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Addressing global health disparities in the management of RSV infection in infants and children: Strategies for preventing bronchiolitis and post-bronchiolitis recurrent wheezing. 解决全球婴幼儿 RSV 感染管理中的健康差异:预防支气管炎和支气管炎后反复喘息的策略。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230089
Giuliana Ferrante, Giorgio Piacentini, Michele Piazza, Attilio L Boner, Joseph A Bellanti

Background: The topic of equitable access to health care and its impact on exacerbating worldwide inequities in child health not only strikes at the heart of our health-care delivery systems but also deeply resonates with our collective social consciences. Nowhere is this better seen on a global scale than in the burden of illness caused by respiratory syncytial virus (RSV) infection, which extracts the most severe morbidity and mortality in infants and children in low- and middle-income countries (LMIC). This report addresses global health disparities that exist in the management of RSV infection in infants and children, and offers strategies for preventing bronchiolitis and postbronchiolitis recurrent wheezing in LMICs. Methods: A systematic literature review was conducted across the PubMed data bases of RSV infection and the socioeconomic impact of bronchiolitis and postbronchiolitis recurrent wheezing in LMICs. Results: The results of the present study address the many issues that deal with the question if prevention of RSV bronchiolitis can mitigate recurrent wheezing episodes and links RSV risks, downstream effects, prevention, malnutrition, and socioeconomic restraints of developing countries with a call for possible global action. Conclusion: The present study stresses the importance of considering the linkage between malnutrition and disease susceptibility because of the known relationships between undernutrition and greater vulnerability to infectious diseases, including RSV infection. These complex interactions between infectious disease and undernutrition also raise issues on the longer-term sequelae of postbronchiolitis recurrent wheezing. This prompts a discussion on whether industrialized countries should prioritize the provision of newly developed monoclonal antibodies and RSV vaccines to LMICs or whether vital nutritional needs should be a first focus. The resolution of these issues will require research and greater international discourse.

背景:公平获得医疗保健服务及其对加剧世界范围内儿童健康不平等的影响,不仅是我们医疗保健服务体系的核心问题,也是我们社会集体良知的深刻共鸣。在全球范围内,呼吸道合胞病毒(RSV)感染造成的疾病负担最能体现这一点,RSV 在中低收入国家(LMIC)的婴幼儿中造成了最严重的发病率和死亡率。本报告探讨了全球在管理婴幼儿 RSV 感染方面存在的健康差异,并提出了在中低收入国家预防支气管炎和支气管炎后反复喘息的策略。方法:在 PubMed 数据库中就 RSV 感染以及支气管炎和支气管炎后反复喘息对低收入国家的社会经济影响进行了系统性文献综述。研究结果本研究的结果探讨了预防 RSV 支气管炎能否减轻反复喘息发作的诸多问题,并将 RSV 风险、下游影响、预防、营养不良和发展中国家的社会经济限制联系起来,呼吁采取可能的全球行动。结论:本研究强调了考虑营养不良与疾病易感性之间联系的重要性,因为营养不良与更易感染传染病(包括 RSV 感染)之间存在已知的关系。传染病与营养不良之间复杂的相互作用还引发了小儿支气管炎后反复喘息的长期后遗症问题。这促使人们讨论工业化国家是否应优先向低收入和中等收入国家提供新开发的单克隆抗体和 RSV 疫苗,还是应首先关注重要的营养需求。这些问题的解决需要研究和更多的国际讨论。
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引用次数: 0
For the Patient. 给病人
IF 2.8 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.240004
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引用次数: 0
Assessing severity of COVID-19 and the development of multi system inflammatory syndrome in children (MIS-C) in pediatric patients with atopic disease. 评估 COVID-19 的严重程度和儿童特应性疾病患者多系统炎症综合征 (MIS-C) 的发展情况。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230087
Natalie E Rudsenske, Jessica B Perkins

