BACKGROUND Dravet syndrome (DS) is one of the most severe forms of drug-resistant epilepsy and available interventions fail to control seizures in most patients. Cannabidiol (CBD) is the first in a new class of antiepileptic drugs with a distinctive chemical structure and mechanism of action. OBJECTIVE The aim of this systematic review was to evaluate the efficacy and safety of CBD as adjunctive treatment for seizures in patients with DS using meta-analytical techniques. METHODS We searched for randomized, placebo-controlled, single- or double-blinded trials. Main outcomes included ≥ 50% reduction in baseline convulsive seizure frequency and the incidence of treatment withdrawal and adverse events (AEs). Risk ratios (RRs) with 95% confidence intervals (95% CIs) were estimated through the inverse variance method. RESULTS Three trials were included involving 359 participants, 228 for CBD and 131 for placebo groups. In all trials, the active treatment was a plant-derived pharmaceutical formulation of purified CBD oral solution. The pooled RR for 50% response during the treatment was 1.69 (95% CI 1.21-2.36; p = 0.002). Across the trials, treatment was discontinued in 20 (9.0%) and 3 (2.3%) cases in the add-on CBD and placebo groups, respectively; the RR for CBD withdrawal was 3.12 (95% CI 1.07-9.10; p = 0.037). The RR to develop any AE during add-on CBD treatment was 1.06 (95% CI 0.87-1.28; p = 0.561). AEs significantly associated with adjunctive CBD were somnolence, decreased appetite, diarrhea, and increased serum aminotransferases. CONCLUSIONS Adjunctive CBD resulted in a greater reduction in convulsive seizure frequency than placebo and a higher rate of AEs in patients with DS presenting with seizures uncontrolled by concomitant antiepileptic therapy.

中文翻译：

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Dravet综合征患者中的辅助卡纳比多二醇：疗效和安全性的系统评价和荟萃分析。

背景技术Dravet综合征（DS）是耐药性癫痫的最严重形式之一，可用的干预措施无法控制大多数患者的癫痫发作。卡纳比多醇（CBD）是新型抗癫痫药中的第一种，具有独特的化学结构和作用机理。目的本系统评价的目的是使用荟萃分析技术评估CBD作为DS治疗癫痫发作的辅助治疗的有效性和安全性。方法我们搜索了随机，安慰剂对照，单盲或双盲试验。主要结局包括基线惊厥发作频率减少≥50％以及停药和不良事件（AE）发生率。通过逆方差方法估算了具有95％置信区间（95％CI）的风险比（RRs）。结果纳入了三项试验，涉及359名参与者，其中CBD 228名，安慰剂组131名。在所有试验中，主动治疗是纯化的CBD口服溶液的植物来源药物制剂。治疗期间50％反应的合并RR为1.69（95％CI 1.21-2.36； p = 0.002）。在所有试验中，附加CBD组和安慰剂组分别终止治疗20例（9.0％）和3例（2.3％）；CBD撤出的RR为3.12（95％CI 1.07-9.10； p = 0.037）。在附加CBD治疗期间发生任何AE的RR为1.06（95％CI 0.87-1.28; p = 0.561）。与辅助CBD显着相关的AE是嗜睡，食欲下降，腹泻和血清转氨酶升高。