多中心、随机、双盲、安慰剂对照评价普瑞巴林添加治疗部分性癫发作的疗效和安全性  

Multicenter Randomized, Double-Blind, Placebo-controlled Trial of Pregabalin as Add-on Therapy in Patients with Refractor Partial Seizures

作　　者：虞培敏[1] 朱国行[1] 丁玎[1] 徐岚[1] 周东[2] 吴立文[3] 廖卫平[4] 迟兆富[5] 朱遂强[6] 杨期明[7] 陈阳美[8] 郑荣远[9] 董万利[10] 狄晴[11] 李继梅[12] 胡兴越[13] 丁成赟[14] 黄远桂[15] 洪震[1] 

机构地区：[1]复旦大学附属华山医院神经内科,200040 [2]四川大学华西医院,610041 [3]中国医学科学院北京协和医院,100730 [4]广州医学院第二附属医院,510260 [5]山东大学齐鲁医院,250012 [6]华中科技大学同济医学院附属同济医院,430030 [7]郴州市第一人民医院,423000 [8]重庆医科大学附属第二医院,400010 [9]温州医科大学附属第一医院,325000 [10]苏州大学附属第一医院,215006 [11]南京医科大学附属脑科医院,210029 [12]首都医科大学附属北京友谊医院,100050 [13]浙江大学医学院附属邵逸夫医院,310016 [14]首都医科大学附属北京天坛医院,100050 [15]中国人民解放军第四军医大学西京医院,710032

出　　处：《中国临床神经科学》2014年第1期31-37,共7页Chinese Journal of Clinical Neurosciences

摘　　要：目的 评价普瑞巴林添加治疗部分性癫（癎）发作的疗效和安全性.方法采用随机、双盲、安慰剂对照、多中心平行设计添加治疗的方法,确诊为有部分性癫（癎）发作的225例癫（癎）患者,被随机分配入普瑞巴林治疗组（114例）与安慰剂组（111例）.在6周前瞻性基线期后,采用灵活剂量的普瑞巴林（150～600 mg·d-1）添加治疗成人部分性癫（癎）发作.主要疗效指标：部分性癫（癎）发作28 d-反应率.次要疗效指标：部分性癫（癎）发作28d-减少率、临床疗效评价、16周内癫（癎）无发作和发作减少率≥50％的病例比例、第13～16周癫（癎）无发作和发作减少率≥50％的病例比例以及临床疗效总评量表评分;并观察研究药物的安全性与不良反应情况.结果 普瑞巴林组部分性癫（癎）发作28 d-反应率（-40.24±37.88）％,显著高于安慰剂组（-22.84±37.61）％（F=15.063 9,P=0.000 l）.普瑞巴林组和安慰剂组的不良事件发生率分别为60.53％和47.75％,组间无显著差异;但普瑞巴林组的不良反应发生率较安慰剂组高（45.61％ vs 23.42％,P=0.000 7）,主要不良反应有头晕、嗜睡、视物模糊、乏力等.结论 普瑞巴林组的疗效显著优于安慰剂组.普瑞巴林作为部分性癫（痈）发作的添加药物有确定的疗效,安全耐受性较好,具有一定临床应用价值.Aim To evaluate the efficacy and tolerability ofpregabalin（PBG） as add-on therapy in patients with refractory partial seizures.Methods In this multicenter,double-blind,randomized,placebo-controlled trial,225 patients diagnosed with partialonset seizures were randomly divided into a PBG therapy group and a placebo group.All patients entered a 6-week baseline period followed by an 8-week titration interval and an 8week maintenance period.The starting dose of PBG group was 150 mg·d-1,and target dose was 400 mg·d-1.The main outcome was 28-day seizure responses ratio.The secondary outcomes points included 28-day seizure response ratio of all seizure types,28-day seizure reduction rate,clinical seizure frequency evaluation,percentage of patients with reduction of secondary generalized tonic clonic seizures（SGTC）,percentage of patients with seizure free or more than 50% seizure reduction,Clinical Global Impression （CGI） rating scales,and adverse events.Results The 28-day seizure response ratio of PBG group was （-40.24 ± 37.88）,and the placebo group was （-22.84 ± 37.61）%（F=15.063 9,P=0.000 1）.The rate of adverse event of PBG and placebo group was 60.53% and 47.75% respectively without statistical significance.However,the adverse effect rate of PBG group was higher than that of placebo group （45.61% vs 23.42%,P=0.000 7）.Commonly reported adverse effects were dizziness,sleepiness,blurred vision and fatigue.Conclusion Pregabalin treatment was generally well tolerated and was associated with significant reductions in seizure frequency as adjunctive treatment for partial-onset seizures.

关 键 词：癫癎 普瑞巴林 抗癫(癎)药物 多中心、随机、双盲、安慰剂对照研究 疗效 安全性 

分 类 号：R742.1[医药卫生—神经病学与精神病学]