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Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system. 对利普瑞林相关不良事件的全面评估:美国食品药品管理局不良事件报告系统的启示。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-31 DOI: 10.1080/14740338.2024.2423680
Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao

Background: Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.

Methods: This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.

Results: A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).

Conclusion: Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.

背景:亮丙瑞林是一种促性腺激素释放激素激动剂,被广泛用于治疗激素相关疾病。本研究旨在通过研究美国食品药品管理局不良事件报告系统(FAERS)数据库中的不良事件报告,探讨和分析亮丙瑞林的安全性:本研究利用2004年第一季度至2024年第一季度的FAERS数据进行了回顾性药物警戒分析。按照系统器官类别和具体不良事件对与亮普瑞林相关的药物不良事件(ADEs)进行了识别和分类。采用比例报告率 (PRR)、报告几率比 (ROR)、贝叶斯置信度传播神经网络 (BCPNN) 和经验贝叶斯几何平均 (EBGM) 等统计方法检测安全信号:共有 63,928 例 ADE 报告涉及亮丙瑞林,其中 500 个首选术语和 25 个系统器官类别显示出明显的不相称性。值得注意的罕见ADE是先天性球海绵状肌萎缩症(n = 26;ROR 1282.72,PRR 1282.52,IC 7.91,EBGM 241.28)、滤泡性膀胱炎(n = 3;ROR 126.84,PRR 126.84,IC 6.48,EBGM 89.09)和无细胞脑膜瘤(n = 3;ROR 46.73,PRR 46.73,IC 5.34,EBGM 40.5):大多数发现都在预料之中,但也出现了一些新的信号,如以前未报道过的滤泡性膀胱炎。进一步的研究对验证这些发现至关重要,这些发现对利普瑞林的临床监测和风险识别至关重要。
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引用次数: 0
Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System. 与卡马西平相关的不良事件:使用美国食品药物管理局不良事件报告系统进行的药物警戒研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-25 DOI: 10.1080/14740338.2024.2416926
Shulan Huang, Hanlin Dong, Dongqiang Luo, Jiazhen Jiang, Manting Liu, Jiayu Wu, Xiangyun Dou, Siyuan Zhou

Introduction: Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.

Areas covered: Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.

Expert opinion: In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.

简介:卡马西平(CBZ)是一种常用的抗癫痫药物(ASM),但其药物不良反应(ADRs)会影响癫痫的成功治疗。目前关于 CBZ 相关药物不良反应的系统研究还很有限,因此有必要进行进一步调查:利用美国食品药物管理局不良事件报告系统(FAERS)数据库,我们提取了以 CBZ 为主要可疑药物的报告,并按性别和年龄进行了亚组分析。我们采用了四种风险信号检测方法 ROR、PRR、BCPNN 和 EGBM,对与 CBZ 相关的 ADR 进行了系统分析:在癫痫人群中,与CBZ相关的ADR通常涉及检查、遗传性疾病和感染。亚组分析显示,男性、女性、老年和年轻患者的ADR信号存在差异。人类疱疹病毒 6 感染和剥脱性皮炎是 CBZ 引起的一致的 ADR,不受年龄或性别的影响。研究还发现了以前被忽视的 ADR,如骨代谢异常、眼毒性和耳毒性。许多与 CBZ 相关的 ADR 仍未得到充分报告。加强对癫痫患者使用 CBZ 的监测和信息传播至关重要。必要时,应考虑调整高危人群的用药方案,并可能结合针灸、传统中药或替代抗癫痫药物。
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引用次数: 0
Drug-induced parkinsonism: diagnosis and treatment. 药物引起的帕金森病:诊断和治疗。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-25 DOI: 10.1080/14740338.2024.2418950
Hannah Conn, Joseph Jankovic

Introduction: Drug-induced parkinsonism (DIP) is one of the most common iatrogenic movement disorders. It is characterized by tremors, slowness of movement, and shuffling gait with postural instability, clinically indistinguishable from idiopathic Parkinson's disease. Prior exposure to antipsychotic medications or other dopamine receptor blocking agents (DRBAs) is required for the diagnosis.

Areas covered: This article aims to review the epidemiology, pathophysiology, clinical features, ancillary testing, and treatment of DIP. A literature search was undertaken in PubMed from January 2013 to January 2024.

