scholarly journals Current Status of Cell-Based Therapy in Patients with Critical Limb Ischemia

Author(s):  
Frantisek Jaluvka ◽  
Peter Ihnat ◽  
Juraj Madaric ◽  
Vaclav Prochazka

Background: The treatment of peripheral arterial disease (PAD) is focused on improving perfusion and oxygenation in the affected limb. Standard revascularization methods include bypass surgery, endovascular interventional procedures, or hybrid revascularization. Cell-based therapy can be an alternative strategy for patients with no-option critical limb ischemia who are not eligible for endovascular or surgical procedures. Aims: This review offers an up-to-date critical overview of the knowledge and data of evidence-based medicine on the position of cell therapy in the treatment of PAD. It provides an overview of current evidence and appraises the future perspectives of cell-based therapy, emphasizing the potential of exosomal cell-free approaches in patients with critical limb ischemia. Results: Meta-analyses focused on cell therapy problems in PAD treatment confirm a significantly greater chance of limb salvage in the first year after the cell therapy administration. The opportunity of defect healing is at least two times higher when compared with the standard conservative therapy. Secondary endpoints of the available meta-analyses are also included in this review. Improvement of perfusion and oxygenation parameters in the affected limb, pain regression, and claudication interval prolongation are discussed. Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective.

2020 ◽  
Vol 21 (23) ◽  
pp. 8999
Author(s):  
Frantisek Jaluvka ◽  
Peter Ihnat ◽  
Juraj Madaric ◽  
Adela Vrtkova ◽  
Jaroslav Janosek ◽  
...  

(1) Background: The treatment of peripheral arterial disease (PAD) is focused on improving perfusion and oxygenation in the affected limb. Standard revascularization methods include bypass surgery, endovascular interventional procedures, or hybrid revascularization. Cell-based therapy can be an alternative strategy for patients with no-option critical limb ischemia who are not eligible for endovascular or surgical procedures. (2) Aims: The aim of this narrative review was to provide an up-to-date critical overview of the knowledge and evidence-based medicine data on the position of cell therapy in the treatment of PAD. The current evidence on the cell-based therapy is summarized and future perspectives outlined, emphasizing the potential of exosomal cell-free approaches in patients with critical limb ischemia. (3) Methods: Cochrane and PubMed databases were searched for keywords “critical limb ischemia and cell therapy”. In total, 589 papers were identified, 11 of which were reviews and 11 were meta-analyses. These were used as the primary source of information, using cross-referencing for identification of additional papers. (4) Results: Meta-analyses focusing on cell therapy in PAD treatment confirm significantly greater odds of limb salvage in the first year after the cell therapy administration. Reported odds ratio estimates of preventing amputation being mostly in the region 1.6–3, although with a prolonged observation period, it seems that the odds ratio can grow even further. The odds of wound healing were at least two times higher when compared with the standard conservative therapy. Secondary endpoints of the available meta-analyses are also included in this review. Improvement of perfusion and oxygenation parameters in the affected limb, pain regression, and claudication interval prolongation are discussed. (5) Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective.


2021 ◽  
Vol 9 (3) ◽  
pp. 149-155
Author(s):  
Naba’a Alkhair ALshaikh ◽  
Haghamad Allzain ◽  
Bashier Eltayeb Shumo

Evidence-based medicine (EBM) is the “conscientious, explicit, and judicious use of current best evidence (Thamer Z. et al. 2018 .It is the evolving science of clinical care. It is the judicious use of the best current evidence in making decisions about the care of the individual patient.  It also integrates clinical expertise, patient desires, values, and needs .  (Michael LeFevre.2014 ) The current study intended to assess Knowledge, attitude and perception toward EBM among medical students in Shendi University in Sudan. It was descriptive cross-sectional one, from October to December 2020; It included one hundred and twenty one (121) medical students. Data was collected employing structural self –administered questionnaire and the data collected was analyzed by SPSS. The findings of the study described the current status of level of awareness and use of EBM .More than half of students have poor knowledge toward EBM. Approximately half or less have good attitude compared with their poor knowledge, while the perception of the importance of evidence based medicine was good (72%).


