Efikasi dan Keamanan Terapi Adjuvan Obat Antikonvulsan untuk Anak dengan Sindrom Dravet: Analisis Perbandingan Menggunakan Network Meta-Analysis.

Abstract

Dravet syndrome (DS) is a rare, severe epileptic encephalopathy with treatment resistant seizures, requiring adjunctive anticonvulsant therapy despite limited comparative evidence on efficacy and safety. This study aimed to systematically compare and rank the efficacy and safety of commonly used adjunctive anticonvulsant therapies in pediatric patients with DS using a network meta analysis (NMA). Randomized controlled trials evaluating stiripentol (STP), cannabidiol (CBD), and fenfluramine (FFA) were included. The primary efficacy outcome was the proportion of patients achieving a lebih dari sama dengan 50% reduction in convulsive seizure frequency. Treatment ranking was assessed using p-scores, reflecting the probability of each intervention being among the most effective options within the network. The analysis demonstrated that low-dose fenfluramine combined with stiripentol achieved the highest p-score, indicating the greatest probability of superior efficacy compared with other interventions. Stiripentol monotherapy and high-dose fenfluramine also showed high p-scores, suggesting consistently strong efficacy. In contrast, both low- and high-dose cannabidiol ranked lower, reflecting a reduced probability of achieving the primary efficacy outcome. Placebo consistently occupied the lowest rank, as expected. Safety outcomes indicated more favorable rankings for placebo and lower-dose regimens, while stiripentol-containing regimens were associated with a higher probability of adverse events, particularly somnolence. Overall, this NMA indicates that fenfluramine-based regimens especially when combined with stiripentol have the highest probability of achieving clinically meaningful seizure reduction in children with DS. However safety profiles should be carefully considered when selecting adjunctive therapy.