Prasad Suyash, Harpin Val, Poole Lynne, Zeitlin Harry, Jamdar Saroj, Puvanendran Kanagasabai
Dept Neurosciences, Eli Lilly and Co Ltd., Basingstoke, UK.
Curr Med Res Opin. 2007 Feb;23(2):379-94. doi: 10.1185/030079906X167309.
To assess the broader efficacy (i.e., improvements in quality of life/functional outcomes) of atomoxetine compared with standard current therapy (SCT) in UK paediatric patients with ADHD and to explore clinician/parent/child perceptions of ADHD.
A total of 201 patients with ADHD were randomised into this multi-centre, open-label study to receive atomoxetine (n = 104) or SCT (n = 97) for 10 weeks. Broader efficacy was assessed using the parent-rated Child Health and Illness Profile-Child Edition (CHIP-CE) total (global) t-score. Secondary outcome measures included the five CHIP-CE domains; parent-rated Family Burden of Illness Module (FBIM); investigator-rated ADHD-Rating Scale; investigator-rated Clinical Global Impression (CGI)-Severity/Improvement scales; and child-rated Harter Self-Perception Profile (HSPP).
Quality of life of children/adolescents with ADHD was extremely compromised at baseline (CHIP-CE total t-scores: atomoxetine, 23.2 +/- 12.2; SCT, 23.9 +/- 11.0), and improved during the 10-week study for both groups; the CHIP-CE score was statistically significantly higher for patients treated with atomoxetine (38.4 +/- 1.3) compared with SCT (30.8 +/- 1.3) at week 10 (p < 0.001). ADHD-RS, CGI-Severity, and CGI-Improvement scores were significantly different between the groups in favour of atomoxetine (p < 0.001). There was a statistically significant difference between the groups in the HSPP Social Acceptance domain in favour of atomoxetine, but not in the five other HSPP domains or FBIM total score. Atomoxetine was well-tolerated.
Results from this open-label trial show that atomoxetine is superior to SCT in addressing broader efficacy and functional outcomes in UK children/adolescents with ADHD. This study contributes to the understanding of broader efficacy in children with ADHD, and is timely in light of recent NICE guidance.
评估在英国患有注意力缺陷多动障碍（ADHD）的儿科患者中，与标准现行疗法（SCT）相比，托莫西汀在更广泛疗效（即生活质量/功能结局改善）方面的情况，并探讨临床医生/家长/儿童对ADHD的看法。
总共201例ADHD患者被随机纳入这项多中心、开放标签研究，接受托莫西汀治疗（n = 104）或SCT治疗（n = 97），为期10周。使用家长评定的儿童健康与疾病概况-儿童版（CHIP-CE）总分（总体）t分数评估更广泛疗效。次要结局指标包括CHIP-CE的五个领域；家长评定的家庭疾病负担模块（FBIM）；研究者评定的ADHD评定量表；研究者评定的临床总体印象（CGI）-严重程度/改善量表；以及儿童评定的哈特自我认知概况（HSPP）。
患有ADHD的儿童/青少年的生活质量在基线时严重受损（CHIP-CE总分t分数：托莫西汀组为23.2±12.2；SCT组为23.9±11.0），且两组在为期10周的研究期间均有所改善；在第10周时，接受托莫西汀治疗的患者的CHIP-CE分数（38.4±1.3）在统计学上显著高于SCT组（30.8±1.3）（p < 0.001）。两组之间的ADHD-RS、CGI-严重程度和CGI-改善分数存在显著差异，有利于托莫西汀（p < 0.001）。两组在HSPP社会接纳领域存在统计学上的显著差异，有利于托莫西汀，但在其他五个HSPP领域或FBIM总分方面不存在差异。托莫西汀耐受性良好。
这项开放标签试验的结果表明，在解决英国患有ADHD的儿童/青少年的更广泛疗效和功能结局方面，托莫西汀优于SCT。本研究有助于理解ADHD儿童的更广泛疗效，并且鉴于最近英国国家卫生与临床优化研究所（NICE）的指南，该研究很及时。
