A double-blind, placebo-controlled study of fluoxetine in patients with DSM-III-R obsessive-compulsive disorder. The Lilly European OCD Study Group.
A double-blind, placebo-controlled study of fluoxetine in patients with DSM-III-R obsessive-compulsive disorder. The Lilly European OCD Study Group.
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DOI：
10.1016/0924-977x(93)90266-o
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发表时间：
1993-06-01
期刊：
影响因子：
--
通讯作者：
Wood, A J
中科院分区：
文献类型：
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作者：
Montgomery, S A;McIntyre, A;Wood, A J
我们研究了每日三个固定剂量的氟西汀对根据DSM-III-R诊断的强迫症（OCD）患者的影响。在一项为期8周的双盲、安慰剂对照研究中对214例患者进行了评价。与安慰剂治疗相比，氟西汀治疗患者中达到前瞻性定义的临床应答标准的患者数量在统计学上显著更多。两组间症状变化的PGI评分有统计学显著性总体差异（P = 0.045），CGI严重程度评分有轻微显著性差异（P = 0.089）。与安慰剂进行配对比较显示，接受每日60 mg百忧解的患者Y-BOCS-总分的改善幅度在统计学上显着更大（P = 0.059），而接受每日40 mg或60 mg百忧解的患者的缓解率显着更高（P < 0.05）。161例患者继续接受16周的扩展评价。安慰剂组和氟西汀组任何个体不良事件的报告率无显著差异，因不良事件而停药的发生率较低（每个研究阶段< 6%）。这项研究支持氟西汀治疗强迫症的安全性和有效性的证据越来越多。
We have studied the effect of three fixed daily doses of fluoxetine in patients with obsessive-compulsive disorder (OCD) diagnosed according to DSM-III-R. Two hundred and fourteen patients were evaluated in an 8-week double blind, placebo-controlled study. A statistically significantly greater number of fluoxetine-treated patients achieved the prospectively defined criteria for clinical response when compared to placebo treatment. There was a statistically significant overall difference in the PGI rating of symptom change (P = 0.045) and a marginally significant difference (P = 0.089) in the CGI severity rating between groups. Pairwise comparison against placebo showed a marginally statistically significantly greater improvement (P = 0.059) in Y-BOCS-Total score for patients receiving fluoxetine 60 mg daily, and a significantly higher response rate in patients receiving fluoxetine 40 mg or 60 mg daily (P < 0.05). One hundred and sixty one patients continued to a 16-week extension evaluation. There was no significant difference in the rate of reporting of any individual adverse event between placebo and fluoxetine, and the rate of discontinuation due to adverse events was low (< 6% in each study phase). This study supports the growing evidence for the safety and efficacy of fluoxetine in the treatment of OCD.