Drug-related adverse reactions

药物相关不良反应
  • 文章类型: Journal Article
    癫痫发作是一种经常与使用迷幻药有关的不良事件,因此,涉及这些物质的研究倾向于排除既往有癫痫史的患者.这一点尤其重要,因为癫痫发作在患有精神疾病的人群中明显增加,迷幻辅助疗法正在研究中,作为一种有希望的治疗方法。为了确定当前有关经典迷幻药与癫痫发作之间关系的文献的范围,使用PRISMA-ScR(系统评价的首选报告项目和范围审查的Meta分析扩展)进行范围审查。搜索是在PubMed中进行的,WebofScience,谷歌学者,LILACS和Scielo,并包括动物和人体模型。共有16篇关于人类的出版物,11关于动物,被发现了。结果是异质的,但在全球范围内表明,在没有其他药物的情况下,迷幻药可能不会增加健康个体或动物的癫痫发作风险。然而,同时使用其他物质或药物,例如kambo或锂,可能会增加癫痫发作的风险。此外,这些结论是从缺乏足够外部有效性的数据中得出的,所以他们应该谨慎解释。还提供了未来的研究路径以及可能阐明经典迷幻药与癫痫发作之间关系的神经生物学基础的总结。
    Seizures are a concerning adverse event frequently associated with the use of psychedelics, and hence, studies involving these substances tend to exclude patients with past history of epilepsy. This is especially relevant because epileptic seizures are markedly increased in the population suffering from mental disorders, and psychedelic assisted therapy is being researched as a promising treatment for several of them. To determine the extent of the current literature on the relationship between classic psychedelics and seizures, a scoping review was performed using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). The search was conducted in PubMed, Web of Science, Google scholar, LILACS and Scielo, and both animal and human models were included. A total of 16 publications on humans, and 11 on animals, were found. The results are heterogeneous, but globally suggest that psychedelics may not increase the risk of seizures in healthy individuals or animals in the absence of other drugs. However, concomitant use of other substances or drugs, such as kambo or lithium, could increase the risk of seizures. Additionally, these conclusions are drawn from data lacking sufficient external validity, so they should be interpreted with caution. Future paths for research and a summary on possible neurobiological underpinnings that might clarify the relationship between classical psychedelics and seizures are also provided.
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  • 文章类型: Case Reports
    慢性免疫性血小板减少性紫癜(ITP)是一种获得性血液学疾病,涉及免疫介导的血小板破坏,并导致严重程度不同的出血。难治性ITP发生在患者不能耐受和/或对多种治疗方式有反应时。在这种情况下,我们研究了一名39岁女性难治性ITP的临床过程,并讨论了我们如何通过调整既定的脱敏方案来应对众多挑战,以满足患者的需求.据我们所知,我们描述了目前文献中用于ITP的Ofatumumab首次成功脱敏.
    Chronic immune thrombocytopenic purpura (ITP) is an acquired hematologic condition that involves immune-mediated platelet destruction with resultant bleeding of variable severity. Refractory ITP occurs when patients fail to tolerate and/or respond to multiple treatment modalities. In this case, we examine the clinical course of a 39-year-old female with refractory ITP and discuss how we navigated a multitude of challenges by adapting an established desensitization protocol to meet our patient\'s needs. To our knowledge, we describe the first successful desensitization to ofatumumab for use in ITP in the current literature.
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  • 文章类型: Journal Article
    注意缺陷/多动障碍(ADHD)是一种非常普遍的疾病,会导致注意力和/或多动冲动的持续问题,并且在不治疗时通常会导致明显的损害。这种疾病的药物不断发展,并提供了新的治疗选择。持续审查相关药物的安全性和耐受性仍然是处方者的一项重要任务。
    本手稿提供了用于治疗儿童和青少年多动症的药物的最新安全性审查。PubMed和OneSearch在线数据库用于搜索与ADHD药物和安全性主题相关的文献。用于治疗多动症的药物的临床试验,系统评价和荟萃分析,以及涵盖特定安全问题(不良或不利事件)的文章,例如心血管影响,癫痫发作,对增长的影响,抑郁症,自杀意念,物质使用障碍,精神病,和Tics被描述。
    可用于ADHD的药物治疗具有良好的疗效,安全性和耐受性,并使许多患者的症状得到显着改善。尽管有多种兴奋剂和非兴奋剂制剂,一些患有ADHD的患者可能无法耐受现有的药物治疗或获得令人满意的改善.为了满足未满足的临床需求,针对多巴胺的兴奋剂和非兴奋剂制剂的多动症药物研究,去甲肾上腺素和新受体正在进行中。
    UNASSIGNED: Attention-Deficit/Hyperactivity Disorder (ADHD) is a highly prevalent condition that causes persistent problems with attention and/or hyperactivity-impulsivity and often results in significant impairment when left untreated. Medications for this disorder continue to evolve and provide new treatment options. Ongoing review of related medication safety and tolerability remains an important task for prescribers.
