Koran L M, McElroy S L, Davidson J R, Rasmussen S A, Hollander E, Jenike M A
Department of Psychiatry, Stanford University Medical Center, CA 94305, USA.
J Clin Psychopharmacol. 1996 Apr;16(2):121-9. doi: 10.1097/00004714-199604000-00004.
The efficacy and tolerability of fluvoxamine (100-300 mg/day) and clomipramine (100-250 mg/day) were compared in a randomized, double-blind, parallel-group study of 79 patients with obsessive-compulsive disorder (OCD) without coexisting major depression. After a 2-week placebo lead-in period, patients were randomized to fluvoxamine (37 patients) or clomipramine (42 patients) for 10 weeks. Efficacy was evaluated with the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the National Institute of Mental Health Obsessive-Compulsive scale, and Patient and Clinical Global Improvement scales. Hamilton Rating Scale for Depression scores and somatic symptoms were also assessed. Seventy-eight percent of fluvoxamine patients and 64% of clomipramine patients completed the study. At the end of treatment, 56% of fluvoxamine patients were classified as responders (> or = 25% decrease in Y-BOCS score), compared with 54% of clomipramine patients. Both groups showed steady improvement throughout the study; no statistically significant differences were observed between the groups for any efficacy variable at any time. A similar percentage of patients in both groups withdrew because of adverse events. No serious adverse events related to drug occurred with either drug. Insomnia, nervousness, and dyspepsia were more statistically frequent with fluvoxamine; dry mouth and postural hypotension were more frequent with clomipramine. In this study, fluvoxamine and clomipramine were equally effective in reducing OCD symptoms over a 10-week treatment period but displayed different side effect profiles.
在一项针对79例无并存重度抑郁症的强迫症（OCD）患者的随机、双盲、平行组研究中，比较了氟伏沙明（100 - 300毫克/天）和氯米帕明（100 - 250毫克/天）的疗效和耐受性。在为期2周的安慰剂导入期后，患者被随机分为氟伏沙明组（37例）或氯米帕明组（42例），治疗10周。使用耶鲁-布朗强迫症量表（Y - BOCS）、美国国立精神卫生研究所强迫症量表以及患者和临床总体改善量表评估疗效。还评估了汉密尔顿抑郁量表评分和躯体症状。78%的氟伏沙明组患者和�4%的氯米帕明组患者完成了研究。治疗结束时，56%的氟伏沙明组患者被归类为有反应者（Y - BOCS评分降低≥25%），而氯米帕明组为54%。在整个研究过程中，两组均显示出稳步改善；在任何时间点，两组在任何疗效变量上均未观察到统计学上的显著差异。两组中因不良事件退出的患者比例相似。两种药物均未发生与药物相关的严重不良事件。氟伏沙明导致的失眠、紧张和消化不良在统计学上更为常见；氯米帕明导致的口干和体位性低血压更为常见。在本研究中，氟伏沙明和氯米帕明在10周的治疗期内减轻强迫症症状方面同样有效，但副作用表现不同。
