De Santis Antonio, Villani Roberto, Sinisi Marco, Stocchetti Nino, Perucca Emilio
Institute of Neurosurgery, Policlinico IRCCS, University of Milan, Italy.
Epilepsia. 2002 Feb;43(2):175-82. doi: 10.1046/j.1528-1157.2002.24801.x.
To determine the potential effectiveness of phenytoin (PHT) in preventing early postoperative seizures in patients undergoing craniotomy for supratentorial brain tumors.
Two hundred patients requiring elective craniotomy for supratentorial brain tumors were randomized to two groups of equal size, with a prospective, open-label, controlled design. One group received PHT (18 mg/kg as an intravenous intraoperative load, followed by additional daily doses aimed at maintaining serum PHT concentrations within the 10- to 20-aeg/ml range) for 7 consecutive days. In the other group, PHT was not administered. More than 90% of patients in both groups continued to take preexisting anticonvulsant medication (AEDs) with carbamazepine or phenobarbital throughout the study. The primary efficacy end point was the number of patients remaining free from seizures during the 7-day period after the operation.
Of 100 patients allocated to PHT, 13 experienced seizures during the 7-day observation period, compared with 11 of 100 patients in the placebo group (p > 0.05). Most seizures occurred in the first day after surgery in both groups. There were no differences between groups in the proportion of patients experiencing more than one seizure, but there was a trend for generalized seizures to be more common in PHT-treated patients than in controls (11 vs. five patients, respectively). Status epilepticus occurred in one patient in the PHT group and in two patients in the control group. Of the 13 PHT-treated seizure patients, 11 had serum PHT concentrations within the target range, and only two had concentrations below range on the days their seizures occurred.
PHT, given at dosages producing serum concentrations within the target range, failed to prevent early postoperative seizures in patients treated with concomitant AEDs. Prophylactic administration of PHT cannot be recommended in these patients.
确定苯妥英（PHT）在预防幕上脑肿瘤开颅手术患者术后早期癫痫发作方面的潜在疗效。
200例需要接受幕上脑肿瘤择期开颅手术的患者被随机分为两组，每组人数相等，采用前瞻性、开放标签、对照设计。一组连续7天接受PHT（术中静脉注射负荷剂量18mg/kg，随后每日追加剂量以维持血清PHT浓度在10至20μg/ml范围内）。另一组未给予PHT。在整个研究过程中，两组中超过90%的患者继续服用先前使用的抗惊厥药物（AEDs），如卡马西平或苯巴比妥。主要疗效终点是术后7天内无癫痫发作的患者数量。
在分配到PHT组的100例患者中，有13例在7天观察期内发生癫痫发作，而安慰剂组100例患者中有11例发生癫痫发作（p>0.05）。两组中大多数癫痫发作均发生在术后第一天。两组中发作不止一次的患者比例无差异，但PHT治疗组全身性癫痫发作比对照组更常见（分别为11例和5例）。PHT组有1例患者发生癫痫持续状态。在13例接受PHT治疗的癫痫患者中，11例血清PHT浓度在目标范围内，只有2例在癫痫发作当天浓度低于目标范围。
给予能使血清浓度在目标范围内的剂量的PHT，未能预防接受AEDs治疗患者的术后早期癫痫发作。不建议在这些患者中预防性使用PHT。
