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  1. Article ; Online: The risk of acute disseminated encephalomyelitis (ADEM) following covid-19 vaccination in England: A self-controlled case-series analysis.

    Stowe, Julia / Lopez-Bernal, Jamie / Andrews, Nick

    Human vaccines & immunotherapeutics

    2024  Volume 20, Issue 1, Page(s) 2311969

    Abstract: Acute disseminated encephalomyelitis (ADEM) has been identified as an Adverse Event of Special Interest in the COVID-19 vaccine programme due to its long-standing temporal association with a wide range of other vaccines. Case reports of ADEM shortly ... ...

    Abstract Acute disseminated encephalomyelitis (ADEM) has been identified as an Adverse Event of Special Interest in the COVID-19 vaccine programme due to its long-standing temporal association with a wide range of other vaccines. Case reports of ADEM shortly following COVID-19 vaccination have now been documented.    There were 217 ADEM admissions in 215 individuals in the period 8th December 2020 to 31st March 2023. An increased risk of ADEM following the first dose of ChAdOx1 vaccine was observed (relative incidence (RI) = 3.13, 95% Confidence Interval (CI) [1.56-6.25]) with a vaccine attributable risk of 0.39 per million doses. When doses 1 and 2 were combined this increased risk remained just significant (1.96 [95%CI 1.01-3.82]). No significant increased risk was observed with any other vaccine or dose. This small, elevated risk after the first dose of ChAdOx1-S vaccine demonstrates how large national electronic datasets can be used to identify very rare risks and provides reassurance that any risk of ADEM following the ChAdOx1-S COVID-19 vaccination is extremely small. Given the rarity of this risk, further studies in settings with access to data on large populations should be carried out to verify these findings.
    MeSH term(s) Humans ; Encephalomyelitis, Acute Disseminated/chemically induced ; Encephalomyelitis, Acute Disseminated/epidemiology ; COVID-19 Vaccines/adverse effects ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19/complications ; Vaccines/adverse effects ; Vaccination/adverse effects ; ChAdOx1 nCoV-19 ; England/epidemiology
    Chemical Substances COVID-19 Vaccines ; Vaccines ; ChAdOx1 nCoV-19 (B5S3K2V0G8)
    Language English
    Publishing date 2024-02-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2664176-8
    ISSN 2164-554X ; 2164-5515
    ISSN (online) 2164-554X
    ISSN 2164-5515
    DOI 10.1080/21645515.2024.2311969
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  2. Article ; Online: Erratum to "Risk of cardiac arrhythmia and cardiac arrest after primary and booster COVID-19 vaccination in England: A self-controlled case series analysis" [Vaccine: X 15 (2023) 100418].

    Stowe, Julia / Whitaker, Heather J / Andrews, Nick J / Miller, Elizabeth

    Vaccine: X

    2024  Volume 16, Page(s) 100449

    Abstract: This corrects the article DOI: 10.1016/j.jvacx.2023.100418.]. ...

    Abstract [This corrects the article DOI: 10.1016/j.jvacx.2023.100418.].
    Language English
    Publishing date 2024-01-31
    Publishing country England
    Document type Published Erratum
    ISSN 2590-1362
    ISSN (online) 2590-1362
    DOI 10.1016/j.jvacx.2024.100449
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  3. Article: Peripheralized sepiapterin reductase inhibition as a safe analgesic therapy.

    Cronin, Shane J F / Andrews, Nick A / Latremoliere, Alban

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1173599

    Abstract: The development of novel analgesics for chronic pain in the last 2 decades has proven virtually intractable, typically failing due to lack of efficacy and dose-limiting side effects. Identified through unbiased gene expression profiling experiments in ... ...