Expert opinion: A clinician's suspicion of DIP must always be present when a patient develops acute to subacute onset of parkinsonism while taking a DRBA. As DIP can be indistinguishable from idiopathic PD, ancillary testing, such as DaTscans and skin biopsy searching for alpha-synuclein deposits, are often required to make a definitive diagnosis. When DIP develops, steps should be taken to discontinue the offending agent or, in the case of antipsychotics, dose reduction or change to an agent with lower risk for DIP, such as quetiapine or clozapine. Prophylactic treatment with anticholinergics is not indicated.

简介药物诱发帕金森病(DIP)是最常见的先天性运动障碍之一。其特点是震颤、行动迟缓、步态不稳,临床上与特发性帕金森病无异。确诊时需要先服用抗精神病药物或其他多巴胺受体阻断剂(DRBAs):本文旨在回顾 DIP 的流行病学、病理生理学、临床特征、辅助检查和治疗。在PubMed上搜索了2013年1月至2024年1月的文献:当患者在服用 DRBA 时出现急性或亚急性帕金森病发作时,临床医生必须始终怀疑 DIP 的存在。由于 DIP 可能与特发性帕金森病难以区分,因此通常需要进行辅助检查,如 DaTscans 和皮肤活检,以寻找α-突触核蛋白沉积物,从而做出明确诊断。当出现 DIP 时,应采取措施停用违规药物,如果是抗精神病药物,则应减少剂量或改用 DIP 风险较低的药物,如喹硫平或氯氮平。无需使用抗胆碱能药物进行预防性治疗。
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引用次数: 0
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine. 针对吉西他滨的 FDA 不良事件报告系统 (FAERS) 真实世界药物警戒研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-24 DOI: 10.1080/14740338.2024.2419999
Cheng Zhang, Ke Li, Shu-Ning Xu, Lei Qiao, Yu-Lin Ren, Qun Li, Ying Liu

Background: Gemcitabine is widely used in the treatment of various cancers. This study aims to evaluate gemcitabine-associated adverse events (AEs) using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Research design and methods: We analyzed data spanning from January 2004 to June 2023. Employing reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) algorithms, we identified AEs with positive signals in patients administered gemcitabine.

Results: Out of 16,623,939 reports, 23,645 involved gemcitabine as the 'primary suspected (PS)' resulting in 74,306 AEs. Consistent with the reports in the specification and clinical trials, thrombocytopenia, pyrexia, neutropenia, and anemia were the most common AEs. Notably, our study identified some unexpected AEs such as abdominal pain, pleural effusion, ascites, and gastrointestinal hemorrhage, among others. The most significant SOC was 'Blood and lymphatic system disorders'. The median onset time for gemcitabine-related AEs was 24 days (interquartile range [IQR] 6-82 days), with most cases occurring within the initial 30 days following gemcitabine administration.

Conclusion: Gemcitabine is associated with a broad spectrum of AEs affecting multiple organ systems, with a notable incidence of hospitalization. The study highlights both expected and unexpected AEs, which could enhance future clinical applications and safety of gemcitabine.

背景:吉西他滨被广泛用于治疗各种癌症。本研究旨在利用美国食品和药物管理局不良事件报告系统(FAERS)数据库评估吉西他滨相关不良事件(AEs):我们分析了2004年1月至2023年6月的数据。采用报告几率比(ROR)和贝叶斯置信传播神经网络(BCPNN)算法,我们确定了吉西他滨用药患者中出现阳性信号的 AEs:在16,623,939份报告中,有23,645份涉及吉西他滨作为 "主要疑似药物(PS)",导致74,306例AE。与规范和临床试验中的报告一致,血小板减少、发热、中性粒细胞减少和贫血是最常见的不良反应。值得注意的是,我们的研究发现了一些意外的 AE,如腹痛、胸腔积液、腹水和消化道出血等。最重要的SOC是 "血液和淋巴系统疾病"。吉西他滨相关AEs的中位发病时间为24天(四分位数间距[IQR] 6-82天),大多数病例发生在服用吉西他滨后的最初30天内:结论:吉西他滨与影响多个器官系统的广泛AEs有关,住院治疗的发生率很高。本研究强调了预期和意外的AEs,这可能会提高吉西他滨未来的临床应用和安全性。
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引用次数: 0
Comparison of adverse events of poly adenosine diphosphate ribose polymerase inhibitors in patients with ovarian cancer using the United States Food and Drug Administration Adverse Event Reporting System. 利用美国食品药品监督管理局不良事件报告系统对卵巢癌患者使用多聚腺苷二磷酸核糖聚合酶抑制剂的不良事件进行比较。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-23 DOI: 10.1080/14740338.2024.2418333
Toru Ogura, Chihiro Shiraishi

Background: Olaparib, niraparib, and rucaparib are the three primary poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors that are currently available in the market. Previous studies indicate different incidences of adverse events based on the PARP inhibitor or country.

