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Vascular endothelial growth factor (VEGF) emerging as a mediator of hereditary angioedema (HAE) 血管内皮生长因子(VEGF)成为遗传性血管性水肿(HAE)的介质
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100942
Pedro Giavina-Bianchi MD, PhD , Marcelo Vivolo Aun MD, PhD , Jorge Kalil MD, PhD
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引用次数: 0
Thank You to Our 2023 Reviewers 感谢我们的 2023 评论员
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100945
Alessandro Fiocchi MD, Mona Al-Ahmad MD
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引用次数: 0
Penicillin allergy de-labeling: Adaptation of risk stratification tool for patients and families 青霉素过敏去标签:为患者和家属调整风险分层工具
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100939
Simonne L. Horwitz MD, JD, MBA , Ye Shen MPH , Stephanie C. Erdle MD, FRCPC , Chelsea Elwood BMScH, MSc, MD, FRCSC , Raymond Mak MD, FRCPC , John Jacob PhD, MSc, MBA , Tiffany Wong MD, FRCPC

Penicillin allergy is reported in 10% of the population; however, over 90% of patients are deemed non-allergic upon allergist assessment. The goal of this quality improvement project is to validate a patient-driven assessment tool to safely identify patients at low risk of penicillin allergy and de-label them. Pediatric patients and pregnant women referred to the institution's allergy clinics for penicillin allergy assessment were invited to use the patient tool to complete a self-assessment, resulting in the assignment of a risk category. The risk stratification determined using the patient tool was compared against the allergist's assessment.

The patient tool demonstrated agreement with the allergist assessment in 57/84 (67.9%, 95% CI [56.7%,77.4%]) assessments, intra-class correlation (ICC) = 0.618, p < 0.001. In 22/84 (26.2%) assessments, the patient tool determined a higher risk category, primarily due to differences in patients’ perceived timing and description of symptoms. Only 5/84 (6.0%) patients were placed in a lower risk category by the patient tool compared to the allergist assessment. The patient tool demonstrates good validity in determining penicillin allergy risk, offering potential as a method of empowering patients to advocate in their care. Iterative changes to the patient tool will be applied to increase agreement.

据报告,10% 的人群对青霉素过敏;然而,超过 90% 的患者经过敏专科医生评估后被认为不过敏。本质量改进项目的目标是验证一种以患者为导向的评估工具,以安全地识别青霉素过敏的低风险患者,并取消对他们的标记。该机构邀请转诊到过敏门诊进行青霉素过敏评估的儿科患者和孕妇使用患者工具完成自我评估,从而确定风险类别。在 57/84 次(67.9%,95% CI [56.7%,77.4%])评估中,患者工具与过敏专科医生的评估结果一致,类内相关性 (ICC) = 0.618,p < 0.001。在 22/84 次(26.2%)评估中,患者工具确定了较高的风险类别,这主要是由于患者感知的时间和症状描述存在差异。与过敏专科医生的评估结果相比,只有 5/84 例(6.0%)患者的患者工具确定的风险类别较低。患者工具在确定青霉素过敏风险方面显示出良好的有效性,可作为一种增强患者能力的方法,让患者在护理过程中发挥倡导作用。将对患者工具进行反复修改,以提高一致性。
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引用次数: 0
Profiling severe asthma: Any relevance for age? An analysis from Severe Asthma Network Italy (SANI) cohort 分析严重哮喘:与年龄有关吗?意大利重症哮喘网络 (SANI) 队列分析
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100941
Marco Caminati MD , Alessandro Marcon PhD , Rachele Vaia MD , Gianenrico Senna MD , Matteo Maule MD , Pierpaolo Marchetti MD , Jessica Miotti MD , Giuseppe Argentino MD , Francesco Blasi MD, PhD , Giorgio W. Canonica MD , Enrico M. Heffler MD, PhD , Pierluigi Paggiaro MD , Andrea Vianello MD, PhD , Gabriella Guarnieri MD

Background

Aging implies changes in terms of lung function, immune system, and respiratory and extra-respiratory comorbidities. Few studies have specifically addressed the relevance of age on severe asthma burden and control. We aimed to evaluate whether age acts as an independent determinant of asthma severity, in terms of clinical, functional, and inflammatory profile, and to explore potential cofactors that contribute to a more difficult disease control in different age groups.

