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A case report of drug-induced liver injury due to the infliximab biosimilar CT-P13 on switching from original infliximab in a patient with Crohn’s disease 一例克罗恩病患者因英夫利昔单抗生物类似物CT-P13从原来的英夫利单抗转为使用而导致药物性肝损伤的病例报告
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221100118
S. Kashima, K. Sawada, K. Moriichi, M. Fujiya
Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the original to a biosimilar is considered an acceptable treatment. While several abnormalities of blood examination have been observed in patients with CT-P13 administration, no cases of drug-induced liver injury (DILI) caused by CT-P13 has been reported. A 23-year-old woman had been diagnosed with Crohn’s disease and was treated with original infliximab (O-IFX) for 9 years. She developed severe jaundice 1 month after switching from O-IFX to CT-P13. Serologic tests of autoimmune and hepatitis viruses were negative, and ultrasonography, computed tomography, and magnetic resonance cholangiopancreatography revealed no abnormalities. A liver biopsy showed prominent pericentral canalicular cholestasis, without features of steatosis or sclerosing cholangitis, which was consistent with drug-induced cholestasis. The cholestasis improved 10 weeks after the discontinuation of CT-P13, and no DILI redeveloped even after re-switching from CT-P13 to O-IFX. This is the first report of DILI due to switching from O-IFX to CT-P13. While the efficacy and safety of CT-P13 are considered equal to those of O-IFX, clinicians need to be alert for certain severe DILIs when switching from O-IFX to CT-P13 with careful monitoring and appropriate treatment. Plain Language Summary A case report of drug-induced liver injury due to switch from original infliximab to infliximab biosimilar Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the entire gastrointestinal tract, although its etiology has largely been unclear. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A biological medicinal product that contains a version of the active substance of an already authorized biological medicinal product. Biosimilars of TNF inhibitors, such as CT-P13, are thought to possess equal efficacy and safety to the original with a lower cost, so switching from the original to a biosimilar considered an acceptable treatment. While several serious adverse reactions of TNF inhibitors have been reported, drug-induced liver injury (DILI) is uncommon, and liver dysfunction due to the administration of CT-P13 has not been reported in IBD patients. We herein report the first case of DILI due to CT-P13 after switching from original infliximab (O-IFX) in a patient
炎症性肠病是一种病因不明的慢性免疫性疾病。肿瘤坏死因子(TNF)抑制剂对IBD的治疗是有效的,并且具有成本效益,因为它们减少了住院人数,并且与IBD患者更少的手术需求和更好的生活质量有关。英夫利昔单抗生物类似物(CT-P13)的大量临床试验表明,生物类似物的给药提供了与原始药物类似的高效性和安全性,且成本较低,因此从原始药物转向生物类似物被认为是一种可接受的治疗方法。虽然在服用CT-P13的患者中观察到了一些血液检查异常,但尚未报告由CT-P13引起的药物性肝损伤(DILI)病例。一名23岁的女性被诊断患有克罗恩病,并接受了9年的原发性英夫利昔单抗(O-IFX)治疗。她从O-IFX转为CT-P13后1个月出现严重黄疸。自身免疫性病毒和肝炎病毒的血清学检测均为阴性,超声、计算机断层扫描和磁共振胰胆管成像均未显示异常。肝活检显示明显的中央管周围胆汁淤积,没有脂肪变性或硬化性胆管炎的特征,这与药物诱导的胆汁淤积一致。停用CT-P13后10周,胆汁淤积情况有所改善,即使从CT-P13重新转换为O-IFX后,DILI也没有重新发展。这是由于从O-IFX转换为CT-P13而引起的首次DILI报告。虽然CT-P13的疗效和安全性被认为与O-IFX相同,但临床医生在从O-IFX转为CT-P13时,需要警惕某些严重的DILI,并进行仔细监测和适当治疗。简明语言摘要一份因从最初的英夫利昔单抗转为英夫利单抗生物相似性炎症性肠病(IBD)而导致药物性肝损伤的病例报告,其特征是整个胃肠道的慢性炎症,尽管其病因在很大程度上尚不清楚。肿瘤坏死因子(TNF)抑制剂对IBD的治疗是有效的,并且具有成本效益,因为它们减少了住院人数,并且与IBD患者更少的手术需求和更好的生活质量有关。一种生物医药产品,含有已获授权的生物医药产品的活性物质。TNF抑制剂的生物仿制药,如CT-P13,被认为以更低的成本与原始药物具有同等的疗效和安全性,因此从原始药物转向生物仿制药被认为是一种可接受的治疗方法。虽然已经报道了TNF抑制剂的几种严重不良反应,但药物诱导的肝损伤(DILI)并不常见,IBD患者因服用CT-P13而导致的肝功能障碍也没有报道。我们在此报告了克罗恩病患者在从原始英夫利昔单抗(O-IFX)转换为CT-P13后出现的第一例DILI。虽然CT-P13的疗效和安全性被认为与O-IFX相同,但临床医生在从O-IFX转为CT-P13时,需要警惕某些严重的DILI,并进行仔细监测和适当治疗。
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引用次数: 2
A survey on self-medication for the prevention or treatment of COVID-19 and distrust in healthcare of veterans in a primary care setting in the United States. 美国基层医疗机构退伍军人预防或治疗COVID-19自我药疗及对医疗保健不信任的调查
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221143265
Eva Amenta, Larissa Grigoryan, Laura Dillon, Casey Hines-Munson, John Van, Barbara Trautner

Background: The SARS-CoV-2 (COVID-19) pandemic brought the public overwhelming and conflicting information. Rates of trust in healthcare professionals have been declining among laypersons over the past five decades. In this setting, we sought to evaluate the use of medications, both with or without a prescription, to prevent and treat SARS-CoV-2 as well as trust in healthcare among patients in a primary care clinic.

Design: We surveyed 150 veterans in primary care clinic waiting rooms at a large southwestern tertiary care Veterans Affairs hospital. This survey was performed in March-November 2021.

Methods: The survey asked about respondents' demographics, use of medications, nutritional supplements, and other remedies for the prevention and treatment of COVID-19, perceived access to care using Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and System (CAHPS), overall health status, and barriers to medical appointments in the last 12 months. Distrust was measured using the Revised Health Care Distrust scale. We used univariate and multivariate linear regression analyses to study predictors of distrust to healthcare.

