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  1. викинг

    Снова о причинах...

    http://media.www.jhunewsletter.com/media/s...s-3912387.shtml это очень важно для нас!
  2. викинг

    Ронбетал-часть вторая

    дорогой Ромб, 1. я бы сконцентрировался на новых разработках в области рс! 2 нужно сделать и испытать аналог TYSABRI тайсабри! думаю это не сложно! но при этом непрерывно иследовать вопрос PML пмл! 3 Сделали ронбетал - хорошо! Но дигайтесь дальше! 4 В аптеках США наконец то появились таблетки от рассеянного склероза- Ampyra™. надо сделать аналог. 5 Выдумвать не надо - сделайте анлог бетаплюса 6. торопитесь! скро появится лекаство. 7.посадите кого-то исследвать вопрос CCSVI
  3. викинг

    Ронбетал-часть вторая

    А Шмидт сама подписала это письмо про Ронбетал?
  4. викинг

    Ронбетал-часть вторая

    так можно угробить все и всех! зту аптекршу надо заставить возместить все расходы!
  5. викинг

    Tysabri

    на месте бизнесменов я бы поторопися!
  6. викинг

    Tysabri

    Кто может сказать?
  7. викинг

    Ронбетал

    ну и где этот ронбетал? в Москве его нет! биокад придумали, чтобы пар выустить!?
  8. 'ЛЕЧЕНИЕ' РС появляется В ВЕЛИКОБРИТАНИИ БРИТАНСКИЕ доктора собираются предложить пациентам иннованционное лечение болезни нервов - рассеяный склероз. Итальянский доктор успешно вылечил пациентов РС при помощи хирургии, расширить суженные вены. Теперь специалисты в этой стране настроены использовать ту же самую процедуру.
  9. MS 'CURE' COMES TO BRITAIN BRITISH doctors are set to offer patients a ground-breaking treatment for the devastating nerve disease ­multiple sclerosis. An Italian doctor has successfully treated MS patients with pioneering surgery to widen narrowed veins. Now specialists in this country are poised to use the same procedure.
  10. викинг

    Ронбетал

    Здавствуйте, уважаемые дамы и господа. Был бы очень рад получить ответ на следующие, как мне представляется, важные вопросы: 1. Когда в России появится лекарство от рассеянного склероза Тайсабри, или его аналог? 2. В США началась продажа лекарства от рассеянного склероза Амиро (бывший фампридин). Когда это лекарство появится в России? Заранее спасибо.
  11. викинг

