癫痫是最常见的慢性脑部疾病之一。几乎三分之一的患者患有耐药性癫痫(DRE)。大麻二酚被认为是治疗DRE的潜在新药。
■探讨大麻二酚治疗DRE的长期疗效和安全性,以及不同特征患者在大麻二酚治疗中的差异。
■系统评价和荟萃分析。
■Medline,Embase,和CENTRAL进行了文献搜索。使用RevMan5.4进行荟萃分析。以意向治疗集和随机效应为主要分析。根据年龄进行亚组分析,剂量,伴随的抗癫痫药物(ASM),癫痫综合征,和研究设计。
■本系统综述包括50项研究。总共收集了4791名参与者。在12-,24-,48-,72-,96-,144周为0.40[0.36,0.45],0.39[0.34,0.44],0.37[0.30,0.44],0.27[0.17,0.37],0.22[0.14,0.30],和0.38[0.23,0.53]。无癫痫发作率为0.04[0.03,0.06],0.04[0.03,0.05],0.03[0.02,0.05],0.03[0.02,0.03],0.02[0.01,0.03],和0.04[0.01,0.06]。不良事件的比例为0.72[0.61,0.83],0.62[0.42,0.81],0.60[0.41,0.79],0.35[0.14,0.56],0.83[0.75,0.90],和0.96[0.94,0.99]。汇集的12-,24-,48-,96-,144周严重不良事件的比例为0.15[0.09,0.21],0.23[0.14,0.31],0.10[0.06,0.15],0.31[0.24,0.38],和0.40[0.35,0.45]。亚组分析表明,年龄亚组和癫痫综合征亚组之间的疗效和安全性没有显着差异。在大多数时期,剂量亚组和伴随ASM之间的疗效没有显着差异。但是,更高的剂量和更多的伴随ASM与更高的不良事件比例相关.
■大麻二酚治疗DRE疗效稳定,早期不良反应少。长期使用可能会降低疗效和增加不良事件。剂量递增可能不会增加疗效,但可能会增加不良事件。此外,使用大麻二酚可能会减少其他ASM的剂量,而不会降低疗效,从而减少不良影响。大麻二酚在各种癫痫综合征中可能具有相似的作用。
■PROSPERO(CRD42022351250)。
UNASSIGNED: Epilepsy is one of the most common chronic brain diseases. Almost one-third of patients have drug-resistant epilepsy (DRE). Cannabidiol is being considered as a potential novel drug for treating DRE.
UNASSIGNED: To investigate long-term efficacy and safety of cannabidiol in treatment of DRE and the differences in cannabidiol treatment among patients with different characteristics.
UNASSIGNED: Systematic
review and meta-analysis.
UNASSIGNED: Medline, Embase, and CENTRAL were searched for literature. RevMan5.4 was used for meta-analysis. The Intention-to-treat set and the random effect were used as the main analysis. Subgroup analyses were performed according to age, dose, concomitant antiseizure medications (ASMs), epilepsy syndromes, and study designs.
UNASSIGNED: Fifty studies were included in this systematic
review. A total of 4791 participants were collected. The responder rates (seizure frequency reduced at least 50%) at 12-, 24-, 48-, 72-, 96-, and 144-week were 0.40 [0.36, 0.45], 0.39 [0.34, 0.44], 0.37 [0.30, 0.44], 0.27 [0.17, 0.37], 0.22 [0.14, 0.30], and 0.38 [0.23, 0.53]. Seizure-free rates were 0.04 [0.03, 0.06], 0.04 [0.03, 0.05], 0.03 [0.02, 0.05], 0.03 [0.02, 0.03], 0.02 [0.01, 0.03], and 0.04 [0.01, 0.06]. Proportion of adverse events were 0.72 [0.61, 0.83], 0.62 [0.42, 0.81], 0.60 [0.41, 0.79], 0.35 [0.14, 0.56], 0.83 [0.75, 0.90], and 0.96 [0.94, 0.99]. The pooled 12-, 24-, 48-, 96-, and 144-week proportion of serious adverse events were 0.15 [0.09, 0.21], 0.23 [0.14, 0.31], 0.10 [0.06, 0.15], 0.31 [0.24, 0.38], and 0.40 [0.35, 0.45]. Subgroup analyses showed that there was no significant difference on efficacy and safety among age subgroups and epilepsy syndromes subgroups. For most periods, there were no significant difference on efficacy among subgroups of dose and concomitant ASMs. However, higher doses and more concomitant ASMs were associated with higher proportion of adverse events.
UNASSIGNED: Cannabidiol treatment of DRE has stable efficacy and fewer adverse events in early period. Long-term use may have decreased efficacy and increased adverse events. Dose escalation may not increase efficacy, but may increase adverse events. Furthermore, cannabidiol use may reduce dosage of other ASMs without reducing efficacy, thereby reducing adverse effects. Cannabidiol may have similar effects in various epilepsy syndromes.
UNASSIGNED: PROSPERO (CRD42022351250).