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当前位置:药品说明书与价格首页 >> 精神心理 >> 抑郁症/焦虑症/躁抑症 >> 药品推荐 >> 抗抑郁症新药-Lexapro(草酸艾司西酞普兰片)

抗抑郁症新药-Lexapro(草酸艾司西酞普兰片)

2010-11-06 14:36:34  作者:新特药房  来源:中国新特药网天津分站  浏览次数:4735  文字大小:【】【】【
简介: 日前,美国食品与药物管理局(FDA)批准将Lexapro一种强效、病人耐受好的选择性5- 羟色胺再吸收抑制剂(SSRIs)用于治疗抑郁症。据哥伦比亚大学精神病学研究所的Jack M.Gorman 博士介绍,Lexapro被认为 ...

日前,美国食品与药物管理局(FDA)批准将Lexapro一种强效、病人耐受好的选择性5- 羟色胺再吸收抑制剂(SSRIs)用于治疗抑郁症。据哥伦比亚大学精神病学研究所的Jack M.Gorman 博士介绍,Lexapro被认为可更好地解决以往抗抑郁治疗的不利因素,即患者对药物反应不好以及发生不能耐受的副反应。该药和迅速缓解抑郁症症状,并且不良反应和药物相互作用很少发生,研究人员预计,该药物作为一种新的药物疗法将会受到病人的欢迎。Lexapro的疗效和良好的耐受性已得到临床试验的证明。与 Celexa40mg/d的剂量相比 Lexapro的推荐剂量仅为10mg/d。研究发现,许多病人在服用此剂量治疗1~2周后,抑郁症状就有了明显改善。

    Forest试验室的首席执行官 Howard Solman说:"Celexa是For est试验室于1998年首先发现的选择性5-羟色胺再吸收抑制剂,被证实可有效治疗重症抑郁。而 Lexapro则是强效与良好耐受性的结合,使患者在治疗早期就能感受到症状的减轻,这正是抑郁症治疗中最想看到的成果。"有趣的是, Lexapro正是一直被广泛使用的抗抑郁药Celexa.(citalopram,西肽普兰)的异构体。

    Lexapro(escitalopram)是Celexa 获批后。FDA批准的第一个抗抑郁新药,这两种药都是由纽约Forest 试验室生产的SSRIs,同类药物还有氟西汀(Prozac)、舍曲林(Zoloft)和帕罗西汀(Paxil)。Lexapro是利用一种新的方法从Celexa的两个对映体中去除一个后创造出的单一对映体药物。Celexa是一种包含两个对映体(S-对映作与R-对映体)的消旋酸化合物。而存Lexapro的结构中,没有抗抑郁作用的R-对联体已被移除,保留了有抗抑郁活性的S-对映体。

    Lexapro获得FDA的批准是基于一项涉及110名18~65岁的中- 重度抑郁症患者使用Lexapro的有效性和安全性的临床研究之上的。在这项双盲、安慰剂对照的我中心 研究中,481名患者作为安慰剂对照组,其余病人分为Lexapro 10mg/d、20mg/d和Celexa40mg/d三个治疗组。试验证实,Lexapro 10mg/d、20mg/d组的症状改善情况明显优于对照组(P=0.01);而 Lexapro10mg/d治疗组的疗效又优于Celexa络。作为主要研究终点的蒙哥马利和阿斯伯格抑郁症等级量表(MADRS)结果显示,每天服用Lexapro10mg或20mg的病人与对照组病人相比,从服药第2周以后,与其症状改善有关的量表的数据就表现出明显的离散性。该研究的次要研究终点包括汉密尔顿抑郁症量表(HAM-D)和临床总体印象量表(CGI-I),测试结果都显示出,Lexapro的两个治疗组与安慰剂相比,其统计数据在治疗的第1 周成每2周就出现明显的离散现象,而与Celexa组相比,数据的离散出现得稍晚些。经过8周的试验,研究人员发现,所有Lexapro治疗组所得到的与疗效有关的数据的统计结果(包括MADRS与CCI-I),在治疗开始时及整个治疗过程中部优于Celexa治疗组和安慰剂组。

    此外。在这项研究中,Lexapro 的两个治疗组病人都表现出良好的对药物的耐受力。在对Lexapro 组病人因不良反应而退出试验的比例(Lexapro组15%,而对照组为 7%)的统计中,研究人员发现, Lexapro主要的不良反应只有恶心呕吐,发生率约10%;通常所报道的Lexapro与安慰剂对照试验中,该药的不良反应(发生率>5%,约为安慰剂组的2倍)有恶心呕吐(15%对7%)、失眠(9%对4%)、射精障碍(9%对<1%)、嗜睡(6%对 2%)、多汗(5%对2%)和疲劳(5%对2%)。

