Adverse drug events

药物不良事件
  • 文章类型: Case Reports
    选择性5-羟色胺再摄取抑制剂与出血风险增加有关,最常见的颅内和胃出血,特别是与抗凝剂一起使用。虽然不常见,艾司西酞普兰与鼻出血呈剂量依赖性。在管理中减少剂量可能是足够的。
    Selective serotonin reuptake inhibitors are associated with an increased risk of bleeding, most commonly intracranial and gastric bleeding, especially in conjunction with anticoagulant use. Although uncommon, escitalopram is associated with epistaxis in a dose-dependent manner. Dosage reduction may be sufficient in management.
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  • 文章类型: Case Reports
    Secukinumab(Cosentyx),一种白细胞介素-17A靶向生物制剂,通常是牛皮癣的处方,银屑病关节炎,和脊柱关节炎(SpA)。斑秃(AA),一种以无疤痕脱发为特征的IL-17介导的自身免疫性疾病,特别是在一种蛇形模式中,代表与苏金单抗治疗相关的罕见不良反应。我们介绍了一例46岁的女性SpA正在接受苏金单抗治疗,他发展出了AA的蛇虫病模式,随后在停药后经历再生。患者的临床过程和治疗反应是详细的,同时讨论了苏金单抗诱导AA的潜在病理生理机制。此外,我们提供了对现有文献的回顾,讨论类似的病例,并在此不良事件的免疫学基础上提出假设。本报告强调了识别和管理苏金单抗诱导的AA的重要性,强调需要进一步调查和量身定制的治疗方法在受影响的患者。
    Secukinumab (Cosentyx), an interleukin-17A-targeting biological agent, is commonly prescribed for psoriasis, psoriatic arthritis, and spondyloarthritis (SpA). Alopecia areata (AA), an IL-17-mediated autoimmune disorder characterized by nonscarring hair loss, particularly in an ophiasis pattern, represents a rare adverse effect associated with secukinumab therapy. We present a case of a 46-year-old female with SpA undergoing secukinumab treatment, who developed an ophiasis pattern of AA, subsequently experiencing regrowth upon medication discontinuation. The patient\'s clinical course and treatment response are detailed, alongside a discussion on the potential pathophysiological mechanisms underlying secukinumab-induced AA. Additionally, we provide a review of existing literature, discussing similar cases and proposing hypotheses on the immunological basis of this adverse event. This report underscores the importance of recognizing and managing secukinumab-induced AA, highlighting the need for further investigation and tailored therapeutic approaches in affected patients.
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  • 文章类型: Case Reports
    Romosozumab是一种针对硬化蛋白的人源化单克隆抗体,调节骨形成和吸收。它是一种治疗绝经后妇女骨质疏松症的新疗法。关于romosozumab心血管安全性的证据是相互矛盾的。我们报告了第一个上市后证明心脏事件的案例(即,房颤和充血性心力衰竭)可能由romosozumab引发的骨质疏松症女性患者。关于romosozumab和心血管疾病的文献综述被广泛讨论。对于具有心血管危险因素的骨质疏松患者(例如,高血压,冠状动脉疾病,和中风),在处方romosozumab之前,应权衡骨折预防的益处和潜在的心血管风险.关于上市后监测的真实世界数据将揭示romosozumab的潜在安全信号。
    Romosozumab is a humanized monoclonal antibody that targets the sclerostin protein, which regulates bone formation and resorption. It is a novel therapy in the treatment of post-menopausal women with osteoporosis. The evidence regarding romosozumab\'s cardiovascular safety is conflicting. We report the first post-marketing case demonstrating cardiac events (i.e., atrial fibrillation and congestive heart failure) in a female patient with osteoporosis likely triggered by romosozumab. A literature review on romosozumab and cardiovascular disease is discussed extensively. For osteoporotic patients with cardiovascular risk factors (e.g., hypertension, coronary artery disease, and stroke), the benefits of fracture prevention should be weighed against potential cardiovascular risks before prescribing romosozumab. Real-world data on post-marketing surveillance will shed light on the potential safety signals of romosozumab.
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  • 文章类型: Case Reports
    万古霉素是一种广泛使用的三环糖肽抗生素,用于治疗各种革兰氏阳性感染,包括艰难梭菌结肠炎。虽然总体上被认为是安全的,它与一些副作用有关。在这个案例报告中,我们强调了一种罕见的不良反应,患者在口服万古霉素治疗后出现慢性畏光.这揭示了口服万古霉素治疗与畏光之间的潜在关系,强调需要提高临床实践的认识,并敦促进一步调查这种关联。
    Vancomycin is a widely used tricyclic glycopeptide antibiotic for treating various Gram-positive infections, including Clostridium difficile colitis. Although considered generally safe, it has been associated with several side effects. In this case report, we highlight a rare adverse effect in which a patient experienced chronic photophobia following treatment with oral vancomycin. This sheds light upon a potential relationship between oral vancomycin therapy and photophobia, emphasizing the need for increased awareness in clinical practice and urging further investigation into this association.
