Gamma Ventral Capsulotomy for Obsessive-Compulsive Disorder A Randomized Clinical Trial
Gamma Ventral Capsulotomy for Obsessive-Compulsive Disorder A Randomized Clinical Trial
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DOI：
10.1001/jamapsychiatry.2014.1193
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发表时间：
2014-09-01
期刊：
影响因子：
25.8
通讯作者：
Miguel, Euripedes C.
中科院分区：
文献类型：
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作者：
Lopes, Antonio C.;Greenberg, Benjamin D.;Miguel, Euripedes C.
重要性选择顽固性强迫症（OCD）的病例进行神经外科消融超过半个世纪。然而，据我们所知，还没有随机临床试验，这些程序的治疗任何精神疾病。目的确定放射外科的有效性和安全性（伽马腹侧囊切开术[GVC]）治疗顽固性强迫症。设计、设置和参与者在一项双盲、安慰剂对照、随机临床试验中，16例难治性强迫症患者随机分为主动（n = 8）和假（n = 8）GVC组。保持盲态12个月。揭盲后，假手术组患者提供积极GVC.INTERVENTIONS患者随机积极GVC有2个不同的等中心点照射在内囊前肢的腹侧边缘的每一侧。随机分配至假GVC组的患者使用相同的设备接受模拟放射外科治疗。主要结果和测量耶鲁-布朗强迫量表（Y-BOCS）和临床总体印象改善（CGI-I）量表评分。反应被定义为一个35%或更大的Y-BOCS的严重程度和“改善”或“大大改善”CGI-I rates.Results的减少3/8例患者随机积极治疗反应在12个月，而没有8个假GVC患者响应（绝对风险降低，0.375，95%CI，0.04-0.71）。在12个月时，主动GVC组的强迫症症状改善显著高于假手术组（Y-BOCS，P = 0.046;维度Y-BOCS，P = 0.01）。第54个月时，活性药物组中另有2例患者成为应答者。在随后接受活性GVC的4名假GVC患者中，2名在GVC后12个月时有反应。最严重的不良事件是一个无症状的辐射引起的囊肿在1 patient.CONCLUSIONS和RELEVANCE伽马腹侧囊切开术受益患者，否则顽固性强迫症，因此似乎是一种替代脑深部电刺激在选定的情况下。鉴于任何精神神经外科手术固有的风险，此类手术应在专业中心进行。
IMPORTANCE Select cases of intractable obsessive-compulsive disorder (OCD) have undergone neurosurgical ablation for more than half a century. However, to our knowledge, there have been no randomized clinical trials of such procedures for the treatment of any psychiatric disorder.OBJECTIVE To determine the efficacy and safety of a radiosurgery (gamma ventral capsulotomy [GVC]) for intractable OCD.DESIGN, SETTING, AND PARTICIPANTS In a double-blind, placebo-controlled, randomized clinical trial, 16 patients with intractable OCD were randomized to active (n = 8) or sham (n = 8) GVC. Blinding was maintained for 12 months. After unblinding, sham-group patients were offered active GVC.INTERVENTIONS Patients randomized to active GVC had 2 distinct isocenters on each side irradiated at the ventral border of the anterior limb of the internal capsule. The patients randomized to sham GVC received simulated radiosurgery using the same equipment.MAIN OUTCOMES AND MEASURES Scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and the Clinical Global Impression-Improvement (CGI-I) Scale. Response was defined as a 35% or greater reduction in Y-BOCS severity and "improved" or "much improved" CGI-I ratings.RESULTS Three of 8 patients randomized to active treatment responded at 12 months, while none of the 8 sham-GVC patients responded (absolute risk reduction, 0.375; 95% CI, 0.04-0.71). At 12 months, OCD symptom improvement was significantly higher in the active-GVC group than in the sham group (Y-BOCS, P = .046; Dimensional Y-BOCS, P = .01). At 54 months, 2 additional patients in the active group had become responders. Of the 4 sham-GVC patients who later received active GVC, 2 responded by post-GVC month 12. The most serious adverse event was an asymptomatic radiation-induced cyst in 1 patient.CONCLUSIONS AND RELEVANCE Gamma ventral capsulotomy benefitted patients with otherwise intractable OCD and thus appears to be an alternative to deep-brain stimulation in selected cases. Given the risks inherent in any psychiatric neurosurgery, such procedures should be conducted at specialized centers.