Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder.
Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder.
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对患有强迫症的儿童和青少年进行氟西汀和安慰剂的双盲、交叉试验。
DOI：
10.1097/00004583-199211000-00011
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发表时间：
1992
影响因子：
13.3
通讯作者：
Cohen,DJ
中科院分区：
文献类型：
--
作者：
Riddle,MA;Scahill,L;King,RA;Hardin,MT;Anderson,GM;Ort,SI;Smith,JC;Leckman,JF;Cohen,DJ
严格设计的临床试验已经证明了氟西汀在成年重度抑郁症和强迫症（OCD）患者中的疗效和安全性，但在18岁以下的患者中则没有。本报告描述了一项在14名8至15岁的儿童和青少年强迫症患者中进行的氟西汀随机、双盲、安慰剂对照、固定剂量（20 mg qd）试验;研究为期20周，8周时交叉。强迫症状的严重程度采用儿童耶鲁-布朗强迫量表（CY-BOCS）和临床医生总体印象强迫症量表（CGI-OCD）进行测量。氟西汀治疗前8周后，CY-BOCS总分下降44%（N= 7，p= .003），而安慰剂治疗后下降27%（N= 6，p= .13）。在最初的8周内，氟西汀组的改善程度显著超过安慰剂组，这是通过CGI-OCD（p= 0.01）而不是CY-BOCS（p= 0.17）测量的。最常见的药物副作用通常耐受良好。结果表明，氟西汀是一种普遍安全和有效的短期治疗儿童强迫症。
Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N= 7,p= .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N= 6,p= .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p= .01) but not by the CY-BOCS (p= .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.