背景:本研究旨在评估BECTS患者抗癫痫药物(ASM)治疗的疗效和耐受性。方法:我们搜索了PubMed,科克伦图书馆,Embase,MEDLINE,WebofScience,中国国家知识基础设施(CNKI),万方数据,1990年1月1日至2021年9月1日,中国科技期刊数据库(VIP)进行随机对照研究。关于癫痫发作自由率的数据,严重不良事件导致的停药率,任何不良事件和脱落率,50%缓解率,脑电图恢复正常的患者比例,和认知功能的改善由两名作者独立提取。使用随机效应模型对汇集的数据进行荟萃分析。结果:共纳入27项评估9个ASM的研究,其中19例适用于荟萃分析。与Sulthiame(STM)相比,左乙拉西坦(LEV)与由于严重不良事件而退出治疗的可能性更高相关[RR=5.12,95%CI(1.19,22.01),I2=0.0%],经历任何不良事件[RR=5.12,95%CI(1.19,22.01)],并因任何原因退出[RR=3.17,95%CI(1.36,10.11)],而不影响癫痫发作自由率[RR=0.90,95%CI(0.75,1.06)]。LEV相对于卡马西平(CBZ)显着改善了认知能力,但对任何不良事件的比例[RR=0.62,95%CI(0.25,1.59)]和待标准化的EEG[RR=1.27,95%CI(0.94,1.71)]均无影响。比较丙戊酸(VPA)与LEV[RR=0.96,95%CI(0.57,1.61)]和奥卡西平(OXC)[RR=0.61,95%CI(0.31,1.20)]时,没有更高的缓解率。此外,与安慰剂相比,STM与EEG正常化的可能性更高[RR=4.61,95%CI(2.12,10.01)]。纳入的单项研究也为其他ASM在BECTS中的疗效和/或耐受性提供了一些证据,包括托吡酯,拉莫三嗪,Clobazam,还有氯硝西泮.纳入研究的偏倚风险通常较低或不清楚。结论:这项研究表明,在BECTS患者中使用ASM的疗效和耐受性存在一些差异。需要更多的随机对照试验(RCT)比较ASM与更大人群,以确定最佳的抗癫痫药物治疗,以指导临床医生。
Background: This study aimed to evaluate the efficacy and tolerability of Anti-Seizure medication (ASM) treatment in patients with BECTS. Method: We searched PubMed, Cochrane Library, Embase, MEDLINE, Web of Science, China National Knowledge Infrastructure (CNKI), WANFANG DATA, and China Science and Technology Journal Database (VIP) between 1 Jan 1990, and 1 Sep 2021, for randomized controlled studies. Data on seizure freedom rate, rate of treatment withdrawal due to serious adverse events, rate of any adverse events and dropout, 50% remission rate, the proportion of patients whose EEG to be normalized, and improvement in cognitive function were extracted by two authors independently. The pooled data were meta-analyzed using a random effects model. Results: A total of 27 studies evaluating 9 ASMs were included, 19 of which were suitable for meta-analysis. Compared with sulthiame (STM), levetiracetam (LEV) was associated with a higher probability of treatment withdrawal due to serious adverse events [RR = 5.12, 95% CI (1.19, 22.01), I 2 = 0.0%], experiencing any adverse events [RR = 5.12, 95% CI (1.19, 22.01)], and dropping out for any reason [RR = 3.17, 95% CI (1.36, 10.11)], while it did not affect the seizure freedom rate [RR = 0.90, 95% CI (0.75, 1.06)]. LEV significantly improved cognitive performance relative to carbamazepine (CBZ) but had no effect on the proportion of any adverse events [RR = 0.62, 95% CI (0.25, 1.59)] and EEG to be normalized [RR = 1.27, 95% CI (0.94, 1.71)]. There was no higher probability of a 50% remission rate when comparing valproic acid (VPA) to LEV [RR = 0.96, 95% CI (0.57, 1.61)] and oxcarbazepine (OXC) [RR = 0.61, 95% CI (0.31, 1.20)]. In addition, STM was related to a higher probability of EEG normalization than placebo [RR = 4.61, 95% CI (2.12, 10.01)]. The included single studies also provided some evidence for the efficacy and/or tolerability of other ASMs in BECTS, including topiramate, lamotrigine, clobazam, and clonazepam. The risk of bias of the included studies was frequently low or unclear. Conclusion: This study indicated some discrepancies in efficacy and tolerability among ASMs used in patients with BECTS. More randomized controlled trials (RCTs) comparing ASMs with larger populations are required to ascertain the optimum antiepileptic drug treatment to guide clinicians.