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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.

项目摘要/摘要非类固醇抗炎药(NSAIDs)是许多疾病的一线治疗药物。从疼痛到心脏病，但整个药物类别的治疗性使用可能被报告排除在外过敏。虽然非甾体类抗炎药是第二种最常见的药物过敏报告，但据估计已报道的非甾体抗炎药引起的反应中，有20%与过敏反应一致(例如，荨麻疹，血管水肿、过敏反应)，其余为非过敏性副作用或耐受性(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导致不必要的药物回避，增加二线药物的使用，成本更高，效果更差替代药物，其结果是对患者结局产生下游不良影响。首要目标是这项建议的目的是确定已报告的非类固醇过敏对处方模式和临床的影响在不同人群中的结果，并定义真正的非类固醇激素诱导的过敏反应的预测因素。这个拟议的研究有三个目的：(1)评估已报道的非类固醇过敏对术后阿片类药物的影响在接受电子健康记录的大型患者队列中开处方和持续使用阿片类药物普通外科手术；(2)评估阿司匹林给药和心血管不良反应的差异有和没有NSAID过敏的急性冠脉综合征患者的结果；(3)使用经过过敏专科医生观察的非甾体抗炎药挑战以确定非甾体类抗炎药引起过敏的患者和药物特有的危险因素。李博士的研究计划将是在临床和流行病学研究设计、高级生物统计学课程和培训的支持下利用大数据集、信息学、患者招募和药物挑战方案进行研究的方法，以及布里格姆妇女医院特殊的科学环境。她将接受来自坦尼娅·莱德洛博士是一位过敏专家，也是阿司匹林和非甾体类抗炎药引起的过敏症的专家。卡伦·科斯滕巴德是一位风湿学家，在研究疾病风险因素和使用大型国家队列和数据集对受影响患者的长期结果进行评估。李博士将获得额外的由三名科学顾问组成的团队提供科学投入和职业指导，其中包括约书亚·博伊斯博士， Elena Losina和Kimberly Blumenthal，他们投入了时间、资源和专业知识来促进她的专业发展和研究目标。这项K23提案与NIH的倡议非常一致，以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，并将使候选人在获奖期间提交R01申请，并确立自己的独立身份以患者为导向的调查者，专注于改善药物过敏患者的护理和健康。