A randomized, controlled trial of surgery for temporal-lobe epilepsy
A randomized, controlled trial of surgery for temporal-lobe epilepsy
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DOI：
10.1056/nejm200108023450501
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发表时间：
2001-08-02
影响因子：
158.5
通讯作者：
Eliasziw, M
中科院分区：
文献类型：
--
作者：
Wiebe, S;Blume, WT;Eliasziw, M
背景资料：由于设计和实施可行性研究的困难，尚未进行癫痫手术的随机试验。由于缺乏支持手术治疗有效性的数据，因此无法对癫痫患者提出强有力的建议。我们进行了一项随机对照试验，以评估手术治疗颞叶癫痫的有效性和安全性。方法：80例颞叶癫痫患者随机分为手术组（40例）和抗癫痫药物治疗组（40例）。最佳的药物治疗和主要结果由不知道患者治疗分配的癫痫病学家进行评估。主要结果是没有癫痫发作，损害了自我和周围环境的意识。次要结局是癫痫发作的频率和严重程度、生活质量、残疾和死亡。结果：1年时，无癫痫发作损害意识的患者的累积比例在手术组为58%，在药物组为8%（P
Background: Randomized trials of surgery for epilepsy have not been conducted, because of the difficulties involved in designing and implementing feasible studies. The lack of data supporting the therapeutic usefulness of surgery precludes making strong recommendations for patients with epilepsy. We conducted a randomized, controlled trial to assess the efficacy and safety of surgery for temporal-lobe epilepsy.Methods: Eighty patients with temporal-lobe epilepsy were randomly assigned to surgery (40 patients) or treatment with antiepileptic drugs for one year (40 patients). Optimal medical therapy and primary outcomes were assessed by epileptologists who were unaware of the patients' treatment assignments. The primary outcome was freedom from seizures that impair awareness of self and surroundings. Secondary outcomes were the frequency and severity of seizures, the quality of life, disability, and death.Results: At one year, the cumulative proportion of patients who were free of seizures impairing awareness was 58 percent in the surgical group and 8 percent in the medical group (P