    Fampridine-sr

    HAWTHORNE, N.Y., Jan 22, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA demonstrated efficacy in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). AMPYRA can be used alone or with existing MS therapies, including immunomodulator drugs. "The approval of AMPYRA marks an important milestone for the many people with MS who suffer walking impairment. Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics, adding: "We are enormously gratified to have achieved approval for the only medication indicated to improve walking in people with MS, and we thank all of the clinicians, people living with MS and medical and patient support organizations who joined in this effort over the past decade. Reaching this milestone underscores Acorda's ongoing commitment to develop innovative therapies for people with neurological diseases." "Walking impairment affects a large majority of people with MS, and we are very pleased that the FDA has approved a new treatment that addresses this aspect of the disease," said John Richert, M.D., Executive Vice President for Research & Clinical Programs at the National Multiple Sclerosis Society. "Continuing to advance clinical research and expand the range of therapeutic options for people with MS, including treatments for the most debilitating symptoms and challenges associated with the disease, is critical to helping people with MS." AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. The FDA granted AMPYRA orphan drug status, which will provide seven years of market exclusivity for the drug. In addition, Acorda has several issued patents that cover the formulation and use of AMPYRA. AMPYRA is administered as a 10 mg tablet twice daily, approximately 12 hours apart. The primary measure of efficacy in its two Phase 3 MS trials was walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25FW), using a responder analysis. A responder was defined as a patient who showed faster walking speed for at least three visits out of a possible four during the double-blind period than the maximum speed achieved in the five non-double-blind, no treatment visits (four before the double-blind period and one after). A significantly greater proportion of patients taking AMPYRA 10 mg twice daily were responders compared to patients taking placebo, as measured by the T25FW (Trial 1: 34.8% vs. 8.3%; Trial 2: 42.9% vs. 9.3%). The increased response rate in the AMPYRA group was observed across all four major types of MS. During the double-blind treatment period, a significantly greater proportion of patients taking AMPYRA 10 mg twice daily had increases in walking speed of at least 10%, 20%, or 30% from baseline, compared to placebo. In both trials, the consistent improvements in walking speed were shown to be associated with improvements on a patient self-assessment of ambulatory disability, the 12-item Multiple Sclerosis Walking Scale (MSWS-12), for both drug and placebo treated patients. However, a drug-placebo difference was not established for that outcome measure. "Walking impairment makes life more difficult for many of my patients," said Dr. Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "With the approval of AMPYRA, we will have the first treatment option shown to improve walking speed in people with MS." Acorda expects AMPYRA to be commercially available in the United States in March 2010. AMPYRA will be distributed exclusively through a network of specialty pharmacies and coordinated by AMPYRA Patient Support Services. Dedicated and experienced customer care agents will be available to help healthcare professionals process prescriptions, work with insurance carriers to facilitate coverage, and help patients to access benefits available through reimbursement assistance and patient assistance programs. AMPYRA Patient Support Services can be reached at 888-881-1918 for more information about AMPYRA. The FDA approved AMPYRA with a risk evaluation and mitigation strategy (REMS) program comprising a medication guide and communication plan. The goals of the communication plan are to inform patients about the serious risks, including seizures, associated with use of higher than recommended doses of AMPYRA therapy, and the change of the established name from fampridine to dalfampridine. AMPYRA will be marketed in the United States by Acorda's established commercial organization, which successfully launched ZANAFLEX CAPSULES® (tizanidine hydrochloride). The Company plans to double the number of field- based sales professionals to approximately 100 by the time of commercial availability in March. Under Acorda's existing license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (NYSE: ELN), AMPYRA will be manufactured by Elan Drug Technologies using one of their Oral Controlled Release Technologies, the MXDAS (MatriX Drug Absorption System) technology. "We are delighted that AMPRYA will now be available to help people with MS. This approval represents another significant milestone in our successful collaboration with Acorda Therapeutics," announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "The approval is the culmination of an enormous amount of work and effort over many years and is the second product in which we have collaborated with Acorda. We hope to find additional opportunities to work together in the future." Important Safety Information AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs. AMPYRA is contraindicated in patients with moderate to severe renal impairment (CrClless-than or equal to 50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA. AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same. Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo The most common adverse events (incidence greater-than or equal to 2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain. For full prescribing information, please visit: http://www.AMPYRA.com. Conference Call Acorda will hold a conference call and audio webcast on January 22, 2010 at 5:30 p.m. ET. To participate in the conference call, please dial 800-573-4752 (domestic) or 617-224-4324(international) and reference the access code 51443395. The presentation will be available via a live webcast at: http://phx.corporate-ir.net/phoenix.zhtml?...eventID=2697617 A replay of the call will be available from 8:30 p.m. ET on January 22, 2010 until midnight on February 22, 2010. To access the replay, please dial 888-286-8010(domestic) or 617-801-6888 (international) and reference the access code 14061810. The archived webcast will be available for 30 days in the Investor Relations section of the Acorda website at http://www.acorda.com. About AMPYRA (dalfampridine) AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured globally by Elan based on an existing supply agreement with Acorda. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. More than 400,000 Americans have MS. Most people living with MS are diagnosed between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect an estimated 2.5 million people. Research indicates 64%-85%of people with MS have difficulty walking, and 70% of people with MS who have difficulty walking report it to be the most challenging aspect of their MS. Within 15 years of an MS diagnosis, 50% of people with MS often require assistance walking and, in later stages, up to a one third are unable to walk. About Acorda Therapeutics Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's marketed products include AMPYRA (dalfampridine), a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain. About Elan Drug Technologies Elan Drug Technologies (EDT) is the world's leading drug delivery company and is a business unit of Elan (NYSE:ELN). EDT developed dalfampridine, using one of their proprietary Oral Controlled Release Technologies, the MXDAS (MatriX Drug Absorption System) technology. EDT aim to deliver clinically meaningful benefits to patients by using their extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies. Products enabled by their technologies are used by millions of patients each day. More information is available at www.elandrugtechnologies.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Ampyra in the United States and to successfully market Zanaflex Capsules, the risk of unfavorable results from future studies of Amypra, the occurrence of adverse safety events with our products, delays in obtaining or failure to obtain regulatory approval of Ampyra outside of the United States and our dependence on our collaboration partner Biogen IDEC in connection therewith, competition, failure to protect Acorda Therapeutics' intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from our preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release. SOURCE: Acorda Therapeutics, Inc. Acorda TherapeuticsJeff Macdonald, 914-347-4300 ext. 232jmacdonald@acorda.com
  12. Chronic Cerebrospinal Venous Insufficiency (CCSVI) and Multiple Sclerosis (MS) December 11, 2009 Part I: Defining CCSVI and Its Possible Involvement with MS A great deal of media attention has been given recently to the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage. Please note that all of these findings should still be considered preliminary at this time. Further studies are needed to confirm the theories given in this writing. Studies with Altered Blood Flow and Its Potential Effects A leader in the current CCSVI research is Paolo Zamboni, MD, director of the Vascular Diseases Center at the University of Ferrara in Milan, Italy. He and others have been studying blood flow, inflammation, and iron stores in MS for several years. The results of Dr. Zamboni's pilot study in Italy were presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) held in September 2009. More recently, Zamboni and colleagues have published their treatment data of 65 MS patients who underwent an angioplasty type of procedure to potentially improve blood flow from the brain to the heart. This experimental procedure and the initial outcome data are explained later in this article. With CCSVI, the veins located on the outside of the brain (extracranial cerebrospinal veins) - those designed to transport blood from the brain back to the heart - collapse and/or become blocked, a condition known as "stenosis." As a result, blood leaving the brain must be rerouted through smaller vessels around these primary veins, referred to as "substitute circles." These ancillary veins, however, cannot transport the blood as quickly or efficiently as those larger ones designed for this purpose. Not only does the blood flow slow down, but the blood may also flow backwards (referred to as "reflux"), and studies suggest that both the reflux of blood as well as a pulsing (back and forth) flow may be unique to individuals with MS. Studies have