Wilens T E, Biederman J, March J S, Wolkow R, Fine C S, Millstein R B, Faraone S V, Geller D, Spencer T J
Department of Psychiatry, Massachusetts General Hospital, Boston 02114, USA.
J Am Acad Child Adolesc Psychiatry. 1999 May;38(5):573-7. doi: 10.1097/00004583-199905000-00019.
In a 12 week, placebo-controlled, parallel-design, multicenter study of sertraline for obsessive-compulsive disorder in 107 children and 80 adolescents, the authors prospectively assessed cardiovascular effects to doses of sertraline of < or = 200 mg/day.
Vital signs (blood pressure and heart rate) and electrocardiograph parameters (ECGs) were systematically evaluated at baseline and again throughout treatment.
There were no clinically significant cardiovascular adverse events in any of the subjects enrolled in the study. Moreover, compared with baseline and placebo, sertraline treatment at an average dose of 167 mg did not result in any clinically meaningful changes in any ECG indices (PR, QRS, and QTc intervals), cardiac rhythm, blood pressure, or heart rate.
These prospectively derived results support the cardiovascular safety of sertraline at doses up to 200 mg in children and adolescents.
在一项为期12周、安慰剂对照、平行设计、多中心的舍曲林治疗107名儿童和80名青少年强迫症的研究中,作者前瞻性地评估了剂量≤200毫克/天的舍曲林对心血管系统的影响。
在基线时以及整个治疗过程中对生命体征(血压和心率)和心电图参数(ECG)进行系统评估。
参与该研究的任何受试者均未出现具有临床意义的心血管不良事件。此外,与基线和安慰剂相比,平均剂量为167毫克的舍曲林治疗在任何心电图指标(PR、QRS和QTc间期)、心律、血压或心率方面均未导致任何具有临床意义的变化。
这些前瞻性研究结果支持舍曲林在儿童和青少年中使用剂量达200毫克时的心血管安全性。