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  1. Article ; Online: Reações adversas a medicamentos em pacientes com COVID-19.

    Ferreira-da-Silva, Renato

    Cadernos de saude publica

    2021  Volume 37, Issue 11, Page(s) e00228121

    Title translation Adverse drug reactions in patients with COVID-19.
    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Brazil ; COVID-19 ; Drug-Related Side Effects and Adverse Reactions ; Humans ; SARS-CoV-2
    Language Portuguese
    Publishing date 2021-11-22
    Publishing country Brazil
    Document type Letter ; Comment
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311X00228121
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    Zs.A 4981: Show issues Location:
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  2. Article ; Online: Reações adversas a medicamentos em pacientes com COVID-19

    Renato Ferreira-da-Silva

    Cadernos de Saúde Pública, Vol 37, Iss

    2021  Volume 11

    Keywords Medicine ; R ; Public aspects of medicine ; RA1-1270
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Reducing Medication Harms: Thoughts and Strategies.

    Ribeiro-Vaz, Inês / Ferreira-da-Silva, Renato

    Global journal on quality and safety in healthcare

    2021  Volume 4, Issue 1, Page(s) 1–2

    Language English
    Publishing date 2021-03-05
    Publishing country United States
    Document type Editorial
    ZDB-ID 3000738-0
    ISSN 2589-9449 ; 2666-2353
    ISSN (online) 2589-9449
    ISSN 2666-2353
    DOI 10.36401/JQSH-20-X8
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  4. Article ; Online: Unveiling the future: precision pharmacovigilance in the era of personalized medicine.

    Silva, Lurdes / Pacheco, Teresa / Araújo, Emília / Duarte, Rita J / Ribeiro-Vaz, Inês / Ferreira-da-Silva, Renato

    International journal of clinical pharmacy

    2024  

    Abstract: In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized ... ...

    Abstract In the era of personalized medicine, pharmacovigilance faces new challenges and opportunities, demanding a shift from traditional approaches. This article delves into the evolving landscape of drug safety monitoring in the context of personalized treatments. We aim to provide a succinct reflection on the intersection of tailored therapeutic strategies and vigilant pharmacovigilance practices. We discuss the integration of pharmacogenetics in enhancing drug safety, illustrating how genetic profiling aids in predicting drug responses and adverse reactions. Emphasizing the importance of phase IV-post-marketing surveillance, we explore the limitations of pre-marketing trials and the necessity for a comprehensive approach to drug safety. The article discusses the pivotal role of pharmacogenetics in pre-exposure risk management and the redefinition of pharmacoepidemiological methods for post-exposure surveillance. We highlight the significance of integrating patient-specific genetic profiles in creating personalized medication leaflets and the use of advanced computational methods in data analysis. Additionally, we examine the ethical, privacy, and data security challenges inherent in precision medicine, emphasizing their implications for patient consent and data management.
    Language English
    Publishing date 2024-02-28
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2601204-2
    ISSN 2210-7711 ; 2210-7703 ; 0928-1231
    ISSN (online) 2210-7711
    ISSN 2210-7703 ; 0928-1231
    DOI 10.1007/s11096-024-01709-x
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  5. Article ; Online: Reducing Medication Harms

    Inês Ribeiro-Vaz / Renato Ferreira-da-Silva

    Global Journal on Quality and Safety in Healthcare, Pp 1-

    Thoughts and Strategies

    2021  Volume 2

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher Innovative Healthcare Institute
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: A comprehensive review of adverse events to drugs used in COVID-19 patients: Recent clinical evidence.

    Ferreira-da-Silva, Renato / Ribeiro-Vaz, Inês / Morato, Manuela / Junqueira Polónia, Jorge

    European journal of clinical investigation

    2022  Volume 52, Issue 7, Page(s) e13763

    Abstract: Background: Since the breakthrough of the pandemic, several drugs have been used to treat COVID-19 patients. This review aims to gather information on adverse events (AE) related to most drugs used in this context.: Methods: We performed a literature ...