    UNASSIGNED: This manuscript provides an updated safety review of medications used to treat ADHD in children and adolescents. PubMed and OneSearch online databases were utilized to search for literature relevant to the topic of ADHD medications and safety. Clinical trials of medications used to treat ADHD, systematic reviews and meta-analyses, and articles covering specific safety issues (adverse or unfavorable events) such as cardiovascular effects, seizures, impact on growth, depression, suicidal ideation, substance use disorders, psychosis, and tics are described.
    UNASSIGNED: Available pharmacologic treatments for ADHD have favorable efficacy, safety and tolerability and allow many patients to achieve significant improvement of their symptoms. Despite the availability of multiple stimulant and non-stimulant formulations, some individuals with ADHD may not tolerate available medications or attain satisfactory improvement. To satisfy unmet clinical needs, ADHD pharmaceutical research with stimulant and nonstimulant formulations targeting dopamine, norepinephrine, and novel receptors is ongoing.
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  • 文章类型: Journal Article
    背景:抗癌剂是癌症患者中大多数药物不良反应(ADR)的原因。由于缺乏对印度药物警戒计划的认识和了解,在印度,抗肿瘤药物的ADR报告非常罕见。因此,本研究旨在评估癌症患者使用抗癌药的ADR模式,并提高医疗保健专业人员对ADR监测的认识.
    方法:这是一个观察性的,在政府ADR监测中心(AMC)进行的回顾性和非干预性研究。GuruGobindSingh医学院和医院,Faridkot,旁遮普,北印度。分析了2016年1月至2022年12月7年间自愿报告的抗癌药作为可疑药物的ADR形式。分析了各种参数,其中包括患者的人口统计细节,ADR的类型,报告药品不良反应和可疑药物的部门。因果关系评估,根据世界卫生组织乌普萨拉监测中心(WHO-UMC)量表进行严重程度评估和可预防性评估,改良的Hartwig和Siegel量表以及改良的Schumock和Thornton量表,分别。
    结果:在41-60岁年龄组(68.29%)和女性(59.75%)中报告了ADR的最大数量。使用紫杉烷类药物(多西他赛和紫杉醇)报告的最大不良反应数(24.39%),靶向药物(吉非替尼,伊马替尼,硼替佐米,贝伐单抗,利妥昔单抗和帕唑帕尼)(24.39%)和铂配合物(顺铂,奥沙利铂和卡铂)(17.07%)。报告的大部分不良反应是发抖和皮肤上的不良反应。大多数ADR是可能的(64.70%),性质温和(85.29%),绝对可以预防(45.58%),也可能可以预防(45.58%)。
    结论:需要进行ADR监测以提高癌症患者的抗癌药物治疗效果。通过及时管理这些不良反应,可以提高癌症患者的治疗质量。当今时代需要向医疗保健专业人员通报药物警戒计划,以增加因抗癌药物引起的不良反应的报告。
    BACKGROUND: Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals.
    METHODS: This is an observational, retrospective and non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively.
    RESULTS: The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%).
    CONCLUSIONS: ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.
