多发性硬化是一种发生在中枢神经系统的自身免疫性疾病。临床表现为运动障碍，从眼睛视觉障碍发展到四肢逐渐无法运动，约15年左右患者完全瘫痪。多发于22到26岁青壮年时期，女性发病率高于男性。此病在欧美国家高发，在我国青壮年人群中亦较常见。
 
    因为没有特效的治疗药，很多人都比较恐惧，但是早在两年前德国先灵公司Schering AG就公布了一项在多发性硬化患者中进行的长达16年的随访研究初步结果显示：长期应用倍泰龙Ò （干扰素β-1b）治疗是安全的。在美国神经病学会（AAN）会议上公布的数据是迄今为止对多发性硬化（MS）特异性治疗的评价中研究期限最长的。

　　16年长期随访研究提供了在1988至1990年间最早加入倍泰龙Ò临床试验的MS患者的临床资料。到目前为止，234名患者接受了随访（占最初人数的63%）。最初的11个试验中心全部参加了这项研究，其中一些中心随访到了最初入组的全部病人。该项随访研究预计在今年晚些时候全部结束。

　　数据表明，倍泰龙Ò 250mcg治疗组的MS患者中有50%保留在有/无帮助下行走的能力，而安慰剂对照组为41%。而且，倍泰龙Ò 250mcg治疗组患者的存活率为94%，而对照组为82%。

　　德国先灵公司Schering AG特殊疾病治疗部门负责人Joachim-Friedrich Kapp 博士说：“倍泰龙Ò 是MS治疗中唯一一种随访时间超过16年的治疗方法，研究在广大患者中证明了倍泰龙Ò 长期治疗的有效性和安全性。由于MS是一种需要长期治疗的慢性疾病，有关长期治疗的经验信息是使医生和患者对长期治疗的有效性和安全性充满信心的唯一方法。我们也深信MS作为一种与多种因素有关的疾病，需要更深入的研究与探索并支持尽早开始治疗的重要性。”

　　16年长期随访研究有望提供与对照群体相比，应用倍泰龙Ò 治疗MS患者在长期有效性和安全性方面的里程碑式数据。另外，结果也有望阐明尽早开始治疗对患者临床病程的可能影响。

　　研究设计和结果

　　参加试验的病人被分为3组：倍泰龙Ò 50mcg治疗组、倍泰龙Ò 250mcg治疗组和安慰剂组。基于这项研究，美国于1993年批准了倍泰龙Ò 250mcg用于治疗多发性硬化。目前根据ITT进行的初步评估显示，相比较低剂量治疗组和安慰剂组，倍泰龙Ò 250mcg治疗组的患者更多地保留了在有/无帮助下行走的能力。该组78名患者中有39名（50%）能够在有/无帮助时行走，而安慰剂对照组78名患者中只有32名（41%）能够在有/无帮助时行走。

　　随访至今的234名患者中约90%仍生活在世。其中倍泰龙Ò 250mcg治疗组78名患者中有73名（94%）在世，而安慰剂对照组78名患者中只有64名（82%）在世。

　　应用倍泰龙Ò治疗MS患者16年随访研究

　　倍泰龙Ò 临床试验是MS治疗中第一个大型、随机、安慰剂对照研究。这项研究在北美开展，1993年倍泰龙Ò 获得批准，成为第一个MS疾病调节治疗药物。参加试验的病人被分为3组：倍泰龙Ò 50mcg治疗组、倍泰龙Ò 250mcg治疗组和安慰剂组，中位随访期为45-48个月。两年期分析表明应用β-干扰素1b治疗的患者中，无复发的患者人数明显增多，而复发者发作的严重程度减轻，因MS住院治疗的人数减少了一半。五年期分析再次显示了同样的结果。

　　倍泰龙Ò 临床试验进行到第12年时再次报道了有效性和安全性的阳性结果。安大略省London MS诊所随访了参加试验的45名患者。12年的随访显示了倍泰龙Ò 的长期有效性和安全性。