Results: Forty-two (28%) of 150 respondents reported taking an agent for the prevention of COVID-19, while 4% reported storing antibiotics for the treatment of COVID-19, if diagnosed. Medications were obtained from medical providers, US stores or markets, the Internet, home stockpiles, and other countries. Medications with potentially harmful effects taken for the prevention and treatment of COVID-19 included hydroxychloroquine, pseudoephedrine, and antibiotics. Among those surveyed, the mean (SD) on the health system distrust score was 2.2 (0.6) on a scale of 1-5, with 5 indicating higher distrust. Younger age, self-reported poor health, lack of a regular physician, and self-reported poor access to care were independently associated with distrust in healthcare.

Conclusion: Self-medication to prevent COVID-19 infection with unproven therapies was common among respondents, as was some level of distrust in the healthcare system. Access to care was one of the modifiable factors associated with distrust. Future studies may explore whether improving trust may moderate self-treatment behavior and storage of potentially harmful medications.

Plain language summary: Self-Medication Habits and Trust in Healthcare Among Patients in a Primary Care Setting in the United States The public has received information from many different sources on COVID-19. Trust in healthcare leadership has also been impacted. We studied self-medication habits to prevent or treat COVID-19 among a group of primary care patients in a large hospital system in the Southwest United States. We also explored these patients' trust in their healthcare system.We asked people waiting in primary

背景:新型冠状病毒(COVID-19)大流行给公众带来了铺天盖地且相互矛盾的信息。在过去的五十年里,外行人对医疗保健专业人员的信任度一直在下降。在这种情况下,我们试图评估有或没有处方的药物使用情况,以预防和治疗SARS-CoV-2,以及初级保健诊所患者对医疗保健的信任。设计:我们调查了西南部一家大型三级护理退伍军人事务医院初级保健诊所候诊室的150名退伍军人。该调查于2021年3月至11月进行。方法:调查询问了受访者的人口统计数据、预防和治疗COVID-19的药物、营养补充剂和其他补救措施的使用情况、使用医疗保健研究和质量机构(AHRQ)对医疗保健提供者和系统的消费者评估(CAHPS)获得护理的感觉、总体健康状况以及过去12个月就诊的障碍。使用修订后的医疗保健不信任量表来测量不信任。我们使用单变量和多变量线性回归分析来研究对医疗保健不信任的预测因素。结果:150名应答者中有42人(28%)报告服用了预防COVID-19的药物,而4%的人报告在诊断出COVID-19后储存了治疗COVID-19的抗生素。药物从医疗服务提供者、美国商店或市场、互联网、家庭库存和其他国家获得。为预防和治疗COVID-19而服用的具有潜在有害影响的药物包括羟氯喹、伪麻黄碱和抗生素。在接受调查的人中,对卫生系统不信任的平均得分(SD)为2.2(0.6),满分为1-5分,满分为5分表示不信任程度较高。年龄较小、自我报告的健康状况不佳、缺乏正规医生和自我报告的难以获得护理与对医疗保健的不信任独立相关。结论:在受访者中,使用未经证实的疗法进行自我药疗以预防COVID-19感染的情况很常见,对医疗保健系统的不信任程度也很普遍。获得护理是与不信任有关的可改变因素之一。未来的研究可能会探讨提高信任是否可以调节自我治疗行为和潜在有害药物的储存。美国初级保健机构患者的自我用药习惯和对医疗保健的信任公众已经从许多不同的来源获得了关于COVID-19的信息。对医疗保健领导层的信任也受到了影响。我们研究了美国西南部一家大型医院系统的一组初级保健患者的自我药疗习惯,以预防或治疗COVID-19。我们还探讨了这些患者对医疗保健系统的信任。我们询问了在初级保健诊所候诊室等候的人,他们是否服用了任何药物、营养补充剂或其他补救措施来预防或治疗COVID-19。我们还询问了人们,如果他们被诊断出患有COVID,他们是否会储存药物。该调查通过一个有效的信任调查工具探讨了患者对医疗保健系统的信任。调查还评估了基本的人口统计信息、卫生知识、获得护理的机会和自我报告的健康状况。对这些调查答案进行分析,以了解对医疗保健的信任与其他因素之间是否存在关联,包括自我用药习惯、获得护理、人口统计或感知健康。这项研究发现,在接受调查的150人中,超过25%的人服用了药物、营养补充剂或药物,试图预防COVID。我们发现有些人正在服用可能有害的药物,包括羟氯喹、伪麻黄碱和抗生素。我们发现患者的不信任得分为2.2分(在1-5的范围内,5分与更高的不信任有关)。预防或治疗COVID的自我药疗与不信任无关;然而,年龄较小、自我认为缺乏获得医疗保健的机会、自我认为整体健康状况不佳以及没有定期看医生是信任度较低的预测因素。这些信息为进一步研究自我用药习惯以及提高对医疗保健系统的信任提供了基础。
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引用次数: 1
Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS. 三唑类抗真菌药物的安全性:2004 - 2021年基于FAERS的药物警戒研究
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221143266
Shuang Chai, Jing-Lun Zhan, Li-Mei Zhao, Xiao-Dong Liu

Background: Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).

Methods: Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021 were selected for disproportionality analysis to assess the connection between antifungal triazoles, and AEs and important medical events (IMEs).

Results: A total of 22,566 records associated with triazole antifungals were identified, with 9584 triazole antifungal-IME pairs. The following system organ classes (SOCs) appeared as significant signals: 'Endocrine disorders' [reported odds ratio (ROR) = 167.94], 'Metabolism and nutrition disorders' (ROR = 46.30), and 'Skin and subcutaneous tissue disorders' (ROR = 21.37). Strong signals were observed with respiratory failure, rash, hepatic function abnormal, and hypokalemia. Uncommon security signals included a change in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations.

Conclusion: Various triazole antifungals cause AEs of different types and intensities of association. Our results are broadly consistent with prescribing information and previous studies; however, additional pharmacoepidemiological studies are required to verify AEs with modest incidence but high signal.

