用于伴有精力减退、愉悦感缺失及兴趣缺乏症状的重度抑郁症患者的缓释安非他酮：一项随机、双盲、安慰剂对照研究的结果
Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study.
作者信息
Jefferson James W, Rush A John, Nelson J Craig, VanMeter Susan A, Krishen Alok, Hampton Kenneth D, Wightman Donna S, Modell Jack G
机构信息
Madison Institute of Medicine, Madison, WI 53717, USA.
出版信息
J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.
OBJECTIVE
This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of extended-release bupropion (bupropion XL) in the treatment of major depressive disorder (MDD) with prominent symptoms of decreased energy, pleasure, and interest.
METHOD
Eligible adult outpatients meeting DSM-IV criteria for MDD were randomly assigned to bupropion XL 300 to 450 mg/day (N = 135) or placebo (N = 139) for 8 weeks. The primary efficacy measure, change from baseline on the 30-item Inventory of Depressive Symptomatology-Self Report (IDS-IVR-30) total score, was obtained using interactive voice response (IVR) technology. Secondary measures included change from baseline on the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C-30) total score and change in domain subset scores for energy, pleasure, and interest; for insomnia; and for anxiety. Response and remission rates were also calculated. Safety was assessed by withdrawal rates, adverse events (AEs), body weight, and vital signs. The study was conducted from June 24, 2003, to June 30, 2004.
RESULTS
Bupropion XL was superior to placebo at endpoint in reducing the IDS-IVR-30 total score (p = .018) and the energy, pleasure, and interest domain (p = .007) and the insomnia domain (p = .023) scores. IDS-C-30 outcomes were also significant (p < .001; p < .001, and p = .008, respectively). Clinician-rated remission rates were significantly higher with bupropion XL than placebo (32% vs. 18%, IDS-C-30; 41% vs. 27%, IDS-IVR-30), as were response rates (50% vs. 35%, IDS-C-30; 53% vs. 38%, Clinical Global Impressions-Improvement of Illness). Most AEs were mild or moderate. The incidence of a >or= 7% body weight loss was 3.7% with bupropion XL and 1.4% with placebo.
CONCLUSION
Bupropion XL was effective and well tolerated in MDD patients with decreased energy, pleasure, and interest.
目的
本多中心、双盲、安慰剂对照研究评估了安非他酮缓释剂（安非他酮XL）治疗伴有精力、愉悦感和兴趣下降等突出症状的重度抑郁症（MDD）的疗效和安全性。
方法
符合DSM-IV标准的成年门诊MDD患者被随机分配至安非他酮XL 300至450毫克/天组（N = 135）或安慰剂组（N = 139），为期8周。主要疗效指标为使用交互式语音应答（IVR）技术获得的30项抑郁症状自评量表（IDS-IVR-30）总分相对于基线的变化。次要指标包括30项临床医生评定的抑郁症状量表（IDS-C-30）总分相对于基线的变化以及精力、愉悦感和兴趣、失眠、焦虑等领域子集分数的变化。还计算了缓解率和有效率。通过撤药率、不良事件（AE）、体重和生命体征评估安全性。该研究于2003年6月24日至2004年6月30日进行。
结果
在研究终点，安非他酮XL在降低IDS-IVR-30总分（p = 0.018）、精力、愉悦感和兴趣领域得分（p = 0.007）以及失眠领域得分（p = 0.023）方面优于安慰剂。IDS-C-30的结果也具有显著性（分别为p < 0.001；p < 0.001和p = 0.008）。临床医生评定的缓解率安非他酮XL显著高于安慰剂（IDS-C-30为32%对18%；IDS-IVR-30为41%对27%），有效率也是如此（IDS-C-30为50%对35%；临床总体印象-病情改善为53%对38%）。大多数不良事件为轻度或中度。体重减轻≥7%的发生率安非他酮XL组为3.7%，安慰剂组为1.4%。
结论
安非他酮XL对伴有精力、愉悦感和兴趣下降的MDD患者有效且耐受性良好。
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