Alderman J, Wolkow R, Chung M, Johnston H F
Central Research Division, Pfizer Inc., New York, NY 10017-5755, USA.
J Am Acad Child Adolesc Psychiatry. 1998 Apr;37(4):386-94. doi: 10.1097/00004583-199804000-00016.
To evaluate the pharmacokinetics, safety, and efficacy of sertraline in children (6 to 12 years old) and adolescents (13 to 17 years old).
Children (n = 29) and adolescents (n = 32) with major depression, obsessive-compulsive disorder (OCD), or both received a single dose of 50 mg of sertraline followed, 1 week later, by 35 days of sertraline treatment as follows: (1) either a starting dose of 25 mg/day titrated to 200 mg/day in 25-mg increments or (2) a starting dose of 50 mg/day titrated to 200 mg/day in 50-mg increments. Sertraline and desmethylsertraline pharmacokinetics were determined approximately weekly, and efficacy measures were assessed before drug administration and at the end of treatment.
Mean area under the plasma concentration-time curve (AUC), peak plasma concentration (Cmax), and elimination half-life (t1/2) for sertraline and desmethylsertraline were similar to previously reported adult values. No titration-dependent pharmacokinetic or safety differences were seen. While Cmax and AUC0-24 were greater for children versus adolescents, these differences disappeared after parameters were normalized for body weight. Sertraline was well tolerated in both children and adolescents, with adverse experiences similar to those previously reported by adult patients. Efficacy measurements indicated improvement (p < .001) in depression and OCD symptomatology.
Sertraline can be safely administered to pediatric patients using the currently recommended adult titration schedule.
评估舍曲林在儿童（6至12岁）和青少年（13至17岁）中的药代动力学、安全性和疗效。
患有重度抑郁症、强迫症（OCD）或两者皆有的儿童（n = 29）和青少年（n = 32）接受单剂量50 mg舍曲林，1周后进行35天的舍曲林治疗，如下：（1）起始剂量为25 mg/天，以25 mg的增量滴定至200 mg/天，或（2）起始剂量为50 mg/天，以50 mg的增量滴定至200 mg/天。大约每周测定舍曲林和去甲舍曲林的药代动力学，并在给药前和治疗结束时评估疗效指标。
舍曲林和去甲舍曲林的血浆浓度-时间曲线下平均面积（AUC）、血浆峰浓度（Cmax）和消除半衰期（t1/2）与先前报道的成人值相似。未观察到滴定依赖性药代动力学或安全性差异。虽然儿童的Cmax和AUC0-24高于青少年，但在将参数按体重标准化后，这些差异消失。舍曲林在儿童和青少年中耐受性良好，不良经历与成年患者先前报道的相似。疗效测量表明抑郁和OCD症状有所改善（p <.001）。
使用目前推荐的成人滴定方案，舍曲林可安全地用于儿科患者。
