Zoe Cooke, Kathryn Lynam, Caroline Tuck, Gina Louise Trakman
Objective
This systematic review aims to synthesise existing literature to examine the relationship between natural food chemical components and reported symptoms.
Design
A systematic literature review was completed. Databases CINAHL (Ebscohost), Medline (Ovid), Scopus, Informit Health and Google Scholar were searched to identify relevant articles. The population included human studies of adults (≥17 years) and excluded those with IgE-mediate food allergies. Studies examining food chemical components or ‘food chemical elimination diets’ and symptoms were included. Data was synthesised based on clinical conditions and specific food chemical components examined. The risk of bias was assessed using the Academy of Nutrition and Dietetics ‘Quality Criteria Checklist: Primary Research’.
Results
Of the 1659 articles retrieved, 21 met inclusion criteria. This included eight randomised controlled trials, four non-randomised controlled trials, four cohort studies with placebo-controlled challenge, one prospective cohort study, three cross sectional cohort studies, one case–controlled study. Available studies support the role of a low-histamine diet for symptoms in chronic urticaria and low-salicylate diet for reducing sino-nasal symptoms in aspirin exacerbated respiratory disease and chronic rhinosinusitis and/or asthma. While further evidence is needed to verify the role of glutamate in respiratory, pain, asthma and gastrointestinal symptoms.
Conclusions
Food chemical elimination diets may improve condition-specific symptoms across the adult cohorts outlined within this review, with the strongest evidence to support the role of a low-histamine diet for management of symptoms in chronic urticaria and a low-salicylate diet in aspirin exacerbated respiratory disease and/or asthma. Further well-designed trials are needed to elucidate the effect of specific natural food chemical components on symptoms.
{"title":"Naturally Occurring Food Chemical Components and Extraintestinal and Gastrointestinal Symptoms in Adults: A Systematic Review","authors":"Zoe Cooke, Kathryn Lynam, Caroline Tuck, Gina Louise Trakman","doi":"10.1111/cea.14561","DOIUrl":"10.1111/cea.14561","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This systematic review aims to synthesise existing literature to examine the relationship between natural food chemical components and reported symptoms.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>A systematic literature review was completed. Databases CINAHL (Ebscohost), Medline (Ovid), Scopus, Informit Health and Google Scholar were searched to identify relevant articles. The population included human studies of adults (≥17 years) and excluded those with IgE-mediate food allergies. Studies examining food chemical components or ‘food chemical elimination diets’ and symptoms were included. Data was synthesised based on clinical conditions and specific food chemical components examined. The risk of bias was assessed using the Academy of Nutrition and Dietetics ‘Quality Criteria Checklist: Primary Research’.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of the 1659 articles retrieved, 21 met inclusion criteria. This included eight randomised controlled trials, four non-randomised controlled trials, four cohort studies with placebo-controlled challenge, one prospective cohort study, three cross sectional cohort studies, one case–controlled study. Available studies support the role of a low-histamine diet for symptoms in chronic urticaria and low-salicylate diet for reducing sino-nasal symptoms in aspirin exacerbated respiratory disease and chronic rhinosinusitis and/or asthma. While further evidence is needed to verify the role of glutamate in respiratory, pain, asthma and gastrointestinal symptoms.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Food chemical elimination diets may improve condition-specific symptoms across the adult cohorts outlined within this review, with the strongest evidence to support the role of a low-histamine diet for management of symptoms in chronic urticaria and a low-salicylate diet in aspirin exacerbated respiratory disease and/or asthma. Further well-designed trials are needed to elucidate the effect of specific natural food chemical components on symptoms.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>Systematic review number: CRD42022322511.</p>\u0000 </section>\u0000 </div>","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 11","pages":"855-880"},"PeriodicalIF":6.3,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.14561","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>Allergy Action Plans (AAPs) represent an essential tool in management of patients with severe allergies who are at risk of anaphylaxis. Such plans must provide clear and concise guidance on how to recognise and treat severe allergic reactions including anaphylaxis, and should align where possible, with the latest clinical treatment guidelines. Although allergic reactions may occur at any age, historically most AAPs have included information to facilitate recognition by parents or carers of allergic symptoms that are more relevant to children such as ‘change in behaviour’ or becoming ‘floppy’. These plans are not appropriate for adults, for whom self-recognition of symptoms as well as self-administration of adrenaline autoinjectors is far more likely to be needed.</p><p>Adults may be exposed to allergens in various settings, such as at work, social gatherings or while travelling. The purpose of an AAP is to provide clear instruction to ensure that adults are prepared to handle allergic reactions promptly and effectively. To do this, the AAP should provide information which enables adults to recognise the symptoms of anaphylaxis so that they know <i>when</i> to treat an allergic reaction with adrenaline, such as in the event of difficulty breathing or dizziness, and when repeat administration with a second device is necessary [<span>1</span>]. Conversely, an AAP can help adults differentiate anaphylaxis from mild/moderate allergic reactions that need not require adrenaline, such as hives, or symptoms of a more non-specific nature, such as throat tightness. The plan also advises on additional measures that need to be taken, that is, calling emergency services and mitigating hypotension by lying flat with leg elevation.</p><p>A national audit in 2017 by the BSACI Nurses Committee found that 46% of adults prescribed an adrenaline autoinjector were not provided with an accompanying written emergency treatment plan to support its use. One potential reason for this is a lack of access to adult-specific AAPs, including those that are up to date with current anaphylaxis management guidelines as well as being aligned with UK Medicines and Healthcare Products Regulatory Agency (MHRA) recommendations [<span>2</span>].</p><p>For this reason, the BSACI undertook to develop an open-access Adult AAP in collaboration with national allergy patient charities, Allergy UK and Anaphylaxis UK, with oversight from the BSACI Standards of Care Committee (SOCC).</p><p>An initial assessment of existing anaphylaxis plans was undertaken, including those from the American Academy of Allergy, Asthma and Immunology, Australasian Society of Allergy and Clinical Immunology, the BSACI Paediatric Allergy Plans, manufacturer proprietary plans and the latest MHRA guidance on the use of autoinjectors. Following this evaluation, additional elements identified for inclusion were pictorial device-specific instructions, positioning advice and a health professional signature to validate t
