Department of Neurology, University of Arizona, PO Box 245023, Tucson, Arizona 85724-5023, USA.
Muscle Nerve. 2012 Jul;46(1):1-8. doi: 10.1002/mus.23419.
Amyotrophic lateral sclerosis (ALS) remains a rapidly progressive fatal degenerative disease of motor neurons for which there are few interventions to slow disease progression or improve quality of life. A diaphragm pacing system was approved by the U.S. Food and Drug Administration in September 2011 for ALS under a Humanitarian Device Exemption. News of this approval has been met with a combination of excitement and uncertainty by members of the ALS community. We review the currently available data on the diaphragm pacing system and its use in ALS. Diaphragm pacing appears to be reasonably safe in carefully selected patients, but flaws in the reporting on it thus far preclude conclusions regarding efficacy. Further study is needed.
肌萎缩侧索硬化症(ALS)仍然是一种快速进展的致命运动神经元退行性疾病,目前几乎没有干预措施可以减缓疾病进展或提高生活质量。2011 年 9 月,美国食品和药物管理局(FDA)根据人道主义设备豁免(HDE)批准膈肌起搏系统用于 ALS。这一批准消息令 ALS 患者群体既兴奋又感到不确定。我们回顾了目前关于膈肌起搏系统及其在 ALS 中的应用的数据。膈肌起搏在经过精心选择的患者中似乎是相对安全的,但迄今为止,关于它的报告存在缺陷,因此无法得出关于疗效的结论。需要进一步研究。