    此外,一份来自杜克大学的临床研究报告指出,Lexapro可以明显改善焦虑症状,同样可以用来治疗普通的焦虑失调症。弗吉尼亚大学医院通过研究证实,采用 Lexapro10~20mg/d对社交焦虑症也有良好的疗效和耐受性。加州大学医院研究报告指出,它还可以明显减少恐惧的频率和程度,减轻预想焦虑和恐怖逃避症,改善患者临床症状和生活质量。这份报告表明它是一种有效的、高依从性的治疗恐怖症的药物。

    每年约有1900万美国人患上抑郁症。在美国,四分之一的女性和十分之一的男性一生中可能会患抑郁症,世界卫生组织预测,到 2020年抑郁症将成为威胁人类健康的首要原因

Lexapro(escitalopram草酸依他普仑片)中英文处方资料
商品名:
Lexapro
通用名: 草酸依他普仑片
英文名:Escitalopram Tablets (es-sye-TAL-oh-pram)

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Lexapro outweigh the risks.

Family and caregivers must closely watch patients who take Lexapro . It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
 
Lexapro适应证:用于治疗抑郁症或焦虑症.
Treating depression or generalized anxiety disorder. It may also be used for other conditions as determined by your doctor.

Lexapro is a 选择性5羟色胺再吸收抑制剂(SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Lexapro禁忌证:
you are allergic to any ingredient in Lexapro
you are taking citalopram
you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1 antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, or sibutramine
Contact your doctor or health care provider right away if any of these apply to you.

Lexapro使用前 :
Some medical conditions may interact with Lexapro . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
if you have a history of seizures, liver problems, severe kidney problems, stomach or bowel bleeding, or metabolism problems
if you are dehydrated, have low blood sodium levels, or drink alcohol
if you will be having electroconvulsive therapy (ECT)
Some MEDICINES MAY INTERACT with Lexapro . Tell your health care provider if you are taking any other medicines, especially any of the following:

Fenfluramine derivatives (eg, dexfenfluramine), linezolid, lithium, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, St. John's wort, or trazodone because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
Tramadol because the risk of seizures may be increased
H1 antagonists (eg, astemizole, terfenadine) or phenothiazines (eg, chlorpromazine, thioridazine) because severe heart problems, including irregular heartbeat, may occur
Carbamazepine or cyproheptadine because they may decrease Lexapro 's effectiveness
Clozapine, pimozide, risperidone, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Lexapro
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lexapro may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Lexapro 使用方法:
Use this medicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lexapro comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lexapro refilled.
Take Lexapro by mouth with or without food.
Taking Lexapro at the same time each day will help you remember to take it.
Continue to take Lexapro even if you feel well. Do not miss any doses.
Do not suddenly stop taking Lexapro without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Lexapro and whenever a change in dose is made.
If you miss a dose of Lexapro , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lexapro .

Important safety information:
Lexapro may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lexapro with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol while you are using Lexapro .
Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lexapro ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
One to 4 weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Lexapro for longer than prescribed without checking with your doctor.
Children, teenagers, and young adults who take Lexapro may be at increased risk for suicidal thoughts or actions. Watch all patients who take Lexapro closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Lexapro and a medicine called citalopram have the same active ingredient. Do not take Lexapro if you are also taking citalopram.
If your doctor tells you to stop taking Lexapro , you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Lexapro .
Lexapro may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
Serotonin syndrome is a possibly fatal syndrome that can be caused by Lexapro . Your risk may be greater if you take Lexapro with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
Caution is advised when using Lexapro in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
Caution is advised when using Lexapro in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
Lexapro should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
Lexapro may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Lexapro .
PREGNANCY and BREAST-FEEDING: Lexapro may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lexapro while you are pregnant. Lexapro is found in breast milk. Do not breast-feed while taking Lexapro .

Lexapro副作用 :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; lightheadedness when you stand or sit up; loss of appetite; nausea; stomach upset; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; fast or irregular heartbeat; hallucinations; memory loss; menstrual period changes; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Lexapro服用过量:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include coma; fast, slow, or irregular heartbeat; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting.

Lexapro 最佳用量:
Store Lexapro at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lexapro out of the reach of children and away from pets.

责任编辑:admin


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