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引用次数: 0
摘要
对于患者和医生以及管理者和药品监管者来说,一种疾病的治疗方法在长期使用中被证明是安全和有临床意义的,这一点至关重要。最近的文献强调了支持和反对改变阿尔茨海默病(AD)潜在疾病过程的三大类论点:病理生理学、生物标志物和临床试验数据。我们认为,阿尔茨海默病领域过分依赖于仅以脑部正电子发射断层扫描(PET)成像和血液中 tau 和 Aβ 肽的生物标志物为基础的疾病改变理论。在此,我们转而关注其他医学领域具有历史基础的经验标准,以克服对阿尔茨海默氏症短期试验的薄弱解释:生存时间(ST)。我们的分析发现了三个关键点。首先,如果抗淀粉样蛋白疗法是改善阿兹海默症的治疗方法,那么我们认为,与使用美金刚和乙酰胆碱酯酶抑制剂的标准 "对症 "治疗相比,它们应该更能延长存活时间。其次,我们质疑将美金刚和胆碱酯酶抑制剂简单地称为 "对症 "阿尔茨海默氏症药物的做法,因为长期使用这两种药物可以改变疾病,即增加 ST。第三,我们主张在淀粉样蛋白降解药物和其他药物的临床试验中将美金刚或胆碱酯酶抑制剂用作对照药,并反对目前在阿尔茨海默病患者护理中使用不足的情况。
Survival time in Alzheimer's disease: An overlooked measure of safety and efficacy of disease-modifying therapies.
It is of vital importance to patients and physicians, as well as administrators and drug regulators, that the treatment for a disease has been shown to be safe and clinically meaningful in long-term use. Recent literature has highlighted 3 major categories of arguments for and against modification of the underlying disease process in Alzheimer's disease (AD): pathophysiology, biomarkers and data from clinical trials. We argue that the Alzheimer's arena is over-reliant on theories of disease modification based solely on brain positron emission tomography (PET) imaging and blood biomarkers of tau and Aβ peptides. Here, we instead focus on a historically-grounded empirical criterion from other fields of medicine to overcome the weak interpretations of short Alzheimer's trials: survival time (ST). Our analysis has identified 3 key points. First, if anti-amyloid therapies are AD-modifying treatments, then we argue that they should increase ST more than the standard "symptomatic" care with memantine and acetylcholinesterase inhibitors. Second, we question memantine and cholinesterase inhibitors being labeled simply as "symptomatic" Alzheimer's drugs since long-term use of them can produce disease modification, that is, increase ST. Third, we make a case for memantine or cholinesterase inhibitors being used as controls in clinical trials with amyloid-lowering and other drugs, and argue against their current under-use in care of Alzheimer's patients.
期刊介绍:
Advances in Clinical and Experimental Medicine has been published by the Wroclaw Medical University since 1992. Establishing the medical journal was the idea of Prof. Bogumił Halawa, Chair of the Department of Cardiology, and was fully supported by the Rector of Wroclaw Medical University, Prof. Zbigniew Knapik. Prof. Halawa was also the first editor-in-chief, between 1992-1997. The journal, then entitled "Postępy Medycyny Klinicznej i Doświadczalnej", appeared quarterly.
Prof. Leszek Paradowski was editor-in-chief from 1997-1999. In 1998 he initiated alterations in the profile and cover design of the journal which were accepted by the Editorial Board. The title was changed to Advances in Clinical and Experimental Medicine. Articles in English were welcomed. A number of outstanding representatives of medical science from Poland and abroad were invited to participate in the newly established International Editorial Staff.
Prof. Antonina Harłozińska-Szmyrka was editor-in-chief in years 2000-2005, in years 2006-2007 once again prof. Leszek Paradowski and prof. Maria Podolak-Dawidziak was editor-in-chief in years 2008-2016. Since 2017 the editor-in chief is prof. Maciej Bagłaj.
Since July 2005, original papers have been published only in English. Case reports are no longer accepted. The manuscripts are reviewed by two independent reviewers and a statistical reviewer, and English texts are proofread by a native speaker.
The journal has been indexed in several databases: Scopus, Ulrich’sTM International Periodicals Directory, Index Copernicus and since 2007 in Thomson Reuters databases: Science Citation Index Expanded i Journal Citation Reports/Science Edition.
In 2010 the journal obtained Impact Factor which is now 1.179 pts. Articles published in the journal are worth 15 points among Polish journals according to the Polish Committee for Scientific Research and 169.43 points according to the Index Copernicus.
Since November 7, 2012, Advances in Clinical and Experimental Medicine has been indexed and included in National Library of Medicine’s MEDLINE database. English abstracts printed in the journal are included and searchable using PubMed http://www.ncbi.nlm.nih.gov/pubmed.