Adverse drug reactions

药物不良反应
  • 文章类型: Journal Article
    先前的研究表明,双膦酸盐(BP)可以改善牙周病,因为它们具有抗骨质疏松症的特性。体外研究表明,BP诱导细胞毒性,抑制伤口愈合,从而影响牙周病。Denosumab和BPs有替代适应症。BP和denosumab与牙龈疾病无关。我们通过对美国FDA不良事件报告系统(FAERS)数据库中的数据应用贝叶斯和非比例分析来评估这种关系。该研究分析了BP和denosumab报告的事件,并在狭窄的牙龈疾病标准化MedDRAQueries中找到了首选术语。总共有5863例报告的牙龈疾病与5个BP(阿仑膦酸盐,帕米膦酸盐,伊班膦酸钠,利塞膦酸盐,和唑来膦酸)和地诺单抗。超过15%的与BPs和除denosumab以外的denosumab相关的牙龈疾病患者在短期或长期住院。我们的发现表明BP和denosumab具有显著的报告优势比(ROR),比例报告比率(PRR),和关于牙龈疾病的信息成分(IC)。帕米膦酸盐具有最高的相关性(ROR=64.58,PRR=57.99,IC=5.71),而与denosumab的相关性最弱(ROR=3.61,PRR=3.60,IC=1.77)。发现六种药物与牙龈疼痛之间存在显着关联,牙龈衰退,牙龈炎,牙周病,和牙周炎。总之,我们对相关性的全面概述,临床特征,BPs和与denosumab相关的牙龈疾病的预后表明,这些问题值得继续监测和适当管理。
    Prior research has indicated that bisphosphonates (BPs) can improve periodontal disease because of their anti-osteoporosis properties. In vitro studies have shown that BPs induce cytotoxicity, inhibit wound healing, and thus affect periodontal disease. Denosumab and BPs have alternative indications. BP and denosumab are not known to correlate with gingival disorders. We assessed such a relationship by applying Bayesian and nonproportional analyses to data in the US FDA Adverse Event Reporting System (FAERS) database. The study analyzed BPs and denosumab-reported incidents with preferred terms found in the narrow Standardized MedDRA Queries for gingival disorders. A total of 5863 reported cases of gingival disorders were associated with five BPs (alendronate, pamidronate, ibandronate, risedronate, and zoledronate) and denosumab. More than 15% of patients with gingival disorders related to BPs and denosumab other than denosumab were hospitalized over short- or long-term periods. Our findings indicated BPs and denosumab had significant reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) with respect to gingival disorders. Pamidronate had the highest association (ROR = 64.58, PRR = 57.99, IC = 5.71), while the weakest association was found with denosumab (ROR = 3.61, PRR = 3.60, IC = 1.77). Significant associations were found between the six drugs and gingival pain, gingival recession, gingivitis, periodontal disease, and periodontitis. In conclusion, our comprehensive overview of the correlations, clinical characteristics, and prognoses of BPs and denosumab-related gingival disorders suggests that these issues deserve continued surveillance and appropriate management.
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  • 文章类型: Case Reports
    非甾体抗炎药(NSAID)广泛用于各种疾病,但与许多药物不良反应(ADR)有关。了解这些不良反应对于降低发病率和死亡率是必要的。NSAID诱导的血管性水肿,虽然罕见,可能危及生命,并且通常是由于COX途径抑制产生的白三烯增加。肥大细胞和嗜碱性粒细胞脱颗粒在其发病机制中起着至关重要的作用。迅速识别并立即停止犯罪药物,伴随着皮质类固醇和抗组胺药的服用,是必不可少的。这里,我们报告一例由双氯芬酸引起的血管性水肿,这需要迅速的警惕和快速的治疗反应。
    Non-steroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for various conditions but are associated with numerous adverse drug reactions (ADRs). Understanding these ADRs is necessary to reduce morbidity and mortality. NSAID-induced angioedema, although rare, can be life-threatening and is often due to increased leukotriene production from COX pathway inhibition. Mast cells and basophil degranulation play vital roles in its pathogenesis. Prompt recognition and immediate cessation of the culprit drug, along with the administration of corticosteroids and antihistamines, are essential. Here, we report a case of angioedema caused by diclofenac administration, which needs prompt vigilance and a rapid therapeutic response.