2021 ◽  
Author(s):  
Sergey Roussakow

Abstract BACKGROUND: Evidence-based medicine (EBM) is in crisis, in part due to bad methods, which are understood as misuse of statistics that is considered correct in itself. The correctness of the basic statistics related to the effect size (ES) based on correlation (CBES) was questioned. METHODS: Monte Carlo simulation of two paired binary samples, mathematical analysis, conceptual analysis, bias analysis. RESULTS: Actual effect size and CBES are not related. CBES is a fallacy based on misunderstanding of correlation and ES and confusion with 2 × 2 tables that makes no distinction between gross crosstabs (GCTs) and contingency tables (CTs). This leads to misapplication of Pearson’s Phi, designed for CTs, to GCTs and confusion of the resulting gross Pearson Phi, or mean-square effect half-size, with the implied Pearson mean square contingency coefficient. Generalizing this binary fallacy to continuous data and the correlation in general (Pearson’s r) resulted in flawed equations directly expressing ES in terms of the correlation coefficient, which is impossible without including covariance, so these equations and the whole CBES concept are fundamentally wrong. misconception of contingency tables (MCT) is a series of related misconceptions due to confusion with 2 × 2 tables and misapplication of related statistics. Problems arising from these fallacies are discussed and the necessary changes to the corpus of statistics are proposed resolving the problem of correlation and ES in paired binary data. CONCLUSIONS: Two related common misconceptions in statistics have been exposed, CBES and MCT. The misconceptions are threatening because most of the findings from contingency tables, including meta-analyses, can be misleading. Since exposing these fallacies casts doubt on the reliability of the statistical foundations of EBM in general, we urgently need to revise them.


Author(s):  
Leila A. Pak ◽  
K. V. Zherdev ◽  
L. M. Kuzenkova ◽  
A. L. Kurenkov ◽  
B. I. Bursagova

In the article the authors consider such methods of the alternative/complementary treatment of the cerebral palsy (CP), presented in the modern domestic and foreign literature, as metabolic (amino acid composites), metamer (I.A. Skvortsov), intravenous administration of baclofen, antiepileptic (vagal stimulation, levetiracetam), acupuncture, transcranial cerebral micropolarization, epidural stimulation, modified motion-induced restriction therapy (MMIRT), stem cell therapy, as well as some other complementary/palliative approaches to the correction of clinical manifestations of various forms of CP. The final part of the article presents the attitude of modern evidence-based medicine to the main methods of the alternative/complementary treatment of cerebral palsy. These data are based almost exclusively on international systematic reviews and relevant meta-analyses.


Author(s):  
Natalia A. Vyatkina

The term "evidence-based medicine" is being increasingly used by various sources of information today, and becomes a discussion subject of professional communities and ordinary citizens. Apart from a brief insight into the origin and development of evidence-based medicine in the world and in Russia, the article deals with the anthropological analysis of the attitudes of the modern Russian physicians and patients towards both the understanding of the term and the current status, prospects and possible risks of the development of this discipline in our country. The views of respondents about the role of pharmaceutical companies, the state and the balance between the development and implementation of clinical guidelines and individual cases are considered. The article presents the arguments of patients about whether there is still a "physician blessed by God" and whether it is important for them that the person who they address for help works in the paradigm of evidence-based medicine. Physicians question whether healing itself is still an art, or evidence-based medicine has finally turned it into a business and well-organized mechanism, which could protect them from criminal prosecution in a critical situation.


Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 435-441 ◽  
Author(s):  
Victor M Lu ◽  
Christopher S Graffeo ◽  
Avital Perry ◽  
Michael J Link ◽  
Fredric B Meyer ◽  
...  

Abstract Systematic reviews and meta-analyses in the neurosurgical literature have surged in popularity over the last decade. It is our concern that, without a renewed effort to critically interpret and appraise these studies as high or low quality, we run the risk of the quality and value of evidence-based medicine in neurosurgery being misinterpreted. Correspondingly, we have outlined 4 major domains to target in interpreting neurosurgical systematic reviews and meta-analyses based on the lessons learned by a collaboration of clinicians and academics summarized as 4 pearls. The domains of (1) heterogeneity, (2) modeling, (3) certainty, and (4) bias in neurosurgical systematic reviews and meta-analyses were identified as aspects in which the authors’ approaches have changed over time to improve robustness and transparency. Examples of how and why these pearls were adapted were provided in areas of cranial neuralgia, spine, pediatric, and neuro-oncology to demonstrate how neurosurgical readers and writers may improve their interpretation of these domains. The incorporation of these pearls into practice will empower neurosurgical academics to effectively interpret systematic reviews and meta-analyses, enhancing the quality of our evidence-based medicine literature while maintaining a critical focus on the needs of the individual patients in neurosurgery.


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