Research design and methods: This study used data from the United States Food and Drug Administration Adverse Event Reporting System collected between January 2018 and December 2023. The data analyzed in this study involved patients receiving PARP inhibitors for treating ovarian cancer. A comparative analysis of the three PARP inhibitors was conducted using the reporting odds ratio (ROR) and the adjusted ROR (aROR) controlling for patient background differences.

Results: The aROR for niraparib was significant at > 1.000, including platelet count decreased (p < 0.001) and thrombocytopenia (p < 0.001) when olaparib was set as the reference. Conversely, the aROR for niraparib was significant at < 1.000, including anemia (p < 0.001). Additionally, significant differences were observed in various adverse events for rucaparib. Moreover, significant differences were observed when comparing between countries.

Conclusions: This study indicates that the types of adverse events may vary by PARP inhibitor and by country. These results will be beneficial in clinical practice.

背景:奥拉帕利(Olaparib)、尼拉帕利(niraparib)和鲁卡帕利(rucaparib)是目前市场上三种主要的多(腺苷二磷酸核糖)聚合酶(PARP)抑制剂。以往的研究表明,PARP抑制剂或国家不同,不良事件的发生率也不同:本研究使用的数据来自美国食品和药物管理局不良事件报告系统,收集时间为 2018 年 1 月至 2023 年 12 月。本研究分析的数据涉及接受PARP抑制剂治疗卵巢癌的患者。使用报告几率(ROR)和控制患者背景差异的调整ROR(aROR)对三种PARP抑制剂进行了比较分析:结果:尼拉帕利的aROR大于1.000,包括血小板计数下降(p p p 结论:尼拉帕利的aROR显著大于1.000:这项研究表明,不同 PARP 抑制剂和不同国家的不良事件类型可能有所不同。这些结果将有助于临床实践。
{"title":"Comparison of adverse events of poly adenosine diphosphate ribose polymerase inhibitors in patients with ovarian cancer using the United States Food and Drug Administration Adverse Event Reporting System.","authors":"Toru Ogura, Chihiro Shiraishi","doi":"10.1080/14740338.2024.2418333","DOIUrl":"10.1080/14740338.2024.2418333","url":null,"abstract":"<p><strong>Background: </strong>Olaparib, niraparib, and rucaparib are the three primary poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors that are currently available in the market. Previous studies indicate different incidences of adverse events based on the PARP inhibitor or country.</p><p><strong>Research design and methods: </strong>This study used data from the United States Food and Drug Administration Adverse Event Reporting System collected between January 2018 and December 2023. The data analyzed in this study involved patients receiving PARP inhibitors for treating ovarian cancer. A comparative analysis of the three PARP inhibitors was conducted using the reporting odds ratio (ROR) and the adjusted ROR (aROR) controlling for patient background differences.</p><p><strong>Results: </strong>The aROR for niraparib was significant at > 1.000, including platelet count decreased (<i>p</i> < 0.001) and thrombocytopenia (<i>p</i> < 0.001) when olaparib was set as the reference. Conversely, the aROR for niraparib was significant at < 1.000, including anemia (<i>p</i> < 0.001). Additionally, significant differences were observed in various adverse events for rucaparib. Moreover, significant differences were observed when comparing between countries.</p><p><strong>Conclusions: </strong>This study indicates that the types of adverse events may vary by PARP inhibitor and by country. These results will be beneficial in clinical practice.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A real-world adverse events study of rimegepant from the FAERS database. 来自 FAERS 数据库的利眠宁实际不良事件研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-23 DOI: 10.1080/14740338.2024.2418319
Hong Pan, Shasha Lin

Background: The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.

Research design and methods: This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).

Results: This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.

Conclusions: This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.

