GABAPENTIN (NEURONTIN) AS ADD-ON THERAPY IN PATIENTS WITH PARTIAL SEIZURES - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
GABAPENTIN (NEURONTIN) AS ADD-ON THERAPY IN PATIENTS WITH PARTIAL SEIZURES - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
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DOI：
10.1111/j.1528-1157.1994.tb02513.x
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发表时间：
1994-07-01
期刊：
影响因子：
5.6
通讯作者：
BILL, PLA
中科院分区：
文献类型：
--
作者：
ANHUT, H;ASHMAN, P;BILL, PLA
一项多中心、双盲、随机、安慰剂对照的研究评估了加巴喷丁(Neurontin，GBP)作为附加治疗在272例接受一到两种标准抗癫痫药物(AEDs)的难治性部分性癫痫患者中的有效性和安全性。疗效评估比较了12周治疗阶段(T)和12周基线期间(B)部分癫痫发作的频率。初步分析比较了每天接受900毫克英镑治疗的患者和服用安慰剂的患者的数据；每天接受1,200毫克英镑治疗的患者提供了剂量反应数据。疗效标准为发作频率变化百分比(PCH)、有效率(发作频率减少大于或等于50%的患者的百分比)和有效率，其中RRatio=(T-B)/(T+B)。900毫克/天组和1,200毫克/天组的PCH中位数分别为-21.8%和-17.8%，而安慰剂组为-0.3%。900mg日剂量组的有效率为22.9%，安慰剂组为10.1%(p=0.020，费舍尔精确检验)。调整后的平均Ratio900 mg/天组为-0.136，安慰剂组为-0.025(p=0.0046，方差分析)。结果显示，1,200毫克/天组的改善略大于900毫克/天组(Ratio=-0.157，应答率28.0%)。每天服用900毫克的患者中有69%的患者发生了不良事件(AE)，每天服用1200毫克的患者中有69%的患者发生了不良事件(AE)，相比之下，接受安慰剂作为附加疗法的患者中这一比例为52%。在接受GBP治疗的患者中，最常见的AE是嗜睡、头晕和疲劳。临床实验室评估没有临床上重要的趋势，也没有证据表明肝脏或造血作用。GBP治疗部分难治性部分性癫痫安全有效。
A multicenter, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of gabapentin (Neurontin, GBP) as add-on therapy in 272 patients with refractory partial seizures who were receiving one to two standard antiepileptic drugs (AEDs). Efficacy assessments compared the frequency of partial seizures during the 12-week treatment phase (T) and the 12-week baseline period (B). The primary analysis compared data for patients receiving GBP 900 mg/day with placebo; the GBP 1,200-mg/day group provided dose-response data. Efficacy criteria were percentage of change in seizure frequency (PCH), responder rate (percentage of patients with greater than or equal to 50% reduction in seizure frequency), and response ratio, where RRatio = (T - B)/(T + B). Median PCH was -21.8% in the 900-mg/day group and -17.8% in the 1,200-mg/day group as compared with -0.3% in the placebo group. Responder rate was 22.9% in the 900-mg/day group and 10.1% in the placebo group (p = 0.020, Fisher's exact test). Adjusted mean RRatio was -0.136 in the 900-mg/day group and -0.025 in the placebo group (p = 0.0046, analysis of variance ANOVA). Results showed slightly greater improvement for the 1,200-mg/day than for the 900-mg/day group (RRatio = -0.157, responder rate 28.0%). Adverse events (AE) occurred in 69% of patients in the 900-mg/day group and in 64% in the 1,200-mg/day group as compared with 52% in patients receiving placebo as add-on therapy. The most frequent AE among patients treated with GBP were somnolence, dizziness, and fatigue. Clinical laboratory evaluations showed no clinically important trends and no evidence of hepatic or hematopoietic effects. GBP is safe and effective in treating some patients with refractory partial seizures.