Division of Clinical Pharmacy, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.
Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Sci Rep. 2021 Dec 6;11(1):23462. doi: 10.1038/s41598-021-02770-6.
Despite the increased use of medical cannabinoids, the efficacy and safety of the treatment among children remain uncertain. The objective was to study the efficacy and safety of medical cannabinoids in children. The search included studies through 11-May-2020. Selection criteria included studies evaluating efficacy and safety outcomes of medical cannabinoids (tetrahydrocannabinol, cannabidiol and other cannabis derivatives) versus control in children, independently assessed by two reviewers. Eight studies were included, all of which are randomized controlled trials. Cannabidiol is associated with 50% reduction in seizures rate (Relative Risk (RR) = 1.69, 95% CI [1.20-2.36]) and caregiver global impression of change (Median Estimated difference = (- 1), 95%CI [- 1.39-(- 0.60)]) in Dravet syndrome, compared to placebo. While cannabidiol was associated with a reduction in reported seizure events (RR = 0.59, 95% CI [0.36-0.97]), no association was found in products contained also tetrahydrocannabinol (RR = 1.35, 95% CI [0.46-4.03]). Higher dose of cannabidiol was associated with decreased appetite (RR = 2.40, 95% CI [1.39-4.15]). A qualitative assessment suggests that medical cannabinoids might be associated with adverse mental events. In conclusion, cannabidiol is associated with clinical improvement in Dravet syndrome. However, cannabidiol is also associated with decreased appetite. Adverse mental events were reported as well, however, more research should be performed to assess well this outcome.
尽管医用大麻素的使用有所增加,但儿童使用该治疗方法的疗效和安全性仍不确定。目的是研究医用大麻素(四氢大麻酚、大麻二酚和其他大麻衍生物)在儿童中的疗效和安全性。检索包括截至 2020 年 5 月 11 日的研究。选择标准包括评估医用大麻素(四氢大麻酚、大麻二酚和其他大麻衍生物)与对照相比在儿童中的疗效和安全性结局的研究,由两名独立评审员评估。纳入了八项研究,均为随机对照试验。与安慰剂相比,在 Dravet 综合征中,大麻二酚可使癫痫发作率降低 50%(相对风险 (RR) = 1.69,95%置信区间 [1.20-2.36]),并使照顾者对变化的总体印象改善(中位数估计差值 = -1,95%CI [-1.39-(-0.60)])。虽然大麻二酚与报告的癫痫发作事件减少相关(RR = 0.59,95%CI [0.36-0.97]),但含四氢大麻酚的产品则无此关联(RR = 1.35,95%CI [0.46-4.03])。较高剂量的大麻二酚与食欲减退相关(RR = 2.40,95%CI [1.39-4.15])。定性评估表明,医用大麻素可能与不良精神事件相关。总之,大麻二酚与 Dravet 综合征的临床改善相关。然而,大麻二酚也与食欲减退相关。此外,还报告了不良精神事件,但需要进一步研究以评估这一结局。