Department of Pediatrics, Peking University First Hospital, Beijing, China.
Epilepsia Open. 2023 Jun;8(2):268-277. doi: 10.1002/epi4.12703. Epub 2023 Mar 14.
This systematic review and meta-analysis aimed to evaluate the efficacy of vigabatrin (VGB) in treating infantile epileptic spasms syndrome (IESS). Databases of PubMed, Embase, Web of Science, MEDLINE, and Cochrane Library were systematically searched. All the relevant randomized controlled trials (RCTs) and observational studies (OSs) of VGB for IESS were included and analyzed separately. The primary outcome was the cessation of epileptic spasms (ES). Five RCTs and nine OSs compared the efficacy of VGB vs hormonal monotherapy for IESS. Meta-analysis of the five RCTs showed that hormonal monotherapy was significantly better than VGB monotherapy (OR = 0.37, 95% CI = 0.20-0.67) for patients with new-onset IESS. Meta-analysis of the nine OSs agrees with the result from RCTs (OR = 0.61, 95% CI = 0.43-0.85). VGB was more effective in patients with TSC than in those with other etiologies (five OSs, OR = 5.59, 95% CI = 2.17-14.41). There was no significant difference in the efficiency of VGB combined with hormonal therapy vs hormonal monotherapy for IESS (two RCTs, OR = 0.75, 95% CI = 0.09-6.45). Hormonal monotherapy is better than VGB monotherapy for non-TSC-associated IESS. But for patients with IESS due to TSC, VGB is the first choice. VGB combined with hormone therapy does not definitely increase ES control rates compared with that of hormonal monotherapy.
本系统评价和荟萃分析旨在评估氨己烯酸(VGB)治疗婴儿癫痫性痉挛综合征(IESS)的疗效。系统检索了 PubMed、Embase、Web of Science、MEDLINE 和 Cochrane Library 数据库。纳入并分别分析了所有关于 VGB 治疗 IESS 的随机对照试验(RCT)和观察性研究(OS)。主要结局是癫痫性痉挛(ES)的停止。五项 RCT 和九项 OS 比较了 VGB 与激素单药治疗 IESS 的疗效。五项 RCT 的荟萃分析表明,对于新诊断的 IESS 患者,激素单药治疗明显优于 VGB 单药治疗(OR=0.37,95%CI=0.20-0.67)。九项 OS 的荟萃分析与 RCT 结果一致(OR=0.61,95%CI=0.43-0.85)。VGB 对 TSC 患者比其他病因患者更有效(五项 OS,OR=5.59,95%CI=2.17-14.41)。VGB 联合激素治疗与激素单药治疗 IESS 的效率无显著差异(两项 RCT,OR=0.75,95%CI=0.09-6.45)。对于非 TSC 相关的 IESS,激素单药治疗优于 VGB 单药治疗。但对于由 TSC 引起的 IESS 患者,VGB 是首选药物。VGB 联合激素治疗并不一定比激素单药治疗更能提高 ES 控制率。