{"title":"Editorial: Adult Allergy Action Plan","authors":"Steve Till, Katherine Powrie, Shifa Shaikh","doi":"10.1111/cea.14559","DOIUrl":"https://doi.org/10.1111/cea.14559","url":null,"abstract":"<p>Allergy Action Plans (AAPs) represent an essential tool in management of patients with severe allergies who are at risk of anaphylaxis. Such plans must provide clear and concise guidance on how to recognise and treat severe allergic reactions including anaphylaxis, and should align where possible, with the latest clinical treatment guidelines. Although allergic reactions may occur at any age, historically most AAPs have included information to facilitate recognition by parents or carers of allergic symptoms that are more relevant to children such as ‘change in behaviour’ or becoming ‘floppy’. These plans are not appropriate for adults, for whom self-recognition of symptoms as well as self-administration of adrenaline autoinjectors is far more likely to be needed.</p><p>Adults may be exposed to allergens in various settings, such as at work, social gatherings or while travelling. The purpose of an AAP is to provide clear instruction to ensure that adults are prepared to handle allergic reactions promptly and effectively. To do this, the AAP should provide information which enables adults to recognise the symptoms of anaphylaxis so that they know <i>when</i> to treat an allergic reaction with adrenaline, such as in the event of difficulty breathing or dizziness, and when repeat administration with a second device is necessary [<span>1</span>]. Conversely, an AAP can help adults differentiate anaphylaxis from mild/moderate allergic reactions that need not require adrenaline, such as hives, or symptoms of a more non-specific nature, such as throat tightness. The plan also advises on additional measures that need to be taken, that is, calling emergency services and mitigating hypotension by lying flat with leg elevation.</p><p>A national audit in 2017 by the BSACI Nurses Committee found that 46% of adults prescribed an adrenaline autoinjector were not provided with an accompanying written emergency treatment plan to support its use. One potential reason for this is a lack of access to adult-specific AAPs, including those that are up to date with current anaphylaxis management guidelines as well as being aligned with UK Medicines and Healthcare Products Regulatory Agency (MHRA) recommendations [<span>2</span>].</p><p>For this reason, the BSACI undertook to develop an open-access Adult AAP in collaboration with national allergy patient charities, Allergy UK and Anaphylaxis UK, with oversight from the BSACI Standards of Care Committee (SOCC).</p><p>An initial assessment of existing anaphylaxis plans was undertaken, including those from the American Academy of Allergy, Asthma and Immunology, Australasian Society of Allergy and Clinical Immunology, the BSACI Paediatric Allergy Plans, manufacturer proprietary plans and the latest MHRA guidance on the use of autoinjectors. Following this evaluation, additional elements identified for inclusion were pictorial device-specific instructions, positioning advice and a health professional signature to validate t","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 9","pages":"644-646"},"PeriodicalIF":6.3,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.14559","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142137841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stephanie J. Lax, Eleanor Van Vogt, Bridget Candy, Lloyd Steele, Clare Reynolds, Beth Stuart, Roses Parker, Emma Axon, Amanda Roberts, Megan Doyle, Derek K. Chu, Masaki Futamura, Miriam Santer, Hywel C. Williams, Suzie Cro, Aaron M. Drucker, Robert J. Boyle
<div> <section> <h3> Objective</h3> <p>Eczema is the most burdensome skin condition worldwide and topical anti-inflammatory treatments are commonly used to control symptoms. The relative effectiveness and safety of different topical anti-inflammatory treatments is uncertain.</p> </section> <section> <h3> Design</h3> <p>Network meta-analysis performed within a Cochrane systematic review to compare and statistically rank efficacy and safety of topical anti-inflammatory eczema treatments.</p> </section> <section> <h3> Data Sources</h3> <p>Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries to June 2023.</p> </section> <section> <h3> Eligibility Criteria for Selected Trials</h3> <p>Included trials were within-participant or between-participant randomised controlled trials. Participants had eczema that was not clinically infected and was not contact dermatitis, seborrheic eczema or hand eczema. Interventions were topical anti-inflammatory treatments but not complementary treatments, antibiotics alone, wet wraps, phototherapy or systemic treatments. Comparators were no treatment/vehicle or another topical anti-inflammatory.</p> </section> <section> <h3> Results</h3> <p>We identified 291 trials (45,846 participants), mainly in high-income countries. Most were industry-funded with median 3 weeks treatment duration. Risk of bias assessed using the Cochrane Risk of Bias 2.0 tool was high in 89% of trials, mainly due to risk of selective reporting. Network meta-analysis of binary outcomes ranked potent and/or very potent topical steroids, tacrolimus 0.1% and ruxolitinib 1.5% among the most effective treatments for improving patient-reported symptoms (40 trials, all low confidence) and clinician-reported signs (32 trials, all moderate confidence). For investigator global assessment, the Janus kinas inhibitors ruxolitinib 1.5%, delgocitinib 0.5% or 0.25%, very potent/potent topical steroids and tacrolimus 0.1% were ranked as most effective (140 trials, all moderate confidence). Continuous outcome data were mixed. Local application site reactions were most common with tacrolimus 0.1% (moderate confidence) and crisaborole 2% (high confidence) and least common with topical steroids (moderate confidence). Skin thinning was not increased with short-term use of any topical steroid potency (low confidence) but skin thinning was reported in 6/2044 (0.3%) participants treated with longer-term (6–60 months) topical steroids.</p>
{"title":"Topical Anti-Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta-Analysis","authors":"Stephanie J. Lax, Eleanor Van Vogt, Bridget Candy, Lloyd Steele, Clare Reynolds, Beth Stuart, Roses Parker, Emma Axon, Amanda Roberts, Megan Doyle, Derek K. Chu, Masaki Futamura, Miriam Santer, Hywel C. Williams, Suzie Cro, Aaron M. Drucker, Robert J. Boyle","doi":"10.1111/cea.14556","DOIUrl":"10.1111/cea.14556","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Eczema is the most burdensome skin condition worldwide and topical anti-inflammatory treatments are commonly used to control symptoms. The relative effectiveness and safety of different topical anti-inflammatory treatments is uncertain.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Network meta-analysis performed within a Cochrane systematic review to compare and statistically rank efficacy and safety of topical anti-inflammatory eczema treatments.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data Sources</h3>\u0000 \u0000 <p>Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries to June 2023.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Eligibility Criteria for Selected Trials</h3>\u0000 \u0000 <p>Included trials were within-participant or between-participant randomised controlled trials. Participants had eczema that was not clinically infected and was not contact dermatitis, seborrheic eczema or hand eczema. Interventions were topical anti-inflammatory treatments but not complementary treatments, antibiotics alone, wet wraps, phototherapy or systemic treatments. Comparators were no treatment/vehicle or another topical anti-inflammatory.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We identified 291 trials (45,846 participants), mainly in high-income countries. Most were industry-funded with median 3 weeks treatment duration. Risk of bias assessed using the Cochrane Risk of Bias 2.0 tool was high in 89% of trials, mainly due to risk of selective reporting. Network meta-analysis of binary outcomes ranked potent and/or very potent topical steroids, tacrolimus 0.1% and ruxolitinib 1.5% among the most effective treatments for improving patient-reported symptoms (40 trials, all low confidence) and clinician-reported signs (32 trials, all moderate confidence). For investigator global assessment, the Janus kinas inhibitors ruxolitinib 1.5%, delgocitinib 0.5% or 0.25%, very potent/potent topical steroids and tacrolimus 0.1% were ranked as most effective (140 trials, all moderate confidence). Continuous outcome data were mixed. Local application site reactions were most common with tacrolimus 0.1% (moderate confidence) and crisaborole 2% (high confidence) and least common with topical steroids (moderate confidence). Skin thinning was not increased with short-term use of any topical steroid potency (low confidence) but skin thinning was reported in 6/2044 (0.3%) participants treated with longer-term (6–60 months) topical steroids.</p>\u0000 ","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 12","pages":"960-972"},"PeriodicalIF":6.3,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Atopic dermatitis (AD) is a common chronic skin disorder in children. We aimed to investigate trends and regional disparities of burden in paediatric AD at global, regional and national levels, and to explore potential associated factors.
