Side effects and mortality associated with use of phenytoin for early posttraumatic seizure prophylaxis
Side effects and mortality associated with use of phenytoin for early posttraumatic seizure prophylaxis
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DOI：
10.3171/jns.1999.91.4.0588
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发表时间：
1999-10-01
影响因子：
4.1
通讯作者：
Winn, HR
中科院分区：
文献类型：
--
作者：
Haltiner, AM;Newell, DW;Winn, HR
物体。本研究的目的是确定使用苯妥英钠预防颅脑损伤后早期创伤后癫痫发作是否与显著的不良反应相关，并确定使用苯妥英钠后早期创伤后癫痫发作的减少是否与颅脑损伤患者死亡率的变化有关。作者对一项前瞻性双盲安慰剂对照研究中获得的数据进行了二次分析，这些患者被随机分配到接受苯妥英钠或安慰剂预防早期和晚期创伤后癫痫发作的患者中。然而，在治疗的前两周，药物不良反应的发生率很低，并且在治疗组和安慰剂组之间没有显著差异。在治疗的第一周，苯妥英组有0.6%的患者发生过敏反应，而安慰剂组为0%(p=1.0)，苯妥英组为2.5%，安慰剂组为0%(p=0.12)。两组的死亡率也是相似的。虽然癫痫患者的死亡率较高，但这一增加与这些患者在原始创伤时遭受的更严重的伤害有关。本研究结果表明，预防性应用苯妥英钠1-2周可有效降低创伤后早期癫痫的发生率，且不会明显增加与药物有关的副作用。然而，在第一周内创伤后癫痫发作的减少与死亡率的降低无关。
Object. The goals of this study were to determine if the use of phenytoin to prevent early posttraumatic seizures following head injury was associated with significant adverse side effects and also to determine if the reduction in early posttraumatic seizures after phenytoin administration was associated with a change in mortality rates in head-injured patients.Methods. The authors performed a secondary analysis of the data obtained in a prospective double-blind placebo-controlled study of 404 patients who were randomly assigned to receive phenytoin or placebo for the prevention of early and late posttraumatic seizures. The incidence of adverse drug effects during the first 2 weeks of treatment, however, was low and not significantly different between the treated and placebo groups. Hypersensitivity reactions occurred in 0.6% of the patients in the phenytoin-treated group compared with 0% in the placebo group (p = 1.0) during week I, and in 2.5% of phenytoin-treated compared with 0% of placebo-treated patients (p = 0.12) far the first 2 weeks of treatment. Mortality rates were also similar in both groups. Although the mortality rate was higher in patients who developed seizures, this increase was related to the greater severity of the injuries sustained by these patients at the time of the original trauma.Conclusions. The results of this study indicate that the incidence of early posttraumatic seizure can be effectively reduced by prophylactic administration of phenytoin far 1 or 2 weeks without a significant increase in drug-related side effects. Reduction in posttraumatic seizure during the Ist week, however, was not associated with a reduction in the mortality rate.