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  • 文章类型: Journal Article
    引言多重风险因素,如人类免疫缺陷病毒(HIV)感染和免疫抑制疗法,增加潜伏性结核感染(LTBI)再激活和进展为活动性结核的几率。异烟肼(INH)6至9个月的预防性治疗可降低LTBI再激活的风险,但其有效性可能受到其持续时间长和不良事件(AE)的限制,包括肝脏毒性.由于合并症和多重用药,HIV感染者(PLHIV)发生INH相关AE的风险可能增加.我们的研究旨在评估接受INH治疗的LTBI患者中AE的患病率,为了确定它们发生的危险因素,并评估PLHIV是否有更高的发生INH相关不良事件的几率。方法采用单中心回顾性病例对照研究,包括2019年7月至2022年3月期间接受INH治疗的130名LTBI门诊患者。将发生AE(病例)的参与者与对照组进行比较,并将PLHIV亚组与HIV阴性参与者进行了比较.人口统计,社会经济变量,合并症,和临床变量在研究组之间进行比较.患者数据来自机构电子病历,并在定期预约时测量结果。结果我们包括130名参与者,其中54人是艾滋病毒感染者。PLHIV亚组显着年轻(p=0.01),并显示出慢性肝病的患病率显着升高,以前的病毒性肝炎,每日饮酒,静脉注射药物(IDU)。三分之一的参与者有AE(45例,34.6%),肝毒性是最常见的(22.3%)。出现不良事件的参与者年龄明显较大(p=0.030),经济困难发生率较高(p=0.037),以及Charlson合并症指数得分(p=0.002)高于对照组。17名参与者(13.1%)发生INH戒断,主要与肝毒性(p<0.01)和胃肠道症状(p=0.022)有关。在调整后的效果模型中,年龄≥65岁,经济困难,过量饮酒与较高的AE几率显着相关,而HIV感染的几率降低了68.4%(p=0.033)。结论在我们的研究中,INH相关的AE很常见,肝脏毒性是最常见的。年纪大了,经济困难,过量饮酒增加了异烟肼相关AE的几率,虽然PLHIV发生INH相关AE的几率较低,即使在多变量分析中调整其他变量时也是如此。应进行进一步的研究,以评估这些结果是否可在更大的人群和不同的环境中复制。
    Introduction Multiple risk factors, such as human immunodeficiency virus (HIV) infection and immunosuppressive therapies, increase the odds of latent tuberculosis infection (LTBI) reactivation and progression to active tuberculosis. A six-to-nine-month preventive treatment with isoniazid (INH) decreases the risk of LTBI reactivation, but its effectiveness can be limited by its long duration and adverse events (AEs), including liver toxicity. Due to comorbidities and polypharmacy, people living with HIV (PLHIV) may be at increased risk of INH-associated AEs. Our study aimed to assess the prevalence of AEs among patients receiving INH treatment for LTBI, to identify risk factors for their occurrence, and to evaluate whether PLHIV have higher odds of developing INH-associated AEs. Methods We conducted a single-center retrospective case-control study, including 130 outpatients with LTBI treated with INH between July 2019 and March 2022. Participants who developed AE (cases) were compared to controls, and a subgroup of PLHIV was compared to HIV-negative participants. Demographics, socioeconomic variables, comorbidities, and clinical variables were compared between study groups. Patient data were obtained from institutional electronic medical records, and outcomes were measured at regularly scheduled appointments. Results We included 130 participants, of which 54 were PLHIV. The PLHIV subgroup was significantly younger (p = 0.01) and demonstrated significantly higher prevalences of chronic liver disease, previous viral hepatitis, daily alcohol consumption, and intravenous drug use (IDU). One-third of the participants had an AE (45 cases, 34.6%), with liver toxicity being the most common (22.3%). Participants who developed AEs were significantly older (p = 0.030) and had a higher prevalence of economic hardship (p = 0.037), as well as higher scores of the Charlson comorbidity index (p = 0.002) than the controls. INH withdrawal occurred in 17 participants (13.1%) and was mainly associated with liver toxicity (p < 0.01) and gastrointestinal symptoms (p = 0.022). In the adjusted effect model, an age ≥ 65 years, economic hardship, and excessive alcohol consumption were significantly associated with higher odds of AEs, while HIV infection decreased the odds by 68.4% (p = 0.033). Conclusions In our study, INH-associated AEs were common, with liver toxicity being the most frequent. Older age, economic hardship, and excessive alcohol consumption increased the odds of INH-associated AEs, while PLHIV had lower odds of developing INH-associated AEs, even when adjusting for other variables in the multivariate analysis. Further studies should be conducted to assess if these results are replicable in a larger population and in different settings.
