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  1. Article ; Online: Anaphylaxis in children.

    Farbman, Karen S / Michelson, Kenneth A

    Current opinion in pediatrics

    2016  Volume 28, Issue 3, Page(s) 294–297

    Abstract: Purpose of review: Anaphylaxis is a serious allergic reaction that can be life threatening. We will review the most recent evidence regarding the diagnosis, treatment, monitoring, and prevention of anaphylaxis in children.: Recent findings: Histamine ...

    Abstract Purpose of review: Anaphylaxis is a serious allergic reaction that can be life threatening. We will review the most recent evidence regarding the diagnosis, treatment, monitoring, and prevention of anaphylaxis in children.
    Recent findings: Histamine and tryptase are not sufficiently accurate for the routine diagnosis of anaphylaxis, so providers should continue to rely on clinical signs. Platelet-activating factor shows some promise in the diagnosis of anaphylaxis. Intramuscular is the best route for epinephrine administration for children of all weights. Glucocorticoids may reduce prolonged hospitalizations for anaphylaxis. Children with anaphylaxis who have resolving symptoms and no history of asthma or previous biphasic reactions may be observed for as few as 3-4 h before emergency department discharge. Early peanut introduction reduces the risk of peanut allergy.
    Summary: Epinephrine remains the mainstay of anaphylaxis treatment, and adjuvant medications should not be used in its place. All patients with anaphylaxis should be prescribed and trained to use an epinephrine autoinjector. Clinically important biphasic reactions are rare. Observation in the emergency department for most anaphylaxis patients is recommended, with the duration determined by risk factors. Admission is reserved for patients with unimproved or worsening symptoms, or prior biphasic reaction.
    Language English
    Publishing date 2016-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1049374-8
    ISSN 1531-698X ; 1040-8703
    ISSN (online) 1531-698X
    ISSN 1040-8703
    DOI 10.1097/MOP.0000000000000340
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  2. Article ; Online: Identification of children with anaphylaxis at low risk of receiving acute inpatient therapies.

    Dribin, Timothy E / Michelson, Kenneth A / Monuteaux, Michael C / Stack, Anne M / Farbman, Karen S / Schneider, Lynda C / Neuman, Mark I

    PloS one

    2019  Volume 14, Issue 2, Page(s) e0211949

    Abstract: ... given wide variation in admission rates across U.S. emergency departments (EDs). We sought to identify ...

    Abstract Objective: Opportunity exists to reduce unnecessary hospitalizations for children with anaphylaxis given wide variation in admission rates across U.S. emergency departments (EDs). We sought to identify children hospitalized with anaphylaxis at low risk of receiving epinephrine and other acute inpatient therapies, as these patients may be candidates for ED discharge rather than inpatient hospitalization.
    Methods: We conducted a single-center retrospective cohort study of children 1-21 years of age hospitalized with anaphylaxis from 2009 to 2016. Acute inpatient therapies included intramuscular (IM) or racemic epinephrine, bronchodilators, fluid boluses, vasopressors, non-invasive ventilation, or intubation. We derived age-specific (pre-verbal [<36 months] vs. verbal [≥ 36 months]) prediction rules using recursive partitioning to identify children at low risk of receiving acute inpatient therapies.
    Results: During the study period 665 children were hospitalized for anaphylaxis, of whom 108 (16.2%) received acute inpatient therapies. The prediction rule for patients < 36 months (no wheezing, no cardiac involvement [hypotension or wide pulse pressure]) had a sensitivity of 90.5% (CI 69.6-98.8%) and a negative predictive value of 98.3% (CI 94.1-99.8%) for identifying children at low risk of receipt of acute inpatient therapies during hospitalization. For children ≥ 36 months, the prediction rule (no wheezing, no cardiac involvement, presence of gastrointestinal symptoms) had a sensitivity of 90.8% (CI 82.7-96.0%) and a negative predictive value of 92.4% (CI 85.6-96.7%).
    Conclusions: We derived age specific prediction rules for children hospitalized with anaphylaxis at low risk of receiving epinephrine and other acute inpatient therapies. These children may be candidates for ED discharge rather than inpatient hospitalization.
    MeSH term(s) Adolescent ; Airway Management/methods ; Anaphylaxis/therapy ; Bronchodilator Agents/administration & dosage ; Bronchodilator Agents/therapeutic use ; Child ; Child, Preschool ; Emergency Service, Hospital ; Epinephrine/administration & dosage ; Epinephrine/therapeutic use ; Female ; Hospitalization ; Humans ; Infant ; Injections, Intramuscular ; Male ; Retrospective Studies ; Treatment Outcome ; United States ; Vasoconstrictor Agents/administration & dosage ; Vasoconstrictor Agents/therapeutic use ; Young Adult
    Chemical Substances Bronchodilator Agents ; Vasoconstrictor Agents ; Epinephrine (YKH834O4BH)
    Language English
    Publishing date 2019-02-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0211949
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  3. Article ; Online: Reducing Hospitalization Rates for Children With Anaphylaxis.

