Abstract：
OBJECTIVE: Despite many new ASM, the rate of patients with drug-resistant epilepsy (DRE) has not changed. Cenobamate (CNB) is a novel ASM for the treatment of focal-onset seizures in adults with high seizure freedom rates in randomized controlled trials (RCT). Although CNB appears to be effective, it is not commonly prescribed to patients with DRE, resulting in a lack of \"real-world data\".
METHODS: To evaluate the real-world effect of CNB and to assess the generalizability of RCT data, a systematic review and meta-analysis was conducted. Pooled proportions were calculated using a random intercept logistic regression model.
RESULTS: The analysis included seven studies with a total of 229 patients with DRE, 77.3 % of whom were adults and 91.5 % had focal-onset seizures. Seizure reduction >50 % was achieved in 68 % of patients [54.54; 79.07], with seizure freedom in 16.2 % [8.38; 28.97]. There was no difference between pediatric and adult patients. CNB was discontinued in 10 % [6.74; 14.6] of patients, mostly due to lack of efficacy (39 %) or adverse effects (AE, 43 %). AE, observed in 57.3 % [39.7; 73.2] of patients, included fatigue and vertigo. A comparison of the rates calculated in this meta-analysis to the active arm of equivalent RCTs revealed no significant difference.
CONCLUSIONS: CNB achieves a good treatment response in patients with DRE in real-world settings, like the effect reported in RCTs. The high heterogeneity between studies calls for studies focusing on specific DRE subpopulations.
METHODS: To evaluate the real-world effect of CNB and to assess the generalizability of RCT data, a systematic review and meta-analysis was conducted. Pooled proportions were calculated using a random intercept logistic regression model.
RESULTS: The analysis included seven studies with a total of 229 patients with DRE, 77.3 % of whom were adults and 91.5 % had focal-onset seizures. Seizure reduction >50 % was achieved in 68 % of patients [54.54; 79.07], with seizure freedom in 16.2 % [8.38; 28.97]. There was no difference between pediatric and adult patients. CNB was discontinued in 10 % [6.74; 14.6] of patients, mostly due to lack of efficacy (39 %) or adverse effects (AE, 43 %). AE, observed in 57.3 % [39.7; 73.2] of patients, included fatigue and vertigo. A comparison of the rates calculated in this meta-analysis to the active arm of equivalent RCTs revealed no significant difference.
CONCLUSIONS: CNB achieves a good treatment response in patients with DRE in real-world settings, like the effect reported in RCTs. The high heterogeneity between studies calls for studies focusing on specific DRE subpopulations.
摘要：
目标：尽管有许多新的ASM，耐药癫痫(DRE)患者的发病率没有变化.Cenobamate（CNB）是一种新型的ASM，用于在随机对照试验（RCT）中治疗高癫痫发作自由率的成人局灶性发作性癫痫发作。尽管CNB似乎有效，它不常用于DRE患者，导致缺乏“真实世界数据”。
方法：为了评估CNB的现实世界效果并评估RCT数据的概括性，我们进行了系统评价和荟萃分析.使用随机截距逻辑回归模型计算集合比例。
结果：分析包括7项研究，共229例DRE患者，其中77.3%为成年人，91.5%为局灶性发作性癫痫发作。68%的患者癫痫发作减少>50%[54.54;79.07]，癫痫发作自由度为16.2%[8.38；28.97]。儿童和成人患者之间没有差异。10%[6.74;14.6]的患者停止了CNB，主要是由于缺乏疗效（39%）或不良反应（AE，43%）。AE,在57.3%[39.7;73.2]的患者中观察到，包括疲劳和眩晕。在此荟萃分析中计算的比率与等效RCT的活动臂的比较没有显着差异。
结论：CNB在现实环境中对DRE患者具有良好的治疗反应，就像RCT中报道的效果一样。研究之间的高度异质性要求研究侧重于特定的DRE亚群。
方法：为了评估CNB的现实世界效果并评估RCT数据的概括性，我们进行了系统评价和荟萃分析.使用随机截距逻辑回归模型计算集合比例。
结果：分析包括7项研究，共229例DRE患者，其中77.3%为成年人，91.5%为局灶性发作性癫痫发作。68%的患者癫痫发作减少>50%[54.54;79.07]，癫痫发作自由度为16.2%[8.38；28.97]。儿童和成人患者之间没有差异。10%[6.74;14.6]的患者停止了CNB，主要是由于缺乏疗效（39%）或不良反应（AE，43%）。AE,在57.3%[39.7;73.2]的患者中观察到，包括疲劳和眩晕。在此荟萃分析中计算的比率与等效RCT的活动臂的比较没有显着差异。
结论：CNB在现实环境中对DRE患者具有良好的治疗反应，就像RCT中报道的效果一样。研究之间的高度异质性要求研究侧重于特定的DRE亚群。
