RESUMO
BACKGROUND: Preterm delivery is associated with cardiovascular remodeling and dysfunction in children and adults. However, it is unknown whether these effects are caused by the neonatal consequences of preterm birth or if these are already present in utero. OBJECTIVE: We evaluated fetal cardiac morphology and function in fetuses of mothers admitted for preterm labor or preterm prelabor rupture of membranes and the association of these changes with the presence of intra-amniotic infection and/or inflammation. STUDY DESIGN: In this prospective cohort study, fetal echocardiography and amniocentesis were performed at admission in singleton pregnant women with preterm labor and/or preterm prelabor rupture of membranes between 24.0 and 34.0 weeks' gestation with (intra-amniotic infection and/or inflammation group, n=41) and without intra-amniotic infection and/or inflammation (non-intra-amniotic infection and/or inflammation, n=54). Controls (n=48) were outpatient pregnant women without preterm labor or preterm prelabor rupture of membranes. Intra-amniotic infection was defined by a positive amniotic fluid culture or positive 16S ribosomal RNA gene. Intra-amniotic inflammation was defined by using the amniotic fluid interleukin-6 cutoff levels previously reported by our group being >1.43 ng/mL in preterm prelabor rupture of membranes and >13.4 ng/mL in preterm labor. Fetal cardiac morphology and function was evaluated using echocardiography, and troponin-I and N-terminal pro-brain natriuretic peptide concentrations were measured in amniotic fluid from women with preterm labor or preterm prelabor rupture of membranes and compared with 20 amniotic fluid Biobank samples obtained for reasons other than preterm labor or preterm prelabor rupture of membranes or cardiac pathology. The data were adjusted for the estimated fetal weight below the 10th percentile and for preterm prelabor rupture of membranes at admission and also for gestational age at amniocentesis when amniotic fluid biomarkers were compared. RESULTS: From 2018 to 2021, 143 fetuses were included; 95 fetuses were from mothers admitted with a diagnosis of preterm labor or preterm prelabor rupture of membranes, and among those, 41 (28.7%) were in the intra-amniotic infection and/or inflammation group and 54 (37.8%) were in the non-intra-amniotic infection and/or inflammation group. A total of 48 (33.6%) fetuses were included in the control group. Fetuses with preterm labor and/or preterm prelabor rupture of membranes had signs of subclinical cardiac concentric hypertrophy (median left wall thickness of 0.93 [interquartile range, 0.72-1.16] in the intra-amniotic infection and/or inflammation group; 0.79 [0.66-0.92] in the non-intra-amniotic infection and/or inflammation group; and 0.69 [0.56-0.83] in controls; P<.001) and diastolic dysfunction (tricuspid A duration 0.23 seconds [0.21-0.25], 0.24 [0.22-0.25], and 0.21 [0.2-0.23]; P=.007). Systolic function was similar among groups. Higher values of amniotic fluid troponin I (1413 pg/mL [927-2334], 1190 [829-1636], and 841 [671-959]; P<.001) and N-terminal pro-brain natriuretic peptide were detected (35.0%, 17%, and 0%; P=.005) in fetuses with preterm labor or preterm prelabor rupture of membranes when compared with the control group. The highest N-terminal pro-brain natriuretic peptide concentrations were found in the intra-amniotic infection and/or inflammation group. CONCLUSION: Fetuses with preterm labor or preterm prelabor rupture of membranes showed signs of cardiac remodeling and subclinical dysfunction, which were more pronounced in those exposed to intra-amniotic infection and/or inflammation. These findings support that the cardiovascular effects observed in children and adults born preterm have, at least in part, a prenatal origin.