    Abstract The development of novel analgesics for chronic pain in the last 2 decades has proven virtually intractable, typically failing due to lack of efficacy and dose-limiting side effects. Identified through unbiased gene expression profiling experiments in rats and confirmed by human genome-wide association studies, the role of excessive tetrahydrobiopterin (BH4) in chronic pain has been validated by numerous clinical and preclinical studies. BH4 is an essential cofactor for aromatic amino acid hydroxylases, nitric oxide synthases, and alkylglycerol monooxygenase so a lack of BH4 leads to a range of symptoms in the periphery and central nervous system (CNS). An ideal therapeutic goal therefore would be to block excessive BH4 production, while preventing potential BH4 rundown. In this review, we make the case that sepiapterin reductase (SPR) inhibition restricted to the periphery (i.e., excluded from the spinal cord and brain), is an efficacious and safe target to alleviate chronic pain. First, we describe how different cell types that engage in BH4 overproduction and contribute to pain hypersensitivity, are themselves restricted to peripheral tissues and show their blockade is sufficient to alleviate pain. We discuss the likely safety profile of peripherally restricted SPR inhibition based on human genetic data, the biochemical alternate routes of BH4 production in various tissues and species, and the potential pitfalls to predictive translation when using rodents. Finally, we propose and discuss possible formulation and molecular strategies to achieve peripherally restricted, potent SPR inhibition to treat not only chronic pain but other conditions where excessive BH4 has been demonstrated to be pathological.
    Language English
    Publishing date 2023-05-12
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1173599
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  4. Article ; Online: BA.1 Bivalent COVID-19 Vaccine Use and Stroke in England.

    Andrews, Nick / Stowe, Julia / Miller, Elizabeth / Ramsay, Mary

    JAMA

    2023  Volume 330, Issue 2, Page(s) 184–185

    MeSH term(s) Humans ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19/virology ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/therapeutic use ; Influenza Vaccines/therapeutic use ; Influenza, Human/prevention & control ; Stroke/epidemiology ; Stroke/etiology ; Vaccination/adverse effects ; England/epidemiology ; Vaccines, Combined/adverse effects ; Vaccines, Combined/therapeutic use
    Chemical Substances COVID-19 Vaccines ; Influenza Vaccines ; Vaccines, Combined
    Language English
    Publishing date 2023-06-15
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.10123
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  5. Article ; Online: Lifting Universal School Masking - Covid-19 Incidence among Students and Staff.

    Ladhani, Shamez N / Andrews, Nick / Ramsay, Mary E

    The New England journal of medicine

    2023  Volume 389, Issue 6, Page(s) 579

    MeSH term(s) Humans ; Incidence ; Lifting ; COVID-19 ; Students
    Language English
    Publishing date 2023-08-17
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2215560
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  6. Article ; Online: Effectiveness of the Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation in England.

    Kirsebom, Freja Cordelia Møller / Andrews, Nick / Stowe, Julia / Dabrera, Gavin / Ramsay, Mary / Lopez Bernal, Jamie

    EClinicalMedicine

    2024  Volume 71, Page(s) 102587

    Abstract: Background: The Sanofi/GSK AS03-adjuvanted (VidPrevtyn Beta) vaccine and the Pfizer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine were offered to adults aged 75 years and over in England from 3rd April 2023. This is the first time ... ...