    Farbman, Karen S / Michelson, Kenneth A / Neuman, Mark I / Dribin, Timothy E / Schneider, Lynda C / Stack, Anne M

    Pediatrics

    2017  Volume 139, Issue 6

    Abstract: ... hours. To control for secular trends, hospitalization rates for anaphylaxis at 34 US children's ...

    Abstract Background and objectives: Most children with anaphylaxis in the emergency department (ED) are hospitalized. Opportunities exist to safely reduce the hospitalization rate for children with anaphylaxis by decreasing unnecessary hospitalizations. A quality improvement (QI) intervention was conducted to improve care and reduce hospitalization rates for children with anaphylaxis.
    Methods: We used the Model for Improvement and began with development and implementation in 2011 of a locally developed evidence-based guideline based on national recommendations for the management of anaphylaxis. Guideline adoption and adherence were supported by interval reminders and feedback to providers. Patients from 2008 to 2014 diagnosed with anaphylaxis were identified, and statistical process control methods were used to evaluate change in hospitalization rates over time. The balancing measure was any return visit to the ED within 72 hours. To control for secular trends, hospitalization rates for anaphylaxis at 34 US children's hospitals over the same time period were analyzed.
    Results: Over the study period, there were 1169 visits for children with anaphylaxis, of which 731 (62%) occurred after the QI implementation. The proportion of children hospitalized decreased from 54% to 36%, with no increase in the 72-hour ED revisit rate. The hospitalization rate across 34 other US pediatric hospitals remained static at 52% over the study period.
    Conclusions: We safely reduced unnecessary hospitalizations for children with anaphylaxis and sustained the change over 3 years by using a QI initiative that included evidence-based guideline development and implementation, reinforced by provider reminders and structured feedback.
    MeSH term(s) Adolescent ; Anaphylaxis/drug therapy ; Boston ; Child ; Child, Preschool ; Female ; Guideline Adherence ; Hospitalization/trends ; Humans ; Male ; Patient Care Management/standards ; Practice Guidelines as Topic ; Quality Improvement
    Language English
    Publishing date 2017-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207677-9
    ISSN 1098-4275 ; 0031-4005
    ISSN (online) 1098-4275
    ISSN 0031-4005
    DOI 10.1542/peds.2016-4114
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  4. Article ; Online: Identification of children with anaphylaxis at low risk of receiving acute inpatient therapies.

    Timothy E Dribin / Kenneth A Michelson / Michael C Monuteaux / Anne M Stack / Karen S Farbman / Lynda C Schneider / Mark I Neuman

    PLoS ONE, Vol 14, Iss 2, p e

    2019  Volume 0211949

    Abstract: ... given wide variation in admission rates across U.S. emergency departments (EDs). We sought to identify ...

