Análisis de reportes de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) en pacientes pediátricos: Estudio observacional en una unidad de oncología.
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| Title: | Análisis de reportes de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) en pacientes pediátricos: Estudio observacional en una unidad de oncología. |
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| Alternate Title: | Analysis of Reporting Adverse Drug Reactions (ADRs) in pediatric patients: Observational study in an oncology unit. |
| Authors: | Garzón Lamarque, Juan Antonio1, Escalante Navarro, Cristhian Daniel2, Becerra Ruiz, Angélica Berenice2, Sánchez Zubieta, Fernando Antonio3, Romero Tejeda, Elba Margarita2, Pardo Zepeda, Monzerrat4 mpardoz@hcg.gob.mx |
| Source: | Acta Pediatrica de Mexico. ene-dic2026, Vol. 47 Issue 1, p1-14. 14p. |
| Subjects: | PEDIATRICS, ONCOLOGY, LYMPHOBLASTIC leukemia, SCIENTIFIC observation, GENDER differences (Sociology), MEDICATION safety, DRUG monitoring, DRUG side effects |
| Geographic Terms: | GUADALAJARA (Mexico) |
| Abstract (English): | INTRODUCTION: The systematic reporting of suspected Adverse Drug Reactions (ADRs) is essential for patient safety, as it allows identifying patterns and adopting preventive measures. OBJECTIVE: Analyze ADRs in pediatric patients with acute lymphoblastic leukemia (ALL) treated under the MAS-ALL18 protocol at the New Civil Hospital of Guadalajara "Dr. Juan I. Menchaca," to characterize ADRs reports. Evaluate associations between specific drugs and ADRs. Analyze associations between severity and gender, and determine causality using standardized criteria. MATERIALS AND METHODS: The present study adopted an observational, retrospective, and analytical approach, drawing upon reports of ADRs. The techniques employed in this study encompassed descriptive and bivariate analyses. The collection and analysis of the reports was conducted through the utilization of the hospital's designated reporting system. RESULTS: A total of 149 patients were included. 602 ADRs were reported, which gives an average of 4 ADRs per patient. The most frequent reactions were febrile neutropenia, mucositis, vomiting, leucopenia, anemia, thrombocytopenia and nausea. In addition, a correlation was identified between the severity of the reported ADRs and the subject's sex. CONCLUSIONS: The analysis of ADRs reports in paediatric patients treated under the MAS-ALL18 protocol in our oncology unit allowed the following to be identified: frequent ADRs, associations with specific drugs, and variations in severity according to gender. The findings, supported by statistical analysis and standardized causality criteria, provide relevant evidence to strengthen pharmacovigilance and improve treatment safety. [ABSTRACT FROM AUTHOR] |
| Abstract (Spanish): | INTRODUCCIÓN: El reporte sistemático de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) es fundamental para la seguridad del paciente, ya que, permite identificar patrones y adoptar medidas preventivas. OBJETIVO: Analizar los reportes de las SRAMs en pacientes pediátricos con Leucemia Linfoblástica Aguda (LLA) tratados bajo el protocolo MAS-ALL18 en el Hospital Civil Nuevo de Guadalajara 'Dr. Juan I. Menchaca', con el fin de caracterizar los reportes de SRAMs, evaluar las asociaciones entre medicamentos específicos y SRAMs, analizar asociaciones entre gravedad y sexo, y determinar la causalidad mediante criterios estandarizados. MATERIALES Y MÉTODOS: Estudio observacional, retrospectivo y analítico, basado en reportes de SRAMs. Se realizaron análisis descriptivos y bivariado para identificar asociaciones entre las variables de interés. Se recopilaron y analizaron notificaciones reportes de SRAMs a través del sistema de reporte del hospital. RESULTADOS: Se incluyeron un total de 149 pacientes. En ellos se reportaron 602 SRAMs, un promedio de 4 SRAMs por paciente. Las reacciones más frecuentes fueron neutropenia febril, mucositis, vómito, leucopenia, anemia, trombocitopenia y náuseas. Además, se encontró una relación entre la gravedad de las SRAMs reportadas y el sexo. CONCLUSIONES: El análisis de reportes de SRAMs en pacientes pediátricos tratados bajo el protocolo MAS-ALL18 en nuestra unidad de oncología permitió identificar SRAMs frecuentes, asociaciones con medicamentos específicos y variaciones de la gravedad según el sexo. Los hallazgos, respaldados por análisis estadísticos y criterios estandarizados de causalidad, ofrecen evidencia relevante para fortalecer la farmacovigilancia y mejorar la seguridad del tratamiento. [ABSTRACT FROM AUTHOR] |
