美国哮喘变态反应免疫学会年会上的报道，用omalizumab（Xolair）（重组抗人免疫球蛋白IgE单克隆抗体）可以改善标准治疗难以控制的中重度哮喘的症状。 
这些资料取自546例中重度过敏哮喘患者的III期临床试验。尽管受试者每日吸入糖皮质激素，但仍存在哮喘症状。他们被随机分为两组：每隔2到4周，分别皮下注射omalizumab或安慰剂。在开始16周疗程中，治疗上将丙酸倍氯米松（BDP）浓度控制在420到840mcg/d范围（此期称为激素治疗稳定期）。在BDP减量8周后，紧接12周的激素减量期，维持最小有效BDP剂量4周。在激素减量期，病人继续接受omalizumab或安慰剂。在试验中，omalizumab剂量由病人的IgE水平和体重决定，共有274例病人接受omalizumab治疗，272例接受安慰剂。 
加利福尼亚大学儿科变态反应和免疫学临床教授William Berger指出：在稳定治疗期，接受omalizumab治疗的病人中12.8％出现一次或多次病情加重，而安慰剂组则有30.5％；在激素减量期，omalizumab组加重病人中占15.7％，而安慰剂组占20.8％。 
研究人员发现，应用omalizumab的病人，病情改善，伴随用药明显减少，BDP减量和无须使用BDP患者的百分数明显高于安慰剂组。而且，在随访结束后的５个月，患者未出现哮喘加重或重新吸入BDP的反弹现象。 
该药最常见的副作用是病毒感染和头疼，未见与药物相关的严重副作用报道。

XOLAIR

Xolair Information

Xolair is a popular antibody that is known to effectively help decrease some of the most common allergic responses that occur in the patient’s organism. Therefore, this drug is highly indicated in the case of patients who are suffering from asthma (especially allergy-based asthma).

Xolair Indications

Xolair is a well known medical product that is generally prescribed to patients who are suffering from severe or moderate asthma. However, this medicine could also serve some other medical purposes that have not been listed in this guide. Ask your personal health care provider for more information about this medicine and its benefits.

Xolair Warnings

Patients whoa re suffering from known allergic reaction to this medicine should not be allowed to start taking Xolair. Furthermore, before, you are allowed to start taking this medicine, you should alert your personal health care specialist if you are allergic to any foods, dyes, preservatives or any other types of substances (this is known to include other medicines). If you also use a steroid medication, do not stop using the steroid suddenly.

Patients who are following a long term treatment with this medicine are known to be more prone to developing some types of cancer such as skin, breast, salivary gland, prostate, etc. Ask your personal physician to tell you more about the risks that a treatment with this drug implies. Before you take your very first dose of this medicine, you should alert your physician if you are suffering from any other medical disorders, as you might not be allowed to start using Xolair or you might have to take smaller doses of this medicine. Your treatment with it should be closely monitored by your physician.

Xolair Intake Guidelines

A patient who starts a treatment with Xolair for the first time should ask his or her personal physician to tell him exactly how and when to take each dose of Xolair. Do not deviate from any of your personal doctor’s advices. If you fail to understand some of them, you should ask a pharmacist, a nurse or a physician for more detailed indications. Carefully read the set of instructions from the medicine’s label. Xolair is unable to stop an asthma attack that is already in progress, as its actions are not fast enough to reverse the attack’s symptoms. You should ask your personal physician to prescribe you a fast acting medical product for your asthma attacks. You might have to take Xolair along with some other medicines, in order to get better results from your treatment with this medicine. Do not stop using this drug without your personal physician’s approval, as this could trigger some severe symptoms.

Xolair Dosage

You should ask your personal health care provider to tell you the exact dose of Xolair that you should use it on a regular basis, in order to make sure that you will get the proper benefic effects from your treatment with it. Do not make any adjustments to the dose that you have been prescribed without your personal doctor’s consent.

Xolair Overdose

In case you suspect that you might be suffering from an overdose with Xolair you should seek medical care as soon as possible. Contact your physician and your local poison control centre as soon as possible. We have no information regarding the possible side effects that could be triggered by an overdose with this medicine, although this medical condition should not trigger any life threatening side effects or symptoms.

Xolair Missed Dose

In order to get the proper benefits from your treatment with Xolair, you should use this drug on a regular basis. Avoid missing any of your prescribed doses of this drug. If you happen to miss one, alert your personal health care provider and ask him or her for further advice and recommendations. Do not use double doses of this medicine, as this increases your risk of developing overdose.

Xolair Side Effects

Several patients who have received this medicine have suffered from an extremely dangerous life-threatening and very severe allergy to this drug’s main components. An allergic reaction to this medicine is known to occur a couple of hours after the patient has been administered this medicine. If you happen to develop any symptoms of an allergic reaction (for example skin rash or hives; light-headedness, difficulty breathing; fainting; swelling of your lips, tongue, face, or throat) you should alert your personal health care specialist as soon as possible, as you are in need of professional medical attention at once. A prolonged treatment with this medicine (Xolair) could also trigger some other severe side effects that are known to include unusual bleeding or bruising, abnormal weakness, etc.

Xolair could also trigger a series of less severe but far more common side effects like:

• tired feeling;
• pain;
• muscle or joint pain;
• ear pain;
• hair loss;
• dizziness;
• sore throat;
• skin rash or mild itching;
• redness, warmth, pain, bruising, burning, itching, stinging, or swelling.
• cold symptoms.

Xolair Drug Reactions

Ask your personal physician to give you a list of the medicines that are known to harmfully interact with Xolair. While you are being treated with this medicine you should avoid starting to use any other topical non prescription or prescription medicines while you are following a treatment with Xolair.

