Consequences of antiepileptic drug withdrawal: A randomized, double-blind study (Akershus Study)
Consequences of antiepileptic drug withdrawal: A randomized, double-blind study (Akershus Study)
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DOI：
10.1111/j.1528-1167.2007.01323.x
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发表时间：
2008-03-01
期刊：
影响因子：
5.6
通讯作者：
Gjerstad, Leif
中科院分区：
文献类型：
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作者：
Lossius, Morten Ingvar;Hessen, Erik;Gjerstad, Leif
目的：尽管使用抗癫痫药物 (AED) 会产生副作用，但即使在长期无癫痫发作后，停用 AED 仍存在争议。本研究的主要目的是评估 AED 戒断对认知功能、癫痫复发、健康相关生活质量 (HRQOL) 和脑电图结果的影响。此外，还研究了 AED 停药后癫痫发作消失的潜在预测因素。方法：招募接受 AED 单药治疗 2 年以上无癫痫发作的患者进行一项持续 12 个月或直至癫痫发作复发的对照、前瞻性、随机、双盲停药研究。患者被随机分为 AED 戒断组 (n = 79) 和非戒断组 (n = 81)。检查计划包括临床神经学检查、神经心理学测试、脑电图记录、脑部 MRI 和 HRQOL 评估。还收集了 12 个月研究期（中位 47 个月）后癫痫发作复发的随访数据。结果：12 个月时戒断组中 15% 的癫痫发作复发，非戒断组中 7% 发生癫痫发作（RR 2.46；95% CI： 0.85-7.08；p = 0.095）。停药后，中位停药 41 个月后癫痫发作复发率为 27%。戒断后所有 15 项神经心理学测试的正常结果从 11% 显着增加到 28%。我们发现戒断对生活质量和脑电图没有显着影响。 AED 停药 1 年后保持无癫痫发作的预测因素是正常的神经系统检查和停药前使用卡马西平。 结论：与继续治疗的患者相比，接受 AED 单药治疗的无癫痫发作患者逐渐减少药物剂量可能会改善神经心理表现，癫痫复发的相对风险为 2.46。
Objective: Despite side effects associated with the use of antiepileptic drugs (AEDs), withdrawal of AEDs remains controversial, even after prolonged seizure freedom. The main objective of this study was to assess the effects of AED withdrawal on cognitive functions, seizure relapse, health-related quality of life (HRQOL), and EEG results. Additionally, potential predictors for freedom from seizures after AED withdrawal were studied.Methods: Patients, seizure-free for more than 2 years on AED monotherapy, were recruited for a controlled, prospective, randomized, double-blinded withdrawal study lasting for 12 months, or until seizure relapse. Patients were randomized to AED withdrawal (n = 79) and nonwithdrawal (n = 81) groups. The examination program included clinical neurological examinations, neuropsychological testing, EEG-recordings, cerebral MRI, and assessments of HRQOL.Follow-up data on seizure relapse were also collected beyond the 12-month study period (median 47 months).Results: Seizure relapse at 12 months occurred in 15% of the withdrawal group and 7% of the nonwithdrawal group (RR 2.46; 95% CI: 0.85-7.08; p = 0.095). After withdrawal, seizure relapse rates were 27% after a median of 41 months off medication. A normal result to all 15 neuropsychological tests increased significantly from 11% to 28% postwithdrawal. We found no significant effects of withdrawal on quality of life and EEG. Predictors for remaining seizure-free after AED-withdrawal over 1 year were normal neurological examination and use of carbamazepine prior to withdrawal.Conclusion: Seizure-free epilepsy patients on AED monotherapy who taper their medication may improve neuropsychological performance with a relative risk of seizure relapse of 2.46, compared to those continuing therapy.