TY - T1的大麻二酚(CBD)的治疗效果和不良事件(AEs)在Lennox-Gastaut综合症患者(LGS):汇集从2试验结果(S19.006) JF -神经学乔-神经学六世- 90 - 15补充SP - S19.006盟伊莱恩·c·Wirrell AU -迈克尔Privitera AU -巴瑟尔哈里盟-马修·h·王盟——j·海伦十字盟——肯首页尼斯·萨默维尔Y1 - 2018/04/10 UR - //www.ez-admanager.com/content/90/15_Supplement/S19.006.abstract N2 -目的:评估发作减少通过四周的间隔和AEs CBD-treated患者的发病时间和分辨率。背景:随机、多中心、双盲、安慰剂对照试验(GWPCARE 3 (NCT02224560);GWPCARE 4 [NCT02224690])已经证明的有效性和安全性插件CBD治疗难治性LGS患者。汇集这些试验的数据进行了分析。设计/方法患者随机安慰剂或制药配方纯化CBD(100毫克/毫升)的口服溶液,给10毫克/公斤/天(CBD10)或20毫克/公斤/天(CBD20) 2同样/剂量,用滴定时间2周后12周保养周期(治疗期)。结果:共有396名患者被随机分配(73 CBD10;162 CBD20;161安慰剂)。平均年龄是15年(≥18年32%)。从基线值变化百分比drop-seizure频率CBD10和CBD20与安慰剂治疗期间是37%,43%和20%,40%和48%比20%维护期间;减少每四周比安慰剂更对CBD的保养周期间隔。CBD比安慰剂患者中断治疗由于AEs (CBD10: 2%; CBD20: 11%; placebo: 1%). AE onset was more common during titration vs. maintenance; 48% (CBD10), 57% (CBD20), and 45% (placebo) of patients had AEs that resolved during the study (most ≤4 weeks of onset) and 36% (CBD10), 33% (CBD20), and 26% (placebo) had ongoing AEs at last visit. Elevated transaminases (>3× ULN) were reported in 3 CBD10, 31 CBD20, and 1 placebo patient, most of whom were on concomitant valproic acid; all elevations resolved spontaneously, with CBD discontinuation, or with CBD/AED dose adjustment.Conclusions: Greater reductions in drop and total seizures were observed with CBD vs. placebo during each 4-week interval of the 12-week dose-maintenance period. AE onset was more common during titration vs. maintenance and the majority resolved during the study.Study Supported by: GW Research LtdDisclosure: Dr. Wirrell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion, Biomarin. Dr. Privitera has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Astellas DSMB; Upsher Smith DSMB. Dr. Privitera has received research support from UCB; GW/Greenwich; Sage. Dr. Bhathal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with UCB, BIAL. Dr. Wong has nothing to disclose. Dr. Cross has nothing to disclose. Dr. Sommerville has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Greenwich Biosciences. Dr. Sommerville holds stock and/or stock options in Greenwich Biosciences, which sponsored research in which Dr. Sommerville was involved as an investigator. Dr. Sommerville holds stock and/or stock options in Johnson and Johnson. ER -