    Abstract Objective Opportunity exists to reduce unnecessary hospitalizations for children with anaphylaxis given wide variation in admission rates across U.S. emergency departments (EDs). We sought to identify children hospitalized with anaphylaxis at low risk of receiving epinephrine and other acute inpatient therapies, as these patients may be candidates for ED discharge rather than inpatient hospitalization. Methods We conducted a single-center retrospective cohort study of children 1-21 years of age hospitalized with anaphylaxis from 2009 to 2016. Acute inpatient therapies included intramuscular (IM) or racemic epinephrine, bronchodilators, fluid boluses, vasopressors, non-invasive ventilation, or intubation. We derived age-specific (pre-verbal [<36 months] vs. verbal [≥ 36 months]) prediction rules using recursive partitioning to identify children at low risk of receiving acute inpatient therapies. Results During the study period 665 children were hospitalized for anaphylaxis, of whom 108 (16.2%) received acute inpatient therapies. The prediction rule for patients < 36 months (no wheezing, no cardiac involvement [hypotension or wide pulse pressure]) had a sensitivity of 90.5% (CI 69.6-98.8%) and a negative predictive value of 98.3% (CI 94.1-99.8%) for identifying children at low risk of receipt of acute inpatient therapies during hospitalization. For children ≥ 36 months, the prediction rule (no wheezing, no cardiac involvement, presence of gastrointestinal symptoms) had a sensitivity of 90.8% (CI 82.7-96.0%) and a negative predictive value of 92.4% (CI 85.6-96.7%). Conclusions We derived age specific prediction rules for children hospitalized with anaphylaxis at low risk of receiving epinephrine and other acute inpatient therapies. These children may be candidates for ED discharge rather than inpatient hospitalization.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2019-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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  5. Article ; Online: A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease.

    McGarry, Andrew / McDermott, Michael / Kieburtz, Karl / de Blieck, Elisabeth A / Beal, Flint / Marder, Karen / Ross, Christopher / Shoulson, Ira / Gilbert, Peter / Mallonee, William M / Guttman, Mark / Wojcieszek, Joanne / Kumar, Rajeev / LeDoux, Mark S / Jenkins, Mary / Rosas, H Diana / Nance, Martha / Biglan, Kevin / Como, Peter /
    Dubinsky, Richard M / Shannon, Kathleen M / O'Suilleabhain, Padraig / Chou, Kelvin / Walker, Francis / Martin, Wayne / Wheelock, Vicki L / McCusker, Elizabeth / Jankovic, Joseph / Singer, Carlos / Sanchez-Ramos, Juan / Scott, Burton / Suchowersky, Oksana / Factor, Stewart A / Higgins, Donald S / Molho, Eric / Revilla, Fredy / Caviness, John N / Friedman, Joseph H / Perlmutter, Joel S / Feigin, Andrew / Anderson, Karen / Rodriguez, Ramon / McFarland, Nikolaus R / Margolis, Russell L / Farbman, Eric S / Raymond, Lynn A / Suski, Valerie / Kostyk, Sandra / Colcher, Amy / Seeberger, Lauren / Epping, Eric / Esmail, Sherali / Diaz, Nancy / Fung, Wai Lun Alan / Diamond, Alan / Frank, Samuel / Hanna, Philip / Hermanowicz, Neal / Dure, Leon S / Cudkowicz, Merit

    Neurology

    2016  Volume 88, Issue 2, Page(s) 152–159

    Abstract: Objective: To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD.: Methods: We performed a multicenter randomized, double-blind, ... ...

