Wigal Tim, Greenhill Laurence, Chuang Shirley, McGOUGH James, Vitiello Benedetto, Skrobala Anne, Swanson James, Wigal Sharon, Abikoff Howard, Kollins Scott, McCRACKEN James, Riddle Mark, Posner Kelly, Ghuman Jaswinder, Davies Mark, Thorp Ben, Stehli Annamarie
Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of California, Irvine; Dr. Abikoff is with the New York University Child Study Center, New York; Drs. McCracken and McGough are with the University of California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the University of Arizona, Tucson.
Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of California, Irvine; Dr. Abikoff is with the New York University Child Study Center, New York; Drs. McCracken and McGough are with the University of California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the University of Arizona, Tucson..
J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 10.1097/01.chi.0000235082.63156.27.
To report on the safety and tolerability of methylphenidate (MPH) 3- to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) during 1 year of treatment.
Exactly 183 children (3-5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n=183); a 5-week placebo-controlled, double-blind phase (n=165); a 5-week double-blind, parallel phase (n=114); and 10 months of open-label maintenance (n=140 entered, 95 completed). Mean total daily MPH doses rose from the titration trial best dose, 14.1 (+/-8.1) mg/day, to 20.5 (+/-9.7) mg/day mean total daily dose at the end of maintenance. Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase.
Thirty percent of parents spontaneously reported moderate to severe AEs in all study phases after baseline. These included emotional outbursts, difficulty falling asleep, repetitive behaviors/thoughts, appetite decrease, and irritability. During titration, decreased appetite (chi=5.4, p<.03), trouble sleeping (chi=5.4, p<.03), and weight loss (chi=4.0, p<.05) occurred statistically more often on MPH than on placebo. During maintenance, trouble sleeping and appetite loss persisted and other MPH-related AEs decreased. There were transient, one-time pulse and blood pressure elevations in five children. Twenty-one children (11%) discontinued because of drug-attributed AEs.
Eleven percent of preschoolers discontinued treatment because of intolerable MPH AEs. Of the serious AEs reported, one occurred in baseline, two in lead-in, three in titration, one in parallel, and one in maintenance. Only one was possibly related to MPH.
报告哌甲酯（MPH）治疗3至5岁注意力缺陷多动障碍（ADHD）儿童1年期间的安全性和耐受性。
共有183名3至5岁儿童进入MPH治疗研究，包括为期1周的开放标签导入期（n = 183）；为期5周的安慰剂对照双盲期（n = 165）；为期5周的双盲平行期（n = 114）；以及10个月的开放标签维持期（140名儿童进入，95名完成）。维持期末，MPH平均每日总剂量从滴定试验最佳剂量14.1（±8.1）mg/天升至20.5（±9.7）mg/天的平均每日总剂量。在每个阶段记录脉搏、血压、治疗中出现的不良事件（AE）、家长和教师对AE的评分以及生命体征。
30%的家长在基线后的所有研究阶段自发报告了中度至重度AE。这些包括情绪爆发、入睡困难、重复行为/想法、食欲减退和易怒。在滴定期间，与安慰剂相比，MPH组食欲减退（χ=5.4，p<0.03）、睡眠问题（χ=5.4，p<0.03）和体重减轻（χ=4.0，p<0.05）在统计学上更常出现。在维持期，睡眠问题和食欲减退持续存在，其他与MPH相关的AE减少。5名儿童出现短暂的一次性脉搏和血压升高。21名儿童（11%）因药物相关AE停药。
11%的学龄前儿童因无法耐受MPH AE而停药。在报告的严重AE中，1例发生在基线期，2例在导入期，3例在滴定期，1例在平行期，1例在维持期。只有1例可能与MPH有关。