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  • 文章类型: Review
    研究晚期癌症患者由于免疫检查点抑制剂(ICIs)治疗而引起的活动性结核病(TB)感染的临床特征。
    我们报告一例肺部恶性肿瘤(鳞状细胞癌,cT4N3M0IIIC),ICIs治疗后继发于活动性结核感染。此外,我们总结和分析了从中国国家知识基础设施(CNKI)收集的其他相关案例,万方数据库,PubMed,WebofScience,和EMBASE(截至2021年10月)。
    共有23名患者,包括20名男性和3名女性,年龄在49-87岁之间,中位年龄为65岁,包括在研究中。通过结核分枝杆菌培养或DNA聚合酶链反应(PCR)诊断22例患者,其余患者通过结核菌素纯化蛋白衍生物和胸膜活检确诊。在应用ICI之前,一个病例进行了干扰素-γ释放试验(IGRA)以排除潜伏的TB感染。15例患者接受了抗结核方案。在20例描述为临床消退的患者中,13人好转,7人死亡。改善的患者中有7例再次接受ICI治疗,其中4例没有复发或结核病恶化。在我院诊断的病例在停止ICI治疗后接受抗结核治疗后也有所改善,在抗结核治疗的基础上继续化疗,目前他的情况相对稳定。
    由于ICIs治疗后结核病感染缺乏特异性,患者应在服药后6.3个月内随访发热和呼吸道症状.建议在ICIs治疗之前进行IGRA,并应密切监测IGRA阳性患者在免疫治疗期间结核病的发展。大多数患者的结核病症状可以通过ICIs戒断和抗结核治疗得到改善,但仍需要警惕结核病的潜在致命风险。
    To investigate the clinical features of active tuberculosis (TB) infection due to immune checkpoint inhibitors (ICIs) treatment in patients with advanced cancer.
    We report the diagnosis and treatment of a case of pulmonary malignancy (squamous cell carcinoma, cT4N3M0 IIIC), secondary to active TB infection following ICIs therapy. Moreover, we summarize and analyze other related cases collected from the China National Knowledge Infrastructure (CNKI), Wanfang Database, PubMed, the Web of Science, and EMBASE (up to October 2021).
    A total of 23 patients, including 20 males and 3 females who were aged 49-87 years with a median age of 65 years, were included in the study. Twenty-two patients were diagnosed by Mycobacterium tuberculosis culture or DNA polymerase chain reaction (PCR), while the remaining patient was diagnosed by tuberculin purified protein derivative and pleural biopsy. One case had an interferon-gamma release assay (IGRA) to rule out latent TB infection prior to the application of ICI. Fifteen patients received an anti-tuberculosis regimen. Among the 20 patients with a description of clinical regression, 13 improved and 7 died. Seven of the patients who improved were treated with ICI again and four of them did not experience a recurrence or worsening of TB. The case diagnosed in our hospital also improved after receiving anti-TB treatment after stopping ICI therapy, and continued chemotherapy on the basis of anti-TB treatment, and his condition is relatively stable at present.
    Due to the lack of specificity of TB infection following ICIs therapy, patients should be followed for fever and respiratory symptoms for 6.3 months after drug administration. It is recommended that IGRA should be performed before ICIs therapy and the development of TB during immunotherapy in patients who are positive in IGRA should be closely monitored. The symptoms of TB in most patients can be improved with ICIs withdrawal and anti-TB treatment, but there is still a need to be alert to the potentially fatal risk of TB.
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  • 文章类型: Journal Article
    “选修”一词是指选择或优先等级较低的药物和程序。患者通常使用选择性药物或接受选择性手术来治疗病理状况或进行美容增强,积极影响他们的生活方式,因此,提高他们的生活质量。然而,这些干预措施会影响泪膜和眼表的稳态。因此,它们会产生可能损害患者生活质量的体征和症状。本报告描述了选择性局部和全身药物和程序对眼表的影响以及潜在机制。此外,为眼部疾病进行的选择性手术,化妆品增强,和非眼科干预,如放疗和减肥手术,正在讨论。该报告还评估了非紧急干预眼表的重大解剖学和生物学后果。如神经性和神经营养性角膜病变。除此之外,它概述了由所研究的干预措施引起的病理状况的预防和管理,并提出了未来研究的领域。该报告还包含一项系统评价,调查了接受小切口微透镜摘除(SMILE)的人们的生活质量。总的来说,在手术后的第一个月,微笑似乎比LASIK引起更多的视力障碍,但在长期随访中干眼症状较少。
    The word \"elective\" refers to medications and procedures undertaken by choice or with a lower grade of prioritization. Patients usually use elective medications or undergo elective procedures to treat pathologic conditions or for cosmetic enhancement, impacting their lifestyle positively and, thus, improving their quality of life. However, those interventions can affect the homeostasis of the tear film and ocular surface. Consequently, they generate signs and symptoms that could impair the patient\'s quality of life. This report describes the impact of elective topical and systemic medications and procedures on the ocular surface and the underlying mechanisms. Moreover, elective procedures performed for ocular diseases, cosmetic enhancement, and non-ophthalmic interventions, such as radiotherapy and bariatric surgery, are discussed. The report also evaluates significant anatomical and biological consequences of non-urgent interventions to the ocular surface, such as neuropathic and neurotrophic keratopathies. Besides that, it provides an overview of the prophylaxis and management of pathological conditions resulting from the studied interventions and suggests areas for future research. The report also contains a systematic review investigating the quality of life among people who have undergone small incision lenticule extraction (SMILE). Overall, SMILE refractive surgery seems to cause more vision disturbances than LASIK in the first month post-surgery, but less dry eye symptoms in long-term follow up.
