6月27日,强生公司宣布FDA批准哌甲酯(methylphenidate,专注达,Concerta)用于治疗18~65岁成人注意缺陷与多动障碍(ADHD)。ADHD是儿童最常见情感、认知和行为障碍疾病,根据美国国立精神卫生研究所的研究,约有30%~70%的ADHD儿童成年后仍出现类似症状。
癫痫儿童中注意力缺陷多动障碍(ADHD)的发病率较高,约为12%~39%。近期的一项研究发现,一种渗透型的缓释哌甲酯复合制剂(Concerta)能在不增加ADHD患者癫痫和抽搐发生风险的基础上有效提高应答率。
共有27名同时患有ADHD和癫痫的患者入组该项交叉研究,患者的平均年龄为10.7岁,常规服用抗癫痫药物,且无抽搐发作至少1个月。研究人员将患者随机分入Concerta治疗组和安慰剂组,随后在双盲的情况下交叉组别。有3名患者的目前用量为18mg/日,8人为36mg/日,16人为54mg/日。采用临床综合印象量表(CGI)的得分改善情况来评估患者的应答情况,再根据应答情况评定患者是“明显改善”还是“改善非常明显”。
结果显示,在27名服用18mg Concerta的患者中,治疗组和安慰剂组中分别有11人和2人出现了应答,且停药率为0;在24名用药量为36mg的患者中,治疗组和安慰剂组中分别有13人和3人出现了应答,8人停药;在12名用药量为54mg的患者中,治疗组和安慰剂组中分别有9人和1人出现了应答,2人停药。研究过程中未发现严重的不良反应事件,与基线相比,每周癫痫的发生率并没有明显的上升,患者对该药的耐受性普遍较好。
Concerta (Methylphenidate)
Concerta (methylphenidate) is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Concerta is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). It is indicated for use in children 6 years of age and older, adolescents, and adults up to the age of 65. Concerta should be used as an integral part of a treatment program that includes psychological, educational, and social measures.
Concerta may also be used for other purposes not listed here.
Most important: Do not use Concerta if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use Concerta before the MAO inhibitor has cleared from your body. Do not use Concerta if you are allergic to methylphenidate or if you have glaucoma, overactive thyroid, severe high blood pressure, tics or Tourette’s syndrome, angina, heart failure, heart rhythm disorder, recent heart attack, a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, or severe anxiety, tension, or agitation.
Concerta may be habit-forming and should be used only by the person it was prescribed for. Never share Concerta with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
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