Zamani Gholamreza, Tavasoli Alireza, Zare-Shahabadi Ameneh, Rezaei Nima, Ahmadvand Alireza
Department of Pediatric Neurology.
Research Center for Immunodeficiencies, Pediatrics Center of Excellence, Children's Medical Center.
Iran J Pediatr. 2014 Feb;24(1):100-4. Epub 2014 Jan 26.
About one third of partial seizures are refractory to treatment. Several anticonvulsant drugs have entered the market in recent decades but concerns about intolerance, drug interactions, and the safety of the drug are notable. One of these new anticonvulsants is pregabalin, a safe drug with almost no interaction with other antiepileptic drugs.
In this open label clinical trial study, pregabalin was used for evaluation of its efficacy on reducing seizure frequency in 29 children suffering from refractory partial seizures. Average daily and weekly seizure frequency of the patients was recorded during a 6-week period (baseline period). Then, during a period of 2 weeks (titration period), pregabalin was started with a dose of 25-75 mg/d, using method of flexible dose, and was brought to maximum dose of drug that was intended in this study (450 mg/d) based on clinical response of the patients and seizure frequency. Then the patients were given the drug for 12 weeks and the average frequency of daily and weekly seizures were recorded again (treatment period). Findings : Reduction in seizure frequency in this study was 36% and the responder rate or number of patients who gained more than 50% reduction in seizure frequency was 51.7%.
This study showed that pregabalin can be used with safety and an acceptable efficacy in treatment of childhood refractory partial seizures.
约三分之一的部分性癫痫发作对治疗无效。近几十年来，几种抗惊厥药物已进入市场，但对不耐受、药物相互作用和药物安全性的担忧较为显著。这些新型抗惊厥药物之一是普瑞巴林，一种几乎不与其他抗癫痫药物相互作用的安全药物。
在这项开放标签临床试验研究中，普瑞巴林用于评估其对29名难治性部分性癫痫发作儿童降低癫痫发作频率的疗效。在6周期间（基线期）记录患者的平均每日和每周癫痫发作频率。然后，在2周期间（滴定期），采用灵活剂量法，以25 - 75mg/d的剂量开始使用普瑞巴林，并根据患者的临床反应和癫痫发作频率将药物剂量增至本研究预期的最大剂量（450mg/d）。然后给予患者药物治疗12周，并再次记录每日和每周癫痫发作的平均频率（治疗期）。结果：本研究中癫痫发作频率降低了36%，癫痫发作频率降低超过50%的缓解率或患者数量为51.7%。
本研究表明，普瑞巴林可安全且有效地用于治疗儿童难治性部分性癫痫发作。
