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1.
Med. clín (Ed. impr.) ; 155(7): 281-287, oct. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-191724

RESUMO

OBJETIVOS: Determinar la prevalencia de interacciones potenciales en pacientes COVID-19 en tratamiento con lopinavir/ritonavir (LPV/r). El objetivo secundario fue elaborar recomendaciones e identificar los factores de riesgo asociados a presentar interacciones potenciales con LPV/r. SUJETOS Y MÉTODOS: Estudio transversal y multicéntrico con la participación de 2 hospitales. Se incluyeron pacientes COVID-19 mayores de 18 años, con ingreso hospitalario y en tratamiento con LPV/r. Se realizó un cribado de las interacciones potenciales relacionadas con LPV/r y la medicación domiciliaria y hospitalaria. Se utilizó como base de datos de consulta Lexicomp® (Uptodate), HIV-drug interacctions y COVID-drug interacctions. RESULTADOS: Se incluyeron 361 pacientes con una media de edad de 62,77 ± 14,64 años, donde el 59,6% (n = 215) fueron hombres. El 62,3% (n=225) tuvieron una o más interacciones potenciales y el 26, 87% (n = 97) 2 o más. Las variables independientes asociadas a presentar ≥ 1 interacciones potenciales fueron la edad (> 65) (OR 1,95; IC 95% 1,06-3,59; P = 0,033), el ingreso en UCI (OR 9,22; IC 95% 1,98-42,93; P = 0,005), la enfermedad previa respiratoria (OR 2,90; IC 95% 1,15-7,36; P = 0,024), psiquiátrica (OR 4,14; IC 95% 1,36-12,61; P = 0,013), la dislipemia (OR 3,21; IC 95% 1,63-6,35; P = 0,001) y el número de fármacos prescrito (OR 4,33; IC 95% 2,40-7,81; P = 0,000). CONCLUSIÓN: La prevalencia de interacciones potenciales en paciente COVID-19 en tratamiento con LPV/r es elevada, comportándose como factores de riesgo asociados la edad (> 65), el ingreso en UCI, la enfermedad previa respiratoria, psiquiátrica y la dislipemia y el número de fármacos prescritos


OBJECTIVES: To determine the prevalence of potential interactions in COVID-19 patients receiving lopinavir/ritonavir (LPV/r). The secondary objective was to develop recommendations and identify the risk factors associated with presenting potential interactions with LPV/r. SUBJECTS AND METHODS: Cross-sectional and multicenter study with the participation of 2 hospitals. COVID-19 patients over 18 years of age, admitted to hospital and under treatment with LPV/r were included. A screening of potential interactions related to LPV/r and home and hospital medication was carried out. Lexicomp® (Uptodate), HIV-drug interactions and COVID-drug interactions were used as the query database. RESULTS: 361 patients with a mean age of 62.77 ± 14.64 years were included, where 59.6% (n = 215) were men. 62.3% (n = 225) had 1 or more potential interactions and 26, 87% (n = 97) 2 or more. The independent variables associated with presenting ≥ 1 potential interactions were age (> 65) (OR 1.95; 95% CI 1.06-3.59, P =.033), ICU admission (OR 9.22; CI 95% 1.98-42.93; P = .005), previous respiratory pathology (OR 2.90; 95% CI 1.15-7.36; P =.024), psychiatric (OR 4.14; 95 CI % 1.36-12.61; P =.013), dyslipidemia (OR 3.21; 95% CI 1.63-6.35; P = .001) and the number of drugs prescribed (OR 4.33; 95% CI 2.40-7.81; P =.000). CONCLUSION: The prevalence of potential interactions in COVD-19 patient undergoing treatment with LPV/r is high, with age (> 65), ICU admission, previous respiratory and psychiatric pathology, dyslipidemia and the number of prescribed drugs acting as risk factors


Assuntos
Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Lopinavir/farmacocinética , Ritonavir/farmacocinética , Infecções por Coronavirus/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Fatores de Risco , Pneumonia Viral/tratamento farmacológico , Lopinavir/uso terapêutico , Ritonavir/uso terapêutico , Interações Medicamentosas , Inibidores de Proteases/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Segurança do Paciente
2.
Yonsei Med J ; 61(10): 875-879, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32975062