Plain language summary: A study on the adverse effects of triazole antifungals Introduction: The triazole antifungals we studied include fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole. Triazole antifungals are widely used as broad-spectrum antifungals; however, there are many undetected and unreported adverse events (AEs).Materials and Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA by different countries regarding post-marketing drugs. Through the FAERS database, we retrieved a total of 22,566 AE reports related to triazole antifungals. We not only counted information about patients' gender, age, weight, reporting country, outcome indicators, and indications but also analyzed the system organ classes (SOCs) of AEs, and the number of reported drug-related AEs and the degree of relevance.Results: We found a total of 22,566 records related to triazole antifungal agents, of which 9584 reports made important medical events (IMEs) about triazole antifungal agents, which are serious AEs. The following SOCs appear as important signals: 'endocrine disorders', 'metabolic and nutritional disorders', and 'skin and subcutaneous tissue disorders'. Triazole antifungals produce AEs, such as respiratory failure, rash, hepatic function abnormal, and hypokalemia. They also produce uncommon AEs, including changes in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucin

背景:三唑类抗真菌药物因具有广谱抗真菌活性而被广泛应用;然而,有许多未被发现和未报告的不良事件(ae)。方法:选取2004年第一季度(Q1)至2021年第三季度(Q3)美国食品药品监督管理局不良事件报告系统(FAERS)的数据进行歧化分析,评估抗真菌三唑类药物与ae和重要医疗事件(IMEs)之间的关系。结果:共鉴定出与三唑类抗真菌药物相关的记录22566条,其中三唑类抗真菌药物- ime对9584对。以下系统器官类别(soc)出现为重要信号:“内分泌紊乱”[报道的优势比(ROR) = 167.94],“代谢和营养紊乱”(ROR = 46.30),以及“皮肤和皮下组织紊乱”(ROR = 21.37)。强烈信号表现为呼吸衰竭、皮疹、肝功能异常、低血钾。不常见的安全信号包括QT间期改变、神经毒性、假性醛固酮增多症和幻觉。结论:不同类型的三唑类抗真菌药物可引起不同类型和强度的ae。我们的结果与处方信息和以前的研究大致一致;然而,需要进一步的药物流行病学研究来证实发生率适中但信号较高的不良反应。摘要:三唑类抗真菌药物不良反应的研究简介:我们研究的三唑类抗真菌药物包括氟康唑、伊曲康唑、伏立康唑、泊沙康唑和异戊康唑。三唑类抗真菌药作为广谱抗真菌药被广泛应用;然而,有许多未被发现和未报告的不良事件(ae)。材料和方法:美国食品和药物管理局不良事件报告系统(FAERS)数据库包含不同国家向FDA报告的有关上市后药物的不良事件。通过FAERS数据库,我们共检索到22,566例与三唑类抗真菌药物相关的AE报告。我们不仅统计了患者的性别、年龄、体重、报告国家、结局指标和适应症等信息,还分析了ae的系统器官分类(soc)、报告的药物相关ae的数量和相关程度。结果:共发现与三唑类抗真菌药物相关的病历22566份,其中涉及三唑类抗真菌药物的重要医学事件(ime) 9584份,均为严重ae。以下soc表现为重要信号:“内分泌紊乱”、“代谢和营养紊乱”以及“皮肤和皮下组织紊乱”。三唑类抗真菌药物可产生不良反应,如呼吸衰竭、皮疹、肝功能异常和低钾血症。它们也会产生不常见的不良反应,包括QT间期改变、神经毒性、假性醛固酮增多症和幻觉。结论:通过分析FAERS数据库的数据,我们发现与这五种三唑类抗真菌药物相关的不良事件比说明书中指出的要多,我们的发现为三唑类相关的不良事件提供了更多的见解,可以在治疗前和治疗期间告知临床医生。
{"title":"Safety of triazole antifungals: a pharmacovigilance study from 2004 to 2021 based on FAERS.","authors":"Shuang Chai,&nbsp;Jing-Lun Zhan,&nbsp;Li-Mei Zhao,&nbsp;Xiao-Dong Liu","doi":"10.1177/20420986221143266","DOIUrl":"https://doi.org/10.1177/20420986221143266","url":null,"abstract":"<p><strong>Background: </strong>Triazole antifungals are widely used as broad-spectrum antifungal activity; however, there are many undetected and unreported adverse events (AEs).</p><p><strong>Methods: </strong>Data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter (Q1) of 2004 to the third quarter (Q3) of 2021 were selected for disproportionality analysis to assess the connection between antifungal triazoles, and AEs and important medical events (IMEs).</p><p><strong>Results: </strong>A total of 22,566 records associated with triazole antifungals were identified, with 9584 triazole antifungal-IME pairs. The following system organ classes (SOCs) appeared as significant signals: 'Endocrine disorders' [reported odds ratio (ROR) = 167.94], 'Metabolism and nutrition disorders' (ROR = 46.30), and 'Skin and subcutaneous tissue disorders' (ROR = 21.37). Strong signals were observed with respiratory failure, rash, hepatic function abnormal, and hypokalemia. Uncommon security signals included a change in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucinations.</p><p><strong>Conclusion: </strong>Various triazole antifungals cause AEs of different types and intensities of association. Our results are broadly consistent with prescribing information and previous studies; however, additional pharmacoepidemiological studies are required to verify AEs with modest incidence but high signal.</p><p><strong>Plain language summary: </strong><b>A study on the adverse effects of triazole antifungals</b> <b>Introduction:</b> The triazole antifungals we studied include fluconazole, itraconazole, voriconazole, posaconazole, and isavuconazole. Triazole antifungals are widely used as broad-spectrum antifungals; however, there are many undetected and unreported adverse events (AEs).<b>Materials and Methods:</b> The Food and Drug Administration Adverse Event Reporting System (FAERS) database contains AEs reported to the FDA by different countries regarding post-marketing drugs. Through the FAERS database, we retrieved a total of 22,566 AE reports related to triazole antifungals. We not only counted information about patients' gender, age, weight, reporting country, outcome indicators, and indications but also analyzed the system organ classes (SOCs) of AEs, and the number of reported drug-related AEs and the degree of relevance.<b>Results:</b> We found a total of 22,566 records related to triazole antifungal agents, of which 9584 reports made important medical events (IMEs) about triazole antifungal agents, which are serious AEs. The following SOCs appear as important signals: 'endocrine disorders', 'metabolic and nutritional disorders', and 'skin and subcutaneous tissue disorders'. Triazole antifungals produce AEs, such as respiratory failure, rash, hepatic function abnormal, and hypokalemia. They also produce uncommon AEs, including changes in the QT interval, neurotoxicity, pseudoaldosteronism, and hallucin","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/95/a3/10.1177_20420986221143266.PMC9761248.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10420306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
The response to the COVID-19 pandemic trusted in pharmacovigilance to diminish communication risk 对新冠肺炎大流行的反应值得信赖的是药物警戒以降低沟通风险
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221088650
Gustavo-Adolfo Quintero
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Background SARS-CoV-2 is one of the most disruptive events in recent history and has become a threat to global health, perhaps the most important one in the world (along with Spanish flu) since the concept of pandemic had been introduced into the public health, approximately a century1 ago.
知识共享非商业CC BY-NC:本文根据知识共享归因非商业4.0许可条款分发(https://creativecommons.org/licenses/by-nc/4.0/)允许对作品进行非商业性使用、复制和分发,而无需进一步许可,前提是原始作品的归属符合SAGE和开放获取页面的规定(https://us.sagepub.com/en-us/nam/open-access-at-sage)。背景严重急性呼吸系统综合征冠状病毒2型是近代史上最具破坏性的事件之一,已成为对全球健康的威胁,可能是自大约一个世纪前大流行概念引入公共卫生以来世界上最重要的一次(与西班牙流感一起)。
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引用次数: 1
Ten-year trends in adverse drug reaction–related hospitalizations among people with dementia 痴呆症患者药物不良反应相关住院治疗的十年趋势
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221080796
Anum Saqib Zaidi, G. Peterson, L. Bereznicki, C. Curtain, M. Salahudeen
