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 详细处方信息以本药内容附件PDF文件（200952600351028.pdf）的“原文Priscribing Information”为准
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部分中文利比处方资料（仅供参考）

【商品名】：利比（Rebif）注射液--重组人干扰素β1a注射液

【通用名】：重组人干扰素β1a注射液

【生产厂家】：Merck serono 默克 雪兰诺（德国）

【剂型】：预装针剂

【使用方法】：皮下或者肌肉注射

【用量】：每周3次，每次44mcg。初次使用可以用22mcg剂量，以适应广泛存在的假流感样不良反应。

【作用机理】：
　　机理尚未完全明确，目前研究所知：主要作用于多发性硬化自身免疫反应的四个阶段，1、下调抗原呈递细胞（巨噬细胞）表达MHC-II（人类主要组织相容性复合物，进行抗体识别的主要蛋白因子，非特异性免疫转化为特异性免疫的关键因子之一）的水平，从而降低了抗原呈递细胞向T细胞（MS免疫反应发生的关键性免疫细胞）呈递抗原的过程，最终减少了T细胞的激活。2、减少T细胞释放IFN 1-r （伽玛干扰素）和a-TNF（法尔法肿瘤坏死因子）等细胞免疫关键性因子，从而减少了T细胞对自身和其他免疫细胞的激活，阻断免疫反应进程。3、降低血管上皮细胞表达vcam-1（细胞黏附因子），增加细胞黏附因子的游离状态（只有非游离状态的vcam-1才能起到协助T细胞突破BBB血脑屏障的作用）从而降低T细胞突破BBB（血脑屏障）入侵中枢神经系统的机会。4、在CNS（中枢神经系统）内，减少炎性分子（主要有伽玛干扰素、阿尔法肿瘤坏死因子）的表达，增加抗炎性分子（主要有TGF-b 生长转化因子和IL-10白介素10）的表达从而减少炎症活动对神经髓鞘的损害。通过多重环节多靶位的免疫调节作用，起到影响疾病进程，减少复发频率，改善脑部MRI（核磁共振）病灶活动，延缓残疾到来的作用。

【试验数据】：
　　PRISMS临床多中心随机双盲对照试验表明，能有效缓解复发症状严重程度，减少复发频率（延长约1倍时间），改善脑部病灶活动程度。且长期使用效果优于短期使用，早期使用效果优于晚期使用，大剂量使用效果优于小剂量。LTFU长期随访观察，该药具有远期疗效，且耐受性较好，安全性高。EVIDENCE试验中，该药效果明显优于Avonex（EDSS评分，残疾进展，MRI活动程度等方面）。由于其分子式完全相同于人体自身产生的干扰素，因此产生中和抗体的时间和发生率都明显优于betaferon(贝泰龙，贝塔干扰素1-B)。中和抗体的产生是影响免疫调节类药品长期疗效的主要原因。

【不良反应】：
　　主要且常见的不良反应有：注射后假流感样症状、皮肤皮疹和注射局部肿块、无症状的转氨酶升高等，其他不良反应参见说明书。

【注意事项】：
　　对于原发进展型的MS疗效不明显；不良反应可以通过服用对乙酰氨基酚等解热镇痛药缓解，转氨酶需要定期监测，如出现黄疸等肝功能损害症状，需要咨询专业医生是否停药；本品是疾病修饰疗法的经典用药，能切实有效缓解症状减少复发延缓残疾，但是不能治愈疾病。

【有效期】：5年

Indication
Rebif is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.
Rebif is not approved for treatment of chronic progressive MS.
Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack by prescription only.

Important Safety Information
Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif.

Let your doctor know:
If you have a history of depression, seizures, liver disease, thyroid problems, or blood cell count or bleeding problems, or if you have had previous allergic reactions to medications.
About all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Rebif and other medicines may affect each other, causing serious side effects.
Before you take any new medicines.

Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include:
Depression and risk of suicide
Liver problems
Risk to pregnancy
Injection-site problems
Severe allergic reactions. Allergic reactions are rare and may be associated with difficulty in breathing and loss of consciousness, which require immediate medical attention.

The most common side effects with Rebif are:
Injection-site reactions
Flu-like symptoms (fever, chills, muscle aches, tiredness)
Depression
Abdominal pain
Increased liver enzymes
Blood cell count decreases

Let your doctor know if you have any of these symptoms or feel sad, tired, hot or cold, or experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also call toll-free 1-877-44-REBIF (1-877-447-3243). Rebif is available by prescription only.

MS LifeLines is an educational support service for people living with MS and their families. MS LifeLines and MS LifeLines Ambassadors are sponsored by EMD Serono, Inc. and Pfizer Inc. Speakers and MS LifeLines Ambassadors who participate in Talk MS or in live events are sponsored by EMD Serono, Inc. and Pfizer Inc. Rebif, Rebiject II and MS LifeLines are registered trademarks and the Rebif logo is a trademark of EMD Serono, Inc. or its affiliates.

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 详细处方信息以本药内容附件PDF文件（200952600351028.pdf）的“原文Priscribing Information”为准
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