PDF(Pubmed)
Abstract：
UNASSIGNED: The purpose of this study is to explore and analyze the FDA Adverse Event Reporting System (FAERS) database to identify drug adverse reaction signals associated with angioedema. The findings aim to provide valuable insights for clinical drug safety considerations.
UNASSIGNED: The Open Vigil 2.1 data platform was utilized to collect adverse event reports related to angioedema from the first quarter of 2004 to the fourth quarter of 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed as disproportionality measures to detect adverse reaction signals Sof drugs associated with angioedema.
UNASSIGNED: A total of 38,921 reports were retrieved, with the majority being reported by healthcare professionals. The analysis included predominantly adult patients (≥18 years of age), with slightly higher representation of females compared to males. Among the top 30 drugs associated with the occurrence of angioedema, 24 drugs showed positive signals in the risk analysis. Based on the individual drug reporting odds ratio (95% confidence interval) as a measure of risk signal strength, the top five drugs are as follows: lisinopril [ROR (95% CI): 46.43 (42.59-50.62)], enalapril [ROR (95% CI): 43.51 (39.88-47.46)], perindopril [ROR (95% CI): 31.17 (27.5-35.32)], alteplase [ROR (95% CI): 29.3 (26.95-31.85)], ramipril [ROR (95% CI): 20.93 (19.66-22.28)]. After categorizing the drugs, the strongest positive signal was observed in the antithrombotic agents [ROR (95% CI): 22.53 (21.16-23.99)], following that, cardiovascular drugs [ROR (95% CI): 9.17 (8.87-9.48)], antibiotics [ROR (95% CI): 6.42 (5.91-6.96)], immunosuppressors [ROR (95% CI): 5.95 (5.55-6.39)], anti-inflammatory analgesics [ROR (95% CI): 4.65 (4.45-4.86)], antiallergic drugs [ROR (95% CI): 4.47 (3.99-5)], antiasthmatics [ROR (95% CI): 2.49 (2.14-2.89)], blood sugar control drugs [ROR (95% CI): 1.65 (1.38-1.97)], and digestive system drugs [ROR (95% CI): 1.59 (1.45-1.74)] exhibited progressively decreasing ROR values.
UNASSIGNED: Many medications are associated with a high risk of angioedema. These medications play a crucial and potentially preventable role in controlling the occurrence of angioedema. It is essential to consider the risk level of drug-induced angioedema in clinical practice to optimize medication therapy.
UNASSIGNED: The Open Vigil 2.1 data platform was utilized to collect adverse event reports related to angioedema from the first quarter of 2004 to the fourth quarter of 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed as disproportionality measures to detect adverse reaction signals Sof drugs associated with angioedema.
UNASSIGNED: A total of 38,921 reports were retrieved, with the majority being reported by healthcare professionals. The analysis included predominantly adult patients (≥18 years of age), with slightly higher representation of females compared to males. Among the top 30 drugs associated with the occurrence of angioedema, 24 drugs showed positive signals in the risk analysis. Based on the individual drug reporting odds ratio (95% confidence interval) as a measure of risk signal strength, the top five drugs are as follows: lisinopril [ROR (95% CI): 46.43 (42.59-50.62)], enalapril [ROR (95% CI): 43.51 (39.88-47.46)], perindopril [ROR (95% CI): 31.17 (27.5-35.32)], alteplase [ROR (95% CI): 29.3 (26.95-31.85)], ramipril [ROR (95% CI): 20.93 (19.66-22.28)]. After categorizing the drugs, the strongest positive signal was observed in the antithrombotic agents [ROR (95% CI): 22.53 (21.16-23.99)], following that, cardiovascular drugs [ROR (95% CI): 9.17 (8.87-9.48)], antibiotics [ROR (95% CI): 6.42 (5.91-6.96)], immunosuppressors [ROR (95% CI): 5.95 (5.55-6.39)], anti-inflammatory analgesics [ROR (95% CI): 4.65 (4.45-4.86)], antiallergic drugs [ROR (95% CI): 4.47 (3.99-5)], antiasthmatics [ROR (95% CI): 2.49 (2.14-2.89)], blood sugar control drugs [ROR (95% CI): 1.65 (1.38-1.97)], and digestive system drugs [ROR (95% CI): 1.59 (1.45-1.74)] exhibited progressively decreasing ROR values.