Aim: Trends in the incidence of adverse drug reaction (ADR)–related hospitalizations have been studied in the general population, but not specifically in people with dementia. This study aimed to investigate trends in the incidence of ADR-related hospitalizations among people with dementia, and identify the most commonly implicated drugs and diagnoses in these admissions. Methods: This study utilized the administrative data of all adults admitted to the four major public hospitals of Tasmania, Australia, with a primary or secondary diagnosis of dementia from July 2010 to December 2019. ADR-related hospitalizations were identified by using diagnosis-based and external cause codes. The Cochran–Armitage test was used to examine trends in the incidence of ADR-related hospitalizations. Results: Of the 7552 people with dementia admitted to the hospital at least once within the study period, 1775 (23.5%) experienced at least one ADR-related hospitalization. The estimated annual incidence of ADR-related hospitalizations increased 18% (1484–1760 per 100,000 population with dementia, p for trend <0.05) from 2010 to 2019. For those ADR-related admissions with a drug code recorded, 19.3% were due to antithrombotics and 11.5% to antihypertensives. The most frequent ADR-related admission diagnoses were renal diseases (72.9%). Length of hospital stay and in-hospital mortality were both significantly greater for ADR-related, relative to non-ADR-related, admissions (median 7 versus 5 days and 11% versus 6.7%, respectively; p < 0.001). Conclusion: The annual incidence of ADR-related hospitalizations in people with dementia increased between 2010 and 2019. Antithrombotics were the most commonly implicated drug class. The ADR-related hospitalizations were associated with increased length of stay and greater mortality. Plain Language Summary Adverse drug reaction–related hospitalizations among people with dementia Introduction: This study aimed to investigate trends in hospitalizations associated with medication problems among people with dementia, and identify the most commonly implicated drugs and diagnoses in these admissions. Methods: This study utilized the administrative data of all adults admitted to the four major public hospitals of Tasmania, Australia, with dementia from July 2010 to December 2019. Results: The annual incidence of hospitalizations associated with medication problems among people with dementia increased nearly 20% over 10 years. The length of hospital stay and in-hospital mortality were significantly greater for hospitalizations related to medication problems. Conclusion: The incidence of hospitalizations associated with medication problems in people with dementia increased between 2010 and 2019.
目的:研究了一般人群中药物不良反应(ADR)相关住院的发生率趋势,但没有专门研究痴呆患者。本研究旨在调查痴呆症患者中与不良反应相关的住院发生率的趋势,并确定这些入院中最常见的相关药物和诊断。方法:本研究利用了2010年7月至2019年12月期间在澳大利亚塔斯马尼亚州四家主要公立医院就诊的所有原发性或继发性痴呆患者的行政数据。通过使用基于诊断和外因代码确定与不良反应相关的住院情况。Cochran-Armitage检验用于检查与不良反应相关的住院发生率的趋势。结果:在研究期间至少住院一次的7552名痴呆患者中,1775名(23.5%)经历了至少一次与不良反应相关的住院治疗。从2010年到2019年,与不良反应相关的住院率估计增加了18%(每10万痴呆患者中有1484-1760人,p <0.05)。在有药物编码记录的不良反应相关入院患者中,19.3%是抗血栓药物,11.5%是抗高血压药物。最常见的与adr相关的入院诊断是肾脏疾病(72.9%)。与非adr相关的住院相比,与adr相关的住院时间和住院死亡率均显著高于非adr相关的住院时间(中位数分别为7天和5天,11%和6.7%;p < 0.001)。结论:2010年至2019年,痴呆症患者中与不良反应相关的住院率逐年上升。抗血栓药是最常见的药物类别。与不良反应相关的住院治疗与住院时间的延长和更高的死亡率有关。前言:本研究旨在调查痴呆症患者与药物问题相关的住院趋势,并确定这些入院中最常见的相关药物和诊断。方法:本研究利用了2010年7月至2019年12月在澳大利亚塔斯马尼亚州四家主要公立医院住院的所有痴呆成年人的管理数据。结果:10年来,痴呆症患者因药物问题而住院的年发生率增加了近20%。与药物问题相关的住院时间和住院死亡率显著更高。结论:2010年至2019年期间,痴呆症患者与药物问题相关的住院率有所增加。
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引用次数: 4
The 5th European pharmacovigilance congress: speaker abstracts 第五届欧洲药物警戒大会:发言摘要
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986211068914
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引用次数: 0
Neurodevelopmental outcomes in children exposed prenatally to levetiracetam 产前接触左乙拉西坦的儿童的神经发育结果
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221088419
B. A. Alsfouk
Some old antiseizure medications (ASMs) pose teratogenic risks, including major congenital malformations and neurodevelopmental delay. Therefore, the use of new ASMs in pregnancy is increasing, particularly lamotrigine and levetiracetam. This is likely due to evidence of low risk of anatomical teratogenicity for both lamotrigine and levetiracetam. Regarding neurodevelopmental effects, lamotrigine is the most frequently investigated new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development, with smaller cohorts and shorter follow-up. The aim of the present review was to explicate neurodevelopmental outcomes in children exposed prenatally to levetiracetam to support clinical decision-making. The available data do not indicate an increased risk of abnormal neurodevelopmental outcomes in children exposed prenatally to levetiracetam. Findings demonstrated comparable outcomes for levetiracetam versus controls and favorable outcomes for levetiracetam versus valproate on global and specific cognitive abilities, and behavioral problems. In addition, the available evidence shows no significant dose-effect association for levetiracetam on neurodevelopmental outcomes. However, this evidence cannot be determined definitively due to the limited numbers of exposures with relatively short follow-up. Therefore, further research is required. Plain Language Summary Antiseizure medications (ASMs) are medicines that inhibit the occurrence of seizures. Levetiracetam is a new ASM. Some old ASMs are linked with an increased risk of physical birth abnormalities and adverse effects on the child’s brain development. Therefore, the use of new ASMs in pregnancy is increasing, especially lamotrigine and levetiracetam. This is likely due to evidence of low risk of birth abnormalities for both lamotrigine and levetiracetam. Regarding effects on development of the brain, lamotrigine is the most frequently examined new ASM with information available for children up to 14 years of age. However, fewer data are available for the effects of levetiracetam on cognitive and behavioral development. Also, levetiracetam studies were smaller and shorter compared with studies investigating lamotrigine effects. The aim of this article was to review the child’s brain development effects after exposure to levetiracetam during pregnancy. The available data do not suggest an increased risk of the child having learning or thinking difficulties. Findings demonstrated comparable outcomes for levetiracetam versus controls (i.e. children unexposed to levetiracetam), and favorable outcomes for levetiracetam versus valproate. In addition, the available evidence shows no link between the higher dose of levetiracetam and an increased risk of adverse effects on the child’s brain development. However, this evidence cannot be determined definitively due to the limited numbers of children ex
一些旧的抗癫痫药物(asm)具有致畸风险,包括严重的先天性畸形和神经发育迟缓。因此,妊娠期使用新型抗炎药的情况越来越多,尤其是拉莫三嗪和左乙拉西坦。这可能是由于有证据表明拉莫三嗪和左乙拉西坦的解剖致畸性风险较低。关于神经发育的影响,拉莫三嗪是最常被调查的新ASM,其信息可用于14岁以下的儿童。然而,关于左乙拉西坦对认知和行为发展的影响的数据较少,队列较小,随访时间较短。本综述的目的是阐明产前暴露于左乙拉西坦的儿童的神经发育结果,以支持临床决策。现有数据并未表明产前暴露于左乙拉西坦的儿童神经发育异常的风险增加。研究结果表明,左乙拉西坦与对照组的结果相当,左乙拉西坦与丙戊酸在整体和特定认知能力以及行为问题上的结果有利。此外,现有证据显示左乙拉西坦对神经发育结局没有显著的剂量效应关联。然而,由于暴露次数有限,随访时间相对较短,因此无法确定这一证据。因此,需要进一步的研究。抗癫痫药物(asm)是抑制癫痫发作的药物。左乙拉西坦是一种新型ASM。一些老年性肌痉挛与身体出生异常的风险增加以及对儿童大脑发育的不利影响有关。因此,妊娠期使用新型抗炎药物越来越多,尤其是拉莫三嗪和左乙拉西坦。这可能是由于有证据表明拉莫三嗪和左乙拉西坦的出生异常风险较低。关于对大脑发育的影响,拉莫三嗪是最常被检查的新ASM,其信息可用于14岁以下儿童。然而,关于左乙拉西坦对认知和行为发展的影响的数据较少。此外,与调查拉莫三嗪作用的研究相比,左乙拉西坦的研究规模较小,时间较短。本文的目的是回顾在怀孕期间暴露于左乙拉西坦后对儿童大脑发育的影响。现有的数据并不表明儿童有学习或思维障碍的风险增加。研究结果表明,左乙拉西坦与对照组(即未暴露于左乙拉西坦的儿童)的结果相当,左乙拉西坦与丙戊酸盐的结果有利。此外,现有证据表明,高剂量的左乙拉西坦与儿童大脑发育不良风险增加之间没有联系。然而,由于接触左乙拉西坦的儿童数量有限,随访时间相对较短,因此无法确定这一证据。因此,需要进一步的研究。
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引用次数: 1
Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics. 韩国非癌症患者处方非注射阿片类镇痛药的潜在不适当阿片类处方趋势及相关危险因素
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221091001
Yoojin Noh, Kyu-Nam Heo, Yun Mi Yu, Ju-Yeun Lee, Young-Mi Ah

