Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：低钠血症是奥卡西平治疗的一种有据可查的不良反应，但尚未进行临床试验以探索任何降低低钠血症发生率的干预措施.
方法：这项开放标签试验评估了在1-18岁接受奥卡西平单药治疗的儿童中，每日口服氯化钠补充1-2g/天，持续12周在降低低钠血症发生率方面的疗效。除了比较症状性低钠血症和严重低钠血症的发生率外，血清和尿钠水平，血清和尿液渗透压，行为和认知的变化，我们还比较了癫痫发作复发和需要额外抗癫痫药物(ASM)的参与者人数.
结果：共纳入120名儿童（每组60名）。干预组12周时的血清钠水平高于对照组（136.5±2.6vs135.4±2.5mEq/L，p=0.01)。干预组低钠血症患者例数明显减少(4/60vs14/60,p=0.01)。然而,有症状和严重低钠血症的发生率（0/60vs1/60，p=0.67），社会商数和儿童行为清单总分的变化（分别为0.6±0.8vs0.7±0.5，p=0.41和0.9±1.2vs1.1±0.9，p=0.30），突破性癫痫发作的患者人数（9/60vs10/60，p=0.89），两组中需要额外ASM的患者数量(8/60vs10/60,p=0.79)具有可比性.
结论：每日口服氯化钠补充剂在降低接受奥卡西平单药治疗的癫痫患儿低钠血症发生率方面是安全有效的。然而,补充氯化钠并不能显著降低更具临床意义的结局指标,如症状性低钠血症和严重低钠血症.试验登记处编号CTRI/2021/12/038388。
方法：这项开放标签试验评估了在1-18岁接受奥卡西平单药治疗的儿童中，每日口服氯化钠补充1-2g/天，持续12周在降低低钠血症发生率方面的疗效。除了比较症状性低钠血症和严重低钠血症的发生率外，血清和尿钠水平，血清和尿液渗透压，行为和认知的变化，我们还比较了癫痫发作复发和需要额外抗癫痫药物(ASM)的参与者人数.
结果：共纳入120名儿童（每组60名）。干预组12周时的血清钠水平高于对照组（136.5±2.6vs135.4±2.5mEq/L，p=0.01)。干预组低钠血症患者例数明显减少(4/60vs14/60,p=0.01)。然而,有症状和严重低钠血症的发生率（0/60vs1/60，p=0.67），社会商数和儿童行为清单总分的变化（分别为0.6±0.8vs0.7±0.5，p=0.41和0.9±1.2vs1.1±0.9，p=0.30），突破性癫痫发作的患者人数（9/60vs10/60，p=0.89），两组中需要额外ASM的患者数量(8/60vs10/60,p=0.79)具有可比性.
结论：每日口服氯化钠补充剂在降低接受奥卡西平单药治疗的癫痫患儿低钠血症发生率方面是安全有效的。然而,补充氯化钠并不能显著降低更具临床意义的结局指标,如症状性低钠血症和严重低钠血症.试验登记处编号CTRI/2021/12/038388。
