使用XGBoost和SHAP可解释性的药物相关流产风险评估:基于FAERS数据库的现实世界药监测分析
Sen Lin1,2, Lanyue Ma2, Ruiqi Zhao2
1Department of Oncology and Hematology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
Frontiers in pharmacology
|March 11, 2026
概括
评估与药物相关的流产风险至关重要. 机器学习将免疫调节剂,抗病毒药物和精神病药物确定为潜在的风险,强调需要个性化妊娠药物安全评估.
科学领域:
- 药物监督和药物安全研究.
- 计算方法在不良事件检测中的应用.
- 生殖健康和怀孕结果.
背景情况:
- 流产是一个重要的不良妊娠结果.
- 评估与药物相关的流产风险对于怀孕期间药物安全至关重要.
- 使用FDA不良事件报告系统 (FAERS) 数据库来识别潜在的高风险药物.
研究的目的:
- 系统地挖掘FAERS数据以寻找流产相关的不良药物事件 (ADEs).
- 采用机器学习 (ML) 和可解释AI (XAI) 来评估潜在的高风险药物导致流产.
- 为了描述药物暴露后流产的发病时间 (TTO).
主要方法:
- 在FAERS数据 (2005-2024) 上进行不成比例分析 (ROR,PRR,BCPNN,MGPS).
- 开发一种XGBoost模型,用于预测流产风险.
- 应用沙普利添加式解释 (SHAP) 进行特征解释和韦布尔分布用于TTO分析.
主要成果:
- 确定免疫调节剂,精神活性/神经活性剂和抗微生物药物作为潜在的高风险药物类.
- XGBoost模型显示出良好的区分 (AUC=0.738);SHAP分析突出显示免疫调节剂 (阿达利穆马布,因弗利西马布) 是重要的预测因子.
- 时间到发作的分析表明,大多数流产发生在2年内,而抗TNF-α药物显示出更高的早期风险.
结论:
- ML和SHAP分析有效地确定了免疫调节剂,抗病毒药物和精神病药物作为流产风险信号.
- 研究结果强调需要根据患者年龄和体重进行个性化药物评估.
- 为怀孕期间药物风险评估提供基于证据的指导.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
518
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
518
Pharmacovigilance
1.9K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.9K
Drug Toxicity: Risk factors
88
Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
88
Regression Toward the Mean
7.3K
Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when...
7.3K
Relative Risk
2.4K
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
2.4K
Pharmacogenetic Phenotypes: Alterations in Pharmacokinetics, Drug Targets and Biologic Milieu
81
Genetic variations significantly influence drug response through pharmacokinetics, receptor interactions, and biologic milieu modifications. Pharmacokinetic alterations impact drug metabolism and clearance, affecting efficacy and toxicity. Variants in drug-metabolizing enzymes, such as CYP2C9 and CYP2C19, alter drug activation and elimination. For example, CYP2C9 loss-of-function variants require lower warfarin doses to prevent excessive bleeding, while CYP2C19 variants reduce clopidogrel...
81