shown that when the normal blood flow is altered, especially when the flow of blood is reversed, the body may react with an inflammatory response. Of particular importance is the activation of surface adhesion molecules, which enable damaging immune-system cells (such as macrophages and T-cells) to cross the blood-brain barrier, infiltrate the central nervous system (consisting of the brain and spinal cord), and potentially injure brain tissue, myelin (the protective covering of the nerves), and nerve cells. The proposed damage from CCSVI also involves an iron overload for individuals with MS. As with certain other neurodegenerative conditions, unusually high levels of iron may be present. Iron levels may be particularly high in the brain and spinal cord of individuals with MS. With CCSVI, where blood flow out of the brain is slowed down and even reversed, extra iron is believed to be deposited and stored in sites near these vessels. How Iron Affects the Body Iron is needed by all living things. In addition to maintaining cellular balance and enabling nerve cells to perform routine functions, iron forms tissues and blood vessels; it transports oxygen through the body via blood circulation; it enables nerve impulses to be transmitted; and is essential to the development of myelin and oligodendrocytes (which produce and maintain healthy myelin). Iron is deposited in varying amounts to the different cells within the body, according to their specific need for proper functioning. While the benefits of iron in normal levels are clear - and critical for bodily function - conversely, too much stored iron can cause problems. For instance, as people age, iron is more likely to accumulate in the brain. Conditions such as Alzheimer's disease and Parkinson's disease can occur in connection with iron stores. The processes associated with excess iron in the body are very complex, but it has been characterized as, "...one of the most dangerous catalytic elements responsible for the neurodegenerative process." (Levenson and Tassabehji, 2004) MS Lesions, Blood Flow, and Advanced Technology Since the first description of MS by Charcot in the mid-1800s, MS lesions have been known to be "venocentric," or occurring around blood vessels. More recent studies have also shown that with MS, iron stores may be found constantly encircling venous walls. Additionally, iron overload is found in MS lesions, although this is a feature also observed with other neurodegenerative diseases. The reason why CCSVI and iron overload in MS is presently under investigation is two-fold. First, studies in recent years have been able to demonstrate altered blood flow from the brain in the course of MS. Second, the development of more sensitive technology - such as advanced MRI and Doppler ultrasound techniques - has allowed researchers to better evaluate and measure the capacity of cerebrospinal veins as well as iron stores in the brain. The CTEVD Study As a follow-up to the small, pilot study conducted in Italy by Dr. Zamboni, a larger study is now underway. Titled, "Combined Transcranial and Extracranial Venous Doppler (CTEVD) Evaluation in MS and related Diseases," this larger study is being conducted at the University of Buffalo in New York. According to the University, "The main goal of the CTEVD study is to investigate the prevalence (frequency) of CCSVI in patients with multiple sclerosis (MS) when compared to healthy controls (HC) and controls with other neurological disorders (OND). Another important aim of the CTEVD study is to investigate the relationship between CCSVI and clinical, magnetic resonance imaging (MRI) and environmental-genetic outcomes in MS patients, HC, and controls with OND." For more information, readers may go to www.buffalo.edu/news/10562 to view a press release from the University of Buffalo. Readers may also go to www.bnac.net/?page_id=517 for specific information on study enrollment at the University of Buffalo. For more details on the study, readers may send an email to the University of Buffalo at ctevd@bnac.net . The internet link to the study information includes the criteria to participate in the study. The University also states that,"Currently, enrollment will be closed until late January 2010 in order to evaluate initial study results on first 500 enrolled subjects." Instructions are then given for anyone who would like to be considered for this study or any future studies. Individuals without internet access may contact MSAA's Helpline consultants for assistance, at (800) 532-7667. Cautionary Note As with all medical theories, information must be considered preliminary until rigorous clinical trials can confirm any findings. Next, more research is needed to determine if such findings are actually related to the condition, and if so, if it is a cause or an effect of a condition. At this point in time, CCSVI with iron overload is one of many theories which may help explain the MS process if confirmed. Until a confirmed, new treatment effect on MS is verified scientifically, MS patients should not change their treatment regimen without consulting their physician. The established disease-modifying therapies have been proven to slow disease activity, reduce exacerbations, and delay disability for many patients. Also, individuals should not reduce their iron intake - as iron deficiencies can cause more serious