Background: Research surrounding the coronavirus disease 2019 (COVID-19) pandemic and its impact on patients who are atopic has mainly focused on adults. After the delta variant showed increased rates of COVID-19 in children, the pediatric population needs to be assessed as well. Objective: The objective was to assess and report outcomes in patients with COVID-19 and with and without certain atopic diseases in our patient cohort at the University of Mississippi Medical Center. Methods: We conducted a retrospective review of patients by using a de-identified data base that allows querying via medical claims codes from the University of Mississippi Medical Center's Research Data Warehouse. We searched for patients who were COVID-19 positive and ages 0-21 years from January 1, 2020, to December 31, 2021. We then divided this population into two cohorts: an atopic population and a non-atopic population. The incidence of hospitalizations, intensive care unit (ICU) admissions, death, length of stay, inhaled corticosteroid prescription history, and the incidence of multi-system inflammatory syndrome in children (MIS-C) outcomes in the two populations were collected. Results: There were 5261 patients ages 0-21 years and with confirmed COVID-19. After exclusion criteria were applied, there were 1420 patients in the atopic cohort and 2525 patients in the non-atopic cohort. There were more hospitalizations and a longer length of stay in the atopic population. Mortality was equivalent in the atopic and non-atopic populations. There were more ICU admissions in the atopic population. There were 101 patients total with the diagnosis of MIS-C, and the incidence of MIS-C was similar in the atopic and non-atopic populations. There were more patients who were atopic on inhaled corticosteroid than were the patients who were non-atopic. Conclusion: This study sought to further elucidate whether asthma, atopic dermatitis, and allergic rhinitis in pediatric patients was associated with severe COVID-19. Our study showed increased hospitalizations, length of stay, and intensive care in the atopic population but similar outcomes in mortality and the development of MIS-C. Future longitudinal prospective studies are needed to assess the long-term effects on patient's atopic disease after COVID-19 infection.

背景:围绕冠状病毒病 2019(COVID-19)大流行及其对特应性患者影响的研究主要集中在成人身上。在 delta 变体显示儿童 COVID-19 感染率增加后,也需要对儿童群体进行评估。目标:目的是评估和报告密西西比大学医学中心患者队列中 COVID-19 患者以及患有和不患有某些特应性疾病的患者的治疗效果。方法: 我们对密西西比大学医学中心的患者群进行了回顾性研究:我们使用密西西比大学医学中心研究数据仓库的一个去标识化数据库对患者进行了回顾性审查,该数据库允许通过医疗索赔代码进行查询。我们搜索了 2020 年 1 月 1 日至 2021 年 12 月 31 日期间 COVID-19 阳性且年龄为 0-21 岁的患者。然后,我们将这一人群分为两个队列:特应性人群和非特应性人群。我们收集了两个人群的住院率、重症监护室(ICU)入院率、死亡人数、住院时间、吸入性皮质类固醇处方史以及儿童多系统炎症综合征(MIS-C)的发病率。研究结果共有5261名年龄在0-21岁之间、确诊为COVID-19的患者。采用排除标准后,特应性人群中有 1420 名患者,非特应性人群中有 2525 名患者。特应性人群的住院次数更多,住院时间更长。特应性人群和非特应性人群的死亡率相当。特应性人群入住重症监护室的人数更多。共有 101 名患者被诊断为 MIS-C,特应性人群和非特应性人群的 MIS-C 发生率相似。吸入皮质类固醇的特应性患者多于非特应性患者。结论本研究旨在进一步阐明儿童患者中的哮喘、特应性皮炎和过敏性鼻炎是否与严重的 COVID-19 有关。我们的研究结果表明,特应性人群的住院时间、住院时间和重症监护时间均有所增加,但死亡率和 MIS-C 的发展结果相似。未来需要进行纵向前瞻性研究,以评估 COVID-19 感染后对特应性疾病患者的长期影响。
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引用次数: 0
Total IgE as a biomarker of omalizumab response in chronic spontaneous urticaria: A meta-analysis. 总 IgE 作为慢性自发性荨麻疹患者对奥马珠单抗反应的生物标记物:一项荟萃分析。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230092
Levi Keller, Ekta K Perera, Brittany Bindon, Aastha Khatiwada, Jenny M Stitt, Stephen C Dreskin