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  • 文章类型: Case Reports
    药物诱导的急性肌张力障碍通常与抗精神病药的联合治疗有关,但很少有各种精神药物的戒断或反弹作用。非常稀疏的报道将急性肌张力障碍描述为哌醋甲酯戒断(反弹效应),特别是在组合模式中。然而,在MPH-IR单药治疗或与胍法辛联合治疗的情况下,没有关于与停用短效哌醋甲酯速释剂型(MPH-IR)相关的急性肌张力障碍的病例报告或研究.在这里,小儿复发性急性肌张力障碍有两种独立的现象,定位口舌和口下颌/下肢,表现为在与胍法辛联合治疗时突然停用MPH-IR后发生的戒断不良反应。各种选择,如抗胆碱能药,重新管理MPH,或者从组合模式转向单一疗法,可以建议在治疗中,以及只有水合作用也可能有解决症状的好处,在目前的情况下。从业人员应了解MPH的所有可能的不利影响,甚至是短效形式的反弹效应。
    Drug-induced acute dystonia is usually associated with combination therapies of neuroleptics, but rarely with the withdrawal or rebound effect of various psychotrops. Very sparse reports have described acute dystonia as a methylphenidate withdrawal (rebound effect), particularly in combination modalities. However, there is no case report or research regarding acute dystonia related to the withdrawal of the short-acting methylphenidate-immediate release form (MPH-IR) in the case of monotherapy of MPH-IR or a combination with guanfacine. Herein, a pediatric case of recurrent acute dystonia with two separate phenomena, locating orolingual and oromandibular/lower extremities, is presented as a withdrawal adverse reaction occurring after abrupt discontinuation of MPH-IR when under a combination therapy with guanfacine. Various options such as anticholinergic agents, re-administrating MPH, or turning to monotherapy from combination modalities, can be suggested in treatment, as well as only hydration may also have the benefit of resolving the symptoms, as in the current case. Practitioners should be aware of all possible adverse effects of MPH, even the rebound effect of short-acting forms.
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  • 文章类型: Journal Article
    背景:药物不良反应(ADR)监测对于确保患者和药物安全至关重要。然而,加纳缺乏关于ADR报告趋势模式的证据。这项研究,因此,旨在分析和描述加纳16年来报告的ADR趋势。
    方法:我们回顾性分析了2005年至2021年加纳国家药物警戒中心收到的个别病例安全反驳(ICSRs)。Jointpoint回归用于估计年龄调整后的ADR率,按性别和患者特征分层,可疑药物组,临床适应症,以及ADR的表现。为了评估一段时间内的趋势,使用年度估算百分比。
    结果:从2005年到2021年,我们总共确定了6853个ICSR。从2005年到2019年,经年龄调整的ICSR比率显着增加,年增长率为18.6%;但是,从2019年到2021年有下降趋势,尽管没有统计学意义。与女性(35.7%)相比,男性占ICSR的大多数(64.3%)。最常与ADR相关的可疑药物组是抗原生动物,占所有ICSRs的35.6%。而血管疾病(21.0%)是最常见的ADR临床指征。胃肠道疾病的ICSR发生率增加,每年增加32.5%(95%CI,20.6-45.6%;p<0.001)。阿莫地喹是与ADR相关的最常见的可疑药物(8.9%),而瘙痒(7.2%)是最常见的首选术语。
    结论:该研究提供了加纳国家药物警戒中心在过去16年中收到的ICSRs的详细概述,并表明随着时间的推移,ADR相关药物的使用以及临床适应症的增加趋势。这项研究的结果要求采取多方面的策略,旨在减少与不适当药物使用相关的风险,提高用药安全知识,从而改善医疗服务的提供和病人的安全。
    BACKGROUND: Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety. However, there is a lack of evidence regarding ADR reporting trend pattern in Ghana. This study, therefore, aimed to analyse and characterise trends in ADRs reported in Ghana over 16 years.