    Abstract Objective: To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD.
    Methods: We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach.
    Results: An interim analysis for futility revealed a conditional power of <5% for the primary analysis, prompting premature conclusion in July 2014. No statistically significant differences were seen between treatment groups for the primary or secondary outcome measures. CoQ was generally safe and well-tolerated throughout the study.
    Conclusions: These data do not justify use of CoQ as a treatment to slow functional decline in HD.
    Clinicaltrialsgov identifier: NCT00608881.
    Classification of evidence: This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD.
    MeSH term(s) Adult ; Australia ; Canada ; Double-Blind Method ; Female ; Humans ; Huntington Disease/drug therapy ; International Cooperation ; Male ; Middle Aged ; Proportional Hazards Models ; Retrospective Studies ; Treatment Outcome ; Ubiquinone/analogs & derivatives ; Ubiquinone/therapeutic use ; United States ; Vitamins/therapeutic use
    Chemical Substances Vitamins ; Ubiquinone (1339-63-5) ; coenzyme Q10 (EJ27X76M46)
    Language English
    Publishing date 2016-12-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 207147-2
    ISSN 1526-632X ; 0028-3878
    ISSN (online) 1526-632X
    ISSN 0028-3878
    DOI 10.1212/WNL.0000000000003478
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial.

    Frank, Samuel / Testa, Claudia M / Stamler, David / Kayson, Elise / Davis, Charles / Edmondson, Mary C / Kinel, Shari / Leavitt, Blair / Oakes, David / O'Neill, Christine / Vaughan, Christina / Goldstein, Jody / Herzog, Margaret / Snively, Victoria / Whaley, Jacquelyn / Wong, Cynthia / Suter, Greg / Jankovic, Joseph / Jimenez-Shahed, Joohi /
    Hunter, Christine / Claassen, Daniel O / Roman, Olivia C / Sung, Victor / Smith, Jenna / Janicki, Sarah / Clouse, Ronda / Saint-Hilaire, Marie / Hohler, Anna / Turpin, Denyse / James, Raymond C / Rodriguez, Ramon / Rizer, Kyle / Anderson, Karen E / Heller, Hope / Carlson, Alexis / Criswell, Susan / Racette, Brad A / Revilla, Fredy J / Nucifora, Frederick / Margolis, Russell L / Ong, MaryJane / Mendis, Tilak / Mendis, Neila / Singer, Carlos / Quesada, Monica / Paulsen, Jane S / Brashers-Krug, Thomas / Miller, Amanda / Kerr, Jane / Dubinsky, Richard M / Gray, Carolyn / Factor, Stewart A / Sperin, Elaine / Molho, Eric / Eglow, Mary / Evans, Sharon / Kumar, Rajeev / Reeves, Christina / Samii, Ali / Chouinard, Sylvain / Beland, Monica / Scott, Burton L / Hickey, Patrick T / Esmail, Sherali / Fung, Wai Lun Alan / Gibbons, Clare / Qi, Lina / Colcher, Amy / Hackmyer, Cory / McGarry, Andrew / Klos, Kevin / Gudesblatt, Mark / Fafard, Lori / Graffitti, Laura / Schneider, Daniel P / Dhall, Rohit / Wojcieszek, Joanne M / LaFaver, Kathrin / Duker, Andrew / Neefus, Erin / Wilson-Perez, Hilary / Shprecher, David / Wall, Paola / Blindauer, Karen A / Wheeler, Lynn / Boyd, James T / Houston, Emily / Farbman, Eric S / Agarwal, Pinky / Eberly, Shirley W / Watts, Arthur / Tariot, Pierre N / Feigin, Andrew / Evans, Scott / Beck, Chris / Orme, Constance / Edicola, Jon / Christopher, Emily

    JAMA

    2017  Volume 316, Issue 1, Page(s) 40–50

    Abstract: Importance: Deutetrabenazine is a novel molecule containing deuterium, which attenuates CYP2D6 metabolism and increases active metabolite half-lives and may therefore lead to stable systemic exposure while preserving key pharmacological activity.: ... ...

