孫鑫 1 , 曹立亞 4 , 馬濤 2 , 蘭奮 4 , 李夏 2 , 肖愛麗 4 , 陳心足 2 , 李幼平 13
  • 1. 四川大學(xué)華西醫(yī)院,衛(wèi)生部移植工程與移植免疫重點(diǎn)實(shí)驗(yàn)室,成都,6100412. 四川大學(xué)華西臨床醫(yī)學(xué)院,成都,6100413. 四川大學(xué)華西醫(yī)院,中國(guó)循征醫(yī)學(xué)中心,成都,6100414. 國(guó)家食品與藥品監(jiān)督管理局,藥品評(píng)價(jià)中心,北京,100038;

目的 　本研究旨在評(píng)價(jià)阿司咪唑、氯雷他丁、西替利嗪和特非那定四種第二代抗組胺藥物的安全性、有效性和經(jīng)濟(jì)性,為國(guó)家基本藥物目錄調(diào)整提供依據(jù).
檢索策略 　檢索Medline,Cochrane圖書館,Embase和中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù).另檢索14個(gè)藥物安全性和經(jīng)濟(jì)學(xué)研究數(shù)據(jù)庫(kù).
納入標(biāo)準(zhǔn) 　中文和英文研究.有效性研究納入比較四種藥物中的兩種用于過敏性鼻炎和蕁麻疹的的高質(zhì)量隨機(jī)對(duì)照試驗(yàn)和系統(tǒng)評(píng)價(jià),經(jīng)濟(jì)學(xué)研究同時(shí)納入非隨機(jī)研究.安全性研究納入四種抗組胺藥物用于過敏性疾病導(dǎo)致心臟不良反應(yīng)的各種級(jí)別證據(jù);質(zhì)量評(píng)價(jià)隨機(jī)對(duì)照試驗(yàn)使用Jadad評(píng)價(jià)表,另評(píng)價(jià)分配隱藏和意向性分析.
數(shù)據(jù)提取和分析 　有效性研究使用固定效應(yīng)模型,并進(jìn)行敏感性分析.安全性評(píng)價(jià)收集不良反應(yīng)病例數(shù)、癥狀和心電圖特征.
結(jié)果 　尚無經(jīng)濟(jì)學(xué)研究.分別有27和6個(gè)隨機(jī)對(duì)照試驗(yàn)評(píng)價(jià)抗組胺藥物用于過敏性鼻炎和蕁麻疹.西替利嗪較其他三種藥物總體上更優(yōu).分別收集到73和27例有關(guān)阿司咪唑和特非那定的心臟不良反應(yīng),西替利嗪和氯雷他丁的心臟不良反應(yīng)報(bào)道極少,特非那定和阿司咪唑與其他藥物合用可引起QTc延長(zhǎng).
結(jié)論 　總體上,西替利嗪較其他三種藥物更有效,阿司咪唑和特非那定易導(dǎo)致心臟不良反應(yīng).

引用本文： 孫鑫,曹立亞,馬濤,蘭奮,李夏,肖愛麗,陳心足,李幼平. 四種第二代抗組胺藥物的衛(wèi)生技術(shù)評(píng)估. 中國(guó)循證醫(yī)學(xué)雜志, 2003, 03(3): 195-206. doi: 復(fù)制

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