complications. Part II: Experimental Treatment of CCSVI and Interpretation of Study Results An Experimental Treatment Trial with Endovascular Widening of Narrowed and Blocked Veins The Procedure With CCSVI, reduced blood flow is seen in the internal jugular (IJV) veins and the azygous (AZY) veins. Reduced blood flow is observed in these veins to varying degrees in the head, neck, and spinal cord. This condition requires a combination of veins to be collapsed. According to the study results presented in the December 2009 issue of the Journal of Vascular Surgery, "CCSVI is strongly associated with multiple sclerosis." An experimental endovascular procedure was used to widen the narrowed or blocked veins in a study of 65 MS patients (endovascular is defined as "within a blood vessel"). Lead investigator Dr. Zamboni refers to this as the "liberation procedure." The purpose of this study was to evaluate the safety and clinical outcome of this procedure in the treatment of CCSVI with MS. The 65 participants included 35 individuals with relapsing-remitting MS (RRMS), 20 with secondary-progressive MS (SPMS), and 10 with primary-progressive MS (PPMS). A number of criteria were used to select the patients, including a confirmed diagnosis of MS as well as CCSVI, normal kidney function, and RRMS patients who were taking FDA-approved disease-modifying treatments. In this study, percutaneous transluminal angioplasty (PTA) was performed on the 65 MS patients by using a tiny balloon inserted into an affected vein. The veins were accessed from a remote location in the groin, and the balloon was threaded through a vein until reaching the affected areas. The balloon was first inflated, held for 30 to 60 seconds, and then deflated. This process was repeated several times in each affected vein before the balloon was removed. The procedure was done as day surgery using a local anesthetic, and patients were released after four hours of postoperative observation. Other physicians at other institutions have used stents to open collapsed veins. Patients were given a preventative dose of heparin for three weeks following the procedure to reduce the risk of blood clots. Safety and Vascular Study Results According to investigators, the procedure was well tolerated, with no serious operative or postoperative complications. Six of the 65 patients reported postoperative headache that was temporary and went away on its own. The theory contends that collapsed veins cause venous hypertension. Interestingly, prior to the procedure, venous pressure was not significantly higher than those without CCSVI blockages. Postoperatively, pressure was reduced. A major issue in the months following the procedure was that restenosis (where veins narrowed again) occurred in the IJV vein of 47 percent of the patients treated for IJV senosis. This disappointing outcome occurred in the IJVs 16-times more frequently than in the AZY, and most often occurred at the eight-to-nine-month point following the procedure. Researchers state that a stent might be a logical solution, although dedicated devices of the correct size for IJVs are not readily available at this time. In other words, technical improvements may be needed in the future. Four patterns of stenosis were observed, and researchers note that certain patterns appeared to be associated with the different types of MS. According to the published results, in 90 percent of the PPMS patients (9 of the 10), the stenoses were limited to the veins which drain blood from the spinal cord. The reduced blood flow in the spinal cord, which occurred in several locations, may explain why the patients with PPMS experienced less benefit from the procedure than those with RRMS. Neurologic Study Results According to the published report, RRMS patients showed a "highly statistical improvement at 18 months" on the Multiple Sclerosis Functional Composite (MSFC). Progressive patients (individuals with SPMS and PPMS), showed a "significant but limited improvement" at six months, but no improvement with respect to baseline at 18 months. The MSFC measures: leg function and ambulation through the Timed 25-Foot Walk; arm function and dexterity through the Nine-Hold Peg Test; and cognitive function through the Paced Auditory Serial Addition Test (PASAT). Specific subscale results were not reported. With regards to relapses in RRMS patients, 27 percent of these individuals were relapse-free during the year prior to the endovascular procedure. Postoperatively, 50 percent of the individuals with RRMS were relapse-free as of the 18-month follow-up time, which is a significant increase in the number of patients who did not experience a relapse (also referred to as an exacerbation, attack, or flare-up of symptoms). However, the lack of an MS control group limits interpretation, since many MS trials have shown that the placebo-treated group may also improve in certain outcomes. The practice effect of repeated testing may have influenced the positive outcomes as well. All of the RRMS patients whose veins remained open were relapse-free following the procedure. However, the numbers are small and the overall annual relapse rate (ARR) for the entire RRMS group was not significantly affected, since this included those RRMS patients who had a restenosis of the IJVs. Nonetheless, this is encouraging preliminary data. In terms of MRI results, the percentage