Methods

Patients from Severe Asthma Network Italy (SANI) registry were retrospectively divided in subgroups according to their age. Cutoffs for age were established according to quartiles in order to obtain a comparable number of patients for each group, and then rounded for the sake of simplicity.

Results

Overall, 1805 severe asthma patients were analyzed. Lung function represented the most important age-related variable. On the opposite the level of asthma control was not differently distributed among age ranges. In young people the presence of atopy-related comorbidities (allergic rhinitis, atopic dermatitis) predominated, whilst systemic-metabolic and degenerative comorbidities such as diabetes, cardiovascular diseases, anxious-depressive syndrome, and osteoporosis prevailed in elderly. Bronchiectasis and sleep disturbances were significantly associated with age.

Conclusions

Despite that it cannot be considered a treatable trait, our study suggests that age should be evaluated within a personalized approach to severe asthma patients, in order to provide a better clinical profiling and a more tailored treatment strategy.

背景衰老意味着肺功能、免疫系统、呼吸系统和呼吸系统外合并症的变化。很少有研究专门探讨年龄与严重哮喘负担和控制的相关性。我们旨在从临床、功能和炎症特征等方面评估年龄是否是哮喘严重程度的独立决定因素,并探索导致不同年龄组患者病情更难控制的潜在辅助因素。为了使每组患者的人数具有可比性,根据四分位数确定了年龄分界线,然后为了简单起见进行了四舍五入。肺功能是最重要的年龄相关变量。相反,不同年龄段的哮喘控制水平并无差异。在年轻人中,与哮喘相关的合并症(过敏性鼻炎、特应性皮炎)占多数,而在老年人中,全身代谢性和退行性合并症(如糖尿病、心血管疾病、焦虑抑郁综合征和骨质疏松症)占多数。结论尽管年龄不能被视为一种可治疗的特征,但我们的研究表明,在对重症哮喘患者进行个性化治疗时,应评估患者的年龄,以便提供更好的临床特征和更有针对性的治疗策略。
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引用次数: 0
Genetic prediction of asthma increases multiple sepsis risks: A Mendelian randomization study 哮喘基因预测会增加多种败血症风险:孟德尔随机研究
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100937
Jihang Luo MD , Puyu Liu MD , Yawen Luo MD

Background

Observational epidemiological studies have indicated a potential association between asthma and sepsis, although the causal relationship between these 2 conditions remains uncertain. To further investigate this relationship, the present study utilized Mendelian randomization (MR) analysis approach to explore the potential links between asthma and various types of sepsis.

Methods

In a large-scale genome-wide association study, single nucleotide polymorphisms (SNPs) associated with asthma were selected as instrumental variables. Three methods, including inverse-variance weighted (IVW), MR-Egger regression, and weighted median were used to assess the causal relationship between asthma and sepsis. The odds ratio (OR) and 95% confidence interval (CI) were used as the evaluation metrics for causal relationships, and sensitivity analysis was conducted to assess pleiotropy and instrument validity. Finally, a reverse MR analysis was conducted to investigate whether there is a causal relationship between sepsis and asthma.

Results

We found a positive association between asthma and an increased risk of sepsis (OR=1.18, P<0.05), streptococcal sepsis (OR=1.23, P=0.04), pneumonia-related sepsis (OR=1.57, P<0.05), pneumococcal sepsis (OR=1.58, P=0.01), other sepsis (OR=1.15, P<0.05), and sepsis in intensive care unit (ICU) settings (OR=1.23, P=0.02). Sensitivity analysis showed consistent results without heterogeneity or pleiotropy. The reverse MR analysis reveals no causal relationship between various types of sepsis and asthma.

Conclusion

Our study demonstrates a causal relationship between asthma and different types of sepsis. These findings suggest the importance of healthcare providers paying attention to the potential risk of sepsis in asthma patients and implementing appropriate preventive and intervention measures in a timely manner.