RESUMO

PURPOSE: To describe adverse drug reactions (ADRs) to carbamazepine (CBZ) and oxcarbazepine (OXC), including severe cutaneous ADRs, at a tertiary care hospital over a 10-year period. MATERIALS AND METHODS: The frequency and clinical features of ADRs caused by CBZ and OXC were analyzed using the pharmacovigilance database and spontaneous ADR reporting data of Yonsei University Severance Hospital & Dental Hospital (Seoul, Korea) from January 1, 2010 to January 31, 2020. RESULTS: Among 10419 cases prescribed CBZ and OXC, 204 ADR cases were reported. The incidences of ADRs were 1.8% and 2.2% for CBZ and OXC respectively, with no significant difference (p=0.169). The most common clinical presentations were skin disorders. Female patients had relatively more frequent ADRs than male patients. Although mild skin ADRs were more frequent with OXC, nervous system disorders, general disorders, and hepatobiliary disorders occurred more often with CBZ. There were six reports of severe cutaneous adverse reactions to CBZ, while OXC had none. Both CBZ and OXC caused ADRs at daily doses lower than the recommended initial dose. CONCLUSION: Due to lower incidence of severe ADRs with OXC than CBZ, we suggest OXC as a first-line prescription.


Assuntos
Anticonvulsivantes/efeitos adversos , Carbamazepina/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Oxcarbazepina/efeitos adversos , Adolescente , Adulto , Idoso , Anticonvulsivantes/uso terapêutico , Transtorno Bipolar , Carbamazepina/uso terapêutico , Epilepsia/tratamento farmacológico , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neuralgia , Oxcarbazepina/uso terapêutico , Farmacovigilância , República da Coreia/epidemiologia , Centros de Atenção Terciária , Adulto Jovem
3.
Medicine (Baltimore) ; 99(36): e22071, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899075

RESUMO

BACKGROUND: Whether prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) offers long-term survival benefit to patients with low-grade appendiceal mucinous neoplasms (LAMNs) after resection surgery is still under heated debate. The aim of the present meta-analysis is to investigate the comparative effectiveness and safety of prophylactic HIPEC regimens in LAMNs METHODS:: A systematic search of MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform (ICTRP), clinicaltrials.gov and controlledtrials.com will be performed. All published RCTs and quasi-RCTs through July 20, 2020 with language restricted in English will be included in this review study. Two reviewers will independently conduct the procedures of study identification, data collection, and methodological quality assessment. The primary outcomes are overall survival (OS) and disease-free survival (DFS). The secondary outcomes consist of peritonitis and sepsis, colonic fistula, chemotherapy-associated adverse events, and adhesive intestinal obstruction. The pooled odds ratios (ORs) or hazard ratios (HRs) and relative 95% confident intervals (CIs) of each outcome measurement will be calculated. EndNote X9 software will be applied to manage all citations. The Stata software version 14.0 and R x64 software version 3.5.1 will be employed for main statistical analyses. DISCUSSION: This study will employ a network meta-analysis to summarize direct and indirect evidence in the specific area to provide detailed individualized guidance on surgical management for LAMNs. REGISTRATION: This protocol was registered with the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) on 25 July 2020 (registration number INPLASY202070112).


Assuntos
Adenocarcinoma Mucinoso/terapia , Neoplasias do Apêndice/patologia , Hipertermia Induzida/métodos , Metanálise em Rede , Adenocarcinoma Mucinoso/mortalidade , Neoplasias do Apêndice/cirurgia , Ensaios Clínicos como Assunto , Intervalo Livre de Doença , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Hipertermia Induzida/efeitos adversos , Fístula Intestinal/epidemiologia , Obstrução Intestinal/epidemiologia , Obstrução Intestinal/etiologia , Masculino , Avaliação de Resultados em Cuidados de Saúde , Peritonite/epidemiologia , Garantia da Qualidade dos Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Segurança , Sepse/epidemiologia , Aderências Teciduais/complicações , Aderências Teciduais/epidemiologia , Resultado do Tratamento
4.
PLoS One ; 15(8): e0237781, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32857798

RESUMO

BACKGROUND: Drug therapy problems (DTPs) are major concerns of healthcare and have been identified to contribute to negative clinical outcomes. The occurrence of DTPs in heart failure patients is associated with worsening of outcomes. The aim of this study was to assess DTPs, associated factors and patient satisfaction among ambulatory heart failure patients at Tikur Anbessa Specialized Hospital (TASH). METHODS: A hospital based prospective cross-sectional study was conducted on 423 heart failure patients on follow up at TASH. Data was collected through patient interview and chart review. Descriptive statistics, binary and multiple logistic regressions were used for analyses and P < 0.05 was used to declare association. RESULTS: Majority of the patients were in NYHA class III (55.6%) and 66% of them had preserved systolic function. DTPs were identified in 291(68.8%) patients, with an average number of 2.51±1.07.per patient. The most common DTPs were drug interaction (27.3%) followed by noncompliance (26.2%), and ineffective drug use (13.7%). ß blockers were the most frequent drug class involved in DTPs followed by angiotensin converting enzyme inhibitors. The global satisfaction was 78% and the overall mean score of treatment satisfaction was 60.5% (SD, 10.5). CONCLUSION: Prevalence of DTPs as well as non-adherence among heart failure patients on follow up is relatively high. Detection and prevention of DTPs along with identifying patients at risk can save lives, help to adopt efficient strategies to closely monitor patients at risk, enhance patient's quality of life and optimize healthcare costs.


