2013年1月14号，辉瑞公司（Pfizer）宣布，Quillivant XR（methylphenidate hydrochloride，盐酸哌甲酯）口服缓释混悬液已在美国上市，用于注意力缺陷多动障碍（ADHD）的治疗。作为首个用于ADHD的每日1次缓释盐酸哌甲酯液体制剂，本品现在能够经开具处方获得。
早在2012年9月27日，本品就获得了美国食品药品监督管理局（FDA）的批准，用于治疗6岁以上的ADHD患者。本品的疗效经一项随机、双盲、安慰剂对照、交叉、多中心的临床研究所证实，该研究涉及45名ADHD儿童。结果表明，相比安慰剂而言，本品能够显著改善ADHD症状，给药后4小时达到了主要观察终点，在给药后45分钟至12小时的次要终点中也表现良好。
ADHD在美国是最为常见的神经性行为疾病之一，根据美国疾病控制和预防中心2007年统计的数据，ADHD在4~17岁儿童中的诊断率约为十分之一。该疾病的主要症状表现为注意力难以集中、易冲动和过度活跃等，并可能影响到成年后的生活。虽然该疾病有很多治疗方法，但之前一直缺乏每日1次的缓释液体制剂，本品的上市弥补了这个空缺。

QUILLIVANT XR
Pharmacological Class:
Stimulant.

Active Ingredient(s):
Methylphenidate HCl extended-release 5mg/mL; pwd for oral suspension after reconstitution.
Indication(s):
Attention deficit hyperactivity disorder (ADHD).

Pharmacology:
Methylphenidate is a racemic mixture comprised of the d-and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Clinical Trials:
The efficacy of Quillivant XR was evaluated in a laboratory classroom study conducted in 45 pediatric patients (ages 6–12 years) with ADHD. The study began with an open-label dose optimization period (4–6 weeks) with an initial Quillivant XR dose of 20mg once daily in the morning. The dose could be titrated weekly in increments of 10 or 20mg until an optimal dose or the maximum dose of 60mg/day was reached. Subjects then entered a 2-week randomized, double-blind, crossover treatment with the individually optimized dose of Quillivant XR or placebo. At the end of each week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy endpoints were the SKAMP-Combined scores at 0.75, 2, 8, 10, and 12 hours post-dosing. Results from the first double-blind, placebo-controlled week of the study demonstrated that the SKAMP-Combined scores were statistically significantly lower (improved) at all time points (0.75, 2, 4, 8, 10, 12 hours) post- dosing with Quillivant XR compared to placebo.

Legal Classification:
CII

Contraindication(s):
During or within 14 days of MAOIs.

Adults & Children:
<6yrs: not established. ≥6yrs: Individualize. Shake bottle for 10 secs before use. Initially 20mg once daily in the morning. May increase by 10–20mg per week if needed; max 60mg daily.

Warnings/Precautions:
Risk of potential abuse and dependence; monitor. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems; evaluate if chest pain, unexplained syncope, or arrhythmias develop. Monitor for hypertension and tachycardia. May exacerbate behavior disturbances, thought disorders in pre-existing psychotic disorder. Depression. Bipolar disorder. History of suicide. Monitor growth (esp. children). Reduce dose or discontinue if paradoxical aggravation occurs. Reassess periodically. Neonates. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interaction(s)
See Contraindications. Concomitant MAOIs can cause hypertensive crisis.

Adverse Reaction(s)
Appetite decreased, insomnia, GI upset, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased; hypersensitivity reactions.

How Supplied:
Bottles (w. oral dosing dispenser)—60mL, 120mL, 180mL

LAST UPDATED:
1/30/2013

完整使用说明附件：http://www.drugs.com/pro/quillivant-xr.html