背景观察性流行病学研究表明,哮喘与败血症之间存在潜在联系,但这两种疾病之间的因果关系仍不确定。方法在一项大规模的全基因组关联研究中,选择了与哮喘相关的单核苷酸多态性(SNPs)作为工具变量。采用逆方差加权(IVW)、MR-Egger回归和加权中位数等三种方法评估哮喘与败血症之间的因果关系。赔率(OR)和 95% 置信区间(CI)被用作因果关系的评估指标,并进行了敏感性分析以评估多义性和工具有效性。结果我们发现哮喘与败血症风险增加之间存在正相关(OR=1.18,P<0.05)、链球菌败血症(OR=1.23,P=0.04)、肺炎相关败血症(OR=1.57,P<0.05)、肺炎球菌败血症(OR=1.58,P=0.01)、其他败血症(OR=1.15,P<0.05)以及重症监护病房(ICU)中的败血症(OR=1.23,P=0.02)之间存在正相关。敏感性分析表明结果一致,没有异质性或多重性。反向 MR 分析显示,各种类型的败血症与哮喘之间没有因果关系。这些研究结果表明,医护人员必须关注哮喘患者发生败血症的潜在风险,并及时采取适当的预防和干预措施。
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引用次数: 0
World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guidelines update – XVI - Nutritional management of cow's milk allergy 世界过敏组织 (WAO) 牛乳过敏诊断与防治行动指南 (DRACMA) 更新版 - XVI - 牛乳过敏的营养管理
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-08-01 DOI: 10.1016/j.waojou.2024.100931
Carina Venter , Rosan Meyer , Marion Groetch , Anna Nowak-Wegrzyn , Maurizio Mennini , Ruby Pawankar , Rose Kamenwa , Amal Assa'ad , Shriya Amara , Alessandro Fiocchi , Antonio Bognanni

Cow's milk allergy (CMA) is one of the most common presentations of food allergy in early childhood. Management of CMA involves individualized avoidance of cow's milk and other mammalian milk and foods containing these. Optimal elimination of cow's milk avoidance includes: label reading; information about safe and nutritious substitute foods; appropriate choice of infant formula or a plant-based food; establishing tolerance to baked milk and monitoring nutritional intake and growth. Substitute formulas are divided into soy formula (not hydrolyzed), milk-based extensively hydrolyzed formulas, rice based extensive, and partially hydrolyzed formulas and amino acid-based formulas. The use of other mammalian milks is not recommended for the management of cow's milk allergy due to a high level of cross-reactivity and nutritional concerns. For toddlers who are eating well, children, and adults, a suitable plant-based beverage may be a suitable alternative to a specialized formula, following careful nutritional considerations. Families need to be instructed on finding suitable nutritious foods and how to prepare suitable meals at home. Individuals with CMA also need to know how to identify and treat acute severe reactions.

牛奶过敏(CMA)是幼儿期最常见的食物过敏症状之一。CMA 的治疗包括因人而异地避免食用牛奶和其他哺乳动物奶类以及含有这些成分的食物。避免饮用牛奶的最佳方法包括:阅读标签;了解安全营养的替代食品;适当选择婴儿配方奶粉或植物性食品;建立对烘焙牛奶的耐受性并监测营养摄入和生长情况。替代配方奶粉分为大豆配方奶粉(未水解)、牛奶基广泛水解配方奶粉、大米基广泛和部分水解配方奶粉以及氨基酸配方奶粉。由于高度交叉反应和营养问题,不建议使用其他哺乳动物奶来治疗牛奶过敏。对于进食良好的幼儿、儿童和成人,在仔细考虑营养因素后,合适的植物性饮料可能是专门配方奶粉的合适替代品。需要指导家庭寻找合适的营养食品,以及如何在家中准备合适的膳食。CMA 患者还需要了解如何识别和治疗急性严重反应。
{"title":"World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guidelines update – XVI - Nutritional management of cow's milk allergy","authors":"Carina Venter ,&nbsp;Rosan Meyer ,&nbsp;Marion Groetch ,&nbsp;Anna Nowak-Wegrzyn ,&nbsp;Maurizio Mennini ,&nbsp;Ruby Pawankar ,&nbsp;Rose Kamenwa ,&nbsp;Amal Assa'ad ,&nbsp;Shriya Amara ,&nbsp;Alessandro Fiocchi ,&nbsp;Antonio Bognanni","doi":"10.1016/j.waojou.2024.100931","DOIUrl":"10.1016/j.waojou.2024.100931","url":null,"abstract":"<div><p>Cow's milk allergy (CMA) is one of the most common presentations of food allergy in early childhood. Management of CMA involves individualized avoidance of cow's milk and other mammalian milk and foods containing these. Optimal elimination of cow's milk avoidance includes: label reading; information about safe and nutritious substitute foods; appropriate choice of infant formula or a plant-based food; establishing tolerance to baked milk and monitoring nutritional intake and growth. Substitute formulas are divided into soy formula (not hydrolyzed), milk-based extensively hydrolyzed formulas, rice based extensive, and partially hydrolyzed formulas and amino acid-based formulas. The use of other mammalian milks is not recommended for the management of cow's milk allergy due to a high level of cross-reactivity and nutritional concerns. For toddlers who are eating well, children, and adults, a suitable plant-based beverage may be a suitable alternative to a specialized formula, following careful nutritional considerations. Families need to be instructed on finding suitable nutritious foods and how to prepare suitable meals at home. Individuals with CMA also need to know how to identify and treat acute severe reactions.</p></div>","PeriodicalId":54295,"journal":{"name":"World Allergy Organization Journal","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1939455124000620/pdfft?md5=5050fcf9b02d4b471df4d639e0322213&pid=1-s2.0-S1939455124000620-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141978507","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}
引用次数: 0
The systemic treatments for drug reaction with eosinophilia and systemic symptoms (DRESS) beyond corticosteroids 除皮质类固醇外,治疗伴有嗜酸性粒细胞增多和全身症状的药物反应(DRESS)的全身疗法
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-07-20 DOI: 10.1016/j.waojou.2024.100935
Sifan Wang BS , Yuanbo Kang BS , Chunxia He MD , Hongzhong Jin MD

