在口服免疫治疗期间消化道症状的管理:来自OUtMATCH调查人员的指导
Sayantani B Sindher1, Mirna Chehade2, Evan S Dellon3
1Department of Medicine, Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA.
The journal of allergy and clinical immunology. In practice
|February 6, 2026
概括
口服免疫疗法 (OIT) 可以引起胃肠道 (GI) 症状,在临床试验中提出挑战. 在OIT试验中针对持续性GI不良事件 (AEs) 的新标准化管理计划旨在提高安全性和一致性.
科学领域:
- 过敏和免疫学 过敏和免疫学
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 口服免疫疗法 (OIT) 是对食物过敏的有效治疗方法,但通常会导致胃肠道 (GI) 的不良事件 (AE).
- 在临床试验中管理这些GIAE是具有挑战性的,因为严格的协议和各种现场做法,导致不一致的结果.
- 在OUtMATCH试验中,需要采用统一的方法来管理OIT期间持续的GIAE.
研究的目的:
- 在OIT临床试验中开发和提出持续性GIAE的标准化定义和管理计划.
- 针对不同临床试验场所的GI AE管理实践的异质性.
- 改进参加OIT的参与者的安全监测和结果分类.
主要方法:
- 一个由过敏学家和胃肠病学家组成的小组委员会制定了持续性GIAE的工作定义.
- 创建了一个管理计划,用于OUtMATCH随机对照试验 (NCT03881696).
- 来自试验的基于案例的场景被用来说明该计划的应用.
主要成果:
- 在OIT期间为持续的GI AEs制定了明确的定义和可执行的管理计划.
- 该计划旨在标准化AE管理,加强症状监测和提高安全性.
- 预计实施将减少 OIT 试验中的变异性,并改善结果分类.
结论:
- 在OIT临床试验中,对GIAE的标准化管理计划对于一致性和安全性至关重要.
- 这种方法可以带来更好的症状监测,AE的分层,并提高参与者安全.
- 开发的定义和计划为未来的OIT临床试验提供了一个框架.
相关概念视频
01:28Pleural Effusion II: Symptoms and Management
797
Pleural Effusion Overview
A pleural effusion is the abnormal collection of fluid between the parietal and visceral pleura layers of tissue that form the lining of the lungs and chest cavity. It can occur independently or due to surrounding parenchymal diseases, such as infection, malignancy, or inflammatory conditions.
Clinical Manifestations:
A pleural effusion is the abnormal collection of fluid between the parietal and visceral pleura layers of tissue that form the lining of the lungs and chest cavity. It can occur independently or due to surrounding parenchymal diseases, such as infection, malignancy, or inflammatory conditions.
Clinical Manifestations:
797
01:27Tumor Immunotherapy
2.0K
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
2.0K
01:26Anatomy of the Gastrointestinal System
2.9K
The human digestive system is an intricate and essential network for nutrient absorption and waste elimination. It encompasses the gastrointestinal (GI) tract and several accessory organs.
Here's a detailed walkthrough of this complex system:
Here's a detailed walkthrough of this complex system:
2.9K
01:15Diabetes: Symptoms, Diagnosis, and Complications
2.4K
For most patients, experiencing several weeks of polyuria, polydipsia, fatigue, and significant weight loss may indicate the presence of diabetes. Furthermore, adults displaying the phenotypic appearance of type 2 diabetes (particularly those who are obese and not initially insulin-requiring), may have islet cell autoantibodies, suggesting autoimmune-mediated β cell destruction and a diagnosis of latent autoimmune diabetes of adults (LADA). The categorization of glucose homeostasis is...
2.4K
01:30Negative and Cognitive Symptoms of Schizophrenia
596
Negative symptoms of schizophrenia indicate a reduction or absence of typical behaviors and emotional responses found in healthy individuals, while positive symptoms reflect an excess or distortion of normal functioning.
Negative Symptoms
Negative symptoms of schizophrenia manifest as deficits in normal emotional and behavioral functioning, profoundly impacting daily life. Individuals with schizophrenia often display a flat affect, characterized by a near-total absence of emotional expression,...
Negative Symptoms
Negative symptoms of schizophrenia manifest as deficits in normal emotional and behavioral functioning, profoundly impacting daily life. Individuals with schizophrenia often display a flat affect, characterized by a near-total absence of emotional expression,...
596
01:11Oral Cavity
3.2K
The oral cavity, or the mouth, is a complex structure in humans that plays a vital role in our day-to-day lives. Its role is not only in chewing and swallowing food; it also plays a role in speech and facial expressions.
Teeth: The teeth are the hardest structures in our bodies. Humans have two sets of teeth throughout their lifetime: deciduous (baby) teeth and permanent teeth. Each tooth consists of several parts: the crown (visible part), the root (embedded in the jaw), enamel (hard outer...
Teeth: The teeth are the hardest structures in our bodies. Humans have two sets of teeth throughout their lifetime: deciduous (baby) teeth and permanent teeth. Each tooth consists of several parts: the crown (visible part), the root (embedded in the jaw), enamel (hard outer...
3.2K