脑康平Aggrenox (aspirin 25mg + dipyridamole 200mg)--预防二度中风新药

Aggrenox (内含25mg aspirin及200mg dipyridamole)胶囊为最近在台湾上市用于预防二度暂时性脑血管缺血或缺血性脑中风药物。美国药物食品管理局于1999年11月22日核准Aggrenox胶囊在美国上市，核准剂量为每天两次，每次一颗胶囊。 Aggrenox内含两种不同机转的抗凝血药物;低剂量aspirin能选择性抑制cox脢在血小板的作用，增加PGI2浓度，提高抗凝血效果，而dipyridamole主要作用机转于细胞内,借抑制phosphodiesterase活性，增加cAMP细胞内的浓度，启动一连串抗凝血机转。两者相辅相乘，提高预防二度中风的效果。

根据大型ESPS-2(1)(2)针对预防二度中风的大型临床试验发现，6602位在试验前三个月内发生中风或TIA的受试者，在两年的follow-up期间发现，四组(1)aspirin 25mg bid: 1649 pts. (2)dipyridamole 200mg bid: 1654 pts.(3)aspirin 25mg+ dipyridamole 200mg bid: 1650 pts. (4)placebo bid: 1649 pts,每天两次服用指定药物的结果，Aspirin组及dipyridamole组达到降低二度中风统计上的意义，分别降低16%及18%机率，而aspirin + dipyridamole组和placebo相比，降低37%中风机率(p<0.001)。和aspirin组相比，降低23%机率(p=0.006)，其ARR(absolute risk reduction)两年为3%，也就是每年约1.5%。

一个分析所有aspirin+dipyridamole的meta-analysis(3) (包括ESPS-2)发现，aspirin+dipyridamole能降低约10%血管病变机率，而主要导因于降低非致命性中风发生的机率。

Aggrenox是目前唯一合并aspirin及dipyridamole的药物，目前并无试验比较其与clopidogrel或ticlopidine预防二度中风的效果差异。但根据ESPS-2, TASS, CAPRIE三个分别针对Aggrenox, ticlopidine, clopidogrel的大型临床试验发现，Aggrenox似乎比另外两者在预防二度中风有较好的效果。

副作用方面,头痛(38%)是较常见的问题,而此问题可能导因于dipyridamole(原因不明)。在ESPS2试验中,有8%服用aspiring+dipyridamole的病人有头痛问题,而服用aspirin或placebo组约有2.1%机率。 (1)而另一个文献中发现(4),健康的人在服用Aggrenox每天两次,五天之后可以耐受这种短暂的头痛现象。其它副作用包括胃部不适(18%),恶心(16%),腹泻(13%)。

药品名称

英文商品名：Aggrenox
中文商品名：脑康平
适应症

具抗血栓的作用，用于曾因血栓引起脑部短暂缺血或完全缺血中风病人，减少中风之再复发。
用法用量

1.请确实依照医师所指示服用，每日服用一至2次。
2.可与或不与食物并用，整颗胶囊配水吞服，不可咀嚼。服用后至少半小时不要躺平，可以减少对食道的伤害。
3.任何疑问，请遵医嘱！
注意事项

1.按时服药，不可随意停药。若忘记服药,则于想起时尽快服用；如果一天服药超过两次以上，若距离下次服药时间少于4小时，不需要补服，按原时间服用即可，切勿一次服用两倍剂量。
2.因此药中含阿司匹林之成分，下列症状患者需小心使用：气喘、过敏性鼻炎、鼻息肉、慢性或再发性胃或十二指肠不适，肾脏或肝脏功能受损，及蚕豆症患者。此外，对非类固醇抗发炎药物过敏者亦应小心使用。
3.此药具血管扩张作用，因此有严重冠状动脉疾病患者应小心使用。
4.服用此药期间如需服用其它药品时，请主动告诉您的医师或药师。
5.请将本剂联同药袋放置於室温之阴凉干燥处避光保存，请勿冷藏或冷冻。请勿放在孩童可以取得的场所。
副作用

常见的副作用：
头痛、低血压、热潮红、心搏加速、腹泻、胃肠道出血、眩昏、耳鸣、皮肤起红疹或痒等过敏现象；当您发生上列症状且持续数日或严重时，请停药并立即就医或与医师联络。
怀孕或哺乳

如果您准备怀孕或已怀孕，请开始服药前告知您的医师或药师。

中文商品名：脑康平
英文药名: Aggrenox (Dipyridamole/Acetylsalicylic acid Capsules)

原产地英文商品名
AGGRENOX 25mg/200mg/capsule 60capsules/box 12 HR
原产地英文药品名:
ASPIRIN/DIPYRIDAMOLE
中文参考商品译名:
脑康平 25毫克/200毫克/胶囊
生产厂家中文参考译名:
勃林格殷格翰
生产厂家英文名:
Boehringer Ingelheim

Aggrenox^® (aspirin/extended release dipyridamole) 25 mg/200 mg capsules, a prescription medication, is approved to reduce the risk of stroke in patients who have had a stroke or a TIA. AGGRENOX contains aspirin. Like aspirin, AGGRENOX should be avoided in the third trimester of pregnancy and should not be used in children or teenagers because of the risk of Reye's syndrome. Patients with a history of stomach ulcers should avoid using aspirin. Because AGGRENOX contains aspirin, the risk of bleeding is increased and it may take longer to stop bleeding. Patients who consume three or more alcoholic drinks every day should be aware of the bleeding risks involved with chronic, heavy alcohol use while taking aspirin. Headache and stomach discomfort are common AGGRENOX side effects.

AGGRENOX is a prescription medication that is indicated to reduce the risk of a stroke recurrence after a TIA (transient ischemic attack) or stroke.

A stroke occurs when a blood clot blocks a blood vessel (known as an ischemic stroke) or when a blood vessel breaks (hemorrhagic stroke). When this happens, blood cannot get through to a section of the brain, so that part of the brain's oxygen supply is cut off. Within minutes, those brain cells die and abilities controlled by those cells are lost. A TIA is a brief episode of stroke-like symptoms with no lasting brain cell damage.

AGGRENOX makes platelets in the blood less sticky, so they don't clump together and form blood clots. AGGRENOX is the only prescription medication that is demonstrated to reduce the risk of stroke in patients who have had a TIA or an ischemic stroke.

What is Aggrenox?

Dipyridamole keeps platelets in your blood from sticking together to form clots.

Aggrenox is a capsule containing 25 mg aspirin and 200 mg dipyridamole.

Aggrenox is used to reduce the risk of stroke in people who have had blood clots or a "mini-stroke" (also called a transient ischemic attack or TIA).

Aggrenox may also be used for purposes other than those listed in this medication guide.

Important information about Aggrenox

Stop using Aggrenox and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include weakness or fainting, black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Before taking Aggrenox

Before taking Aggrenox, tell your doctor if you are allergic to any drugs, or if you have:

• a history of stomach ulcers or bleeding;

• a bleeding disorder such as hemophilia;

• heart disease, congestive heart failure, or recent heart attack;

• liver disease;
• kidney disease; or

• low blood pressure.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Aggrenox without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Aggrenox can pass into breast milk and may harm a nursing baby. Do not use Aggrenox without telling your doctor if you are breast-feeding a baby.