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  • 文章类型: Case Reports
    本报告是第一个介绍在接受阿达木单抗治疗时出现细菌性脓肿性前列腺炎的患者的病例。肿瘤坏死因子-α阻断治疗,化脓性汗腺炎.一名36岁的男性出现持续的肛门生殖器疼痛和排尿困难约三周。在急诊室(ER)演示的前两天,我们进行了橡皮筋结扎,以解决疑似痔疮的I-II期.在急诊室,临床和实验室检查提示急性前列腺炎,促使开始抗生素治疗。如果没有足够的回应,进行了磁共振成像,确定了源自右前列腺叶的复杂脓肿和瘘管系统。插入排水管后,阿达木单抗停药,加强了抗生素治疗,导致脓肿的解决。六周后,随访显示患者无症状。该病例突出了使用免疫调节药物的患者的罕见不良事件,并可能帮助医生在未来处理类似病例。免疫调节药物可导致年轻患者前列腺脓肿的发展,在罕见的病例中,有必要进行低阈值的专心和仔细的临床检查,以进行进一步的诊断检查。
    This report is the first to present the case of a patient who developed bacterial abscess-forming prostatitis while undergoing treatment with adalimumab, a tumor necrosis factor-alpha blocking therapy, for hidradenitis suppurativa. A 36-year-old male presented with persistent anogenital pain and dysuria for approximately three weeks. Two days before presentation at the emergency room (ER), a rubber band ligation was performed to address suspected hemorrhoids stages I-II. In the ER, clinical and laboratory examinations suggested acute prostatitis, prompting the initiation of antibiotic therapy. In the absence of an adequate response, magnetic resonance imaging was performed, which identified a complex abscess and fistulation system originating from the right prostatic lobe. Following the insertion of a drain, adalimumab was discontinued, and antibiotic therapy was intensified, resulting in the resolution of the abscess. After six weeks, follow-up showed the patient to be free of symptoms. This case highlights a rare adverse event of patients using immunomodulating medications and may help physicians to manage similar cases in the future. Immunomodulating drugs can lead to the development of prostatic abscesses in young patients, necessitating attentive and careful clinical examination with a low threshold for further diagnostic workup in uncommon case presentations.
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  • 文章类型: Case Reports
    Denosumab是一种人类单克隆抗体,适用于骨质疏松症和骨折高风险患者。它的目标是RANKL,NF-κB受体激活剂(RANK)配体,阻断RANKL-RANK相互作用并导致快速破骨细胞介导的骨吸收抑制。但是RANK在神经元中广泛表达,小胶质细胞,和星形胶质细胞。RANKL/RANK/NF-κB系统在神经炎症反应中发挥重要作用,抑郁行为,记忆障碍,和神经营养。我们在2012年至2022年期间,提供了两份记录良好的Denosumab治疗患者复发神经精神表现的病例报告,并对食品和药物管理局不良事件报告系统(FAERS)数据库中报告的类似病例进行了描述性审查。只有医疗保健专业人员报告的,将denosumab编码为唯一的可疑药物,被保留。一名患有轻度认知障碍的81岁女性患有两次急性混乱发作,另一名患有抑郁症缓解期的81岁女性患有两次抑郁复发,伴有焦虑和精神运动抑制,在这两种情况下,连续服用地诺塞马后,没有潜在的钙/磷酸盐失衡。Naranjo药品不良反应概率量表评分分别为6分和7分,表明可能的因果关系。在FAERS报告的91,151例Denosumab暴露病例中,5.7%与精神/神经系统疾病有关,其中23.8%与认知障碍有关,抑郁/情绪障碍,或者精神运动迟钝.Denosumab可能通过涉及RANKL阻断和随后的免疫炎症变化的几种机制引起短暂但严重的神经精神症状。至少在预先存在神经生物学脆弱性的受试者中。我们建议在denosumab给药后谨慎并仔细监测这些患者。
    Denosumab is a human monoclonal antibody indicated for patients with osteoporosis and a high risk of fractures. It targets RANKL, the receptor activator of NF-κB (RANK) ligand, blocking RANKL-RANK interaction and leading to rapid osteoclast-mediated bone resorption inhibition. But RANK is widely expressed in neurons, microglia, and astrocytes. RANKL/RANK/NF-κB system can play an important role in the neuroinflammatory response, depressive behavior, memory impairments, and neurotrophism. We present two well-documented case reports of recurrent neuropsychiatric manifestations in patients treated with denosumab and a descriptive review of similar cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database between 2012 and 2022. Only those reported by healthcare professionals, coding denosumab as the only suspected drug, were retained. An 81-year-old woman with pre-existing mild cognitive impairment suffered two acute confusional episodes and another 81-year-old woman with depression in remission suffered two depressive recurrences with anxiety and psychomotor inhibition, in both cases following sequential administrations of denosumab without underlying calcium/phosphate imbalance. Scores on Naranjo Adverse Drug Reaction Probability Scale were 6 and 7, respectively, suggesting a probable causal relationship. Of the 91,151 cases with denosumab exposure reported to FAERS, 5.7% were related to psychiatric/neurological disorders and 23.8% of these corresponded to cognitive impairment, depressive/mood disturbances, or psychomotor retardation. Denosumab may cause transient but severe neuropsychiatric symptoms by several mechanisms involving RANKL blockade and subsequent immuno-inflammatory changes, at least in subjects with pre-existing neurobiological vulnerability. We recommend caution and careful monitoring of these patients following denosumab administrations.
