperbaric oxygen therapy.

Patients did not experience any device-related complications in the clinical studies of efficacy or in a separate study of the device’s safety.

ClearMate was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of ClearMate to Thornhill Research, Inc.

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.

来源：FDA

原文链接：https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633533.htm

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