Assuntos
Antagonistas Adrenérgicos beta/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Insuficiência Cardíaca/tratamento farmacológico , Adesão à Medicação/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Adolescente , Antagonistas Adrenérgicos beta/farmacocinética , Adulto , Idoso , Idoso de 80 Anos ou mais , Inibidores da Enzima Conversora de Angiotensina/farmacocinética , Estudos Transversais , Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/psicologia , Etiópia/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Adesão à Medicação/psicologia , Pessoa de Meia-Idade , Ambulatório Hospitalar/estatística & dados numéricos , Prevalência , Estudos Prospectivos , Qualidade de Vida , Inquéritos e Questionários/estatística & dados numéricos , Centros de Atenção Terciária/estatística & dados numéricos , Adulto Jovem
5.
PLoS One ; 15(7): e0236109, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32692774

RESUMO

BACKGROUND: Pyrazinamide (PZA) is a common drug that causes serious adverse events (SAEs). The aim of this study was to determine the incidence of and risk factors for SAEs due to PZA during first-line anti-tuberculosis treatment. METHODS: The medical records of patients with tuberculosis (TB) treated with PZA-containing regimens including first-line drugs-ethambutol, rifampicin, and isoniazid-from January 2003 to June 2016 were reviewed. SAEs were defined as side effects that led to drug discontinuation. The causative drug was determined based on the disappearance of the SAEs upon drug withdrawal and/or the recurrence of the same SAEs with re-challenge. RESULTS: Of 2,478 patients with TB, 16.4% experienced SAEs. The incidence of SAEs increased significantly as age increased, except with rifampin. PZA accounted for most SAEs (55.8%). Hepatotoxicity was the most common SAE due to PZA (44.5%), followed by gastrointestinal (GI) intolerance (23.8%). The risk of SAEs due to PZA increased significantly as age increased, when sex and comorbidities were adjusted (odds ratio, 1.013; 95% confidence interval, 1.004-1.023; P = 0.007). In the subgroup analysis, older age was an independent risk factor for GI intolerance but not for hepatotoxicity. CONCLUSION: PZA was the most common drug associated with SAEs among the first-line anti-TB drugs, and old age was an independent factor for SAE occurrence. This study suggests that the early recognition of whether the causative agent is PZA may improve effective treatment compliance, particularly in elderly patients.


Assuntos
Antituberculosos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Mycobacterium tuberculosis/efeitos dos fármacos , Pirazinamida/efeitos adversos , Tuberculose/tratamento farmacológico , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , República da Coreia/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Tuberculose/microbiologia
6.
PLoS One ; 15(7): e0235353, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32609783

RESUMO

AIMS: This review aims to determine the prevalence of clinically manifested drug-drug interactions (DDIs) in hospitalized patients. METHODS: PubMed, Scopus, Embase, Web of Science, and Lilacs databases were used to identify articles published before June 2019 that met specific inclusion criteria. The search strategy was developed using both controlled and uncontrolled vocabulary related to the following domains: "drug interactions," "clinically relevant," and "hospital." In this review, we discuss original observational studies that detected DDIs in the hospital setting, studies that provided enough data to allow us to calculate the prevalence of clinically manifested DDIs, and studies that described the drugs prescribed or provided DDI adverse reaction reports, published in either English, Portuguese, or Spanish. RESULTS: From the initial 5,999 articles identified, 10 met the inclusion criteria. The pooled prevalence of clinically manifested DDIs was 9.2% (CI 95% 4.0-19.7). The mean number of medications per patient reported in six studies ranged from 4.0 to 9.0, with an overall average of 5.47 ± 1.77 drugs per patient. The quality of the included studies was moderate. The main methods used to identify clinically manifested DDIs were evaluating medical records and ward visits (n = 7). Micromedex® (27.7%) and Lexi-Comp® (27.7%) online reference databases were commonly used to detect DDIs and none of the studies evaluated used more than one database for this purpose. CONCLUSIONS: This systematic review showed that, despite the significant prevalence of potential DDIs reported in the literature, less than one in ten patients were exposed to a clinically manifested drug interaction. The use of causality tools to identify clinically manifested DDIs as well as clinical adoption of DDI lists based on actual adverse outcomes that can be identified through the implementation of real DDI notification systems is recommended to reduce the incidence of alert fatigue, enhance decision-making for DDI prevention or resolution, and, consequently, contribute to patient safety.


