阿斯利康日前宣布FDA已经批准symbicort160/4.5 mcg两次/日,用于COPD(包括慢性支气管炎和肺气肿)患者改善气流障碍治疗。FDA的这个决定是基于两个关键性代号分别为SHINE(6个月)和 SUN(12个月)临床试验结果而确立的。这两个试验发现symbicort在用首剂量5分钟内能改善肺功能，同时在研究期间能维持和促进肺功能。自从 2007年6月，适合12岁以上的哮喘患者长期维持治疗的Symbicort定量加压式气雾器(pMDI)在美国已经可以买到。

阿斯利康的首席医务官霍华德. 哈钦森医生说：每天有超过1200万名的美国COPD患者在饱受其症状之苦。Symbicort的批准给COPD患者带来一个新的治疗选择，它可以改善肺功能，控制症状，同时迅速起效。COPD是美国人死亡的第四大原因。在这 1200万患者外，估计有相等数量的未诊断的COPD患者。COPD包括两种严重的肺部疾病——肺气肿和慢性支气管炎，它们导致慢性气道炎症以及肺功能的进一步丧失，使正常呼吸困难。

FDA的批准基于两个关键、有效、安全的试验(第III 阶段)，这两个实验评估了超过3600名年龄在40岁及以上有中到重度COPD的患者。研究证明使用symbicort pMDI(苯均四酸二亚酰胺) 160/4.5 mcg 有相当大的意义，在治疗期间平均一秒钟用力呼气量(FEV1)超过4.5mcg的福莫特罗和安慰剂。另外，治疗期间对比于布地奈德160mcg和安慰剂，病人使用Symbicort后在1小时FEV1从基线水平超越了前两者。而且，从开始到显著地支气管扩张(FEV1改善超过15%)的时间是5分钟。在 12个月的研究中 Symbicort有很好的耐受性，并且肺炎的发生率相比安慰剂没有不同。除了肺炎外，接受symbicort pMDI 160/4.5 mcg治疗相比于用福莫特罗4.5mcg和安慰剂潜在肺部感染(如：支气管炎和下呼吸道感染)发生率较高。据报道，最常见的药物相关性副作用包括鼻咽炎 (普通感冒)，口腔念珠菌感染，支气管炎，鼻窦炎，上呼吸道病毒感染。

“通过这些关键性的研究，Symbicort很快的被证明可以维持改善肺功能，在长期有中到重度COPD的患者中有良好的耐受性”，首席研究员 Donald博士说。保健专业人员和有严重的COPD的病人现在能考虑使用Symbicort作为一种改善症状和控制疾病的治疗选择。

世界COPD组织推荐对于那些重度以上的COPD患者，除了其他的治疗选择外，可以使用吸入式皮质类固醇加长效β受体激动剂。COPD的普通症状包括气短、慢性咳嗽、喘息和粘液过度分泌。它是一种进展性疾病，这表明COPD患者随时间流逝会发生预期性肺功能恶化。症状严重时，病人从事简单的、日常的工作就很困难。随着疾病发展，COPD患者患者可能需要长期氧疗。

SYMBICORT 160/4.5 mcg被证实可以用于COPD患者(包括慢性支气管炎和肺气肿)改善气流障碍的治疗。SYMBICORT 用于COPD患者的推荐剂量是160/4.5 mcg吸入两次每日，同时也证明SYMBICORT可用于12岁及以上的哮喘患者的长期维持治疗。SYMBICORT治疗呼吸性疾病的效果兼容了布地奈德、皮质类固醇和福莫特罗(快速长效β受体激动剂)三种药物的疗效，这三种药物都是已经证明了的治疗呼吸性疾病效果较好的药物，但是SYMBICORT不能代替速效吸入剂，也不能用于急性COPD和哮喘的治疗。

据报道，可控性吸入皮质类固醇的主要副作用是下呼吸道感染包括肺炎。在SYMBICORT用于COPD治疗的两个对比性临床试验中，相比于安慰剂组，SYMBICORT160/4.5 mcg组的肺炎发生率没有不同，但是肺部感染(如支气管炎)的发生率较高。SYMBICORT不是急救药，不能代替速效吸入剂来治疗急性症状;它也不是哮喘和COPD患者迅速恶化期或有潜在生命危险期的首选药。接受SYMBICORT治疗的病人不能再用福莫特罗或者吸入其它长效β受体激动剂。

过多的β肾上腺素能药刺激可引起中枢神经系统和心血管系统效应。SYMBICORT，像其它含拟交感神经胺类的产品一样，用于心血管疾病包括冠状动脉功能不全、心律不齐、高血压治疗时须谨慎。一些病人可能会有血压升高和心率加快。在COPD临床试验中有不低于3%的报告说最常见的副作用是鼻咽炎，口腔念珠菌感染，支气管炎，鼻窦炎，上呼吸道感染。在哮喘临床试验中有不低于5%的报道说最常见的副作用是鼻咽炎、头痛、上呼吸道感染、咽喉痛、鼻窦炎和胃部不适。从全身应用皮质类固醇到吸入皮质类固醇的病人需要特别注意。

Symbicort Turbuhaler 160/4.5ug

Brand Name: Symbicort
Generic Name: Budesonide and formoterol inhalation
Manufacturer: AstraZeneca

What is Symbicort?
Budesonide is a steroid that reduces inflammation in the body.