    METHODS: We retrospectively analysed individual case safety retorts (ICSRs) received by the Ghana National Pharmacovigilance Centre from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications, and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used.
    RESULTS: We identified a total of 6853 ICSRs from 2005 to 2021. The age-adjusted ICSR rates increased significantly from 2005 to 2019, with an annual increase of 18.6%; however, there was a downward trend from 2019 to 2021, although not statistically significant. Males accounted for the majority (64.3%) of ICSRs compared to females (35.7%). The suspected medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ICSRs, while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ICSR rates was noted for gastrointestinal disorders with an annual increase of 32.5% (95% CI, 20.6-45.6%; p < 0.001). Amodiaquine was the most commonly suspected medication (8.9%) associated with ADRs, while pruritus (7.2%) was the most frequently reported preferred term.
    CONCLUSIONS: The study provides a detailed overview of ICSRs received by the Ghana National Pharmacovigilance Centre over the past 16 years and demonstrates an increasing trend of ADR-related medication use as well as clinical indications over time. The findings of this study call for multifaceted strategies aimed at reducing the risks associated with inappropriate drug use, and enhancing knowledge of medication safety, thus improving healthcare service delivery and patient safety.
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  • 文章类型: Journal Article
    目的:评估暴露于选定类别的处方药与发生缺铁性贫血(IDA)的风险之间的关联强度,特别考虑口服抗凝剂(OAC),抗抑郁药,抗血小板药,质子泵抑制剂(PPI)和非甾体抗炎药。
    方法:一项病例对照研究,涉及IDA患者中社区重复处方的分析,和无与伦比的对照被称为胃肠病学其他适应症的快速通道。使用多变量逻辑回归模型来计算IDA表现与每个药物类别之间的关联的OR。根据年龄调整,性和共同处方。对于那些显示意义的课程,它还用于计算IDA组中有或没有出血病变的风险差异.
    结果:IDA组总共分析了1210例病例-409例,对照组为801。发现IDA表现与长期暴露于PPI(OR3.29,95%CI:2.47至4.41,p<0.001)和OAC(OR2.04,95%CI:1.29至3.24,p=0.002)之间存在显着关联。IDA与长期暴露于其他三种药物中的任何一种无关。与PPI的关系相反,与OAC的关联主要发生在有出血性病变的IDA亚组.
    结论:长期暴露于PPI和OAC与发生IDA的风险独立相关。有理由认为这些关联可能是因果关系,尽管潜在的机制可能有所不同。
    OBJECTIVE: To estimate the strength of association between exposure to selected classes of prescribed medications and the risk of developing iron deficiency anaemia (IDA), specifically considering oral anticoagulants (OACs), antidepressants, antiplatelet agents, proton pump inhibitors (PPIs) and non-steroidal anti-inflammatories.
    METHODS: A case-control study involving the analysis of community repeat prescriptions among subjects referred with IDA, and unmatched controls referred as gastroenterology fast-tracks for other indications. Multivariable logistic regression modelling was used to calculate ORs for the association between IDA presentation and each medication class, adjusted for age, sex and coprescribing. For those classes showing significance, it was also used to calculate risk differences between those in the IDA group with or without haemorrhagic lesions on investigation.
    RESULTS: A total of 1210 cases were analysed-409 in the IDA group, and 801 in the control group. Significant associations were identified between presentation with IDA and long-term exposure to PPIs (OR 3.29, 95% CI: 2.47 to 4.41, p<0.001) and to OACs (OR 2.04, 95% CI: 1.29 to 3.24, p=0.002). IDA was not associated with long-term exposure to any of the other three drug classes. In contrast to the relationship with PPIs, the association with OACs was primarily in the IDA sub-group with haemorrhagic lesions.
