Motte J, Pedespan J M, Sevestre M, Chiron C
Service de pédiatrie A, American Memorial Hospital, CHU, 47, rue Cognac-Jay, 51092 Reims, France.
Arch Pediatr. 2005 Oct;12(10):1533-9. doi: 10.1016/j.arcped.2005.07.009. Epub 2005 Aug 11.
Sodium valproate (VPA) is an anti-epileptic drug which was until now administered to children as drinkable or injectable form. A new galenic form of this compound has been developed as microgranules with prolonged release (Micropakine)LP; MPK). This new galenic form of VPA allows a greater stability of the plasmatic rates, thus limiting the risk of amount-dependent adverse effects at the time of the peaks, and of less effectiveness at the time of the fall of the circulating rates. The main objective of this study was to evaluate the acceptability of the new galenic form of VPA, in monotherapy, for epileptic children with >or=3 years old. The evaluation was performed at day (D)90 by the patients using a hedonic visual scale. The secondary objectives were to evaluate the acceptability by the parents, the treatment compliance, the percentage of patients free of seizure at D 90, and the tolerance. Finally, the authors compared all these data to those recovered at the baseline in patients already treated by the previous drinkable VPA. A total of 307 patients were involved by 76 hospital neuropediatric physicians. The population was constituted by 110 children <5 years old and 197 children from 5 to 14 years old. MPK was well accepted for total population at D 90 (<5 years old: 83.3%; >or=5 years old: 80%). For patients previously treated by drinkable form of VPA (N=199), MPK was significantly better accepted than the drinkable form at D1 (<5 years, P=0.0189; >or=5 years, P<0.0001). Less difficulties were experienced by the parents to administrate MPK when compared to the drinkable form (P<0.001), mainly due to his neutral taste. Patients free of seizure at D 90 were 77% [70,3; 82,5]. Specially, fewer epileptic seizures were evidenced for all children previously treated at D1 by drinkable form of VPA. The treatment was well respected by the patients, which were compliant in 80% of the cases. The adherence to treatment was good since the treatment compliance was 87%. MPK was well tolerated.
MPK in the microgranule form significantly improves the treatment acceptability with a good tolerance. Two daily intakes and neutral taste are two major advantages to favour the compliance in children, thus contributing to the efficacy of the antiepileptic treatment.
丙戊酸钠（VPA）是一种抗癫痫药物，此前一直以可饮用或注射的形式给儿童使用。这种化合物的一种新剂型已被开发为缓释微颗粒（Micropakine LP；MPK）。VPA的这种新剂型能使血浆浓度更稳定，从而降低峰值时剂量依赖性不良反应的风险，以及循环浓度下降时疗效降低的风险。本研究的主要目的是评估VPA新剂型在单药治疗中对3岁及以上癫痫儿童的可接受性。在第90天由患者使用享乐视觉量表进行评估。次要目的是评估家长的可接受性、治疗依从性、第90天无癫痫发作患者的百分比以及耐受性。最后，作者将所有这些数据与之前接受可饮用VPA治疗的患者在基线时恢复的数据进行比较。76名医院神经儿科医生共纳入了307名患者。该人群由110名5岁以下儿童和197名5至14岁儿童组成。MPK在第90天被总体人群很好地接受（5岁以下：83.3%；5岁及以上：80%）。对于之前接受可饮用形式VPA治疗的患者（N = 199），MPK在第1天的接受度明显优于可饮用形式（5岁以下，P = 0.0189；5岁及以上，P < 0.0001）。与可饮用形式相比，家长在服用MPK时遇到的困难更少（P < 0.001），主要是因为其味道中性。第90天无癫痫发作的患者为77%[70.3；82.5]。特别是，所有之前在第1天接受可饮用形式VPA治疗的儿童癫痫发作次数更少。患者对治疗的依从性良好，80%的病例依从。由于治疗依从性为87%，治疗依从性良好。MPK耐受性良好。
微颗粒形式的MPK显著提高了治疗的可接受性且耐受性良好。每日两次服用和味道中性是有利于儿童依从性的两个主要优点，从而有助于抗癫痫治疗的疗效。
