Department of Pediatrics, University of Chieti, Italy.
Acta Neurol Scand. 2012 Mar;125(3):e14-8. doi: 10.1111/j.1600-0404.2011.01568.x. Epub 2011 Jun 28.
A new modified-release (MR) granule formulation of valproate (VPA) has been recently developed for the treatment of children with epilepsy. It consists of tasteless microspheres that can be sprinkled on soft foods and easily swallowed. There are no data on the effectiveness of this formulation in pediatric age.
To evaluate the effects of the abrupt switch from solution to VPA MR granules in children undergoing chronic treatment.
We enrolled children receiving VPA solution as sole or adjunctive therapy and switched them to MR granules at identical dosages. VPA blood level, treatment efficacy (clinical and EEG data), tolerability (adverse reactions), palatability, ease of administration, and compliance were evaluated before switching (T0) and after 4 weeks (T1).
Out of 112 enrolled children, 108 (96.4%) completed the evaluation. We observed no significant differences between the patients at T0 and T1 in VPA blood levels, treatment efficacy, tolerability, and compliance. MR granules were judged more palatable (P < 0.05) and easier to administer (P < 0.05) than solution by children and parents. At 6-month follow-up, all patients continued to use MR granules.
Modified-release granule formulation of VPA may be a reliable alternative to solution for its convenience of use.
最近开发了一种新的丙戊酸钠（VPA）控释颗粒制剂，用于治疗癫痫儿童。它由无味的微球组成，可以撒在软食上，易于吞咽。目前尚无关于这种制剂在儿科年龄组有效性的数据。
评估在接受慢性治疗的儿童中，从溶液到 VPA 控释颗粒的突然转换的效果。
我们招募了正在接受 VPA 溶液作为单一或辅助治疗的儿童，并以相同的剂量将他们转换为控释颗粒。在转换前（T0）和 4 周后（T1）评估 VPA 血药浓度、治疗效果（临床和 EEG 数据）、耐受性（不良反应）、可接受性（口感）、给药的便利性和依从性。
在 112 名入组的儿童中，有 108 名（96.4%）完成了评估。我们发现 T0 和 T1 时 VPA 血药浓度、治疗效果、耐受性和依从性在患者之间没有显著差异。与溶液相比，控释颗粒制剂被儿童和家长认为更可口（P < 0.05）和更易于给药（P < 0.05）。在 6 个月的随访中，所有患者继续使用控释颗粒。
VPA 控释颗粒制剂可能是溶液的可靠替代品，因其使用方便。
