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 详细处方信息以本药内容附件PDF文件（2018101618380015.pdf）的“原文Priscribing Information”为准
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英文药名: Aripiprazole Tablets

中文药名: 阿立哌唑片

药物名称

中文药名: 阿立哌唑

英文药名: Aripiprazole Tablets

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。

English name: Aripiprazole Tablets

Chinese Medicine Name: Aripiprazole Tablets

Drug name

Chinese medicine name: aripiprazole

English name: Aripiprazole Tablets

Indications

Aripiprazole is effective not only for the positive symptoms of schizophrenia, but also for the negative symptoms and cognitive functions of schizophrenia, and also for anxiety and depression.

In addition, the FDA has approved its aripiprazole (Abilify) for the treatment of acute manic depression including manic episodes and mixed episodes associated with bipolar affective disorder.

Adverse reactions

The adverse reactions were mild. After treatment with this product, the body weight changed very little, and extrapyramidal symptoms (EPS) rarely occurred, and the incidence of sedation was lower (11% vs. 8%) compared with placebo.

In addition, the incidence of QTc prolongation treated with this product was similar to placebo. In the short-term placebo-controlled study, the incidence of EPS was 6% in both the product and placebo groups, and the mean body weight change was 0.7 kg and 0.05 kg, respectively, in the product and placebo groups.

The safety and tolerability of this product was determined in more than 5,500 patient studies, including more than 1,250 patients who were treated for at least 1 year. In the short-term (4 weeks and 6 weeks) placebo-controlled clinical studies, there was no difference in discontinuation rates due to adverse events between the product group and the placebo group, 7% and 9%, respectively. The most common adverse events (incidence >15% and higher than placebo) were headache (32% vs. placebo 25%), anxiety (25% vs. 24%), and insomnia (24% versus 19%).

A study of 311 patients with stable schizophrenia for 8 weeks showed that patients taking olanzapine, risperidone or haloperidol were switched to aripiprazole. Significantly decreased weight gain, improved extrapyramidal symptoms, and decreased prolactin levels.

Dr. Jeffrey Lieberman, professor of psychiatry and pharmacology at North Carolina State University, said: "This product represents an important new treatment for schizophrenia. Clinical studies have shown that this treatment can significantly improve symptoms. And the product is safe and well tolerated."

Medication method

Aripiprazole only needs to be taken once a day, depending on the patient's condition, or in the morning or evening. Because there is no interaction between the drug and the food, it can be taken with or without food. The effective dose ranges from 10 to 30 mg. The recommended starting and target doses are 10 or 15 mg per day. Any questions, please follow the doctor's advice!

Contraindications

Patients who are known to be allergic to aripiprazole are banned.

Notes

1. It should be used with caution in patients with cardiovascular disease (myocardial infarction, ischemic heart disease, heart failure or abnormal conduction history), patients with cerebrovascular disease or hypokemia (dehydration, hypovolemia and hypotension) Pressure medication).

2. It should be used with caution in cases with a history of epilepsy or a low threshold for epilepsy (eg Alzheimer's disease dementia).

3. Patients should be warned to drive the car carefully.

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 详细处方信息以本药内容附件PDF文件（2018101618380015.pdf）的“原文Priscribing Information”为准
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