Wilens Timothy E, McBurnett Keith, Turnbow John, Rugino Thomas, White Carla, Youcha Sharon
1 Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
2 University of California, San Francisco, San Francisco, CA, USA.
J Atten Disord. 2017 Jan;21(2):110-119. doi: 10.1177/1087054713500144. Epub 2016 Jul 28.
To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ).
Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo.
CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate.
Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.
使用康纳斯全球指数家长版(CGI-P)和学前功能问卷(BSFQ),研究辅助使用缓释胍法辛(GXR)对注意缺陷多动障碍(ADHD)患儿早晚症状的疗效和安全性。
选取461例6至17岁、对精神兴奋剂反应欠佳的ADHD患儿,维持当前精神兴奋剂治疗,随机分为早晨服用剂量优化的GXR(≤4mg/d)组(GXR AM)、晚上服用剂量优化的GXR组(GXR PM)或安慰剂组。
GXR治疗后CGI-P评分改善(早晨评估,GXR AM组、安慰剂校正最小二乘均值=-1.7,GXR PM组=-2.6;晚上评估,GXR AM组=-2.4,GXR PM组=-3.0;所有p值均<0.01)。家长评定的BSFQ评分显示GXR改善了早晨功能(GXR AM组、安慰剂校正最小二乘均值=-5.1;GXR PM组=-4.7;p值均<0.01)。多数不良事件为轻度或中度。
辅助使用早晨或晚上的GXR与改善儿童和青少年ADHD的早晚症状相关。