Assuntos
Amniocentese , Líquido Amniótico , Corioamnionite , Ruptura Prematura de Membranas Fetais , Trabalho de Parto Prematuro , Humanos , Feminino , Gravidez , Adulto , Estudos Prospectivos , Ecocardiografia , Peptídeo Natriurético Encefálico/sangue , Peptídeo Natriurético Encefálico/metabolismo , Cardiomegalia/diagnóstico por imagem , Estudos de Casos e Controles , Fragmentos de Peptídeos/metabolismo , Interleucina-6/metabolismo , Complicações Infecciosas na Gravidez , Coração Fetal/diagnóstico por imagem , Coração Fetal/fisiopatologia , Diástole , Estudos de CoortesRESUMO
INTRODUCTION: Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) indicated for the treatment of epidermal growth factor receptor mutated non-small cell lung cancer (NSCLC). It has demonstrated better results concerning effectiveness than other TKIs for the same indication. However, despite a good safety profile, it could produce some cardiotoxicity that does not occur with other drugs of the same group. CASE REPORT: We report the evolution and management of a female patient diagnosed with NSCLC who developed a grade 3 cardiotoxicity due to treatment with osimertinib. This patient suffered from a left bundle branch block, dyslipidemia, and hypertension as cardiovascular risk factors. After a long period of treatment with osimertinib, she developed a severe heart failure (HF) with an important decrease in left ventricular ejection fraction (LVEF), which triggered an admission to the oncology unit for eight days. MANAGEMENT AND OUTCOMES: Treatment with osimertinib was first suspended and then resumed after stabilization of the HF. She also developed atrial fibrillation during admission and has required narrow cardiac monitoring and management since the debut of the HF. After evaluating the benefit-risk balance, osimertinib was reintroduced and the patient continues in treatment at the moment, although the baseline LVEF is not recovered. DISCUSSION: There is scarce evidence in the literature concerning HF and important LVEF decrease due to osimertinib. However, its severity and repercussion for the patient justify the thorough screening of cardiovascular risk factors before starting the therapy.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Insuficiência Cardíaca , Neoplasias Pulmonares , Feminino , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Volume Sistólico , Cardiotoxicidade , Mutação , Função Ventricular Esquerda , Insuficiência Cardíaca/induzido quimicamenteRESUMO
BACKGROUND: Preterm premature rupture of membranes complicates approximately 3% of pregnancies. Currently, in the absence of chorioamnionitis or placental abruption, expectant management, including antenatal steroids for lung maturation and prophylactic antibiotic treatment, is recommended. The benefits of individualized management have not been adequately explored. OBJECTIVE: This study aimed to compare the impact of 2 different management strategies of preterm premature rupture of membranes in 2 tertiary obstetrical centers on latency of >7 days, latency to birth, chorioamnionitis, funisitis, and short-term adverse maternal and neonatal outcomes. STUDY DESIGN: This was a multicenter retrospective study of women with singleton pregnancies with preterm premature rupture of membranes from 23 0/7 to 33 6/7 weeks of gestation between 2014 and 2018 and undelivered within 24 hours after hospital admission managed at Sunnybrook Health Sciences Center, Toronto, Canada (standard management group), and BCNatal (Hospital Clínic of Barcelona and Hospital Sant Joan de Déu Barcelona), Barcelona, Spain (individualized management group), following local protocols. The standard management group received similar management for all patients, which included a standard antibiotic regimen and routine maternal and fetal surveillance, whereas the individualized management group received personalized management on the basis of amniocentesis at hospital admission (if possible), to rule out microbial invasion of the amniotic cavity and targeted treatment. The exclusion criteria were cervical dilatation >2 cm, active labor, contraindications to expectant management (acute chorioamnionitis, placental abruption, or abnormal fetal tracing), and major fetal anomalies. The primary outcome was latency of >7 days, and the secondary outcomes included latency to birth, chorioamnionitis, and short-term adverse maternal and neonatal outcomes. Statistical comparisons between groups were conducted with propensity score weighting. RESULTS: A total of 513 pregnancies with preterm premature rupture of membranes were included in this study: 324 patients received standard management, and 189 patients received individualized management, wherein amniocentesis was performed in 112 cases (59.3%). After propensity score weighting, patients receiving individualized management had a higher latency of >7 days (76.0% vs 41.6%; P<.001) and latency to birth (18.1±14.7 vs 9.7±9.7 days; P<.001). Although a higher rate of clinical chorioamnionitis was suspected in the individualized management group than the standard group (34.5% vs 22.0%; P<.01), there was no difference between the groups in terms of histologic chorioamnionitis (67.2% vs 73.4%; P=.16), funisitis (57.6% vs 58.1%; P=.92), or composite infectious maternal outcomes (9.1% vs 7.9%; P=.64). Prolonged latency in the individualized management group was associated with a significant reduction of preterm birth at <32 weeks of gestation (72.1% vs 90.5%; P<.001), neonatal intensive care unit admission (75.6% vs 83.0%; P=.046), and neonatal respiratory support at 28 days of life (16.1% vs 26.1%; P<.01) compared with that in the standard management group. Moreover, prolonged latency was not associated with neonatal severe morbidity at discharge (survival without severe morbidity, 80.4% vs 73.5%; P=.09). CONCLUSION: Individualized management of preterm premature rupture of membranes may prolong pregnancy and reduce preterm birth at <32 weeks of gestation, the need for neonatal support, and neonatal intensive care unit admissions, without an increase in histologic chorioamnionitis, funisitis, neonatal infection-related morbidity, and short-term adverse maternal and neonatal outcomes.