Introduction: The aim of this study was to investigate trends in the prevalence of potentially inappropriate opioid prescribing (PIOP) and identify potential risk factors among Korean noncancer patients.

Methods: We conducted a cross-sectional study of annual national patient sample data from the Korean Health Insurance Review and Assessment Service (HIRA-NPS) for the period 2012-2018. Noncancer patients who were prescribed non-injectable opioid analgesics (NIOAs) at least once were included. The proportion of patients with at least one PIOP in terms of concurrent use of benzodiazepines or gabapentinoids, substance use disorder, treatment duration, and dosage was evaluated. Multivariable logistic regression was performed to identify the risk factors associated with PIOP.

Results: Of the 9,772,503 noncancer patients, 1,583,444 (16.2%) were prescribed NIOAs at least once. Among them, 15.7% were exposed to PIOP, and the prevalence was much higher (31.6%) in the elderly group (age: ⩾65 years). The prevalence of PIOP increased 1.1-fold over 7 years (14.8-16.8%) among the total NIOA users and was more pronounced in non-tramadol NIOA users (a 1.5-fold increase, from 13.2% to 19.4%). Multivariable logistic regression indicated that older age, beneficiaries of medical aid or national meritorious service, exposure to polypharmacy, psychological disorder, chronic pain indication, and concomitant sedative use were independently associated with higher odds of PIOP.