    Abstract Background: Since the breakthrough of the pandemic, several drugs have been used to treat COVID-19 patients. This review aims to gather information on adverse events (AE) related to most drugs used in this context.
    Methods: We performed a literature search to find articles that contained information about AE in COVID-19 patients. We analysed and reviewed the most relevant studies in the Medline (via PubMed), Scopus and Web of Science. The most frequent AE identified were grouped in our qualitative analysis by System Organ Class (SOC), the highest level of the MedDRA medical terminology for each of the drugs studied.
    Results: The most frequent SOCs among the included drugs are investigations (n = 7 drugs); skin and subcutaneous tissue disorders (n = 5 drugs); and nervous system disorders, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, and metabolism and nutrition disorders (n = 4 drugs). Other SOCs also emerged, such as general disorders and administration site conditions, renal and urinary disorders, vascular disorders and cardiac disorders (n = 3 drugs). Less frequent SOC were eye disorders, respiratory, thoracic and mediastinal disorders, musculoskeletal and connective tissue disorders, and immune system disorders (n = 2 drugs). Psychiatric disorders, and injury, poisoning and procedural complications were also reported (n = 1 drug).
    Conclusions: Some SOCs seem to be more frequent than others among the COVID-19 drugs included, although neither of the studies included reported causality analysis. For that purpose, further clinical studies with robust methodologies, as randomised controlled trials, should be designed and performed.
    MeSH term(s) COVID-19/drug therapy ; Humans ; Pandemics ; Pharmaceutical Preparations
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2022-02-27
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 186196-7
    ISSN 1365-2362 ; 0014-2972 ; 0960-135X
    ISSN (online) 1365-2362
    ISSN 0014-2972 ; 0960-135X
    DOI 10.1111/eci.13763
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    Zs.A 677: Show issues Location:
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  7. Article ; Online: Assessing medication use patterns by clinical outcomes severity among inpatients with COVID-19: A retrospective drug utilization study.

    Ferreira-da-Silva, Renato / Maranhão, Priscila / Dias, Cláudia Camila / Alves, João Miguel / Pires, Lígia / Morato, Manuela / Polónia, Jorge Junqueira / Ribeiro-Vaz, Inês

    Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

    2024  Volume 172, Page(s) 116242

    Abstract: Purpose: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases.: Methods: A retrospective study analyzed inpatient medication data, coded ... ...

    Abstract Purpose: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases.
    Methods: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes.
    Results: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes.
    Conclusions: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.
    MeSH term(s) Humans ; Male ; Middle Aged ; Female ; Inpatients ; Retrospective Studies ; COVID-19 ; Anti-Bacterial Agents ; Drug Utilization
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2024-02-09
    Publishing country France
    Document type Journal Article
    ZDB-ID 392415-4
    ISSN 1950-6007 ; 0753-3322 ; 0300-0893
    ISSN (online) 1950-6007
    ISSN 0753-3322 ; 0300-0893
    DOI 10.1016/j.biopha.2024.116242
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    Ud II Zs.198: Show issues Location:
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  8. Article ; Online: Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis.

    Sousa-Pinto, Bernardo / Vieira, Rafael José / Brozek, Jan / Cardoso-Fernandes, António / Lourenço-Silva, Nuno / Ferreira-da-Silva, Renato / Ferreira, André / Gil-Mata, Sara / Bedbrook, Anna / Klimek, Ludger / Fonseca, João A / Zuberbier, Torsten / Schünemann, Holger J / Bousquet, Jean

    The Journal of allergy and clinical immunology

    2024  

    Abstract: Background: There is insufficient systematised evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR).: Objective: To perform a systematic review to compare the efficacy of individual intranasal corticosteroids ... ...

