左乙拉西坦与苯妥英钠预防颅脑损伤患者痫性发作疗效及安全性的荟萃分析  

Comparisons of efficacy and safety of levetiracetam versus phenytoin for seizure prophylaxis in patients with brain injury： a meta analysis

作　　者：李佳妮[1] 陈阳美[1] 

机构地区：[1]重庆医科大学附属第二医院神经内科,400010

出　　处：《中华医学杂志》2016年第39期3170-3177,共8页National Medical Journal of China

基　　金：国家自然科学基金（81171225）

摘　　要：目的 系统评价左乙拉西坦（LEV）与苯妥英钠（PHT）预防颅脑损伤后痫性发作的疗效、药物不良反应及病死率等.方法 通过关键词PHT、LEV、颅脑损伤在PubMed、Medline、Springer、中国知网、万方等数据库,收集2000至2016年国内外针对LEV和PHT预防颅脑损伤后痫性发作疗效对比的高质量研究,通过严格的纳入和排除标准,提取有效数据并利用RevMan5.3软件进行荟萃分析.结果 经文献检索、筛选后共纳入13篇英文研究,共包含2 529例患者.荟萃分析结果显示：LEV组对比PHT组对痫性发作预防用药效果评价上,差异无统计学意义（RR =0.88,95％ CI：0.61 ～1.27）;对早期痫性发作预防用药效果评价上,差异无统计学意义（RR=0.74,95％ CI：0.42～ 1.27）;对晚期癫痫预防用药效果评价上,差异无统计学意义（RR=0.71,95％ CI：0.43 ～1.20）;两药对比在药物不良反应的人数上,差异无统计学意义（RR =0.73,95％ CI：0.48 ～ 1.11）,但在因药物不良反应需要停药或改变治疗方案的患者,PHT组多于LEV组,差异有统计学意义（RR=0.11,95％ CI：0.06 ～0.23）;预防用药对病死率比较分析中,差异无统计学意义（RR=1.57,95％ CI：0.92 ～2.67）;住院时间上两者差异无统计学意义（WMD=-1.03,95％ CI：-4.97～2.91）.结论 LEV和PHT在颅脑损伤后痫性发作的预防上有同等效力;在药物不良反应的人数、病死率及住院时间方面,LEV与PHT相比没有优势.但在因药物不良反应而需要停药或改变治疗方案的患者,PHT组多于LEV组,差异有统计学意义.根据目前的证据分析得出PHT仍是颅脑损伤患者药物的首选,但当其出现不可耐受的药物不良反应及药物相互作用时,LEV是一个很好的替代治疗.由于本荟萃分析纳入高质量随机对照试验（RCT）较少,有必要针对两药开展前瞻性、大样本、多中心、跨种族人群的高质量研究.Objective To systematically review the efficacy,side effects and case-fatality rate of levetiracetam （LEV） versus phenytoin （PHT） for seizure prophylaxis of brain injured patients.Methods Randomized controlled trials of high quality about LEV versus PHT in seizure prophylaxis of brain injured patients from 2000 to 2016 were collected according to the key word PHT,LEV,brain injury in PubMed,Medline,Ovid,Springer,CNKI,Wanfang data and so on.Valid data were extracted to conduct metaanalysis by RevMan 5.3 software according to inclusion and exclusion criteria.Results A total of 13 English articles were finally included with 2 529 patients in total.Meta-analysis showed that no significant differences were observed in LEV versus PHT at preventing the occurrence of seizures （RR =0.88,95% CI：0.61-1.27）.No superiority of either drug at preventing early seizures （RR =0.74,95 % CI：0.42-1.27）.As to the occurrence of late seizures,the differences of the two drugs were not statistically significant （RR =0.71,95%CI：0.43-1.20）.Number of patients with side effect was not statistically significantly different between the two groups （RR =0.73,95% CI：0.48-1.11）.But significant difference was found between LEV and PHT in discontinuation because of side effect （RR =0.11,95% CI：0.06-0.23）;no significant differences were noted in the case-fatality rate of patients received pretreatment between the two drugs （RR =1.57,95% CI：0.92-2.67）.There were no significant differences between the two groups in the length of stay （WMD =-1.03,95%CI：-4.97-2.91）.Conclusions LEV and PHT demonstrate equal efficacy in seizure prevention after brain injury.The differences are insignificant in the side effect,the case-fatality rate and the length of stay between LEV and PH treatment,but adverse drug reactions requiring change in therapy occur more in PHT.Phenytoin remains the first choice for seizure prevention after brain injury based on the existing evidence,while levetiracetam seems to be a favorable choic

关 键 词：左乙拉西坦 苯妥英钠 颅脑损伤 痫性发作 预防 

分 类 号：R651.15[医药卫生—外科学]