Discussion and conclusion: We found that the prevalence of PIOP was 15.7% among Korean noncancer patients, and it increased over the 7-year study period. This increasing trend is alarming because it was more drastic with non-tramadol NIOAs compared with that with tramadol. Several patient-level risk factors associated with PIOP would be useful in targeted management strategies for the safe use of opioids.

Plain language summary: Potentially inappropriate opioid prescribing and related risk factors among noncancer patients prescribed non-injectable opioids in Korea In Korea, the prevalence of non-injectable opioid analgesic (NIOA) use in noncancer patients steadily increased from 15.3% in 2012 to 17.1% in 2018.Also, the prevalence of potentially inappropriate opioid prescribing (PIOP) increased from 14.8% in 2012 to 16.8% in 2018.The following factors were associated with a markedly increased risk of PIOP: age, beneficiaries of medical aid or national meritorious service, polypharmacy, psychological disorder, chronic pain, and concomitant medications.

本研究的目的是调查韩国非癌症患者中潜在不适当的阿片类药物处方(PIOP)的流行趋势,并确定潜在的危险因素。方法:我们对2012-2018年韩国健康保险审查和评估服务(HIRA-NPS)的年度全国患者样本数据进行了横断面研究。至少一次服用非注射阿片类镇痛药(NIOAs)的非癌症患者被纳入研究。评估同时使用苯二氮卓类药物或加巴喷丁类药物、物质使用障碍、治疗持续时间和剂量方面至少有一种PIOP的患者比例。采用多变量logistic回归来确定与PIOP相关的危险因素。结果:在9,772,503例非肿瘤患者中,1,583,444例(16.2%)至少服用过一次nioa。其中,15.7%暴露于PIOP,并且在老年组(年龄:大于或等于65岁)中的患病率要高得多(31.6%)。在所有NIOA使用者中,PIOP的患病率在7年内增加了1.1倍(14.8-16.8%),在非曲马多NIOA使用者中更为明显(从13.2%增加到19.4%,增加了1.5倍)。多变量logistic回归表明,年龄较大、接受医疗救助或国家功勋服务、使用多种药物、心理障碍、慢性疼痛指征和同时使用镇静剂与PIOP的高发生率独立相关。讨论和结论:我们发现韩国非癌症患者中PIOP的患病率为15.7%,并且在7年的研究期间有所增加。这种增长趋势令人担忧,因为与曲马多相比,非曲马多nioa的增长更为剧烈。与PIOP相关的几个患者层面的风险因素将有助于阿片类药物安全使用的有针对性的管理策略。在韩国,非癌症患者使用非注射性阿片类镇痛药(NIOA)的比例从2012年的15.3%稳步上升至2018年的17.1%。此外,潜在不适当阿片类药物处方(PIOP)的患病率从2012年的14.8%上升到2018年的16.8%。以下因素与PIOP风险显著增加相关:年龄、医疗援助或国家功勋服务的受益人、多种药物、心理障碍、慢性疼痛和伴随药物。
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引用次数: 5
Analysis of drug-induced hand-foot syndrome using a spontaneous reporting system database. 利用自发报告系统数据库分析药物性手足综合征。
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221101963
Yu Yoshida, Sayaka Sasaoka, Mizuki Tanaka, Kiyoka Matsumoto, Misaki Inoue, Riko Satake, Kazuyo Shimada, Ririka Mukai, Takaaki Suzuki, Mari Iwata, Fumiya Goto, Takayuki Mori, Koki Mori, Tomoaki Yoshimura, Mitsuhiro Nakamura

Purpose: The aim of our study was to assess the clinical features of hand-foot syndrome (HFS) associated with certain systemic chemotherapeutic drugs in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database.

Methods: HFS was defined using the preferred terms from the Medical Dictionary for Regulatory Activities. We used several indices, such as the reporting odds ratios (RORs) at 95% confidence interval (CI), the time-to-onset profile of HFS, and cluster analysis.

Results: Of 646,779 reports (submission period: April 2004 to September 2020), 1814 reported HFS events. The RORs (95% CI) for axitinib, capecitabine, lapatinib, regorafenib, sorafenib, and sunitinib were 14.9 (11.1-20.1), 54.6 (49.2-60.6), 130.4 (110.7-153.6), 63.3 (55.2-72.6), 29.0 (25.8-32.7), and 13.9 (11.7-16.5), respectively. The analysis of time-to-onset profiles revealed that the median values (interquartile range: 25.0-75.0%) of drug-induced HFS caused by capecitabine, cisplatin, docetaxel, everolimus, regorafenib, sorafenib, and trastuzumab were 21.0 (13.0-42.0), 15.0 (10.0-82.0), 6.0 (3.0-25.0), 86.5 (67.0-90.5), 9.0 (6.0-14.0), 9.0 (6.0-14.0), and 70.0 (15.0-189.0) days, respectively. The number of clusters was set to 4. Among these, one cluster, which included capecitabine, regorafenib, and lapatinib, exhibited a higher reporting ratio and ROR of drug-induced HFS than other drugs.

Conclusions: The RORs and results of time-to-onset analysis obtained in this study indicated the potential risk of HFS associated with chemotherapeutic drugs. Our results suggest that health care professionals must be aware of the potential onset of drug-induced HFS with docetaxel, regorafenib, and sorafenib for at least 4 weeks; therefore, careful observation is recommended.