    Abstract Background: There is insufficient systematised evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR).
    Objective: To perform a systematic review to compare the efficacy of individual intranasal corticosteroids and antihistamines against placebo in improving the nasal and ocular symptoms and the rhinoconjunctivitis-related quality-of-life of patients with perennial or seasonal AR.
    Methods: We searched four electronic bibliographic databases and three clinical trials databases for randomised controlled trials (i) assessing adult patients with seasonal or perennial AR and (ii) comparing the use of intranasal corticosteroids or antihistamines versus placebo. Assessed outcomes included the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We performed random-effects meta-analyses of mean differences for each medication and outcome. We assessed evidence certainty using the GRADE approach.
    Results: We included 151 primary studies, most of which assessed patients with seasonal AR and displayed unclear or high risk of bias. Both in perennial and seasonal AR, most assessed treatments were more effective than placebo. In seasonal AR, azelastine-fluticasone, fluticasone furoate and fluticasone propionate were the medications with the highest probability of resulting in moderate or large improvements in the TNSS and RQLQ. Azelastine-fluticasone displayed the highest probability of resulting in moderate or large improvements of TOSS. Overall, evidence certainty was considered "high" in 6/46 analyses, "moderate" in 23/46 analyses, and "low"/"very low" in 17/46 analyses.
    Conclusion: Most intranasal medications are effective in improving rhinitis symptoms and quality-of-life. However, there are relevant differences in the associated evidence certainty.
    Language English
    Publishing date 2024-04-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 121011-7
    ISSN 1097-6825 ; 1085-8725 ; 0091-6749
    ISSN (online) 1097-6825 ; 1085-8725
    ISSN 0091-6749
    DOI 10.1016/j.jaci.2024.04.016
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  9. Article ; Online: Retrospectiva de 20 anos de atividade da Unidade de Farmacovigilância do Porto, Portugal.

    Ferreira-da-Silva, Renato / Ribeiro-Vaz, Inês / Silva, Ana Marta / Marques, Joana / Polónia, Jorge Junqueira

    Cadernos de saude publica

    2021  Volume 37, Issue 10, Page(s) e00304420

    Abstract: Since 1963, the World Health Organization has acknowledged pharmacovigilance as a priority area in global public health, guaranteeing permanent monitoring of drug safety. This study aimed to characterize the reports of adverse drug reactions received by ... ...

    Title translation Looking back on 20 years of work at the Porto Pharmacovigilance Centre, Portugal.
    Abstract Since 1963, the World Health Organization has acknowledged pharmacovigilance as a priority area in global public health, guaranteeing permanent monitoring of drug safety. This study aimed to characterize the reports of adverse drug reactions received by the Porto Pharmacovigilance Centre (UFPorto), Portugal, in the unit's two decades of work. The analysis included all reports of suspected adverse drug reactions received from January 2001 to December 2019. We calculated the annual reporting rates and distribution by origin, type of notifier and place of work, severity, prior knowledge, and causality of the reported adverse drug reactions. During the study period, UFPorto received 9,711 notifications of suspected adverse drug reactions. Hospital institutions reported the most suspected adverse drug reactions (n = 6,003; 64%), as did physicians among healthcare workers (n = 5,284; 54.4%). The most frequently reported adverse events were severe (n = 6,275; 72%) and are described in the respective Summary of Product Characteristics (n = 6,978; 72%). Most of the reports received by UFPorto were evaluated as having "probable" causality (n = 7,473; 77%), independently of the type of notifier. The results are consistent with other data previously reported in the international medical literature and official national reports. However, the underreporting rates are still higher than expected. In approximately 20 years, UFPorto has experienced an increase in its activity in various areas of drug safety.
    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Brazil ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Pharmacovigilance ; Portugal/epidemiology
    Language Portuguese
    Publishing date 2021-10-08
    Publishing country Brazil
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311X00304420
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    Zs.A 4981: Show issues Location:
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  10. Article ; Online: Guiding axes for drug safety management of pharmacovigilance centres during the COVID-19 era.

    Ferreira-da-Silva, Renato / Ribeiro-Vaz, Inês / Morato, Manuela / Polónia, Jorge Junqueira

    International journal of clinical pharmacy

    2021  Volume 43, Issue 4, Page(s) 1133–1138

    Abstract: The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of ... ...

    Abstract The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.
    MeSH term(s) Adverse Drug Reaction Reporting Systems/organization & administration ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; COVID-19/epidemiology ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/etiology ; Humans ; Patient Safety ; Pharmacovigilance ; SARS-CoV-2/drug effects
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2021-06-02
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2601204-2
    ISSN 2210-7711 ; 2210-7703 ; 0928-1231
    ISSN (online) 2210-7711
    ISSN 2210-7703 ; 0928-1231
    DOI 10.1007/s11096-021-01289-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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