Background: Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) that is refractory to antihistamines. Total immunoglobulin E (IgE) levels have emerged as a possible biomarker to predict response to omalizumab. However, the existing literature is heterogenous, with conflicting conclusions with regard to the role of total IgE levels. Objective: We sought to clarify the role of evaluating total IgE levels in patients with CSU by performing a meta-analysis on the existing literature to determine if meaningful changes exist between responders and nonresponders to omalizumab. Methods: A total of 68 unique citations were returned and screened by two independent reviewers. Editorials, reviews, and case reports were excluded, and a total of 33 original articles were identified and underwent secondary evaluation. Studies that present mean ± standard deviation total IgE levels and/or 95% confidence intervals (CI) were included, whereas studies with < 25 subjects were excluded. Three studies ultimately met these criteria. Results: We found a mean difference in total IgE levels between those who responded to omalizumab versus those without a response of 49.76 (95% CI, 7.13-92.38; p = 0.02), which demonstrated higher mean IgE values in responders compared with nonresponders. Conclusion: This study presents additional evidence that supports evaluation of total IgE levels as it pertains to response to omalizumab therapy in CSU. When considering the current evidence, it seems reasonable to consider the baseline total IgE level as a biomarker to predict the treatment response to omalizumab. Based on the existing literature, we cannot conclude at what threshold nonresponse is more likely to occur.

背景介绍奥马珠单抗被批准用于治疗抗组胺药难治的慢性自发性荨麻疹(CSU)。总免疫球蛋白E(IgE)水平已成为预测对奥马珠单抗反应的可能生物标志物。然而,现有文献各不相同,关于总 IgE 水平的作用的结论也相互矛盾。我们的目标是我们试图通过对现有文献进行荟萃分析,明确评估总 IgE 水平在 CSU 患者中的作用,以确定奥马珠单抗应答者和非应答者之间是否存在有意义的变化。方法:共检索到 68 篇引文,并由两名独立审稿人进行了筛选。排除了社论、综述和病例报告,共确定了 33 篇原创文章并进行了二次评估。纳入了提供总 IgE 水平平均值 ± 标准偏差和/或 95% 置信区间 (CI) 的研究,但排除了受试者少于 25 人的研究。最终有三项研究符合上述标准。研究结果我们发现,奥马珠单抗应答者与无应答者的总 IgE 水平的平均差异为 49.76 (95% CI, 7.13-92.38; p = 0.02),这表明应答者的平均 IgE 值高于无应答者。结论本研究提供了更多证据,支持评估总 IgE 水平,因为它与 CSU 对奥马珠单抗治疗的反应有关。考虑到现有证据,将基线总 IgE 水平视为预测奥马珠单抗治疗反应的生物标志物似乎是合理的。根据现有的文献,我们无法断定在什么阈值时更有可能出现无应答。
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引用次数: 0
Impact of steroids on the immune profiles of children with asthma living in the inner-city. 类固醇对生活在市内的哮喘儿童免疫特征的影响。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230090
Aishwarya Navalpakam, Narin Thanaputkaiporn, Crystal Aijja, Wimwipa Mongkonsritragoon, Ahmad Farooqi, Jenny Huang, Pavadee Poowuttikul

Background: Inner-city asthma is associated with high morbidity and systemic steroid use. Chronic steroid use impacts immune function; however, there is a lack of data with regard to the extent of immunosuppression in patients with asthma and who are receiving frequent systemic steroids. Objective: To identify the impact of frequent systemic steroid bursts on the immune function of children with asthma who live in the inner city. Methods: Children ages 3-18 years with asthma were divided into study (≥2 systemic steroid bursts/year) and control groups (0-1 systemic steroid bursts/year). Lymphocyte subsets; mitogen proliferation assay; total immunoglobulin G (IgG) value, and pneumococcal and diphtheria/tetanus IgG values were evaluated. Results: Ninety-one participants were enrolled (study group [n = 42] and control group [n = 49]). There was no difference in adequate pneumococcal IgG value, diphtheria/tetanus IgG value, mitogen proliferation assays, lymphocyte subsets, and IgG values between the two groups. Children who received ≥2 steroid bursts/year had a significantly lower median pneumococcal IgG serotype 7F value. Most of the immune laboratory results were normal except for the pneumococcal IgG value. Most of the participants (n/N = 72/91 [79%]) had an inadequate pneumococcal IgG level (<7/14 serotypes ≥1.3 µg/mL). The participants with inadequate pneumococcal IgG level and who received a pneumococcal polysaccharide vaccine 23 (PPSV23) boost had a robust response. There was no significant difference in infection, steroid exposure, asthma severity, or morbidities between those with adequate versus inadequate pneumococcal IgG values. Conclusion: Children with asthma who live in the inner city and receive ≥2 steroid bursts/year do not have a significantly different immune profile from those who receive ≤1 steroid bursts/year do not have a significantly different immune profile from those who do not. Although appropriately vaccinated, most participants had an inadequate pneumococcal IgG level, regardless of steroid exposure and asthma severity. These children may benefit from PPSV23.

