Casaer P
Department of Paediatrics, University Hospital Gasthuisberg, Leuven, Belgium.
Neuropediatrics. 1987 Nov;18(4):191-5. doi: 10.1055/s-2008-1052478.
Twelve children with alternating hemiplegia were treated with the calcium-entry blocker flunarizine for 4 months. All but one patient responded favourably with a reduction in frequency and/or duration and severity of attacks. Interictal symptoms decreased and mental development improved in several patients. Nine of the patients entered a subsequent double-blind placebo-controlled withdrawal study lasting another 4 months. Relapses were observed in part of the placebo as well as of the flunarizine-treated patients. The reason for this is not clear, since it is unlikely that the favourable response during the initial open-label study would be due to a placebo effect, or that tolerance to the drug had developed. Feed-back from the parents rather suggests that stress and tension, which were known trigger factors in a majority of these patients, played a role when the patient was switched to the double-blind treatment. Although the present study is not fully conclusive, apparently because of the use of an inadequate trial design, flunarizine, the first truly promising drug in this disease, deserves further study. An appeal is made to join another international double-blind study.
12例交替性偏瘫患儿接受了钙通道阻滞剂氟桂利嗪治疗4个月。除1例患者外，所有患者发作频率和/或持续时间及严重程度均有所减轻，反应良好。部分患者发作间期症状减轻，智力发育改善。其中9例患者随后进入了另一项为期4个月的双盲安慰剂对照撤药研究。安慰剂组和氟桂利嗪治疗组的部分患者均出现了复发。原因尚不清楚，因为在最初的开放标签研究中出现的良好反应不太可能是由于安慰剂效应，也不太可能是对药物产生了耐受性。家长的反馈表明，压力和紧张是这些患者中大多数已知的触发因素，在患者转为双盲治疗时起到了作用。尽管本研究由于试验设计不完善而并非完全具有结论性，但氟桂利嗪作为该疾病中首个真正有前景的药物，值得进一步研究。呼吁参与另一项国际双盲研究。