Plain language summary: Elucidation of the relationship between cancer drugs and risk of hand-foot syndrome: Purpose: Hand-foot syndrome (HFS) is an adverse effect of some cancer drugs, which is characterized by symptoms such as redness, swelling, blistering, and pain in the area of palms and soles. HFS reduces the quality of life of patients and can sometimes interfere with anticancer treatment plans. It is important to understand the clinical manifestations of HFS and gain knowledge that will allow for early intervention by clinicians.Methods: In this study, we used a large-scale side effect database of real-world cases for a comprehensive investigation of anticancer-drug-induced HFS. The database contained 646,779 adverse event reports from April 2004 to September 2020; among which, we identified 1814 HFS events. Using these data, we could obtain information on the relationship between 19 types of anticancer drugs and HFS, and the onset time of HFS and HFS prognosis related to each anticancer drug. Results: Our results suggest that clinicians should monitor

目的:我们研究的目的是利用日本不良药物事件报告(JADER)数据库,评估与某些全身化疗药物相关的手足综合征(HFS)的临床特征。方法:HFS的定义采用《医学规范活动词典》中的首选术语。我们使用了几个指标,如95%置信区间(CI)的报告优势比(RORs)、HFS发病时间概况和聚类分析。结果:在646,779份报告(提交期:2004年4月至2020年9月)中,1814份报告了HFS事件。阿西替尼、卡培他滨、拉帕替尼、瑞非尼、索拉非尼和舒尼替尼的RORs (95% CI)分别为14.9(11.1-20.1)、54.6(49.2-60.6)、130.4(110.7-153.6)、63.3(55.2-72.6)、29.0(25.8-32.7)和13.9(11.7-16.5)。发病时间谱分析显示,卡培他滨、顺铂、多西他赛、依维莫司、瑞非尼、索拉非尼和曲妥珠单抗引起的药物性HFS的中位值(四分位数范围:25.0-75.0%)分别为21.0(13.0-42.0)、15.0(10.0-82.0)、6.0(3.0-25.0)、86.5(67.0-90.5)、9.0(6.0-14.0)、9.0(6.0-14.0)和70.0(15.0-189.0)天。集群数设置为4。其中,卡培他滨、瑞非尼和拉帕替尼的药物性HFS报告率和ROR高于其他药物。结论:本研究获得的RORs和发病时间分析结果提示化疗药物与HFS相关的潜在风险。我们的研究结果表明,医疗保健专业人员必须意识到多西他赛、瑞非尼和索拉非尼至少4周内可能发生药物性HFS;因此,建议仔细观察。简明语言总结:阐明抗癌药物与手足综合征风险的关系:目的:手足综合征(hand-foot syndrome, HFS)是某些抗癌药物的不良反应,以手掌和脚底发红、肿胀、起泡、疼痛等症状为特征。HFS会降低患者的生活质量,有时还会干扰抗癌治疗计划。重要的是要了解HFS的临床表现,并获得知识,以便临床医生进行早期干预。方法:在本研究中,我们使用大规模的真实病例副作用数据库,对抗癌药物诱导的HFS进行全面调查。该数据库包含2004年4月至2020年9月期间646779例不良事件报告;其中,我们确定了1814个HFS事件。利用这些数据,我们可以得到19种抗癌药物与HFS的关系,以及每种抗癌药物与HFS的发病时间和预后的关系。结果:我们的研究结果表明,临床医生应在给药后至少4周内监测多西他赛、瑞非尼和索拉非尼联合使用HFS的风险。结论:这些发现对提高抗肿瘤药物不良反应的管理具有重要意义。
{"title":"Analysis of drug-induced hand-foot syndrome using a spontaneous reporting system database.","authors":"Yu Yoshida,&nbsp;Sayaka Sasaoka,&nbsp;Mizuki Tanaka,&nbsp;Kiyoka Matsumoto,&nbsp;Misaki Inoue,&nbsp;Riko Satake,&nbsp;Kazuyo Shimada,&nbsp;Ririka Mukai,&nbsp;Takaaki Suzuki,&nbsp;Mari Iwata,&nbsp;Fumiya Goto,&nbsp;Takayuki Mori,&nbsp;Koki Mori,&nbsp;Tomoaki Yoshimura,&nbsp;Mitsuhiro Nakamura","doi":"10.1177/20420986221101963","DOIUrl":"https://doi.org/10.1177/20420986221101963","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of our study was to assess the clinical features of hand-foot syndrome (HFS) associated with certain systemic chemotherapeutic drugs in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database.</p><p><strong>Methods: </strong>HFS was defined using the preferred terms from the Medical Dictionary for Regulatory Activities. We used several indices, such as the reporting odds ratios (RORs) at 95% confidence interval (CI), the time-to-onset profile of HFS, and cluster analysis.</p><p><strong>Results: </strong>Of 646,779 reports (submission period: April 2004 to September 2020), 1814 reported HFS events. The RORs (95% CI) for axitinib, capecitabine, lapatinib, regorafenib, sorafenib, and sunitinib were 14.9 (11.1-20.1), 54.6 (49.2-60.6), 130.4 (110.7-153.6), 63.3 (55.2-72.6), 29.0 (25.8-32.7), and 13.9 (11.7-16.5), respectively. The analysis of time-to-onset profiles revealed that the median values (interquartile range: 25.0-75.0%) of drug-induced HFS caused by capecitabine, cisplatin, docetaxel, everolimus, regorafenib, sorafenib, and trastuzumab were 21.0 (13.0-42.0), 15.0 (10.0-82.0), 6.0 (3.0-25.0), 86.5 (67.0-90.5), 9.0 (6.0-14.0), 9.0 (6.0-14.0), and 70.0 (15.0-189.0) days, respectively. The number of clusters was set to 4. Among these, one cluster, which included capecitabine, regorafenib, and lapatinib, exhibited a higher reporting ratio and ROR of drug-induced HFS than other drugs.</p><p><strong>Conclusions: </strong>The RORs and results of time-to-onset analysis obtained in this study indicated the potential risk of HFS associated with chemotherapeutic drugs. Our results suggest that health care professionals must be aware of the potential onset of drug-induced HFS with docetaxel, regorafenib, and sorafenib for at least 4 weeks; therefore, careful observation is recommended.</p><p><strong>Plain language summary: </strong><b>Elucidation of the relationship between cancer drugs and risk of hand-foot syndrome:</b> <b>Purpose:</b> Hand-foot syndrome (HFS) is an adverse effect of some cancer drugs, which is characterized by symptoms such as redness, swelling, blistering, and pain in the area of palms and soles. HFS reduces the quality of life of patients and can sometimes interfere with anticancer treatment plans. It is important to understand the clinical manifestations of HFS and gain knowledge that will allow for early intervention by clinicians.