本帖最后由 渐冻人石头 于 2013-3-15 12:57 编辑
开发的NeuRx膈肌起搏系统，通过突触生物医学，已被批准为“人道主义”由美国食品和药物管理局（FDA）治疗ALS的呼吸功能不全，使用的设备。 The system is designed to supplement breathing efforts and help preserve diaphragm muscle function; it may delay or negate the need for invasive tracheostomy ventilation and can be used in conjunction with noninvasive ventilation.
该系统被设计以补充呼吸努力和帮助保留膈肌功能，它可能会延迟或否定需要用于侵入性气管切开通风，并可以用在与无创正压通气。 The pacing system will help people with ALS who still have some preservation of the diaphragm (the main muscle used in breathing) and also in the nerves that normally control its movement.起搏系统将有助于人们仍然有一些保留的隔膜（主要用于呼吸的肌肉），通常控制其运动的神经，也与ALS。 The device will be available for physicians to prescribe in the near future.
该设备将用于医师处方在不久的将来。美国食品和药物管理局（FDA）已批准NeuRx的膈肌起搏系统低通气不足，呼吸治疗肌萎缩性脊髓侧索硬化症（ALS） 。
The DPS received FDA approval as a "humanitarian use device" (HUD), a designation given to medical devices intended for use in rare diseases.
DPS收到FDA批准作为“人道主义用途设备”（HUD），指定用于罕见疾病的医疗设备。 The FDA requires sufficient evidence that HUD devices do not pose "an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use."
FDA要求有足够的证据，HUD设备不构成“不合理的或重大的疾病或受伤的风险，而且可能对健康的好处超过了其使用的受伤或生病的风险。”
In people with ALS who have chronic breathing problems and whose primary breathing muscle, the
diaphragm , still is able to respond to electrical stimulation, the pacing system may forestall or negate the need for
invasive ventilation (ventilation via
tracheostomy , or an opening in the neck).
人谁患有慢性呼吸问题和ALS，其主要呼吸肌， 膈肌 ，仍然能够响应电刺激，起搏系统可以防止或否定，需要有创通气 （通气气管切开术 ，或在脖子上的开放）。
The device does not treat the underlying molecular mechanisms that cause ALS, so it is unable to slow, stop or reverse the disease course.
该设备不治疗潜在的分子机制，导致ALS，因此它不能放慢，停止或逆转病程。 However, the treatment may improve quality of life.然而，治疗可以提高生活质量。
"Approval of NeuRx DPS, with its potential to improve both survival and quality of life, is great news for the ALS community," said Valerie Cwik, MDA medical director and executive vice president for research. “
NeuRx DPS的批准，其潜在的生存和生活质量的提高都为ALS社区，是个好消息，说：”瓦莱丽Cwik，丙二醛（MDA）医疗董事兼执行副总裁，研究。 "MDA is very pleased that NeuRx DPS will now be a treatment option for individuals with ALS across the United States."
“MDA是非常高兴的是，NeuRx DPS现在是美国与ALS的治疗选择个人。”
|
| 。 |
FDA approval was announced by the system's developer,
Synapse Biomedical , Sept. 29, 2011.
系统的开发， 突触生物医学 ，2011年9月29日宣布了美国食品和药物管理局的批准。 Synapse says it plans to work closely with medical professionals at MDA/ALS centers to facilitate access to the NeuRx DPS treatment for those who are interested and eligible.
突触表示，它计划MDA / ALS中心，以方便访问，对于那些有兴趣及合资格的人的NeuRx DPS治疗的医疗专业人员紧密合作，。
About the NeuRx diaphragm pacing system (DPS) 关于NeuRx膈肌起搏系统（DPS）
The DPS requires minimally invasive laparoscopic surgery, in which electrodes are surgically implanted in the diaphragm, a dome-shaped sheet of muscle that extends across the bottom of the rib cage and plays an important function in respiration.
每秒需要腹腔镜微创手术，其中外科手术植入电极隔膜中，圆顶状的片材的肌肉，横跨肋条笼形件的底部延伸，并起着重要的功能的呼吸。
The device then activates the diaphragm muscle, not only supplementing the patient's breathing ability, but also delaying diaphragm
atrophy (shrinkage) and the need for invasive ventilation, says Synapse.
突触的设备，然后激活的隔膜肌肉，而不是只补充患者的呼吸能力，同时也延迟隔膜萎缩 （收缩）和有创通气的需要。
In order to benefit from the pacing system, people with ALS must have adequate function not only in the diaphragm, but in the phrenic nerves, which stimulate this muscle.
为了受益于起搏系统，ALS的人必须有足够的功能不仅在膜片，但在膈神经，刺激这肌肉。 If the nerves or diaphragm have deteriorated too much, the device is not likely to have any benefit.
如果已经恶化的神经或隔膜太多，该器件是不可能有任何好处。
The DPS can be used in conjunction with
noninvasive positive-pressure ventilation (ie,
BiPAP ), received through oral or nasal delivery.