Methods
Based on data from Global Burden of Disease study 2019, we assessed trends in burden of AD aged <19 years from 1990 to 2019, including prevalent and incident cases, age-standardised prevalence and age-standardised incidence. For potential associated factors, correlations of above trends and indexes of socio-economic status (sociodemographic index, SDI) and health service coverage (universal health coverage index, UHCI) were evaluated. We conducted decomposition analysis to understand the net contribution of population-level factors and their contribution proportions on changes of prevalent and incident cases, including age structure, population change and epidemiological change.
Results
Global prevalent and incident cases of paediatric AD increased by about 5.7 and 0.7 million between 1990 and 2019, respectively. Global age-standardised prevalence and incidence decreased by −0.17% (−0.19% to −0.16%) and −0.12% (−0.13% to −0.11%) per year from 1990 to 2019, respectively. Regionally, the highest increase of prevalent and incident cases was in low SDI region (by 96.77% and 84.85%); the highest decrease of age-standardised prevalence and incidence was in high SDI regions (by −0.20% and −0.27% per year). The correlation analyses identified significant negative correlations between trends and SDI and UHCI. Population change was a major driver of case rise; epidemiological change and age structure showed negative impact of case rise. Regional disparities in contribution of three population-level factors were seen, including net contribution direction (positive or negative) and contribution proportion levels.
Conclusion
Global paediatric AD case numbers increased, primarily due to population growth. Prevalence and incidence decreased slightly. Geographic inequalities were seen. Developing region-specific strategies targeting potential factors is essential to reduce paediatric AD burden.
{"title":"Global, Regional and National Burden of Paediatric Atopic Dermatitis: A Trend and Geographic Inequalities Analysis","authors":"Xueshan Cao, Minmin Wang, Mengge Zhou, Yuanqi Mi, Qi Guo, Yanbin Fan, Yang Guo","doi":"10.1111/cea.14558","DOIUrl":"10.1111/cea.14558","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Atopic dermatitis (AD) is a common chronic skin disorder in children. We aimed to investigate trends and regional disparities of burden in paediatric AD at global, regional and national levels, and to explore potential associated factors.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Based on data from Global Burden of Disease study 2019, we assessed trends in burden of AD aged <19 years from 1990 to 2019, including prevalent and incident cases, age-standardised prevalence and age-standardised incidence. For potential associated factors, correlations of above trends and indexes of socio-economic status (sociodemographic index, SDI) and health service coverage (universal health coverage index, UHCI) were evaluated. We conducted decomposition analysis to understand the net contribution of population-level factors and their contribution proportions on changes of prevalent and incident cases, including age structure, population change and epidemiological change.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Global prevalent and incident cases of paediatric AD increased by about 5.7 and 0.7 million between 1990 and 2019, respectively. Global age-standardised prevalence and incidence decreased by −0.17% (−0.19% to −0.16%) and −0.12% (−0.13% to −0.11%) per year from 1990 to 2019, respectively. Regionally, the highest increase of prevalent and incident cases was in low SDI region (by 96.77% and 84.85%); the highest decrease of age-standardised prevalence and incidence was in high SDI regions (by −0.20% and −0.27% per year). The correlation analyses identified significant negative correlations between trends and SDI and UHCI. Population change was a major driver of case rise; epidemiological change and age structure showed negative impact of case rise. Regional disparities in contribution of three population-level factors were seen, including net contribution direction (positive or negative) and contribution proportion levels.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Global paediatric AD case numbers increased, primarily due to population growth. Prevalence and incidence decreased slightly. Geographic inequalities were seen. Developing region-specific strategies targeting potential factors is essential to reduce paediatric AD burden.</p>\u0000 </section>\u0000 </div>","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 10","pages":"747-759"},"PeriodicalIF":6.3,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.14558","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Émilie Margoline, Emeline Cailliau, Sarah Gephine, Stéphanie Fry, Olivier Le Rouzic, Jean-Marie Grosbois, Cécile Chenivesse
<p>Severe asthma is the main cause of asthma burden, morbidity and asthma-related healthcare costs. Although biologics transformed the prognosis, they are mainly effective in type-2 phenotypes, where they exhibit a wide range of responses [<span>1</span>], leaving many patients uncontrolled. Pulmonary rehabilitation (PR) is a transdisciplinary programme improving asthma control in non-severe asthma [<span>2, 3</span>]. In this exploratory study, we aimed to evaluate the effect of PR on severe asthma outcomes.</p><p>We conducted a single-centre retrospective cohort study. Adults with severe asthma referred for home-based PR between June 2017 and December 2020 were included. Socio-demographic, clinical and functional data were prospectively collected using CareItou software (French data protection authority: 1413001). Participants signed a written consent. The study was approved by the Committee for the Evaluation of Observational Research Protocols of the French Society for Respiratory Diseases (2021-054). The primary objective was to assess changes in asthma control before and after PR using the asthma control test (ACT). Secondary objectives included evaluating changes in the annual number of severe asthma exacerbations (glucocorticoid intake for at least 3 days and/or hospitalisation and/or emergency room admission), the annual cumulative glucocorticoid dose (self-reported combined with medical record review), airway obstruction (FEV<sub>1</sub>), hyperventilation symptoms (Nijmegen score) and anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADs] scores). Study endpoints were evaluated before PR (M0), at the end of PR (M2), and at 6 (M8) and 12 months (M14). The home-based PR programme was