Drug reaction with eosinophilia and systemic symptoms (DRESS), also known as drug-induced hypersensitivity syndrome (DiHS), is a severe type of cutaneous adverse reaction. The gold standard therapy for DRESS involves the discontinuation of the culprit drug, supportive therapies, and administration of corticosteroids. However, in cases of primary treatment failure or suboptimal response, there arises an urgent need for alternative interventions. This review focuses on exploring alternative systemic therapies for patients with steroid-resistant DRESS, steroid-dependent DRESS, or refractory DRESS, encompassing immunosuppressive agents, intravenous immunoglobulin, plasmapheresis, biologics, and small molecule drugs, with an emphasis on their clinical efficacy and the underlying mechanisms in the treatment of DRESS. Furthermore, this review provides a summary of potential management strategies and laboratory workup during the treatment of DRESS.

伴有嗜酸性粒细胞增多和全身症状的药物反应(DRESS),又称药物诱发超敏反应综合征(DiHS),是一种严重的皮肤不良反应。DRESS 的金标准疗法包括停用罪魁祸首药物、支持疗法和使用皮质类固醇。然而,在初级治疗失败或反应不理想的情况下,迫切需要采取替代干预措施。本综述重点探讨了针对类固醇耐药的 DRESS、类固醇依赖性 DRESS 或难治性 DRESS 患者的替代性全身疗法,包括免疫抑制剂、静脉注射免疫球蛋白、血浆置换术、生物制剂和小分子药物,重点介绍了这些疗法的临床疗效和治疗 DRESS 的内在机制。此外,本综述还总结了治疗 DRESS 的潜在管理策略和实验室检查。
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引用次数: 0
Blood and local eosinophil levels in chronic rhinitis: Observations during seasonal allergen exposure and non-exposure 慢性鼻炎患者的血液和局部嗜酸性粒细胞水平:季节性接触和不接触过敏原期间的观察结果
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-07-01 DOI: 10.1016/j.waojou.2024.100930
Xu Xu MSc , Jingyun Li MD, PhD , Xu Zhang MD , Lin Xi MD , Yunbo Gao MD , Xian Li MSc , Yuan Zhang MD, PhD , Luo Zhang MD, PhD

Background

Allergic rhinitis (AR) is a typical type 2 inflammatory disease and eosinophils play a critical role of cardinal effectors in type 2 inflammation. However, the distribution of eosinophils in patients with different subtypes of rhinitis and the effect of allergen exposure on them remain understudied. The aim of this study was to investigate the characteristics and factors influencing the distribution of systemic and local eosinophils in patients with non-AR (NAR), perennial AR (PAR), and seasonal AR (SAR), as well as the effect of seasonal allergen exposure levels on eosinophils.

Methods

This was a population-based, cross-sectional observational study of consecutive chronic rhinitis (CR) outpatients who volunteered to participate in the survey during the spring pollen season and non-pollen season of 2023 in Beijing. All participants underwent serum allergen testing, blood routine examination, and nasal secretion smear cytology, and completed questionnaires mainly involving basic information, history review, and symptom assessment. Spring pollen dispersal concentration were considered.