<b>Methods:</b> In this study, we used a large-scale side effect database of real-world cases for a comprehensive investigation of anticancer-drug-induced HFS. The database contained 646,779 adverse event reports from April 2004 to September 2020; among which, we identified 1814 HFS events. Using these data, we could obtain information on the relationship between 19 types of anticancer drugs and HFS, and the onset time of HFS and HFS prognosis related to each anticancer drug. <b>Results:</b> Our results suggest that clinicians should monitor","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/5d/10.1177_20420986221101963.PMC9136434.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10619326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Prescription for COVID-19 by non-medical professionals during the pandemic in Colombia: a cross-sectional study 哥伦比亚疫情期间非医疗专业人员对新冠肺炎的处方:一项横断面研究
IF 4.4 3区 医学 Q2 Medicine Pub Date : 2022-01-01 DOI: 10.1177/20420986221101964
María José Niño-Orrego, Daniela Baracaldo-Santamaría, Claudia Patricia Ortiz, Heyde Patricia Zuluaga, Sthefany Alejandra Cruz-Becerra, F. Soler, Andrés M. Pérez-Acosta, Daniel Ricardo Delgado, C. Calderón-Ospina
Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions (DDIs), disease masking, and antibiotic resistance. Rationale: SM with drugs advertised for COVID-19 can have consequences, and people should be aware of approved uses, potential contraindications, and ADRs. Thus, the aim of this study was to know the drug therapies including natural products and homeopathic drugs offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: An observational, cross-sectional mystery shopping study was carried out to determine the pharmaceutical alternatives for the management of COVID-19 offered by pharmaceutical establishments (drugstores, pharmacies, homeopathic pharmacies, and nutritional supplements stores) in Colombia, and information related to the safe use of the product. The study included 482 pharmaceutical establishments from 16 Colombian departments. Data collection was done through telephone calls to each of the establishments following an interview protocol pretending to be a patient who presents symptoms related to COVID-19. Results: About 57.3% (276) of the establishments recommended a product for the treatment of COVID-19 infection, 66.6% (321) asked whether the caller had COVID-19 symptoms and what they are, and 44.2% (213) suggested taking a COVID-19 test. Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and ASA (aspirin). From the establishments that recommended a product, dosage was indicated in 85.5% (236) of the pharmaceutical establishments and 14.5% (40) of the establishments reported the most common adverse effects of this substance. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements.Conclusion: Pharmaceutical establishments in Colombia seem to have significantly contributed to self-medication for COVID-19 in Colombia during the pandemic. This behavior is inappropriate, since the mild forms of the disease do not have a specific treatment. Plain Language Summary Self-medication induced by pharmaceutical establishments in Colombia during the COVID-19 pandemic Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, hydroxychloroquine among others, which are not useful for preventing or treating COVID-19 and could expose patients to unnecessary
背景:新冠肺炎大流行导致自我药物治疗(SM)行为的增加。鉴于疫情期间大量发布误导性信息,一些药店推荐伊维菌素、阿奇霉素和羟氯喹等药物,这些药物对预防或治疗新冠肺炎无效,可能使患者面临不必要的药物不良反应(ADR)、药物相互作用(DDI)、疾病掩盖和抗生素耐药性。理由:宣传新冠肺炎药物的SM可能会产生后果,人们应了解批准的用途、潜在禁忌症和不良反应。因此,本研究的目的是了解哥伦比亚制药机构为预防和治疗新冠肺炎提供的药物疗法,包括天然产品和顺势疗法药物,以及提供的安全使用该产品的信息。方法:进行了一项观察性、横断面神秘购物研究,以确定哥伦比亚制药机构(药店、药店、顺势疗法药店和营养补充剂店)提供的用于管理新冠肺炎的药物替代品,以及与产品安全使用相关的信息。这项研究包括来自哥伦比亚16个部门的482家制药机构。数据收集是通过按照采访协议打电话给每个机构完成的,假装是一名出现与新冠肺炎相关症状的患者。结果:约57.3%(276)的机构推荐治疗新冠肺炎感染的产品,66.6%(321)的机构询问打电话的人是否有新冠肺炎症状以及症状是什么,44.2%(213)的机构建议进行新冠肺炎检测。在药店推荐的59种药物中,最推荐的是阿奇霉素、伊维菌素、对乙酰氨基酚、布洛芬和ASA(阿司匹林)。在推荐产品的机构中,85.5%(236)的制药机构显示了剂量,14.5%(40)的机构报告了该物质最常见的不良反应。约9.4%(26)的机构报告了推荐药物和物质与食品、饮料或补充剂可能存在的相互作用。结论:在大流行期间,哥伦比亚的制药机构似乎对哥伦比亚新冠肺炎的自我用药做出了重大贡献。这种行为是不恰当的,因为轻度疾病没有特定的治疗方法。简明语言摘要新冠肺炎大流行期间哥伦比亚制药机构诱导的自我适应背景:新冠肺炎大流行导致自我用药行为(SM)的增加。鉴于疫情期间大量发布误导性信息,一些药店推荐伊维菌素、阿奇霉素、羟氯喹等药物,这些药物对预防或治疗新冠肺炎无效,可能会使患者面临不必要的副作用和与其他药物的相互作用。人们应该了解这些药物的批准和非批准用途,以及潜在的副作用。理由:本研究的目的是了解哥伦比亚制药机构提供的用于预防和治疗新冠肺炎的药物,包括天然产品和顺势疗法药物,以及提供的有关该产品安全使用的信息。方法:该研究采用神秘购物法进行,由一名训练有素的伪装成新冠肺炎症状患者的个人通过给每个机构打电话收集数据。这项研究包括来自哥伦比亚16个部门的482家制药机构。结果:在药店推荐的59种药物中,最推荐的是阿奇霉素、伊维菌素、对乙酰氨基酚、布洛芬和阿司匹林。85.5%(236家)的制药机构指出了推荐剂量,其中14.5%(40家)的机构报告了推荐产品最常见的不良反应。约9.4%(26)的机构报告了推荐药物和物质与食品、饮料或补充剂可能存在的相互作用。结论:研究中包括的大多数制药机构在大流行期间促进了哥伦比亚新冠肺炎的自我用药不足。
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引用次数: 5
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Therapeutic Advances in Drug Safety
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