基于大麻的产品治疗小儿癫痫：系统评价。

Cannabis-based products for pediatric epilepsy: A systematic review.

机构信息

School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.

Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

出版信息

Epilepsia. 2019 Jan;60(1):6-19. doi: 10.1111/epi.14608. Epub 2018 Dec 4.

DOI:10.1111/epi.14608

PMID:30515765

Abstract

OBJECTIVE

To assess the benefits and harms of cannabis-based products for pediatric epilepsy.

METHODS

We identified in this living systematic review randomized controlled trials (RCTs) and nonrandomized studies (NRSs) involving children with epilepsy treated with cannabis-based products. We searched MEDLINE, Embase, PsycINFO, Cochrane Library, and gray literature (April 25, 2018). The primary outcome was seizure freedom; secondary outcomes were seizure frequency (total, ≥50% reduction), quality of life, sleep, status epilepticus, death, gastrointestinal adverse events, and visits to the emergency room. Data were pooled by random-effects meta-analysis. Risk of bias was assessed for each study, and GRADE was used to assess the quality of evidence for each outcome.

RESULTS

Four RCTs and 19 NRSs were included, primarily involving cannabidiol. All RCTs were at low risk of bias, whereas all NRSs were at high risk. Among RCTs, there was no statistically significant difference between cannabidiol and placebo in seizure freedom (relative risk [RR] = 6.77, 95% confidence interval [CI] = 0.36-128.38; 1 RCT), quality of life (mean difference = 0.6, 95% CI = -2.6 to 3.9; 3 RCTs), sleep disruption (mean difference = -0.3, 95% CI = -0.8 to 0.2; 3 RCTs), or vomiting (RR = 1.00, 95% CI = 0.51-1.96; 4 RCTs). There was a statistically significant reduction in the median frequency of monthly seizures with cannabidiol compared with placebo (-19.8%, 95% CI = -27.0% to -12.6%; 3 RCTs) and an increase in the number of participants with at least a 50% reduction in seizures (RR = 1.76, 95% CI = 1.07-2.88; 1 RCT) and diarrhea (RR = 2.25, 95% CI = 1.38-3.68; 3 RCTs). Death and status epilepticus were infrequently reported.

SIGNIFICANCE

Evidence from high-quality RCTs suggests that cannabidiol probably reduces seizures among children with drug-resistant epilepsy (moderate certainty). At this time, the evidence base is primarily limited to cannabidiol, and these findings should not be extended to all cannabis-based products.

摘要

目的

评估大麻素类产品治疗儿科癫痫的疗效和安全性。

方法

本系统评价纳入了大麻素类产品治疗癫痫儿童的随机对照试验（RCT）和非随机研究（NRS）。我们检索了 MEDLINE、Embase、PsycINFO、Cochrane 图书馆和灰色文献（2018 年 4 月 25 日）。主要结局是无癫痫发作；次要结局是癫痫发作频率（总发作、≥50%减少）、生活质量、睡眠、癫痫持续状态、死亡、胃肠道不良事件和急诊就诊。采用随机效应荟萃分析汇总数据。评估了每个研究的偏倚风险，并使用 GRADE 评估了每个结局的证据质量。

结果

纳入了 4 项 RCT 和 19 项 NRS，主要涉及大麻二酚。所有 RCT 均为低偏倚风险，而所有 NRS 均为高偏倚风险。在 RCT 中，大麻二酚与安慰剂在无癫痫发作方面无统计学差异（RR=6.77，95%CI=0.36-128.38；1 项 RCT）、生活质量（平均差=0.6，95%CI=-2.6 至 3.9；3 项 RCT）、睡眠障碍（平均差=-0.3，95%CI=-0.8 至 0.2；3 项 RCT）或呕吐（RR=1.00，95%CI=0.51-1.96；4 项 RCT）方面无统计学差异。与安慰剂相比，大麻二酚可显著降低月癫痫发作频率（中位数减少 19.8%，95%CI=-27.0%至-12.6%；3 项 RCT），并增加至少 50%癫痫发作减少的参与者数量（RR=1.76，95%CI=1.07-2.88；1 项 RCT）和腹泻（RR=2.25，95%CI=1.38-3.68；3 项 RCT）。死亡和癫痫持续状态发生率较低。