School of Medicine,University of Pennsylvania School of Medicine, Philadelphia, PA 19104-3309, United States.
J Psychiatr Res. 2011 Mar;45(3):412-20. doi: 10.1016/j.jpsychires.2010.07.009.
This secondary analysis from the Prevention of Recurrent Episodes of Depression with Venlafaxine Extended Release (ER) for Two Years (PREVENT) study compared the efficacy of venlafaxine ER and fluoxetine for the prevention of recurrence in patients with a history of recurrent major depressive disorder (MDD). Patients received double-blind treatment with venlafaxine ER (75-300 mg/d) or fluoxetine (20-60 mg/d) for 10 weeks (acute phase). Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] score ≤ 12 and ≥ 50% reduction from baseline) continued on the same treatment during the 6-month continuation phase. At the start of the first and second 12-month maintenance phases, venlafaxine ER responders were randomly assigned to receive venlafaxine ER or placebo, whereas patients receiving fluoxetine continued to receive fluoxetine throughout both maintenance phases. The primary outcome was time to recurrence (HAM-D(17) > 12, reduction in HAM-D(17) score ≤ 50% from acute baseline, and meeting DSM-IV criteria for a diagnosis of MDD), which was assessed using Kaplan-Meier estimates. Using the primary definition of recurrence, the estimated probability of not experiencing a recurrence was 71.9% for venlafaxine ER (n = 160) and 55.8% for fluoxetine (n = 99) across 24 months of maintenance treatment. For this primary analysis, the overall effect of venlafaxine ER treatment was not statistically significant (p = 0.399) compared with fluoxetine; however, a significant treatment-by-time interaction was observed (p = 0.034). No significant between-group differences were observed with any of the secondary efficacy variables. Venlafaxine ER and fluoxetine were similarly well tolerated across 2 years of maintenance-phase therapy.
这项来自预防复发性抑郁障碍的文拉法辛缓释剂（ER）治疗两年（PREVENT）的二次分析研究比较了文拉法辛 ER 和氟西汀预防有复发性重度抑郁症（MDD）病史患者复发的疗效。患者接受文拉法辛 ER（75-300mg/d）或氟西汀（20-60mg/d）的双盲治疗 10 周（急性期）。应答者（汉密尔顿抑郁量表[HAM-D（17）]评分≤12，与基线相比≥50%的降低）在 6 个月的延续期继续接受相同的治疗。在第一个和第二个 12 个月维持期开始时，文拉法辛 ER 应答者被随机分配接受文拉法辛 ER 或安慰剂，而接受氟西汀的患者在两个维持期都继续接受氟西汀。主要结局是复发时间（HAM-D（17）>12，HAM-D（17）评分从急性期基线降低≤50%，符合 DSM-IV 重度抑郁症诊断标准），采用 Kaplan-Meier 估计进行评估。使用复发的主要定义，在 24 个月的维持治疗中，文拉法辛 ER（n=160）不复发的估计概率为 71.9%，氟西汀（n=99）为 55.8%。对于这项主要分析，文拉法辛 ER 治疗的总体效果与氟西汀相比没有统计学意义（p=0.399）；然而，观察到治疗-时间交互作用有统计学意义（p=0.034）。在次要疗效变量中，未观察到组间有显著差异。在 2 年的维持期治疗中，文拉法辛 ER 和氟西汀的耐受性相似。
