Browne T R, Mattson R H, Penry J K, Smith D B, Treiman D M, Wilder B J, Ben-Menachem E, McBride R G, Sherry K M
Department of Neurology, Boston University School of Medicine, MA.
Neurology. 1991 Mar;41(3):363-4. doi: 10.1212/wnl.41.3.363.
We followed 66 patients with refractory complex partial seizures and a favorable initial response to vigabatrin for 5 to 72 (median, 43) months. Thirty-seven patients discontinued vigabatrin for the following reasons: benefit-to-risk evaluation, 8; seizure breakthrough, 6; adverse events, 6; seizure breakthrough and adverse events, 5; moved or lost, 4; no longer eligible for study, 2; non-drug-related death, 2; narcotic abuse, 1; and patient request, three. There were no clinically significant abnormalities in laboratory studies including SMA 12, complete blood count, ECG, EEG, and visual evoked response testing, and no toxicity other than reversible, dose-dependent side effects. Based on this and other long-term data, clinical trials of vigabatrin have resumed in the United States and Canada.
我们对66例难治性复杂部分性癫痫患者进行了随访，这些患者最初对氨己烯酸反应良好，随访时间为5至72个月（中位数为43个月）。37例患者因以下原因停用氨己烯酸：效益风险评估，8例；癫痫发作突破，6例；不良事件，6例；癫痫发作突破和不良事件，5例；搬迁或失访，4例；不再符合研究条件，2例；非药物相关死亡，2例；药物滥用，1例；患者要求，3例。实验室检查包括十二项血液生化指标、全血细胞计数、心电图、脑电图和视觉诱发电位测试，均未发现具有临床意义的异常，除可逆性、剂量依赖性副作用外无其他毒性反应。基于此及其他长期数据，氨己烯酸的临床试验已在美国和加拿大恢复。