    Abstract Background: The Sanofi/GSK AS03-adjuvanted (VidPrevtyn Beta) vaccine and the Pfizer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine were offered to adults aged 75 years and over in England from 3rd April 2023. This is the first time an adjuvanted COVID-19 vaccine has been administered as part of a UK COVID-19 vaccination programme. In clinical trials, antibody levels generated were comparable with mRNA vaccines but there are no real-world data on the effectiveness or duration of protection.
    Methods: We used a test-negative case-control study design to estimate the incremental vaccine effectiveness of the Sanofi/GSK and Pfizer bivalent BA.4-5 boosters against hospitalisation amongst those aged 75 years and older in England. Cases (those testing positive) and controls (those testing negative) were identified from the national COVID-19 PCR testing data undertaken in hospital settings. The study period included tests from 3rd April 2023 to 27th August 2023. Tests were linked to the COVID-19 vaccination register and to the national hospital admission database, restricting to those with an acute respiratory infection coded in the primary diagnosis field. Vaccine effectiveness was estimated using multivariable logistic regression amongst those who had last received an autumn 2022 booster given at least 3 months prior. The test result was the outcome and vaccination status the exposure. Analyses were adjusted for week of test, gender, age, clinical risk group status, care home resident status, region, index of multiple deprivation, ethnicity, influenza vaccination status and recent COVID-19 positivity.
    Findings: There were 14,169 eligible tests from hospitalised individuals aged 75 years and older; 3005 cases (positive tests) and 11,164 controls (negative tests). Effectiveness was highest in the period 9-13 days post vaccination for both manufacturers at about 50%; 43.7% (95% CI, 20.1-60.3%) and 56.1% (95% CI, 25.2-74.2%) for Sanofi/GSK and Pfizer BA.4-5, respectively. There was evidence of waning with a reduction to about 30% for both manufacturers after 5-9 weeks. The longest time interval post vaccination for which we were able to estimate effectiveness was 10+ weeks post vaccination, at which point vaccine effectiveness was 17.6% (95% CI, -3.6 to 34.5%) and 37.9% (95% CI, 13.2-55.5%) for the Sanofi/GSK and Pfizer BA.4-5 boosters, respectively.
    Interpretation: Both boosters provided good protection against hospitalisation amongst older adults. The finding that the adjuvanted vaccine targeting the distant Beta strain had similar effectiveness to the bivalent mRNA vaccine targeting more closely matched Omicron sub-lineages is notable and highlights the need for further real-world studies into the effectiveness of vaccines from different vaccine platforms and formulations in the presence of matched and unmatched strains.
    Funding: No external funding.
    Language English
    Publishing date 2024-04-10
    Publishing country England
    Document type Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2024.102587
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  7. Article ; Online: Risk of myocarditis and pericarditis after a COVID-19 mRNA vaccine booster and after COVID-19 in those with and without prior SARS-CoV-2 infection: A self-controlled case series analysis in England.

    Stowe, Julia / Miller, Elizabeth / Andrews, Nick / Whitaker, Heather J

    PLoS medicine

    2023  Volume 20, Issue 6, Page(s) e1004245

    Abstract: Background: An increased risk of myocarditis or pericarditis after priming with mRNA Coronavirus Disease 2019 (COVID-19) vaccines has been shown but information on the risk post-booster is limited. With the now high prevalence of prior Severe Acute ... ...

