Efficacy and tolerability of controlled-release and immediate-release paroxetine in the treatment of depression
Efficacy and tolerability of controlled-release and immediate-release paroxetine in the treatment of depression
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DOI：
10.4088/jcp.v63n0707
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发表时间：
2002-07-01
影响因子：
5.3
通讯作者：
Dubé, EM
中科院分区：
文献类型：
--
作者：
Golden, RN;Nemeroff, CB;Dubé, EM
背景资料：继发于常见的治疗后出现的副作用（包括恶心、激越和嗜睡）的早期停药可能会损害抗抑郁疗效。帕罗西汀控释片（CR）是一种用于改善一般耐受性，特别是胃肠道耐受性的药物。目的：探讨帕罗西汀CR对18 ~ 65岁的成人抑郁症患者的疗效和耐受性。（25-62.5 mg/天; N = 212）和帕罗西汀速释（IR; 20-50 mg/天; N = 217）与安慰剂（N = 211）在来自2个相同、双盲、12周临床试验的汇总数据集中进行比较。通过与安慰剂相比17项汉密尔顿抑郁量表总分的降低来评估，帕罗西汀CR和帕罗西汀IR对重度抑郁症均表现出疗效。此外，与安慰剂组相比，帕罗西汀CR组的抑郁情绪和精神焦虑症状早在治疗第一周就得到改善。治疗6周后，安慰剂组的应答率和缓解率分别为41.5%和20.5%，帕罗西汀IR组为52.8%和29.6%，帕罗西汀CR组为58.9%和34.4%。治疗12周后，安慰剂组有效率和缓解率分别为61.2%和44.0%，帕罗西汀IR组为72.9%和52.5%，帕罗西汀CR组为73.7%和56.2%。在第1周，帕罗西汀CR组（14%）的恶心发生率显著低于帕罗西汀IR组（23%; p ≤ 0.05）。由于不良事件的脱落率之间帕罗西汀CR和安慰剂，而显着（p = 0.0008）更多的患者与帕罗西汀IR治疗退出研究过早与安慰剂treated with placebo.Conclusion：帕罗西汀CR是一种有效的和耐受性良好的抗抑郁药表现出症状改善早在第1周。与安慰剂相比，帕罗西汀CR与较低的早发性恶心发生率和不良事件导致的脱落率相关。帕罗西汀CR的临床改善，加上其有利的不良事件特征，表明帕罗西汀CR的治疗结果是有益的。
Background: Antidepressant efficacy may be compromised by early discontinuation of treatment secondary to common, treatment-emergent side effects, including nausea, agitation, and somnolence. Paroxetine controlled-release (CR) was developed to improve general tolerability and, in particular, gastrointestinal tolerability.Objective: To determine the antidepressant efficacy and tolerability of paroxetine CR in adult patients 18 to 65 years of age with DSM-IV major depressive disorder.Method: Paroxetine CR (25-62.5 mg/day; N = 212) and paroxetine immediate-release (IR; 20-50 mg/day; N = 217) were compared with placebo (N = 211) in the pooled dataset from 2 identical, double-blind, 12-week clinical trials.Results: Both paroxetine CR and paroxetine IR exhibited efficacy in major depressive disorder as assessed by the reduction in 17-item Hamilton Rating Scale for Depression total score compared with placebo. Moreover, depressed mood and psychic anxiety symptoms improved as early as treatment week I in the paroxetine CR group compared with the placebo group. After 6 weeks of treatment, response and remission rates were 41.5% and 20.5% for placebo, 52.8% and 29.6% for paroxetine IR, and 58.9% and 34.4% for paroxetine CR, respectively. After 12 weeks of treatment, response and remission rates were 61.2% and 44.0% for placebo, 72.9% and 52.5% for paroxetine IR, and 73.7% and 56.2% for paroxetine CR, respectively. Rates of nausea were significantly lower for paroxetine CR (14%) than for paroxetine IR (23%; p less than or equal to .05) during week 1. Rates of dropout due to adverse events were comparable between paroxetine CR and placebo, while significantly (p = .0008) more patients treated with paroxetine IR withdrew from the study prematurely compared with those treated with placebo.Conclusion: Paroxetine CR is an effective and well-tolerated antidepressant exhibiting symptomatic improvement as early as week 1. Paroxetine CR is associated with low rates of early-onset nausea and dropout rates due to adverse events comparable to those of placebo. The clinical improvement seen with paroxetine CR, coupled with its favorable adverse event profile, suggests a benefit for therapeutic outcome with paroxetine CR.