药品信息: 近日，FDA已批准精神病治疗药Abilify的最新适应症，即作为维持疗法用于I型双向情感障碍患者。该药由百时美-施贵宝和日本大冢制药株式会社共同推出。
至此，Abilify可以作为辅助用药与情绪稳定剂（锂或2-丙基戊酸钠）联用，以保持这类患者病情稳定。2008年，该药获准用作紧急疗法药。
Abilify这次获准的依据是在一项为期52周的临床实验中获取的数据。实验结果证实：与安慰剂相比较，该药与锂或2-丙基戊酸钠联用在防止患者病情复发方面（如因躁狂症、混合型和抑郁情绪障碍发作住院，因疗效欠佳或病情恶化中断实验）的效果更好。
这种药由日本大冢制药株式会社研制，并由大冢制药和施贵宝共同开发和销售，它是市场上第一种也是唯一一种局部作用型多巴胺受体激动剂。
此前，它也已经获准的适应症如下：作为单用紧急疗法药/维持疗法药医治躁狂症或伴有I型双向情感障碍的混合型精神疾病；作为辅助用药用于成人重度抑郁症患者；作为精神病治疗药；以及用于治疗儿童孤独症患者出现的烦躁易怒症状。
中文药名: Abilify (Aripiprazole Tablets)
中文药名: 阿立哌唑片
生产厂家: Otsuka America Pharma Inc.
药物名称
中文药名: 阿立哌唑
英文药名: Abilify (Aripiprazole Tablets)
生产厂家
Otsuka America Pharma Inc.
大冢制药公司
适应症
阿立哌唑不仅对精神分裂症的阳性症状有效，而且对精神分裂症的阴性症状、认知功能有改善作用，同时对焦虑、抑郁也有作用。此外，FDA已批准其阿立哌唑（aripiprazole，Abilify）用于治疗包括双极情感障碍相关的躁狂发作和混合发作在内的急性躁狂抑郁症。
不良反应
不良反应轻微, 用本品治疗后，体重变化极微，极少发生锥体外系症状（EPS），且与安慰剂相比，镇静发生率较低（11%对8%）。
另外，用本品治疗的QTc 间期延长的发生率与安慰剂相似。在短期安慰剂对照研究中，EPS的发生率本品组和安慰剂组都为6%，平均体重变化本品组和安慰剂组分别为增加0.7kg和减少0.05kg。
在5500多例病人的研究中确定了本品的安全性和耐受性，其中包括1250多例接受治疗至少1年的病人。在短期（4周和6周）安慰剂对照临床研究中，因不良反应的停药率本品组和安慰剂组无差异，分别为7%和9%。最常见的不良反应（发生率>15%且高于安慰剂）有头痛（32%对安慰剂25%），焦虑（25%对24%）和失眠（24%对19%）。
一项在311例稳定型精神分裂症患者中进行8周的试验结果表明，患者服用奥兰扎平、利培酮或氟哌啶醇后，转用阿立哌唑治疗，可使体重增加显著下降、锥体外系症状改善、催乳素水平降低。
美国北卡罗来纳州立大学的精神病学和药理学教授Jeffrey Lieberman 博士说：“本品代表了一种重要的新的精神分裂症治疗法，临床研究显示本品治疗可使症状获得显著改善，且本品安全性和耐受性良好。”
用药方法
阿立哌唑每日只需服药1次，可根据患者的具体情况早上或者晚上口服，由于该药与食物之间不存在相互作用，可与或不与食物同服。有效剂量范围为10～30mg。推荐的起始剂量和目标剂量为一日10或15mg。
任何疑问，请遵医嘱！
禁忌症
已知(阿立哌唑)过敏的患者禁用。
注意事项
1.应慎用于心血管疾病(心肌梗塞、缺血性心脏病、心脏衰竭或传导异常病史)患者、脑血管疾病患者或诱发低血压的情况（脱水、血容量过低和降压药治疗）。
2. 应慎用于有癫痫病史或癫痫阈值较低的情况（如：阿尔茨海默氏病性痴呆）。
3. 应警告患者小心驾驶汽车。
Manufacturer: Otsuka America Pharma Inc.
Drug Name
Chinese drug name: Aripiprazole
English drug name: Abilify (Aripiprazole Tablets)
Manufacturer
Otsuka America Pharma Inc.
Otsuka Pharmaceutical Company
Indications
Aripiprazole not effective for the positive symptoms of schizophrenia, but also negative symptoms of schizophrenia, cognitive function improving effect, while anxiety and depression are effective. In addition, FDA has approved aripiprazole (aripiprazole, Abilify) for the treatment of affective disorders, including bipolar and mixed episodes associated with manic episodes, including acute manic depression.
Adverse reactions
Adverse reactions were mild, after using this treatment, minimal weight change, rare extrapyramidal symptoms (EPS), and compared with placebo, a lower incidence of sedation (11% vs 8%).
In addition, using this treatment QTc interval prolonged incidence similar to placebo. In the short-term placebo-controlled study, EPS incidence of the product group and the placebo group were 6%, with an average weight change of the product group and the placebo group were increased by 0.7kg and reduction of 0.05kg.
Determine the product's safety and tolerability in more than 5500 cases of patient studies, including more than 1250 cases of patients treated for at least one year. In the short-term (4 weeks and 6 weeks) placebo-controlled clinical studies, the discontinuation rate due to adverse reactions was no difference in the product group and the placebo group were 7% and 9%. The most common adverse reactions (incidence> 15% and higher than placebo) are headache (32% vs placebo 25%), anxiety (25% vs. 24%) and insomnia (24% vs. 19%).
The test results of a 311 patients with stable schizophrenia patients for 8 weeks showed that patients taking olanzapine, risperidone or haloperidol after, switch to aripiprazole treatment, can add significant weight decreased extrapyramidal symptoms, reduce prolactin levels.
Dr. Jeffrey Lieberman, Professor of Psychiatry and Pharmacology, North Carolina State University, said: "This product represents an important new treatment for schizophrenia, clinical studies have shown that treatment of this product can achieve significant improvement in symptoms, and the product safety and well tolerated. "
Treatment methods
Aripiprazole medication only once a day, according to the specific circumstances of the patient in the morning or oral night, because there is no interaction between the drug and food, with or without food. Effective dose range of 10 ~ 30mg. Recommended starting dose and target dose of 10 or day 15mg.
Any questions, please doctor!
Contraindications
Known (aripiprazole) in patients with allergic disabled.
Precautions
1 should be used with caution in cardiovascular disease (myocardial infarction, ischemic heart disease, a history of heart failure or conduction abnormalities) patients, patients with cerebrovascular disease, or conditions induced hypotension (dehydration, hypovolemia, and antihypertensive drug treatment ).
(2) should be used with caution in history of seizures or lower the seizure threshold (such as: Alzheimer's disease, dementia).
3 Patients should be warned to drive carefu
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