March J S, Biederman J, Wolkow R, Safferman A, Mardekian J, Cook E H, Cutler N R, Dominguez R, Ferguson J, Muller B, Riesenberg R, Rosenthal M, Sallee F R, Wagner K D, Steiner H
Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA.
JAMA. 1998 Nov 25;280(20):1752-6. doi: 10.1001/jama.280.20.1752.
The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder; however, empirical support for this assertion has been weaker for children and adolescents than for adults.
To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder.
Randomized, double-blind, placebo-controlled trial.
One hundred eighty-seven patients: 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years randomized to receive either sertraline (53 children, 39 adolescents) or placebo (54 children, 41 adolescents).
Twelve US academic and community clinics with experience conducting randomized controlled trials.
Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy, after which patients continued to receive this dosage of medication for 8 more weeks. Control patients received placebo.
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH GOCS), and the NIMH Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) rating scales.
In intent-to-treat analyses, patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS (adjusted mean, -6.8vs -3.4, respectively; P=.005), the NIMH GOCS (-2.2 vs -1.3, respectively; P=.02), and the CGI-I (2.7 vs 3.3, respectively; P=.002) scales. Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study. Based on CGI-I ratings at end point, 42% of patients receiving sertraline and 26% of patients receiving placebo were very much or much improved. Neither age nor sex predicted response to treatment. The incidence of insomnia, nausea, agitation, and tremor were significantly greater in patients receiving sertraline; 12 (13%) of 92 sertraline-treated patients and 3 (3.2%) of 95 placebo-treated patients discontinued prematurely because of adverse medical events (P=.02). No clinically meaningful abnormalities were apparent on vital sign determinations, laboratory findings, or electrocardiographic measurements.
Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder.
血清素再摄取抑制剂是强迫症患者的首选治疗药物；然而，与成年人相比，这一观点在儿童和青少年中的实证支持较弱。
评估盐酸舍曲林这种选择性血清素再摄取抑制剂在患有强迫症的儿童和青少年中的安全性和有效性。
随机、双盲、安慰剂对照试验。
187名患者，其中107名6至12岁儿童和80名13至17岁青少年，随机分为接受舍曲林治疗组（53名儿童，39名青少年）和安慰剂组（54名儿童，41名青少年）。
美国12家有进行随机对照试验经验的学术和社区诊所。
在双盲治疗的前4周，将盐酸舍曲林滴定至最大剂量200毫克/天，之后患者继续接受该剂量药物治疗8周。对照组患者接受安慰剂。
儿童耶鲁-布朗强迫症量表（CY-BOCS）、美国国立精神卫生研究所全球强迫症量表（NIMH GOCS）以及美国国立精神卫生研究所疾病严重程度临床总体印象量表（CGI-S）和改善情况量表（CGI-I）。
在意向性分析中，接受舍曲林治疗的患者在CY-BOCS量表（调整后均值分别为-6.8和-3.4；P = 0.005）、NIMH GOCS量表（分别为-2.2和-1.3；P = 0.02）以及CGI-I量表（分别为2.7和3.3；P = 0.002）上的改善程度明显高于接受安慰剂治疗的患者。舍曲林和安慰剂在疗效上的显著差异在第3周出现，并在研究期间持续存在。根据终点时的CGI-I评分，接受舍曲林治疗的患者中有42%以及接受安慰剂治疗的患者中有26%有非常明显或较大改善。年龄和性别均不能预测治疗反应。接受舍曲林治疗的患者失眠、恶心、激动和震颤的发生率明显更高；92名接受舍曲林治疗的患者中有12名（13%）因不良医疗事件过早停药，95名接受安慰剂治疗的患者中有3名（3.2%）过早停药（P = 0.02）。在生命体征测定、实验室检查结果或心电图测量中未发现具有临床意义的异常。
舍曲林似乎是治疗患有强迫症的儿童和青少年的一种安全有效的短期治疗药物。
