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首页> 外文期刊>The Canadian Journal of Neurological Sciences: le Journal Canadien des Sciences Neurologiques >Prophylactic anticonvulsants in patients with brain tumour.
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Prophylactic anticonvulsants in patients with brain tumour.

机译：脑肿瘤患者的预防性抗惊厥药。

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OBJECTIVE: We conducted a clinical trial to determine if prophylactic anticonvulsants in brain tumour patients (without prior seizures) reduced seizure frequency. We stopped accrual at 100 patients on the basis of the interim analysis. METHODS: One hundred newly diagnosed brain tumour patients received anticonvulsants (AC Group) or not (No AC Group) in this prospective randomized unblinded study. Sixty patients had metastatic, and 40 had primary brain tumours. Forty-six (46%) patients were randomized to the AC Group and 54 (54%) to the No AC Group. Median follow-up was 5.44 months (range 0.13-30.1 months). RESULTS: Seizures occurred in 26 (26%) patients, eleven in the AC Group and 15 in the No AC Group. Seizure-free survivals were not different; at three months 87% of the AC Group and 90% of the No AC Group were seizure-free (log rank test, p = 0.98). Seventy patients died (unrelated to seizures) and survival rates were equivalent in both groups (median survival = 6.8 months versus 5.6 months, respectively; log rank test, p = 0.50). We then terminated accrual at 100 patients because seizure and survival rates were much lower than expected; we would need > or = 900 patients to have a suitably powered study. CONCLUSIONS: These data should be used by individuals contemplating a clinical trial to determine if prophylactic anticonvulsants are effective in subsets of brain tumour patients (e.g. only anaplastic astrocytomas). When taken together with the results of a similar randomized trial, prophylactic anticonvulsants are unlikely to be effective or useful in brain tumour patients who have not had a seizure.
机译：目的：我们进行了一项临床试验，以确定脑肿瘤患者（无先前发作）的预防性抗惊厥药是否可降低癫痫发作频率。根据中期分析，我们停止了100名患者的应计费用。方法：在这项前瞻性随机无盲研究中，一百名新诊断的脑肿瘤患者接受了抗惊厥药（AC组）或未接受抗惊厥药（No AC组）。 60名患者发生转移，其中40名患有原发性脑肿瘤。四十六（46％）位患者被随机分为AC组，而54位（54％）患者被分为No AC组。中位随访时间为5.44个月（范围0.13-30.1个月）。结果：癫痫发作发生在26（26％）例患者中，AC组为11例，No AC组为15例。无癫痫的生存率没有不同。在三个月时，AC组的87％和No AC组的90％均无癫痫发作（对数秩检验，p = 0.98）。两组有70名患者死亡（与癫痫发作无关），两组的存活率相同（中位生存期分别为6.8个月和5.6个月;对数秩检验，p = 0.50）。然后我们终止了100例患者的应计，因为癫痫发作和生存率远低于预期。我们将需要>或= 900名患者进行适当的研究。结论：打算进行临床试验的个人应使用这些数据来确定预防性抗惊厥药在脑肿瘤患者的亚群中是否有效（例如，仅间变性星形细胞瘤）。与类似的随机试验结果一起使用时，预防性抗惊厥药在没有癫痫发作的脑肿瘤患者中不太可能有效或有用。

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