Effect of Cannabidiol on Interictal Epileptiform Activity and Sleep Architecture in Children with Intractable Epilepsy: A Prospective Open-Label Study.
Effect of Cannabidiol on Interictal Epileptiform Activity and Sleep Architecture in Children with Intractable Epilepsy: A Prospective Open-Label Study.
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DOI：
10.1007/s40263-021-00867-0
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发表时间：
2021-11
期刊：
影响因子：
6
通讯作者：
Jacobs J
中科院分区：
文献类型：
--
作者：
Klotz KA;Grob D;Schönberger J;Nakamura L;Metternich B;Schulze-Bonhage A;Jacobs J
大麻二酚已被证明可有效减少Dravet综合征、Lennox-Gastaut综合征和结节性硬化症患者的癫痫发作。然而，很少有人知道它的潜力，以减少发作间期癫痫样活动和改善睡眠结构。这项前瞻性研究的目的是评估大麻二酚治疗对耐药性癫痫儿童队列中发作间期癫痫样放电（IED）频率和睡眠微结构的影响。2019年11月至2021年1月，在一项剂量为20 mg/kg/天（最高剂量为50 mg/kg/天）的大麻二酚和稳定合并用药的开放标签试验期间，对耐药性癫痫儿童进行了前瞻性随访。在基线（T0）和3个月后（T1）记录脑电图。两个独立的评分者，对临床结果不知情，评价了5分钟的睡眠阶段2或低噪音清醒状态。目视识别简易爆炸装置并计算每分钟的爆炸率。如果在T1时观察到T0时不存在的睡眠结构，则认为睡眠微结构得到改善。比较T0和T1时的IED率，并与癫痫发作结局、大麻二酚剂量、初始IED率和疾病持续时间相关。共纳入35名儿童（平均值±标准差，年龄10.1 ± 0.86）。T1时的IED率显著低于T0时（分别为19.6 ± 19.5 vs. 36.8 ± 27.2; p < 0.0001）。我们发现，与基线相比，IED减少和癫痫发作减少百分比之间存在中度相关性（Pearson r = 0.39; p = 0.02），T0时IED减少与IED率之间存在中度负相关性（r =-0.34; p = 0.04），IED减少与疾病持续时间之间呈中度负相关趋势（r =-0.32; p = 0.06）。记录了23例患者的睡眠情况。在56.5%的睡眠记录中，睡眠微结构最初异常，其中84.6%的情况下得到改善。我们的研究结果强烈表明大麻二酚在减少IED和改善耐药性癫痫儿童的睡眠微结构方面的效用。需要更大规模的对照研究来评估这种效应在不同癫痫类型中的临床相关性。DRKS 00013177; 2019年6月25日。
Cannabidiol has been shown to be effective in seizure reduction in patients with Dravet syndrome, Lennox–Gastaut syndrome, and tuberous sclerosis. However, very little is known about its potential to reduce interictal epileptiform activity and improve sleep architecture. The objective of this prospective study was to evaluate the influence of cannabidiol therapy on the frequency of interictal epileptiform discharges (IEDs) and sleep microstructure in a cohort of children with drug-resistant epilepsy. Children with drug-resistant epilepsy were prospectively followed from November 2019 to January 2021 during an open-label trial of cannabidiol at a dose of 20 mg/kg/day (to a maximum of 50 mg/kg/day) and stable concomitant medication. Electroencephalograms were recorded at baseline (T0) and after 3 months (T1). Two independent raters, blinded to clinical outcome, evaluated 5-min segments of sleep stage 2 or low-noise awake state. IEDs were visually identified and rates per minute calculated. Sleep microstructure was considered improved if sleep structures were seen at T1 that were not present at T0. IED rates at T0 and T1 were compared and correlated with seizure outcome, cannabidiol dose, initial IED rate, and disease duration. In total, 35 children (mean ± standard deviation age 10.1 ± 0.86) were included. The IED rate at T1 was significantly lower than at T0 (19.6 ± 19.5 vs. 36.8 ± 27.2, respectively; p < 0.0001). We found a moderate correlation between IED reduction and percentage of seizure reduction compared with baseline (Pearson’s r = 0.39; p = 0.02), a moderate negative correlation between IED reduction and IED rate at T0 (r = − 0.34; p = 0.04), and a trend towards a moderate negative correlation between IED reduction and disease duration (r = − 0.32; p = 0.06). Sleep was recorded in 23 patients. Sleep microstructure was initially abnormal in 56.5% of sleep recordings and improved in 84.6% of those cases. Our results strongly suggest the utility of cannabidiol in reducing IEDs and improving sleep microstructure in children with drug-resistant epilepsy. Larger controlled studies are needed to evaluate the clinical relevance of this effect in different epilepsy types. DRKS00013177; 25 June 2019.
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影响因子：
5.6
作者：
Horak PC;Meisenhelter S;Song Y;Testorf ME;Kahana MJ;Viles WD;Bujarski KA;Connolly AC;Robbins AA;Sperling MR;Sharan AD;Worrell GA;Miller LR;Gross RE;Davis KA;Roberts DW;Lega B;Sheth SA;Zaghloul KA;Stein JM;Das SR;Rizzuto DS;Jobst BC
通讯作者：
Jobst BC
影响因子：
5.6
作者：
Birnbaum, Angela K.;Karanam, Ashwin;Leppik, Ilo E.
通讯作者：
Leppik, Ilo E.
影响因子：
3.4
作者：
Klotz, Kerstin A.;Grob, Daniel;Jacobs, Julia
通讯作者：
Jacobs, Julia
影响因子：
4.7
作者：
Goncharova, Irina I.;Alkawadri, Rafeed;Zaveri, Hitten P.
通讯作者：
Zaveri, Hitten P.
影响因子：
2.6
作者：
Press, Craig A.;Knupp, Kelly G.;Chapman, Kevin E.
通讯作者：
Chapman, Kevin E.