previously described [<span>4</span>]. Briefly, it consisted of an 8-week programme with weekly supervised 90-min sessions including educational and self-management strategies and physical training. Between sessions, patients performed physical training and followed a self-management plan on their own. Statistical analysis was performed using SAS software. Changes in outcomes between M2, M8, M14 and M0 were evaluated using a mixed linear model (covariance pattern) which included time as a fixed effect and an unstructured covariance matrix to account for the correlation between repeated measures. Changes and their 95% CI were estimated using linear contrasts. In cases where residuals deviated from normality, differences between M0–M2, M0–M8 and M0–M14 were assessed using the Wilcoxon signed-rank test. For each outcome, missing values were handled using multiple imputation procedures under the missing at random assumption using a regression switching approach (chained equation with 20 imputations), with the predictive mean matching method for continuous variables and logistic regression for qualitative variables. Estimates from mixed linear models obtained in the imputed datasets were combined using the Rubin's rules. Wilcoxon signed-ran
{"title":"Effectiveness of Pulmonary Rehabilitation on Severe Asthma Outcomes: A Pre–Post Study","authors":"Émilie Margoline, Emeline Cailliau, Sarah Gephine, Stéphanie Fry, Olivier Le Rouzic, Jean-Marie Grosbois, Cécile Chenivesse","doi":"10.1111/cea.14555","DOIUrl":"10.1111/cea.14555","url":null,"abstract":"<p>Severe asthma is the main cause of asthma burden, morbidity and asthma-related healthcare costs. Although biologics transformed the prognosis, they are mainly effective in type-2 phenotypes, where they exhibit a wide range of responses [<span>1</span>], leaving many patients uncontrolled. Pulmonary rehabilitation (PR) is a transdisciplinary programme improving asthma control in non-severe asthma [<span>2, 3</span>]. In this exploratory study, we aimed to evaluate the effect of PR on severe asthma outcomes.</p><p>We conducted a single-centre retrospective cohort study. Adults with severe asthma referred for home-based PR between June 2017 and December 2020 were included. Socio-demographic, clinical and functional data were prospectively collected using CareItou software (French data protection authority: 1413001). Participants signed a written consent. The study was approved by the Committee for the Evaluation of Observational Research Protocols of the French Society for Respiratory Diseases (2021-054). The primary objective was to assess changes in asthma control before and after PR using the asthma control test (ACT). Secondary objectives included evaluating changes in the annual number of severe asthma exacerbations (glucocorticoid intake for at least 3 days and/or hospitalisation and/or emergency room admission), the annual cumulative glucocorticoid dose (self-reported combined with medical record review), airway obstruction (FEV<sub>1</sub>), hyperventilation symptoms (Nijmegen score) and anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADs] scores). Study endpoints were evaluated before PR (M0), at the end of PR (M2), and at 6 (M8) and 12 months (M14). The home-based PR programme was previously described [<span>4</span>]. Briefly, it consisted of an 8-week programme with weekly supervised 90-min sessions including educational and self-management strategies and physical training. Between sessions, patients performed physical training and followed a self-management plan on their own. Statistical analysis was performed using SAS software. Changes in outcomes between M2, M8, M14 and M0 were evaluated using a mixed linear model (covariance pattern) which included time as a fixed effect and an unstructured covariance matrix to account for the correlation between repeated measures. Changes and their 95% CI were estimated using linear contrasts. In cases where residuals deviated from normality, differences between M0–M2, M0–M8 and M0–M14 were assessed using the Wilcoxon signed-rank test. For each outcome, missing values were handled using multiple imputation procedures under the missing at random assumption using a regression switching approach (chained equation with 20 imputations), with the predictive mean matching method for continuous variables and logistic regression for qualitative variables. Estimates from mixed linear models obtained in the imputed datasets were combined using the Rubin's rules. Wilcoxon signed-ran","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 12","pages":"1016-1019"},"PeriodicalIF":6.3,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>Asthma is a common chronic respiratory illness worldwide, consisting of longstanding airway inflammation with acute exacerbations. Traditionally, asthma has been managed in a step-wise fashion, with older guidance recommending short-acting beta-agonists (SABAs) as required for mild cases, and the addition of regular inhaled corticosteroids (ICS) for more persistent symptoms [<span>1</span>]. Since 2019, GINA has highlighted the risks of SABA-only treatment, and advised for a combination ICS and long-acting beta agonist (LABA), to be used as required with mild symptoms, and regularly for more persistent symptoms [<span>2</span>]. Long-acting muscarinic agonists (LAMAs) are considered a later add-on therapy if initial stages of therapy are not sufficient to control symptoms.</p><p>This Cochrane review addresses the approach to a patient with residual asthma symptoms despite the use of a first-line preventer therapy (MD-ICS), a common consultation in both the primary and secondary care setting.</p><p>We included 38,276 participants from 35 studies (median duration 24 weeks [range 12–78]; mean age 44.1; 38% male; 69% white; mean forced expiratory volume in one second 2.1 L and 68% of predicted).</p><p>MD- and HD-ICS/LABA likely reduce and MD-ICS/LAMA possibly reduces moderate to severe asthma exacerbations compared to MD-ICS (hazard ratio [HR] 0.70, 95% credible interval [CrI] 0.59–0.82; moderate certainty; HR 0.59, 95% CrI 0.46–0.76; moderate certainty; and HR 0.56, 95% CrI 0.38–0.82; low certainty, respectively), whereas HD-ICS probably does not (HR 0.94, 95% CrI 0.70–1.24; moderate certainty). There is no clear evidence to suggest that any combination therapy or HD-ICS reduces severe asthma exacerbations compared to MD-ICS (low to moderate certainty).</p><p>This study suggests no clinically meaningful differences in the symptom or quality of life score between dual combinations and monotherapy (low to high certainty).