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Abciximab(阿昔单抗:ReoPro)

 

【适应症】  

          参见用法用量。 

【适应症/成人常用量】 
         静脉给药 不稳定型心绞痛；经皮冠脉介入 (PCI)治疗期间辅助用药预防急性缺血发作 250 mcg/kg，静脉小壶，然后以0.125 mcg/kg/分的速率滴注(最大：10 mcg/分)。不稳定型心绞痛：最早在PCI前24小时开始滴注至手术后12小时。预防PCI急性缺乏并发症：PCI前 10-60分钟开始滴注，直至手术后12小时。
        点击查看不同适应症和各年龄组别患者的用法用量 

【禁忌】 
          以下情况禁用：对本药任何成份或鼠类蛋白质过敏，活动性出血，近期（6周以内）胃肠道出血或有临床意义的泌尿生殖系出血，2年内脑血管意外或遗留明显神经系统缺陷，出血体质，血小板减少症（<10000/uL），凝血功能异常，1周内曾使用口服抗凝药，近期（6周）外科大手术或创伤，颅内肿瘤，动静脉畸形或动脉瘤，严重未控制的高血压，重度肝肾功能损害，可疑或明确的脉管炎病史，PTCA术前或术中需静脉注射右旋糖苷。 

【注意事项 】 
         以下情况慎用：75岁以上的老人，妊娠和哺乳期妇女、18岁以下儿童，体重低于75 kg，近期溶栓治疗和经皮冠状动脉成形术未成功的患者。再次给药，合用溶栓药、抗凝药和其它抗血小板药物，静脉开放和/或动静脉穿刺/插管的患者。给药前，检查血小板计数、凝血酶原时间和活化部分凝血活酶时间，明确是否存在凝血异常。

【不良反应】 
          低血压、心动过缓、胸骨后或胸痛、心房颤动/扑动、恶心、呕吐、头痛、发热、血肿、血管疾病、贫血、白细胞增多、感觉迟钝、精神混乱、思维异常、头晕、胸膜炎、胸腔渗液、肺炎、尿路感染、疼痛、周围水肿、视力异常、发音困难、瘙痒症、溶血性贫血、皮肤淤斑。
        严重不良反应: 出血（给药后首3个小时，如胃肠道、泌尿生殖道、腹膜后）、血小板减少、产生抗人嵌合抗体。

【药物相互作用】 
          人抗嵌合抗体（HACA）阳性的患者如使用其它诊断性或治疗性单克隆抗体，可能出现过敏或超敏反应。
严重药物相互作用: 合用溶栓药、抗凝药和其它抗血小板药，增加出血的风险。
        查看 详细药物相互作用 

FDA妊娠分级
     
        C级: 动物研究证明药物对胎儿有危害性（致畸或胚胎死亡等），或尚无设对照的妊娠妇女研究，或尚未对妊娠妇女及动物进行研究。本类药物只有在权衡对孕妇的益处大于对胎儿的危害之后，方可使用。 
 
        法国研究者报告，对急性ST段抬高的心肌梗死(STEMI)患者的长期随访显示，进行支架置入同时接受GPIIb/IIIa受体抑制剂阿昔单抗（abciximab ）的患者比只接受支架置入的患者有较高的生存率。

        Pitie-Salpetriere大学医院的Gilles Montalescot医生说，药物的初始益处在3年的随访中持续存在。先前的研究只对患者随访了30天。在12月的《欧洲心脏杂志》（Eur Heart J 2005; 26:2520-2523）上，Montalescot医生及其同事指出，本研究继续随访接受了阿昔单抗以及支架置入的149例STEMI患者。另外151例患者接受安慰剂和支架置入。

        对288例患者盲随访3年并使用意向－治疗分析显示，全因死亡率阿昔单抗组为9.1%，安慰剂组为12.2%。死亡或再梗死的累及发生率阿昔单抗组为11.8%，安慰剂组为16.9%。阿昔单抗组复发性缺血也显著减少(11.5% vs 21.7%)。

        Montalescot医生总结说，使用基础血管成形术治疗的ST段抬高的心肌梗死是使用GPIIb/IIIa抑制剂的最佳临床指征。

 

 

阿昔单抗 Abciximab   中文别名： 阿昔单抗、抗血小板凝聚单克隆抗体 英文别名： Centorx、Reopro 生产企业：   药品类别： 其它循环系统用药

