Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial.
Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial.
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DOI：
10.1001/jama.2008.929
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发表时间：
2009-01-07
影响因子：
120.7
通讯作者：
Huang, Grant D.
中科院分区：
文献类型：
--
作者：
Weaver, Frances M.;Follett, Kenneth;Stern, Matthew;Hur, Kwan;Harris, Crystal;Marks, William J., Jr.;Rothlind, Johannes;Sagher, Oren;Reda, Domenic;Moy, Claudia S.;Pahwa, Rajesh;Burchiel, Kim;Hogarth, Penelope;Lai, Eugene C.;Duda, John E.;Holloway, Kathryn;Samii, Ali;Horn, Stacy;Bronstein, Jeff;Stoner, Gatana;Heemskerk, Jill;Huang, Grant D.
深部脑刺激是晚期帕金森病 (PD) 的公认治疗方法，但比较治疗方法的随机试验很少，而且大多数研究都排除了老年患者。比较接受深部脑刺激或最佳药物治疗的 PD 患者的 6 个月结果。 2002 年 5 月至 2005 年 10 月期间，在 7 个退伍军人事务部和 6 个大学医院对接受深部脑刺激或最佳药物治疗的患者进行随机对照试验，按研究地点和患者年龄（<70 岁与≥70 岁）进行分层。总共纳入了 255 名 PD 患者（未服用药物时 Hoehn 和 Yahr 分期≥2 级）； 25%的人年龄在70岁或以上。最后一次为期 6 个月的随访于 2006 年 5 月进行。双侧丘脑底核 (n=60) 或苍白球 (n=61) 的深部脑刺激。接受最佳药物治疗的患者 (n=134) 由运动障碍神经科医生积极管理。主要结果是使用运动日记，处于“开启”状态（良好的运动控制和不受阻碍的运动功能）的时间，而不会出现运动障碍。其他结果包括运动功能、生活质量、神经认知功能和不良事件。接受深部脑刺激的患者平均每天准时 4.6 小时，而没有出现令人烦恼的运动障碍，而接受最佳药物治疗的患者则为 0 小时/天（组间平均差异为 4.5 小时/天 [95% CI，3.7-5.4 小时/天]；P<.001）。与最佳药物治疗相比，深部脑刺激患者的运动功能显着改善 (P<.001)，例如 71% 的深部脑刺激患者和 32% 的最佳药物治疗患者经历了具有临床意义的运动功能改善 (≥5 分)。与最佳药物治疗组相比，深部脑刺激组在生活质量综合衡量指标和 8 项 PD 生活质量评分中的 7 项上经历了显着改善 (P<.001)。神经认知测试显示，与最佳药物治疗相比，接受深部脑刺激的患者在某些信息处理领域略有下降。 49 名深部脑刺激患者和 15 名最佳药物治疗患者中至少发生 1 例严重不良事件（P<.001），其中 39 例与手术操作相关的不良事件和 1 例继发于脑出血的死亡。在这项针对晚期帕金森病患者的随机对照试验中，深部脑刺激比最佳药物治疗更能有效地按时改善病情，且不会出现运动障碍、运动功能和 6 个月时的生活质量，但会增加严重不良事件的风险。 ClinicalTrials.gov 标识符：NCT00056563
Deep brain stimulation is an accepted treatment for advanced Parkinson disease (PD), although there are few randomized trials comparing treatments, and most studies exclude older patients. To compare 6-month outcomes for patients with PD who received deep brain stimulation or best medical therapy. Randomized controlled trial of patients who received either deep brain stimulation or best medical therapy, stratified by study site and patient age (<70 years vs ≥70 years) at 7 Veterans Affairs and 6 university hospitals between May 2002 and October 2005. A total of 255 patients with PD (Hoehn and Yahr stage ≥2 while not taking medications) were enrolled; 25% were aged 70 years or older. The final 6-month follow-up visit occurred in May 2006. Bilateral deep brain stimulation of the subthalamic nucleus (n=60) or globus pallidus (n=61). Patients receiving best medical therapy (n=134) were actively managed by movement disorder neurologists. The primary outcome was time spent in the “on” state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries. Other outcomes included motor function, quality of life, neurocognitive function, and adverse events. Patients who received deep brain stimulation gained a mean of 4.6 h/d of on time without troubling dyskinesia compared with 0 h/d for patients who received best medical therapy (between group mean difference, 4.5 h/d [95% CI, 3.7-5.4 h/d]; P<.001). Motor function improved significantly (P<.001) with deep brain stimulation vs best medical therapy, such that 71% of deep brain stimulation patients and 32% of best medical therapy patients experienced clinically meaningful motor function improvements (≥5 points). Compared with the best medical therapy group, the deep brain stimulation group experienced significant improvements in the summary measure of quality of life and on 7 of 8 PD quality-of-life scores (P<.001). Neurocognitive testing revealed small decrements in some areas of information processing for patients receiving deep brain stimulation vs best medical therapy. At least 1 serious adverse event occurred in 49 deep brain stimulation patients and 15 best medical therapy patients (P<.001), including 39 adverse events related to the surgical procedure and 1 death secondary to cerebral hemorrhage. In this randomized controlled trial of patients with advanced PD, deep brain stimulation was more effective than best medical therapy in improving on time without troubling dyskinesias, motor function, and quality of life at 6 months, but was associated with an increased risk of serious adverse events. clinicaltrials.gov Identifier: NCT00056563
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