Assuntos
Descolamento Prematuro da Placenta , Corioamnionite , Ruptura Prematura de Membranas Fetais , Nascimento Prematuro , Descolamento Prematuro da Placenta/epidemiologia , Antibacterianos/uso terapêutico , Corioamnionite/tratamento farmacológico , Corioamnionite/epidemiologia , Feminino , Ruptura Prematura de Membranas Fetais/epidemiologia , Idade Gestacional , Humanos , Recém-Nascido , Placenta , Gravidez , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/tratamento farmacológico , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle , Estudos RetrospectivosRESUMO
INTRODUCTION: Spironolactone when combined with abiraterone in metastatic castration-resistant prostate cancer (mCRPC) may theoretically exert androgenic properties, thereby compromising the therapeutic effectiveness of abiraterone. CASE REPORT: Two patients with a medical history of cardiovascular disease and mCRPC combined spironolactone within the course of abiraterone regimen. The abiraterone-spironolactone interaction was identified using the Lexicomp® interaction tool (classified as risk C). MANAGEMENT & OUTCOME: Spironolactone treatment was maintained as it was considered beneficial due to the cardiac condition. The prostate-specific antigen (PSA) levels started to rise when these two drugs were used together. Eventually, tumour progression was observed. DISCUSSION: There is increasing evidence that spironolactone behaves as a selective androgen receptor modulator. Strategies to overcome abiraterone-spironolactone interaction could involve the use of eplerenone, although this drug is also controversial. The best strategy should imply a multidisciplinary evaluation by cardiologists and oncologists.
Assuntos
Neoplasias de Próstata Resistentes à Castração , Espironolactona , Masculino , Humanos , Espironolactona/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/patologia , Acetato de Abiraterona/uso terapêutico , Resultado do Tratamento , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
BACKGROUND: Diarrhea is one of the most frequent class adverse events associated with targeted oral antineoplastic agents (OAAs). Our objective was to analyze the incidence, characteristics, and severity of diarrhea in cancer patients in clinical practice. METHODS: An observational, longitudinal, and prospective study of cancer outpatients treated with targeted OAAs was carried out in a tertiary hospital. Targed OAAs analyzed were anaplastic lymphoma kinase inhibitors, BCR-ABL inhibitors, cyclin-dependent kinase inhibitors, epidermal growth factor receptor inhibitors, mTOR inhibitors, poly (ADP-ribose) polymerase inhibitors, and vascular endothelial growth factor receptor inhibitors. Patients were given a data collection form to record daily the number, severity (CTCAE version 5.0), and characteristics of stools during the first 30 days of treatment with OAAs. Multivariate analysis was performed to identify risk factors associated with the incidence of diarrhea. RESULTS: We analyzed 240 patients, of whom 28.7% experienced diarrhea (25.4% grades 1-2 and 3.3% grades 3-4). Patients treated with EGFR and VEGFR inhibitors had a higher incidence of diarrhea. The multivariate analysis revealed that taking the OAA with food was associated with a lower risk of diarrhea (OR = 0.404 [0.205-0.956], p = 0.038). CONCLUSIONS: More than a third of patients in treatment with OAAs presented diarrhea (any grade), and 22.1% of stools were semi-liquid/liquid. In multivariate analysis, taking the OAA on an empty stomach was associated with a statistically significant increase in the incidence of diarrhea.
