Millan Sarah H, Hacker Mallory L, Turchan Maxim, Molinari Anna L, Currie Amanda D, Charles David
Department of Neurology, Vanderbilt University Medical Center, 1611 21st Ave S., A-0118 Medical Center North, Nashville, TN 37223-2551, USA.
Parkinsons Dis. 2017;2017:7163801. doi: 10.1155/2017/7163801. Epub 2017 Jun 6.
Previous studies suggest that deep brain stimulation of the subthalamic nucleus (STN-DBS) for Parkinson's disease (PD) leads to weight gain. This study analyzes changes in body mass index (BMI) in 29 subjects from a prospective, single-blind trial of DBS in early stage PD (age 50-75, Hoehn & Yahr stage II off medication, treated with antiparkinsonian medications for ≥6 months but <4 years, and without a history of motor fluctuations, dyskinesias, or dementia). Subjects were randomized to DBS plus optimal drug therapy (DBS+ODT; = 15) or ODT ( = 14) and followed for 24 months. Weight and height were recorded at baseline and each follow-up visit and used to calculate BMI. BMIs were compared within and between groups using nonparametric -tests. Mean BMI at baseline was 29.7 in the ODT group and 32.3 in the DBS+ODT group ( > 0.05). BMI change over two years was not different between the groups ( = 0.62, ODT = -0.89; DBS+ODT = -0.17). This study suggests that STN-DBS is not associated with weight gain in subjects with early stage PD. This finding will be tested in an upcoming FDA-approved phase III multicenter, randomized, double-blind, placebo-controlled, pivotal clinical trial evaluating DBS in early stage PD (ClinicalTrials.gov identifier NCT00282152).
先前的研究表明,对帕金森病(PD)患者进行丘脑底核深部脑刺激(STN-DBS)会导致体重增加。本研究分析了29名受试者的体重指数(BMI)变化,这些受试者来自一项针对早期PD的前瞻性单盲DBS试验(年龄50 - 75岁,霍恩和雅尔分级II级,未服药,接受抗帕金森药物治疗≥6个月但<4年,且无运动波动、异动症或痴呆病史)。受试者被随机分为DBS加最佳药物治疗组(DBS + ODT;n = 15)或最佳药物治疗组(n = 14),并随访24个月。在基线和每次随访时记录体重和身高,并用于计算BMI。使用非参数检验对组内和组间的BMI进行比较。ODT组基线时的平均BMI为29.7,DBS + ODT组为32.3(P>0.05)。两组之间两年内的BMI变化无差异(P = 0.62,ODT组=-0.89;DBS + ODT组=-0.17)。本研究表明,STN-DBS与早期PD患者的体重增加无关。这一发现将在即将进行的由美国食品药品监督管理局(FDA)批准的III期多中心、随机、双盲、安慰剂对照的关键临床试验中进行验证,该试验评估早期PD患者的DBS治疗(ClinicalTrials.gov标识符NCT00282152)。