UNASSIGNED: Many medications are associated with a high risk of angioedema. These medications play a crucial and potentially preventable role in controlling the occurrence of angioedema. It is essential to consider the risk level of drug-induced angioedema in clinical practice to optimize medication therapy.
摘要：
■这项研究的目的是探索和分析FDA不良事件报告系统（FAERS）数据库，以识别与血管性水肿相关的药物不良反应信号。这些发现旨在为临床药物安全考虑提供有价值的见解。
■OpenVigil2.1数据平台用于收集2004年第一季度至2023年第四季度与血管性水肿相关的不良事件报告。采用报告比值比（ROR）和比例报告比（PRR）作为不相称性指标来检测与血管性水肿相关的药物的不良反应信号。
■共检索到38,921份报告，大多数是由医疗保健专业人员报告的。分析主要包括成年患者（≥18岁），与男性相比，女性的代表性略高。在与血管性水肿发生相关的前30种药物中，24种药物在风险分析中显示阳性信号。基于个体药物报告比值比(95%置信区间)作为风险信号强度的度量,前五名药物如下：赖诺普利[ROR（95％CI）：46.43（42.59-50.62）]，依那普利[ROR（95%CI）：43.51（39.88-47.46）]，培多普利[ROR（95%CI）：31.17（27.5-35.32）]，阿替普酶[ROR（95%CI）：29.3（26.95-31.85）]，雷米普利[ROR（95%CI）：20.93（19.66-22.28）]。在对药物进行分类后，在抗血栓药物中观察到最强的阳性信号[ROR（95％CI）：22.53（21.16-23.99）]，之后,心血管药物[ROR（95%CI）：9.17（8.87-9.48）]，抗生素[ROR（95%CI）：6.42（5.91-6.96）]，免疫抑制剂[ROR（95％CI）：5.95（5.55-6.39）]，抗炎镇痛药[ROR（95％CI）：4.65（4.45-4.86）]，抗过敏药物[ROR（95％CI）：4.47（3.99-5）]，平喘药[ROR（95%CI）：2.49（2.14-2.89）]，血糖控制药物[ROR（95%CI）：1.65（1.38-1.97）]，和消化系统药物[ROR（95％CI）：1.59（1.45-1.74）]显示出逐渐降低的ROR值。
■许多药物与血管性水肿的高风险相关。这些药物在控制血管性水肿的发生中起着至关重要的和潜在的可预防的作用。在临床实践中必须考虑药物性血管性水肿的风险水平，以优化药物治疗。
■OpenVigil2.1数据平台用于收集2004年第一季度至2023年第四季度与血管性水肿相关的不良事件报告。采用报告比值比（ROR）和比例报告比（PRR）作为不相称性指标来检测与血管性水肿相关的药物的不良反应信号。
■共检索到38,921份报告，大多数是由医疗保健专业人员报告的。分析主要包括成年患者（≥18岁），与男性相比，女性的代表性略高。在与血管性水肿发生相关的前30种药物中，24种药物在风险分析中显示阳性信号。基于个体药物报告比值比(95%置信区间)作为风险信号强度的度量,前五名药物如下：赖诺普利[ROR（95％CI）：46.43（42.59-50.62）]，依那普利[ROR（95%CI）：43.51（39.88-47.46）]，培多普利[ROR（95%CI）：31.17（27.5-35.32）]，阿替普酶[ROR（95%CI）：29.3（26.95-31.85）]，雷米普利[ROR（95%CI）：20.93（19.66-22.28）]。在对药物进行分类后，在抗血栓药物中观察到最强的阳性信号[ROR（95％CI）：22.53（21.16-23.99）]，之后,心血管药物[ROR（95%CI）：9.17（8.87-9.48）]，抗生素[ROR（95%CI）：6.42（5.91-6.96）]，免疫抑制剂[ROR（95％CI）：5.95（5.55-6.39）]，抗炎镇痛药[ROR（95％CI）：4.65（4.45-4.86）]，抗过敏药物[ROR（95％CI）：4.47（3.99-5）]，平喘药[ROR（95%CI）：2.49（2.14-2.89）]，血糖控制药物[ROR（95%CI）：1.65（1.38-1.97）]，和消化系统药物[ROR（95％CI）：1.59（1.45-1.74）]显示出逐渐降低的ROR值。
■许多药物与血管性水肿的高风险相关。这些药物在控制血管性水肿的发生中起着至关重要的和潜在的可预防的作用。在临床实践中必须考虑药物性血管性水肿的风险水平，以优化药物治疗。
