■为了评估各种剂量的口服大麻二酚(CBD)治疗难治性癫痫适应症的比较疗效和安全性,从而为临床决策提供更多的信息证据。
■PubMed的文献检索,Embase,科克伦图书馆,和WebofScience(WoS)进行检索相关的随机对照试验(RCT),比较不同剂量的口服CBD与安慰剂或其他难治性癫痫适应症。从每个数据库开始到2023年1月3日,搜索都受到限制。用95%置信区间[CI]的相对危险度[RR]来表达结果。采用STATA/SE14进行网络荟萃分析。
■最终数据分析中包括6个RCT,涉及972名患者。网络荟萃分析表明,CBD10(10mg/kg/天)(RR:1.77,95CI:1.28至2.44),CBD20(20mg/kg/天)(RR:1.91,95CI:1.49至2.46),CBD25(25mg/kg/天)(RR:1.61,95CI:0.96至2.70),和CBD50(50mg/kg/天)(RR:1.78,95CI:1.07~2.94)与更高的抗癫痫疗效相关,尽管CBD25的合并结果仅接近显著.此外,就治疗紧急不良事件(TEAE)的风险而言,不同剂量间差异不显著。然而,CBD20在抗癫痫疗效方面排名第一,其次是CBD50、CBD10和CBD25。对于TEAE,CBD25排名第一,其次是CBD10、CBD50、CBD5和CBD20。
■对于难治性适应症,CBD20可能是抗癫痫疗效的最佳选择;然而,CBD25对于TEAE可能是最好的。因此,口服CBD应根据实际情况选择合适的剂量。由于符合条件的研究的局限性和有限的样本量,未来需要更多的研究来验证我们的发现.
UNASSIGNED: To evaluate the comparative efficacy and safety of various doses of oral cannabidiol (CBD) in treating refractory epilepsy indications, thus providing more informative evidence for clinical decision-making.
UNASSIGNED: A literature search of PubMed, Embase, the Cochrane library, and Web of Science (WoS) was performed to retrieve relevant randomized controlled trials (RCTs) that compared different doses of oral CBD with placebo or each other in refractory epilepsy indications. The search was limited from the inception of each database to January 3, 2023. Relative risk [RR] with a 95% confidence interval [CI] was used to express results. STATA/SE 14 was employed for network meta-analysis.
UNASSIGNED: Six RCTs involving 972 patients were included in the final data analysis. Network meta-analysis showed that, CBD10 (10 mg/kg/day) (RR: 1.77, 95%CI: 1.28 to 2.44), CBD20 (20 mg/kg/day) (RR: 1.91, 95%CI: 1.49 to 2.46), CBD25 (25 mg/kg/day) (RR: 1.61, 95%CI: 0.96 to 2.70), and CBD50 (50 mg/kg/day) (RR: 1.78, 95%CI: 1.07 to 2.94) were associated with higher antiseizure efficacy although the pooled result for CBD25 was only close to significant. In addition, in terms of the risk of treatment-emergent adverse events (TEAEs), the difference between different doses is not significant. However, CBD20 ranked first in terms of antiseizure efficacy, followed by CBD50, CBD10, and CBD25. For TEAEs, CBD25 ranked first, followed by CBD10, CBD50, CBD5, and CBD20.
UNASSIGNED: For refractory indications, CBD20 may be optimal option for antiseizure efficacy; however, CBD25 may be best for TEAEs. Therefore, an appropriate dose of oral CBD should be selected based on the actual situation. Due to the limitations of eligible studies and the limited sample size, more studies are needed in the future to validate our findings.