</p><p>MD- and HD-ICS/LABA increase or likely increase the odds of Asthma Control Questionnaire (ACQ) responders at 6 and 12 months compared to MD-ICS (odds ratio [OR] 1.47, 95% CrI 1.23–1.76; high certainty; and OR 1.59, 95% CrI 1.31–1.94; high certainty at 6 months; and OR 1.61, 95% CrI 1.22–2.13; moderate certainty and OR 1.55, 95% CrI 1.20–2.00; high certainty at 12 months, respectively).</p><p>MD-ICS/LAMA probably increases the odds of ACQ responders at 6 months (OR 1.32, 95% CrI 1.11–1.57; moderate certainty). No data were available at 12 months. There is no clear evidence to suggest that HD-ICS increases the odds of ACQ responders or improves the symptom or quality of life score compared to MD-ICS (very low to high certainty).</p><p>There is no evidence to suggest that ICS/LABA or ICS/LAMA reduces asthma-related or all-cause serious adverse events (SAEs) compared to MD-ICS (very low to high certainty). HD-ICS results in or likely results in little or no difference in the included safety outcomes compared to MD-ICS as well as
BTS/SIGN[1]和美国国立卫生研究院（NIH）[4]的指南建议，如果患者症状未得到控制，可在低剂量 ICS 的基础上加用 LABA，而 GINA[2] 则建议从一开始就使用低剂量 ICS/LABA。与单独使用 HD-ICS 相比，两种组合都能减少中度-重度病情恶化。尽管如此，所有指南都将 LABA 作为 ICS 的首选附加疗法。有研究表明，在 ICS/LABA 组合中添加 LAMA 有益[5]，但指南将其保留为专科治疗[1, 2]。只有在添加 LABA 无益，或 LABA 不能耐受或无法获得的情况下，指南才会推荐使用 ICS/LAMA（不含 LABA）[2]。LAMA 的证据不足，以及指南后期增加 LAMA（依赖于这些证据）的原因可能是，与许多可用于 ICS/LABA 的联合吸入器（表 1）相比，目前还没有市售的 ICS/LAMA 联合吸入器。我们知道，通过简化治疗方案可以最大限度地提高哮喘患者的依从性，因此增加第二个吸入器来提供 LAMA 很可能会降低依从性，从而降低哮喘控制率。在本综述包括的两项 LAMA 研究中，一项研究排除了有不依从风险的参与者[6]，另一项研究指出，临床试验中的依从性高于常规临床实践[7]。据估计，50% 的患者对药物的依从性不完全[2]，因此，尽管本综述发现 ICS/LABA 与 ICS/LAMA 的影响没有显著差异，但在实践中，含有 ICS/LABA 的单一组合装置可能更胜一筹。Baigel博士在攻读过敏与免疫学硕士学位时获得了利洁时公司和ALK公司的资助，并获得了利洁时公司提供的出席国际会议的资助。
{"title":"Cochrane Corner: Addition of Long-Acting Beta2 Agonists or Long-Acting Muscarinic Antagonists Versus Doubling the Dose of Inhaled Corticosteroids (ICS) in Adolescents and Adults With Uncontrolled Asthma With Medium-Dose ICS","authors":"Rachel Baigel, Ian Gregory","doi":"10.1111/cea.14554","DOIUrl":"10.1111/cea.14554","url":null,"abstract":"<p>Asthma is a common chronic respiratory illness worldwide, consisting of longstanding airway inflammation with acute exacerbations. Traditionally, asthma has been managed in a step-wise fashion, with older guidance recommending short-acting beta-agonists (SABAs) as required for mild cases, and the addition of regular inhaled corticosteroids (ICS) for more persistent symptoms [<span>1</span>]. Since 2019, GINA has highlighted the risks of SABA-only treatment, and advised for a combination ICS and long-acting beta agonist (LABA), to be used as required with mild symptoms, and regularly for more persistent symptoms [<span>2</span>]. Long-acting muscarinic agonists (LAMAs) are considered a later add-on therapy if initial stages of therapy are not sufficient to control symptoms.</p><p>This Cochrane review addresses the approach to a patient with residual asthma symptoms despite the use of a first-line preventer therapy (MD-ICS), a common consultation in both the primary and secondary care setting.</p><p>We included 38,276 participants from 35 studies (median duration 24 weeks [range 12–78]; mean age 44.1; 38% male; 69% white; mean forced expiratory volume in one second 2.1 L and 68% of predicted).</p><p>MD- and HD-ICS/LABA likely reduce and MD-ICS/LAMA possibly reduces moderate to severe asthma exacerbations compared to MD-ICS (hazard ratio [HR] 0.70, 95% credible interval [CrI] 0.59–0.82; moderate certainty; HR 0.59, 95% CrI 0.46–0.76; moderate certainty; and HR 0.56, 95% CrI 0.38–0.82; low certainty, respectively), whereas HD-ICS probably does not (HR 0.94, 95% CrI 0.70–1.24; moderate certainty). There is no clear evidence to suggest that any combination therapy or HD-ICS reduces severe asthma exacerbations compared to MD-ICS (low to moderate certainty).</p><p>This study suggests no clinically meaningful differences in the symptom or quality of life score between dual combinations and monotherapy (low to high certainty).</p><p>MD- and HD-ICS/LABA increase or likely increase the odds of Asthma Control Questionnaire (ACQ) responders at 6 and 12 months compared to MD-ICS (odds ratio [OR] 1.47, 95% CrI 1.23–1.76; high certainty; and OR 1.59, 95% CrI 1.31–1.94; high certainty at 6 months; and OR 1.61, 95% CrI 1.22–2.13; moderate certainty and OR 1.55, 95% CrI 1.20–2.00; high certainty at 12 months, respectively).</p><p>MD-ICS/LAMA probably increases the odds of ACQ responders at 6 months (OR 1.32, 95% CrI 1.11–1.57; moderate certainty). No data were available at 12 months. There is no clear evidence to suggest that HD-ICS increases the odds of ACQ responders or improves the symptom or quality of life score compared to MD-ICS (very low to high certainty).</p><p>There is no evidence to suggest that ICS/LABA or ICS/LAMA reduces asthma-related or all-cause serious adverse events (SAEs) compared to MD-ICS (very low to high certainty). HD-ICS results in or likely results in little or no difference in the included safety outcomes compared to MD-ICS as well as","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 9","pages":"647-650"},"PeriodicalIF":6.3,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cea.14554","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. P. Morales-Palacios, J. M. Núñez-Córdoba, E. Tejero, O. Matellanes, C. M. D'Amelio, G. Gastaminza
<p>The intradermal test (IDT) and skin prick test (SPT) represent the primary diagnostic tool [<span>1</span>], and most common used in vivo biomarker in the study of immediate hypersensitive reactions [<span>2</span>]. IDT is used in the study of drug and hymenoptera venom allergy [<span>1</span>], consisting in a manual procedure (MP) that involves different measurement techniques and criteria with the consequent variability between health professionals [<span>3</span>], being the lack of their standardisation still a pending task [<span>4</span>]. The current positive criteria (an increase of 3 or more millimetres in maximum diameter (MD) of the initial wheal and surrounding erythema) [<span>3</span>] depends on a manual measurement, where it is difficult to obtain such a small measurement in a reproducible and reliable way. After all, the final decision on whether a test is positive or negative will depend on the judgement of the professional doing the study.