    CONCLUSIONS: Long-term exposure to PPIs and OACs are independently associated with the risk of developing IDA. There are grounds for considering that these associations may be causal, though the underlying mechanisms probably differ.
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  • 文章类型: Case Reports
    目的:头孢吡肟是一种与头孢吡肟诱导的神经毒性(CIN)相关的抗生素,尤其是那些肾功能下降的患者,或在不适当的药物剂量的情况下。本报告描述了一例与输液持续时间从180分钟到30分钟变化相关的CIN,据我们所知,这在文献中以前没有报道过。摘要:一名73岁的男性因复发性肺炎住院期间接受了超过180分钟的头孢吡肟延长输注治疗。出院时,头孢吡肟继续作为门诊肠胃外抗菌治疗(OPAT)给药30分钟.患者在接受OPAT1天后开始出现神经毒性症状,随后由于神经症状恶化而导致再次入院。停用头孢吡肟,症状在48小时内缓解。在整个治疗期间肾功能是稳定的,并且没有注意到神经毒性的其他原因。结论:这是CIN继发于缩短输注时间的独特案例,这是临床相关的,特别是在护理过渡期间。进一步调查,包括更广泛使用治疗药物监测将有助于进一步阐明输注时间与CIN发展之间的关系。
    Purpose: Cefepime is an antibiotic associated with cefepime induced neurotoxicity (CIN), particularly in those with reduced renal function, or in cases of inappropriate medication dosing. This report describes a case of CIN associated with a change in infusion duration from 180 to30 minutes, which to the best of our knowledge has not been previously reported in the literature. Summary: A 73-year old male was treated with extended infusion cefepime over 180 minutes while hospitalized with recurrent pneumonia. On discharge, cefepime was continued as outpatient parenteral antimicrobial therapy (OPAT) administered over 30 minutes. The patient began to experience symptoms of neurotoxicity after 1 day of receiving OPAT, which subsequently led to a readmission as neurological symptoms worsened. Cefepime was discontinued and symptoms resolved within 48 hours. Renal function was stable throughout treatment and no other causes for neurotoxicity were noted. Conclusion: This is a unique case of CIN secondary to shortened infusion time, which is clinically relevant, particularly during transitions of care. Further investigation, including more widespread use of therapeutic drug monitoring will be beneficial to further elucidate the relationship between infusion time and CIN development.
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  • 文章类型: Case Reports
    在当代,以转移生长为特征的恶性肿瘤已经接受了创新的治疗方法,该方法涉及称为程序性死亡受体1(PD-1)抑制剂的免疫药物。尽管它们显著的免疫治疗效果,这些治疗可能会产生不良的免疫相关效应。Sintilimab,2018年被中国国家医药产品管理局批准上市的PD-1抑制剂,与市场上报告的51例不良反应相关,不包括牛皮癣,到现在的时刻。
    这里,我们报道了1例转移性胃腺癌患者在接受Sindilimab治疗后发生点滴状银屑病的临床特征.患者是一名老年男性,表现出从米粒到大豆的丘疹,伴有全身散落的红斑.值得注意的是,观察到一个非典型的Auspitz的迹象,其中某些病变被最小量的规模覆盖,加上报告的持续瘙痒。疾病的进展表现在一周的跨度内。
    PD1抑制剂与复发有关,恶化,或者新发牛皮癣.因此,牛皮癣的个人或家族史是PD1抑制剂药物治疗前需要考虑的重要风险因素,这有助于牛皮癣的早期诊断。新发病点滴状银屑病的早期诊断提出了挑战。建议早期咨询皮肤科医生,并且可以通过组织病理学检查获得决定性的诊断。
    UNASSIGNED: In contemporary times, malignancies characterized by metastatic growth have been subjected to innovative therapeutic approaches involving immunological agents known as Programmed Death Receptor 1 (PD-1) inhibitors. Notwithstanding their remarkable immunotherapeutic effectiveness, these treatments can give rise to undesirable immune-related effects. Sintilimab, a PD-1 inhibitor sanctioned for marketing by the Chinese National Medical Products Administration in 2018, has been associated with 51 reported cases of adverse reactions on the market, excluding psoriasis, up to the present moment.
