Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
Department of Microbiology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
Epilepsy Behav. 2024 Sep;158:109939. doi: 10.1016/j.yebeh.2024.109939. Epub 2024 Jul 12.
Hyponatremia is a well-documented adverse effect of oxcarbazepine treatment, but no clinical trial has yet been conducted to explore any intervention for reducing the incidence of hyponatremia.
This open-label trial evaluated the efficacy of add-on daily oral sodium chloride supplementation of 1-2 g/day for 12 weeks in reducing the incidence of hyponatremia in children receiving oxcarbazepine monotherapy aged 1-18 years. Apart from comparing the incidence of symptomatic and severe hyponatremia, serum and urine sodium levels, serum and urine osmolality, changes in behavior and cognition, and the number of participants with recurrence of seizures and requiring additional antiseizure medication (ASM) were also compared.
A total of 120 children (60 in each group) were enrolled. The serum sodium level at 12 weeks in the intervention group was higher than that of the control group (136.5 ± 2.6 vs 135.4 ± 2.5 mEq/L, p = 0.01). The number of patients with hyponatremia was significantly lower in the intervention group (4/60vs14/60, p = 0.01). However, the incidence of symptomatic and severe hyponatremia (0/60vs1/60, p = 0.67 for both), changes in social quotient and child behavior checklist total score (0.6 ± 0.8 vs 0.7 ± 0.5, p = 0.41 and 0.9 ± 1.2 vs 1.1 ± 0.9, p = 0.30 respectively), the number of patients with breakthrough seizures (9/60vs10/60, p = 0.89), and the number of patients requiring additional ASMs (8/60vs10/60, p = 0.79) were comparable in both groups.
Daily oral sodium chloride supplementation is safe and efficacious in reducing the incidence of hyponatremia in children with epilepsy receiving oxcarbazepine monotherapy. However, sodium chloride supplementation does not significantly reduce more clinically meaningful outcome measures like symptomatic and severe hyponatremia. Trial registry No. CTRI/2021/12/038388.
低钠血症是奥卡西平治疗的一种已被充分记录的不良反应，但尚未进行临床试验来探索任何降低低钠血症发生率的干预措施。
这项开放性试验评估了在接受奥卡西平单药治疗的 1-18 岁儿童中，每日口服补充 1-2g 氯化钠 12 周，以降低低钠血症发生率的效果。除了比较症状性和严重低钠血症的发生率外，还比较了血清和尿液钠水平、血清和尿液渗透压、行为和认知变化，以及复发癫痫和需要额外抗癫痫药物（ASM）的参与者人数。
共纳入 120 名儿童（每组 60 名）。干预组在 12 周时的血清钠水平高于对照组（136.5±2.6 与 135.4±2.5mEq/L，p=0.01）。干预组低钠血症患者人数明显较少（4/60 与 14/60，p=0.01）。然而，症状性和严重低钠血症的发生率（0/60 与 1/60，两者均为 p=0.67）、社会商数和儿童行为检查表总分的变化（0.6±0.8 与 0.7±0.5，p=0.41 和 0.9±1.2 与 1.1±0.9，p=0.30）、突破性癫痫发作患者人数（9/60 与 10/60，p=0.89）和需要额外 ASM 的患者人数（8/60 与 10/60，p=0.79）在两组之间无差异。
在接受奥卡西平单药治疗的癫痫儿童中，每日口服补充氯化钠既安全又有效，可降低低钠血症的发生率。然而，氯化钠补充并不能显著降低更具临床意义的结局指标，如症状性和严重低钠血症。试验注册号：CTRI/2021/12/038388。
