Goodman W K, Kozak M J, Liebowitz M, White K L
Department of Psychiatry, University of Florida College of Medicine, Gainesville 32610, USA.
Int Clin Psychopharmacol. 1996 Mar;11(1):21-9.
One hundred and sixty patients with a primary diagnosis of obsessive-compulsive disorder were enrolled in a multicentre, randomized, double-blind, placebo-controlled study of fluvoxamine. After a placebo washout phase, patients were randomized to treatment with placebo or fluvoxamine (100-300 mg/day) for 10 weeks. Seventy-eight patients in each group were evaluable for efficacy. Fluvoxamine was significantly more effective than placebo as assessed by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the National Institute of Mental Health Obsessive-Compulsive (NIMH-OC) scale and the Global Improvement item of the Clinical Global Impression (CGI) scale. The percentage of patients classified as "responders" (much or very much improved according to the Global Improvement item) was also significantly higher in the fluvoxamine group from Week 6 onwards, with 33.3% of fluvoxamine-treated patients and 9.0% of those given placebo classified as "responders" at endpoint. The "responders" to fluvoxamine experienced a substantial clinical benefit as reflected in decreases in their Y-BOCS and NIMH-OC scores. Fluvoxamine was well tolerated with the majority of adverse events considered mild or moderate.
160例初步诊断为强迫症的患者参与了一项关于氟伏沙明的多中心、随机、双盲、安慰剂对照研究。在经过安慰剂洗脱期后，患者被随机分配接受安慰剂或氟伏沙明（100 - 300毫克/天）治疗10周。每组78例患者可进行疗效评估。通过耶鲁-布朗强迫症量表（Y - BOCS）、美国国立精神卫生研究所强迫症（NIMH - OC）量表以及临床总体印象（CGI）量表的总体改善项目评估，氟伏沙明显著比安慰剂更有效。从第6周起，氟伏沙明组中被归类为“有反应者”（根据总体改善项目有很大或非常大改善）的患者百分比也显著更高，在研究终点时，接受氟伏沙明治疗的患者中有33.3%被归类为“有反应者”，而接受安慰剂治疗的患者中这一比例为9.0%。氟伏沙明的“有反应者”在Y - BOCS和NIMH - OC评分降低方面体现出显著的临床获益。氟伏沙明耐受性良好，大多数不良事件被认为是轻度或中度。