Results

A total of 558 CR patients eligible for enrollment were collected, including 198 NAR, 204 PAR, and 156 SAR patients. PAR had the highest blood eosinophil levels and the most severe overall nasal and ocular symptoms of SAR. Compared with subjects with blood eosinophil counts <0.3 × 109/L, those with ≥0.3 × 109/L had significantly more severe nasal and ocular symptoms and a significantly higher rate of comorbid asthma and allergic conjunctivitis. Blood eosinophil levels were significantly higher in SAR patients during the pollen season compared to the non-pollen season, and pollen concentrations were positively correlated with systemic and local eosinophil levels.

Conclusions

Blood eosinophil levels varied in patients with different subtypes of rhinitis. Patients with high blood eosinophil levels had more severe overall nasal and ocular symptoms, and that blood eosinophils levels were significantly higher in patients with asthma or allergic conjunctivitis than patients without comorbidities. There was a positive trend between allergen exposure and systemic and local eosinophil levels. Further longitudinal cohort studies are still needed to better analyze the influence of eosinophil levels on the clinical traits of AR.

背景过敏性鼻炎(AR)是一种典型的2型炎症性疾病,而嗜酸性粒细胞在2型炎症中扮演着重要的效应因子角色。然而,嗜酸性粒细胞在不同亚型鼻炎患者中的分布以及过敏原暴露对其的影响仍未得到充分研究。本研究旨在探讨非鼻炎型(NAR)、常年性鼻炎型(PAR)和季节性鼻炎型(SAR)患者全身和局部嗜酸性粒细胞分布的特点和影响因素,以及季节性过敏原暴露水平对嗜酸性粒细胞的影响。所有参与者均接受了血清过敏原检测、血常规检查和鼻分泌物涂片细胞学检查,并填写了以基本信息、病史回顾和症状评估为主要内容的调查问卷。结果 共收集了 558 名符合入组条件的 CR 患者,包括 198 名 NAR 患者、204 名 PAR 患者和 156 名 SAR 患者。PAR患者的血液中嗜酸性粒细胞水平最高,SAR患者的鼻部和眼部症状最严重。与血液中嗜酸性粒细胞计数为 0.3 × 109/L 的受试者相比,血液中嗜酸性粒细胞计数≥0.3 × 109/L 的受试者的鼻部和眼部症状明显更严重,合并哮喘和过敏性结膜炎的比例也明显更高。花粉季节与非花粉季节相比,SAR 患者的血液嗜酸性粒细胞水平明显更高,花粉浓度与全身和局部嗜酸性粒细胞水平呈正相关。血液中嗜酸性粒细胞水平高的患者整体鼻部和眼部症状更严重,哮喘或过敏性结膜炎患者的血液中嗜酸性粒细胞水平明显高于无合并症的患者。过敏原暴露与全身和局部嗜酸性粒细胞水平之间呈正相关趋势。仍需进一步开展纵向队列研究,以更好地分析嗜酸性粒细胞水平对 AR 临床特征的影响。
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引用次数: 0
General practitioner and patient perspectives on intranasal corticosteroids for allergic rhinitis: Treatment duration and obstacles to adherence, findings from a recent survey 全科医生和患者对鼻内皮质类固醇治疗过敏性鼻炎的看法:最近一项调查的结果:治疗持续时间和坚持治疗的障碍
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-07-01 DOI: 10.1016/j.waojou.2024.100925
Désirée E.S. Larenas-Linnemann MD , Pornanan Domthong MD , Renata C. Di Francesco MD, PhD , Ruperto González-Pérez MD, PhD , Manish Verma MD

Background and objective

Currently, there are no guideline recommendations for the duration of intranasal corticosteroid (INCS) treatment for allergic rhinitis (AR). We aimed to catalogue real-world AR-INCS prescription patterns.

