Altin Murat, El-Shafei Ahmed A, Yu Maria, Desaiah Durisala, Treuer Tamas, Zavadenko Nikolay, Gao Hong Yun
Eli Lilly Neuroscience, Eli Lilly & Company Turkey, Lilly İlaç Ticaret Ltd. Şti. Kuşbakişi Caddesi, Rainbow Plaza No:4 Kat:3,34662; Altunizade, İstanbul, Turkey;
Eli Lilly, 1229 El Sheikh Aly Gad El Haq St., Floor 6 Sheraton Bldgs, Heliopolis, Cairo, Egypt;
Drugs Context. 2013 Sep 13;2013:212260. doi: 10.7573/dic.212260.
Functional outcomes were measured over a 12-month period in children and adolescents with attention deficit hyperactivity disorder (ADHD) after they received monotherapy.
Prospective, observational, noninterventional study.
Conducted in six non-Western countries.
Outpatients 6 to 17 years of age with a verified diagnosis of ADHD in accordance with the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR), together with their physicians, decided to initiate or switch treatment for ADHD. Patients were prescribed pharmacological monotherapy: methylphenidate (n=221), nootropic agents (n=91), or atomoxetine (n=234).
Patients were followed for changes in their functional status and quality of life, which were assessed with the Child Health and Illness Profile-Child Edition (CHIP-CE) Achievement domain.
At the end of the study, a mean improvement on the CHIP-CE Achievement domain score was observed for all countries and therapies except in Taiwan, where patients received atomoxetine, and in Lebanon, where patients received methylphenidate. No patient experienced a serious adverse event during the study. Four patients discontinued due to a treatment-emergent adverse event.
After 12 months of treatment, clinical and functional outcomes were improved in children and adolescents from non-Western countries who initiated and remained on their prescribed pharmacological monotherapy.
在患有注意力缺陷多动障碍(ADHD)的儿童和青少年接受单一疗法治疗后的12个月内,对其功能结局进行测量。
前瞻性、观察性、非干预性研究。
在六个非西方国家进行。
根据《精神疾病诊断与统计手册》第四版修订本(DSM-IV-TR)确诊为ADHD的6至17岁门诊患者,与其医生共同决定开始或更换ADHD治疗方案。患者接受药物单一疗法:哌甲酯(n = 221)、益智药(n = 91)或托莫西汀(n = 234)。
对患者的功能状态和生活质量变化进行随访,采用儿童健康与疾病概况-儿童版(CHIP-CE)成就领域进行评估。
在研究结束时,除了接受托莫西汀治疗的台湾患者和接受哌甲酯治疗的黎巴嫩患者外,所有国家和治疗方法在CHIP-CE成就领域得分均有平均改善。在研究期间,没有患者发生严重不良事件。四名患者因治疗中出现的不良事件而停药。
经过12个月的治疗,开始并持续接受规定药物单一疗法治疗的非西方国家儿童和青少年的临床和功能结局得到改善。