    UNASSIGNED: Herein, we report the clinical characteristics of a patient with metastatic gastric adenocarcinoma who developed guttate psoriasis after receiving Sintilimab. The patient was an elderly male presenting with papules varying in size from that of rice grains to soybeans, accompanied by scattered erythematous lesions across his body. Notably, an atypical Auspitz\'s sign was observed, wherein certain lesions were covered with a minimal amount of scale, coupled with reported persistent itching. The progression of the disease manifested within a span of one week.
    UNASSIGNED: PD1 inhibitors have been associated with the recurrence, exacerbation, or new onset of psoriasis. Consequently, a personal or family history of psoriasis is an essential risk factor that needs to be considered before PD1 inhibitor medication, which helps with the early diagnosis of psoriasis. Early diagnosis of new-onset guttate psoriasis poses challenges. An early consultation with a dermatologist is recommended, and a conclusive diagnosis can be obtained through a histopathologic examination.
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  • 文章类型: Systematic Review
    后部可逆性脑病综合征(PRES)是一种与不同病因相关的急性神经系统疾病,包括抗生素治疗.迄今为止,有关抗生素相关PRES的大多数数据仅限于病例报告和小病例系列.这里,我们报告了一个新的病例描述,并对现有的与抗生素治疗相关的PRES病例的临床放射学特征和预后进行了系统评价.从成立到2024年1月10日,我们遵循PRISMA指南和预定义的协议,在PubMed和Scopus进行了系统的文献检索。数据库搜索产生了12个受试者(包括我们的病例)。我们描述了一名55岁的女性PRES患者在服用甲硝唑后一天发生的情况,并显示出血清神经丝轻链蛋白水平升高和良好的预后。在我们的系统审查中,抗生素相关PRES在女性患者中更常见(83.3%).甲硝唑和氟喹诺酮类药物是报道最多的抗生素(各占33.3%)。由于其他原因,临床和放射学特征与PRES相当。关于预后,大约三分之一的病例被送往重症监护室,但几乎所有受试者(90.0%)在立即停止致病药物后,临床和放射学完全恢复或几乎完全恢复。与抗生素相关的PRES似乎具有经典PRES的大部分特征。鉴于该疾病的总体预后良好,及时诊断抗生素相关PRES并停用致病药物非常重要.
    Posterior reversible encephalopathy syndrome (PRES) is an acute neurological condition associated with different etiologies, including antibiotic therapy. To date, most data regarding antibiotic-related PRES are limited to case reports and small case series. Here, we report a novel case description and provide a systematic review of the clinico-radiological characteristics and prognosis of available cases of PRES associated with antibiotic therapy. We performed a systematic literature search in PubMed and Scopus from inception to 10 January 2024, following PRISMA guidelines and a predefined protocol. The database search yielded 12 subjects (including our case). We described the case of a 55-year-old female patient with PRES occurring one day after administration of metronidazole and showing elevated serum neurofilament light chain protein levels and favorable outcome. In our systematic review, antibiotic-associated PRES was more frequent in female patients (83.3%). Metronidazole and fluoroquinolones were the most reported antibiotics (33.3% each). Clinical and radiological features were comparable to those of PRES due to other causes. Regarding the prognosis, about one third of the cases were admitted to the intensive care unit, but almost all subjects (90.0%) had a complete or almost complete clinical and radiological recovery after prompt cessation of the causative drug. Antibiotic-associated PRES appears to share most of the characteristics of classic PRES. Given the overall good prognosis of the disease, it is important to promptly diagnose antibiotic-associated PRES and discontinue the causative drug.