of patients with active gadolinium-enhanced lesions at MRI was significantly reduced from 50 percent to 12 percent. However, the authors note that different MRI equipment was used, and this lack of consistency could have an effect on the actual outcome. Also, without an MS control group, regression to the mean may be a partial explanation for improvement. Mental and physical quality of life measures, as determined by a 54-item questionnaire (the Multiple Sclerosis quality of Life-54 Instrument), was significantly improved in the RRMS patients. For the individuals with progressive types of MS (SPMS and PPMS), a limited improvement was reported after the first six months, but not at the 18-month point. The RRMS patients were early in their disease course and were required to remain on disease-modifying therapies, which may also partially explain the improvement in the RRMS group. Interpretation of Study Results from MSAA's Chief Medical Officer MSAA Chief Medical Officer Jack Burks, MD, points out the value of putting forth a new hypothesis such as this, which is both creative and encouraging. He also explains that "thinking out of the box" may be needed to develop future treatments. Dr. Burks adds, "Finding interesting data to support this hypothesis is intriguing. These mixed results in a small pilot study are not surprising and may lead to more precise findings in larger, scientific trials in the future. "Over the past century, more than 100 proposed treatments for MS have reached this stage of development," Dr. Burks continues. "From here, scientifically valid, multi-center studies are needed to demonstrate efficacy without significant adverse effects. The CCSVI scientists recognize the need for these additional studies and are not recommending this procedure, except as part of future clinical trials. Specifically, in an article from Medscape Medical News (dated December 3, 2009 and written by Susan Jeffrey), Dr. Zamboni emphasizes that "...the current report should be viewed as an interesting finding that urgently requires replication by other groups." Dr. Burks explains, "Dr. Zamboni is not advising patients to rush out and have this procedure. I agree with his perspective. Additionally, in non-experienced hands, surgery may not be as safe as demonstrated by Dr. Zamboni. Changes in the surgical approach may be forthcoming (such as stents versus balloon catheterization). Future trial results may be better, with fewer incidences of restenosis. "Many variables exist with most pilot studies. However, these studies often generate more specific hypotheses. Delineating patients who experienced restenosis versus those with continued venous patency (open veins) may prove very interesting. Adding an MS control group will add credibility to future studies." "This procedure cannot be considered a cure at this time. Fifty percent of RRMS patients still had relapses after surgery. The specific relationship to relapses and restenosis is important. The researchers are planning the right steps. However, the results from future studies are needed before relevant conclusions and recommendations can be established." Dr. Burks comments, "As with much of the research with MS, this study raises more questions than answers. While the surgery is aimed at opening blocked veins and returning normal blood flow, the resultant immunologic and chemical changes will need to be addressed in the future. Can returning normal blood flow from the brain stop the attack on myelin and nerve cells? Will it also remove excess iron stores from the central nervous system, or will another type of treatment be developed? Do iron deposits in the brain differ in areas affected by CCSVI versus areas with normal venous flow? Such questions present many exciting areas for further research." The authors state the need for further scientific data, and they point out the shortcomings of this pilot study, which include: failure to maintain open blood vessels in about half of the patients with IJV stenosis a small number of patients lack of an MS control group mixed results open label design, which may inadvertently lead to bias the study was conducted at only one MS Center patients were required to stay on FDA-approved, disease-modifying therapies lack of consistency in MRI protocol "In addition," Dr. Burks continues, "there appears to be less of an effect on people with progressive disease, who lack effective treatment options. This trial is also complicated by the fact that most of the positive results were demonstrated in RRMS patients, with minimal disease and on current DMTs. These medical treatments may have of themselves created dramatic positive results, with or without the venous insufficiency intervention. "In light of these shortcomings, I would encourage MS patients to wait for scientific results before considering this unproven procedure as part of their own treatment. The current data does not justify the use of this procedure outside of clinical trials. I hear that some people with long standing MS are considering taking a loan to have this procedure done immediately. Some are even thinking of selling their homes to get the needed funds, which have been estimated at more than $80,000. If this hypothesis does not eventually end with a positive treatment effect, these patients will be left with their MS - and no home. Obviously, the investigators