Assuntos
Antineoplásicos/efeitos adversos , Diarreia/induzido quimicamente , Feminino , Humanos , Incidência , Estudos Longitudinais , Masculino , Estudos Prospectivos , Fatores de RiscoRESUMO
INTRODUCTION: Use of oral antineoplastic agents (OAAs) has increased significantly in recent years. OAAs currently represent 30-50% of all cancer treatments. Drug interactions are the most frequent drug-related problem affecting OAAs. We describe the case of a patient who presented acute pancreatitis, possibly induced by the concomitant use of imatinib and gefitinib. CASE REPORT: A female patient received imatinib and gefitinib for the treatment of chronic myeloid leukemia and lung adenocarcinoma, respectively. Liver function and pancreatic enzyme values gradually worsened after initiation of imatinib, and the patient was diagnosed with acute pancreatitis. MANAGEMENT AND OUTCOMES: Imatinib was discontinued owing to pancreatic toxicity. Gefitinib was subsequently discontinued owing to tumor progression. The patient received supportive measures for pancreatitis, although she eventually died 3 months after the onset of symptoms. DISCUSSION: To our knowledge, this is the first case in the medical literature of acute pancreatitis possibly induced by an interaction between imatinib and gefitinib. The interaction most likely arose because imatinib is a CYP2D6 inhibitor and could therefore impair the metabolism of gefitinib (a CYP2D6 substrate) and increase its serum concentration. This interaction is extremely rare. However, due to its severity, hepatic and pancreatic function should be carefully monitored in patients treated with imatinib and/or gefitinib and other inhibitors or inducers of CYP2D6 and CYP3A4.
Assuntos
Antineoplásicos/efeitos adversos , Gefitinibe/efeitos adversos , Mesilato de Imatinib/efeitos adversos , Pancreatite/induzido quimicamente , Pancreatite/diagnóstico , Inibidores de Proteínas Quinases/efeitos adversos , Antineoplásicos/administração & dosagem , Interações Medicamentosas/fisiologia , Feminino , Gefitinibe/administração & dosagem , Humanos , Mesilato de Imatinib/administração & dosagem , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/metabolismo , Pessoa de Meia-Idade , Pancreatite/metabolismo , Inibidores de Proteínas Quinases/administração & dosagemRESUMO
BACKGROUND: Early spontaneous preterm delivery is often associated with microbial invasion of the amniotic cavity and/or intraamniotic inflammation. OBJECTIVE: The objective of the study was to develop and validate clinically feasible multivariable prediction models of spontaneous delivery within 7 days and microbial invasion of the amniotic cavity in women admitted with diagnose of preterm labor and intact membranes below 34 weeks. STUDY DESIGN: We used data from a cohort of women admitted from 2012 to 2018 with diagnosis of preterm labor below 34 weeks who had undergone amniocentesis to rule out microbial invasion of the amniotic cavity. The main outcome was spontaneous delivery within 7 days from admission. The secondary outcome was microbial invasion of the amniotic cavity, defined by a positive culture and/or 16S ribosomal RNA gene in the amniotic fluid. The sample (n = 358) was divided into derivation (2012-2016) and validation cohorts (2017-2018). Logistic regression models using a stepwise selection of variables were developed for the outcomes evaluated. We explored as predictive variables ultrasound cervical length measurement at admission, maternal C-reactive protein, gestational age, amniotic fluid glucose, and interleukin-6 (expressed as log units). Models were developed in the derivation cohort and applied to the validation cohort and diagnostic performance was calculated. RESULTS: The derivation cohort included 263 women and the validation cohort 95 women. One hundred five of the women (39%, 105 of 268) spontaneously delivered in the following 7 days and 68 (19%, 68 of 358) had microbial invasion of the amniotic cavity. For spontaneous delivery within 7 days after admission, 4 predictors were identified: cervical length at admission, gestational age, amniotic fluid glucose, and interleukin-6. The diagnostic performance of the model was assessed in the validation cohort using the receiver operating characteristic curve and showed an area under curve of 0.86 (95% confidence interval, 0.77-0.95) with a detection rate of spontaneous delivery within 7 days of 87%, a false-positive rate of 33%, a negative predictive value of 80%, and a negative likelihood ratio of 0.1908. For microbial invasion of the amniotic cavity, 2 independent predictors of the amniotic cavity were identified: amniotic fluid glucose and maternal C-reactive protein. The receiver operating characteristic curve and an area under curve in the validation cohort was 0.83 (95% confidence interval, 0.70-0.96) with a detection rate of 76%, a false-positive rate of 8%, a negative predictive value of 93%, and a negative likelihood ratio of 0.2591. CONCLUSION: In women with preterm labor, we propose 2 clinically feasible prediction models to classify as low vs high risk of spontaneous delivery within 7 days and of microbial invasion of the amniotic cavity. The models showed a high diagnostic performance and could be of value to optimize clinical management.