研究背景本研究的主要目的是利用美国食品和药物管理局不良事件报告系统(FAERS)资料库对利美昔康(rimegepant)进行详尽评估:本研究下载了2020年第二季度至2024年第一季度与rimegepant相关的报告文件。结果:本研究分析了 6659 例药物不良事件(ADEs):本研究分析了 6659 份与利美喷作为主要可疑 (PS) 药物相关的 ADE 报告。在对系统器官类别(SOCs)的不成比例分析中,利美喷剂的重要信号是一般疾病和用药部位条件。信号强度较高的前 5 个 ADE 为药物过度使用性头痛、鼻水肿、紧张性头痛、工作状态下降和晕车。最常见的 ADE 为恶心、感觉异常、上腹部疼痛、嗜睡和过敏。此外,我们还需要注意说明书中未提及但具有临床意义的 ADE:眩晕、听觉异常、嗜睡、雷诺现象、晕车、惊恐发作和恐惧:本研究强调了以前未认识到的与使用利美喷相关的安全问题。这些新的安全问题表明,虽然这些治疗方法可能有效,但可能还需要进一步探讨其他风险。
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引用次数: 0
Mining and analysis of adverse event signals for alendronate based on the real-world data of FDA adverse event reporting system database. 基于 FDA 不良事件报告系统数据库的真实世界数据,挖掘和分析阿仑膦酸钠的不良事件信号。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-22 DOI: 10.1080/14740338.2024.2419995
Ziyi Zhao, Hongxiang Ji, Chenghao Zhang, Zhengdan Wang, Shengquan Ren, Chunlei Liu, Caifeng Wu, Jian Wang, Xiaoheng Ding

Objective: Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database.

Methods: The AE data associated with alendronate between the first quarter of 2004 and the first quarter of 2024 were selected. Various signal quantification methods, including the ROR, PRR, BCPNN, and EBGM, were applied for analysis.

Results: In 34,943 reports where alendronate was the primary suspected drug for the AE, 24 affected system organ classes and 1046 significant preferred terms were identified in this study. Several significant AEs beyond drug instructions with strong signals were determined, including low turnover osteopathy, fracture delayed union, fracture nonunion, loss of anatomical alignment after fracture reduction, fracture malunion, periprosthetic fracture, carotid bruit, oral fibroma, traumatic occlusion, and phlebolith. The median time to onset of alendronate-related AEs was 306 days (interquartile range [IQR] 12-1,461 days), and the majority of cases occurred 2 years later (18.80%) and within 30 days (14.49%).

Conclusions: The current study detected multiple potential new AE signals for alendronate, and more clinical research is required to further validate our results and clarify their associations.

研究目的我们的研究旨在评估美国 FDA 不良事件报告系统数据库中与阿仑膦酸钠相关的不良事件(AEs):方法:选取 2004 年第一季度至 2024 年第一季度与阿仑膦酸钠相关的 AE 数据。应用各种信号量化方法进行分析,包括 ROR、PRR、BCPNN 和 EBGM:在 34,943 份阿仑膦酸钠为 AE 主要可疑药物的报告中,本研究确定了 24 个受影响的系统器官类别和 1046 个重要首选术语。除药物说明书外,还确定了几种具有强烈信号的重要 AE,包括低翻转骨病、骨折延迟愈合、骨折不愈合、骨折复位后解剖对位丧失、骨折错位、假体周围骨折、颈动脉淤血、口腔纤维瘤、创伤性闭塞和静脉结石。阿仑膦酸盐相关AE的中位发病时间为306天(四分位距[IQR] 12-1,461天),大多数病例发生在2年后(18.80%)和30天内(14.49%):目前的研究发现了阿仑膦酸钠多种潜在的新 AE 信号,还需要更多的临床研究来进一步验证我们的结果并明确其关联性。
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引用次数: 0
Mining and analysis of adverse event signals of vandetanib based on the FAERS database. 基于 FAERS 数据库挖掘和分析凡德他尼的不良事件信号。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-22 DOI: 10.1080/14740338.2024.2418326
Ying Zhou, Na Li, Guowei Ma, Ning Su, Jiang Liu, Wenxi Yue, Rui Yin, Jie Chen

Objective: By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.

Methods: This study provides signal detection and analysis of AEs associated with vandetanib using the FAERS from Q2 2011 to Q1 2023.

Results: Disproportionality analyses were conducted using the ROR and the MHRA method, with AEs categorized and described based on SOC and PT from the MedDRA. A total of 1,721 AEs reports identified vandetanib as the primary suspect. The analyses yielded 187 AEs signals across 20 SOCs categories, with 47 signals not previously reported in the vandetanib labeling. Additionally, the study analyzes factors influencing AEs. The results are as follows: There are significant differences in Investigations based on gender and nationality (p < 0.05); skin and subcutaneous tissue disorders and gastrointestinal disorders exhibit differences based on gender, age, and nationality (p < 0.05).

