左乙拉西坦治疗成人癫疒间临床疗效和安全性的随机对照试验

Efficacy and safety of levetiracetam for adult seizure:a randomized controlled trial

目的评价左乙拉西坦治疗成人癫疒间的临床疗效和安全性。方法采用随机、双盲、双模拟、阳性药物平行对照试验设计方案,将纳入研究的120例癫疒间受试者随机分为试验组和对照组,每组各60例。试验组给予左乙拉西坦片+丙戊酸钠缓释模拟片治疗;对照组给予丙戊酸钠缓释片+左乙拉西坦模拟片治疗。两组疗程均为26周,治疗结束后随访3个月。评定两组受试者在治疗后(治疗结束后1~3d)及随访3个月时的总有效率、癫疒间每周发作频率、癫疒间发作持续时间、生活质量(QOLIE-31评分量表)及药物相关的不良反应。结果治疗前,两组受试者的癫疒间每周发作频率、癫疒间发作持续时间和QOLIE-31评分比较差异均无统计学意义。治疗后及随访3个月时,试验组受试者的总有效率为95.0%(57/60)和91.7%(55/60),均分别高于对照组[71.7%(43/60),63.3%(38/60);P<0.01]。治疗后及随访3个月时,两组受试者的癫疒间每周发作频率、癫疒间发作持续时间和QOLIE-31评分与同组治疗前相比差异均有统计学意义(P<0.01),两组间差异也有统计学意义(P<0.01)。治疗后两组受试者的不良反应差异无统计学意义。结论左乙拉西坦治疗成人癫疒间的临床疗效优于丙戊酸钠缓释片,不良反应轻微,可作为临床治疗成人癫疒间的首选药物。

Objective To evaluate the efficacy and safety of levetiracetam（LTA）for adult seizure（AS）.Methods A randomized,double-blinded,double-dummy,positive drug controlled trial was conducted.One hundred and twenty eligible AS patients were randomly divided into two groups：intervention group and control group,with 60 in each group.Patients in the intervention group received LTA tablet plus valproate sodium mimetic tablet,and patients in the control group received valproate sodium tablet and LTA mimetic tablet.The treatment course was 26 weeks in both groups,and the patients was followed up for 3months after the treatment.The outcomes included total efficacy rate,weekly epilepsy seizure frequency,seizure duration,quality of life（measured by QOLIE-31Scale）and adverse events related to drugs after 1-3 days of treatment and at 3 months of follow-up.Results The weekly epilepsy seizure frequency,seizure duration and QOLIE-31 score were not significantly different between the two groups before treatment.The total efficacy rates after treatment and at 3months of follow-up in the intervention group were 95.0%（57/60）and 91.7%（55/60）,respectively,and were significantly higher than those in the control group of 71.7%（43/60）and 63.3%（38/60）（P〈0.01）.The weekly epilepsy seizure frequency,seizure duration and QOLIE-31 score after treatment and at 3 months of follow-up were significantly different as compared with before treatment in both groups（P〈0.01）;and there were significantly different between the two groups（P〈0.01）.The adverse events after treatment were similar between both groups.Conclusion The efficacy of LAT is superior to the valproate sodium tablet for AS,with the less toxicity,and it can be clinical drug of choice for AS.