Assuntos
Corioamnionite/diagnóstico , Trabalho de Parto Prematuro , Diagnóstico Pré-Natal , Adulto , Líquido Amniótico/química , Líquido Amniótico/microbiologia , Corioamnionite/microbiologia , Estudos de Coortes , Parto Obstétrico , Feminino , Humanos , Modelos Logísticos , Valor Preditivo dos Testes , Gravidez , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
WHAT IS KNOWN AND OBJECTIVES: Inadequate management of chronic medication puts patients at risk and causes unnecessary suspension of surgical procedures. The objective of the study was to calculate the rate of cancellation of elective surgical procedures due to inadequate management of chronic medications and to analyse the underlying causes of cancellation. METHODS: We designed an analytic, observational, retrospective study of all elective surgical procedures performed from July to October 2017 in a tertiary hospital. The main variable was the percentage of surgeries cancelled owing to inadequate management of chronic medications. Other variables recorded included demographic characteristics, time between the preanaesthesia evaluation and surgery, drug involved, and the reason for incorrect management of the medication. RESULTS: During the study period, 5415 surgical procedures were programmed, and 793 (14.6%) were cancelled. Cancellations due to inadequate patient preparation accounted for 5.3% (42 cases), and 19 were related to incorrect medication management (2.4% of the total number of cancellations). The 19 patients, who were mostly men (73.7%), had a median age of 76 years (IQR 68-81). The drugs involved were acenocoumarol (6), enoxaparin (4), clopidogrel (4), direct-acting oral anticoagulants (2), acetylsalicylic acid (1), tocilizumab (1) and leflunomide (1). The reasons for drug mishandling were poor understanding of the anaesthesiology recommendations (15) and lack of a preanaesthesia evaluation (4). WHAT IS NEW AND CONCLUSION: Inadequate management of chronic medications (2.4%) is not the most frequent reason for cancellation, although it is one of the easiest to avoid. Based on our results, starting in October 2017, the Pharmacy Department began to offer a pharmaceutical service to patients with doubts about the preoperative management of chronic medications.
Assuntos
Doença Crônica/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Agendamento de Consultas , Gerenciamento Clínico , Feminino , Humanos , Masculino , Estudos Retrospectivos , Centros de Atenção TerciáriaRESUMO
BACKGROUND/OBJECTIVE: Pharmaceutical care is needed in hepatitis C virus (HCV)-infected patients treated with direct-acting antivirals (DAA). We describe the implementation of a comprehensive pharmaceutical care programme (CPCP) for HCV-infected patients treated with DAA in a tertiary-care hospital and provide data about health outcomes and costs. METHODS: Quasi-experimental study between 1 April 2015 and 30 June 2016. A group of hospital pharmacists collaborating on HCV infection implemented interventional measures for validation of drug prescriptions, detection of clinically relevant drug-drug interactions and adverse drug events (ADEs), and patient education. Quality, health and cost-effectiveness outcomes were evaluated. RESULTS: A total of 1070 patients were enrolled. Pharmacists made 327 interventions that led to the prevention of 299 (91.4%) medication errors, 16 of which were grade G-H (NCC MERP classification). The main reasons for the pharmacist's intervention were management of 143 drug-drug interactions. The overall sustained virologic response at week 12 posttreatment (SVR12) rate was 93.0% (95% CI 91.4-94.6). The SVR12 was higher than 90.0% in all populations, except in genotype 3 patients (86.0%, 95% CI 78.7-93.9), decompensated cirrhotic patients (81.1%, 95% CI 69.7-92.6) and transplant recipients (86.8%, 95% CI 76.7-96.9). ADEs occurred in 85.5% of the study patients, but only 1.0% (11 patients) experienced an ADE that led to premature discontinuation. The total cost of treatment was 18 279 225 (17 083 per patient). The most cost-effective treatment was selected in 93.1% of patients. CONCLUSIONS: The implementation of a CPCP developed by hospital pharmacists in patients treated with DAAs for HCV infection is an effective approach that improves patient safety and education. The active involvement of the pharmacist in improving adherence to local guidelines promoted the selection of the most cost-effective treatment in the majority of cases.
