经前烦躁障碍的黄体期间歇性舍曲林治疗疗效

Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder.

作者信息

Halbreich Uriel, Bergeron Richard, Yonkers Kimberly A, Freeman Ellen, Stout Anna L, Cohen Lee

机构信息

State University of New York at Buffalo School of Medicine, 14215, USA.

出版信息

Obstet Gynecol. 2002 Dec;100(6):1219-29. doi: 10.1016/s0029-7844(02)02326-8.

DOI:10.1016/s0029-7844(02)02326-8

PMID:12468166

Abstract

OBJECTIVE

Premenstrual dysphoric disorder is a menstrually related disorder that intermittently causes disabling emotional, behavioral, and physical symptoms. The goal of the current study was to evaluate the efficacy and tolerability of sertraline for premenstrual dysphoric disorder when treatment was limited to the luteal phase.

METHODS

Two hundred eighty-one women who met Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria for premenstrual dysphoric disorder and who completed two prospective screening cycles and one single-blind placebo cycle were randomized to three cycles of double-blind, luteal phase treatment with either a placebo or sertraline in a flexible daily dose of 50-100 mg. Outcome measures included the Daily Record of Severity of Problems and the Clinical Global Impression Severity and Improvement scales.

RESULTS

Luteal phase treatment with sertraline was significantly superior to the placebo, as demonstrated by end- point analysis of Clinical Global Impression Improvement scale scores (sertraline, 2.3 +/- 1.1, versus placebo, 2.7 +/- 1.1; P <.001), and cycle 3 Daily Record of Severity of Problems change scores (sertraline, 27.6 +/- 26.8, versus placebo, 17.6 +/- 23.3; P <.002). A significant difference was also noted in responder rates in favor of sertraline (50%) versus placebo (26%, P <.001) by cycle 1 (with responder defined as a Clinical Global Impression Improvement scale score of 1 or 2). Quality of life and functioning outcomes were also significantly improved. Intermittent luteal administration of sertraline was well tolerated, with only approximately 8% of patients on sertraline and less than 1% on placebo discontinuing because of adverse events.

CONCLUSION

Sertraline was significantly more effective than a placebo and was well tolerated as a treatment for premenstrual dysphoric disorder when administered intermittently during the luteal phase of the menstrual cycle.

摘要

目的

经前烦躁障碍是一种与月经相关的疾病，会间歇性地引发使人丧失能力的情绪、行为及身体症状。本研究的目的是评估在仅限于黄体期进行治疗时，舍曲林治疗经前烦躁障碍的疗效和耐受性。

方法

281名符合《精神疾病诊断与统计手册》（第4版）经前烦躁障碍标准且完成了两个前瞻性筛查周期和一个单盲安慰剂周期的女性，被随机分配接受三个周期的双盲黄体期治疗，分别使用安慰剂或灵活每日剂量为50 - 100mg的舍曲林。结果测量指标包括问题严重程度每日记录以及临床总体印象严重程度和改善量表。

结果

临床总体印象改善量表评分的终点分析表明，黄体期使用舍曲林治疗显著优于安慰剂（舍曲林，2.3±1.1，安慰剂，2.7±1.1；P <.001），且第3周期问题严重程度每日记录变化评分也显示如此（舍曲林，27.6±26.8，安慰剂，17.6±23.3；P <.002）。在第1周期时，应答率方面也观察到有利于舍曲林（50%）而非安慰剂（26%，P <.001）的显著差异（应答者定义为临床总体印象改善量表评分为1或2）。生活质量和功能结局也有显著改善。间歇性黄体期给予舍曲林耐受性良好，因不良事件而停用舍曲林的患者仅约8%，安慰剂组则不到1%。