随机对照研究比较了长期视频脑电图监测期间快速和缓慢撤抗癫痫药物的疗效。
Randomized controlled study comparing the efficacy of rapid and slow withdrawal of antiepileptic drugs during long-term video-EEG monitoring.
机构信息
Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.
出版信息
Epilepsia. 2018 Feb;59(2):460-467. doi: 10.1111/epi.13966. Epub 2017 Dec 7.
OBJECTIVE
Antiepileptic drugs (AEDs) are routinely withdrawn during long-term video-electroencephalography (EEG) monitoring (LTM), to record sufficient number of seizures. The efficacy of rapid and slow AED taper has never been compared in a randomized control trial (RCT), which was the objective of this study.
METHODS
In this open-label RCT, patients aged 2-80 years with drug-resistant epilepsy (DRE) were randomly assigned (1:1) to rapid and slow AED taper groups. Outcome assessor was blinded to the allocation arms. Daily AED dose reduction was 30% to 50% and 15% to <30% in the rapid and slow taper groups, respectively. The primary outcome was difference in mean duration of LTM between the rapid and slow AED taper groups. Secondary outcomes included diagnostic yield, secondary generalized tonic-clonic seizure (GTCS), 4- and 24- hour seizure clusters, status epilepticus, and need for midazolam rescue treatment. The study was registered with Clinical Trial Registry-India (CTRI/2016/08/007207).
RESULTS
One hundred forty patients were randomly assigned to rapid (n = 70) or slow taper groups (n = 70), between June 13, 2016 and February 20, 2017. The difference in mean LTM duration between the rapid and slow taper groups was -1.8 days (95% confidence interval [CI] -2.9 to -0.8, P = .0006). Of the secondary outcome measures, time to first seizure (2.9 ± 1.7 and 4.6 ± 3.0 days in the rapid and slow taper groups respectively, P = .0002) and occurrence of 4-hour seizure clusters (11.9% and 2.9% in the rapid and slow taper groups, respectively, P = .04) were statistically significant. None of the other safety variables were different between the 2 groups. LTM diagnostic yield was 95.7% and 97.1%, in rapid and slow taper groups respectively (P = .46).
SIGNIFICANCE
Rapid AED tapering has the advantage of significantly reducing LTM duration over slow tapering, without any serious adverse events.
目的
在长程视频-脑电图（EEG）监测（LTM）期间，常规停用抗癫痫药物（AED），以记录足够数量的癫痫发作。在随机对照试验（RCT）中，从未比较过快速和缓慢 AED 逐渐减量的效果，这是本研究的目的。
方法
在这项开放标签 RCT 中，将年龄在 2-80 岁的耐药性癫痫（DRE）患者按 1:1 随机分配到快速和缓慢 AED 逐渐减量组。结果评估者对分配臂不知情。快速和缓慢逐渐减量组的每日 AED 剂量减少分别为 30%至 50%和 15%至<30%。主要结局是快速和缓慢 AED 逐渐减量组之间 LTM 平均持续时间的差异。次要结局包括诊断产量、继发性全身性强直-阵挛性发作（GTCS）、4 小时和 24 小时发作群、癫痫持续状态以及咪达唑仑解救治疗的需求。该研究在印度临床试验注册中心（CTRI/2016/08/007207）进行了注册。
结果
2016 年 6 月 13 日至 2017 年 2 月 20 日期间，140 名患者被随机分配至快速（n=70）或缓慢减量组（n=70）。快速和缓慢逐渐减量组之间 LTM 持续时间的平均差异为-1.8 天（95%置信区间[CI]-2.9 至-0.8，P=0.0006）。在次要结局测量中，首次发作的时间（分别为 2.9±1.7 和 4.6±3.0 天，P=0.0002）和 4 小时发作群的发生（分别为 11.9%和 2.9%，P=0.04）在快速和缓慢逐渐减量组之间有统计学意义。两组之间的其他安全性变量没有差异。快速和缓慢逐渐减量组的 LTM 诊断产量分别为 95.7%和 97.1%（P=0.46）。
意义
与缓慢逐渐减量相比，快速 AED 逐渐减量具有显著缩短 LTM 持续时间的优势，且无严重不良事件。
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