Buy Xolair

Buy Xolair through our Online Pharmacy Escrow Service or at any Canada Pharmacy where it is sold. In some countries XOLAIR may also be known as: Omalizumab

【新药介绍】：Omalizumab (Xolair®)
omalizumab与药物或疫苗交互作用的试验。但就药理学的观点来看，一般处方用于治疗气喘的药品和omalizumab预期并不会产生交互作用3。必须特别注意的是，omalizubmab不适用于治疗急性气喘恶化，急性支气管痉挛或气喘重积症。 Omalizumub一般常见( >10 % )的副作用包括有:注射部位疼痛、红肿、搔痒(轻度45 %，重度12 % ) 、病毒性疾病( 23 % ) 、上呼吸道感染( 20 % ) 、窦炎( 16 % ) 、头痛( 15 % ) 、咽喉炎( 11 % ) 。而不常见( 1-10 % )的副作用包括有：疼痛、疲劳、头昏眼花、皮肤炎、搔痒、关节痛、手臂与腿部疼痛、骨折和耳痛。罕见( <1 % )副作用包括：秃头、过敏性反应( 0.1-0.2 % ) 、恶性肿瘤

 ( 0.5 % ) 、喉头或舌头水肿、血小板减少症和荨麻疹7。另外，由于每剂150毫克的omalizumab含有108毫克的蔗糖，所以应事先告知患有糖尿病、葡萄糖-半乳糖吸收不良症、果糖不耐性或缺乏蔗糖¬异麦芽糖酶的病人3
【药理作用】

当IgE和巨细胞及嗜碱细胞表面具高亲和力的FcεRI接受体结合，并和过敏原交叉连结时，会开始启动过敏反应，导致这些作用细胞去颗粒化而释出组织胺、白三烯素、细胞激素( cytokines )及其他媒介物质。这些媒介物质和过敏性气喘的病理生理学相关，包括呼吸道肿胀、平滑肌收缩及改变与发炎过程相关的细胞活性，并造成过敏性疾病的症状，例如支气管收缩、黏液产生、哮喘、呼吸困难、胸部紧绷、鼻塞、打喷嚏、搔痒、流鼻水及鼻痒、流眼泪。
Omalizumab为基因重组的类人化单株抗体，可选择性与人类IgE结合。此抗体为kappa免疫球蛋白G1 ( IgG1 kappa ) ，含有人类基本架构区及可与IgE结合的啮齿类互补决定区。当omalizumab和IgE结合后，可以防止IgE和高亲和力的FcεRI接受体结合，因此减少了可以启动过敏反应的游离IgE量3 。 Omalizumab的治闻用在遗传性过敏症病人的身上也会减少嗜碱细胞上IgE接受体的数量4。
【药动学特性】
皮下投与omalizumab吸收后的平均绝对生体可用率为62 %。在患有气喘的成人及青少年皮下单一剂量投与后，omalizumab的吸收缓慢，平均于7-8天后达最高血中浓度。 Omalizumab的药物动力学在剂量大于0.5毫克/公斤时呈线性。多次投与omalizumab后，于稳定状态下自第0天至第14天血清浓度-时间曲线下面积达到初始剂量的6倍。在体外试验，omalizumab与IgE形成有限大小的复合物。于体外或体内并无观察到沉淀复合物及大于一百万道尔顿( Dalton )的复合物。于猕猴组织分布试验显示无任何器官或组织特定的摄取125I-omalizumab 。病人于皮下投与后的拟分布体积为78±32毫升/公斤。 Omalizumab的清除方式包括药物本身IgG的清除以及与IgE形成复合物后的清除等机转。肝脏清除IgG的方式包括在网状内皮组织系统( RES )及内皮状细胞中的破坏。完整的IgG亦会被分
泌于胆汁中。在小鼠与猴子的试验当中，omalizumab：IgE复合物于小鼠体内是藉由RES的Fcγ接受器的交互作用而排除，通常较IgG的排除为快。在气喘病人，omalizumab血清排除半衰期平均为26天，拟清除率平均为2.4±1.1毫升/公斤/天。另外，体重加倍清除率亦大约加倍3。
【适应症】
Omalizumab为附加疗法用于改善已接受高剂量吸入性类固醇制剂及长效乙二型作用剂治疗下仍有频繁的日间症状或夜间觉醒且具有多次重度气喘恶化记录的重度持续过敏性气喘成人与青少年( 1 2岁以上)的气喘控制。这些气喘患者必须有经由皮肤测试或体外试验显示长期空气对中过敏原呈阳性且肺功能降低( FEV1 <80 % ) 。 Omalizumab仅适用于证实为IgE媒介型的气喘病人3。
【用法用量】
Omalizumab仅适用于青少年及成人( 12岁或大于12岁) 。其适当的给药剂量和频率是根据开始治疗前IgE (国际单位/毫升)的测量基底值及体重(公斤)而定。建议给药剂量请参阅表二、表三。 IgE基底值或体重(公斤)在剂量对应表之外的病患不可投与omalizumab 。由于omalizumab治疗期间和停止治疗1年后，其总IgE的浓度仍持续升高。因此治疗期间再次检验之IgE值不可作为决定剂量的指标。中止治疗未达一年，剂量订定应以初始治疗剂量所测得的血清IgE浓度为基准。若终止治疗达一年以上，则需再次测定总血清IgE值以订定剂量。另外，omalizumab仅供皮下注射，不得以静脉注射或肌肉注射方式投与3。
【药物安全性】
Omalizumab的清除与细胞色素P450酵素，排出唧筒( cefflur pumps )及蛋白质的结合机转无关，因此与药物产生交互作用的可能很低。