在临床试验下语言免疫疗法片中的过敏反应
Hendrik Nolte1, Moisés A Calderon2, David I Bernstein3
1ALK, Bedminster, NJ.
The journal of allergy and clinical immunology. In practice
|November 16, 2023
概括
在语言下免疫疗法 (SLIT) 试验中,过敏反应很少发生. 标准化监管活动医学词典 (MedDRA) 查询 (SMQs) 有效地确定了潜在的过敏反应病例,在SLIT平板研究中观察到的治疗相关事件很少.
科学领域:
- 过敏和免疫学 过敏和免疫学
- 临床药理学 临床药理学
- 药物安全和药物监督 药物安全和药物监督
背景情况:
- 语言下免疫疗法 (SLIT) 缺乏在临床试验中识别过敏反应的标准化方法.
- 标准化监管活动医学词典 (MedDRA) 查询 (SMQ) 是药物安全监测的既定工具.
研究的目的:
- 开发和验证一种方法来检测潜在的过敏反应在SLIT-平板电脑试验.
- 使用SMQ搜索结合国家过敏和传染病研究所 (NIAID) 的病例定义来识别过敏反应.
主要方法:
- 开发了一个SMQ搜索工具,其中包含了有关过敏反应的MedDRA术语和系统性不良事件的标准.
- 将SMQ工具应用于48个SLIT药片试验 (N=15,233) 的大型聚合数据集.
- 包括对"过敏"和上腺素使用的额外搜索,其次是盲目的专家审查.
主要成果:
- 在SMQ搜索和专家审查中,发现了8例潜在的过敏反应病例;3例与治疗有关 (0.02%的SLIT片,0.01%的安慰剂).
- 通过"过敏"术语发现了与SLIT-tablet相关的另一个病例.
- 上腺素的使用率很低 (0.2%的SLIT-tablet与0.03%的安慰剂).
结论:
- 建立有效的SMQ搜索标准,用于识别SLIT试验中的潜在过敏反应.
- 过敏反应是一种与使用SLIT药片相关的罕见事件.
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