第一个治疗儿童和12个月大婴儿哮喘的新药获得FDA批准
Pulmicort Respules(TM)-也是唯一的一个激素喷雾剂，阿斯利康公司今天宣布该公司用于幼儿和婴儿的哮喘药物已经获得美国食品和药品管理局（U.S. Food and Drug Administration，FDA）的批准。该药品商品名为Pulmicort Respules（布地奈德吸入悬液），它是第一个唯一的获准用于儿童和12个月大婴儿的哮喘治疗药物，而且还是第一个，同时也是唯一的一个激素喷雾剂剂型。以前，激素吸入治疗仅适用于4岁以上的儿童，而且儿童往往不能正确使用。
该公司呼吸疾病和炎症研究部门的执行主任Frank Casty医生称，Pulmicort Respules开创了激素服用新途径。“该药物获得批准使临床医生在使用吸入型激素治疗婴幼儿哮喘时又增添了新的手段。”Pulmicort Respules具有渗透性，可用于1岁到8岁婴幼儿哮喘的控制。它不是一种迅速释放的剂型（支气管舒张剂），因此不应用于哮喘发作的初期治疗。今年10月就可以在药房凭处方买到该药。
满足目前医疗需求
匹兹堡儿童医院变态反应和免疫科主任David Skoner博士称，哮喘是最常见的儿科慢性疾病之一，全球范围内该病在儿童中呈上升趋势。
(1) 在美国，大约有5百万儿童受到哮喘困扰；
(2) 5岁前的儿童大约有80%出现哮喘症状；
(3) “在Pulmicort Respules出现之前，对于婴幼儿哮喘，要么抗炎治疗十分有限，要么根本没有治疗措施”。对于婴幼儿患者，目前的抗炎治疗并没有使用口服激素（片剂或糖浆）或非激素类的喷雾剂型。
Skoner强调，“Pulmicort Respules是儿童持续哮喘治疗的一个里程碑”。哮喘是一种重症炎症性肺部疾病，对于儿童哮喘，激素治疗的发展是势在必行的。
临床研究证实Pulmicort Respules是安全有效
根据在美国对946例1岁到8岁患有轻度到中度持续性哮喘的儿童进行的三个12周的双盲临床试验的结果，Pulmicort Respules获得了FDA的批准。该药可以减少对支气管舒张剂的需要，而且可以改善夜间和白天的哮喘症状。在临床试验中，最常见的副作用是呼吸道感染、流涕、咳嗽、耳痛、病毒感染、胃痛和耳朵感染以及无须药物治疗的不适。副作用发生率和非药物治疗组基本一致。
自1990年Pulmicort Respules就已经上市，目前在55个国家广泛应用。其主要成分-布地奈德，用于治疗哮喘已经超过了15年。Pulmicort Turbuhaler（布地奈德吸入粉剂）是阿斯利康公司推广的第一个干粉制剂。1998年在美国就开始使用无CFC的激素喷雾剂。
炎症治疗作用，美国国家卫生研究所（National Institutes of Health，NIH）制订的哮喘治疗指南强调应该使用吸入型激素控制气道炎症。吸入型激素的开发研制使临床医生能够直接针对气道炎症进行治疗。
NIH关于哮喘诊断和治疗的专家小组报告II指出，吸入型激素治疗是控制持续性哮喘的最佳措施。Skoner医生称，“对于临床医生、家长及其孩子，Pulmicort Respules获得FDA批准是一个鼓舞人心的消息。根据我的经验，该药对改善婴幼儿哮喘症状是一个飞跃。”
Skoner医生指出，哮喘必须得到适宜的治疗-否则儿童可能受到生命威胁。当然，哮喘患儿在服用吸入型激素时应当受到监护，这样就可以对该药物的疗效和副作用进行评估。吸入型激素的剂量应该降低到控制哮喘所需的最小剂量。如果哮喘患儿停用口服激素（片剂或糖浆）而改用Pulmicort Respules，他们必须受到严密监护以防出现停用激素的戒断反应。
实用性的喷雾治疗，对于婴幼儿哮喘，雾化吸入是常用的服药途径。
Pulmicort Respules是第一个获得批准在美国广泛使用的喷雾剂剂型。该喷雾罐使用压缩空气使Pulmicort Respules（水基药物）雾化。
患儿可通过连接在喷雾器上的面罩吸入该药物。该药是无色无味的水剂，贮存于一个家长才能拧开的喷雾罐中。服用Pulmicort Respules可每日一次或两次。Skoner医生称，“对于婴幼儿哮喘，此激素雾化吸入非常使用且有效。”
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普米克气雾剂 【Pulmicort】
药品英文名
Budesonide
药品别名
泼米考特得宝、普米克令舒、英福美、拉埃诺考特、丁地去炎松、雷诺考特、普米克、都保、布德松、布地缩松、Pulmicort、Rhinocort
 
药物剂型
普米克气雾剂： 90MCG、180MCG。

药理作用
现已明确，糖皮质激素制剂可与靶细胞浆内的糖皮质激素受体结合形成复合物，该复合物进入细胞核内，与DNA中有关靶基因启动子上的促进性或抑制性糖皮质激素反应元件结合，分别促进或抑制多种酶、细胞因子、受体或其他活性物质的mRNA转录、翻译，从而发挥广泛复杂的药理作用。其中与抗哮喘作用有关的主要为：
1.诱导脂皮素的合成而抑制磷脂酶A2，减少由该酶催化膜磷脂水解生成的血小板活化因子、白三烯类、前列腺素类等脂类炎症介质的产生和释放。
2.诱导血管紧张素Ⅰ转化酶、中性肽链内切酶的表达，分别加速血管紧张素Ⅱ的生成，及缓激肽、速激肽的降解灭活；抑制氧化亚氮合成酶的表达，减少氧化亚氮的生成。从而收缩血管，或减轻除血管紧张Ⅱ外的其他多种活性物质的扩张血管、致炎、诱发神经源性炎症反应等作用。此外，还可诱导缩血管物质血管皮素(vasocortin)的生成。
3.抑制多种细胞因子的表达，如白介素1、3、4、6、8，肿瘤坏死因子，粒细胞集落刺激因子。减轻上述因子在气道炎症特别是慢性炎症中的作用。
4.促进肾上腺素β2受体的表达，提高对内源性及外源性药用β2受体激动药的敏感性。
5.免疫抑制作用：对从抗原的吞噬处理，淋巴细胞的分裂增殖、分化，到效应期的整个免疫过程均有抑制作用。
药动学
本品吸入后，主要在气道及肺组织通过上述环节的综合作用，抑制致炎致敏介质和细胞因子等活性物质的生成，收缩扩张的黏膜血管，提高支气管平滑肌和炎症细胞对β2激动剂的敏感性等，对外因性及内因性哮喘均可产生良好治疗作用。除解除哮喘、呼吸困难等临床症状、改善肺通气功能外，较其他治疗哮喘药更突出的是该类药物的抗炎作用。
据一组长期应用本品者，治疗前后支气管镜检及摘取组织进行组织学检查发现，本品可缓解或一定程度逆转慢性哮喘者气道黏膜水肿、上皮下因胶原沉积导致基膜增厚等气道炎性重构病变。本品的抗炎作用约为地塞米松的500倍，故在微量吸入本品产生上述局部治疗作用时，即便通过气道吸收及吞下部分（生物利用度仅11%)，亦不至于产生明显的全身性糖皮质激素不良反应。
适应证
支气管哮喘等慢性可逆性气道阻塞性疾病。
禁忌证
1.中度及重度支气管扩张症。
2.哮喘急性加重或重症患者不宜单用本药，控制急性症状，孕妇禁用。
注意事项
1.当气道有真菌、病毒或结核菌感染时，应慎用本药。
2.吸入本药之后应以净水漱洗口腔和咽部，以防生长真菌。
3.儿童应按医师处方量，并在成人指导下使用。
不良反应
剂量控制在每天800μg以内，一般认为不会出现糖皮质激素全身性不良反应，亦不会明显影响下丘脑-垂体-肾上腺皮质调节轴功能。仅偶见咽喉部不适、声嘶等局部刺激症状，以及口腔、咽部念珠菌感染。后者为本品的药理作用使局部抵抗力降低所致。
用法用量
1.治疗支气管哮喘：气雾剂或干粉（都保，普米克)吸入200μg每天2次，或400μg，每天1次；严重或难治性哮喘短期内可加大剂量至每次400μg～800μg，每天1～2次吸入，病情控制后逐渐减至上述常用量维持。
2.治疗鼻炎：50μg每天2次喷入鼻腔。
药物相应作用
酮康唑能提高布地奈德的血浆浓度，其作用机制可能是抑制了细胞色素P4503A介导的布地奈德的代谢。
专家点评
