Thase M E
University of Pittsburgh, WPIC, PA 15213, USA.
J Clin Psychiatry. 1997 Sep;58(9):393-8. doi: 10.4088/jcp.v58n0904.
This was a randomized, double-blind, placebo-controlled evaluation of the efficacy and safety of once-daily venlafaxine extended release (XR) in out-patients with DSM-IV major depression.
Patients were randomly assigned to venlafaxine XR (75-225 mg) once daily or placebo for up to 8 weeks. The primary efficacy variables were the 21-item Hamilton Rating Scale for Depression (HAM-D) total score and HAM-D depressed mood item, the Montgomery-Asberg Depression Rating Scale (MADRS) total scores, and the Clinical Global Impressions (CGI) Severity scale. Data were analyzed on a modified intent-to-treat basis using the last-observation-carried-forward method.
Venlafaxine XR (N = 91) was significantly more effective than placebo (N = 100) beginning at Week 2 on the CGI Severity scale, at Week 3 on the HAM-D depressed mood item, and at Week 4 on the HAM-D and MADRS; this superiority was maintained through Week 8. The most common treatment-emergent adverse events associated with venlafaxine XR were nausea, insomnia, and somnolence. The incidence of nausea was highest during the first week, decreased by 50% during the second week, and was comparable to that of placebo from Week 3 onward.
These results demonstrate that venlafaxine XR is an effective and well-tolerated treatment of major depression.
这是一项针对患有DSM-IV重度抑郁症的门诊患者，对每日一次的文拉法辛缓释片（XR）的疗效和安全性进行的随机、双盲、安慰剂对照评估。
患者被随机分配至每日一次服用文拉法辛XR（75 - 225毫克）或安慰剂，为期长达8周。主要疗效变量包括21项汉密尔顿抑郁评定量表（HAM-D）总分及HAM-D抑郁情绪项目、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分以及临床总体印象（CGI）严重程度量表。采用末次观察结转法在改良意向性分析基础上对数据进行分析。
从第2周起在CGI严重程度量表上、第3周起在HAM-D抑郁情绪项目上以及第4周起在HAM-D和MADRS上，文拉法辛XR组（N = 91）比安慰剂组（N = 100）显著更有效；这种优势持续至第8周。与文拉法辛XR相关的最常见治疗中出现的不良事件为恶心、失眠和嗜睡。恶心的发生率在第一周最高，第二周下降50%，从第3周起与安慰剂组相当。
这些结果表明文拉法辛XR是一种治疗重度抑郁症有效且耐受性良好的药物。
