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  1. Article ; Online: Pathophysiology, assessment and management of multiple sclerosis fatigue: an update.

    Rottoli, Mariarosa / La Gioia, Sara / Frigeni, Barbara / Barcella, Valeria

    Expert review of neurotherapeutics

    2017  Volume 17, Issue 4, Page(s) 373–379

    Abstract: Introduction: Fatigue is one of the most common symptoms associated with multiple sclerosis, affecting almost 80% of patients with 55% of them reporting it as one of the worst symptoms experienced, often independently of the level of disability. Areas ... ...

    Abstract Introduction: Fatigue is one of the most common symptoms associated with multiple sclerosis, affecting almost 80% of patients with 55% of them reporting it as one of the worst symptoms experienced, often independently of the level of disability. Areas covered: We review the main pathophysiological hypothesis, fatigue assessment scales, and its management. Expert commentary: Fatigue pathophysiology is complex and is often influenced by other secondary but relevant factors (e.g. psychological disturbances, musculoskeletal problems, sleep disorders and medication side effects) which may vary over time. Both peripheral and central mechanisms are implicated. The large heterogeneity of the assessment scales, which were used in the therapeutic trials, is partially responsible for the uncertainty of their results. To date, the best therapeutic approach seems to be from a multidisciplinary management involving exercise, rehabilitation and education in conjunction with medication.
    MeSH term(s) Exercise Therapy ; Fatigue/diagnosis ; Fatigue/therapy ; Humans ; Multiple Sclerosis/physiopathology ; Sleep Wake Disorders
    Language English
    Publishing date 2017
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2112534-X
    ISSN 1744-8360 ; 1473-7175
    ISSN (online) 1744-8360
    ISSN 1473-7175
    DOI 10.1080/14737175.2017.1247695
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  2. Article ; Online: Sex differences in ischemic stroke during COVID-19 first outbreak in northern Italy.

    Sangalli, Davide / Versino, Maurizio / Colombo, Irene / Ciccone, Alfonso / Beretta, Simone / Marcheselli, Simona / Roncoroni, Mauro / Beretta, Sandro / Lorusso, Lorenzo / Cavallini, Anna / Prelle, Alessandro / Guidetti, Donata / La Gioia, Sara / Canella, Stefania / Zanferrari, Carla / Grampa, Giampiero / d'Adda, Elisabetta / Peverelli, Lorenzo / Colombo, Antonio /
    Martinelli-Boneschi, Filippo / Salmaggi, Andrea

    Journal of the neurological sciences

    2023  Volume 454, Page(s) 120848

    Abstract: Introduction: COVID-19 pandemic had a great impact on outcome in SARS-CoV-2 positive patients with ischemic stroke during the first wave in Italy. Few data are available on outcome stratified by sex.: Methods: The Italian Society of Hospital ... ...

    Abstract Introduction: COVID-19 pandemic had a great impact on outcome in SARS-CoV-2 positive patients with ischemic stroke during the first wave in Italy. Few data are available on outcome stratified by sex.
    Methods: The Italian Society of Hospital Neuroscience conducted a multi-center, retrospective, observational study on neurological complications in COVID-19 patients with ischemic stroke. All the patients admitted from March 1st to April 30th, 2020 in 20 Neurology Units in Northern Italy were recruited. Demographical and clinical features, treatment and outcome data were compared focusing on sex differences.
    Results: 812 patients with ischemic stroke were enrolled, of whom 129 with COVID-19; males were 53.8%. In-hospital mortality in COVID-19 patients was 35.3% in males and 27.9% in females while 8.5% in male and 5.8% in female patients without COVID-19. SARS-CoV-2 positive patients had a higher frequency of stroke of undetermined etiology, than negative ones (32.8% vs 22.5%; p = 0.02), especially in females compared to males (36.1% vs 27.9%), albeit without statistical significance. Male patients with SARS-CoV-2 were more likely to require cPAP (30.9% vs 14.8%; p = 0.03), endotracheal tube (14.9% vs 3.3%; p = 0.02) and reperfusion strategies (29.4% vs 11.5%; p = 0.01) than females, as well as to have a higher CRP and D-dimer. These elements together with older age, a total anterior circulation stroke and lymphopenia were predictors of a worse outcome.
    Discussion: Our study detected some differences due to sex in ischemic stroke with and without COVID-19, supporting the possibility to perform sex analyses for SARS-CoV-2 positive patients for a better clinical management.
    MeSH term(s) Humans ; Female ; Male ; COVID-19/epidemiology ; SARS-CoV-2 ; Ischemic Stroke/epidemiology ; Retrospective Studies ; Pandemics ; Sex Characteristics ; Stroke/therapy ; Italy/epidemiology
    Language English
    Publishing date 2023-10-31
    Publishing country Netherlands
    Document type Observational Study ; Journal Article
    ZDB-ID 80160-4
    ISSN 1878-5883 ; 0022-510X ; 0374-8642
    ISSN (online) 1878-5883
    ISSN 0022-510X ; 0374-8642
    DOI 10.1016/j.jns.2023.120848
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  3. Article ; Online: Impact of SARS-CoV-2 infection on acute intracerebral haemorrhage in northern Italy.

