【摘要】：目的：系統(tǒng)評價唑尼沙胺添加治療難治性部分性癲癇發(fā)作療效和藥物的安全性,為臨床治療難治性部分性發(fā)作提供證據(jù)。 方法：計算機檢索2000年1月-2013年12月MEDLINE、EBbase、Pubmed、 FMJS、社會科學(xué)引文索引、維普中文科技期刊、中國知網(wǎng)相關(guān)期刊論文和中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫,并手工檢索相關(guān)雜志,由兩名研究者獨立進(jìn)行質(zhì)量評價及數(shù)據(jù)分析,用RevMan5.2統(tǒng)計軟件進(jìn)行Meta分析。 結(jié)果：檢索到8篇唑尼沙胺的雙盲、隨機、安慰劑對照的臨床試驗,共1433例受試者(唑尼沙胺組751例,安慰劑對照組682例)。Meta分析結(jié)果顯示：唑尼沙胺組癲癇部分性發(fā)作頻率減少≥50%的病例數(shù)高于對照組,差異有統(tǒng)計學(xué)意義[OR=2.26,95%CI (1.79,2.85), P0.00001];唑尼沙胺組失訪率與安慰劑對照組之間差異無統(tǒng)計學(xué)意義[OR=1.16,95%CI (0.82,1.63), P=0.39];治療期間常見藥物不良反應(yīng)包括疲乏、頭暈、嗜睡、厭食等,各種不良反應(yīng)實驗組和對照組之間差異均無統(tǒng)計學(xué)意義[OR=1.38,95%CI(0.66,2.89),P=0.40; OR=1.33,95%CI (0.79,2.25), P=0.28; OR=1.29,95%CI (0.73,2.27), P=0.38; OR=2.09,95%CI (0.81,5.37), P=0.13]. 結(jié)論：唑尼沙胺添加治療難治性部分性癲癇發(fā)作的療效與安慰劑組相比效果顯著,耐受性好。
[Abstract]:Objective: to systematically evaluate the efficacy and safety of zonisalamine in the treatment of refractory partial seizures, and to provide evidence for clinical treatment of refractory partial seizures. Methods: from January 2000 to December 2013, MEDLINE,EBbase,Pubmed, FMJS, social science citation index, Weipu Chinese sci-tech journal, Chinese journal full-text database and Chinese biomedical literature database were searched by computer, and related magazines were searched by hand. The quality evaluation and data analysis were carried out independently by two researchers, and Meta analysis was carried out with RevMan5.2 statistical software. Results: eight double-blind, randomized, placebo-controlled clinical trials of zonisalamine were searched, with a total of 1433 subjects (751 in zonisalamine group and 682 in placebo control group). Meta-analysis showed that the number of cases with partial seizures decreased by more than 50% in zonisalamine group was significantly higher than that in control group [OR=2.26,95%CI (1.79, 2.85), P0.00001]. There was no significant difference in the loss of visit rate between the zonisalamine group and the placebo control group [OR=1.16,95%CI (0.82, 1.63), P 鈮，

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