| Copyright of Acta Pediatrica de Mexico is the property of Instituto Nacional de Pediatria (INP) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | MedicLatina |
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| Header | DbId: lth DbLabel: MedicLatina An: 192242451 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Análisis de reportes de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) en pacientes pediátricos: Estudio observacional en una unidad de oncología. – Name: TitleAlt Label: Alternate Title Group: TiAlt Data: Analysis of Reporting Adverse Drug Reactions (ADRs) in pediatric patients: Observational study in an oncology unit. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Garzón+Lamarque%2C+Juan+Antonio%22">Garzón Lamarque, Juan Antonio</searchLink><relatesTo>1</relatesTo><br /><searchLink fieldCode="AR" term="%22Escalante+Navarro%2C+Cristhian+Daniel%22">Escalante Navarro, Cristhian Daniel</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Becerra+Ruiz%2C+Angélica+Berenice%22">Becerra Ruiz, Angélica Berenice</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Sánchez+Zubieta%2C+Fernando+Antonio%22">Sánchez Zubieta, Fernando Antonio</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Romero+Tejeda%2C+Elba+Margarita%22">Romero Tejeda, Elba Margarita</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Pardo+Zepeda%2C+Monzerrat%22">Pardo Zepeda, Monzerrat</searchLink><relatesTo>4</relatesTo><i> mpardoz@hcg.gob.mx</i> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Acta+Pediatrica+de+Mexico%22">Acta Pediatrica de Mexico</searchLink>. ene-dic2026, Vol. 47 Issue 1, p1-14. 14p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22PEDIATRICS%22">PEDIATRICS</searchLink><br /><searchLink fieldCode="DE" term="%22ONCOLOGY%22">ONCOLOGY</searchLink><br /><searchLink fieldCode="DE" term="%22LYMPHOBLASTIC+leukemia%22">LYMPHOBLASTIC leukemia</searchLink><br /><searchLink fieldCode="DE" term="%22SCIENTIFIC+observation%22">SCIENTIFIC observation</searchLink><br /><searchLink fieldCode="DE" term="%22GENDER+differences+%28Sociology%29%22">GENDER differences (Sociology)</searchLink><br /><searchLink fieldCode="DE" term="%22MEDICATION+safety%22">MEDICATION safety</searchLink><br /><searchLink fieldCode="DE" term="%22DRUG+monitoring%22">DRUG monitoring</searchLink><br /><searchLink fieldCode="DE" term="%22DRUG+side+effects%22">DRUG side effects</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22GUADALAJARA+%28Mexico%29%22">GUADALAJARA (Mexico)</searchLink> – Name: Abstract Label: Abstract (English) Group: Ab Data: INTRODUCTION: The systematic reporting of suspected Adverse Drug Reactions (ADRs) is essential for patient safety, as it allows identifying patterns and adopting preventive measures. OBJECTIVE: Analyze ADRs in pediatric patients with acute lymphoblastic leukemia (ALL) treated under the MAS-ALL18 protocol at the New Civil Hospital of Guadalajara "Dr. Juan I. Menchaca," to characterize ADRs reports. Evaluate associations between specific drugs and ADRs. Analyze associations between severity and gender, and determine causality using standardized criteria. MATERIALS AND METHODS: The present study adopted an observational, retrospective, and analytical approach, drawing upon reports of ADRs. The techniques employed in this study encompassed descriptive and bivariate analyses. The collection and analysis of the reports was conducted through the utilization of the hospital's designated reporting system. RESULTS: A total of 149 patients were included. 