FDA批准Entocort EC治疗Crohn病
阿斯特拉捷利康公司（AstraZeneca）2001年10月3日宣布，该公司成分为布地奈德的Entocort EC胶囊获得了FDA的批准。所批准的适应证为累及回肠和升结肠的轻到中度活动性Crohn病。
Crohn病是一种慢性炎症性疾病，病变主要累及肠，目前还不清楚此病的确切病因。主要的症状包括腹泻、腹部绞痛、发热和直肠出血等。治疗此病一般会耗费包括诊疗、检查和药物等大量的医疗资源，而且，目前临床上很难控制这种疾病。
布地奈德是一种合成的皮质激素，主要起糖皮质激素的作用，也有微弱的盐皮质激素作用。Entocort EC是一种新型的局部起效的布地奈德制剂，它可以明显缓解多数患者通常难以治疗的症状。由于Crohn病是一种急需新治疗药物的疾病，FDA对此药的批准可以被认为是Crohn病治疗方面的一个重要进展。Entocort EC不仅具有很好的疗效，而且也能很好地被患者耐受，所以此药是治疗Crohn病时一种不错的选择。
约1000名患者参与了评价Entocort EC的5项临床试验，他们均为轻到中度的回肠和升结肠活动性Crohn病患者。在这些试验中，48~69%的用Entocort EC 9mg每日一次治疗的患者在用药8周后病情缓解。试验规定“病情缓解”的标准为CDAI（Corhn病活动指标）评分低于或等于150。而这些患者治疗前的CDAI评分在272~290之间。
Entocort EC的另一个优势在于其有效成分在肠内释放，而此部位正是Crohn病主要累及的部位。此药在肠内迅速而充分的代谢，因此防止了大量药物被吸收入血。
Entocort EC最常见的不良反应是头痛、呼吸道感染、恶心和肾上腺功能亢进样症状。与Crohn病的系统治疗用糖皮质激素氢化泼尼松相比，在相当剂量下，此药较少引起糖皮质激素通常引起的不良反应。
Entocort EC不宜用于对布地耐德过于敏感的患者。另外，糖皮质激素能减弱下丘脑—垂体—肾上腺轴的应激能力，所以使用Entocort EC的患者在手术等应激情况发生前应系统性地补充糖皮质激素。接受系统性糖皮质激素治疗的患者改用Entocort EC治疗时，需监测肾上腺皮质功能。使用皮质激素的患者还应注意预防水痘、麻疹等感染性疾病。

部分中文Entocort EC处方资料（仅供参考）

英文药名: Entocort(Budesonide Capsules)

中文药名: 布地奈德胶囊

药品简介
轻-中度远端结肠炎的治疗：病变累及结肠远端30～40cm称远端溃疡性结肠炎，也称直乙状结肠炎。多有血性大便，轻中度患者一般无全身症状或轻微。
对表现为直肠炎或远端结肠炎的患者来说，采用口服或局部作用的治疗方式一般均可奏效，其治疗方案在一定程度上取决于患者本身的选择(如是否愿意经口服药，是否能适应局部给药，或经济承受力如何等)。
布地奈德(Budesonide，商品名为Entocort，即盐酸丁地松灌肠剂)保留灌肠。具有极高的首过效应，因此几乎无全身作用。当应用2mg剂量时，可相当于20～30mg泼尼松(或100mg氢化可的松)的作用。反复多个疗程使用布地奈德灌肠剂治疗后并不具有抑制机体下丘脑-垂体-肾上腺轴的不良作用。因此，长期使用布地奈德具有较好的安全性。其标准剂量为9mg，加大至15mg并不增加疗效，且有抑制肾上腺皮质的作用，出现晨间血浆皮质醇浓度减低。18mg的剂量不良反应增多，但仍低于全身用药。

药理作用
布地奈德是一具有高效局部抗炎作用的糖皮质激素。它能增强内皮细胞、平滑肌细胞和溶酶体膜的稳定性，抑制免疫反应和降低抗体合成，从而使组胺等过敏活性介质的释放减少和活性降低，并能减轻抗原抗体结合时激发的酶促过程，抑制支气管收缩物质的合成和释放而减轻平滑肌的收缩反应。急性、亚急性和长期毒性研究发现，布地奈德的全身作用，如体重下降、淋巴组织及肾上腺皮质萎缩，比其他糖皮质激素弱或者与其他糖皮质激素相当。经过六个不同的试验测试系统评价，布地奈德无致突变作用，亦无致癌作用。