Assuntos
Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Ásia , Bases de Dados Factuais , Estudos Epidemiológicos , Europa (Continente) , Hospitalização , Humanos , América do Norte , Segurança do Paciente , Prevalência
7.
Indian J Med Microbiol ; 38(1): 117-123, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32719218

RESUMO

Background: Cytokine release storm (CRS) in severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) is thought to be the cause for organ damage and death which is independent of the actual viral burden. Tocilizumab (TCZ), an interleukin-6 receptor antagonist, is approved for the treatment of CRS. We describe the efficacy and safety of TCZ in SARS CoV-2 pneumonia. Methods: This retrospective study was conducted at a tertiary care hospital from April 20 2020 to May 21 2020. The primary endpoint was the cumulative incidence of a composite of either need for admission to the intensive care unit (ICU) with invasive mechanical ventilation or death. Safety outcomes included an increase in liver transaminases and/or evidence of infection. Results: A total of 20 patients received TCZ during the study period. The median age was 54 years (95% confidence interval [CI] 47-63). About 85% of the patients were male. Nearly 70% of the patients had at least one comorbidity. About 55% required ICU admission. The median duration of ICU stay was 11 days (95% CI: 3-13 days). The cumulative incidence of the requirement for mechanical ventilation, clinical improvement and mortality was 11% (95% CI: 0.03%-1%), 74% (95% CI 37%-89%) and 25% (95% CI: 11%-63%), respectively. There was no difference in outcomes according to age, gender or computed tomography severity score. Asymptomatic transaminitis was the most common drug reaction (55%), and one patient developed bacteraemia. Conclusions: TCZ is likely a safe and effective modality of treatment for improving clinical and laboratory parameters of SARS CoV-2 patients with a reduction in ICU stay and ventilatory care need.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/tratamento farmacológico , Fatores Imunológicos/administração & dosagem , Fatores Imunológicos/efeitos adversos , Pneumonia Viral/tratamento farmacológico , Infecções por Coronavirus/mortalidade , Cuidados Críticos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/mortalidade , Respiração Artificial/estatística & dados numéricos , Estudos Retrospectivos , Análise de Sobrevida , Centros de Atenção Terciária , Transaminases/sangue , Resultado do Tratamento
8.
PLoS One ; 15(7): e0236370, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32702709

RESUMO

INTRODUCTION: Measuring the impact of care complexity on health outcomes, based on psychosocial, biological and environmental circumstances, is important in order to detect predictors of early deterioration of inpatients. We aimed to identify care complexity individual factors associated with selected adverse events and in-hospital mortality. METHODS: A multicenter, case-control study was carried out at eight public hospitals in Catalonia, Spain, from January 1, 2016 to December 31, 2017. All adult patients admitted to a ward or a step-down unit were evaluated. Patients were divided into the following groups based on the presence or absence of three adverse events (pressure ulcers, falls or aspiration pneumonia) and in-hospital mortality. The 28 care complexity individual factors were classified in five domains (developmental, mental-cognitive, psycho-emotional, sociocultural and comorbidity/complications). Adverse events and complexity factors were retrospectively reviewed by consulting patients' electronic health records. Multivariate logistic analysis was performed to identify factors associated with an adverse event and in-hospital mortality. RESULTS: A total of 183,677 adult admissions were studied. Of these, 3,973 (2.2%) patients experienced an adverse event during hospitalization (1,673 [0.9%] pressure ulcers; 1,217 [0.7%] falls and 1,236 [0.7%] aspiration pneumonia). In-hospital mortality was recorded in 3,996 patients (2.2%). After adjustment for potential confounders, the risk factors independently associated with both adverse events and in-hospital mortality were: mental status impairments, impaired adaptation, lack of caregiver support, old age, major chronic disease, hemodynamic instability, communication disorders, urinary or fecal incontinence, vascular fragility, extreme weight, uncontrolled pain, male sex, length of stay and admission to a medical ward. High-tech hospital admission was associated with an increased risk of adverse events and a reduced risk of in-hospital mortality. The area under the ROC curve for both outcomes was > 0.75 (95% IC: 0.78-0.83). CONCLUSIONS: Several care complexity individual factors were associated with adverse events and in-hospital mortality. Prior identification of complexity factors may have an important effect on the early detection of acute deterioration and on the prevention of poor outcomes.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Mortalidade Hospitalar , Pneumonia Aspirativa/epidemiologia , Úlcera/epidemiologia , Idoso , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Cuidadores , Disfunção Cognitiva/tratamento farmacológico , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/patologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade , Pneumonia/induzido quimicamente , Pneumonia/tratamento farmacológico , Pneumonia/epidemiologia , Pneumonia Aspirativa/patologia , Fatores de Risco , Espanha/epidemiologia , Úlcera/induzido quimicamente , Úlcera/tratamento farmacológico
9.
Neurology ; 95(3): e239-e246, 2020 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-32601123