Materials and methods

This multicenter, non-interventional, cross-sectional study used online general practitioner (GP) and patient surveys from 4 countries. Eligible GPs had 3–35 years of practical experience, regularly prescribed INCSs for AR treatment, and had managed ≥5 patients with AR per month according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines in the previous year. Eligible patients with AR were non-pregnant females or males, aged 18–65 years, previous AR-INCS users (≥12 months), and receiving GP-prescribed AR therapy. Survey participants were from countries with 15–50% AR prevalence and mostly prescription-only INCS use of ≥100 million units annually (Brazil, Mexico, Spain, Thailand). GP surveys and GP-completed patient record forms (PRFs) gathered AR-care and INCS-use data over 10 months; each GP completed patient record forms (PRFs) for 3 patients with AR under their care. The patient survey reflected actual AR-INCS experience, treatment duration, and adherence factors from patient perspectives. The target sample size was 75 GPs, 75 patients, and ≥30 respondents per country.

Results

From 900 GP-PRFs, the mean GP-recommended AR-INCS durations reported were 8.4 (Brazil), 8.3 (Mexico), 5.4 (Spain), and 6.4 (Thailand) weeks. From 300 patient surveys, mean reported INCS recommended durations were 6.4 (Brazil), 5.1 (Mexico), 4.0 (Spain), and 4.9 (Thailand) weeks; reported actual use durations were 6.2, 4.8, 3.6, and 6.4 weeks, respectively. The most frequent GP-PRF-reported factors influencing AR-INCS treatment duration were symptom severity (76–85%), symptom recurrence (49–73%), and existing comorbidities (33–57%). The most frequent GP-PRF-reported obstacles to adherence included forgetting to take medication regularly (54–100%), subsiding symptoms (42–91%), and being unable to continue activities (33–51%). Subsiding symptoms (36–53%) and reaching the prescription duration end (20–51%) were most frequent obstacles reported by the patient survey. Patients from all surveyed countries indicated that they visited the GP, a different physician, or a pharmacy for assistance with symptom recurrence; some patients also self-medicated.

Conclusions

Real-world AR-INCS prescription durations vary between countries and actual use tends to be shorter than prescribed. Understanding underlying factors may support appropriate AR-INCS use. The study was not powered to statistically compare intercountry differences; hence, comparisons have not been drawn, and the small sample may not reflect a complete picture of clinical practice and patients with AR in each country.

背景和目的目前,过敏性鼻炎(AR)鼻内皮质类固醇(INCS)治疗的持续时间尚无指南建议。材料和方法这项多中心、非干预、横断面研究使用了来自 4 个国家的在线全科医生(GP)和患者调查。符合条件的全科医生具有 3-35 年的实际工作经验,定期开具 INCS 用于 AR 治疗,并且在过去一年中根据过敏性鼻炎及其对哮喘的影响(ARIA)指南每月管理的 AR 患者≥5 人。符合条件的 AR 患者为非怀孕女性或男性,年龄在 18-65 岁之间,曾使用过 AR-INCS(≥12 个月),并正在接受全科医生开具的 AR 治疗处方。调查参与者来自 AR 患病率为 15%-50% 的国家,这些国家大多仅凭处方使用 INCS,年使用量≥1 亿单位(巴西、墨西哥、西班牙、泰国)。全科医生调查和全科医生填写的患者记录表(PRF)收集了 10 个月内 AR 护理和 INCS 使用数据;每位全科医生填写了其护理的 3 位 AR 患者的患者记录表(PRF)。患者调查从患者角度反映了 AR-INCS 的实际体验、治疗持续时间和依从性因素。结果从 900 份全科医生病历表中,全科医生推荐的 AR-INCS 平均疗程分别为 8.4 周(巴西)、8.3 周(墨西哥)、5.4 周(西班牙)和 6.4 周(泰国)。在 300 份患者调查中,报告的 INCS 推荐持续时间平均值分别为 6.4 周(巴西)、5.1 周(墨西哥)、4.0 周(西班牙)和 4.9 周(泰国);报告的实际使用持续时间分别为 6.2 周、4.8 周、3.6 周和 6.4 周。GP-PRF 最常报告的影响 AR-INCS 治疗持续时间的因素是症状严重程度(76-85%)、症状复发(49-73%)和现有合并症(33-57%)。GP-PRF 报告的最常见的坚持治疗障碍包括忘记按时服药(54%-100%)、症状减轻(42%-91%)和无法继续活动(33%-51%)。症状缓解(36-53%)和达到处方期限(20-51%)是患者调查报告中最常见的障碍。所有接受调查国家的患者都表示,如果症状复发,他们会去全科医生、其他医生或药房寻求帮助;一些患者还会自行用药。了解潜在的因素有助于适当使用抗逆转录病毒药物。这项研究没有对国家间的差异进行统计比较,因此无法得出比较结果,而且样本较少可能无法反映各国临床实践和 AR 患者的全貌。
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引用次数: 0
Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data 300IR 屋尘螨舌下含片的安全性,来自临床试验和上市后的汇总数据
IF 3.9 2区 医学 Q2 ALLERGY Pub Date : 2024-07-01 DOI: 10.1016/j.waojou.2024.100924
Margitta Worm MD , Pascal Demoly MD, PhD , Yoshitaka Okamoto MD, PhD , Carmen Vidal MD, PhD , Katia Daghildjian PharmD, PhD , Kwok Yan MD , Thomas B. Casale MD , Karl-Christian Bergmann MD, PhD

