[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評價(jià)吡侖帕奈治療難治性癲癇部分發(fā)作的有效性與安全性。方法 計(jì)算機(jī)檢索PubMed、EBSCO、EMbase、Cochrane Library、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、中國期刊全文數(shù)據(jù)庫(CNKI)、中文科技期刊全文數(shù)據(jù)庫(VIP)和萬方數(shù)據(jù)庫,收集吡侖帕奈治療難治性癲癇部分發(fā)作的隨機(jī)對照試驗(yàn),檢索時(shí)限從建庫至2017年2月,采用RevMan 5.0軟件對各效應(yīng)指標(biāo)進(jìn)行Meta分析。結(jié)果 共納入5項(xiàng)研究,計(jì)1 500例患者。Meta分析結(jié)果顯示:吡侖帕奈組癲癇完全不發(fā)作率[OR=3.75,95%CI (1.77,7.93),P=0.000 6]、發(fā)作頻率減少≥ 50%的患者百分率[OR=2.08,95%CI (1.69,2.56),P<0.001]均高于安慰劑組,差異有統(tǒng)計(jì)學(xué)意義;吡侖帕奈主要不良反應(yīng)有眩暈、困倦、頭痛、共濟(jì)失調(diào)、鼻咽炎等;吡侖帕奈8 mg和12 mg組總不良反應(yīng)發(fā)生率高于安慰劑組,差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。結(jié)論 吡侖帕奈治療難治性癲癇部分發(fā)作能有效減少癲癇發(fā)作頻率,且不良反應(yīng)較輕,患者基本耐受。
[Key word]
[Abstract]
Objective To evaluate the efficacy and safety of perampanel in the treatment of refractory partial-onset seizures. Methods The randomized controlled trials of perampanel in treatment of refractory partial-onset seizures were searched from PubMed, EBSCO, EMbase, Cochrane Library, CBM, CNKI, VIP database, and Wanfang database by computer. Data were collected from establishment of the database to February 2017 and the each index was analyzed by meta-analysis with RevMan 5.0 software. Results Five RCT were included, including 1 500 patients with refractory partial-onset seizures. Meta-analysis results showed that there was a significant difference between perampanel and placebo in term of seizure-free rate[OR=3.75, 95%CI(1.77, 7.93), P=0.000 6] and percentage of patients achieving 50% reduction in seizure frequency[OR=2.08, 95%CI(1.69, 2.56), P<0.001]. Common adverse reactions of perampanel were dizziness, somnolence, headache, ataxia, nasopharyngitis, etc. The total rate of adverse reactions of the two Perampanel groups of 8 mg group and 12 mg group doses were higher than placebo group (P<0.05). Conclusion The clinical efficacy of perampanel in the treatment of refractory partial-onset seizures, and the adverse reactions is slight, patient is well tolerated.
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