药动学
吸入给药后，约10%～15%在肺部吸收，吸入单剂布地奈德1mg，约10分钟后达最大血药浓度2nmol/L。经气雾剂吸入布地奈德的全身生物利用度约为26%，其中2/5来自经口吞咽的部分。分布容积(Vd)约3L/kg，平均血浆蛋白结合率为85%～90%。本品主要经肝首过代谢(约90%)，代谢物的糖皮质激素活性较低。主要代谢物6β-羟布地奈德和16α-羟泼尼松龙的活性不到布地奈德的1%。布地奈德的代谢物以其原形或结合的形式经肾排泄。尿中检测不到原型布地奈德。

生产厂家
AstraZeneca

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原产地英文商品名:
ENTOCORT EC CAPSULE SR 24H 3MG/CAP 100CAPS/BOTTLE
原产地英文药品名:
BUDESONIDE
中文参考商品译名:
ENTOCORT EC 24小时缓释胶囊 3毫克/胶囊 100胶囊/瓶
中文参考药品译名:
布地奈德
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
ASTRAZENECA

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Entocort（布地奈德）药物在某些chronial炎症的治疗，导致腹泻和腹部疼痛使用。 Entocort EC和Entocort使用药物基本上控制专栏的疾病。
它包含了布地奈德是一种抗发炎类固醇是在肠道释放。 Entocort（布地奈德）会导致非常少副作用比较其他药物，因为它不是一个人的血液中释放。 Entocort（布地奈德）可以用于其他目的，以及不是上述其他。

可用性

Entocort

通用BuyEntocort（布地奈德）3毫克-50，100和150 Entocort胶囊（S）。

品牌BuyEntocort 3毫克：-45，90，135，100，200和300 Entocort胶囊（S）。

Entocort EC

通用BuyEntocort EC（布地奈德）：50，100，200，300，400，500，600，700，800，900和1000 Entocort EC胶囊（S）。

什么是Entocort EC建议剂量？

Entocort EC和Entocort药物剂量应被视为由医生或医疗保健专业指导。 但是，您采取9mg。 Entocort（布地奈德）药物在每天早上。 Entocort药物剂量可能会改变你的医生根据不同的健康和病人的年龄，你应该买Entocort相应药物按照医生的建议。

多久我可以放心地使用Entocort药物？

你可以购买医生precription Entocort用药，可以放心地使用7-8周。 然而，与Entocort（布地奈德）药物治疗的持续时间可以改变你的健康护理专业上的情况而定。 您应该咨询您的医生或健康护理专业之前先服用Entocort药物，因为它可能会在一些严重的副作用，结果也是如此。

可以Entocort药物对所有病人使用？

Entocort（布地奈德）药物不宜用于病人谁是从，如糖尿病，高血压，肝脏和肾脏疾病的治疗疾病的痛苦。 你不应该购买Entocort始终告知你的医生，如果您是从这些疾病的痛苦。 Entocort EC和Entocort药物也是不建议怀孕或谁试图怀孕的妇女。

是否有任何可能的副作用的Entocort EC和Entocort造成的影响？

Entocort EC和Entocort药物是不溶于血液流的人，非常少，因此导致副作用比较其他medicines.However，它可能会引起呕吐疲劳，丧失，异常疲倦，头晕，头痛。 你应该定期就医，同时使用Entocort（布地奈德）用药。

应该如何以及何时采取Entocort药？

Entocort（布地奈德）药物应采取或者不采取在早上的食物。 您应该压碎或咀嚼或打破Entocort欧共体和Entocort胶囊（S），并应在一次吞下整个药片。

Entocort (budesonide) | AstraZeneca
AstraZeneca
CLICK HERE for more Product Information

The active ingredient of Entocort is called budesonide, which is a locally acting medicine of the steroid type (glucocorticosteroid). It is highly effective as an anti-inflammatory drug and, because it works mainly where it is needed, it does not affect other body systems to any great degree
Entocort (budesonide)
 
Entocort (budesonide) is glucocorticosteroid for inflammatory bowel diseases.

Entocort is available as an oral controlled-release formulation of budesonide,Entocort capsules, for the treatment of Crohn's disease, and also as Entocortenema for topical treatment of ulcerative colitis.

Entocort is available in the US (as Entocort EC) and is registered in more than 40 countries.
 
Entocort EC Description
Entocort EC is a medication used in the treatment of Crohn’s disease. This is a form of medication known as a glucocorticosteroid and works by decreasing the amount of inflammation in those with this form of inflammatory bowel disease.

