目的 評(píng)價(jià)艾司西酞普蘭治療抑郁癥的有效性和安全性。
方法 選擇符合CCMD-3診斷標(biāo)準(zhǔn)的內(nèi)源性抑郁癥患者56例，隨機(jī)分配到艾司西酞普蘭試驗(yàn)組和西酞普蘭陽(yáng)性藥物對(duì)照組，每組各28例，進(jìn)行雙盲、為時(shí)6周的觀察評(píng)估。利用漢密爾頓抑郁量表（HAMD）、臨床總體印象（CGI）和漢密爾頓焦慮量表（HAMA）進(jìn)行療效評(píng)定，并根據(jù)癥狀、體征、實(shí)驗(yàn)室和心電圖檢查結(jié)果評(píng)價(jià)藥物安全性。
結(jié)果 全分析集結(jié)果顯示，治療結(jié)束時(shí)試驗(yàn)組HAMD的減分為15.1±7.8，對(duì)照組HAMD的減分為12.1±7.7，兩者差異無(wú)統(tǒng)計(jì)學(xué)意義（t=1.42，P=0.1613）；基于HAMD減分率的顯效率，試驗(yàn)組為78.6%，對(duì)照組為67.9%，兩組差異無(wú)統(tǒng)計(jì)學(xué)意義（χ2 =0.8195，P=0.3653）。治療結(jié)束時(shí)試驗(yàn)組HAMA評(píng)分從治療前的15.1±3.7降至3.3±4.5，對(duì)照組從治療前的14.0±4.1降至5.0±3.7，兩組差異無(wú)統(tǒng)計(jì)學(xué)意義（t=1.5756，P=0.1223）。CGI評(píng)分結(jié)果表明，在觀察的各個(gè)時(shí)點(diǎn)兩者的評(píng)分結(jié)果差異均無(wú)統(tǒng)計(jì)學(xué)意義。治療結(jié)束時(shí)試驗(yàn)組顯著進(jìn)步以上的患者占90.0%，對(duì)照組為87.8%，兩組差異無(wú)統(tǒng)計(jì)學(xué)意義（CMH檢驗(yàn)值為1.5013，P=0.2205）。綜合整個(gè)試驗(yàn)過程的安全性數(shù)據(jù)集的分析結(jié)果顯示，試驗(yàn)組不良反應(yīng)發(fā)生率為32.5%，對(duì)照組為30.8%，兩者差異無(wú)統(tǒng)計(jì)學(xué)意義（χ2 = 0.0770，P= 0.7814）。試驗(yàn)組中常見不良反應(yīng)有惡心（11.7%）、口干（9.2%）、頭暈（5.8%）、失眠（3.3%）、乏力（2.5%）、轉(zhuǎn)氨酶升高（1.7%）、心悸（1.7%）、便秘（1.7%）等。
結(jié)論 與廣泛使用的西酞普蘭一樣，艾司西酞普蘭治療內(nèi)源性抑郁癥有效、安全。
引用本文： 李 進(jìn),申文武,劉 陽(yáng),徐 理,劉善明,況偉宏. 艾司西酞普蘭治療抑郁癥有效性和安全性的隨機(jī)雙盲陽(yáng)性藥物對(duì)照試驗(yàn). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(8): 552-556. doi: 復(fù)制
版權(quán)信息： ?四川大學(xué)華西醫(yī)院華西期刊社《中國(guó)循證醫(yī)學(xué)雜志》版權(quán)所有，未經(jīng)授權(quán)不得轉(zhuǎn)載、改編
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- 1. Montgomery SA. Clinically relevant effect sizes in depresion. Eur Neuropsychopharcol. 1994；4 (4): 283-284.
- 2. Hyttel J,Bogeso KP,Perregaard J, et al. The pharmacological effect of citalopram residues in the (S)-(+)-enantionmer . J Neural Transm Gen Sect, 1992;88 (2):157-159.
- 3. Owen MJ, Knight DL, Nemerof CB. Second generation SSRIs: human monioamine transporter blinding profile of esitapram and R-fluoxetine. Bio Psychiatry, 2001; 50 (5):345-350.
- 4. Von Moltke LL,Greenblatt DJ, Giancarlo GM, et al. Escitalopram(S-citalopram) and its metabolites in vitro: cytochromes mediating biotransformation, inhibitory effects, and comparison to R-citalopram. Drug Metab Dispos, 2001; 29 (9):1102-1109.
- 5. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI Escitalopram in depressed outpatients. J Clin Psychiatry, 2002; 63 (4):331-339.
- 6. Lepola UM, Loft H, Reines EH. Escitalopram is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol, 2003; 18（4）:211-220.