dxy

    FDA星期五称，精神分裂症药物是第一类获准用于治疗儿童和青少年自闭症的药物。强生公司的利培酮能用于治疗易激惹，包括攻击行为、蓄意自伤和发脾气。易激惹泛指一系列症状，从重复性动作到语言障碍和间断智力迟钝。

    利培酮是强生公司的拳头产品，2005年全球销售额为3.5亿美元。

    FDA称，新适应症的批准基于两个为期8周的研究结果，156个5至16岁的易激惹患者服用利培酮或安慰剂，90%的患者年龄在5至12岁。服用利培酮的患者其两项行为测试分值得到了改善。

    疾病预防控制中心在五月份评估了受易激惹影响的儿童，每175儿童就有一个受其影响。在美国至少有300,000儿童患有易激惹。

    强生公司说，利培酮不能治疗社交障碍等易激惹的核心症状，但已证明其对干扰学校、学习和家庭生活有关的行为有益。

    口服药物利培酮，1993批准用于成人精神分裂症的短期治疗。2003年批准用于双相成人精神分裂症的短期治疗。最常见的不良反应为：困倦、便秘、疲劳和体重增加。

Schizophrenia drug approved for autism
Sunday Oct 8 08:31 AEST
A schizophrenia drug won US approval as the first medicine to treat symptoms of autism in children and adolescents, the Food and Drug Administration said on Friday.

The FDA said Johnson & Johnson's Risperdal could be used to treat irritability, including aggression, deliberate self-injury and temper tantrums.

Autism is a term used to describe a broad range of symptoms, from repetitive behaviours to trouble with language and sometimes mental retardation.

Risperdal is already Johnson & Johnson's biggest-selling product, with 2005 global sales of about $3.5 billion.

The FDA said it based the new approval on two eight-week studies in 156 autistic patients ages 5 to 16 who took Risperdal or a placebo. Ninety-per cent of them were between the ages of 5 to 12.

Patients treated with Risperdal had improved scores on two scales measuring behavioural symptoms, the FDA said.

The Centers for Disease Control and Prevention estimated in May that autism affected up to one in every 175 children. That would mean at least 300,000 US school children have autism.

Johnson & Johnson said Risperdal does not treat core autism symptoms such as communication problems and trouble with social interactions, but "it has been shown to be beneficial in treating the associated behavioural disturbances that can interfere with school, learning and family life."

Risperdal, an oral drug, has been sold since 1993 for the short-term treatment of adults with schizophrenia. It was approved in 2003 for short-term treatment of adults with bipolar mania. The most common side effects include drowsiness, constipation, fatigue and weight gain.

编辑：蓝色幻想