本品为一新型甾体强效脂溶性糖皮质激素制剂，以气雾剂或干粉吸入，主要在呼吸道产生局部抗炎、抗过敏、抗哮喘作用。较少全身性不良反应。但新近一项研究发现：长期吸入本品及另一吸入性糖皮质激素药丙酸倍氯米松的各组青春期前哮喘患儿，均可观察到比同龄接受非糖皮质激素治疗的哮喘组患儿生长缓慢，并伴有胶原合成速度及血清骨钙素水平降低。因此，本品及同类药对儿童生长和胶原代谢的负面影响，正引起重视。
【规格】10ml：10mg，50mg/喷200喷/瓶10ml：20mg，100mg/喷200喷/瓶5ml：20mg，200mg/喷100喷/瓶
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Drug Information For: PULMICORT 0.5MG/2ML RESPULES
Ingredient Name: BUDESONIDE (byoo-DESS-oh-nide)
Drug Manufacturer: ASTRA ZENECA LP
Common Uses: This medicine is a corticosteroid used for the long-term treatment of asthma and prevention of asthma in children 1 to 8 years old. It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine: WARNING: USE CAUTION IF YOU SWITCH FROM AN ORAL STEROID (eg, prednisone) to this medicine. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid again. Carry a card at all times that says you may need an oral steroid if any of these events occur. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are taking mifepristone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking cimetidine, clarithromycin, steroidal contraceptives (eg, birth control pills), imidazole antifungals (eg, ketoconazole, itraconazole), barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, anticoagulants (eg, warfarin), live vaccines, quinolones (eg, ciprofloxacin), ritodrine, or interleukin-2. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including glaucoma; cataracts; weak bones (osteoporosis); a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chicken pox; shingles; allergies; pregnancy; or breast-feeding. Tell your doctor if you have had a positive TB skin test, have recently been vaccinated, or will be having surgery. This medicine should not be used in CHILDREN younger than 12 months old; safety and effectiveness in these children have not been established. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. AN EXTRA PATIENT LEAFLET is available with this medicine. Talk to your pharmacist if you have questions about this information. This medicine is to be used in a jet nebulizer. Do NOT use this medicine in an ultrasonic nebulizer. OPEN THE ALUMINUM FOIL ENVELOPE and remove 1 ampule. Record the date that you open the foil on the back of the envelope. Once the foil is open, the unused ampules should be used within 2 weeks. ONCE AN AMPULE IS OPENED, use the medicine immediately or discard. GENTLY SHAKE THE AMPULE, and then squeeze the contents into the nebulizer. DO NOT MIX this medicine with other medicines in the nebulizer. Connect the nebulizer to the air pump and begin treatment as directed. Breathe calmly and evenly. When there is no more mist in the nebulizer chamber, the treatment is complete. RINSE THE MOUTH WITH WATER (without swallowing) after each treatment to help prevent mouth infections. Make sure to wash the face after using a face mask. AFTER USE, wash the reservoir of the nebulizer, mouth piece, and mask according to the manufacturer's directions. Rinse well and dry. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the foil envelope. Store away from heat, moisture, and light. Do not refrigerate or freeze. Do not store in the bathroom. IMPROVEMENT MAY BE SEEN within 2 to 8 days after beginning treatment, although the full benefit may not be seen for 4 to 6 weeks after starting treatment. If the asthma symptoms do not improve in 4 to 6 weeks or if they get worse, contact your health care provider. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, use 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 use 2 doses at once.
