NEJM：下丘脑刺激有助于改善早期帕金森症状

2013-02-18 佚名 EGMN

　　法国和德国研究人员合作开展的一项随机试验显示，在药物治疗基础上加用下丘脑刺激，不仅可改善早期帕金森病患者的生活质量和轻度左旋多巴诱导的运动并发症，还可以减少后续的运动残疾。　　主要作者W.M.M. Schüpbach博士和EARLYSTIM(对于早期帕金森病患者进行深部脑刺激的对照试验)研究组的同事指出，已知这种联合治疗对晚期帕金森病患者有益，而这一新发现提示“神经刺激可能作为较当前

　　法国和德国研究人员合作开展的一项随机试验显示，在药物治疗基础上加用下丘脑刺激，不仅可改善早期帕金森病患者的生活质量和轻度左旋多巴诱导的运动并发症，还可以减少后续的运动残疾。

　　主要作者W.M.M. Schüpbach博士和EARLYSTIM(对于早期帕金森病患者进行深部脑刺激的对照试验)研究组的同事指出，已知这种联合治疗对晚期帕金森病患者有益，而这一新发现提示“神经刺激可能作为较当前建议更早期患者的一种治疗选择” (N. Engl. J. Med. 2013;368:610-22 [doi:10.1056/NEJMoa1205158])。

　　研究者将127例有早期运动并发症的患者随机分配到最佳药物治疗组，同时将124例患者随机分配到上述治疗加下丘脑神经刺激组。神经刺激组患者接受双侧立体定位手术，置入电极(model 3389，美敦力公司)和一个脉冲发生器(Kinetra或Soletra，美敦力公司)。双侧半球的刺激相似，平均强度为2.8 V，平均刺激频率为142 Hz，平均脉冲持续时间为66微秒。刺激达到最大获益所需的时间大约为5个月。主要终点为100分帕金森病(自测)问卷(PDQ-39)汇总指数。基线时，两组各项指标无显著差异。两组患者的平均年龄均约为52岁，病程约7.5年，接受左旋多巴治疗约5年。患者发生左旋多巴诱导的运动并发症平均约18个月。作者认为，总之，研究受试者较以往神经刺激试验中的患者稍年轻，且病情较轻。

　　结果显示，2年时，神经刺激组报告PDQ-39汇总指数生活质量评分提高了7.8分；药物治疗组患者报告评分降低0.2分。2年时相对于基线的平均变化的组间差异为8.0分(P=0.002)。神经刺激组的运动残疾评分也更优，在无药物治疗情况下，70分统一帕金森疾病评定量表(UPDRS)第Ⅲ部分的组间差异为16.4分，神经刺激组更优(P<0.001)。使用适当的UPDRS部分评估发现，神经刺激组日常生活活动(P<0.001)和左旋多巴诱导的运动并发症(P<0.001)评定也中度优于药物治疗组。根据患者日记中的报告，接受神经刺激治疗组还报告有良好运动和无运动功能障碍的时间较长(P=0.01)。神经刺激组患者每日左旋多巴等效剂量减少了39%，而药物治疗组患者增加了大约21%。“因为仅接受药物治疗组的运动症状和生活质量保持相对稳定，故接受手术患者的改善可归因于神经刺激。”

　　神经刺激组有68例患者(55%)发生严重不良事件；共发生26起与手术或设备有关的严重事件，包括1起脑脓肿，但在治疗后痊愈。神经刺激组中重症抑郁症更多见。药物治疗组中有56例(44%)发生严重不良事件，多数为运动障碍和药物副作用的结果，如冲动控制障碍和幻觉。并且，该组患者因健康问题就诊的情况也更多见。神经刺激组的2例患者和药物治疗组的1例患者自杀；两组各有2例患者有自杀企图。

　　这项研究部分由美敦力公司资助，该公司为试验中使用的神经刺激设备的生产商。除1名研究者外，其他49名研究者披露与美敦力公司之间存在某种形式的利益关系，包括补助金、差旅费以及讲课、咨询、数据审查和教育材料开发费用。1位研究者为美敦力公司顾问委员会成员。首席研究者的部分薪酬是由该公司支付的。除美敦力公司之外，德国研究部和法国Clinique国家奥皮塔利耶研究项目也对这项研究给予了资助。

Neurostimulation for Parkinson's Disease with Early Motor Complications

BACKGROUND

Subthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson's disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson's disease.

METHODS

In this 2-year trial, we randomly assigned 251 patients with Parkinson's disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson's Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia.

RESULTS

For the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group.

CONCLUSIONS

Subthalamic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.)

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2013-02-20 zhouqu_8

#下丘脑#

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2013-02-20 amyloid

#脑刺激#

96 0
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2013-02-20 howi

#帕金森症#

99 0
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2013-02-20 xlwang2696

#丘脑#

92 0
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2013-02-20 xlwang2696

#丘脑#

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NEJM：下丘脑刺激有助于改善早期帕金森症状

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NEJM：下丘脑刺激有助于改善早期帕金森症状

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