　　*倍泰龙Ò （干扰素β-1b） 50mcg剂量只是一种研究剂量。FDA批准上市的剂量250mcg。

　　德国先灵公司Schering AG为一个以科研为基石的制药集团，专注发展以下四个专业领域的药物： 男性科&妇科、肿瘤科、影像诊断及致残疾病的特殊治疗。作为全球新特药物的主要开发者，先灵公司Schering AG的目标是保持在特殊药品市场的领先地位。凭借国内R&D和全球合作伙伴的杰出工作，先灵公司已建立了富有前景的生产和销售网络。在新理念指导下，先灵公司希望能为新药的开发和改善人类生活质量做出卓越的贡献.

PRESS RELEASE

New Betaferon® Injection System Provides Easier, More Convenient Treatment Method for People Living with Multiple Sclerosis

Berlin, Germany, February 1, 2007 – Bayer Schering Pharma AG, Germany, today announced the availability of a new injection system to provide greater flexibility and convenience for patients with multiple sclerosis (MS) who are using Betaferon®. This improved system will be released throughout Europe in the course of 2007, and will replace the Betaferon syringe currently on the market. Betaferon® was the first disease-modifying drug introduced for MS and is a well-established therapy worldwide.

"The advanced injection technology is designed to better meet the needs of MS patients and to help make administration of the drug as easy and convenient as possible," said Dr. Christoph Taschke, Head of European Business Unit Specialized Therapeutics, Bayer Schering Pharma AG. “Changes to the Betaferon injection system represent the latest innovation from Bayer Schering Pharma to help patients with MS better manage their condition, and are based on our long-standing commitment to improving their quality of life. The drug itself, however, has not been altered.”

The New System At-A-Glance

The following provides a snapshot of changes made to the Betaferon® injection system to make adherence to drug regimens easier for people living with MS:

1. Improved application system:

• The New Betaferon® syringe – using the thinnest needle (30G) available for MS treatments on the market to increase comfort and lower injection-related pain.
• The New Mixject® adapter – comes with the needle pre-attached and requires fewer steps to dissolve the Betaferon® powder thus simplifying the preparation process.

2. New multipack – includes 15 single-use packs, each containing everything a patient needs for their injection. This packaging provides added convenience, especially when patients travel.

3. New autoinjectors – Autoinjectors are medical devices that allow automatic drug delivery at the right injection depth and speed. The two autoinjectors, BETAJECT® Comfort and BETAJECT® Lite, were developed recognizing that patients’ needs change throughout the course of the disease and the drug only works if patients inject it correctly. The two new autoinjectors were specially designed to satisfy the needs of MS patients. They will not only help make injecting easier, but also will limit injection site reactions (e.g., pain, stinging). The new technology facilitates individual administration of the drug to hard-to-reach locations and is especially useful for those patients who have a fear of injecting themselves.

As part of Bayer Schering Pharma’s ongoing efforts to provide practical solutions to people with MS, dedicated Betaferon® nurses will be available 24/7 to assist patients in switching from the old to the new application system.

Additional information

ABOUT MS

Multiple sclerosis (MS) is a chronic, unpredictable disease of the central nervous system (CNS), which consists of the brain, spinal cord and optic (eye) nerves. It is thought to be an autoimmune disorder, meaning an individual’s own immune system attacks their healthy cells and tissue. When this occurs, myelin, the protective insulation surrounding nerve fibers of the CNS, is destroyed and replaced by scars. Ultimately this damage interferes with nerve communication between the brain, spinal cord and optic nerves, which causes MS symptoms.

ABOUT BETAFERON

As the first disease-modifying drug introduced for MS, Betaferon®/Betaseron® is a well established treatment around the world. Betaferon® has the broadest indication of any MS medication in the US, Europe and Japan. Betaferon® has been approved for clinically isolated syndroms in high risk patients, in relapsing-remitting and secondary progressive forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow up of people treated with Betaferon has shown that it is safe and well tolerated.