目的 了解甲基維生素B12治療糖尿病周圍神經(jīng)病變的療效和安全性.
方法 按照國際Cochrane協(xié)作網(wǎng)的系統(tǒng)評價方法,檢索全世界關(guān)于甲基維生素B12治療糖尿病周圍神經(jīng)病變的隨機或半隨機對照試驗,包括Cochrane 圖書館2003年第4期、臨床對照試驗資料庫、MEDLINE、EMBASE、中國生物醫(yī)學(xué)文獻(xiàn)光盤數(shù)據(jù)庫、中文科技期刊全文數(shù)據(jù)庫以及所有納入研究的參考文獻(xiàn).由兩位評價者獨立地對符合納入標(biāo)準(zhǔn)的試驗進(jìn)行質(zhì)量評價和資料提取.采用下列指標(biāo)對甲基維生素B12治療糖尿病周圍神經(jīng)病變的療效和安全性進(jìn)行評價:臨床癥狀體征的總有效率、感覺及運動神經(jīng)傳導(dǎo)速度以及嚴(yán)重不良反應(yīng)的發(fā)生率.
結(jié)果 30個試驗共納入1 949例糖尿病周圍神經(jīng)病變患者.大部分試驗的方法學(xué)質(zhì)量較低.甲基維生素B12與其他B族維生素比較的13個試驗的"漏斗圖"圖分析顯示基本對稱,提示發(fā)表偏倚的可能性較小,結(jié)果比較可靠,但是不一定能代表整體發(fā)表偏倚情況.Meta分析結(jié)果顯示:甲基維生素B12可明顯改善糖尿病周圍神經(jīng)病變的臨床癥狀和體征,且療效優(yōu)于其他B族維生素;甲基維生素B12改善某些周圍神經(jīng)傳導(dǎo)速度的療效優(yōu)于其他B族維生素;在治療期間,試驗未發(fā)現(xiàn)嚴(yán)重不良反應(yīng).
結(jié)論 甲基維生素B12可能是一種相對安全和有效的治療糖尿病周圍神經(jīng)病變的藥物.但由于納入試驗的方法學(xué)質(zhì)量低下和可能存在發(fā)表偏倚,證據(jù)強度不足,尚有待大樣本、高質(zhì)量的多中心隨機雙盲對照試驗加以證實.
引用本文: 賈海燕,田浩明,魏 東. 甲基維生素B12治療糖尿病周圍神經(jīng)病變的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2005, 05(8): 609-618. doi: 復(fù)制
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