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  • 文章类型: Journal Article
    目的:使用潜在的不适当药物(PIM)会损害老年人药物治疗的安全性和有效性。因此,一些国家有清单和标准来表明这些药物,以促进处方的安全性和在老年医学实践中的合理用药。
    目的:本研究旨在通过专家批准,将老年人PIM纳入巴西标准(BCPIM/2016)-巴西目前使用的清单和拉丁美洲国家的参考,比较与国际AGS列表的融合啤酒/2019,STOPP/START/2015,PRISCUS/2010和EU(7)-PIM列表/2015。
    方法:这是对巴西标准列表中老年人使用的潜在不适当药物的关键分析,加上他们没有在国际清单上的一些药物(BEERS/2019;Priscus/2010;Stopp/Start/2015;EU7-PIMlist/2015)。本研究分为6个阶段:选择国家标准,根据解剖治疗化学的药物分类,BCPIM/2016与国际榜单的比较,选择不在巴西清单中的药物,选择专家进行评估和关于未包括在巴西清单中的药物的建议,以及专家进行的分析的综合。
    结果:我们对在巴西上市的66种国际上市药物进行了分类,但不是在巴西的共识中,其中24项已由专家验证为纳入本共识所必需,考虑老年人医疗保健的风险和收益。然而,名单之间有分歧和相似之处。我们观察到八种药物在所有研究标准中都是常见的,主要与神经系统有关。
    结论:结果表明需要针对研究诊所定期验证PIM,国家基本药物清单和其他临床方案以及老年人治疗处方指南的修订中列入了这一议程。
    OBJECTIVE: The use of potentially inappropriate medications (PIM) can impair the safety and effectiveness of pharmacotherapy in the older adults. Thus, several countries have lists and criteria to indicate these drugs, in order to promote the safety of prescription and the rational use of drugs in geriatric practice.
    OBJECTIVE: This study sought to contribute to the inclusion of PIM for the older adults in the Brazilian criterion (BCPIM/2016) - current list used in Brazil and reference in Latin American countries - through expert approval, comparing convergences with international AGS lists BEERS/2019, STOPP/START/2015, PRISCUS/2010 and EU (7)-PIM List/2015.
    METHODS: This is a critical analysis of potentially inappropriate medications for use in the older adults present in the list of Brazilian criteria, together with their absence of some drugs that are on international lists (BEERS/2019; Priscus/2010; Stopp/Start/2015; EU7-PIM list/2015). This study was subdivided in 6 stages: selection of national criteria, classification of drugs according to Anatomic Therapeutic Chemical, comparison between BCPIM/2016 with international lists, selection of drugs not included in the Brazilian list, selection of experts for evaluation and suggestions about drugs not included in the Brazilian list and the synthesis of the analysis carried out by the specialists.
    RESULTS: We cataloged 66 drugs marketed in Brazil that are on international lists, but not in the Brazilian consensus, of which 24 were validated by experts as necessary for inclusion in this consensus, considering the risks and benefits in health care for the older adults. However, the lists have divergences and similarities between them. We observed that eight drugs were common to all criteria studied, mainly related to the nervous system.
    CONCLUSIONS: The results suggest the need for periodic validation of PIM against research clinics, new drugs and the inclusion of this agenda by the Ministry of Health in the revision of the National List of Essential Drugs and other Clinical Protocols and Therapeutic Prescription Guidelines for the older adults.
