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多中心、双盲、氟伏沙明与氯米帕明治疗强迫症的比较

Multicentre, double-blind, comparison of fluvoxamine and clomipramine in the treatment of obsessive-compulsive disorder.

作者信息

Mundo E, Maina G, Uslenghi C

机构信息

Department of Neuropsychiatric Sciences, San Raffaele Hospital, University of Milan, School of Medicine, Italy.

出版信息

Int Clin Psychopharmacol. 2000 Mar;15(2):69-76. doi: 10.1097/00004850-200015020-00002.

Abstract

The aim of this prospectively randomized, double-blind, parallel group, multicentre study was to compare the efficacy and tolerability of fluvoxamine and clomipramine in patients suffering from obsessive-compulsive disorder (OCD) (DSM-III-R). Fourteen centres participated in this trial. Sixty-eight patients were randomized to receive fluvoxamine and 65 to receive clomipramine. The duration of the study was 10 weeks. The two treatment groups showed a marked improvement of obsessive-compulsive symptomatology, as determined by the Yale-Brown Obsessive-Compulsive Scale, the National Institute of Mental Health Obsessive-Compulsive Global Scale and Clinical Global Impression. No statistically significant differences were found between fluvoxamine and clomipramine in terms of efficacy during the study. A similar number of patients in each group withdrew from the study prematurely, but there were more dropouts due to adverse events in the clomipramine group. Concerning tolerability, there were significantly more reports of constipation and dry mouth in the clomipramine group. The results show that fluvoxamine and clomipramine have similar efficacy in the treatment of patients suffering from OCD, but fluvoxamine is better tolerated. In view of the superior safety profile of fluvoxamine compared to clomipramine in terms of a risk-benefit assessment, the use of fluvoxamine would appear to be advantageous for this patient population.

摘要

这项前瞻性随机、双盲、平行组、多中心研究的目的是比较氟伏沙明和氯米帕明对患有强迫症(DSM-III-R)患者的疗效和耐受性。14个中心参与了该试验。68名患者被随机分配接受氟伏沙明治疗,65名患者接受氯米帕明治疗。研究持续时间为10周。根据耶鲁-布朗强迫症量表、美国国立精神卫生研究所强迫症总体量表和临床总体印象评估,两个治疗组的强迫症状均有显著改善。在研究期间,氟伏沙明和氯米帕明在疗效方面未发现统计学上的显著差异。每组中提前退出研究的患者数量相似,但氯米帕明组因不良事件退出的患者更多。在耐受性方面,氯米帕明组便秘和口干的报告明显更多。结果表明,氟伏沙明和氯米帕明在治疗强迫症患者方面疗效相似,但氟伏沙明的耐受性更好。鉴于在风险效益评估方面氟伏沙明比氯米帕明具有更好的安全性,对于该患者群体而言,使用氟伏沙明似乎更具优势。

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