Pearlstein Teri B, Bellew Kevin M, Endicott Jean, Steiner Meir
Department of Psychiatry and Human Behavior, Brown Medical School, Providence, R.I. ; GlaxoSmithKline Neurosciences Medicine Development Center, Psychiatry, King of Prussia, Pa. ; Research Assessment and Training, New York State Psychiatric Institute, New York ; and St. Joseph's Hospital, Hamilton, Ontario, Canada.
Prim Care Companion J Clin Psychiatry. 2005;7(2):53-60. doi: 10.4088/pcc.v07n0203.
Objective: To compare the efficacy and safety of paroxetine controlled release (CR) (12.5 mg/day or 25 mg/day) versus placebo in premenstrual dysphoric disorder (PMDD).Method: A double-blind, randomized, placebo-controlled trial was conducted over 3 menstrual cycles in women aged 18-45 years with confirmed DSM-IV PMDD in 47 outpatient centers across the United States and Canada from November 1999 to January 2002. The primary efficacy measure was the visual analog scale (VAS)-Mood, which is the mean of 4 core symptoms: irritability, tension, depressed mood, and affective lability.Results: A statistically significant difference was observed in favor of paroxetine CR 25 mg versus placebo on the VAS-Mood (adjusted mean difference = -12.58 mm, 95% CI = -18.40 to -6.76; p < .001) and for paroxetine CR 12.5 mg versus placebo (adjusted mean difference = -7.51 mm, 95% CI = -13.40 to -1.62; p = .013). Paroxetine CR was generally well tolerated.Conclusion: Paroxetine CR doses of 12.5 mg/day and 25 mg/day are effective in treating PMDD and are well tolerated.
比较帕罗西汀控释片（12.5毫克/天或25毫克/天）与安慰剂治疗经前烦躁障碍（PMDD）的疗效和安全性。
1999年11月至2002年1月期间，在美国和加拿大的47个门诊中心，对年龄在18 - 45岁、确诊为DSM-IV标准的PMDD女性进行了一项为期3个月经周期的双盲、随机、安慰剂对照试验。主要疗效指标是视觉模拟量表（VAS）-情绪，它是4种核心症状（易怒、紧张、情绪低落和情感不稳定）的平均值。
在VAS-情绪方面，观察到帕罗西汀控释片25毫克组与安慰剂组相比有统计学显著差异（调整后平均差异=-12.58毫米，95%置信区间=-18.40至-6.76；p<.001），帕罗西汀控释片12.5毫克组与安慰剂组相比也有差异（调整后平均差异=-7.51毫米，95%置信区间=-13.40至-1.62；p=.013）。帕罗西汀控释片总体耐受性良好。
帕罗西汀控释片剂量为12.5毫克/天和25毫克/天对治疗PMDD有效且耐受性良好。