Assuntos
Antivirais/uso terapêutico , Prescrições de Medicamentos , Hepatite C Crônica/tratamento farmacológico , Serviço de Farmácia Hospitalar/métodos , Idoso , Antivirais/efeitos adversos , Antivirais/economia , Interações Medicamentosas , Quimioterapia Combinada/economia , Feminino , Humanos , Masculino , Erros de Medicação/prevenção & controle , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Desenvolvimento de Programas , Resposta Viral Sustentada , Centros de Atenção TerciáriaRESUMO
BACKGROUND: No previous studies exist examining the effectiveness and safety in real clinical practice of the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. METHODS: This was an observational study of a prospective cohort of treatment-naïve and pretreated adult patients who received 12 weeks of OBV/PTV/r (25/150/100 mg once daily) and DSV (250 mg twice daily) with or without ribavirin. The primary effectiveness outcome was sustained virological response 12 weeks after the end of treatment (SVR12). Safety outcomes were presented by the incidence of adverse events. RESULTS: A total of 116 of 121 patients achieved a SVR12 (95.9%, 95% CI = 90.6-98.6). The SVR12 rate was 93.8% (95% CI = 86.0-97.9) in cirrhotic patients and 100% (95% CI = 91.4-100.0) in noncirrhotic patients. Adverse events occurred in 91.7% of patients, of which 81.8% were grade 1/2, and none led to premature discontinuation. Grade 3 adverse events were reported in 9.9% of patients. The most frequent adverse event was anemia (52.1%), although only 1.6% had a hemoglobin level below 8 g/dL. The incidence of any adverse event was higher in the group of patients who received ribavirin (96.5% vs 80.0%, P = 0.002). CONCLUSIONS: The combination of OBV/PTV/r+DSV with or without ribavirin for 12-week settings achieved a high rate of SVR12, with an acceptable safety profile in routine clinical care.
Assuntos
Antivirais/administração & dosagem , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , 2-Naftilamina , Idoso , Anilidas/administração & dosagem , Antivirais/efeitos adversos , Antivirais/uso terapêutico , Carbamatos/administração & dosagem , Ciclopropanos , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Humanos , Lactamas Macrocíclicas , Compostos Macrocíclicos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Prolina/análogos & derivados , Estudos Prospectivos , Ribavirina/administração & dosagem , Ribavirina/uso terapêutico , Ritonavir/administração & dosagem , Ritonavir/uso terapêutico , Sulfonamidas/administração & dosagem , Uracila/administração & dosagem , Uracila/análogos & derivados , ValinaRESUMO
OBJECTIVE: To develop by consensus a dashboard model to standardize and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centers, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different autonomous communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (need = 100%) with a basic structure and a common minimum set of data for all them (need = 87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (need = 87.5%), and a definition was approved on the leadership of these projects according to whether they are single-center or multicenter. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyze the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
Assuntos
Técnica Delphi , Serviço de Farmácia Hospitalar , Serviço de Farmácia Hospitalar/organização & administração , Espanha , Inquéritos e Questionários , Consenso , HumanosRESUMO
OBJECTIVE: To develop by consensus a dashboard model to standardise and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centres, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different Autonomous Communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (Need=100%) with a basic structure and a common minimum set of data for all them (Need=87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (Need=87.5%), and a definition was approved on the leadership of these projects according to whether they are single-centre or multicentre. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyse the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
Assuntos
Técnica Delphi , Serviço de Farmácia Hospitalar , Serviço de Farmácia Hospitalar/organização & administração , Espanha , Consenso , Inquéritos e Questionários , HumanosRESUMO