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  • 文章类型: Journal Article
    背景:虽然许多药物组都与老年人跌倒有关,关于风险的绝对增加以及这些风险在不同药物组或个体之间的差异知之甚少.
    方法:我们在Tayside和Fife苏格兰地区65岁以上人群中进行了一项基于人群的巢式病例对照研究。病例是2010年至2020年之间因骨折住院的个体,我们匹配了多达10名对照。我们检查了被称为“跌倒风险增加药物”(FRID)的药物组的相对和绝对风险,单独和组合,以及年轻和年长(≥75岁)的成年人。根据以前的住院情况进行调整,药物使用和实验室数据,我们使用条件逻辑回归量化药物暴露与结局之间的关联.我们进行了四次敏感性分析,以测试我们发现的稳健性。
    结果:该队列包括246,535名年龄≥65岁的人,其中18,456人遭受了意外骨折。大多数FRID检查的骨折风险显著增加。老年人与年轻人的绝对风险更大,并且相对和绝对风险随着FRID的合并数量而增加。总的来说,选择性5-羟色胺再摄取抑制剂的年龄≥75岁人群的绝对风险增加最高(伤害所需的人数为53),三环抗抑郁药(NNH81),抗精神病药(NNH75)和使用三种或更多种FRID(NNH≤66)。
    结论:年龄≥75岁的患者服用抗抑郁药或抗精神病药或服用增加跌倒风险的三种或更多种药物可能从处方干预措施中获益最大。
    while many drug groups are associated with falls in older people, less is known about absolute increases in risk and how these risks vary across different groups of drugs or individuals.
    we conducted a population based nested case-control study among people aged ≥65 years in the Scottish regions of Tayside and Fife. Cases were individuals hospitalised with a fracture between 2010 and 2020, to whom we matched up to 10 controls. We examined relative and absolute risks of drug groups known as \'Fall-Risk-Increasing Drugs\' (FRIDs), alone and in combination, and among younger and older (≥75 years) adults. Adjusting for previous hospitalisations, drug use and laboratory data, we used conditional logistic regression to quantify associations between drug exposures and outcomes. We conducted four sensitivity analyses to test the robustness of our findings.
    the cohort comprised 246,535 people aged ≥65 years, of whom 18,456 suffered an incident fracture. Fracture risks were significantly increased for most FRIDs examined. Absolute risks were much larger among older vs younger people and both relative and absolute risks increased with the number of FRIDs combined. Overall, the highest absolute increase in risk were found in people aged ≥75 years for selective serotonin reuptake inhibitors (number needed to harm 53), tricyclic antidepressants (NNH 81), antipsychotics (NNH 75) and use of three or more FRIDs (NNH ≤66).
    patients aged ≥75 years prescribed antidepressants or antipsychotics or taking three or more drugs that increase risk of falls may benefit most from deprescribing interventions.
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  • 文章类型: Case Reports
    卡托普利的使用与以腮腺肿大为特征的罕见不良事件有关。我们报告了一例未控制的高血压患者卡托普利引起的腮腺肿大。一名57岁的男性因头痛而出现在急诊科(ED)。该患者具有未经治疗的高血压的背景,在急诊科(ED)通过舌下施用卡托普利12.5mg来控制血压。药物管理后不久,他开始经历双侧无痛性腮腺肿大,在停药几小时后缓解。
    The use of captopril has been linked to scarce adverse events characterized by parotid glands enlargement. We report a case of captopril-induced parotid enlargement in a patient with uncontrolled hypertension. A 57-year-old male presented to the emergency department (ED) with an acute state of headache. The patient has a background of untreated hypertension for which he was managed in the emergency department (ED) by the administration of captopril 12.5 mg sublingually to control his blood pressure. Shortly after the drug administration, he started to experience bilateral painless enlargement of parotid glands that resolved a few hours after the drug was withdrawn.
