一项针对对5-羟色胺再摄取抑制剂难治的强迫症患者加用喹硫平的双盲、随机、安慰剂对照试验。
A double-blind, randomized, placebo-controlled trial of quetiapine addition in patients with obsessive-compulsive disorder refractory to serotonin reuptake inhibitors.
作者信息
Denys Damiaan, de Geus Femke, van Megen Harold J G M, Westenberg Herman G M
机构信息
Rudolf Magnus Institute of Neuroscience, Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.
出版信息
J Clin Psychiatry. 2004 Aug;65(8):1040-8. doi: 10.4088/jcp.v65n0803.
BACKGROUND
Although serotonin reuptake inhibitors (SRIs) are the most effective pharmacologic treatment currently available for patients with obsessive-compulsive disorder (OCD), 40% to 60% of patients do not respond to this treatment. This study was conducted to evaluate the efficacy and tolerability of quetiapine in addition to an SRI for treatment-refractory patients with OCD.
METHOD
Forty patients (10 men/30 women, mean +/- SD age = 35.2 +/- 12.1 years; range, 18-60 years) with primary OCD according to DSM-IV criteria who were recruited between February 2001 and December 2002 were randomly assigned in an 8-week, double-blind, placebo-controlled trial to receive dosages titrated upward to 300 mg/day of quetiapine (N = 20) or placebo (N = 20) in addition to their SRI treatment. At entry, all patients were unresponsive to courses of treatment with at least 2 different SRIs at a maximum tolerated dose for 8 weeks. During the study, primary efficacy was assessed according to change from baseline on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). A responder was defined as having a final Clinical Global Impressions-Improvement scale rating of "very much improved" or "much improved" and a decrease of > or = 35% in Y-BOCS score.
RESULTS
An intent-to-treat, last-observation-carried-forward analysis demonstrated a mean +/- SD decrease in Y-BOCS score of 9.0 +/- 7.0 (31%) in the quetiapine group and 1.8 +/- 3.4 (7%) in the placebo group (F=16.99, df=1,38; p <.001). Eight (40%) of 20 patients in the quetiapine group and 2 (10%) of 20 patients in the placebo group were responders (chi2=4.8, df=1, p=.028). The most common side effects in the quetiapine group were somnolence, dry mouth, weight gain, and dizziness.
CONCLUSION
The results of this study show that quetiapine in addition to an SRI is beneficial for patients with OCD who do not respond to SRI treatment alone.
背景
尽管血清素再摄取抑制剂（SRIs）是目前可用于强迫症（OCD）患者的最有效的药物治疗方法，但40%至60%的患者对此治疗无反应。本研究旨在评估喹硫平联合SRIs对难治性OCD患者的疗效和耐受性。
方法
根据DSM-IV标准，2001年2月至2002年12月招募的40例原发性OCD患者（10例男性/30例女性，平均±标准差年龄 = 35.2±12.1岁；范围18 - 60岁）在一项为期8周的双盲、安慰剂对照试验中被随机分配，除接受SRIs治疗外，还接受剂量递增至300毫克/天的喹硫平（N = 20）或安慰剂（N = 20）治疗。入组时，所有患者对至少2种不同的SRIs在最大耐受剂量下进行8周的治疗疗程均无反应。在研究期间，主要疗效根据耶鲁-布朗强迫症量表（Y-BOCS）相对于基线的变化进行评估。反应者定义为最终临床总体印象改善量表评分为“显著改善”或“明显改善”且Y-BOCS评分降低≥35%。
结果
意向性分析、末次观察结转分析显示，喹硫平组Y-BOCS评分平均±标准差降低9.0±7.0（31%），安慰剂组降低1.8±3.4（7%）（F = 16.99，自由度 = 1,38；p <.001）。喹硫平组20例患者中有8例（40%）为反应者，安慰剂组20例患者中有2例（10%）为反应者（χ² = 4.8，自由度 = 1，p =.028）。喹硫平组最常见的副作用是嗜睡、口干、体重增加和头晕。
结论
本研究结果表明，喹硫平联合SRIs对单独使用SRIs治疗无反应的OCD患者有益。
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