    Sangalli, Davide / Martinelli-Boneschi, Filippo / Versino, Maurizio / Colombo, Irene / Ciccone, Alfonso / Beretta, Simone / Marcheselli, Simona / Altavilla, Riccardo / Roncoroni, Mauro / Beretta, Sandro / Lorusso, Lorenzo / Cavallini, Anna / Prelle, Alessandro / Guidetti, Donata / La Gioia, Sara / Santalucia, Paola / Zanferrari, Carla / Grampa, Giampiero / D'Adda, Elisabetta /
    Peverelli, Lorenzo / Colombo, Antonio / Salmaggi, Andrea

    Journal of the neurological sciences

    2021  Volume 426, Page(s) 117479

    Abstract: Introduction: Growing evidence has been published as to the impact of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) on cerebrovascular events over the last few months, with considerable attention paid to ischemic strokes. Conversely, ... ...

    Abstract Introduction: Growing evidence has been published as to the impact of SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) on cerebrovascular events over the last few months, with considerable attention paid to ischemic strokes. Conversely, little is known about the clinical course of intracerebral haemorrhage (ICH) and simultaneous SARS-CoV-2 infection.
    Method: The Italian Society of Hospital Neurosciences (SNO) promoted a multicentre, retrospective, observational study (SNO-COVID-19), involving 20 Neurological Departments in Northern Italy. Clinical data on patients with acute cerebrovascular diseases, admitted from March 1st to April 30th, 2020, were collected. A comparison was made of the demographical and clinical features of both SARS-CoV-2 positive and negative patients with ICH.
    Results: 949 patients were enrolled (average age 73.4 years; 52.7% males); 135 patients had haemorrhagic stroke and 127 (13.4%) had a primary ICH. Only 16 patients with ICH (12.6%) had laboratory confirmed SARS-CoV-2 infection, both symptomatic and asymptomatic. SARS-CoV-2 related pneumonia or respiratory distress (OR 5.4), lobar location (OR 5.0) and previous antiplatelet or anticoagulant treatment (OR 2.9) were the only factors significantly associated with increased mortality in ICH. SARS-CoV-2 infection, regardless of respiratory involvement, led to a non-significantly increased risk of in-hospital death (37.5% vs 23.4%, p = 0.2).
    Discussion: ICH patients with COVID-19 did not experience an increase in mortality as striking as ischemic stroke. The inflammatory response and respiratory complications could justify the slight increase of death in ICH. Bleeding sites and previous antiplatelet or anticoagulant treatment were the only other predictors of a worse outcome.
    MeSH term(s) Aged ; COVID-19 ; Cerebral Hemorrhage/complications ; Cerebral Hemorrhage/epidemiology ; Female ; Hospital Mortality ; Humans ; Italy/epidemiology ; Male ; Retrospective Studies ; SARS-CoV-2
    Language English
    Publishing date 2021-05-05
    Publishing country Netherlands
    Document type Journal Article ; Observational Study
    ZDB-ID 80160-4
    ISSN 1878-5883 ; 0022-510X ; 0374-8642
    ISSN (online) 1878-5883
    ISSN 0022-510X ; 0374-8642
    DOI 10.1016/j.jns.2021.117479
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  4. Article ; Online: Wake-up stroke within 3 hours of symptom awareness: imaging and clinical features compared to standard recombinant tissue plasminogen activator treated stroke.