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  • 文章类型: Review
    重症肌无力(MG)是一种罕见的自身免疫性疾病,可能威胁患者的生命。针对神经肌肉接头结构的自身抗体,特别是乙酰胆碱受体(AchR),常存在于MG患者的血清中。自从引入疫苗接种以来,很少有报道在SARS-CoV-2疫苗接种后出现新的MG。据报道,感染和COVID-19感染可能是肌无力危机的诱因。我们报告了一例接受COVID-19mRNA疫苗接种后新发MG的病例。该患者是一名73岁的男性,最初表现为眼部症状并迅速普及。我们还对SARS-CoV-2免疫后的26例MG进行了文献修订。患者大多数是男性,在第一剂疫苗后出现广泛性迟发性MG,和我们的病人相似.只有我们的病人出现胸腺瘤。胸腺质量和AchR抗体的阳性表明,疫苗接种可能引发了亚临床先前存在的MG,症状明显。临床医生应该意识到COVID-19疫苗接种后可能出现的新发MG,特别是在有风险的患者中。尽管应建议MG患者接种COVID-19疫苗,特别是在补偿良好的患者中。然而,未来需要进行更多的研究。
    Myasthenia gravis (MG) is a rare autoimmune disease that is potentially threatening for patient life. Auto-antibodies targeting structures of the neuromuscular junction, particularly the acetylcholine receptor (AchR), are often found in the serum of MG patients. New-onset MG after SARS-CoV-2 vaccination has rarely been reported since the introduction of vaccination. Infections and COVID-19 infection have also been reported as possible triggers for a myasthenic crisis. We report a case of new-onset MG after receiving the mRNA COVID-19 vaccination. The patient was a 73-year-old male initially presenting with ocular symptoms and a rapid generalization. We also performed a literature revision of 26 described cases of MG after SARS-CoV-2 immunization. The patients were a majority of males with generalized late-onset MG occurring after the first dose of vaccine, similar to our patient. Only our patient showed a thymoma. Thymic mass and the positivity of AchR antibodies suggest that vaccination might have triggered a subclinical pre-existing MG with symptoms flaring. Clinicians should be aware of possible new-onset MG after COVID-19 vaccination, particularly in at-risk patients. Even though COVID-19 vaccination should be recommended in MG patients, particularly in well-compensated patients. However, more studies need to be performed in the future.
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  • 文章类型: Journal Article
    在过去的十年里,越来越多的用户开始在社交媒体平台上报告药物不良事件(ADE),博客,健康论坛。鉴于大量报告,药物警戒专注于使用自然语言处理(NLP)技术快速检查这些大型文本集合的方法,检测药物相关不良反应的提及,以引发医学调查。然而,尽管人们对这项任务和NLP的进步越来越感兴趣,面对否定和猜测等语言现象,这些模型的鲁棒性是一个悬而未决的研究问题。否定和猜测是自然语言中普遍存在的现象,会严重阻碍自动化系统区分文本中的事实陈述和非事实陈述的能力。在这篇文章中,我们考虑了四个最先进的系统,用于在社交媒体文本上检测ADE。我们介绍SAX,一个基准,用于测试它们对含有否定和推测的ADE的样品的性能,显示了他们对这些现象的脆弱性。然后,我们引入两种可能的策略来增加这些模型的稳健性,表明它们都带来了性能的显着提高,将模型预测的虚假实体数量减少60%的否定和80%的猜测。
    In the last decade, an increasing number of users have started reporting adverse drug events (ADEs) on social media platforms, blogs, and health forums. Given the large volume of reports, pharmacovigilance has focused on ways to use natural language processing (NLP) techniques to rapidly examine these large collections of text, detecting mentions of drug-related adverse reactions to trigger medical investigations. However, despite the growing interest in the task and the advances in NLP, the robustness of these models in face of linguistic phenomena such as negations and speculations is an open research question. Negations and speculations are pervasive phenomena in natural language and can severely hamper the ability of an automated system to discriminate between factual and non-factual statements in text. In this article, we take into consideration four state-of-the-art systems for ADE detection on social media texts. We introduce SNAX, a benchmark to test their performance against samples containing negated and speculated ADEs, showing their fragility against these phenomena. We then introduce two possible strategies to increase the robustness of these models, showing that both of them bring significant increases in performance, lowering the number of spurious entities predicted by the models by 60% for negation and 80% for speculations.
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