RESUMO

OBJECTIVE: To determine whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life in patients with epilepsy. METHODS: Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers. AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group. Co-primary endpoints were changes in AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores. RESULTS: Of 809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45 and were randomized to the intervention (n = 111) or control group (n = 111). A total of 206 patients completed the 18-month follow-up. Compared with baseline, AEP scores decreased on average by 7.2% at 6 months, 12.1% at 12 months, and 13.8% at 18 months in the intervention group (p < 0.0001), and by 7.7% at 6 months, 9.2% at 12 months, and 12.0% at 18 months in controls (p < 0.0001). QOLIE-31 scores also improved from baseline to final visit, with a mean 20.7% increase in the intervention group and a mean 24.9% increase in the control group (p < 0.0001). However, there were no statistically significant differences in outcomes between groups for the 2 co-primary variables. CONCLUSIONS: Contrary to findings from a previous study, systematic screening for adverse effects of AEDs using AEP scores did not lead to a reduced burden of toxicity over usual physician treatment. ITALIAN MEDICINES AGENCY AIFA IDENTIFIER: FARM52K2WM_003. CLINICALTRIALSGOV IDENTIFIER: NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated). CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that the additional collection of formal questionnaires regarding adverse effects of AEDs does not reduce toxicity burden over usual physician treatment.


Assuntos
Anticonvulsivantes/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Epilepsia/tratamento farmacológico , Programas de Rastreamento/métodos , Adolescente , Adulto , Idoso , Epilepsia/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Programas de Rastreamento/tendências , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
10.
Arch Cardiol Mex ; 90(Supl): 19-25, 2020.
Artigo em Inglês | MEDLINE | ID: covidwho-596502

RESUMO

The COVID-19 pandemic has had major negative health, psychological, social and economic repercussions for individuals, families, communities, countries and for humanity in general. The interrelation with age and the presence of chronic non-communicable diseases (hypertension, diabetes, obesity, smoking) seems to go further than what would be explained by the prevalence and distribution of both. The drugs that act on the renin-angiotensin-aldosterone system are in many cases the backbone for the management of these diseases, it has been known for a long time that these drugs significantly increase the expression of receptors for angiotensin conversion enzyme type 2 in the lung tissue. This fact, together with the knowledge that the route of entry of the virus into the cell is precisely the ACE-2 receptor, initiated a hypothesis, based on very low-quality evidence, which quickly became generalized in the media, that the use of these drugs could be negative and that they should be interrupted immediately. The response of practically all Scientific Societies was almost immediate, with the precise indication that treatment with these drugs should not be discontinued, since the evidence of their usefulness is based on very solid and high-quality evidence. Simultaneously, a different hypothesis also appeared, also based on very preliminary evidence, that these drugs are not only harmful but also beneficial, however these medicaments are not yet accepted as agents for the prevention or treatment of this disease or its complications. This review reports current knowledge on the relationship between COVID-19 and SRAA.


Assuntos
Infecções por Coronavirus/virologia , Pneumonia Viral/virologia , Sistema Renina-Angiotensina/fisiologia , Animais , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Pandemias , Peptidil Dipeptidase A/metabolismo , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Sistema Renina-Angiotensina/efeitos dos fármacos , Fatores de Risco
11.
Paediatr Drugs ; 22(4): 425-432, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32557243