    Roveri, Luisa / La Gioia, Sara / Ghidinelli, Chiara / Anzalone, Nicoletta / De Filippis, Costantino / Comi, Giancarlo

    Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association

    2013  Volume 22, Issue 6, Page(s) 703–708

    Abstract: Background: Patients with wake-up stroke (WUS) are excluded from thrombolysis because of unknown time of symptom onset. Previous studies have reported similar stroke severity and early ischemic changes (EICs) in patients with WUS and stroke of known ... ...

    Abstract Background: Patients with wake-up stroke (WUS) are excluded from thrombolysis because of unknown time of symptom onset. Previous studies have reported similar stroke severity and early ischemic changes (EICs) in patients with WUS and stroke of known onset. These studies, however, included patients within a large timeframe to imaging or did not quantify EICs. The aim of our study was to quantify EICs of patients with WUS presenting within 3 hours of symptom recognition compared to standard 3-hours recombinant tissue plasminogen activator (rt-PA)-treated patients and assess the extent of ischemic lesion and functional independence at follow-up.
    Methods: Patients were selected from our prospectively collected stroke database. Baseline and follow-up computed tomographic scans were graded with Alberta Stroke Program Early Computed Tomography Score (ASPECTS). Clinical outcome measures were modified Rankin Scale score, mortality, and symptomatic intracerebral hemorrhage.
    Results: Demographic features, risk factors, stroke severity, and baseline ASPECTS were similar in both groups. WUS and rt-PA-treated patients had similar tissue outcome (median ASPECTS 7.0 vs 7.5; P = .202). Functional outcome was more favorable in rt-PA-treated patients (61.6% vs 43.1%; odds ratio [OR] 2.12; 95% confidence interval [CI] 1.05-4.28; P = .037). After adjusting for age, stroke severity, treatment, and EICs in less than one-third of middle cerebral artery territory, rt-PA and National Institutes of Health Stroke Scale scores remained the only significant predictors of outcome (OR 7.76; 95% CI 2.40-25.05; P = .001 and OR 0.74; 95% CI 0.67-0.82; P < .001, respectively).
    Conclusions: Within 3 hours of symptom recognition, patients with WUS have EICs similar to rt-PA-treated patients. It is reasonable to expect that selected WUS patients might benefit from thrombolysis within 3 hours of symptom awareness.
    MeSH term(s) Aged ; Awareness ; Cerebral Angiography/methods ; Cerebral Hemorrhage/etiology ; Chi-Square Distribution ; Disability Evaluation ; Female ; Fibrinolytic Agents/administration & dosage ; Fibrinolytic Agents/adverse effects ; Humans ; Infarction, Middle Cerebral Artery/complications ; Infarction, Middle Cerebral Artery/diagnosis ; Infarction, Middle Cerebral Artery/drug therapy ; Infarction, Middle Cerebral Artery/mortality ; Infarction, Middle Cerebral Artery/physiopathology ; Infarction, Middle Cerebral Artery/psychology ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Patient Selection ; Predictive Value of Tests ; Recognition (Psychology) ; Recombinant Proteins/administration & dosage ; Recovery of Function ; Risk Factors ; Severity of Illness Index ; Symptom Assessment ; Thrombolytic Therapy/adverse effects ; Time Factors ; Time-to-Treatment ; Tissue Plasminogen Activator/administration & dosage ; Tissue Plasminogen Activator/adverse effects ; Tomography, X-Ray Computed ; Treatment Outcome ; Wakefulness
    Chemical Substances Fibrinolytic Agents ; Recombinant Proteins ; Tissue Plasminogen Activator (EC 3.4.21.68)
    Language English
    Publishing date 2013-08
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 1131675-5
    ISSN 1532-8511 ; 1052-3057
    ISSN (online) 1532-8511
    ISSN 1052-3057
    DOI 10.1016/j.jstrokecerebrovasdis.2011.10.003
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  5. Article ; Online: Neurologic manifestations in 1760 COVID-19 patients admitted to Papa Giovanni XXIII Hospital, Bergamo, Italy.

