Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine
Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine
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DOI：
10.4088/jcp.v64n0919
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发表时间：
2003-09-01
影响因子：
5.3
通讯作者：
Burnham, DB
中科院分区：
文献类型：
--
作者：
Hollander, E;Allen, A;Burnham, DB
背景：关于强迫症中血清素再摄取抑制剂的最佳剂量或长期药物治疗的信息有限。本研究评估了帕罗西汀治疗强迫症的急性安全性和有效性以及长期疗效、安全性以及对复发预防的影响。 方法：我们在第 1 期中招募了 348 名患有 DSM-III-R 强迫症的门诊患者，这是一项为期 12 周的随机、双盲、平行研究，固定剂量的帕罗西汀（20 毫克/天、40 毫克/天或 60 毫克/天）毫克/天）和安慰剂。在第 2 阶段，263 名 I 期完成者参加了为期 6 个月的灵活剂量开放标签帕罗西汀治疗。在第 3 阶段，105 名对开放标签帕罗西汀有反应的患者被随机接受为期 6 个月的双盲、固定剂量、平行帕罗西汀/安慰剂治疗，以评估长期疗效、安全性和对复发预防的影响。该研究于1991年7月至1994年2月进行。结果：接受40毫克/天或60毫克/天帕罗西汀治疗的I期急性治疗患者比接受安慰剂的患者有显着改善（p < .05）；帕罗西汀 40 毫克/天的耶鲁-布朗强迫量表评分平均降低 25%，60 毫克/天的帕罗西汀平均降低 29%，而安慰剂则降低 13%。在长期治疗的第 3 阶段，安慰剂组 (59%) 患者复发的比例高于帕罗西汀治疗组 (38%)。帕罗西汀在所有剂量下均具有良好的耐受性，与短期治疗相比，长期治疗期间不良事件的发生频率没有显着增加。第 3 阶段安慰剂组比帕罗西汀组出现更多不良事件可能代表停药效应。结论：帕罗西汀剂量 40 mg/天和 60 mg/天（但不是 20 mg/天）可有效治疗急性强迫症。帕罗西汀长期治疗有效、安全，降低复发率，延长复发时间。
Background: Limited information is available regarding optimal dosing or long-term pharmacotherapy with serotonin reuptake inhibitors in obsessive-compulsive disorder. This study evaluated the acute safety and efficacy and long-term efficacy, safety, and impact on relapse prevention of paroxetine in obsessive-compulsive disorder.Method: We enrolled 348 outpatients with DSM-III-R obsessive-compulsive disorder in phase 1, a 12-week randomized, double-blind, parallel study of fixed doses of paroxetine (20 mg/day, 40 mg/day, or 60 mg/day) and placebo. In phase 2, 263 phase I completers were enrolled in 6 months of flexibly dosed open-label paroxetine treatment. In phase 3, 105 responders to open-label paroxetine were randomized to 6-month double-blind, fixed-dose, parallel paroxetine/placebo treatment to evaluate long-term efficacy, safety, and impact on relapse prevention. The study was conducted from July 1991 to February 1994.Results: Patients in phase I acute treatment receiving 40 mg/day or 60 mg/day of paroxetine improved significantly (p < .05) more than those receiving placebo; the mean reduction in Yale-Brown Obsessive-Compulsive Scale score was 25% on 40 mg/day of paroxetine and 29% on 60 mg/day compared with 13% on placebo. During phase 3, long-term treatment, a greater proportion of placebo- (59%) than paroxetine-treated (38%) patients relapsed. Paroxetine was well tolerated at all doses, with no significant increase in frequency of adverse events during long-term compared with short-term therapy. Greater adverse events in the placebo than in the paroxetine group in phase 3 probably represent a discontinuation effect.Conclusion: Paroxetine doses of 40 mg/day and 60 mg/day (but not 20 mg/day) are effective in treating acute obsessive-compulsive disorder. Long-term treatment with paroxetine is effective and safe, decreases the rate of relapse, and lengthens the time to relapse.