Eriksson Elias, Ekman Agneta, Sinclair Suzanne, Sörvik Karin, Ysander Christina, Mattson Ulla-Britt, Nissbrandt Hans
Department of Pharmacology, Institute of Neuroscience and Physiology, University of Göteborg, Göteborg, Sweden.
J Clin Psychopharmacol. 2008 Apr;28(2):195-202. doi: 10.1097/JCP.0b013e3181678a28.
This is the first placebo-controlled trial evaluating the efficacy of the selective serotonin reuptake inhibitor (SSRI), escitalopram, in the treatment of premenstrual dysphoric disorder (PMDD). Women with PMDD (intention-to-treat population, n = 151) were treated intermittently for 3 months, during luteal phases only, with 10 mg/d escitalopram, 20 mg/d escitalopram, or placebo. Escitalopram was found to exert a marked and a dose-dependent symptom-reducing effect, 20 mg/d being clearly superior to 10 mg/d. Although the primary outcome parameter, that is, the sum of the symptoms irritability, depressed mood, tension, and affective lability, was decreased by 90% with 20 mg/d escitalopram, the effect of active treatment on breast tenderness, food craving, and lack of energy was more modest and not significantly different from that of placebo; this outcome supports our previous assumption that the former symptoms are more inclined to respond to intermittent administration of an SSRI than are the latter. Although the placebo response was high, the difference between the placebo group and the 20-mg/d escitalopram group with respect to the percentage of subjects displaying 80% or greater reduction in the rating of the cardinal symptom of PMDD, that is, irritability, was considerable: 30% versus 80%. Adverse events were those normally reported in SSRI trials, such as nausea and reduced libido, and were not more common in patients given 20 mg/d of escitalopram than in patients given the lower dose. This study supports the usefulness of escitalopram for the treatment of PMDD and sheds further light on how different components of this syndrome are differently influenced by intermittent administration of an SSRI.
这是第一项评估选择性5-羟色胺再摄取抑制剂（SSRI）艾司西酞普兰治疗经前烦躁障碍（PMDD）疗效的安慰剂对照试验。患有PMDD的女性（意向性治疗人群，n = 151）仅在黄体期接受为期3个月的间歇性治疗，分别服用10mg/d艾司西酞普兰、20mg/d艾司西酞普兰或安慰剂。结果发现，艾司西酞普兰具有显著且剂量依赖性的症状减轻效果，20mg/d明显优于10mg/d。虽然主要结局参数，即易怒、情绪低落、紧张和情感不稳定等症状的总和，在服用20mg/d艾司西酞普兰时降低了90%，但积极治疗对乳房胀痛、嗜食和乏力的效果较为有限，与安慰剂组无显著差异；这一结果支持了我们之前的假设，即前一组症状比后一组症状更倾向于对间歇性服用SSRI产生反应。尽管安慰剂反应率较高，但安慰剂组与20mg/d艾司西酞普兰组在PMDD主要症状（即易怒）评分降低80%或更多的受试者百分比方面存在显著差异：分别为30%和80%。不良事件为SSRI试验中常见的事件，如恶心和性欲减退，服用20mg/d艾司西酞普兰的患者中不良事件的发生率并不高于服用低剂量药物的患者。这项研究支持了艾司西酞普兰治疗PMDD的有效性，并进一步揭示了该综合征的不同组成部分如何受到间歇性服用SSRI的不同影响。