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  • 文章类型: Journal Article
    背景:关于性别不合格(GNC)人群中胃肠道特异性病理发生率的数据有限。
    方法:回顾性分析暴露和未暴露于性别确认激素治疗(GAHT)的变性人和GNC人群胰腺炎发生率。
    结果:1333例接受激素治疗的患者中有7例发生胰腺炎。无GAHT使用史的615例患者中,有0例发展为胰腺炎。在接受GAHT治疗的患者中,胰腺炎的发展为6.96(95%CI2.76至848.78)。
    结论:与GNC个体一起工作的临床医生应该意识到这种可能的关联。
    BACKGROUND: There is limited data on the incidence of gastrointestinal-specific pathology in gender non-conforming (GNC) populations.
    METHODS: Retrospective analysis of pancreatitis incidence rates in transgender and GNC persons exposed and not exposed to gender-affirming hormone therapy (GAHT).
    RESULTS: 7 of the 1333 patients on hormone therapy had an incidence of pancreatitis. 0 of the 615 patients with no history of GAHT use developed pancreatitis. Representing a 6.96 (95% CI 2.76 to 848.78) for the development of pancreatitis in patients with exposure to GAHT therapy.
    CONCLUSIONS: Clinicians working with GNC individuals should be aware of this possible association.
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  • 文章类型: Journal Article
    本研究旨在总结哌拉西林引起的药物不良反应(ADR)的病例报告,并探讨其在现实环境中对人体器官的影响。
    哌拉西林不良反应的病例报告是通过检索PubMed、Embase,WebofScience,CNKI,万方,和VIP从成立到2022年12月。
    最终纳入了170例患者。结果显示,哌拉西林引起的不良反应主要与全身有关,其次是血液系统,皮肤和软组织,还有神经系统.最常报告的病例包括过敏性休克,药物热,皮疹,和血小板减少症.最严重的不良反应为过敏性休克和大疱性表皮坏死松解症。此外,比较哌拉西林单药和两种哌拉西林/β-内酰胺酶抑制剂复合制剂引起的全身不良反应。说明书中未提及的ADR包括抽搐或幻觉和Kounis综合征(KS)。
    本综述表明,与哌拉西林相关的最严重的不良反应是中毒性表皮坏死松解症和过敏性休克。哌拉西林引起的罕见不良反应,比如肌阵挛性抽搐,幻觉,KS,已确定。哌拉西林/舒巴坦和哌拉西林钠国产制剂最常见的症状是呼吸困难。
    UNASSIGNED: This study aimed to summarize case reports of adverse drug reactions (ADRs) caused by piperacillin and explore their effects on human organs in real-world settings.
    UNASSIGNED: Case reports of piperacillin ADRs were collected by searching databases such as PubMed, Embase, Web of Science, CNKI, WanFang, and VIP from inception to December 2022.
    UNASSIGNED: A total of 170 patients were ultimately included. The results revealed that ADRs caused by piperacillin were primarily associated with the entire body, followed by the blood system, skin and soft tissues, and the nervous system. The most frequently reported cases included anaphylactic shock, drug fever, rash, and thrombocytopenia. The most severe ADRs were identified as anaphylactic shock and bullous epidermal necrolysis. Furthermore, a comparison was made between systemic adverse reactions caused by piperacillin as a single drug and two composite preparations of piperacillin/β-lactamase inhibitor. ADRs not mentioned in the instructions included convulsions or hallucinations and Kounis syndrome (KS).
    UNASSIGNED: This review suggests that the most severe ADRs associated with piperacillin are toxic epidermal necrolysis and anaphylactic shock. Rare ADRs caused by piperacillin, such as myoclonic jerks, hallucinations, and KS, were identified. The most common symptom with domestic preparations of piperacillin/sulbactam and piperacillin sodium was dyspnea.
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