    Abstract Importance: Deutetrabenazine is a novel molecule containing deuterium, which attenuates CYP2D6 metabolism and increases active metabolite half-lives and may therefore lead to stable systemic exposure while preserving key pharmacological activity.
    Objective: To evaluate efficacy and safety of deutetrabenazine treatment to control chorea associated with Huntington disease.
    Design, setting, and participants: Ninety ambulatory adults diagnosed with manifest Huntington disease and a baseline total maximal chorea score of 8 or higher (range, 0-28; lower score indicates less chorea) were enrolled from August 2013 to August 2014 and randomized to receive deutetrabenazine (n = 45) or placebo (n = 45) in a double-blind fashion at 34 Huntington Study Group sites.
    Interventions: Deutetrabenazine or placebo was titrated to optimal dose level over 8 weeks and maintained for 4 weeks, followed by a 1-week washout.
    Main outcomes and measures: Primary end point was the total maximal chorea score change from baseline (the average of values from the screening and day-0 visits) to maintenance therapy (the average of values from the week 9 and 12 visits) obtained by in-person visits. This study was designed to detect a 2.7-unit treatment difference in scores. The secondary end points, assessed hierarchically, were the proportion of patients who achieved treatment success on the Patient Global Impression of Change (PGIC) and on the Clinical Global Impression of Change (CGIC), the change in 36-Item Short Form- physical functioning subscale score (SF-36), and the change in the Berg Balance Test.
    Results: Ninety patients with Huntington disease (mean age, 53.7 years; 40 women [44.4%]) were enrolled. In the deutetrabenazine group, the mean total maximal chorea scores improved from 12.1 (95% CI, 11.2-12.9) to 7.7 (95% CI, 6.5-8.9), whereas in the placebo group, scores improved from 13.2 (95% CI, 12.2-14.3) to 11.3 (95% CI, 10.0-12.5); the mean between-group difference was -2.5 units (95% CI, -3.7 to -1.3) (P < .001). Treatment success, as measured by the PGIC, occurred in 23 patients (51%) in the deutetrabenazine group vs 9 (20%) in the placebo group (P = .002). As measured by the CGIC, treatment success occurred in 19 patients (42%) in the deutetrabenazine group vs 6 (13%) in the placebo group (P = .002). In the deutetrabenazine group, the mean SF-36 physical functioning subscale scores decreased from 47.5 (95% CI, 44.3-50.8) to 47.4 (44.3-50.5), whereas in the placebo group, scores decreased from 43.2 (95% CI, 40.2-46.3) to 39.9 (95% CI, 36.2-43.6), for a treatment benefit of 4.3 (95% CI, 0.4 to 8.3) (P = .03). There was no difference between groups (mean difference of 1.0 unit; 95% CI, -0.3 to 2.3; P = .14), for improvement in the Berg Balance Test, which improved by 2.2 units (95% CI, 1.3-3.1) in the deutetrabenazine group and by 1.3 units (95% CI, 0.4-2.2) in the placebo group. Adverse event rates were similar for deutetrabenazine and placebo, including depression, anxiety, and akathisia.
    Conclusions and relevance: Among patients with chorea associated with Huntington disease, the use of deutetrabenazine compared with placebo resulted in improved motor signs at 12 weeks. Further research is needed to assess the clinical importance of the effect size and to determine longer-term efficacy and safety.
    Trial registration: clinicaltrials.gov Identifier: NCT01795859.
    MeSH term(s) Adrenergic Uptake Inhibitors/therapeutic use ; Chorea/drug therapy ; Cytochrome P-450 CYP2D6/metabolism ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Huntington Disease/drug therapy ; Maintenance Chemotherapy/methods ; Male ; Middle Aged ; Tetrabenazine/analogs & derivatives ; Tetrabenazine/therapeutic use ; Treatment Outcome
    Chemical Substances Adrenergic Uptake Inhibitors ; Cytochrome P-450 CYP2D6 (EC 1.14.14.1) ; deutetrabenazine (P341G6W9NB) ; Tetrabenazine (Z9O08YRN8O)
    Language English
    Publishing date 2017-02-12
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; 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.2016.8655
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