RESUMO

AIMS: The risk to develop adverse drug reactions (ADRs) is high for paediatric patients. This is, amongst other reasons, due to the inevitable use of off-label and unlicensed medicines. Moreover, there is limited knowledge on ADRs in children. Thus, adequate recognition may be challenging. The lack of dedicated studies and the voluntary nature of pharmacovigilance systems used to gain insight into the characteristics of ADRs contribute to this problem. The goal of this study is to identify whether ADRs in paediatric patients are adequately documented by the medical team and whether they are subsequently reported to the national pharmacovigilance system. METHODS: All patients admitted to the paediatric medium care of the Radboudumc Amalia Children's hospital during 1 month, and using one or more drugs, were included. Two researchers analysed retrospectively and independently the number of possible ADRs in the medical records. The ADRs were listed per paediatric subspecialty, to evaluate any differences in documentation and reporting of the ADRs. Subsequently, the causality, severity, and seriousness of the ADRs were assessed. The ADRs were categorised by system organ class and drug class. The national pharmacovigilance centre was consulted to check if there were any reports coming from our hospital and to collect the total number of reports. RESULTS: The medical records of 301 patients were analysed, 81 patients were suffering from one or more ADRs. In total 132 suspected ADRs were found, divided among 19 different paediatric subspecialties. Numbers were too small to investigate the differences in ADR documentation. Of these found ADRs, 55% were not explicitly noted as such in the medical records by the treating physician. None of the ADRs were reported to the national pharmacovigilance centre. Most ADRs scored 'possible' in the causality assessment, were mild or moderate, and a small number were serious. The ADRs occurred in 25 different organ systems. In total 25 different drug classes were involved. CONCLUSIONS: The results of the present study show that a large number of ADRs are not registered in the medical records and are not reported to the national pharmacovigilance system. Furthermore, it is shown that the number of ADRs occurring at our centre is much higher than the number reported to the national pharmacovigilance centre. Only an average of 513 ADRs in paediatric patients are reported per year nationwide, suggesting that there is extensive underreporting.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Criança , Pré-Escolar , Feminino , Hospitalização , Hospitais Pediátricos , Humanos , Lactente , Masculino , Países Baixos , Estudos Retrospectivos
12.
Tunis Med ; 98(5): 404-412, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32548844

RESUMO

BACKGROUND: Thiopurines have proven efficacy in inflammatory bowel disease. However, their use is limited by adverse effects in a subset of patients. AIMS: The present study aimed to evaluate toxicity profile and identify clinical predictive factors of thiopurine adverse effects in inflammatory bowel disease patients. METHODS: A retrospective longitudinal study was conducted among inflammatory bowel disease patients treated with thiopurines. Multiple logistic regression was used to identify risk factors for thiopurine adverse effects. RESULTS: A total of  210 patients were enrolled in the study. Mean age at disease onset was 29.8±11.4 years.  One hundred sixty-nine (169) patients had Crohn's disease, 29 had ulcerative colitis and 12 had indeterminate colitis. During a median follow-up of 28.5 ± 20 months, 56 patients (26.6%) had thiopurine-related adverse effects including digestive intolerance (n=14; 6.6%), immunoallergic reactions (n=8; 3.8%), myelotoxicity (n=25; 11.9%) and hepatotoxicity (n=8; 3.8%). Treatment withdrawal was reported in 19 patients (9%).  The only independent predictive factor for thiopurine adverse effects found in this study was steroid-dependence (OR= 3.96; 95% CI: 1.07- 14.53; p= 0.038). CONCLUSIONS: Almost a quarter of inflammatory bowel disease patients treated with thiopurines developed adverse effects. These adverse effects lead to drug withdrawal in almost 9% of patients either as monotherapy or as in combination with biologic therapies.  Steroid-dependent patients were significantly at higher risk for thiopurine-related toxicity.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Imunossupressores/efeitos adversos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Doenças Inflamatórias Intestinais/epidemiologia , Adolescente , Adulto , Azatioprina/efeitos adversos , Azatioprina/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Imunossupressores/uso terapêutico , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Purinas/efeitos adversos , Purinas/uso terapêutico , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
13.
Artigo em Inglês | MEDLINE | ID: mdl-32536336

RESUMO

Background: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Imunização/efeitos adversos , Imunização/estatística & dados numéricos , Farmacovigilância , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Vigilância da População , Estudos Retrospectivos , Vitória/epidemiologia , Adulto Jovem
14.
Artigo em Inglês | MEDLINE | ID: mdl-32536339

