避免对急性损伤的错误分类:时机是一切
Amy Legg1,2, Jason A Roberts2,3,4,5, Matthew A Roberts6
1Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Nephrology (Carlton, Vic.)
|October 11, 2023
概括
在临床试验中,试验前基线肌素水平更准确地检测急性损伤 (AKI). 从试验招生中使用肌素错过了许多AKI病例,突出了试验协议中最佳时间的需要.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床试验 临床试验
- 医学诊断 医学诊断 医学诊断
背景情况:
- 准确检测急性损伤 (AKI) 在临床试验中至关重要.
- 作为基线,从试验招生中使用肌素水平可能不反映真正的功能.
- 基线肌素测量的时间可以影响AKI发病率评估.
研究的目的:
- 为了比较试验前基线肌与试验基线肌.
- 评估基线肌素时间如何影响CAMERA2试验中的AKI检测.
- 在临床试验中确定基线肌素收集的理想时间.
主要方法:
- 追溯收集试验前基线肌素 (最多在1年前).
- 在随机化前24小时内定义的试验基线肌素最高值.
- 使用威尔科克森标志排名测试来比较217名患者的肌氨酸度.
主要成果:
- 试验前的中位数肌素 (82μmol/L) 显著低于试验基线肌素 (86μmol/L).
- 在入学时,预试验氨酸确定了22%的AKI患者,而使用试验基线氨酸的患者仅为2.3%.
- 试验注册肌素未能检测到许多AKI病例.
结论:
- 试验前基线肌素提供了比试验招募肌素更准确的功能评估.
- 目前的试验方案可能低估了AKI发病率,原因是基线肌素时间不足最佳.
- 在临床试验中,考虑疾病前基线肌的水平对于准确的AKI检测至关重要.
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