    Abstract Background: An increased risk of myocarditis or pericarditis after priming with mRNA Coronavirus Disease 2019 (COVID-19) vaccines has been shown but information on the risk post-booster is limited. With the now high prevalence of prior Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, we assessed the effect of prior infection on the vaccine risk and the risk from COVID-19 reinfection.
    Methods and findings: We conducted a self-controlled case series analysis of hospital admissions for myocarditis or pericarditis in England between 22 February 2021 and 6 February 2022 in the 50 million individuals eligible to receive the adenovirus-vectored vaccine (ChAdOx1-S) for priming or an mRNA vaccine (BNT162b2 or mRNA-1273) for priming or boosting. Myocarditis and pericarditis admissions were extracted from the Secondary Uses Service (SUS) database in England and vaccination histories from the National Immunisation Management System (NIMS); prior infections were obtained from the UK Health Security Agency's Second-Generation Surveillance Systems. The relative incidence (RI) of admission within 0 to 6 and 7 to 14 days of vaccination compared with periods outside these risk windows stratified by age, dose, and prior SARS-CoV-2 infection for individuals aged 12 to 101 years was estimated. The RI within 27 days of an infection was assessed in the same model. There were 2,284 admissions for myocarditis and 1,651 for pericarditis in the study period. Elevated RIs were only observed in 16- to 39-year-olds 0 to 6 days postvaccination, mainly in males for myocarditis. Both mRNA vaccines showed elevated RIs after first, second, and third doses with the highest RIs after a second dose 5.34 (95% confidence interval (CI) [3.81, 7.48]; p < 0.001) for BNT162b2 and 56.48 (95% CI [33.95, 93.97]; p < 0.001) for mRNA-1273 compared with 4.38 (95% CI [2.59, 7.38]; p < 0.001) and 7.88 (95% CI [4.02, 15.44]; p < 0.001), respectively, after a third dose. For ChAdOx1-S, an elevated RI was only observed after a first dose, RI 5.23 (95% CI [2.48, 11.01]; p < 0.001). An elevated risk of admission for pericarditis was only observed 0 to 6 days after a second dose of mRNA-1273 vaccine in 16 to 39 year olds, RI 4.84 (95% CI [1.62, 14.01]; p = 0.004). RIs were lower in those with a prior SARS-CoV-2 infection than in those without, 2.47 (95% CI [1.32,4.63]; p = 0.005) versus 4.45 (95% [3.12, 6.34]; p = 0.001) after a second BNT162b2 dose, and 19.07 (95% CI [8.62, 42.19]; p < 0.001) versus 37.2 (95% CI [22.18, 62.38]; p < 0.001) for mRNA-1273 (myocarditis and pericarditis outcomes combined). RIs 1 to 27 days postinfection were elevated in all ages and were marginally lower for breakthrough infections, 2.33 (95% CI [1.96, 2.76]; p < 0.001) compared with 3.32 (95% CI [2.54, 4.33]; p < 0.001) in vaccine-naïve individuals respectively.
    Conclusions: We observed an increased risk of myocarditis within the first week after priming and booster doses of mRNA vaccines, predominantly in males under 40 years with the highest risks after a second dose. The risk difference between the second and the third doses was particularly marked for the mRNA-1273 vaccine that contains half the amount of mRNA when used for boosting than priming. The lower risk in those with prior SARS-CoV-2 infection, and lack of an enhanced effect post-booster, does not suggest a spike-directed immune mechanism. Research to understand the mechanism of vaccine-associated myocarditis and to document the risk with bivalent mRNA vaccines is warranted.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Humans ; Male ; Middle Aged ; Young Adult ; 2019-nCoV Vaccine mRNA-1273 ; BNT162 Vaccine ; ChAdOx1 nCoV-19 ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; England/epidemiology ; mRNA Vaccines ; Myocarditis/epidemiology ; Myocarditis/etiology ; SARS-CoV-2 ; Vaccination/adverse effects
    Chemical Substances 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) ; BNT162 Vaccine ; ChAdOx1 nCoV-19 (B5S3K2V0G8) ; COVID-19 Vaccines ; mRNA Vaccines
    Language English
    Publishing date 2023-06-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1004245
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    Zs.A 6042: Show issues Location:
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  8. Article ; Online: Estimating the effectiveness of COVID-19 vaccination against COVID-19 hospitalisation and death: a cohort study based on the 2021 Census, England

    Bermingham, Charlotte / Nafilyan, Vahe / Andrews, Nick / Gethings, Owen

    medRxiv

    Abstract: Objective: To estimate the effectiveness of COVID-19 vaccination against hospitalisation for COVID-19 and death involving COVID-19 in England using linked population level data sources including the 2021 Census. Design: Retrospective cohort study. ... ...

