Kupsch Andreas, Benecke Reiner, Müller Jörg, Trottenberg Thomas, Schneider Gerd-Helge, Poewe Werner, Eisner Wilhelm, Wolters Alexander, Müller Jan-Uwe, Deuschl Günther, Pinsker Marcus O, Skogseid Inger Marie, Roeste Geir Ketil, Vollmer-Haase Juliane, Brentrup Angela, Krause Martin, Tronnier Volker, Schnitzler Alfons, Voges Jürgen, Nikkhah Guido, Vesper Jan, Naumann Markus, Volkmann Jens
Charité Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.
N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.
Neurostimulation of the internal globus pallidus has been shown to be effective in reducing symptoms of primary dystonia. We compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.
Forty patients with primary segmental or generalized dystonia received an implanted device for deep-brain stimulation and were randomly assigned to receive either neurostimulation or sham stimulation for 3 months. The primary end point was the change from baseline to 3 months in the severity of symptoms, according to the movement subscore on the Burke-Fahn-Marsden Dystonia Rating Scale (range, 0 to 120, with higher scores indicating greater impairment). Two investigators who were unaware of treatment status assessed the severity of dystonia by reviewing videotaped sessions. Subsequently, all patients received open-label neurostimulation; blinded assessment was repeated after 6 months of active treatment.
Three months after randomization, the change from baseline in the mean (+/-SD) movement score was significantly greater in the neurostimulation group (-15.8+/-14.1 points) than in the sham-stimulation group (-1.4+/-3.8 points, P<0.001). During the open-label extension period, this improvement was sustained among patients originally assigned to the neurostimulation group, and patients in the sham-stimulation group had a similar benefit when they switched to active treatment. The combined analysis of the entire cohort after 6 months of neurostimulation revealed substantial improvement in all movement symptoms (except speech and swallowing), the level of disability, and quality of life, as compared with baseline scores. A total of 22 adverse events occurred in 19 patients, including 4 infections at the stimulator site and 1 lead dislodgment. The most frequent adverse event was dysarthria.
Bilateral pallidal neurostimulation for 3 months was more effective than sham stimulation in patients with primary generalized or segmental dystonia. (ClinicalTrials.gov number, NCT00142259 [ClinicalTrials.gov].).
内侧苍白球神经刺激已被证明在减轻原发性肌张力障碍症状方面有效。我们在一项随机对照临床试验中将这种外科治疗与假刺激进行了比较。
40例原发性节段性或全身性肌张力障碍患者接受了深部脑刺激植入装置，并被随机分配接受神经刺激或假刺激3个月。主要终点是根据伯克-法恩-马斯登肌张力障碍评定量表的运动子评分（范围为0至120，分数越高表明损伤越严重），从基线到3个月症状严重程度的变化。两名不知道治疗状态的研究人员通过查看录像来评估肌张力障碍的严重程度。随后，所有患者接受开放标签的神经刺激；在积极治疗6个月后重复进行盲法评估。
随机分组3个月后，神经刺激组平均（±标准差）运动评分相对于基线的变化（-15.8±14.1分）显著大于假刺激组（-1.4±3.8分，P<0.001）。在开放标签延长期，最初分配到神经刺激组的患者症状持续改善，而假刺激组的患者在转为积极治疗后也有类似的改善。对整个队列在神经刺激6个月后的综合分析显示，与基线评分相比，所有运动症状（除言语和吞咽外）、残疾水平和生活质量都有显著改善。19例患者共发生22起不良事件，包括4例刺激器部位感染和1例导线移位。最常见的不良事件是构音障碍。
对于原发性全身性或节段性肌张力障碍患者，双侧苍白球神经刺激3个月比假刺激更有效。（ClinicalTrials.gov编号，NCT00142259 [ClinicalTrials.gov]。）
