Marcelo Bueno de Camargo, Inês Ribeiro-Vaz, Cristiane de Cássia Bergamaschi, Marcus Tolentino Silva
{"title":"抗生素和药物反应与嗜酸性粒细胞增多和全身症状（DRESS）综合征：巴西药物警戒登记的分析","authors":"Marcelo Bueno de Camargo, Inês Ribeiro-Vaz, Cristiane de Cássia Bergamaschi, Marcus Tolentino Silva","doi":"10.1002/pds.70128","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and purpose: </strong>This study investigated the association between the use of antibiotics and the occurrence of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a rare and serious adverse event characterized by eosinophilia and acute skin rash. Without early diagnosis, the syndrome can lead to complications or even death.</p><p><strong>Methods: </strong>In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.</p><p><strong>Results: </strong>A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).</p><p><strong>Conclusions: </strong>An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. Given the seriousness of the findings, further studies should be conducted to obtain more accurate information about this adverse reaction.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 4","pages":"e70128"},"PeriodicalIF":2.4000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries.\",\"authors\":\"Marcelo Bueno de Camargo, Inês Ribeiro-Vaz, Cristiane de Cássia Bergamaschi, Marcus Tolentino Silva\",\"doi\":\"10.1002/pds.70128\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and purpose: </strong>This study investigated the association between the use of antibiotics and the occurrence of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a rare and serious adverse event characterized by eosinophilia and acute skin rash. Without early diagnosis, the syndrome can lead to complications or even death.</p><p><strong>Methods: </strong>In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.</p><p><strong>Results: </strong>A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).</p><p><strong>Conclusions: </strong>An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. 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Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries.
Background and purpose: This study investigated the association between the use of antibiotics and the occurrence of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a rare and serious adverse event characterized by eosinophilia and acute skin rash. Without early diagnosis, the syndrome can lead to complications or even death.
Methods: In 2020, the Brazilian National Health Surveillance Agency (Anvisa) made available a system for reporting adverse drug events, called VigiMed. Reports of adverse events registered on this system between December 1, 2018 and December 31, 2022, were analyzed. Reporting odds ratio (ROR), together with the respective 95% confidence intervals (95% CI), was calculated as a measure of the association between antibiotics and DRESS syndrome.
Results: A total of 160,101 reports of adverse drug events were analyzed, with 136 suspected cases of DRESS syndrome. Compared with other drugs, the following frequencies of suspected DRESS syndrome were observed for the use of any antibiotic (ROR: 4.8; 95% CI: 3.3-7.0), meropenem (ROR: 13.0; 95% CI: 8.0-21.0), vancomycin (ROR: 11.5; 95% CI: 7.4-17.6), ampicillin (ROR: 6.8; 95% CI: 2.1-21.8), amoxicillin (ROR: 4.7; 95% CI: 1.5-15.0), cefepime (ROR: 4.3; 95% CI: 1.3-13.6), piperacillin + tazobactam (ROR: 2.5; 95% CI: 1.1-5.8) and ceftriaxone (ROR: 2.4; 95% CI: 1.1-5.1). The ROR for DRESS syndrome and the use of oxacillin was 2.7 with a wide 95% CI (0.7-11.1).
Conclusions: An association was observed between reports of DRESS syndrome and the use of antibiotics, particularly those routinely used in a hospital setting. Although there is a potential risk of underreporting or unattributed causality, the information obtained in this study is valuable for the analysis of rare adverse reactions. Given the seriousness of the findings, further studies should be conducted to obtain more accurate information about this adverse reaction.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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