    Rifino, Nicola / Censori, Bruno / Agazzi, Emanuela / Alimonti, Dario / Bonito, Virginio / Camera, Giorgia / Conti, Marta Zaffira / Foresti, Camillo / Frigeni, Barbara / Gerevini, Simonetta / Grimoldi, Maria / La Gioia, Sara / Partziguian, Tania / Quadri, Stefano / Riva, Riccardo / Servalli, Maria Cristina / Sgarzi, Manlio / Storti, Benedetta / Vedovello, Marcella /
    Venturelli, Elisabetta / Viganò, Martina / Callegaro, Annapaola / Arosio, Marco / Sessa, Maria

    Journal of neurology

    2020  Volume 268, Issue 7, Page(s) 2331–2338

    Abstract: Objectives: Evidences from either small series or spontaneous reporting are accumulating that SARS-CoV-2 involves the Nervous Systems. The aim of this study is to provide an extensive overview on the major neurological complications in a large cohort of ...

    Abstract Objectives: Evidences from either small series or spontaneous reporting are accumulating that SARS-CoV-2 involves the Nervous Systems. The aim of this study is to provide an extensive overview on the major neurological complications in a large cohort of COVID-19 patients.
    Methods: Retrospective, observational analysis on all COVID-19 patients admitted from February 23rd to April 30th, 2020 to ASST Papa Giovanni XXIII, Bergamo, Italy for whom a neurological consultation/neurophysiological assessment/neuroradiologic investigation was requested. Each identified neurologic complication was then classified into main neurologic categories.
    Results: Of 1760 COVID-19 patients, 137 presented neurologic manifestations that manifested after COVID-19 symptoms in 98 pts and was the presenting symptom in 39. Neurological manifestations were classified as: (a) cerebrovascular disease [53 pts (38.7%)] including 37 ischemic and 11 haemorrhagic strokes, 4 transient ischemic attacks, 1 cerebral venous thrombosis; (b) peripheral nervous system diseases [31 (22.6%)] including 17 Guillain-Barrè syndromes; (c) altered mental status [49 (35.8%)] including one necrotizing encephalitis and 2 cases with RT-PCR detection of SARS-Cov-2 RNA in CSF; (d) miscellaneous disorders, among whom 2 patients with myelopathy associated with Ab anti-SARS-CoV-2 in CSF. Patients with peripheral nervous system involvement had more frequently severe ARDS compared to patients with cerebrovascular disease (87.1% vs 42%; difference = 45.1% 95% CI 42.0-48.2; χ
    Conclusion: This study confirms that involvement of nervous system is common in SARS-CoV-2 infection and offers clinicians useful information for prevention and prompt identification in order to set the adequate therapeutic strategies.
    MeSH term(s) COVID-19/complications ; Hospitals ; Humans ; Italy ; Nervous System Diseases/virology ; RNA, Viral ; Retrospective Studies
    Chemical Substances RNA, Viral
    Keywords covid19
    Language English
    Publishing date 2020-10-07
    Publishing country Germany
    Document type Journal Article ; Observational Study
    ZDB-ID 187050-6
    ISSN 1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    ISSN (online) 1432-1459
    ISSN 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    DOI 10.1007/s00415-020-10251-5
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  6. Article ; Online: Glatiramer acetate-induced hepatitis in a young female patient with multiple sclerosis.

    La Gioia, Sara / Bacis, Giuseppe / Sonzogni, Aurelio / Frigeni, Barbara / Conti, Marta Zaffira / Vedovello, Marcella / Rottoli, Mariarosa

    Multiple sclerosis and related disorders

    2014  Volume 3, Issue 6, Page(s) 732–734

    Abstract: We report the first Italian case of glatiramer acetate-related acute hepatotoxicity. A 25-years-old woman suffering from multiple sclerosis presented acute hepatitis after eight months of treatment. Neither infective, nor autoimmune markers were detected. ...

