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Clinical Impact and Epidemiology of Nonsteroidal Anti-inflammatory Drug Allergies

非甾体抗炎药过敏的临床影响和流行病学

基本信息

批准号：
10621863
负责人：
Lily Li
金额：
$ 16.37万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-08 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10621863
关键词：
Acute Pain Adverse effects Adverse reactions Affect Allergic Anaphylaxis Angioneurotic Edema Anxiety Aspirin Award Biological Biostatistical Methods Boston Cardiovascular system Caring Clinical Clinical Data Clinical Informatics Clinical Investigator Clinical Research Coronary heart disease Data Data Set Databases Development Disease Dose Drug Hypersensitivity Drug Prescriptions Electronic Health Record Environment Epidemiology Evaluation Event Female Goals Health Heart Diseases Hemorrhage Hospitals Hypersensitivity Informatics Integrated Health Care Systems Intervention Label Mentorship Methodology Modeling Morbidity - disease rate National Institute of Allergy and Infectious Disease Natural History Non-Steroidal Anti-Inflammatory Agents Operative Surgical Procedures Opioid Outcome Pain Patient Care Patient Recruitments Patient Self-Report Patient-Focused Outcomes Patients Pattern Persons Pharmaceutical Preparations Population Positioning Attribute Postoperative Pain Postoperative Period Protocols documentation Reaction Recommendation Regimen Regression Analysis Reporting Research Research Design Research Methodology Research Personnel Resources Rest Risk Risk Factors Specialist Survival Analysis Therapeutic Uses Time Training United States United States National Institutes of Health Urticaria Vocational Guidance Woman Work acute coronary syndrome career chronic back pain chronic pain clinical epidemiology cohort comorbidity cost effective therapy epidemiology study evidence base experience gastrointestinal high risk high risk population improved insight large datasets longitudinal analysis mortality nephrotoxicity opioid use opioid use disorder patient oriented prescription opioid research and development rheumatologist risk stratification sex side effect skills

项目摘要

PROJECT SUMMARY/ABSTRACT Nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for first-line treatment of many conditions ranging from pain to heart disease, but therapeutic use of the entire medication class can be precluded by reported allergy. While NSAIDs represent the second most commonly reported class of drug allergies, it is estimated that <20% of reported NSAID-induced reactions are consistent with allergic hypersensitivity (eg, urticaria, angioedema, anaphylaxis), with the rest representing non-allergic side effects or intolerances (eg, gastrointestinal upset, bleeding, nephrotoxicity). Allergy over-reporting and lack of reaction clarification can lead to unnecessary drug avoidance, and increased use of second line, more costly, and less effective alternative medications, with resultant downstream adverse effects on patient outcomes. The primary objective of this proposal is to determine the impact of reported NSAID allergies on prescribing patterns and clinical outcomes in distinct populations and to define predictors for true NSAID-induced allergic hypersensitivity. The proposed study has three Aims: (1) to assess the impact of reported NSAID allergy on postoperative opioid prescribing and sustained opioid use in a large electronic health record-derived cohort of patients undergoing common surgical procedures; (2) to evaluate differences in aspirin administration and adverse cardiovascular outcomes in patients with acute coronary syndromes with and without reported NSAID allergy; (3) to use a well-defined cohort of subjects who have undergone allergist-observed NSAID drug challenge to determine patient- and drug-specific risk factors for NSAID-induced hypersensitivity. Dr. Li’s research plan will be supported by coursework and training in clinical and epidemiological study design, advanced biostatistical methods for research with large datasets, informatics, patient recruitment, and drug-challenge protocols, and the exceptional scientific environment at the Brigham and Women’s Hospital. She will receive mentorship from Dr. Tanya Laidlaw, an allergy specialist and expert in aspirin- and NSAID-induced hypersensitivity, and Dr. Karen Costenbader, a rheumatologist with extensive experience in investigating risk factors for disease and long-term outcomes in affected patients using large national cohorts and datasets. Dr. Li will obtain additional scientific input and career guidance from a team of three scientific advisors, including Drs. Joshua Boyce, Elena Losina, and Kimberly Blumenthal, who have committed their time, resources and expertise to facilitate her professional development and research goals. This K23 proposal is well-aligned with NIH initiatives to reduce unnecessary opioid prescribing and NIAID support of drug allergy research, and will position the candidate to submit an R01 application during the award period and to establish herself as an independent patient-oriented investigator with a focus on improving the care and health of patients with drug allergies.

项目概要/摘要非甾体抗炎药（NSAID）适用于多种疾病的一线治疗，包括从疼痛到心脏病，但整个药物类别的治疗用途可能会被报道所排除过敏。虽然非甾体抗炎药是第二大最常见的药物过敏类别，但据估计据报道，不到 20% 的 NSAID 引起的反应与过敏性超敏反应一致（例如荨麻疹、血管性水肿、过敏反应），其余则代表非过敏性副作用或不耐受（例如，胃肠道不适、出血、肾毒性）。过敏过度报告和缺乏反应澄清可能会导致不必要的药物回避，并增加二线药物的使用，成本更高，效果更差替代药物，对患者的治疗结果产生下游不利影响。主要目标该提案的目的是确定报告的 NSAID 过敏对处方模式和临床的影响不同人群的结果，并定义真正的非甾体抗炎药引起的过敏性超敏反应的预测因素。这拟议的研究有三个目的：(1) 评估报告的 NSAID 过敏对术后阿片类药物的影响在来自电子健康记录的大型患者队列中开出处方并持续使用阿片类药物常见的外科手术； (2) 评估阿司匹林给药与心血管不良的差异患有或不患有非甾体抗炎药过敏的急性冠脉综合征患者的结局； (3) 使用明确的受试者队列，他们接受了过敏专家观察的 NSAID 药物挑战，以确定 NSAID 引起的超敏反应的患者和药物特异性危险因素。李博士的研究计划是由临床和流行病学研究设计、高级生物统计方面的课程和培训支持使用大型数据集、信息学、患者招募和药物挑战方案进行研究的方法，以及布莱根妇女医院卓越的科学环境。她将接受来自 Tanya Laidlaw 博士是一位过敏症专家，也是阿司匹林和非甾体抗炎药引起的超敏反应方面的专家。 Karen Costenbader 是一位风湿病学家，在调查疾病和疾病的危险因素方面拥有丰富的经验。使用大型全国队列和数据集对受影响患者的长期结果进行研究。李博士将获得额外由三名科学顾问组成的团队提供科学投入和职业指导，其中包括博士。约书亚·博伊斯， Elena Losina 和 Kimberly Blumenthal 投入了时间、资源和专业知识来促进她的职业发展和研究目标。这项 K23 提案与 NIH 的倡议非常一致减少不必要的阿片类药物处方和 NIAID 对药物过敏研究的支持，并将定位候选人在奖励期间提交 R01 申请并确立自己的独立地位以患者为中心的研究者，专注于改善药物过敏患者的护理和健康。