Bang Lynne M, Keating Gillian M
Adis International Limited, Auckland, New Zealand.
CNS Drugs. 2004;18(6):355-64; discussion 365-6. doi: 10.2165/00023210-200418060-00003.
A controlled-release (CR) formulation of the SSRI paroxetine has been developed. This CR formulation delays the release of paroxetine until the tablet has passed through the stomach; the drug is then released over 4-5 hours. In well designed placebo-controlled trials in patients with major depressive disorder (including a study in the elderly), social anxiety disorder or premenstrual dysphoric disorder (PMDD), paroxetine CR was consistently superior to placebo with regards to primary endpoints (i.e. mean Hamilton Rating Scale for Depression total score [major depressive disorder], Liebowitz social anxiety scale total score and Clinical Global Impressions-Global Improvement score [social anxiety disorder] and Visual Analogue Scale-Mood score [PMDD]). The duration of treatment was 12 weeks or, in PMDD, over three menstrual cycles (intermittent or continuous administration). Paroxetine CR also demonstrated efficacy in three well designed studies in patients with panic disorder with or without agoraphobia. Paroxetine CR was generally well tolerated in clinical trials, with an adverse-event profile typical of SSRIs, although recipients of paroxetine CR experienced significantly less nausea than recipients of immediate-release paroxetine in the first week of treatment.
已研发出选择性5-羟色胺再摄取抑制剂（SSRI）帕罗西汀的控释（CR）制剂。这种CR制剂会延迟帕罗西汀的释放，直到片剂通过胃部；然后药物会在4-5小时内释放。在针对重度抑郁症患者（包括一项老年患者研究）、社交焦虑症或经前烦躁障碍（PMDD）患者精心设计的安慰剂对照试验中，帕罗西汀CR在主要终点方面（即抑郁的汉密尔顿评定量表总分[重度抑郁症]、利博维茨社交焦虑量表总分以及临床总体印象-改善分数[社交焦虑症]和视觉模拟量表-情绪分数[PMDD]）始终优于安慰剂。治疗持续时间为12周，或在PMDD中为三个月经周期（间歇或连续给药）。帕罗西汀CR在三项针对伴或不伴有广场恐惧症的惊恐障碍患者的精心设计研究中也显示出疗效。帕罗西汀CR在临床试验中总体耐受性良好，具有SSRI类药物典型的不良事件特征，尽管在治疗的第一周，帕罗西汀CR的接受者比速释帕罗西汀的接受者恶心症状明显更少。