and I do not recommend this drastic action at this time." Dr. Burk concludes, "We need to let the science proceed as planned and to wish the researchers much success. MSAA will continue to provide balanced updates as the research work progresses." Written by: Jack Burks, MD MSAA's Chief Medical Officer Director of Program Development at the Multiple Sclerosis Comprehensive Care Center Holy Name Hospital, Teaneck, New Jersey Susan Wells Courtney MSAA's Senior Writer and Creative Director All media inquires should be addressed to Amanda Bednar, MSAA Public Relations Manager, at (800) 532-7667, extension 122 or via email: abednar@msassociation.org. Resources: Ajay vikram Singh and Paolo Zamboni, "Anomalous venous blood flow and iron deposition in multiple sclerosis,"Journal of Cerebral Blood flow & Metabolism (2009) 29, 1867-1878, doi:10.1038; published online September 2, 2009. Paolo Zamboni et al, "A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency," Journal of Vascular Surgery, December 2009, vol.50(6), 1348-1358. Susan Jeffrey, "Endovascular Treatment of Cerebrospinal Venous Insufficiency Safe, May Provide Benefit in MS," Medscape Medical News, December 3, 2009. University of Buffalo 's press release, "Buffalo neurologists investigate possible new underlying cause of MS," available at www.buffalo.edu/news/10562 .
  13. Граждане! Пришел ответ! Письмо длинное, но Суть такова: предложения об использовании новых пепаратов должлны исходить от их производителя; положительные предложения, содежащиеся в письме будут учтены. возрастных ограничений для болных рс нет.
  14. мне массаж делали. но пзвоночник при этом не трогали!
  15. Операцию по расширению или стентированию восудов(вен) уже начали делать в Индии. По английски это состояние назыается Chronic Cerebrospinal Venous Insufficiency (CCSVI). - хроническая цереброспинальная венозная недотаоность. Так понимаю, что это вполне рядовая операция для любого сосудистого хирурга!
  16. в Катовице эта продура стоит 1400-1800 Евро!
  17. эту процеуру от рс уже начали делать в Кракове (Польша) . Глядишь и до нас дойдет! http://www.rp.pl/galeria/9138,399689.html
  18. Volume 50, Issue 6, Pages 1348-1358.e3 (December 2009) A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency This work was presented at the Thirty-first Charing Cross Symposium, London, United Kingdom, Apr 3-7, 2009. Paolo Zamboni, MDa, Roberto Galeotti, MDa, Erica Menegatti, RVTa, Anna Maria Malagoni, MDa, Sergio Gianesini, MDa, Ilaria Bartolomei, MDb, Francesco Mascoli, MDa, Fabrizio Salvi, MDb Received 11 June 2009; accepted 23 July 2009. Objective Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by combined stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJVs) and the azygous (AZY) vein, with development of collateral circles and insufficient drainage shown by increased mean transit time in cerebral magnetic resonance (MR) perfusion studies. CCSVI is strongly associated with multiple sclerosis (MS). This study evaluated the safety of CCSVI endovascular treatment and its influence on the clinical outcome of the associated MS. Methods Sixty-five consecutive patients with CCSVI, subdivided by MS clinical course into 35 with relapsing remitting (RR), 20 with secondary progressive (SP), and 10 with primary progressive (PP) MS, underwent percutaneous transluminal angioplasty (PTA). Mean follow-up was 18 months. Vascular outcome measures were postoperative complications, venous pressure, and patency rate. Neurologic outcome measures were cognitive and motor function assessment, rate of MS relapse, rate of MR active positive-enhanced gadolinium MS lesions (Gad+), and quality of life (QOL) MS questionnaire. Results Outpatient endovascular treatment of CCSVI was feasible, with a minor and negligible complication rate. Postoperative venous pressure was significantly lower in the IJVs and AZY (P < .001). The risk of restenosis was higher in the IJVs compared with the AZY (patency rate: IJV, 53%; AZY, 96%; odds ratio, 16; 95% confidence interval, 3.5-72.5; P < .0001). CCSVI endovascular treatment significantly improved MS clinical outcome measures, especially in the RR group: the rate of relapse-free patients changed from 27% to 50% postoperatively (P < .001) and of MR Gad+ lesions from 50% to 12% (P < .0001). The Multiple Sclerosis Functional Composite at 1 year improved significantly in RR patients (P < .008) but not in PP or SP. Physical QOL improved significantly in RR (P < .01) and in PP patients (P < .03), with a positive trend in SP (P < .08). Mental QOL showed significant improvement in RR (P < .003) and in PP (P < .01), but not in SP. Conclusions PTA of venous strictures in patients with CCSVI is safe, and especially in patients with RR, the clinical course positively influenced clinical and QOL parameters of the associated MS compared with the preoperative assessment. Restenosis rates are elevated in the IJVs but very promising in the AZY, suggesting the need to improve endovascular techniques in the former. The results of this pilot study warrant a subsequent randomized control study.
  19. ннтерересная статья http://www.fondazionehilarescere.org/pdf/CX.PDF
  20. “ I am confident that this could be a revolution for the research and diagnosis of multiple sclerosis ” — Dr. Paolo Zamboni
  21. http://watch.ctv.ca/news/w5/the-liberation...ent/#clip237656
  22. А чем ты болеешь?
  23. викинг