602 ADRs were reported, which gives an average of 4 ADRs per patient. The most frequent reactions were febrile neutropenia, mucositis, vomiting, leucopenia, anemia, thrombocytopenia and nausea. In addition, a correlation was identified between the severity of the reported ADRs and the subject's sex. CONCLUSIONS: The analysis of ADRs reports in paediatric patients treated under the MAS-ALL18 protocol in our oncology unit allowed the following to be identified: frequent ADRs, associations with specific drugs, and variations in severity according to gender. The findings, supported by statistical analysis and standardized causality criteria, provide relevant evidence to strengthen pharmacovigilance and improve treatment safety. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Abstract (Spanish) Group: Ab Data: INTRODUCCIÓN: El reporte sistemático de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) es fundamental para la seguridad del paciente, ya que, permite identificar patrones y adoptar medidas preventivas. OBJETIVO: Analizar los reportes de las SRAMs en pacientes pediátricos con Leucemia Linfoblástica Aguda (LLA) tratados bajo el protocolo MAS-ALL18 en el Hospital Civil Nuevo de Guadalajara 'Dr. Juan I. Menchaca', con el fin de caracterizar los reportes de SRAMs, evaluar las asociaciones entre medicamentos específicos y SRAMs, analizar asociaciones entre gravedad y sexo, y determinar la causalidad mediante criterios estandarizados. MATERIALES Y MÉTODOS: Estudio observacional, retrospectivo y analítico, basado en reportes de SRAMs. Se realizaron análisis descriptivos y bivariado para identificar asociaciones entre las variables de interés. Se recopilaron y analizaron notificaciones reportes de SRAMs a través del sistema de reporte del hospital. RESULTADOS: Se incluyeron un total de 149 pacientes. En ellos se reportaron 602 SRAMs, un promedio de 4 SRAMs por paciente. Las reacciones más frecuentes fueron neutropenia febril, mucositis, vómito, leucopenia, anemia, trombocitopenia y náuseas. Además, se encontró una relación entre la gravedad de las SRAMs reportadas y el sexo. CONCLUSIONES: El análisis de reportes de SRAMs en pacientes pediátricos tratados bajo el protocolo MAS-ALL18 en nuestra unidad de oncología permitió identificar SRAMs frecuentes, asociaciones con medicamentos específicos y variaciones de la gravedad según el sexo. Los hallazgos, respaldados por análisis estadísticos y criterios estandarizados de causalidad, ofrecen evidencia relevante para fortalecer la farmacovigilancia y mejorar la seguridad del tratamiento. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Acta Pediatrica de Mexico is the property of Instituto Nacional de Pediatria (INP) and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.18233/apm.v47i1.3049 Languages: – Code: spa Text: Spanish PhysicalDescription: Pagination: PageCount: 14 StartPage: 1 Subjects: – SubjectFull: PEDIATRICS Type: general – SubjectFull: ONCOLOGY Type: general – SubjectFull: LYMPHOBLASTIC leukemia Type: general – SubjectFull: SCIENTIFIC observation Type: general – SubjectFull: GENDER differences (Sociology) Type: general – SubjectFull: MEDICATION safety Type: general – SubjectFull: DRUG monitoring Type: general – SubjectFull: DRUG side effects Type: general – SubjectFull: GUADALAJARA (Mexico) Type: general Titles: – TitleFull: Análisis de reportes de Sospechas de Reacciones Adversas a Medicamentos (SRAMs) en pacientes pediátricos: Estudio observacional en una unidad de oncología. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Garzón Lamarque, Juan Antonio – PersonEntity: Name: NameFull: Escalante Navarro, Cristhian Daniel – PersonEntity: Name: NameFull: Becerra Ruiz, Angélica Berenice – PersonEntity: Name: NameFull: Sánchez Zubieta, Fernando Antonio – PersonEntity: Name: NameFull: Romero Tejeda, Elba Margarita – PersonEntity: Name: NameFull: Pardo Zepeda, Monzerrat IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Text: ene-dic2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 01862391 Numbering: – Type: volume Value: 47 – Type: issue Value: 1 Titles: – TitleFull: Acta Pediatrica de Mexico Type: main |
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