RESUMO

Introduction: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine-preventable diseases and potential adverse events following immunisation (AEFI). This report presents surveillance data for 2017 and 2018. Methods: Specialist nurses screened hospital admissions, emergency department (ED) records, laboratory and other data on a daily basis in seven paediatric tertiary referral hospitals across Australia to identify children with the conditions under surveillance. In 2017 and 2018 these included acute flaccid paralysis (AFP; a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis, varicella-zoster virus infection (varicella and herpes zoster), invasive meningococcal, and invasive Group A streptococcus diseases. An additional social research component was added to evaluate parental attitudes to vaccination. Results: PAEDS captured 1,580 and 925 cases for 2017 and 2018, respectively, across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach the World Health Organization reporting targets; identification of a third human parechovirus outbreak among other infectious diseases linked to ACE; demonstration of variable influenza activity between 2017 and 2018, with vaccine effectiveness (VE) analysis demonstrating that the protection offered through vaccination is season-dependent. All IS cases associated with vaccine receipt were reported to the relevant state health department. Varicella and herpes zoster case numbers remained unchanged, with vaccine uptake found to be suboptimal among eligible children under the NIP. Enhanced pertussis surveillance continues to capture controls for VE estimation. Surveillance for invasive meningococcal disease showed predominance for serotype B at 57% over 2 years among 77 cases where serotyping was available, and surveillance for invasive group A streptococcus captured severe disease in children. Conclusion: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Pediatria/estatística & dados numéricos , Pediatria/tendências , Vigilância da População , Doenças Preveníveis por Vacina/epidemiologia , Adolescente , Austrália/epidemiologia , Criança , Pré-Escolar , Feminino , Previsões , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos
15.
Arch Cardiol Mex ; 90(Supl): 19-25, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32523145

RESUMO

The COVID-19 pandemic has had major negative health, psychological, social and economic repercussions for individuals, families, communities, countries and for humanity in general. The interrelation with age and the presence of chronic non-communicable diseases (hypertension, diabetes, obesity, smoking) seems to go further than what would be explained by the prevalence and distribution of both. The drugs that act on the renin-angiotensin-aldosterone system are in many cases the backbone for the management of these diseases, it has been known for a long time that these drugs significantly increase the expression of receptors for angiotensin conversion enzyme type 2 in the lung tissue. This fact, together with the knowledge that the route of entry of the virus into the cell is precisely the ACE-2 receptor, initiated a hypothesis, based on very low-quality evidence, which quickly became generalized in the media, that the use of these drugs could be negative and that they should be interrupted immediately. The response of practically all Scientific Societies was almost immediate, with the precise indication that treatment with these drugs should not be discontinued, since the evidence of their usefulness is based on very solid and high-quality evidence. Simultaneously, a different hypothesis also appeared, also based on very preliminary evidence, that these drugs are not only harmful but also beneficial, however these medicaments are not yet accepted as agents for the prevention or treatment of this disease or its complications. This review reports current knowledge on the relationship between COVID-19 and SRAA.


Assuntos
Infecções por Coronavirus/virologia , Pneumonia Viral/virologia , Sistema Renina-Angiotensina/fisiologia , Animais , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Pandemias , Peptidil Dipeptidase A/metabolismo , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Sistema Renina-Angiotensina/efeitos dos fármacos , Fatores de Risco
18.
PLoS One ; 15(5): e0230215, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32369489

RESUMO

OBJECTIVE: To identify risk factors for potential Drug-Related Problems (DRP) at admission in hospitalized patients. METHODOLOGY: Prospective cohort study conducted in adults patients hospitalized (May 2016 to May 2018) in a general tertiary care hospital in Brazil. Potential DRP were detected by daily review of 100% of electronic medication orders by hospital pharmacists and classified by the Pharmaceutical Care Network Europe classification system (PCNE version 6.2). For the identification of risk factors of potential DRP, backward stepwise logistic regression was used to identify the set of independent predictors among over 120 variables collected in the initial 48 hours after admission in a training set consisting of 2/3 of the study population. The model was validated in the remaining sample. RESULTS: The study population consisted of 1686 patients aged 52.0+/- 18.3 years-old, 51.4% females, with a median length of stay of 3.24 days, and 4.5% in-hospital mortality. The cumulative incidence of potential DRP was 14.5%. Admission for elective surgery and main diagnosis of disease of the circulatory system were associated with reduced risk of DRP (OR 0.41 and 0.57, respectively, p<0.05). The independent risk factors of DRP are heart rate ≥ 80 bpm (OR 1.41, p = 0.05), prescription of more than seven drugs in day 2 (OR 1.63, p = 0.05), prescription in day 1 of drugs of the Anatomical Therapeutic Chemical Code (ATC) class A (alimentary tract and metabolism, OR 2.24, p = 0.003), prescription in day 2 of two or more ATC class A drugs (OR = 3.52, p<0.001), and in day 1 of ATC class J drugs (antiinfectives for systemic use, OR 1.97, p = 0.001). In the validation set, the c-statistic of the predictive model was 0.65, the sensitivity was 56.1% and the specificity was 65.2%. CONCLUSION: This study identified seven independent risk factors of potential DRP in patients hospitalized in a general hospital that have fair predictive performance for utilization in clinical practice.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Mortalidade Hospitalar , Hospitais Gerais , Centros de Atenção Terciária , Adulto , Idoso , Brasil/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Registros Eletrônicos de Saúde , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Farmacêutica , Fatores de Risco
19.
Tunis Med ; 98(1): 35-40, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32395775

