A placebo controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline
A placebo controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline
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DOI：
10.1016/s0149-2918(00)88317-4
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发表时间：
1999-04-01
影响因子：
3.2
通讯作者：
Ascher, JA
中科院分区：
文献类型：
--
作者：
Croft, H;Settle, E;Ascher, JA
性功能障碍是许多抗抑郁药物经常报告的副作用，可能会导致患者不满意和不遵守治疗方案。本文介绍了首次安慰剂对照比较安非他酮缓释片(安非他酮SR)和选择性5-羟色胺再摄取抑制剂舍曲林的有效性、安全性和对性功能的影响的结果。这项随机、双掩蔽、双模拟、平行分组、多中心试验纳入了360名中到重度复发性抑郁症患者。患者接受安非他酮SR 150~400 mg/d、舍曲林50~200 mg/d或安慰剂治疗8周。患者的抑郁和性功能在每周或每两周的诊所就诊时进行评估；安全性通过定期监测不良事件、生命体征和体重来评估。治疗组在年龄、性别和种族方面的基线相似，大多数患者被诊断为中度、不复杂的抑郁症。接受安非他酮缓释剂或舍曲林治疗的患者在所有疗效指标上都有类似的改善；在不同时间点，两种积极治疗方法在抑郁症的所有评分标准上的改善均优于安慰剂。在整个研究过程中，接受舍曲林治疗的患者比接受安非他酮SR或安慰剂治疗的患者经验性高潮功能障碍的患者要多得多(P<；0.001)。头痛是所有3个治疗组中最常见的不良事件，在每组中发生的频率相似(30%至40%)。舍曲林组恶心(31%)、腹泻(26%)、失眠(18%)和嗜睡(17%)的发生率明显高于安慰剂组(分别为18%、7%、13%和3%)和安慰剂组(分别为10%、11%、4%和6%)。安非他酮缓释组(19%)比舍曲林组(14%)或安慰剂组(12%)更容易出现口干，尽管差异不显著。所有组的生命体征变化都是相似的。在安非他酮SR(-1.06千克)和舍曲林(-0.79千克)两组中，平均体重都出现了类似的(较小的，但没有统计学意义的)下降，而安慰剂组的平均体重略有增加(0.21千克)。尽管安非他酮SR和舍曲林在治疗抑郁症方面的耐受性和有效性相似，但与安慰剂相比，舍曲林治疗更多地与性功能障碍和某些其他不良事件有关。因此，安非他酮SR可能是治疗性生活活跃患者的一种合适的抗抑郁药物。
Sexual dysfunction, a frequently reported side effect of many antidepressants, may result in patient dissatisfaction and noncompliance with treatment regimens. This paper describes the results of the first placebo-controlled comparison of the efficacy, safety, and effects on sexual functioning of sustained-release bupropion (bupropion SR) and the selective serotonin reuptake inhibitor sertraline. This randomized, double-masked, double-dummy, parallel-group, multicenter trial enrolled 360 patients with moderate-to-severe recurrent major depression. Patients were treated with bupropion SR 150 to 400 mg/d, sertraline 50 to 200 mg/d, or placebo for up to 8 weeks. Patients' depression and sexual functioning were assessed at weekly or biweekly clinic visits; safety was assessed by regular monitoring of adverse events, vital signs, and body weight. Treatment groups were similar at baseline in terms of age, sex, and race, and most patients had a diagnosis of moderate uncomplicated depression. Patients treated with bupropion SR or sertraline showed similar improvements on all efficacy measures; both active treatments were superior to placebo in improving scores on all rating scales for depression at various time points. Significantly more patients treated with sertraline experienced orgasmic dysfunction throughout the study than did patients treated with bupropion SR or placebo (P < 0.001). Headache was the most frequently reported adverse event in all 3 treatment groups and occurred with similar frequency in each group (30% to 40%). Nausea (31%), diarrhea (26%), insomnia (18%), and somnolence (17%) occurred in significantly more patients in the sertraline group than in the bupropion SR group (18%, 7%, 13%, and 3%, respectively) and the placebo group (10%, 11%, 4%, and 6%, respectively). Dry mouth occurred more frequently with bupropion SR (19%) than with sertraline (14%) or placebo (12%), although the differences were not significant. Changes in vital signs were similar in all groups. Similar (small, but not statistically significant) decreases in mean body weight were seen in both the bupropion SR (-1.06 kg) and sertraline (-0.79 kg) groups, whereas the placebo group experienced a minor increase (0.21 kg). Although bupropion SR and sertraline were similarly well tolerated and effective in the treatment of depression, sertraline treatment was more often associated with sexual dysfunction and certain other adverse events compared with bupropion SR and placebo. Therefore, bupropion SR may be an appropriate choice as an antidepressant for the treatment of sexually active patients.