Liebowitz Michael R, Turner Samuel M, Piacentini John, Beidel Deborah C, Clarvit Susan R, Davies Sharon O, Graae Flemming, Jaffer Margaret, Lin Shu-Hsing, Sallee Floyd R, Schmidt Andrew B, Simpson H Blair
New York State Psychiatric Institute, Department of Psychiatry, Columbia University, New York 10032, USA.
J Am Acad Child Adolesc Psychiatry. 2002 Dec;41(12):1431-8. doi: 10.1097/00004583-200212000-00014.
To examine the safety and efficacy of fluoxetine in child and adolescent obsessive-compulsive disorder (OCD).
Between 1991 and 1998, 43 patients were randomly assigned to fluoxetine or placebo for 8 weeks. Dosing was fixed for the first 6 weeks (up to 60 mg/day) and then could be increased to 80 mg/day. Responders entered an 8-week maintenance phase. The primary outcome measures were the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinical Global Impression-Improvement (CGI-I) scale. Analyses were done on the intent-to-treat sample.
Fluoxetine patients (n = 21) had significantly lower CY-BOCS scores than placebo patients (n = 22) after 16 (but not 8) weeks. Fluoxetine responders (n = 11) had significantly lower CY-BOCS scores than placebo responders (n = 7) after an additional 8 weeks of treatment. After 16 weeks, 57% of fluoxetine (versus 27% of placebo) patients were much or very much improved on the CGI-I scale (p <.05). No patient terminated the study because of adverse medication effects.
Fluoxetine was well tolerated and effective for the treatment of child and adolescent OCD, but fluoxetine's full effect took more than 8 weeks to develop.
探讨氟西汀治疗儿童及青少年强迫症（OCD）的安全性和有效性。
1991年至1998年期间，43例患者被随机分配接受氟西汀或安慰剂治疗8周。前6周剂量固定（最高60毫克/天），之后可增至80毫克/天。有反应者进入为期8周的维持期。主要结局指标为儿童耶鲁-布朗强迫症量表（CY-BOCS）和临床总体印象改善量表（CGI-I）。对意向性治疗样本进行分析。
16周（而非8周）后，氟西汀组患者（n = 21）的CY-BOCS评分显著低于安慰剂组患者（n = 22）。在额外8周的治疗后，氟西汀组有反应者（n = 11）的CY-BOCS评分显著低于安慰剂组有反应者（n = 7）。16周后，57%的氟西汀组患者（相比之下安慰剂组为27%）在CGI-I量表上有很大或非常大的改善（p <.05）。没有患者因药物不良反应而终止研究。
氟西汀耐受性良好，对儿童及青少年强迫症有效，但氟西汀的充分疗效需要8周以上时间才能显现。
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