DPS可用于无创正压通气 （即，BiPAP呼吸 ），接收通过口服或鼻腔给药的结合。
Synapse Biomedical reports the NeuRx DPS helps people with ALS "live longer and sleep better than the current standard of care alone."
突触生物报告的NeuRx DPS，帮助人们与ALS“活的时间更长，比现行标准的护理单独睡得更好。” These findings came from a multicenter clinical trial that enrolled 106 patients and treated 86 for chronic hypoventilation at seven US sites and one French site.
这些研究结果来自一项多中心的临床试验，纳入106例患者和治疗慢性肺换气不足86在美国七个站点和一个法国网站。
DPS development began in 1996, when Raymond Onders, co-founder of Synapse Biomedical, began clinical research aimed at helping patients with spinal cord injuries — including the late actor Christopher Reeve — breathe better.
DPS的发展始于1996年，雷蒙德Onders时，突触生物医学的创始人之一，开始了临床研究，旨在帮助患者脊髓损伤 - 包括已故演员克里斯托弗·里夫 - 呼吸更顺畅。 In 2004, this research expanded to include patients with ALS.
2004年，这项研究扩大到包括ALS患者。
In late 2008, Onders presented
results from two clinical trials of people with ALS who received NeuRx systems , which showed that trial participants tolerated the device well and that those with declining respiratory capacity during the lead-in period to the study showed a slower rate of decline after they had pacing systems implanted.
在2008年年底，Onders 人与ALS收到NeuRx系统 ，这表明，试验参与者的耐受性设备以及从两个临床试验的结果与呼吸能力下降过程中导入期的研究显示，以较慢的速度下降后，他们已经起搏系统植入。 Onders, who lost his sister to ALS in the past year, currently holds the Margaret and Walter Remen Chair in Surgical Innovation and is a professor of surgery at Case Western Reserve University School of Medicine in Cleveland.
谁失去了他的妹妹ALS在过去的一年，Onders，目前担任外科创新的的玛格丽特和沃尔特·Remen主席在和教授的手术是在美国凯斯西储大学医学院的克利夫兰。
Meaning for people with
FDA approval "allows us to now offer individuals living with ALS more time to be able to breathe with their own muscles," Synapse Biomedical President and Chief Executive Officer Anthony R. Ignagni said in a press release.
美国食品和药物管理局的批准，“让我们现在提供个人生活与ALS更多的时间能够用自己的肌肉呼吸，”突触生物医学主席及行政总裁安东尼·R. Ignagni在一份新闻稿中说。
The DPS should be available soon for physicians to prescribe. DPS应该可以很快医师处方。 FDA approval also clears the way for potential insurance coverage of the device for people with ALS.
美国食品和药物管理局的批准扫清了道路，为潜在的保险覆盖面的设备与ALS的人。
Those considering the device should discuss their current health problems and medications, as well as the possible benefits and risks of the new system, with their physicians.
考虑到设备，与他们的医生讨论他们目前的健康问题和药物，以及可能带来的好处和风险的新系统。
MDA ALS Division Co-Chair Augie Nieto , who received an ALS diagnosis in 2005, participated in the clinical trial of the device that led to FDA approval.
MDA ALS部联席主席奥吉·涅托在2005年，谁收到了ALS诊断，参加临床试验的设备，导致美国食品和药物管理局的批准。 In the summer of 2011, Nieto underwent a tracheostomy and switched to invasive ventilation.
在2011年的夏天，涅托进行了气管切开术，并切换到创机械通气。
"Getting this device was one of the best decisions I've made since my diagnosis," Nieto said. “
闻听此设备是我，因为我的诊断的最好的决定之一，”涅托说。 "It helped me delay the need for a tracheostomy for more than six years after my diagnosis. Most people with ALS ultimately will face a decision about going on a vent. The pacer will help extend that decision while we help find a cure." “
它帮助我延迟超过6年后，我的诊断需要进行气管切开术。与ALS的大多数人最终将面临决定去发泄。而我们可以帮助找到治疗，起搏器将有助于延长这一决定。”
About breathing difficulties in ALS关于在ALS呼吸困难
Respiratory problems are one of the most serious medical complications in ALS and a major cause of death for those with the disease.
呼吸系统的问题是最严重的并发症在ALS和主要的死因与疾病之一。
Breathing difficulties begin with the gradual loss of muscle-controlling nerve cells (
motor neurons ), and the concurrent deterioration and loss of function of the muscles responsible for breathing.
呼吸困难开始逐渐丧失肌肉控制神经细胞（ 运动神经元 ），以及并发的变质和丢失负责呼吸的肌肉的功能。 Symptoms of respiratory insufficiency and distress include shortness of breath when lying down, or with exertion, and sleep disturbances.
呼吸功能不全和痛苦的症状包括气短，平躺时，与劳累，睡眠障碍。
狗仔卡
发表于 2013-3-15 12:23:37
提升卡
置顶卡
沉默卡
喧嚣卡
变色卡
抢沙发
千斤顶
显身卡
楼主