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Symbicor is used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD).

Symbicort may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about Symbicort?
Do not use Symbicort to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, short-acting inhalation medication to treat an asthma attack. Symbicort may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of Symbicort and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using Symbicort.
Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.
It is important to use Symbicort regularly to get the most benefit. Get your prescription refilled before you run out of Symbicort completely.

What should I discuss with my healthcare provider before using Symbicort?
Symbicort may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of Symbicort and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using Symbicort.
Before using Symbicor, tell your doctor if you are allergic to budesonide or formoterol, or if you have:

a food or drug allergy;

• heart disease or high blood pressure;
• epilepsy or other seizure disorder;
• diabetes;
• herpes infection of the eyes;
• tuberculosis;
• any active infection;
• a metabolic disorder (such as low potassium levels in your blood); or
• a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Symbicort.

FDA pregnancy category C. Symbicort may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Symbicort passes into breast milk or if it could harm a nursing baby. Do not use Symbicort without telling your doctor if you are breast-feeding a baby. Do not give Symbicort to a child younger than 12 years old.
Long-term use of a steroid medicine may lead to bone loss (osteoporosis). Other factors such as smoking, lack of exercise, poor nutrition, and family history of osteoporosis can increase your risk of bone loss. Talk with your doctor if you have any of these risk factors.

How should I use Symbicort?
Use Symbicort exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. It is important to use Symbicort regularly to get the most benefit.

Do not use Symbicort to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, short-acting inhalation medication to treat an asthma attack.
Symbicort comes with patient instructions for safe and effective use. Follow these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist if you have any questions. Always rinse your mouth after using the inhaler device.

Prime the inhaler device before the first use by pumping 2 test sprays into the air, away from your face. Shake the inhaler for at least 5 seconds before each spray. Prime the inhaler if it has not been used for longer than 7 days, or if the inhaler has been dropped.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.
To be sure Symbicort is not causing harmful effects, your doctor will need to check your progress on a regular basis. Your eyes may also need to be checked for cataracts or glaucoma. Do not miss any scheduled visits to your doctor.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

You may have withdrawal symptoms if you stop using Symbicort after using it over a long period of time. Withdrawal symptoms include joint or muscle pain, depression, and tired feeling. Do not stop using Symbicort suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.
Do not try to clean or take apart the inhaler device. Throw it away when the Symbicort runs out. The dose indicator on the inhaler will turn red when there are 10 doses left in the device. Get your prescription refilled before you run out of Symbicort completely. Always use the new device provided with the medication when you get your prescription refilled.

Store Symbicort at room temperature, away from moisture, light, and heat. Always keep the cover on the inhaler device when you are not using it.

What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use Symbicort at the next regularly scheduled time. Do not use extra Symbicort to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a Symbicort overdose may include chest pain, nervousness, dry mouth, nausea, vomiting, sleep problems (insomnia), tremors, chest pain, fast or irregular heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

What should I avoid while using Symbicort?
Avoid using other long-acting inhaled bronchodilators such as salmeterol (Advair, Serevent) or formoterol (Foradil Aerolizer) while you are using Symbicort.
Symbicort side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• chest pain, fast or pounding heartbeats, tremors, nervousness;
• wheezing, choking, or other breathing problems after using Symbicort;
• fever, flu symptoms;
• white patches or sores in your mouth or throat; or
• worsening asthma symptoms.
• Less serious Symbicort side effects may include::
• headache;
• back pain;
• nausea, vomiting, diarrhea, upset stomach;
• back pain, muscle cramps;
• sore throat, stuffy nose;
• joint or muscle pain; or
• changes in your voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect formoterol?
Before using Symbicort tell your doctor if you are taking any of the following medicines:

antibiotics such as ketoconazole (Nizoral), itraconazole (Sporanox), azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), or telithromycin (Ketek);

an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil);

a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren); ora diuretic (water pill) such as bumetanide (Bumex), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), torsemide (Demadex).

If you are using any of these drugs, you may not be able to use Symbicort, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Symbicort. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about Symbicort.
What does my medication look like?
Budesonide and formoterol inhalation is available with a prescription under the brand name Symbicort. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Symbicort, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Symbicort only for the indication prescribed.
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