Department of Child and Adolescent Psychiatry, University of Göttingen, Von-Siebold-Str. 5, 37075, Göttingen, Germany.
Eur Child Adolesc Psychiatry. 2011 Oct;20 Suppl 2(Suppl 2):S257-65. doi: 10.1007/s00787-011-0203-3.
Attention deficit hyperactivity disorder (ADHD) impacts significantly on the quality of life (QoL) of patients and their families. Choice of therapy is increasingly influenced by treatment satisfaction and patient preference, with once-daily modified-release methylphenidate (MPH-MR) formulations offering clear benefits compared with immediate-release (IR) dosage forms. The effects of MPH-MR on QoL in ADHD have not been widely investigated and need more clarity in practice. The open-label OBSEER study evaluated the effectiveness and tolerability of Equasym XL(®), a MPH-MR formulation, in routine practice. Children and adolescents (aged 6-17 years) with ADHD and attending school were included if Equasym XL(®) treatment was planned by the treating physician. Physicians, parents and patients completed questionnaires assessing QoL (KINDL; parent, child or adolescent versions), satisfaction with medication, adherence and treatment tolerability at baseline (Visit 1), 1-3 weeks (Visit 2) and 6-12 weeks (Visit 3) over a maximum 3-month observation period. Data from 822 consecutively referred patients were analysed. QoL and medication satisfaction increased from Visit 1 to Visit 3, with both patients and parents rating therapy with Equasym XL(®) as better than previous drug therapy. KINDL total score effect sizes were 0.67 (parents' ratings), 0.52 (children's ratings) and 0.51 (adolescents' ratings; all p < 0.001). All KINDL subscores also increased: both parents and patients had the greatest improvement for school. Adherence to Equasym XL(®) was frequently rated as superior to prior treatment, particularly compared with MPH-IR repeated dosing. Treatment was generally well tolerated; approximately 3% of the patients discontinued treatment due to adverse events. Equasym XL(®) improved QoL compared with prior therapy, and resulted in good medication satisfaction and adherence in drug-naïve and previously treated patients.
注意缺陷多动障碍（ADHD）显著影响患者及其家属的生活质量（QoL）。治疗选择越来越受到治疗满意度和患者偏好的影响，与速释（IR）剂型相比，每日一次的缓释哌甲酯（MPH-MR）制剂具有明显的优势。MPH-MR 对 ADHD 患者生活质量的影响尚未得到广泛研究，在实践中需要更加明确。开放性 OBSEER 研究评估了 Equasym XL（®），一种 MPH-MR 制剂，在常规实践中的疗效和耐受性。计划由主治医生为 Equasym XL（®）治疗的 ADHD 儿童和青少年（6-17 岁）被纳入研究。医生、家长和患者在 3 个月的观察期内，在基线（就诊 1）、1-3 周（就诊 2）和 6-12 周（就诊 3）时完成评估生活质量（KINDL；家长、儿童或青少年版本）、对药物的满意度、依从性和治疗耐受性的问卷。对 822 例连续转诊的患者进行了数据分析。生活质量和药物满意度从就诊 1 到就诊 3 逐渐提高，患者和家长都认为 Equasym XL（®）治疗优于之前的药物治疗。KINDL 总分的效应大小为 0.67（家长评分）、0.52（儿童评分）和 0.51（青少年评分；均 p<0.001）。所有 KINDL 子量表均有所增加：父母和患者都认为学校方面的改善最大。Equasym XL（®）的依从性经常被评为优于之前的治疗，尤其是与 MPH-IR 重复剂量相比。治疗通常耐受性良好；约 3%的患者因不良反应而停止治疗。Equasym XL（®）与之前的治疗相比改善了生活质量，并在初治和既往治疗的患者中产生了良好的药物满意度和依从性。
