Meng Ying, Wu Jiahuan, Shi Jianxin, Weng Wenyu, Zhou Zhikun
Department of Pharmacology, Guangdong Medical University, Dongguan, Guangdong 523808, P.R. China.
Exp Ther Med. 2020 Dec;20(6):133. doi: 10.3892/etm.2020.9262. Epub 2020 Oct 2.
The present study aimed to compare the safety of brivaracetam (BRV) at various doses among patients with epilepsy through a network meta-analysis. Randomized controlled trials (RCTs) were retrieved from different databases, which were then pooled for a network analysis for calculating the odds ratios (ORs), together with the corresponding 95% confidence intervals (CIs) and surface under the cumulative ranking curve (SUCRA). A total of 9 RCTs were included in the final analysis. Compared with placebo, BRV at a dose of 50 mg daily led to a markedly increased risk of nervous system disorders (OR, 0.62; 95% CI, 0.43-0.90; P=0.01) and evidently increased the risk of psychiatric disorders (OR, 0.16; 95% CI, 0.04-0.64; P=0.022). However, BRV treatment was not associated with a statistically significant change in the prevalence of infectious diseases. SUCRA analysis suggested that treatment with BRV at 50 mg/day posed the highest risk of nervous system disorders and psychiatric disorders compared with placebo or other doses of BRV. In conclusion, BRV treatment at a dose of 50 mg/day may increase the risk of nervous system diseases and psychosis disorders compared with the placebo group. However, more high-quality clinical studies are warranted to validate these results.
本研究旨在通过网络荟萃分析比较不同剂量的布瓦西坦(BRV)在癫痫患者中的安全性。从不同数据库检索随机对照试验(RCT),然后将其汇总进行网络分析,以计算比值比(OR)以及相应的95%置信区间(CI)和累积排序曲线下面积(SUCRA)。最终分析共纳入9项RCT。与安慰剂相比,每日50 mg剂量的BRV导致神经系统疾病风险显著增加(OR,0.62;95%CI,0.43 - 0.90;P = 0.01),并明显增加精神疾病风险(OR,0.16;95%CI,0.04 - 0.64;P = 0.022)。然而,BRV治疗与传染病患病率的统计学显著变化无关。SUCRA分析表明,与安慰剂或其他剂量的BRV相比,每日50 mg的BRV治疗导致神经系统疾病和精神疾病的风险最高。总之,与安慰剂组相比,每日50 mg的BRV治疗可能增加神经系统疾病和精神疾病的风险。然而,需要更多高质量的临床研究来验证这些结果。