Ballús C, Quiros G, De Flores T, de la Torre J, Palao D, Rojo L, Gutiérrez M, Casais L, Riesgo Y
Hospital Clinico, Barcelona, pain.
Int Clin Psychopharmacol. 2000 Jan;15(1):43-8. doi: 10.1097/00004850-200015010-00007.
A 24-week, double-blind, randomized trial was performed to compare the efficacy and tolerability of venlafaxine and paroxetine in patients with major depression or dysthymia. Outpatients aged 18-70 years with a baseline score of 17 on the 21-item Hamilton Depression Rating Scale (HAM-D) were eligible. Patients were randomly assigned to venlafaxine, 37.5 mg, in the morning and evening or paroxetine, 20 mg, in the morning and placebo in the evening, which could be increased to venlafaxine, 75 mg twice daily, or paroxetine, 20 mg twice daily, after 4 weeks. Efficacy was assessed with the 21-item HAM-D, the Montgomery-Asberg Rating Scale, the Hamilton Anxiety Rating Scale, and the Clinical Global Impressions Scale. Forty-one patients were randomized to venlafaxine and 43 to paroxetine. At week 6, a response was observed in 55% of patients on venlafaxine and 29% on paroxetine (P = 0.03). At week 12, significantly (P = 0.011) more patients in the venlafaxine group had a HAM-D remission score of 8 or less (59% versus 31%). Discontinuation for any reason occurred in 16 (39%) patients on venlafaxine and 11 (26%) on paroxetine. The most common adverse events were nausea (28%), headache (18%) and dry mouth (15%) with venlafaxine and headache (40%) and constipation (16%) with paroxetine. Venlafaxine was effective and well tolerated for the treatment of patients with mild to moderate depression or dysthymia. A consistently higher proportion of patients had a response or remission on venlafaxine than on paroxetine.
进行了一项为期24周的双盲随机试验，以比较文拉法辛和帕罗西汀治疗重度抑郁症或心境恶劣障碍患者的疗效和耐受性。年龄在18 - 70岁、21项汉密尔顿抑郁量表（HAM - D）基线评分17分的门诊患者符合条件。患者被随机分配接受文拉法辛，早晚各37.5mg，或帕罗西汀，早上20mg，晚上服用安慰剂，4周后可将文拉法辛增至每日两次，每次75mg，或帕罗西汀增至每日两次，每次20mg。疗效通过21项HAM - D、蒙哥马利 - 阿斯伯格评定量表、汉密尔顿焦虑量表和临床总体印象量表进行评估。41例患者被随机分配至文拉法辛组，43例至帕罗西汀组。在第6周时，接受文拉法辛治疗的患者中有55%出现反应，接受帕罗西汀治疗的患者中有29%出现反应（P = 0.03）。在第12周时，文拉法辛组HAM - D缓解评分≤8分的患者显著更多（59% 对31%，P = 0.011）。因任何原因停药的情况在接受文拉法辛治疗的16例（39%）患者和接受帕罗西汀治疗的11例（26%）患者中出现。最常见的不良事件是文拉法辛组的恶心（28%）、头痛（18%）和口干（15%），以及帕罗西汀组的头痛（40%）和便秘（16%）。文拉法辛治疗轻至中度抑郁症或心境恶劣障碍患者有效且耐受性良好。与帕罗西汀相比，接受文拉法辛治疗的患者出现反应或缓解的比例始终更高。