背景:城市内的哮喘与高发病率和全身使用类固醇有关。长期使用类固醇会影响免疫功能;然而,关于经常接受全身性类固醇治疗的哮喘患者的免疫抑制程度,目前还缺乏相关数据。研究目的确定频繁使用全身类固醇对居住在内城的哮喘儿童免疫功能的影响。方法:对 3-18 岁的哮喘儿童进行研究:将 3-18 岁的哮喘儿童分为研究组(≥2 次全身性类固醇注射/年)和对照组(0-1 次全身性类固醇注射/年)。对淋巴细胞亚群、有丝分裂原增殖试验、免疫球蛋白 G (IgG) 总值、肺炎球菌和白喉/破伤风 IgG 值进行了评估。结果91 名参与者参加了研究(研究组 [n = 42] 和对照组 [n = 49])。两组儿童在足够的肺炎球菌 IgG 值、白喉/破伤风 IgG 值、有丝分裂原增殖试验、淋巴细胞亚群和 IgG 值方面没有差异。每年接受≥2次类固醇注射的儿童的肺炎球菌IgG血清型7F中位值明显较低。除肺炎球菌 IgG 值外,大多数免疫实验室结果均正常。大多数参与者(n/N = 72/91 [79%])的肺炎球菌 IgG 水平不足(结论:生活在内城且每年接受≥2次类固醇注射的哮喘儿童与每年接受≤1次类固醇注射的儿童的免疫状况没有明显差异。虽然已适当接种疫苗,但大多数参与者的肺炎球菌 IgG 水平不足,与类固醇暴露和哮喘严重程度无关。这些儿童可能会从 PPSV23 中受益。
{"title":"Impact of steroids on the immune profiles of children with asthma living in the inner-city.","authors":"Aishwarya Navalpakam, Narin Thanaputkaiporn, Crystal Aijja, Wimwipa Mongkonsritragoon, Ahmad Farooqi, Jenny Huang, Pavadee Poowuttikul","doi":"10.2500/aap.2024.45.230090","DOIUrl":"10.2500/aap.2024.45.230090","url":null,"abstract":"<p><p><b>Background:</b> Inner-city asthma is associated with high morbidity and systemic steroid use. Chronic steroid use impacts immune function; however, there is a lack of data with regard to the extent of immunosuppression in patients with asthma and who are receiving frequent systemic steroids. <b>Objective:</b> To identify the impact of frequent systemic steroid bursts on the immune function of children with asthma who live in the inner city. <b>Methods:</b> Children ages 3-18 years with asthma were divided into study (≥2 systemic steroid bursts/year) and control groups (0-1 systemic steroid bursts/year). Lymphocyte subsets; mitogen proliferation assay; total immunoglobulin G (IgG) value, and pneumococcal and diphtheria/tetanus IgG values were evaluated. <b>Results:</b> Ninety-one participants were enrolled (study group [n = 42] and control group [n = 49]). There was no difference in adequate pneumococcal IgG value, diphtheria/tetanus IgG value, mitogen proliferation assays, lymphocyte subsets, and IgG values between the two groups. Children who received ≥2 steroid bursts/year had a significantly lower median pneumococcal IgG serotype 7F value. Most of the immune laboratory results were normal except for the pneumococcal IgG value. Most of the participants (n/N = 72/91 [79%]) had an inadequate pneumococcal IgG level (<7/14 serotypes ≥1.3 µg/mL). The participants with inadequate pneumococcal IgG level and who received a pneumococcal polysaccharide vaccine 23 (PPSV23) boost had a robust response. There was no significant difference in infection, steroid exposure, asthma severity, or morbidities between those with adequate versus inadequate pneumococcal IgG values. <b>Conclusion:</b> Children with asthma who live in the inner city and receive ≥2 steroid bursts/year do not have a significantly different immune profile from those who receive ≤1 steroid bursts/year do not have a significantly different immune profile from those who do not. Although appropriately vaccinated, most participants had an inadequate pneumococcal IgG level, regardless of steroid exposure and asthma severity. These children may benefit from PPSV23.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"45 2","pages":"100-107"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140048562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
For the Patient. 给病人
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.240004
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引用次数: 0
Oral immunotherapy with sunflower seed butter and a review of seed allergy. 葵花籽油口服免疫疗法和种子过敏综述。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230091
Carolyn H Baloh, Joyce T Hsu