</p><p>Nexkin DSPT (Digital Skin Prick Test) is a medical device that automatically assess the wheal size in SPT. This device, based on 3D-laser technology, reconstructs the geometry of the arm of the patient, followed by an algorithm-based methodology that locates the wheals and calculates their shape and size (area in mm<sup>2</sup>, and MD and orthogonal diameters in mm) automatically [<span>5</span>]. In 2021, our group conducted a clinical trial to validate the use of Nexkin DSPT for the measurement of SPT; our results showed higher reliability for the device in comparison to MP, correlations between the MP and Nexkin DSPT showed a relatively strong association (area: <i>r</i> = 0.742, <i>p</i> < 0.001; MD: <i>r</i> = 0.700, <i>p</i> < 0.001; OD: <i>r</i> = 0.644, <i>p</i> < 0.001) and the consistency of Nexkin DSPT readings were greater than those of the MP in the test–retest: reading variations in Nexkin DSPT area (2.02 mm<sup>2</sup>; SD = 3.42) were lower than those of the MP (4.94 mm<sup>2</sup>; SD = 4.14) (<i>p</i> < 0.001) [<span>6</span>].</p><p>A prospective study, company-sponsored, was conducted at Clínica Universidad de Navarra (PI_2021/155), IDTs were performed in 194 participants with positive (histamine) and negative (saline solution) controls. Two readings were executed (immediate and after 20 min) both automatically, with Nexkin DSPT and by the MP (performed by the same allergology specialist in all cases). We aimed to determine sensitivity and specificity, agreement between both methods as well as a potential cut-off point for diagnosis.</p><p>For the estimation of sensitivity, specificity, discrimination capability and the identification of potential cut-off points we randomly selected 97 wheals from each of both groups (histamine and saline solution). The complete sample was used for the evaluation of the agreement between the MP and the device, and for the comparisons between the immediate and second reading of the device. Characteristics of the part
{"title":"Evaluation of a Novel Automated Allergy Intradermal Skin Test Reader: A Diagnostic Accuracy Study","authors":"M. P. Morales-Palacios, J. M. Núñez-Córdoba, E. Tejero, O. Matellanes, C. M. D'Amelio, G. Gastaminza","doi":"10.1111/cea.14553","DOIUrl":"10.1111/cea.14553","url":null,"abstract":"<p>The intradermal test (IDT) and skin prick test (SPT) represent the primary diagnostic tool [<span>1</span>], and most common used in vivo biomarker in the study of immediate hypersensitive reactions [<span>2</span>]. IDT is used in the study of drug and hymenoptera venom allergy [<span>1</span>], consisting in a manual procedure (MP) that involves different measurement techniques and criteria with the consequent variability between health professionals [<span>3</span>], being the lack of their standardisation still a pending task [<span>4</span>]. The current positive criteria (an increase of 3 or more millimetres in maximum diameter (MD) of the initial wheal and surrounding erythema) [<span>3</span>] depends on a manual measurement, where it is difficult to obtain such a small measurement in a reproducible and reliable way. After all, the final decision on whether a test is positive or negative will depend on the judgement of the professional doing the study.</p><p>Nexkin DSPT (Digital Skin Prick Test) is a medical device that automatically assess the wheal size in SPT. This device, based on 3D-laser technology, reconstructs the geometry of the arm of the patient, followed by an algorithm-based methodology that locates the wheals and calculates their shape and size (area in mm<sup>2</sup>, and MD and orthogonal diameters in mm) automatically [<span>5</span>]. In 2021, our group conducted a clinical trial to validate the use of Nexkin DSPT for the measurement of SPT; our results showed higher reliability for the device in comparison to MP, correlations between the MP and Nexkin DSPT showed a relatively strong association (area: <i>r</i> = 0.742, <i>p</i> < 0.001; MD: <i>r</i> = 0.700, <i>p</i> < 0.001; OD: <i>r</i> = 0.644, <i>p</i> < 0.001) and the consistency of Nexkin DSPT readings were greater than those of the MP in the test–retest: reading variations in Nexkin DSPT area (2.02 mm<sup>2</sup>; SD = 3.42) were lower than those of the MP (4.94 mm<sup>2</sup>; SD = 4.14) (<i>p</i> < 0.001) [<span>6</span>].</p><p>A prospective study, company-sponsored, was conducted at Clínica Universidad de Navarra (PI_2021/155), IDTs were performed in 194 participants with positive (histamine) and negative (saline solution) controls. Two readings were executed (immediate and after 20 min) both automatically, with Nexkin DSPT and by the MP (performed by the same allergology specialist in all cases). We aimed to determine sensitivity and specificity, agreement between both methods as well as a potential cut-off point for diagnosis.</p><p>For the estimation of sensitivity, specificity, discrimination capability and the identification of potential cut-off points we randomly selected 97 wheals from each of both groups (histamine and saline solution). The complete sample was used for the evaluation of the agreement between the MP and the device, and for the comparisons between the immediate and second reading of the device. Characteristics of the part","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 12","pages":"1006-1009"},"PeriodicalIF":6.3,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kirsten Stewart, Chris RuiWen Kuo, Rory Chan, Brian Lipworth
<p>Few studies have prospectively looked in detail at concomitant upper and lower airway outcomes in patients with Type 2 (T2) high unified airway disease (UAD); severe asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Remote follow-up of the clinical burden of upper and lower airway disease in response to treatment, including biologics, can be challenging. There is an unmet need for a portable mobile phone-connected device which records both upper and lower airway outcomes. Useful measures of clinical improvement include assessment of airflow obstruction as peak expiratory flow (PEF) for asthma and peak nasal inspiratory flow (PNIF) for CRSwNP, visual analogue scale (VAS) symptom scores and inhaler use. We evaluated a novel hand-held device (Smart peak flow, Smart Respiratory Products Ltd, Imperial College, London, UK), which connects to android or iOS mobile phones via wireless Bluetooth or headphone jack.