Abstract：
UNASSIGNED: The aim of this study is to monitor, identify, and compare the adverse events (AEs) related to tenecteplase and alteplase, with the objective of exploring the potential safety of tenecteplase for acute ischemic stroke (AIS) and guiding its use to enhance patient safety.
UNASSIGNED: In order to evaluate the disproportionality of AEs associated with tenecteplase and alteplase in real-world data, four algorithms (ROR, PRR, BCPNN, EBGM) were utilized as measures to detect signals of AEs related to both drugs. Subsequently, Breslow-Day statistical analysis was applied to compare the RORs of the main system organ classes (SOCs) and key preferred terms (PTs) between tenecteplase and alteplase.
UNASSIGNED: A statistical analysis was performed utilizing data gleaned from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, encompassing 19,514,140 case reports from 2004Q1 to 2023Q1. There were 1,004 cases where tenecteplase was reported as the primary suspected (PS) and 2,363 tenecteplase-related adverse drug reactions (ADRs) at the PTs level were identified, the two data of alteplase were 10,945 and 25,266, respectively. The occurrence of drug-induced ADRs was analyzed across 27 organ systems, The analysis revealed several expected ADRs, such as Haemorrhage, Hypersensitivity which were consistent with the two drug-labels. It is of note that the signal strengths of \'death,\' \'ventricular fibrillation,\' \'cardiogenic shock\' and \'pneumonia aspiration\' at the PT level were markedly higher for tenecteplase than for alteplase, whereas the signal strength of \'angioedema\' at the PT level was significantly higher for alteplase in comparison to tenecteplase. Additionally, unexpected significant ADRs associated with ocular adverse reactions and pneumonia aspiration at the PT level were identified, indicating potential AEs not currently mentioned in the drug instructions.
UNASSIGNED: This study identified and compared signals of ADRs associated with tenecteplase and alteplase, although tenecteplase is as effective as alteplase and has advantages such as ease of use and affordability, it cannot replace alteplase in the treatment of AIS until its safety profile is fully recognized. Additionally, previously unreported ocular ADRs and pneumonia were identified, providing valuable insights into the relationship between ADRs and the use of these thrombolytic drugs. These findings underscore the importance of continuous monitoring and effective detection of AEs to ultimately enhance the safety of AIS patients undergoing thrombolytic therapy.
UNASSIGNED: In order to evaluate the disproportionality of AEs associated with tenecteplase and alteplase in real-world data, four algorithms (ROR, PRR, BCPNN, EBGM) were utilized as measures to detect signals of AEs related to both drugs. Subsequently, Breslow-Day statistical analysis was applied to compare the RORs of the main system organ classes (SOCs) and key preferred terms (PTs) between tenecteplase and alteplase.
UNASSIGNED: A statistical analysis was performed utilizing data gleaned from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, encompassing 19,514,140 case reports from 2004Q1 to 2023Q1. There were 1,004 cases where tenecteplase was reported as the primary suspected (PS) and 2,363 tenecteplase-related adverse drug reactions (ADRs) at the PTs level were identified, the two data of alteplase were 10,945 and 25,266, respectively. The occurrence of drug-induced ADRs was analyzed across 27 organ systems, The analysis revealed several expected ADRs, such as Haemorrhage, Hypersensitivity which were consistent with the two drug-labels. It is of note that the signal strengths of \'death,\' \'ventricular fibrillation,\' \'cardiogenic shock\' and \'pneumonia aspiration\' at the PT level were markedly higher for tenecteplase than for alteplase, whereas the signal strength of \'angioedema\' at the PT level was significantly higher for alteplase in comparison to tenecteplase. Additionally, unexpected significant ADRs associated with ocular adverse reactions and pneumonia aspiration at the PT level were identified, indicating potential AEs not currently mentioned in the drug instructions.
UNASSIGNED: This study identified and compared signals of ADRs associated with tenecteplase and alteplase, although tenecteplase is as effective as alteplase and has advantages such as ease of use and affordability, it cannot replace alteplase in the treatment of AIS until its safety profile is fully recognized. Additionally, previously unreported ocular ADRs and pneumonia were identified, providing valuable insights into the relationship between ADRs and the use of these thrombolytic drugs. These findings underscore the importance of continuous monitoring and effective detection of AEs to ultimately enhance the safety of AIS patients undergoing thrombolytic therapy.