Food allergy to seeds is increasingly more common, with sesame being the most prevalent. Allergy to other seeds, including sunflower, pumpkin, poppy, mustard, and flaxseed, have been reported. Diagnosing a seed allergy is challenging, with many seeds being hidden additives in processed foods and cross-reactive testing. Food labels in the United States are now required to indicate the presence of sesame but other seeds are not required. Oral immunotherapy (OIT) protocols for peanut, milk, and egg are clinically being extrapolated to other foods, including sesame and sunflower seed. This article highlights a case of a patient in whom sunflower seed OIT was administered in a clinical setting.

对种子的食物过敏越来越常见,其中以芝麻最为普遍。对其他种子(包括葵花籽、南瓜籽、罂粟籽、芥末籽和亚麻籽)过敏的报道也时有发生。由于许多种子都是加工食品中的隐性添加剂,并且存在交叉反应测试,因此诊断种子过敏具有挑战性。美国现在要求食品标签标明芝麻的存在,但不要求标明其他种子。在临床上,针对花生、牛奶和鸡蛋的口服免疫疗法(OIT)方案被推广到其他食物,包括芝麻和葵花籽。本文重点介绍一例在临床环境中接受葵花籽口服免疫疗法的患者。
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引用次数: 0
The relationship between childhood atopic dermatitis and asthma in an under resourced community. 一个资源匮乏社区的儿童特应性皮炎与哮喘之间的关系。
IF 2.6 3区 医学 Q2 ALLERGY Pub Date : 2024-03-01 DOI: 10.2500/aap.2024.45.230093
Jonathan A Bernstein, Larry J Wymer, Michael Nye, Stephen J Vesper

Background: Atopic dermatitis (AD) is an inflammatory skin disease caused by allergen exposures and estimated to affect ∼20% of children. Children in urban areas have a higher prevalence of AD compared with those living outside of urban areas. AD is believed to lead to asthma development as part of the "atopic march." Objective: Our objective was to determine the sequential and chronological relationships between AD and asthma for children in an under-resourced community. Methods: The progression from AD to asthma in the under-resourced, urban community of Sun Valley, Colorado, was examined by assessing Medicaid data for the years 2016 to 2019 for a diagnosis of AD or asthma in children 6 and 7 years old. Results: Pearson correlations between AD and asthma diagnoses were significant only with respect to AD at age 6 years compared with asthma 1 year later, at age 7 years. Conclusion: By studying a susceptible community with a consistent but mixed genetic background, we found sequential and chronological links between AD and asthma.

背景:特应性皮炎(AD)是一种因接触过敏原而引起的炎症性皮肤病,估计有 20% 的儿童受到影响。与居住在城市以外地区的儿童相比,城市儿童的特应性皮炎发病率更高。AD 被认为会导致哮喘的发生,是 "特应性进展 "的一部分。目的:我们的目的是确定一个资源匮乏社区中儿童的 AD 与哮喘之间的先后关系。方法在科罗拉多州太阳谷这个资源匮乏的城市社区,我们通过评估 2016 年至 2019 年医疗补助(Medicaid)数据,对 6 岁和 7 岁儿童的 AD 或哮喘诊断进行了研究,以了解 AD 向哮喘发展的过程。研究结果只有 6 岁时的注意力缺失症与 1 年后 7 岁时的哮喘相比,注意力缺失症与哮喘诊断之间的皮尔逊相关性才显著。结论通过研究一个具有一致但混合遗传背景的易感群体,我们发现注意力缺失症和哮喘之间存在顺序和时间上的联系。
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引用次数: 0
Real-world reporting rates of administration-site reactions with on-demand treatment of hereditary angioedema attacks. 按需治疗遗传性血管性水肿发作的给药部位反应的真实世界报告率。
IF 2.8 3区 医学 Q2 ALLERGY Pub Date : 2024-01-22 Epub Date: 2023-11-22 DOI: 10.2500/aap.2024.45.230073
Raffi Tachdjian, Sinisa Savic, Moshe Fridman, Joao P Frade, Marie Fasehun, Paul K Audhya

