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帕金森病神经外科植入物的研究:设计问题

Studying neurosurgical implants for Parkinson disease: a question of design.

作者信息

Prehn A W, Vawter D E, Gervais K G, DeVries R G, Garrett J E, Freeman T B, McIndoo T Q

机构信息

Minnesota Center for Health Care Ethics, 601 25th Avenue South, Minneapolis, MN 55454, USA.

出版信息

Neurology. 2006 Oct 24;67(8):1503-5. doi: 10.1212/01.wnl.0000240221.78518.5e.

DOI:10.1212/01.wnl.0000240221.78518.5e
PMID:17060588
Abstract

North American researchers' perspectives on designing neurosurgical implant studies for Parkinson disease (PD) challenged the custom of holding surgical trials to less stringent evidentiary standards than other clinical studies. Researchers supported placebo surgery-controlled trials. The framework they used to design and evaluate studies both of deep brain stimulation and cellular implants for PD may be applicable to a broad range of surgical implants for other disorders.

摘要

北美研究人员对于帕金森病(PD)神经外科植入物研究设计的观点,对将外科手术试验的证据标准设定得比其他临床研究更为宽松的惯例提出了挑战。研究人员支持采用假手术对照试验。他们用于设计和评估针对PD的深部脑刺激和细胞植入物研究的框架,可能适用于针对其他疾病的广泛外科植入物。

相似文献

1
Studying neurosurgical implants for Parkinson disease: a question of design.帕金森病神经外科植入物的研究:设计问题
Neurology. 2006 Oct 24;67(8):1503-5. doi: 10.1212/01.wnl.0000240221.78518.5e.
2
Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers.假手术的科学与伦理:帕金森病临床研究人员的调查
Arch Neurol. 2005 Sep;62(9):1357-60. doi: 10.1001/archneur.62.9.1357.
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Frontiers in the surgical treatment of Parkinson's disease.帕金森病外科治疗前沿
Expert Rev Neurother. 2008 Jun;8(6):897-906. doi: 10.1586/14737175.8.6.897.
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Reoperation for suboptimal outcomes after deep brain stimulation surgery.针对脑深部电刺激手术效果欠佳进行的再次手术。
Neurosurgery. 2008 Oct;63(4):754-60; discussion 760-1. doi: 10.1227/01.NEU.0000325492.58799.35.
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Implantation of electrodes for deep brain stimulation of the subthalamic nucleus in advanced Parkinson's disease with the aid of intraoperative microrecording under general anesthesia.在全身麻醉下借助术中微记录技术,为晚期帕金森病患者植入电极以对丘脑底核进行深部脑刺激。
Neurosurgery. 2006 Nov;59(5):E1138; discussion E1138. doi: 10.1227/01.NEU.0000245603.77075.55.
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Is deep brain stimulation neuroprotective if applied early in the course of PD?如果在帕金森病病程早期应用,深部脑刺激是否具有神经保护作用?
Nat Clin Pract Neurol. 2008 Aug;4(8):424-6. doi: 10.1038/ncpneuro0848. Epub 2008 Jul 1.
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[Deep brain stimulation in Parkinson disease].[帕金森病中的深部脑刺激]
Rev Neurol (Paris). 2008 Apr;164 Spec No 2:F89-93.
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Frameless stereotactic for deep brain stimulation placement: operative technique.用于脑深部电刺激植入的无框架立体定向:手术技术
J Med Assoc Thai. 2008 Apr;91(4):497-501.
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Future directions: use of interventional MRI for cell-based therapy of Parkinson disease.未来方向:介入性磁共振成像在帕金森病细胞治疗中的应用
Neurosurg Clin N Am. 2009 Apr;20(2):211-8. doi: 10.1016/j.nec.2009.04.005.
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[Predictive clinical factors of response to subthalamic nucleus stimulation in Parkinson's disease].[帕金森病丘脑底核刺激反应的预测性临床因素]
Neurologia. 2007 Jan-Feb;22(1):1-4.

引用本文的文献

1
Sham surgery trial controls: perspectives of patients and their relatives.假手术试验对照组:患者及其亲属的观点。
J Empir Res Hum Res Ethics. 2012 Jul;7(3):15-28. doi: 10.1525/jer.2012.7.3.15.
2
Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations.针对帕金森病开展侵袭性、首例人体试验:伦理考量。
Mov Disord. 2009 Oct 15;24(13):1893-901. doi: 10.1002/mds.22712.
3
Placebo-controlled procedural trials for neurological conditions.针对神经系统疾病的安慰剂对照程序试验。
Neurotherapeutics. 2007 Jul;4(3):531-6. doi: 10.1016/j.nurt.2007.03.001.