    Abstract We report the first Italian case of glatiramer acetate-related acute hepatotoxicity. A 25-years-old woman suffering from multiple sclerosis presented acute hepatitis after eight months of treatment. Neither infective, nor autoimmune markers were detected. Liver biopsy histology was consistent with drug-induced acute injury. Liver function tests became normal after eight weeks of treatment discontinuation. This report points out the importance of monitoring liver function during the first year of treatment with glatiramer acetate.
    MeSH term(s) Adjuvants, Immunologic/adverse effects ; Adjuvants, Immunologic/therapeutic use ; Adult ; Female ; Glatiramer Acetate ; Hepatitis/blood ; Hepatitis/diagnosis ; Hepatitis/etiology ; Hepatitis/pathology ; Humans ; Italy ; Liver/pathology ; Liver/physiopathology ; Multiple Sclerosis, Relapsing-Remitting/complications ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Peptides/adverse effects ; Peptides/therapeutic use
    Chemical Substances Adjuvants, Immunologic ; Peptides ; Glatiramer Acetate (5M691HL4BO)
    Language English
    Publishing date 2014-11
    Publishing country Netherlands
    Document type Case Reports ; Journal Article
    ISSN 2211-0356
    ISSN (online) 2211-0356
    DOI 10.1016/j.msard.2014.08.001
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  7. Article ; Online: A real-world study of alemtuzumab in a cohort of Italian patients.

    Russo, Cinzia Valeria / Saccà, Francesco / Frau, Jessica / Annovazzi, Pietro / Signoriello, Elisabetta / Bonavita, Simona / Grasso, Roberta / Clerico, Marinella / Cordioli, Cinzia / Laroni, Alice / Capobianco, Marco / Torri Clerici, Valentina / Sartori, Arianna / Cavalla, Paola / Maniscalco, Giorgia Teresa / La Gioia, Sara / Caleri, Francesca / Giugno, Alessia / Iodice, Rosa /
    Carotenuto, Antonio / Cocco, Eleonora / Fenu, Giuseppe / Zaffaroni, Mauro / Baroncini, Damiano / Lus, Giacomo / Gallo, Antonio / De Mercanti, Stefania Federica / Lapucci, Caterina / Di Francescantonio, Valeria / Brambilla, Laura / Sormani, Maria Pia / Signori, Alessio

    European journal of neurology

    2021  Volume 29, Issue 1, Page(s) 257–266

    Abstract: Background and purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous ...

    Abstract Background and purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous DMTs on clinical response to alemtuzumab.
    Methods: Sixteen Italian multiple sclerosis centers retrospectively included patients who started alemtuzumab from January 2015 to December 2018, and recorded demographics, previous therapies, washout duration, relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging data. Negative binomial regression models were used to assess the effect of factors on annualized relapse (ARR) after alemtuzumab initiation.
    Results: We studied 322 patients (mean age 36.8 years, median EDSS score 3, median follow-up 1.94 years). Previous treatments were: fingolimod (106), natalizumab (80), first-line oral agents (56), first-line injectables (interferon/glatiramer acetate; 30), and other drugs (15). Thirty-five patients were treatment-naïve. The pre-alemtuzumab ARR was 0.99 and decreased to 0.13 during alemtuzumab treatment (p < 0.001). The number of previous-year relapses was associated with alemtuzumab ARR (adjusted risk ratio [RR] 1.38, p = 0.009). Progression-free survival was 94.5% after 1 year, and 89.2% after 2 years of alemtuzumab treatment. EDSS score improvement occurred in 13.5% after 1 year, and 20.6% after 2 years. Re-baselining patients after 6 months of alemtuzumab treatment, led to no evidence of disease activity status in 71.6% after 1 year and 58.9% after 2 years.
    Conclusions: Alemtuzumab decreases ARR independent of previous therapy, including patients with disease activity during natalizumab treatment. Overall, 90% of patients showed no disease progression, and 20% an improvement after 2 years of alemtuzumab.
    MeSH term(s) Adult ; Alemtuzumab/therapeutic use ; Fingolimod Hydrochloride/therapeutic use ; Glatiramer Acetate/therapeutic use ; Humans ; Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Natalizumab/therapeutic use ; Retrospective Studies
    Chemical Substances Natalizumab ; Alemtuzumab (3A189DH42V) ; Glatiramer Acetate (5M691HL4BO) ; Fingolimod Hydrochloride (G926EC510T)
    Language English
    Publishing date 2021-10-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 1280785-0
    ISSN 1468-1331 ; 1351-5101 ; 1471-0552
    ISSN (online) 1468-1331
    ISSN 1351-5101 ; 1471-0552
    DOI 10.1111/ene.15121
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  8. Article ; Online: Erythroblastaemia in natalizumab-treated patients with multiple sclerosis.

