Lopez Frank, Silva Raul, Pestreich Linda, Muniz Rafael
Children's Developmental Center, Maitland, Florida, USA.
Paediatr Drugs. 2003;5(8):545-55. doi: 10.2165/00148581-200305080-00005.
The primary objective was to compare the differences in clinical efficacy of the starting dose of Ritalin LA (20mg) to the starting dose of Concerta (18mg), in a laboratory school setting for the duration of an entire school day. Secondary objectives were to compare Ritalin LA 20mg with Concerta 36mg, and Ritalin LA and both Concerta doses versus placebo across the school day.
Thirty-six children (29 males, 7 females), aged 6-12 years, with attention deficit hyperactivity disorder, previously stabilized on methylphenidate (MPH), completed this four-way, randomized, single-blind crossover, analog classroom study. Patients were evaluated on day 0 and randomized to receive treatment on days 7, 14, 21, and 28 (Ritalin LA 20mg, Concerta 18mg, Concerta 36mg, or placebo).
Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale (SKAMP)-attention: The effect of Ritalin LA 20mg across the morning was statistically different from that of Concerta 18mg and 36mg, as demonstrated by the change in the area under the curve (AUC) during the first 4 hours (0-4) from pre-dose. AUC((0-4)) for RitalinLA was -2.48 versus -1.36 for Concerta 18mg (p = 0.015), and -1.55 for Concerta 36mg (p = 0.043). AUC((0-8)) change from pre-dose for Ritalin LA was -4.48 versus -2.72 for Concerta 18mg (p = 0.074), and -3.24 for Concerta 36mg (p = 0.208).SKAMP-deportment: AUC((0-4)) for Ritalin LA was -1.67 compared with -0.28 for Concerta 18mg (p < 0.001), and -0.55 for Concerta 36mg (p = 0.004). AUC((0-8)) change from pre-dose for Ritalin LA was -2.81 compared with -0.82 for Concerta 18mg (p = 0.018), and -1.34 for Concerta 36mg (p = 0.078).Combined: Mean AUC((0-4)) change from pre-dose for Ritalin LA was -2.05 compared with -0.78 for Concerta 18mg (p < 0.001), -1.01 for Concerta 36mg (p = 0.003). The mean AUC((0-8)) change from pre-dose for Ritalin LA was -3.58 compared with -1.70 for Concerta 18mg (p = 0.010), -2.22 for Concerta 36mg (p = 0.061). Math test-attempted: Mean pre-dose score for Ritalin LA was about 73 compared with 74, 90, and 81 for Concerta 18mg, 36mg, and placebo, respectively. Mean AUC((0-8)) change from pre-dose for Ritalin LA was 202 compared with 115 for Concerta 18mg (p = 0.135), 137 for Concerta 36mg (p = 0.265). Math test-correct: Mean pre-dose score for Ritalin LA was 68 compared with 64, 78, and 76 for Concerta 18mg, 36mg, and placebo, respectively. Mean AUC((0-8)) change from pre-dose for Ritalin LA was 183 compared with 100 for Concerta 18mg (p = 0.144), and 117 for Concerta 36mg (p = 0.245).
One patient from each treatment group experienced a single mild adverse event that included abdominal pain, nausea, and dyspnea.
While both Ritalin LA and Concerta were shown to be effective, the different release profiles of each formulation can result in distinct differences between the effects on measures of attention and deportment.
主要目的是在实验室学校环境中，针对整个上学日的时长，比较利他林长效型（Ritalin LA，20毫克）起始剂量与康纳达（Concerta，18毫克）起始剂量的临床疗效差异。次要目的是比较20毫克利他林长效型与36毫克康纳达，以及上学日期间利他林长效型和两种康纳达剂量与安慰剂的效果。
三十六名年龄在6至12岁、患有注意力缺陷多动障碍且之前已使用哌甲酯（MPH）稳定病情的儿童（29名男性，7名女性）完成了这项四组随机、单盲交叉模拟课堂研究。患者在第0天接受评估，并随机分配在第7、14、21和28天接受治疗（20毫克利他林长效型、18毫克康纳达、36毫克康纳达或安慰剂）。
斯旺森、科特金、阿格勒、M - 弗林和佩勒姆评定量表（SKAMP） - 注意力方面：上午时段，20毫克利他林长效型的效果与18毫克和36毫克康纳达在统计学上存在差异，从给药前开始的前4小时（0 - 4）曲线下面积（AUC）变化表明了这一点。利他林长效型的AUC((0 - 4))为 - 2.48，而18毫克康纳达为 - 1.36（p = 0.015），36毫克康纳达为 - 1.55（p = 0.043）。利他林长效型给药前到(0 - 8)的AUC变化为 - 4.48，18毫克康纳达为 - 2.72（p = 0.074），36毫克康纳达为 - 3.24（p = 0.208）。SKAMP - 行为方面：利他林长效型的AUC((0 - 4))为 - 1.67，而18毫克康纳达为 - 0.28（p < 0.001），36毫克康纳达为 - 0.55（p = 0.004）。利他林长效型给药前到(0 - 8)的AUC变化为 - 2.81，18毫克康纳达为 - 0.82（p = 0.018），36毫克康纳达为 - 1.34（p = 0.078）。综合方面：利他林长效型给药前到(0 - 4)的平均AUC变化为 - 2.05，而18毫克康纳达为 - 0.78（p < 0.001），36毫克康纳达为 - 1.01（p = 0.003）。利他林长效型给药前到(0 - 8)的平均AUC变化为 - 3.58，18毫克康纳达为 - 1.70（p = 0.010），36毫克康纳达为 - 2.22（p = 0.061）。数学测试 - 尝试次数：利他林长效型给药前平均分数约为73，而18毫克康纳达、36毫克康纳达和安慰剂分别为74、90和81。利他林长效型给药前到(0 - 8)的平均AUC变化为202，18毫克康纳达为115（p = 0.135），36毫克康纳达为137（p = 0.265）。数学测试 - 答对次数：利他林长效型给药前平均分数为68，而18毫克康纳达、36毫克康纳达和安慰剂分别为64、78和76。利他林长效型给药前到(0 - 8)的平均AUC变化为183，18毫克康纳达为100（p = 0.144），36毫克康纳达为117（p = 0.245）。
每个治疗组各有一名患者经历了一次轻度不良事件，包括腹痛、恶心和呼吸困难。
虽然利他林长效型和康纳达均显示有效，但每种制剂不同的释放特性可导致在注意力和行为测量方面的效果存在明显差异。
