Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - A Randomized Pilot Study.
Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - A Randomized Pilot Study.
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DOI：
10.1167/tvst.12.8.17
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发表时间：
2023-08-01
影响因子：
3
通讯作者：
Tyler, Christopher
中科院分区：
文献类型：
--
作者：
Silkiss, Rona Z.;Koppinger, Jayson;Truong, Timothy;Gibson, David;Tyler, Christopher
本研究的目的是评估低剂量大麻二酚（CBD; Epidiolex）作为特发性成人眼睑痉挛（BPS）辅助治疗的安全性和有效性，并开发一种新型客观评估方法来衡量反应。前瞻性、随机、双盲、安慰剂对照交叉设计，12例接受常规最大剂量肉毒杆菌毒素（BTX）治疗并出现突破性症状的BPS患者持续6个月。参与者每3个月接受一次标准BTX，并被随机分配到A组=第1周期每天CBD，然后在第2周期接受安慰剂，或B组=安慰剂，然后接受CBD。分析在每个周期的第0、45和90天记录的视频以量化眼睑运动学。Jankovic评定量表（JRS）用于提供临床评级。所有12例患者均完成了研究，未发生不良事件。CBD使中位眼睑闭合幅度降低19.1%（−1.66 mm，置信区间[CI] = −3.19至−0.14 mm，P = 0.03），眼睑闭合时间中位数减少15.8%（−18.35 ms，CI = −29.37至−7.32 ms，P = 0.001），最大眼睑闭合速度增加34.8%（−13.26 mm/ms，CI = −20.93至−5.58 mm/ms，P = 0.001）。JRS显示严重程度和频率降低0.5，无统计学显著性。低剂量CBD是安全耐受的，并改善了几个BPS运动学参数。临床量表提示了作用方向，但可能效力不足。需要进一步的研究来更好地量化临床相关性。这项工作描述了一种新的评估方法和治疗方法bBPS。
The purpose of this study was to evaluate the safety and efficacy of low dose cannabidiol (CBD; Epidiolex) as adjunctive therapy for idiopathic adult-onset blepharospasm (BPS), as well as develop a novel objective assessment methodology to gauge response. Prospective, randomized, double-masked, placebo-controlled crossover design of 6 months duration of 12 patients with BPS undergoing routine maximal botulinum toxin (BTX) therapy and experiencing breakthrough symptoms. Participants received their standard BTX every 3 months and were randomized to group A = CBD daily in cycle 1, followed by placebo in cycle 2 or group B = placebo followed by CBD. Videos recorded at days 0, 45, and 90 of each cycle were analyzed to quantify eyelid kinematics. The Jankovic Rating Scale (JRS) was used to provide a clinical rating. All 12 patients completed the study without adverse events. CBD decreased median eyelid closure amplitude by 19.1% (−1.66 mm, confidence interval [CI] = −3.19 to −0.14 mm, P = 0.03), decreased median eyelid closure duration by 15.8% (−18.35 ms, CI = −29.37 to −7.32 ms, P = 0.001), and increased the maximum eyelid closure velocity by 34.8% (−13.26 mm/ms, CI = −20.93 to −5.58 mm/ms, P = 0.001). The JRS showed a 0.5 reduction in severity and frequency, which was not statistically significant. Low dose CBD was safely tolerated and improved several BPS kinematic parameters. The clinical scale suggested a direction of effect but may have been underpowered. Further studies are needed to better quantify the clinical relevance. This work describes a novel assessment methodology and therapeutic approach to bBPS.
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影响因子：
9.9
作者：
BURKE, RE;FAHN, S;FRIEDMAN, J
通讯作者：
FRIEDMAN, J
影响因子：
9.9
作者：
JANKOVIC, J;ORMAN, J
通讯作者：
ORMAN, J
影响因子：
2.9
作者：
Garcia-Arencibia, Moises;Gonzalez, Sara;Fernandez-Ruiz, Javier
通讯作者：
Fernandez-Ruiz, Javier
影响因子：
158.5
作者：
Devinsky, Orrin;Patel, Anup D.;Zuberi, Sameer M.
通讯作者：
Zuberi, Sameer M.
DOI：
10.1097/00002341-199809000-00002
发表时间：
1998-09-01
影响因子：
2
作者：
Anderson, RL;Patel, BCK;Jordan, DR
通讯作者：
Jordan, DR