    Abstract Objective: To estimate the effectiveness of COVID-19 vaccination against hospitalisation for COVID-19 and death involving COVID-19 in England using linked population level data sources including the 2021 Census. Design: Retrospective cohort study. Setting: England, 21 March 2021 to 20 March 2022. Participants: Individuals alive and aged 16+ on 21 March 2021, resident in England, enumerated in the 2021 Census as a usual resident, and able to link to an NHS number. A sample of 583,840 individuals was used for the analysis. Exposures: COVID-19 vaccination: first dose, second dose and third dose/first booster dose, with categories for time since each dose. Main outcome measures: Hospitalisation for COVID-19 or death involving COVID-19. An adjusted Cox proportional hazard model was used to estimate the hazard ratio for the outcomes for vaccinated participants for different doses and time since dose compared to unvaccinated individuals. Vaccine effectiveness was estimated as (1 minus hazard ratio)x 100%. A control outcome of non-COVID-19 death was also assessed. Results: Vaccine effectiveness against hospitalisation for COVID-19 was 52.1% (95% confidence interval 51.3% to 52.8%) for a first dose, 55.6% (55.2% to 56.1%) for a second dose and 77.6% (77.3% to 78.0%) for a third dose, with a decrease in vaccine effectiveness 3+ months after the third dose. Vaccine effectiveness against COVID-19 mortality was 58.7% (52.7% to 63.9%) for a first dose, 88.5% (87.5% to 89.5%) for a second dose and 93.2% (92.9% to 93.5%) for a third dose, with evidence of waning 3+ months after the second and third doses. For the second dose, which is the most comparable across the different time-periods, vaccine effectiveness was higher against COVID-19 hospitalisation but slightly lower against COVID-19 mortality in the Omicron dominant period than the period before the Omicron variant became dominant. Vaccine effectiveness against both COVID-19 hospitalisation and mortality was higher in general for mRNA vaccines than non mRNA vaccines, however this could be influenced by the different populations given each vaccine vector. Non-zero VE against non-COVID-19 mortality indicates that residual confounding may impact the results, despite the inclusion of up-to-date socio-demographic adjustments and various sources of health data, with possible frailty bias, confounding by indication and a healthy vaccinee effect observed. Conclusions: The vaccine effectiveness estimates show increased protection with number of doses and a high level of protection against both COVID-19 hospitalisation and mortality for the third/booster dose, as would be expected from previous research. However, despite the various sources of health data used to adjust the models, the estimates for different breakdowns and for non-COVID-19 mortality expose residual confounding by health status, which should be considered when interpreting estimates of vaccine effectiveness.
    Keywords covid19
    Language English
    Publishing date 2023-06-07
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2023.06.06.23290982
    Database COVID19

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  9. Article ; Online: Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. Reply.

    Lopez Bernal, Jamie / Gower, Charlotte / Andrews, Nick

    The New England journal of medicine

    2021  Volume 385, Issue 25, Page(s) e92

    MeSH term(s) COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-11-10
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2113090
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  10. Article: Quantification of stimulus-evoked tactile allodynia in free moving mice by the chainmail sensitivity test.

    Ozdemir, Yildirim / Nakamoto, Kazuo / Boivin, Bruno / Bullock, Daniel / Andrews, Nick A / González-Cano, Rafael / Costigan, Michael

    Frontiers in pharmacology

    2024  Volume 15, Page(s) 1352464

    Abstract: Chronic pain occurs at epidemic levels throughout the population. Hypersensitivity to touch, is a cardinal symptom of chronic pain. Despite dedicated research for over a century, quantifying this hypersensitivity has remained impossible at scale. To ... ...

    Abstract Chronic pain occurs at epidemic levels throughout the population. Hypersensitivity to touch, is a cardinal symptom of chronic pain. Despite dedicated research for over a century, quantifying this hypersensitivity has remained impossible at scale. To address these issues, we developed the Chainmail Sensitivity Test (CST). Our results show that control mice spend significantly more time on the chainmail portion of the device than mice subject to neuropathy. Treatment with gabapentin abolishes this difference. CST-derived data correlate well with von Frey measurements and quantify hypersensitivity due to inflammation. Our study demonstrates the potential of the CST as a standardized tool for assessing mechanical hypersensitivity in mice with minimal operator input.
    Language English
    Publishing date 2024-02-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2024.1352464
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