Entocort EC Directions
As is the case with all drugs, it is vital that you carefully follow the instructions given to you by your doctor. In most cases this will be written on the label of the medicine bottle or box and you must read this information very carefully. If you do happen to have any questions about how to take this medicine then you should talk to your pharmacist, nurse or doctor and they will be happy to help you. You must not crush, break or chew this medicine and should instead swallow it whole with a glass of water. It is not important if you take this medicine with food or on an empty stomach, however you must not mix the medicine in with your food or with any liquid. You must avoid drinking grapefruit juice or eating grapefruit while taking this medication. Where you keep the medicine is very important and in this case it must be stored at room temperature (77 degrees F) away from the sun and in the bottle or box provided or in an airtight container. You must take the medicine as directed by your doctor and if you can take it at the same time everyday i.e. at breakfast time, then that may help you to remember. It is very important that you take this medicine everyday as directed and do not miss a dose, even if you are feeling better. Failure to take your medicine as directed will likely result in the worsening of your symptoms. In the unfortunate scenario that you do forget to take a dose, you must take the missed dose as soon as you remember unless this is near the time of your next dose. In this case you should just forget about the missed dose and carry on with your normal schedule, as you must never take two doses of a single medication at the same time. If you have any concerns then you should contact your pharmacist, nurse or doctor for more information.

Entocort EC Cautions
First and foremost you should not take Entocort EC if you have experienced an allergic or other adverse reaction to it or any other ingredient that is used in the production of Entocort EC. If you are worried that you may have had an adverse reaction to Entocort EC in the past then you should discuss this with your doctor. Entocort EC will not offer you a magic cure overnight and will in most cases take many weeks to reach its full effect. For this reason it is important that you do not give up on this medicine and never stop taking a medicine without first talking to your doctor. Stopping a medicine suddenly will often result in a worsening of symptoms and side effects and in most cases your doctor will want you to come off a medicine slowly, a process known as tapering. There may be tests that are required by your doctor to check for side effects and/or monitor how effective the medicine is for you, however your doctor will talk to you about what is required. It is important to attend all laboratory and doctor appointments while you are taking Entocort EC and additional appointments may be necessary when a change to the dose is made and during the initial starting period. Entocort EC does not mix well with alcohol s and so when on this medication you should avoid alcohol as much as possible. Before having any emergency care or surgery you must alert the doctor or dentist that you are taking this medication. As this medicine takes several weeks to reach its full effect you should avoid performing tasks such as driving, operating heavy machinery or any other dangerous activities during this time, until you know what effects Entocort EC will have on your body. Entocort EC can cause dizziness and lightheadedness and using this medicine alone or with other medications, or with alcohol may impair your ability to perform dangerous tasks such as driving. Entocort EC may lower the resistance that your body has towards fighting infection and as such you should avoid those with coughs, colds, or other infections. You must not touch the inside of your nose or your eyes unless you have thoroughly washed your hands first. You must see your doctor immediately if you are exposed to tuberculosis, measles, or chickenpox during the course of this medication and up to twelve months after you have stopped taking it. You must also contact your doctor if you have any signs of infection such as muscle aches, sore throat, fever, or pain during urination.
Entocort EC may have adverse effects on the fetus in pregnant women and so all women who may be thinking about getting pregnant should weigh up the pros and cons of taking this medicine during pregnancy with their doctor. Also Entocort EC is excreted in the breast milk and so general advice at this time is to speak with your doctor or pharmacist about whether it is safe for you to breastfeed. Diabetic patients must monitor blood sugar levels carefully when on this medication; it often helps to keep a diary of your recordings to show the doctor. Ensure that you check with your doctor before you make any attempt to alter your diabetes medications while taking Entocort EC.

Entocort EC Side Effects
As is the case with most drugs Entocort EC is not without its side effects. Some of the things that you may notice when taking this medication include: nausea, headache, dizziness, vomiting, stomach upset, back pain, excess gas, tremor, changes in the menstrual cycle, trouble sleeping or nervousness. These may be minor and go away during the course of treatment, however if they do bother you then you must talk to your doctor. Entocort EC was prescribed to you, as your doctor believes that the benefits will outweigh the side effects and so it is usual to expect some symptoms. However these symptoms should not cause you major discomfort and if this is the case then please talk to your doctor. You must talk to your doctor as soon as possible if you experience any unusual bruising, change in behavior or mood, vision changes, acne, an increase in weight, swollen face or ankles, severe headache, or chest pain. Fortunately it is uncommon for someone to have an allergic reaction to this medicine, however they do occur and if you notice severe dizziness, a rash, itching, trouble breathing or swelling then you must seek immediate medical attention. If you experience any symptoms that worry you, even if they are not listed above, then it is vital that you talk to your doctor, pharmacist or nurse about it.