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5-羟色胺再摄取抑制剂治疗抑郁症失败后的药物增效治疗。

Medication augmentation after the failure of SSRIs for depression.

作者信息

Trivedi Madhukar H, Fava Maurizio, Wisniewski Stephen R, Thase Michael E, Quitkin Frederick, Warden Diane, Ritz Louise, Nierenberg Andrew A, Lebowitz Barry D, Biggs Melanie M, Luther James F, Shores-Wilson Kathy, Rush A John

机构信息

Mood Disorder Program and Clinic, Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX 75390-9119, USA.

出版信息

N Engl J Med. 2006 Mar 23;354(12):1243-52. doi: 10.1056/NEJMoa052964.

Abstract

BACKGROUND

Although clinicians frequently add a second medication to an initial, ineffective antidepressant drug, no randomized controlled trial has compared the efficacy of this approach.

METHODS

We randomly assigned 565 adult outpatients who had nonpsychotic major depressive disorder without remission despite a mean of 11.9 weeks of citalopram therapy (mean final dose, 55 mg per day) to receive sustained-release bupropion (at a dose of up to 400 mg per day) as augmentation and 286 to receive buspirone (at a dose of up to 60 mg per day) as augmentation. The primary outcome of remission of symptoms was defined as a score of 7 or less on the 17-item Hamilton Rating Scale for Depression (HRSD-17) at the end of this study; scores were obtained over the telephone by raters blinded to treatment assignment. The 16-item Quick Inventory of Depressive Symptomatology--Self-Report (QIDS-SR-16) was used to determine the secondary outcomes of remission (defined as a score of less than 6 at the end of this study) and response (a reduction in baseline scores of 50 percent or more).

RESULTS

The sustained-release bupropion group and the buspirone group had similar rates of HRSD-17 remission (29.7 percent and 30.1 percent, respectively), QIDS-SR-16 remission (39.0 percent and 32.9 percent), and QIDS-SR-16 response (31.8 percent and 26.9 percent). Sustained-release bupropion, however, was associated with a greater reduction (from baseline to the end of this study) in QIDS-SR-16 scores than was buspirone (25.3 percent vs. 17.1 percent, P<0.04), a lower QIDS-SR-16 score at the end of this study (8.0 vs. 9.1, P<0.02), and a lower dropout rate due to intolerance (12.5 percent vs. 20.6 percent, P<0.009).

CONCLUSIONS

Augmentation of citalopram with either sustained-release bupropion or buspirone appears to be useful in actual clinical settings. Augmentation with sustained-release bupropion does have certain advantages, including a greater reduction in the number and severity of symptoms and fewer side effects and adverse events. (ClinicalTrials.gov number, NCT00021528.).

摘要

背景

尽管临床医生经常在初始使用无效的抗抑郁药物时添加第二种药物,但尚无随机对照试验比较这种方法的疗效。

方法

我们将565例患有非精神病性重度抑郁症的成年门诊患者随机分组,这些患者尽管平均接受了11.9周的西酞普兰治疗(平均最终剂量为每日55毫克)但仍未缓解,其中一组接受缓释安非他酮(剂量最高达每日400毫克)作为增效治疗,286例接受丁螺环酮(剂量最高达每日60毫克)作为增效治疗。症状缓解的主要结局定义为本研究结束时17项汉密尔顿抑郁评定量表(HRSD-17)评分≤7分;评分由对治疗分配不知情的评估者通过电话获取。使用16项抑郁症状快速自评量表(QIDS-SR-16)来确定缓解(定义为本研究结束时评分<6分)和反应(基线评分降低50%或更多)的次要结局。

结果

缓释安非他酮组和丁螺环酮组的HRSD-17缓解率相似(分别为29.7%和30.1%),QIDS-SR-16缓解率相似(分别为39.0%和32.9%),QIDS-SR-16反应率相似(分别为31.8%和26.9%)。然而,与丁螺环酮相比,缓释安非他酮与更大幅度的QIDS-SR-16评分降低相关(从基线到本研究结束时,分别为25.3%和17.1%,P<0.04),本研究结束时QIDS-SR-16评分更低(分别为8.0和9.1,P<0.02),且因不耐受导致的退出率更低(分别为12.5%和20.6%,P<0.009)。

结论

用缓释安非他酮或丁螺环酮对西酞普兰进行增效治疗在实际临床环境中似乎是有效的。用缓释安非他酮进行增效治疗确实具有某些优势,包括症状数量和严重程度的更大幅度降低以及更少的副作用和不良事件。(ClinicalTrials.gov编号,NCT00021528。)

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