</p><p>Thirteen participants were prospectively assessed who completed e-diary recordings, of 21 enrolled subjects with uncontrolled T2 high UAD as part of a study where patients received open-label dupilumab 300 mg every 2 weeks [<span>1, 2</span>] for 12 weeks (EudraCT 2021-005593-25), with the primary endpoint of mannitol challenge (reported elsewhere). Patients used maintenance and reliever therapy [<span>3</span>] (MART 2–8 actuations daily) extra-fine beclometasone/formoterol 100/6 μg as their inhaled corticosteroid (ICS) along with their usual intranasal corticosteroid (INCS) and entered a 4-week run-in period. Rescue albuterol could be used beyond the maximum MART dose of 8 actuations/day. Electronic diary recordings were made in the morning, including inhaler use (actuations/day) and the best of three readings for PNIF and PEF. VAS symptom scores for hyposmia, nasal congestion and global asthma symptoms were made by selecting a point on a 0–10 electronic scale. The study had local research ethics committee approval 21/WS/0151 and all participants gave their informed consent. Participants e-diaries were assessed for 2 weeks prior to, and for 2 weeks following, the first dose of dupilumab. The e-diaries were then assessed for 4 weeks following the final dose of dupilumab. Initial repeated measures analysis of variance (ANOVA) was performed followed by pairwise Student's <i>t</i>-test with a two-tailed alpha error of 0.05 to compare the two-weekly mean results from 2 weeks prior to the first dose to 2 weeks following the first dose (Weeks −2 and −1 vs. Weeks 1 and 2), baseline to end of treatment (Weeks −2 and −1 vs. Weeks 11 and 12) and the 4 weeks following the final dose of dupilumab (Weeks 11 and 12 vs. Weeks 13 and 14). e-Diary results were assessed in relation to the minimal clinical important difference values (MCID) [<span>4-9</span>].</p><p>Thirteen patients completed 12 weeks of e-diary recordings; eight had aspirin exacerbated respiratory disease (AERD) and six were males. The mean age was 53 years, mean (SEM) I
很少有研究前瞻性地详细观察2型（T2）高度统一气道疾病（UAD）患者伴随的上、下气道结局；重度哮喘和慢性鼻窦炎伴鼻息肉病（CRSwNP）。对包括生物制剂在内的治疗反应的上呼吸道和下呼吸道疾病的临床负担进行远程随访可能具有挑战性。对便携式移动电话连接设备的需求尚未得到满足，该设备可以记录上呼吸道和下呼吸道的结果。有用的临床改善措施包括评估气流阻塞为哮喘的呼气峰流量（PEF）和CRSwNP的鼻吸气峰流量（PNIF），视觉模拟量表（VAS）症状评分和吸入器的使用。我们评估了一种新型手持设备（Smart peak flow, Smart Respiratory Products Ltd, Imperial College, London， UK），它通过无线蓝牙或耳机接口连接到android或iOS手机。13名参与者完成了电子日记记录的前瞻性评估，21名未控制T2高UAD的入组受试者作为研究的一部分，患者每2周接受开放标签dupilumab 300 mg，持续12周（EudraCT 2021-005593-25），主要终点为甘露醇挑战（其他地方报道）。患者使用维持和缓解治疗[3]（每日2-8次启动）超细倍氯米松/福莫特罗100/6 μg作为吸入皮质类固醇（ICS）和常规鼻内皮质类固醇（INCS），并进入4周的磨合期。抢救沙丁胺醇可以在MART最大剂量8次/天之外使用。在早上进行电子日记记录，包括吸入器的使用（动作/天）和PNIF和PEF的三个最佳读数。通过在0-10级电子量表中选择一个点，对低呼吸、鼻塞和整体哮喘症状进行VAS症状评分。该研究获得了当地研究伦理委员会的批准21/WS/0151，所有参与者都给予了知情同意。在首次给药前2周和后2周评估参与者的电子日记。在最终剂量dupilumab后的4周内，对电子日记进行评估。首次重复测量方差分析(方差分析)进行了紧随其后的是成对学生的学习错误的小动物——一张长有α为0.05比较前两周意味着结果2周第一剂量2周后第一个剂量(周2和−−1与周1和2),基线治疗结束(周2和−−1与周11和12)和4周后的最后剂量dupilumab(11和12周与周13和14)。根据最小临床重要差异值（MCID）对电子日记结果进行评估[4-9]。13例患者完成了12周的电子日记记录；8例患有阿司匹林加重呼吸系统疾病（AERD）， 6例为男性。平均年龄53岁，筛查时ICS的平均（SEM）剂量为1292 μg (102)， INCS的平均剂量为849 μg（131）。评估开始,基线值e-diary录音前2周第一剂量(周2−−1)相比,2周后的第一剂量dupilumab(周1和2),并发现意味着95%置信区间(95% CI)改善PNIF 21 L / min (40) p & lt; 0.05, PEF 23 L / min (44) p & lt; 0.05,脉管嗅觉减退1.0 (0.1,1.9)p & lt; 0.05,血管堵塞1.4 (0.8,2.1)p & lt; 0.001,脉管全球哮喘症状1.4 (0.8,2.0)p & lt; 0.001和集市吸入器使用1.4 (0.8,2.0) p <； 0.001个动作每天。在第一次注射dupilumab后的2周内明显的显著改善与相对早期的起效一致。滚动两天平均值说明的早期发病症状和气流改进(图1),e-diary意味着(95% CI)差异从基线到第12周(周2和−−1与周11和12)后的最后剂量dupilumab显示改善PNIF总计52 L / min (82) p & lt; 0.01(祝辞MCID 5 L / min), PEF 53 L / min (95) p & lt; 0.05(祝辞MCID 19 L / min),脉管嗅觉减退5.3 (2.9,7.7)p & lt; 0.001,血管堵塞4.3 (2.5,6.2)p & lt; 0.001,VAS总体哮喘症状3.5 (1.9,5.1)p < 0.001，均超过VAS MCID 2.3。此外，报告的MART吸入器使用减少了2.7次/天（0.3,5.0）p < 0.05。通过比较第11周和第12周与第13周和第14周，对最终剂量后4周的偏移电子日志数据进行分析，以确定停药后杜匹单抗的益处是否减弱。最后一次给药后2周和4周，气流阻塞和症状评分的平均差异无统计学意义。在12周的积极治疗期间，任何参与者都不需要口服皮质类固醇治疗。 治疗后早期的连续每日改善表明，dupilumab在治疗的前2周内开始起作用，如果在稳定状态下错过一次剂量，则没有明显的恶化。我们认为，使用智能峰值流量电子日记来测量一系列结果，可以详细评估上呼吸道和下呼吸道阻塞、症状和吸入器使用情况。这可以实现对哮喘和CRSwNP症状的虚拟监测，可以减少预约，节省患者和临床医生的时间和医院资源。我们的初步数据表明，智能峰值流量装置可能在检测未控制的哮喘和CRSwNP患者对杜匹单抗等生物制剂的早期上呼吸道和下呼吸道反应方面具有价值，这在偏远和农村地区也很有用。和C.R.K.构思了这个项目，b.l.、R.C.和K.S.担任导演。K.S.和C.R.K.收集并分析了数据。K.S.和C.R.K.准备了表格和数字。K.S.和B.L.起草了手稿。所有作者都对手稿的修改和写作做出了贡献。斯图尔特女士称没有利益冲突。郭博士报告了来自阿斯利康的个人费用，来自Chiesi的个人费用以及来自GSK的非经济支持。陈博士报告了来自阿斯利康的个人费用（讲座）和参加ERS的支持，来自Vitalograph的个人费用（咨询）和来自Thorasys的个人费用（讲座）。Lipworth博士报告了来自GSK的非财政支持（设备）；阿斯利康的补助金、个人费用（咨询、演讲和顾问委员会）、其他支持（参加ATS和ERS）；赛诺菲的个人费用（演讲和咨询），Circassia的个人费用（咨询、演讲和顾问委员会）；补助金、个人费用（咨询、演讲、顾问委员会）、Teva的其他支持（参加ERS）；来自Chiesi的个人费用（演讲和咨询），补助金和其他支持（参加ERS和BTS）；Lupin个人费用（咨询），Glenmark个人费用（咨询）；Reddy博士的个人费用（咨询）；山德士的个人费用（咨询）；勃林格殷格翰提供的补助金、个人费用（咨询、演讲、顾问委员会）、其他支持（参加BTS）；在提交的作品之外，Mylan提供的补助金和个人费用（咨询委员会和演讲）；BJL的儿子目前是阿斯利康的雇员。
{"title":"Onset and Offset of Early Dupilumab Response Using Domiciliary Monitoring in Type 2 High Unified Airway Disease","authors":"Kirsten Stewart, Chris RuiWen Kuo, Rory Chan, Brian Lipworth","doi":"10.1111/cea.14550","DOIUrl":"10.1111/cea.14550","url":null,"abstract":"<p>Few studies have prospectively looked in detail at concomitant upper and lower airway outcomes in patients with Type 2 (T2) high unified airway disease (UAD); severe asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Remote follow-up of the clinical burden of upper and lower airway disease in response to treatment, including biologics, can be challenging. There is an unmet need for a portable mobile phone-connected device which records both upper and lower airway outcomes. Useful measures of clinical improvement include assessment of airflow obstruction as peak expiratory flow (PEF) for asthma and peak nasal inspiratory flow (PNIF) for CRSwNP, visual analogue scale (VAS) symptom scores and inhaler use. We evaluated a novel hand-held device (Smart peak flow, Smart Respiratory Products Ltd, Imperial College, London, UK), which connects to android or iOS mobile phones via wireless Bluetooth or headphone jack.</p><p>Thirteen participants were prospectively assessed who completed e-diary recordings, of 21 enrolled subjects with uncontrolled T2 high UAD as part of a study where patients received open-label dupilumab 300 mg every 2 weeks [<span>1, 2</span>] for 12 weeks (EudraCT 2021-005593-25), with the primary endpoint of mannitol challenge (reported elsewhere). Patients used maintenance and reliever therapy [<span>3</span>] (MART 2–8 actuations daily) extra-fine beclometasone/formoterol 100/6 μg as their inhaled corticosteroid (ICS) along with their usual intranasal corticosteroid (INCS) and entered a 4-week run-in period. Rescue albuterol could be used beyond the maximum MART dose of 8 actuations/day. Electronic diary recordings were made in the morning, including inhaler use (actuations/day) and the best of three readings for PNIF and PEF. VAS symptom scores for hyposmia, nasal congestion and global asthma symptoms were made by selecting a point on a 0–10 electronic scale. The study had local research ethics committee approval 21/WS/0151 and all participants gave their informed consent. Participants e-diaries were assessed for 2 weeks prior to, and for 2 weeks following, the first dose of dupilumab. The e-diaries were then assessed for 4 weeks following the final dose of dupilumab. Initial repeated measures analysis of variance (ANOVA) was performed followed by pairwise Student's <i>t</i>-test with a two-tailed alpha error of 0.05 to compare the two-weekly mean results from 2 weeks prior to the first dose to 2 weeks following the first dose (Weeks −2 and −1 vs. Weeks 1 and 2), baseline to end of treatment (Weeks −2 and −1 vs. Weeks 11 and 12) and the 4 weeks following the final dose of dupilumab (Weeks 11 and 12 vs. Weeks 13 and 14). e-Diary results were assessed in relation to the minimal clinical important difference values (MCID) [<span>4-9</span>].