    La Gioia, Sara / Seghezzi, Michela / Barcella, Valeria / Dominoni, Paola / Mecca, Tommaso / Frigeni, Barbara / Conti, Marta Zaffira / Vedovello, Marcella / Vidali, Matteo / Rottoli, Mariarosa / Buoro, Sabrina

    Multiple sclerosis and related disorders

    2016  Volume 8, Page(s) 141–144

    Abstract: Background: Natalizumab is a monoclonal antibody that significantly reduces the occurrence of relapses in relapse-remitting multiple sclerosis (RRMS) patients. Early papers on the clinical use of natalizumab in RRMS patients reported erythroblastemia as ...

    Abstract Background: Natalizumab is a monoclonal antibody that significantly reduces the occurrence of relapses in relapse-remitting multiple sclerosis (RRMS) patients. Early papers on the clinical use of natalizumab in RRMS patients reported erythroblastemia as occasional and transient.
    Objectives: to determine the prevalence and absolute count of erythroblasts (nucleated red blood cells, NRBCs) in peripheral blood of RRMS patients in different treatment groups and healthy controls from the same geographic area using the same equipment for laboratory analysis.
    Methods: We retrospectively evaluated the samples of 203 consecutive RRMS patients including 26 subjects on natalizumab, 17 on fingolimod, 72 on interferon, 41 on glatiramer acetate, 47 treatment-naïve and 240 healthy controls from the same geographic area. Blood samples were processed using an XN-9000-Hematology Analyzer and subsequent microscopic verification. In the natalizumab-treated patients we performed an additional analysis in order to detect the expression of CD34+ cells in peripheral blood, as confirmation of a bone marrow mobilization.
    Results: The prevalence of patients with NRBCs positivity was significantly higher in natalizumab-treated patients (92%) compared with the other treatment groups and healthy controls (0%) (p<0.0005). The median absolute NRBCs count was significantly higher in natalizumab-treated patients (median 0.020, p<0.0005) than in the other treatment groups and healthy controls. Natalizumab-treated patients also had higher levels of white blood cells than all other groups and lower haemoglobin levels than healthy subjects (p<0.01), but no morphologic alterations were evident at a subsequent review of red blood cells, platelets and white blood cells. CD34+ cells levels were consistent with mobilization of haematopoietic stem cells from the bone marrow (median 8 cells/µL, IQR 5-12).
    Conclusions: We confirm erythroblastaemia as a frequent finding of natalizumab treatment in RRMS patients. More extended knowledge and adequate long-term observation of this phenomenon are essential to better understand any pathological implication.
    MeSH term(s) Adult ; Erythroblasts ; Erythrocyte Count ; Female ; Fingolimod Hydrochloride/therapeutic use ; Glatiramer Acetate/therapeutic use ; Humans ; Immunologic Factors/therapeutic use ; Interferons/therapeutic use ; Logistic Models ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/blood ; Multiple Sclerosis, Relapsing-Remitting/complications ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/epidemiology ; Natalizumab/therapeutic use ; Prevalence ; Retrospective Studies
    Chemical Substances Immunologic Factors ; Natalizumab ; Glatiramer Acetate (5M691HL4BO) ; Interferons (9008-11-1) ; Fingolimod Hydrochloride (G926EC510T)
    Language English
    Publishing date 2016-07
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-0356
    ISSN (online) 2211-0356
    DOI 10.1016/j.msard.2016.05.020
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  9. Article ; Online: Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study.