    Fampridine-sr

    Зарегистрирован: 18.04.2006 Возраст: (35) Сообщения: 1064 Откуда,: Киев, Украина Добавлено: Сб Янв 26, 2008 16:55:36 Заголовок сообщения: -------------------------------------------------------------------------------- http://www.msrc.co.uk/index.cfm?fuseaction...FTOKEN=73463063 Препарат дает больным РС большую самостоятельность (Fampridine) 24 января, 2008 Новое лекарство для лечения РС демонстрирует многообещающие результаты. Вот уже 28 лет Крис Нигро страдает РС. Из четырех возможных течений РС у нее вторично-прогрессирующее, при котором чаще всего состояние ухудшается. Ей сказали, что лечения нет, но она никогда не оставляла надежду пойти вновь. Когда Нигро начала лечение в центре Рассеянного склероза в Нью-Йорке, и ее состояние не только стабилизировалось, но она окрепла благодаря лечению. Эти улучшения сделали ее кандидатом номер один на участие в исследовании лекарства под названием Fampridine. "В течение нескольких лет я пыталась сделать шаг, держась за перекладину, и всегда чувствовала, могу ли я сделать шаг, а может даже попробовать сделать два, а то и три – в конце концов силы покидали меня", – рассказывает она. А сейчас она может сделать около 50 шагов на беговой дорожке. "Даже просто поставить одну стопу рядом с другой и встать, перенеся мой вес на ноги – чудесное ощущение", – говорит она. Первый раз за 14 лет ее сестра Нора Рейд видит ее стоящей. "Это так удивительно и чудесно – видеть ее на ногах. Она выше меня, а я уже долгое время не видела этого", – рассказывает Рейд. Новая жизнь старого лекарства Fampridine. "Течение болезни этот препарат не изменяет, но помогает людям лучше двигаться", – объясняет доктор Кит Эдвардз, невролог из РС-центра. Нигро одна из 500 человек в стране, принимающих участие в новом клиническом испытании. Хотя она и не знала, что именно принимает, было ясно – ей становилось лучше. "Это симптоматическое лечение дает возможность сигналу лучше проходить через спинной мозг", – пояснил Эдвардз. Недавно исследование завершилось. Т.к. Нигро все еще под наблюдением, она получает препарат бесплатно. "Я не знаю, удастся ли ей пробежать 100 ярдов за 10 секунд, но ее самостоятельность продолжает повышаться", – говорит Эдвардз. Fampridine, принимаемый в форме таблеток, все еще исследуется. Поэтому непонятно, будет ли он так же удачно работать и у других пациентов. Так как он еще изучается, Эдвардз может сказать только о том, что у Нигро лекарство дает результат. Он также напоминает, что лекарства от РС не всем одинаково хорошо идут. Источник: wnyt.com © Copyright 2008 WNYT-TV, LLC (24/01/0 _________________ Каждое мгновение в жизни - это шанс изменить ее! (к.ф "Ванильное небо") http://www.belboh.com Java книги для мобилок
  24. викинг

    Tysabri

    в Генеральную Прокуратуру РФ,! Если по-другому они не понимают!
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