Venlafaxine與Fluoxetine治療重鬱症之單盲隨機臨床試驗

A Single-blind and Randomized Trial of Venlafaxine and Fluoxetine for the Treatment of Major Depression

本研究之目的在於測試venlafaxine 相對於fluoxetine 在罹患重鬱症之國人，其臨床療效、安全性、以及副作用之比較。本藥物試驗之設計為單盲、隨機取樣、對照於憂鬱症患者之研究。樣本為符合DSM-IV 重度憂鬱症發作、初次診視於漢氏憂鬱量表（Hamilton Depression Rating Scale:HDRS-21）得分18分以上之患者。本研究之個案共63名，其中男性22名，女性41名。其中31名被隨機分派至venlafaxine組，32名被隨機分派至fluoxetine組。每位病患將參與為期六週之療程，於試驗開始、第一週、第二週、第三週、第四週、以及第六週由資深精神科醫師實施臨床評估。臨床療效部分之測量以HDRS-21、簡式症狀量表（Brief Symptom Rating Scale : BSRS）、以及整體印象評估表（Clinical Global Impression: CGI）評量之。於第一週及第二週內，每天固定給予口服venlafaxine 75mg 或fluoxetine 20mg。在第三週至第六週，則視受試者之症狀及耐受性調整用藥，若需增量則投以venlafaxine 150mg 或fluoxetine 40mg 。共有venlafaxine 組 19名及fluoxetine 組21名個案完成六週之治療及評估。經過六週之治療，兩組個案在以HDRS-21為主之憂鬱症嚴重程度方面，以及BSRS-30為主之綜合症狀嚴重度方面，皆有顯著之改善（P<0.0001）。就venlafaxine 與fluoxetine 兩組間之療效差異而言，不論以HDRS-21 或BSRS-30 之平均得分以及進步大於50%為顯著改善標準之個案比率，兩組間並無顯著之統計差異。於第四週時CGI改善程度，venlafaxine 顯著高於fluoxetine。副作用之頭暈於第一週enlafaxine組顯著高於fluoxetine組。除上述各項之外，在其他藥物療效指標及副作用方面，兩組並無顯著統計差異。本研究顯示，與fluoxetine相比較，venlafaxine 具有相似之療效與安全性。故對於需長期服用抗憂鬱劑之患者，venlafaxine 可以與fluoxetine 共同考慮做為第一線用藥。

This single-blind and randomized trial aims to compare the clinical efficacy and safety of venlafaxine and fluoxetine in the treatment of major depression. All patients included in the study met the Diagnostic and Statistic Manual of Mental Disorder, 4th edition (DSM-IV) criteria for a major depressive episode and presented with a total Hamilton Depression Rating Scale (HAM-D) score over 18 on the 21-item scale. Clinical efficacy was evaluated by 21-item HAM-D, Brief Symptom Rating Scale (BSRS) and Clinical Global Impression (CGI) weekly in the first four weeks and finally in the sixth week. A total of 63 patients who met the inclusion criteria were recruited in this study. In comparison of 31 venlafaxine and 32 fluoxetine treated patients, there was no significant difference in the scores of HAM-D and BSRS over the whole six-week study periods. The improvement based on CGI score at the fourth-week assessment was significantly higher in the patients treated by venlafaxine. There were no significant differences in the side effect profile except that the frequencies of dizziness were higher in the patients treated by venlafaxine in the first-week evaluation. This study revealed comparable clinical efficacy and safety of venlafaxine and fluoxetine in the treatment of major depression.