Background

The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data.

Methods

Subjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed.

Results

Across RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised.

Conclusion

Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status.

Clinical trial registrations

NCT00674700; Retrospectively registered 06 May 2008.

NCT01199133; Retrospectively registered 09 September 2010.

NCT01527188; Retrospectively registered 01 February 2012.

NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.

jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.

jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.

背景300IR屋尘螨(HDM)舌下免疫疗法(SLIT)片剂被批准用于治疗HDM诱发的过敏性鼻炎(AR)。根据随机对照试验(RCT)的汇总数据和上市后(PM)的药物警戒数据,对 300IR HDM-SLIT 片剂的安全性进行全面回顾。方法在 8 项随机对照试验中,用 300IR 或安慰剂对确诊为 HDM-AR 并伴有或不伴有哮喘的受试者(5-65 岁)进行治疗。汇总并描述性分析了成人/青少年和儿童子集中报告的治疗突发不良事件(TEAEs)。此外,还分析了自首次获得上市许可以来通过药物警戒系统从自发报告和 PM 研究中收集的不良反应 (ADR)。在成人/青少年和儿童(以哮喘状况为准)这两个子群体中,与治疗相关的 TEAEs 在活性组和安慰剂组中的发生率较高,大多为轻度或中度局部用药部位反应。这些反应主要发生在治疗的最初几天,随后逐渐减少。4例严重的喉咽反应(2例需要肾上腺素/肾上腺素)和1例中度湿疹被认为是严重的,用药后迅速缓解;没有过敏性休克的报告。在 PM 环境中,235,000 多名患者报告的 ADR 与 RCT 研究结果一致。严重的全身反应很少发生;12 例过敏性反应安全缓解(5 例使用肾上腺素)。临床试验注册NCT00674700;2008 年 5 月 6 日回顾性注册。NCT01199133;追溯注册2010年9月09日.NCT01527188;追溯注册2012年2月01日.NCT02443805;注册2015年4月29日/EudraCT 2014-004223-46;注册2015年9月16日.jRCT2080221872/JapicCTI-121917;注册2012年8月01日.jRCT2080222929/JapicCTI-15298;注册2015年8月04日。
{"title":"Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data","authors":"Margitta Worm MD ,&nbsp;Pascal Demoly MD, PhD ,&nbsp;Yoshitaka Okamoto MD, PhD ,&nbsp;Carmen Vidal MD, PhD ,&nbsp;Katia Daghildjian PharmD, PhD ,&nbsp;Kwok Yan MD ,&nbsp;Thomas B. Casale MD ,&nbsp;Karl-Christian Bergmann MD, PhD","doi":"10.1016/j.waojou.2024.100924","DOIUrl":"https://doi.org/10.1016/j.waojou.2024.100924","url":null,"abstract":"<div><h3>Background</h3><p>The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data.</p></div><div><h3>Methods</h3><p>Subjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed.</p></div><div><h3>Results</h3><p>Across RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised.</p></div><div><h3>Conclusion</h3><p>Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status.</p></div><div><h3>Clinical trial registrations</h3><p>NCT00674700; Retrospectively registered 06 May 2008.</p><p>NCT01199133; Retrospectively registered 09 September 2010.</p><p>NCT01527188; Retrospectively registered 01 February 2012.</p><p>NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.</p><p>jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.</p><p>jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.</p></div>","PeriodicalId":54295,"journal":{"name":"World Allergy Organization Journal","volume":null,"pages":null},"PeriodicalIF":3.9,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1939455124000553/pdfft?md5=3e70914086c616effd128639fee77999&pid=1-s2.0-S1939455124000553-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141481635","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}
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World Allergy Organization Journal
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