RESUMO

INTRODUCTION: Digoxin is a cardiac glycoside, used to control rapid ventricular rates in atrial fibrillation and to reduce the hospitalizations due to heart failure. Digoxin has a narrow therapeutic range. So, in the treatment of older patients (≥ 65 years), it is important to set the optimal dose of digoxin to prevent toxicity and therapeutic drug monitoring of digoxin trough plasmatic concentration (C0) may be useful. AIM: To assess measured C0, to evaluate age influence on digoxin pharmacokinetic parameters and to report adverse events in patients administered digoxin. METHODS: It consisted in a retrospective study. We included all the patients addressed to the department of clinical pharmacology for digoxin C0 measurement by an automated fluorescence polarization immunoassay. Therapeutic ranges of digoxin C0 were: 1 to 2.5 ng.mL-1 in children, 0.8 to 2 ng.mL-1 in adults and 0.5 to 0.9 ng.mL-1 in older adults (≥ 65 years) in atrial fibrillation and heart failure. RESULTS: We collected 183 samples from 132 patients. Sex ratio M/W was 0.47. Mean age was 60 years and 57% of patients were older adults. Mean dose of digoxin was 0.3 mg.day-1. In older adults, 45% were administered daily doses over 0.125 mg.day-1. Mean digoxin C0 was 1.6 ng.mL-1. There was more supra-therapeutic C0 in older adults than younger ones (p<0.0001).There was no correlation between C0 and daily dose of digoxin. Adverse events, mainly cardiac and digestive, were reported in 47 patients (36%), among this population 47% were older adults. CONCLUSION: TDM is useful to prevent toxicity, mainly in older adults where diagnosis may be difficult to establish.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Digoxina/uso terapêutico , Monitoramento de Medicamentos , Adolescente , Adulto , Fatores Etários , Idade de Início , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Criança , Pré-Escolar , Digoxina/efeitos adversos , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos/métodos , Monitoramento de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
20.
Tunis Med ; 98(2): 123-130, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32395801

RESUMO

BACKGROUND: Cardiac arrest (CA) is a public health problem, with various etiologies and a fatal issue in 90-95% of cases. Toxin-induced cardiac arrests (TICA) are poorly described. Scarcity of national data prompted us to carry-out this study. AIM: To determine TICA frequency in a Tunisian reference center in toxicology and its hospital prognosis, and to describe its clinical and therapeutic aspects Methods : Data were collected retrospectively over an 8-years period. We included patients admitted for post-CA care with highly suspected or confirmed TICA. Clinical and toxicological data were recorded. RESULTS: We recorded 21 cases of TICA, which represented 48.8% of CA. A single toxic agent was incriminated in 90% of cases. Main causative agents identified in our series were pesticides and betablockers: chloralosed (n = 6), carbamate inhibitor of cholinesterase (n = 5), acebutolol (n = 4) and organophosphate (n = 2). One case of opiates and cocaine poisoning was reported. Median duration of "no flow" was 0 minutes. Mean duration of "low flow" was 13.74±9.15 minutes. An initial shockable rhythm was noted only in three patients. Mortality rate was 76% (16/21). Four of the five survivors had a Cerebral Performance Category Scale (CPC) 1, only one patient survived with a CPC 3. Factors associated with mortality were : the duration of "low flow" (p=0.02) and APACHE II score (p=0.014). APACHE II≥29 was the only independent factor (OR=2.0, 95%CI [1.07;3.71]). CONCLUSION: TICA were most frequently provoked by pesticides, mortality was high and was independently predicted by APACHE II score.


Assuntos
Cardiotoxicidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Parada Cardíaca/induzido quimicamente , Parada Cardíaca/diagnóstico , Parada Cardíaca/terapia , Toxinas Biológicas/toxicidade , Antagonistas Adrenérgicos beta/toxicidade , Cardiotoxicidade/diagnóstico , Cardiotoxicidade/epidemiologia , Cardiotoxicidade/etiologia , Cardiotoxicidade/terapia , Cocaína/envenenamento , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Parada Cardíaca/epidemiologia , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Mortalidade , Organofosfatos/toxicidade , Praguicidas/toxicidade , Estudos Retrospectivos , Fatores de Risco , Toxinas Biológicas/classificação , Resultado do Tratamento , Tunísia/epidemiologia
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