    Frau, Jessica / Saccà, Francesco / Signori, Alessio / Baroncini, Damiano / Fenu, Giuseppe / Annovazzi, Pietro / Capobianco, Marco / Signoriello, Elisabetta / Laroni, Alice / La Gioia, Sara / Sartori, Arianna / Maniscalco, Giorgia Teresa / Bonavita, Simona / Clerico, Marinella / Russo, Cinzia Valeria / Gallo, Antonio / Lapucci, Caterina / Carotenuto, Antonio / Sormani, Maria Pia /
    Cocco, Eleonora

    Journal of neurology

    2019  Volume 266, Issue 10, Page(s) 2440–2446

    Abstract: Background: A high reactivation of multiple sclerosis (MS) was reported in patients treated with alemtuzumab after fingolimod. We aimed to understand whether this shift enhanced the risk for reactivation in a real-life cohort.: Methods: Subjects with ...

    Abstract Background: A high reactivation of multiple sclerosis (MS) was reported in patients treated with alemtuzumab after fingolimod. We aimed to understand whether this shift enhanced the risk for reactivation in a real-life cohort.
    Methods: Subjects with relapsing MS, shifting from fingolimod to alemtuzumab were enrolled. We collected the following data: age, sex, disease duration, relapses after fingolimod withdrawal, new T2/gadolinium (Gd)-enhancing lesions in the last magnetic resonance imaging (MRI) during fingolimod and in the first, while on alemtuzumab, lymphocyte counts at alemtuzumab start, and Expanded Disability Status Scale (EDSS) before and after alemtuzumab.
    Results: We enrolled 77 patients (women 61 (79%); mean age 36.2 years (SD 9.6), and disease duration 12.3 years (SD 6.8) at fingolimod discontinuation; median washout 1.8 months). The annualised relapse rate was 0.89 during fingolimod, 1.32 during washout, and 0.15 after alemtuzumab (p = 0.001). The EDSS changed from a median of 3 (IQR 2-4) at the end of fingolimod to 2.5 after alemtuzumab (IQR 1.5-4) (p = 0.013). The washout length and the lymphocyte count before alemtuzumab were not associated with EDSS change after alemtuzumab (p = 0.59 and p = 0.33, respectively). MRI activity decreased after alemtuzumab compared to that during fingolimod (p = 0.001). At alemtuzumab start, lymphocyte counts were < 0.8 × 10
    Conclusions: In our cohort, alemtuzumab reduced relapse, new T2/Gd-enhancing lesions, and EDSS score, as compared to the previous periods (fingolimod/washout). These results were not related to washout length or lymphocyte counts. Therefore, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.
    MeSH term(s) Adult ; Alemtuzumab/administration & dosage ; Alemtuzumab/adverse effects ; Alemtuzumab/pharmacology ; Female ; Fingolimod Hydrochloride/administration & dosage ; Fingolimod Hydrochloride/adverse effects ; Fingolimod Hydrochloride/pharmacology ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/adverse effects ; Immunologic Factors/pharmacology ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/diagnostic imaging ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/physiopathology ; Outcome Assessment, Health Care ; Retrospective Studies ; Severity of Illness Index
    Chemical Substances Immunologic Factors ; Alemtuzumab (3A189DH42V) ; Fingolimod Hydrochloride (G926EC510T)
    Language English
    Publishing date 2019-06-17
    Publishing country Germany
    Document type Journal Article ; Multicenter Study
    ZDB-ID 187050-6
    ISSN 1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    ISSN (online) 1432-1459
    ISSN 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    DOI 10.1007/s00415-019-09424-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Thrombolysis after dabigatran reversal: A nation-wide Italian multicentre study, systematic review and meta-analysis.