</p><p>Thirteen patients completed 12 weeks of e-diary recordings; eight had aspirin exacerbated respiratory disease (AERD) and six were males. The mean age was 53 years, mean (SEM) I","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 12","pages":"1010-1012"},"PeriodicalIF":6.3,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marta Alexandra Martins Ferreira, Adalberto Fernandes dos Santos, Bernardo Sousa-Pinto, Luís Taborda-Barata
<div> <section> <h3> Objective</h3> <p>Digital interventions such as remote monitoring of symptoms and physiological measurements have the potential to reduce the economic burden of asthma and chronic obstructive pulmonary disease (COPD) but their cost-effectiveness remains unclear. This systematic review of randomised controlled trials (RCT) aims to assess whether digital health interventions can be cost-effective in these patients.</p> </section> <section> <h3> Design</h3> <p>Systematic review of RCTs. Study quality was assessed using RoB2 tool.</p> </section> <section> <h3> Data Sources</h3> <p>Systematic search in three databases: PubMed, Scopus and Web of Science.</p> </section> <section> <h3> Eligibility Criteria</h3> <p>Studies were eligible if they were RCTs with health economic evaluations assessing participants with asthma and/or COPD and comparing a digital health intervention to standard of care.</p> </section> <section> <h3> Results</h3> <p>We included 35 RCTs, of which 21 were related to COPD, 13 to asthma and one to both diseases. Overall, studies assessed four categories of digital health interventions: (i) Electronic patient diaries (<i>n</i> = 4), (ii) real-time monitoring (<i>n</i> = 19), (iii) teleconsultations (<i>n</i> = 6) and (iv) others (<i>n</i> = 6). Eleven studies performed a full economic evaluation analysis, while 24 studies performed a partial economic analysis. Most studies involving real-time monitoring or teleconsultations presented economic results in favour of digital health interventions (indicating them to be cost-effective or less expensive than the standard of care). Mixed results were obtained for electronic patient diaries. In the studies that conducted a full economic analysis, the incremental cost-effectiveness ratio (ICER) ranged from 3530,93€/QALY and 286,369,28€/QALY. In the studies that conducted a partial economic analysis, the cost differences between the intervention group and the control group ranged from 0,12€ and 85,217,86€. Half studies with low risk of bias concluded that the intervention was economically favourable.</p> </section> <section> <h3> Conclusion</h3> <p>Although costs varied based on intervention type, follow-up period and country, most studies report digital health interventions to be affordable or associated with decreased costs.</p> </section> <section> <h3> Trial Registration</h3> <p>PROSPERO: CRD42023439195</p>
{"title":"Cost-Effectiveness of Digital Health Interventions for Asthma or COPD: Systematic Review","authors":"Marta Alexandra Martins Ferreira, Adalberto Fernandes dos Santos, Bernardo Sousa-Pinto, Luís Taborda-Barata","doi":"10.1111/cea.14547","DOIUrl":"10.1111/cea.14547","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Digital interventions such as remote monitoring of symptoms and physiological measurements have the potential to reduce the economic burden of asthma and chronic obstructive pulmonary disease (COPD) but their cost-effectiveness remains unclear. This systematic review of randomised controlled trials (RCT) aims to assess whether digital health interventions can be cost-effective in these patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Systematic review of RCTs. Study quality was assessed using RoB2 tool.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data Sources</h3>\u0000 \u0000 <p>Systematic search in three databases: PubMed, Scopus and Web of Science.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Eligibility Criteria</h3>\u0000 \u0000 <p>Studies were eligible if they were RCTs with health economic evaluations assessing participants with asthma and/or COPD and comparing a digital health intervention to standard of care.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We included 35 RCTs, of which 21 were related to COPD, 13 to asthma and one to both diseases. Overall, studies assessed four categories of digital health interventions: (i) Electronic patient diaries (<i>n</i> = 4), (ii) real-time monitoring (<i>n</i> = 19), (iii) teleconsultations (<i>n</i> = 6) and (iv) others (<i>n</i> = 6). Eleven studies performed a full economic evaluation analysis, while 24 studies performed a partial economic analysis. Most studies involving real-time monitoring or teleconsultations presented economic results in favour of digital health interventions (indicating them to be cost-effective or less expensive than the standard of care). Mixed results were obtained for electronic patient diaries. In the studies that conducted a full economic analysis, the incremental cost-effectiveness ratio (ICER) ranged from 3530,93€/QALY and 286,369,28€/QALY. In the studies that conducted a partial economic analysis, the cost differences between the intervention group and the control group ranged from 0,12€ and 85,217,86€. Half studies with low risk of bias concluded that the intervention was economically favourable.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Although costs varied based on intervention type, follow-up period and country, most studies report digital health interventions to be affordable or associated with decreased costs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>PROSPERO: CRD42023439195</p>\u0000 ","PeriodicalId":10207,"journal":{"name":"Clinical and Experimental Allergy","volume":"54 9","pages":"651-668"},"PeriodicalIF":6.3,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号