Cautions: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. LAB TESTS may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. THIS MEDICINE WILL NOT STOP AN ASTHMA ATTACK. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of this medicine (eg, severe or sudden onset wheezing or shortness of breath). If you have questions about which medicines stop asthma attacks, check with your doctor or pharmacist. TELL YOUR DOCTOR OR DENTIST THAT YOU TAKE THIS MEDICINE before you receive any medical or dental care, emergency care, or surgery. USE CAUTION IF YOU SWITCH FROM AN ORAL STEROID (eg, prednisone) to this medicine. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid again. Carry a card at all times that says you may need an oral steroid if any of these events occur. THIS MEDICINE MAY LOWER THE ABILITY OF YOUR BODY TO FIGHT INFECTION. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. IF YOU HAVE NOT HAD CHICKENPOX, SHINGLES, OR MEASLES, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) while you are taking this medicine. Talk with your doctor before you receive any vaccine. TELL YOUR DOCTOR AT ONCE IF YOU NOTICE that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if you have a decrease in your peak flow meter results. CONTACT YOUR DOCTOR OR SEEK MEDICAL CARE right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief. THIS MEDICINE MAY SOMETIMES CAUSE BREATHING PROBLEMS RIGHT AFTER YOU USE A DOSE. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use this medicine. FOR WOMEN: IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS UNKNOWN IF THIS MEDICINE IS FOUND in breast milk. IF YOU ARE
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include cough; diarrhea; nosebleed; runny or stuffy nose; or throat irritation. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone or joint pain; depression; ear pain or discharge; fainting; increased wheezing; infection (fever, chills, persistent cough or sore throat); mental or mood changes (eg, aggressiveness, anxiety, irritability); red, swollen, itchy, or watery eyes; severe dizziness; sudden weight loss; tightness in the lungs; unusual weakness; vision changes; or white patches in the mouth or throat. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information: CARRY AN ID CARD at all times that says you take this medicine. TALK WITH YOUR DOCTOR OR PHARMACIST ABOUT ALL OF YOUR ASTHMA MEDICINES and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
附件:
201242220402211.PDF 
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注：以下产品不同规格和不同价格，购买以咨询为准！
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产地国家: 美国
原产地英文商品名:
BUDESONIDE RESPULE(PULMICORT RESPULE GENERIC) 0.5MG/2ML/AMPULE 30AMPULES/BOX
原产地英文药品名:
BUDESONIDE
中文参考商品译名:
布地奈德RESPULE(普米克RESPULE仿制药) 0.5毫克/2毫升/安醅 30安醅/盒
中文参考药品译名:
布地奈德
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产地国家: 美国
原产地英文商品名:
BUDESONIDE RESPULE(PULMICORT RESPULE GENERIC) 0.25MG/2ML/AMPULE 30AMPULES/BOX
原产地英文药品名:
BUDESONIDE
中文参考商品译名:
布地奈德RESPULE(普米克RESPULE仿制药) 0.25毫克/2毫升/安醅 30安醅/盒
中文参考药品译名:
布地奈德