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安非他酮缓释片和氟西汀对性功能影响的安慰剂对照比较。

A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine.

作者信息

Coleman C C, King B R, Bolden-Watson C, Book M J, Segraves R T, Richard N, Ascher J, Batey S, Jamerson B, Metz A

机构信息

Mississippi Neuropsychiatric Clinic, Paragon Center, Ridgeland 39157, USA.

出版信息

Clin Ther. 2001 Jul;23(7):1040-58. doi: 10.1016/s0149-2918(01)80090-4.

DOI:10.1016/s0149-2918(01)80090-4
PMID:11519769
Abstract

BACKGROUND

Many antidepressants are associated with sexual dysfunction, a side effect that may lead to patients' dissatisfaction and noncompliance with treatment.

OBJECTIVE

This study compared the efficacy, tolerability, and effects on sexual functioning of bupropion sustained release (bupropion SR) and the selective serotonin reuptake inhibitor fluoxetine.

METHODS

In this multicenter, randomized, double-blind, double-dummy, parallel-group study, patients with recurrent major depression were treated with bupropion SR 150 to 400 mg/d, fluoxetine 20 to 60 mg/d, or placebo for up to 8 weeks. Depression and sexual-functioning status were assessed by site-specific trained investigators at weekly clinic visits; tolerability was assessed primarily by monitoring adverse events.

RESULTS

Four hundred fifty-six patients participated in the study, 150 receiving bupropion SR, 154 fluoxetine, and 152 placebo. The majority of patients in each group completed the study (63% each, bupropion SR [n = 94] and fluoxetine [n = 97]; 67%, placebo [n = 102]). Bupropion SR and fluoxetine were similarly effective in the treatment of depressive symptoms. Beginning at week 2 and continuing throughout the study, significantly more fluoxetine-treated patients experienced orgasm dysfunction than did patients receiving bupropion SR or placebo (P < 0.001); similar results were seen in patients defined as clinical responders (> or =50% decrease from baseline in 21-item Hamilton Rating Scale for Depression [HAM-D] total score) (P < 0.001) and in those experiencing remission of depression (HAM-D total score <8) (P < 0.05). At various time points, worsened sexual functioning, sexual desire disorder, sexual arousal disorder, and dissatisfaction with sexual functioning in those satistied at baseline were more frequently associated with fluoxetine treatment than with bupropion SR or placebo. Both active treatments were well tolerated.

CONCLUSIONS

Bupropion SR and fluoxetine were similarly effective and well tolerated in the treatment of depression. Fluoxetine, however, was more frequently associated with sexual dysfunction compared with bupropion SR. Bupropion SR may be an appropriate initial choice for the treatment of depression in patients concerned about sexual functioning.

摘要

背景

许多抗抑郁药都与性功能障碍有关,这种副作用可能导致患者对治疗不满并依从性降低。

目的

本研究比较了安非他酮缓释片(安非他酮SR)与选择性5-羟色胺再摄取抑制剂氟西汀在疗效、耐受性以及对性功能的影响方面的差异。

方法

在这项多中心、随机、双盲、双模拟、平行组研究中,复发性重度抑郁症患者接受150至400毫克/天的安非他酮SR、20至60毫克/天的氟西汀或安慰剂治疗,为期8周。由特定地点经过培训的研究人员在每周的门诊就诊时评估抑郁和性功能状况;耐受性主要通过监测不良事件来评估。

结果

456名患者参与了研究,150人接受安非他酮SR治疗,154人接受氟西汀治疗,152人接受安慰剂治疗。每组中的大多数患者完成了研究(安非他酮SR组[n = 94]和氟西汀组[n = 97]各为63%;安慰剂组为67%[n = 102])。安非他酮SR和氟西汀在治疗抑郁症状方面同样有效。从第2周开始并持续至整个研究过程,与接受安非他酮SR或安慰剂治疗的患者相比,接受氟西汀治疗的患者出现性高潮功能障碍的人数明显更多(P < 0.001);在被定义为临床缓解者(21项汉密尔顿抑郁量表[HAM-D]总分较基线下降≥50%)的患者中(P < 0.001)以及在抑郁症状缓解(HAM-D总分<8)的患者中(P < 0.05)也观察到了类似结果。在各个时间点,与安非他酮SR或安慰剂相比,氟西汀治疗更常与性功能恶化、性欲障碍、性唤起障碍以及基线时满意的患者对性功能的不满相关。两种活性治疗的耐受性均良好。

结论

安非他酮SR和氟西汀在治疗抑郁症方面同样有效且耐受性良好。然而,与安非他酮SR相比,氟西汀更常与性功能障碍相关。对于关注性功能的抑郁症患者,安非他酮SR可能是一种合适的初始治疗选择。

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