药理药动

本品选择性阻断血小板糖蛋白Ⅱb／Ⅲa受体，而防止纤维蛋白元、血小板凝集因子(VWD)、玻璃体结合蛋白及纤维蛋白结合素与激活的血小板结合。  本品是一种带有精氨酸-甘氨酸-天门冬氨酸(RGD)合成的肽按顺序与血小板糖蛋白Ⅱb／Ⅲ受体结合。本品不是与RGD位点结合，而是阻断大分子进入受体(通过空间障碍和／或结构形态的作用)。  本品为嵌合性单克隆抗体7E3的碎片，它与血小板表面的糖蛋白Ⅱb／Ⅲa受体结合，以阻断纤维蛋白元，VWD因子和其它有粘性的分子与受体位点结合，从而抑制血小板聚集防止形成血栓，堵塞血流而致心肌急性缺血。  药动学  静脉注射本品后，游离血小板数量迅速下降，主要发生在第一个半衰期(10min)内和第二个半衰期(30min)内，作用快可能是因为该药与血小板糖蛋白Ⅱb／Ⅲa受体结合迅速。与以每分钟10mg阿司匹林给药的患者作对照，本品静脉滴注(0.25mg/kg)2小时后，抑制了90％以上的血小板凝集。给药10天后，仍出现少量的糖蛋白Ⅱb／Ⅲa受体阻断。

适 应 症
	本品适用于经皮穿刺冠状血管成形术或动脉粥样化切除术，为防止病人突然发生冠状血管堵塞引起心肌急性缺血的辅助治疗。  处于突然发生堵塞的高危病人，至少要伴有以下情况之一：不稳定的心绞痛或无Q性心肌梗塞；在12小时内发作的急性Q性心肌梗塞；在扩张动脉时Ⅱ型血管损伤；至少65岁以上的妇女，在扩张动脉时Ⅰ型血管损伤；糖尿病人扩张动脉时Ⅰ型血管损伤或与7日内发生的心肌梗塞有关的血管成形术。在这些情况下，本品与阿司匹林和肝素是必须使用的。  本品对正在进行的血管成形术有抗血栓形成的活性并可预防血管再狭窄的发生。

用法用量
	在血管成形术前10分钟，由静脉滴注本品按每公斤体重250μg，滴注1分钟以上，然后以每分钟滴入10μg，维持12小时。  [制剂与规格]静脉注射剂：每小瓶(5ml)含本品10mg。  [贮藏]本品应冷藏，但不可冻结或振摇。

不良反应
	给药后36小时出血是最常见的不良反应。因此，本品不应给予活动性出血或有出血倾向的病人。  其它不良反应包括低血压、恶心、呕吐、头痛、心动过缓、发热和血管功能障碍等。

禁忌症
	给药后36小时出血是最常见的不良反应。因此，本品不应给予活动性出血或有出血倾向的病人。  本品还未经过动物遗传研究，因此尚不清楚用于孕妇时会否引起致命危害或影响胎儿。除非确实需要，才能将本品用于孕妇。本品对儿童及哺乳期妇女的安全情况尚未确定，故不宜使用。  由于本品会增加出血的危险，故有以下情况者禁用：急性内出血；近期内(6周内)胃肠道出血或泌尿道出血；2年内的脑意外损伤；脑损伤出现明显的神经系统缺陷；有出血倾向；7天内口服抗凝药(除非凝血时间低于对照组的1.2倍)；血小板减少症(＜100000 cells/ul)；近期内(6周内)作过大的外科手术或有严重损伤；颅内肿瘤；动静脉畸形或动脉瘤；严重的失控性高血压；有脉管炎史；经皮透腔血管成形手术前或手术中注射了右旋糖酐者；对本品或鼠蛋白过敏者。

药物相互作用
	由于本品有抑制血小板凝集的作用，故在与其它影响凝血的药物合用时要谨慎。这些药物包括：溶血栓药、口服抗凝药、非甾体抗炎药及潘生丁等。本品不能与低分子右旋糖配合用，在11例既用本品又用低分子右旋糖酐的病例中，5例发生大出血，4例发生轻微出血，而5例以安慰剂合用低分子右旋糖酐的病人未出现出血。

 

Uses of Abciximab:

It is used during a heart treatment to protect the arteries.It is used to lower the number of heart attacks in patients who have unstable angina or mild heart attacks.

What do I need to tell my doctor BEFORE I take Abciximab?

If you have an allergy to abciximab or any other part of abciximab.If you are allergic to mouse proteins, talk with the doctor.If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.If you have any of these health problems: Aneurysm, arteriovenous malformations, bleeding problems, blood vessel problems, brain tumor, low platelet count, or high blood pressure.If you have ever had a stroke.If you have had any of these health problems within the past 6 weeks: Blood in the urine, stomach or bowel bleeding, surgery or injury, or vaginal bleeding.If you are taking a blood thinner.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take abciximab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Abciximab?

Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.Have blood work checked as you have been told by the doctor. Talk with the doctor.Very bad and sometimes deadly bleeding problems have happened with abciximab. Talk with the doctor.Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Abciximab) best taken?

Use abciximab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.Very bad dizziness or passing out.Chest pain or pressure.Slow heartbeat.Feeling very tired or weak.

What are some other side effects of Abciximab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Back pain.Upset stomach or throwing up.Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Abciximab?

If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

If your symptoms or health problems do not get better or if they become worse, call your doctor.Do not share your drugs with others and do not take anyone else's drugs.Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Check with your pharmacist about how to throw out unused drugs.Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about abciximab, please talk with your doctor, nurse, pharmacist, or other health care provider.If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abciximab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using abciximab.

Review Date: December 6, 2017