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  • 文章类型: Journal Article
    背景:年龄在12-17岁的男性患者患mRNA疫苗接种相关的心肌/心包炎的风险升高。尚未根据健康状况和SARS-CoV-2感染史对青春期男孩的第一剂和第二剂mRNA疫苗接种进行风险收益分析。
    方法:使用疫苗不良事件报告系统(VAERS),我们根据CDC标准确定了BNT162b2[Pfizer-BioNTech]心肌/心包炎的发生。主要结果如下:1)12-15岁和16-17岁青少年的疫苗接种后心肌/心包炎粗发生率;2)按年龄进行的两项风险-效益分析,性别,合并症,变异和感染史。
    结果:肌/心包炎病例(n=253)包括剂量1后129例和剂量2后124例;86.9%住院。在12-15岁和16-17岁的男性患者中,剂量2后每百万的发病率分别为162.2和93.0。在三角洲期间,对COVID-19住院期间接种疫苗后的心肌/心包炎进行称重,我们的风险收益分析表明,在12-17岁的青少年中,仅在有合并症的非免疫女孩中,两剂量疫苗接种是一致有利的.在先前感染且没有合并症的男孩中,根据国际估计,即使是一剂,风险也大于收益。在omicron的设置中,一剂可能对非免疫儿童有保护作用,但剂量2似乎并不能在人群水平上带来额外的益处。
    结论:我们的研究结果强烈支持个性化的儿科COVID-19疫苗接种策略,这些策略权衡了对严重疾病的保护与保护疫苗相关的心肌/心包炎的风险。需要研究这种不利影响的性质和含义,以及减少整个低风险队列中危害的免疫策略。
    BACKGROUND: Male patients ages 12-17 years have an elevated risk of mRNA vaccination-associated myo/pericarditis. A risk-benefit analysis of first and second doses of mRNA vaccination in adolescent boys by health status and history of SARS-CoV-2 infection has not been performed.
    METHODS: Using the Vaccine Adverse Event Reporting System (VAERS), we identified BNT162b2 [Pfizer-BioNTech] myo/pericarditis occurrence according to CDC criteria. Main outcomes were as follows: 1) post-vaccination myo/pericarditis crude incidence in adolescents aged 12-15 and 16-17; and 2) two risk-benefit analyses by age, sex, comorbidity, variant and history of infection.
    RESULTS: Cases of myo/pericarditis (n = 253) included 129 after dose 1 and 124 after dose 2; 86.9% were hospitalized. Incidence per million after dose two in male patients aged 12-15 and 16-17 was 162.2 and 93.0, respectively. Weighing post-vaccination myo/pericarditis against COVID-19 hospitalization during delta, our risk-benefit analysis suggests that among 12-17-year-olds, two-dose vaccination was uniformly favourable only in nonimmune girls with a comorbidity. In boys with prior infection and no comorbidities, even one dose carried more risk than benefit according to international estimates. In the setting of omicron, one dose may be protective in nonimmune children, but dose two does not appear to confer additional benefit at a population level.
    CONCLUSIONS: Our findings strongly support individualized paediatric COVID-19 vaccination strategies which weigh protection against severe disease vs. risks of vaccine-associated myo/pericarditis. Research is needed into the nature and implications of this adverse effect as well as immunization strategies which reduce harms in this overall low-risk cohort.
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  • 文章类型: Journal Article
    UNASSIGNED: In December 2019, coronavirus disease 2019 (COVID-19) was first identified in Wuhan, and rapidly spread throughout China. Patients with mild symptoms were admitted to Fangcang shelter hospitals for centralized quarantine. We aimed to clarify the medication usage, related adverse reactions, and pharmaceutical interventions in patients with mild COVID-19.
    UNASSIGNED: We innovatively carried out targeted pharmacy services. We provided online and off-line pharmaceutical services to patients in the Fangcang shelter hospital. The use of medication, related adverse reactions, and the effects of pharmaceutical intervention were analyzed.
    UNASSIGNED: Lower blood lymphocyte count was proposed as the most significant risk factor in patients with mild illness. All patients received antiviral treatment (arbidol, oseltamivir, and ribavirin); 78.4% of patients received antibiotic therapy (moxifloxacin, levofloxacin, and cefdinir); patients in the moderate disease group received more antibiotic therapy than those in the mild disease group. Most of the patients were treated with traditional Chinese medicine. Patients with moderate disease preferred to receive sedative hypnotic therapy. Diarrhea, nausea and vomiting, insomnia, arrhythmia, and constipation were the most common adverse reactions. The rate of mild-to-moderate illness in the pharmaceutical intervention and non-intervention groups was 20.6% and 31.7%, respectively.
    UNASSIGNED: Most patients with mild illness were treated with antiviral, antibiotic, and Chinese medicine therapy. However, attention should be paid to patients with mild illness presenting with hypertension and low lymphocyte count at the onset; these patients are more likely to develop moderate or severe disease. Moreover, there were many drug-related problems in Fangcang shelter hospital; pharmaceutical care might contribute to alleviate the progress of the patient\'s condition. Pharmacists should be prepared to provide skilled and effective services to patients, with the aim to ensure medication safety and promote the overall control of the COVID-19 pandemic.
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