Background: Hereditary angioedema (HAE) is characterized by recurrent and unpredictable episodes of subcutaneous and/or submucosal swelling. Objective: To characterize the real-world treatment burden associated with existing on-demand therapies, we analyzed administration-site adverse drug reactions (ADR) associated with approved on-demand HAE therapies reported in the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Methods: We searched the FAERS database from October 1, 2009, to March 31, 2022, for reports of all FDA-approved on-demand therapies for HAE: plasma-derived C1-inhibitor (pdC1-INH), ecallantide, icatibant, and recombinant C1-inhibitor (rhC1-INH). ADRs in which the drug was listed as the "primary suspect" were recorded for each drug. ADR preferred terms were grouped into 18 ADR domains based on semantic and/or clinical similarity, and the number of reports for each drug was calculated per year from the time of approval through March 2022, and descriptive results were presented. Preferred terms associated with administration-site ADRs identified from clinical trials and denoted on approved HAE drug U.S. package inserts were examined in a complementary analysis. Results: The highest reported rates of administration-site ADRs per year were site pain (17.9 reports per year), site erythema (7.4 per year), and site swelling (6.7 per year). RhC1-INH was the only drug for which access-site complications and/or malfunctions were reported (9.5 per year). PdC1-INH had the highest rate of incorrect route of product administration (3.7 per year). PdC1-INH showed statistically significant elevated reporting rate of injection-site reactions (reporting odds ratio [ROR] 3.59 [2.36-5.46]; empirical Bayesian geometric mean [EBGM] 1.97 [1.39]). Icatibant and rhC1-INH showed a statistical trend toward an increased reporting rate of administration-site reactions. Conclusion: Real-world data from FAERS were generally consistent with adverse events reported in clinical trials and suggest that patients experience substantial treatment burden associated with FDA-approved parenteral on-demand therapies for HAE attacks. It should be noted that ADR rates are not exposure adjusted and are based on spontaneous reporting.

背景:遗传性血管性水肿(HAE)以反复发作和不可预测的皮下和/或粘膜下肿胀为特征。目的:为了描述与现有按需治疗相关的现实世界治疗负担,我们分析了美国食品和药物管理局(FDA)不良事件报告系统(FAERS)中报告的与已批准的HAE按需治疗相关的给药部位药物不良反应(ADR)。方法:从2009年10月1日至2022年3月31日,我们检索了FAERS数据库中所有fda批准的HAE按需治疗的报告:血浆源性c1抑制剂(pdC1-INH)、ecallantide、icatibant和重组c1抑制剂(rhC1-INH)。将药物列为“主要嫌疑”的药物的不良反应记录下来。根据语义和/或临床相似性将ADR首选术语分为18个ADR域,从批准之日起至2022年3月,每年计算每种药物的报告数量,并给出描述性结果。在一项补充分析中,研究人员检查了与临床试验中发现的给药部位不良反应相关的首选术语,并在已批准的HAE药物美国说明书上标注。结果:每年报告的给药部位不良反应发生率最高的是部位疼痛(每年17.9例)、部位红斑(每年7.4例)和部位肿胀(每年6.7例)。RhC1-INH是唯一报告通路部位并发症和/或功能障碍的药物(每年9.5例)。PdC1-INH的给药途径错误率最高(3.7 /年)。PdC1-INH组注射部位反应报告率升高有统计学意义(报告优势比[ROR] 3.59 [2.36-5.46];经验贝叶斯几何平均[EBGM] 1.97[1.39])。伊卡替班和rhC1-INH的给药部位反应报告率呈统计学上升趋势。结论:来自FAERS的真实数据与临床试验中报告的不良事件基本一致,表明患者经历了与fda批准的针对HAE发作的静脉外按需治疗相关的巨大治疗负担。值得注意的是,不良反应发生率不是根据暴露情况调整的,而是基于自发报告。
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引用次数: 0
Unraveling allergic, pseudoallergic, and idiosyncratic complexities of hypersensitivity reactions to NSAIDs. 解开非甾体抗炎药过敏反应的过敏性、假过敏性和特异性复杂性。
IF 2.8 3区 医学 Q2 ALLERGY Pub Date : 2024-01-01 DOI: 10.2500/aap.2024.45.230086
Joseph A Bellanti, Russell A Settipane
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引用次数: 0
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