摘要：
■这项研究的目的是监测，identify,并比较与替奈普酶和阿替普酶相关的不良事件（AE），目的探讨替奈普酶治疗急性缺血性卒中（AIS）的潜在安全性，并指导其使用以提高患者安全性。
■为了评估真实世界数据中与替奈普酶和阿替普酶相关的AE的不成比例性，四种算法(ROR，PRR,BCPNN,EBGM)被用作检测与两种药物相关的AE信号的措施。随后，Breslow-Day统计分析用于比较替奈普酶和阿替普酶之间的主要系统器官类别（SOC）和关键首选术语（PT）的ROR。
利用从食品和药物管理局不良事件报告系统（FAERS）数据库收集的数据进行统计分析，涵盖2004Q1至2023Q1的19,514,140例病例报告。有1,004例报告替奈普酶为主要可疑（PS），并在PT水平确定了2,363个替奈普酶相关的药物不良反应（ADR）。阿替普酶的两个数据分别为10,945和25,266。分析了27个器官系统中药物引起的ADR的发生情况，分析揭示了几个预期的ADR，比如出血，与两种药物标签一致的超敏反应。值得注意的是，死亡的信号强度，\'\'心室纤颤,替奈普酶在PT水平的“心源性休克”和“肺炎吸入”明显高于阿替普酶，而与替奈普酶相比，阿替普酶在PT水平的“血管性水肿”信号强度明显更高。此外,发现了与PT水平的眼部不良反应和肺炎吸入相关的意外重大ADR，表明药物说明书中目前未提及的潜在AE。
■这项研究确定并比较了与替奈普酶和阿替普酶相关的ADR信号，尽管替奈普酶与阿替普酶一样有效，并且具有易用性和可负担性等优点，在完全认识到其安全性之前，它不能替代阿替普酶治疗AIS。此外,先前未报告的眼部不良反应和肺炎被发现，为ADR与这些溶栓药物的使用之间的关系提供有价值的见解。这些发现强调了持续监测和有效检测AE的重要性，以最终提高接受溶栓治疗的AIS患者的安全性。
■为了评估真实世界数据中与替奈普酶和阿替普酶相关的AE的不成比例性，四种算法(ROR，PRR,BCPNN,EBGM)被用作检测与两种药物相关的AE信号的措施。随后，Breslow-Day统计分析用于比较替奈普酶和阿替普酶之间的主要系统器官类别（SOC）和关键首选术语（PT）的ROR。
利用从食品和药物管理局不良事件报告系统（FAERS）数据库收集的数据进行统计分析，涵盖2004Q1至2023Q1的19,514,140例病例报告。有1,004例报告替奈普酶为主要可疑（PS），并在PT水平确定了2,363个替奈普酶相关的药物不良反应（ADR）。阿替普酶的两个数据分别为10,945和25,266。分析了27个器官系统中药物引起的ADR的发生情况，分析揭示了几个预期的ADR，比如出血，与两种药物标签一致的超敏反应。值得注意的是，死亡的信号强度，\'\'心室纤颤,替奈普酶在PT水平的“心源性休克”和“肺炎吸入”明显高于阿替普酶，而与替奈普酶相比，阿替普酶在PT水平的“血管性水肿”信号强度明显更高。此外,发现了与PT水平的眼部不良反应和肺炎吸入相关的意外重大ADR，表明药物说明书中目前未提及的潜在AE。
■这项研究确定并比较了与替奈普酶和阿替普酶相关的ADR信号，尽管替奈普酶与阿替普酶一样有效，并且具有易用性和可负担性等优点，在完全认识到其安全性之前，它不能替代阿替普酶治疗AIS。此外,先前未报告的眼部不良反应和肺炎被发现，为ADR与这些溶栓药物的使用之间的关系提供有价值的见解。这些发现强调了持续监测和有效检测AE的重要性，以最终提高接受溶栓治疗的AIS患者的安全性。