    Romoli, Michele / Matteo, Eleonora / Migliaccio, Ludovica / Gentile, Mauro / Mosconi, Maria Giulia / Scura, Giuseppe Maria / Naccarato, Marcello / Colangeli, Enrico / Candelaresi, Paolo / Andreone, Vincenzo / Giammello, Fabrizio / Fortunata Musolino, Rosa / Dell'Aera, Cristina / Sepe, Federica Nicoletta / Pronello, Edoardo / Barbarini, Leonardo / Caggiula, Marcella / Rizzo, Federica / Petruzzellis, Marco /
    Giorli, Elisa / Zedde, Maria Luisa / Anticoli, Sabrina / Mangiardi, Marilena / Muto, Mario / Diana, Francesco / De Angelis, Maria Vittoria / Digiovanni, Anna / Concari, Letizia / La Gioia, Sara / Sessa, Maria / Biguzzi, Sara / Cordici, Francesco / Longoni, Marco / Ruggiero, Maria / Cenciarelli, Silvia / Eusebi, Paolo / Sacco, Simona / Caso, Valeria / Paciaroni, Maurizio / Ricci, Stefano / Zini, Andrea / Toni, Danilo / Giannandrea, David

    European stroke journal

    2022  Volume 8, Issue 1, Page(s) 117–124

    Abstract: Introduction: Recent anticoagulant intake represents a contraindication for thrombolysis in acute ischemic stroke. Idarucizumab reverses the anticoagulant effect of dabigatran, potentially allowing for thrombolysis. This nation-wide observational cohort ...

    Abstract Introduction: Recent anticoagulant intake represents a contraindication for thrombolysis in acute ischemic stroke. Idarucizumab reverses the anticoagulant effect of dabigatran, potentially allowing for thrombolysis. This nation-wide observational cohort study, systematic review, and meta-analysis evaluated the efficacy and safety of thrombolysis preceded by dabigatran-reversal in people with acute ischemic stroke.
    Patients and methods: We recruited people undergoing thrombolysis following dabigatran-reversal at 17 stroke centers in Italy (reversal-group), people on dabigatran treated with thrombolysis without reversal (no-reversal group), and age, sex, hypertension, stroke severity, and reperfusion treatment-matched controls in 1:7 ratio (control-group). We compared groups for symptomatic intracranial hemorrhage (sICH, main outcome), any brain hemorrhage, good functional outcome (mRS 0-2 at 3 months), and death. The systematic review followed a predefined protocol (CRD42017060274), and odds ratio (OR) meta-analysis was implemented to compare groups.
    Results: Thirty-nine patients in dabigatran-reversal group and 300 matched controls were included. Reversal was associated with a non-significant increase in sICH (10.3% vs 6%, aOR = 1.32, 95% CI = 0.39-4.52), death (17.9% vs 10%, aOR = 0.77, 95% CI = 0.12-4.93) and good functional outcome (64.1% vs 52.8%, aOR = 1.41, 95% CI = 0.63-3.19). No hemorrhagic events or deaths were registered in no-reversal group (n = 12). Pooling data from 3 studies after systematic review (n = 1879), reversal carried a non-significant trend for sICH (OR = 1.53, 95% CI = 0.67-3.50), death (OR = 1.53, 95% CI = 0.73-3.24) and good functional outcome (OR = 2.46, 95% CI = 0.85-7.16).
    Discussion and conclusion: People treated with reperfusion strategies after dabigatran reversal with idarucizumab seem to have a marginal increase in the risk of sICH but comparable functional recovery to matched patients with stroke. Further studies are needed to define treatment cost-effectiveness and potential thresholds in plasma dabigatran concentration for reversal.
    MeSH term(s) Humans ; Dabigatran/adverse effects ; Antithrombins/adverse effects ; Ischemic Stroke/complications ; Brain Ischemia/drug therapy ; Thrombolytic Therapy/adverse effects ; Stroke/drug therapy ; Anticoagulants/therapeutic use ; Intracranial Hemorrhages/chemically induced ; Observational Studies as Topic ; Multicenter Studies as Topic
    Chemical Substances Dabigatran (I0VM4M70GC) ; Antithrombins ; Anticoagulants
    Language English
    Publishing date 2022-10-29
    Publishing country England
    Document type Meta-Analysis ; Systematic Review ; Journal Article
    ZDB-ID 2851287-X
    ISSN 2396-9881 ; 2396-9873
    ISSN (online) 2396-9881
    ISSN 2396-9873
    DOI 10.1177/23969873221131635
    Database MEDical Literature Analysis and Retrieval System OnLINE

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