零时指定对观察性研究中估计的COVID-19抗病毒有效性的影响
Kristina L Bajema1,2, Lei Yan3,4, Kristin Berry5
1Veterans Affairs Portland Health Care System, Portland, OR, United States.
American journal of epidemiology
|October 13, 2025
概括
在研究中定义开始时间 (零时间) 会影响结果. 在对Nirmatrelvir-ritonavir治疗COVID-19的观察性研究中,用于设定零时间的不同方法产生了不同的有效性估计.
科学领域:
- 药学流行病学 药学流行病学
- 临床试验设计 临床试验设计
- 生物统计学 生物统计学
背景情况:
- 在临床试验中,对准时间为零对于准确性至关重要.
- 观察性研究在确定精确的零时间方面面临挑战,可能引入偏差.
- 尼尔马特雷尔维尔 - 里托纳维尔是一种抗病毒治疗COVID-19的药物.
研究的目的:
- 为了比较各种时间零定义对尼尔马特雷尔维尔-里托纳维尔在COVID-19治疗中估计有效性的影响.
- 评估不同的零时指定如何影响药物流行病学研究结果.
主要方法:
- 美国退伍军人被诊断患有SARS-CoV-2的回顾性队列研究 (2022年4月至2023年3月).
- 尼尔马特雷尔维尔-里托纳维尔与没有治疗的比较,使用五种不同的零时间方法.
- 分析包括匹配,克隆-传感器-重量方法,以及不同的日期参考 (测试日期,治疗日期).
主要成果:
- 所有时间零方法都表明,使用nirmatrelvir-ritonavir的30天住院或死亡率较低.
- 效果大小估计在五种零时间方法中差异很大.
- 克隆-传感器-权重方法 (方法1c) 产生了最小的风险差异 (-0.95%).
结论:
- 选择零时指定对药物流行病学中估计的治疗有效性产生了重大影响.
- 仔细考虑和证明零时定义对于强大的研究设计至关重要.
- 这些发现强调了在观测研究中需要标准化的零时协议.
相关概念视频
Time Course of Drug Effect
2.6K
The progression of a drug's impact can be analyzed by examining both the concentration-time course and the effect-time course. The concentration-time course is determined by the drug's half-life and is influenced by factors such as its pharmacokinetics, including absorption, distribution, metabolism, and elimination. The effect of the drug is often related to its concentration in the plasma and is calculated using the maximum drug effect and the plasma concentration that generates 50...
2.6K
Antimicrobial Effectiveness
904
The effectiveness of antimicrobial agents depends on various factors influencing their ability to eliminate microbial populations. Larger microbial populations require more time for complete eradication, emphasizing the importance of population size analysis when evaluating antimicrobial efficacy.Microbial resistance to antimicrobial agents varies significantly. Highly resilient microorganisms include endospores, gram-negative bacteria, and non-enveloped viruses, while prions are exceptionally...
904
Drug Concentration Versus Time Correlation
2.0K
The plasma drug concentration-time curve is a crucial tool in pharmacokinetics, representing the drug's concentration in plasma at different time intervals post-administration. This curve illustrates the drug's journey from absorption into the systemic circulation, distribution to body tissues, and eventual elimination through excretion or biotransformation.
Two pivotal parameters are the minimum effective concentration (MEC) and the minimum toxic concentration (MTC). The MEC is the...
Two pivotal parameters are the minimum effective concentration (MEC) and the minimum toxic concentration (MTC). The MEC is the...
2.0K
Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
350
Circadian rhythms are cyclic changes that are crucial in plasma drug concentrations. Various standard circadian parameters, including core body temperature, heart rate, and other cardiovascular factors, directly impact disease states and the therapeutic response to drug therapy.
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
350
Truncation in Survival Analysis
577
Truncation in survival analysis refers to the exclusion of individuals or events from the dataset based on specific criteria related to the time of the event. This exclusion can happen in two primary forms: left truncation and right truncation.
Left truncation occurs when individuals who experienced the event of interest before a certain time are not included in the study. This is often due to a "delayed entry" into the study where only those who survive until a certain entry point are...
Left truncation occurs when individuals who experienced the event of interest before a certain time are not included in the study. This is often due to a "delayed entry" into the study where only those who survive until a certain entry point are...
577
Bias in Epidemiological Studies
1.3K
Biases can arise at various stages of research, from study design and data collection to analysis and interpretation. Recognizing and addressing these biases is essential to ensure the validity and reliability of epidemiological findings.Broadly speaking, biases in epidemiology fall into three main categories: selection bias, information bias, and confounding. A more detailed description of possible biases is:
1.3K


