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.
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。