Conclusion: Common AEs signals identified align with those documented in the drug labeling. However, AEs such as tumor lysis syndrome, skin discoloration, and pigmentary disorders, which are not listed in the labeling, warrant special attention. It is essential that abnormalities in patients' skin and laboratory indicators are closely monitored and addressed promptly to safeguard medication safety.

目的:通过分析凡德他尼AEs的信号挖掘,为临床合理用药提供参考:通过对凡德他尼AEs的信号挖掘分析,为临床合理用药提供参考:本研究利用FAERS对2011年第二季度至2023年第一季度与凡德他尼相关的AE进行信号检测和分析:使用 ROR 和 MHRA 方法进行了比例失调分析,根据 MedDRA 中的 SOC 和 PT 对 AE 进行了分类和描述。共有1,721份AEs报告确定凡德他尼为主要疑似药物。分析得出了 187 个 AEs 信号,涉及 20 个 SOCs 类别,其中 47 个信号以前未在凡德他尼标签中报告过。此外,研究还分析了影响 AEs 的因素。结果如下基于性别和国籍的调查存在重大差异(p p 结论:发现的常见 AEs 信号与药物标签中记录的一致。然而,诸如肿瘤溶解综合征、皮肤变色和色素失调等未在标签中列出的 AEs 值得特别关注。必须密切监测并及时处理患者的皮肤和实验室指标异常,以保障用药安全。
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引用次数: 0
Correction. 更正。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-22 DOI: 10.1080/14740338.2024.2420148
{"title":"Correction.","authors":"","doi":"10.1080/14740338.2024.2420148","DOIUrl":"https://doi.org/10.1080/14740338.2024.2420148","url":null,"abstract":"","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adverse events associated with tezepelumab: a safety analysis of clinical trials and a pharmacovigilance system. 与替塞普鲁单抗相关的不良事件:临床试验和药物警戒系统的安全性分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-22 DOI: 10.1080/14740338.2024.2416921
Zhenyu Mao, Yuchen Huang, Xiaoyan Zhu, Pengdou Zheng, Lingling Wang, Fengqin Zhang, Wei Liu, Huiguo Liu, Wenhui Liao, Ling Zhou

Background: Tezepelumab is the first asthma biologic approved by the FDA that is not restricted by biomarker phenotypes. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of tezepelumab.

Research design and methods: This study included a comprehensive evaluation of AE reports related to tezepelumab since its approval (4th quarter of 2021 to 1st quarter of 2024) using the FAERS database, and compared with the currently reported clinical trial results (ClinicalTrials.gov).

Results: A total of 2153 reports of tezepelumab-related AEs were extracted. 256 preferred terms (PTs) of adverse reactions involving 27 system organ classes were identified. Significant AEs that were not reported on the drug label, such as 'dyspnea,' 'body temperature,' and 'tongue pruritus,' were reported. The median time to onset (TTO) of tezepelumab-related AEs was 35 days.The most frequent AEs in different sexes were 'arthralgia' and 'dyspnea,' with differences in signal strength ranking between the sexes.

Conclusions: This study represents the largest report to date on tezepelumab-related AEs, providing valuable insights into the potential side effects of tezepelumab. This work is crucial for the broader clinical application of this novel biologic and improving outcomes for patients with severe asthma.

背景特珠单抗是美国食品药品管理局批准的首个不受生物标记物表型限制的哮喘生物制剂。迄今为止,尚未有研究报告与特珠单抗实际使用相关的不良事件(AEs):这项研究包括利用FAERS数据库对替塞普鲁单抗获批以来(2021年第四季度至2024年第一季度)的相关AE报告进行全面评估,并与目前报告的临床试验结果(ClinicalTrials.gov)进行比较:结果:共提取了2153份与替塞普鲁单抗相关的AEs报告。确定了涉及 27 个系统器官类别的 256 个不良反应首选术语 (PT)。报告了药物标签上未报告的重要不良反应,如 "呼吸困难"、"体温 "和 "舌头瘙痒"。不同性别最常见的不良反应是 "关节痛 "和 "呼吸困难",不同性别的信号强度排名存在差异:这项研究是迄今为止关于替塞单抗相关不良反应的最大规模报告,为了解替塞单抗的潜在副作用提供了宝贵的信息。这项工作对于这种新型生物制剂更广泛的临床应用以及改善重症哮喘患者的治疗效果至关重要。
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引用次数: 0
期刊
Expert Opinion on Drug Safety
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