OBJECTIVES: Preoperative medication errors can be prevented by screening patients through a preoperative pharmaceutical care consultation. The aim of this study was to analyse the cost-effectiveness of implementing such a consultation and to determine which patients would benefit most. METHODS: A retrospective study was conducted that included all patients who underwent a preoperative pharmacy consultation between 2016 and 2020. During this consultation, two part-time pharmacists reviewed patients' appropriate preoperative chronic medication management. All prevented errors were collected and classified by therapeutic group and type of error. A team of pharmacists and anaesthetists assigned to each prevented medication error a probability of causing an adverse event 'p', following the methodology of Nesbit et al by establishing five different 'p' values: 0, 0.01, 0.1, 0.4, and 0.6. 'p' = 1 was not considered. The cost of an adverse event was determined to be between 4124 and 6946 according to current literature, and a sensitivity analysis was performed by increasing the interval by 20% above and below. The cost of employing two part-time specialist pharmacists was estimated to be 59 142. Savings per medication error prevented were calculated as (4124 OR 6946) × 'p'. Total savings were the sum of all costs associated with prevented medication errors. Patients on chronic medications who were in therapeutic groups with a 0.6 probability of an adverse event or who were in therapeutic groups responsible for 50% of the prevented adverse events were considered prioritisable. RESULTS: 3105 patients attended the consultation and 1179 medication errors were prevented, corresponding to 300 adverse events. 42.2% of the errors had a 'p' of 0.4. The costs avoided by this consultation ranged from 1 237 200 to 2 083 800, while the cost of its implementation was 295 710. The cost-effectiveness ratio was between 4.2 and 7.0 saved per euro invested. In the sensitivity analysis, the ratios ranged from 3.3 to 8.5 per euro invested. Fifteen different therapeutic groups accounted for 90% of the medication errors prevented. The therapeutic groups 'Agents acting on the renin-angiotensin system', 'Antidiabetics, non-insulin (excluding SGLT2)' and 'Antithrombotics: low molecular weight heparins' were responsible for 56% of the prevented adverse events. The therapeutic groups 'Antidiabetics: rapid-acting insulin' and 'Antithrombotic agents: vitamin K antagonists, low-molecular-weight heparins, or direct oral anticoagulants' had a 'p' of 0.6. Therefore, patients in six therapeutic groups should be prioritised for preoperative pharmacy counselling. CONCLUSIONS: The implementation of preoperative pharmaceutical care consultations in Spain has proven to be cost-effective. Incorporating the probability of a medication error causing an adverse event allowed the prioritisation of patients for these consultations. Patients taking anticoagulants, oral antidiabetics, rapid-acting insulins, and agents acting on the renin-angiotensin system benefited the most. This study could serve as a basis for implementing such consultations in other hospitals, as they are effective in reducing the cost of medication errors in surgical patients.
RESUMO
The African horse sickness virus (AHSV) belongs to the Genus Orbivirus, family Sedoreoviridae, and nine serotypes of the virus have been described to date. The AHSV genome is composed of ten linear segments of double-stranded (ds) RNA, numbered in decreasing size order (Seg-1 to Seg-10). Genome segment 2 (Seg-2) encodes outer-capsid protein VP2, the most variable AHSV protein and the primary target for neutralizing antibodies. Consequently, Seg-2 determines the identity of the virus serotype. An African horse sickness (AHS) outbreak in an AHS-free status country requires identifying the serotype as soon as possible to implement a serotype-specific vaccination program. Considering that nowadays 'polyvalent live attenuated' is the only commercially available vaccination strategy to control the disease, field and vaccine strains of different serotypes could co-circulate. Additionally, in AHS-endemic countries, more than one serotype is often circulating at the same time. Therefore, a strategy to rapidly determine the virus serotype in an AHS-positive sample is strongly recommended in both epidemiological situations. The main objective of this study is to describe the development and validation of three triplex real-time RT-PCR (rRT-PCR) methods for rapid AHSV serotype detection. Samples from recent AHS outbreaks in Kenia (2015-2017), Thailand (2020), and Nigeria (2023), and from the AHS outbreak in Spain (1987-1990), were included in the study for the validation of these methods.
Assuntos
Vírus da Doença Equina Africana , Doença Equina Africana , Orbivirus , Vacinas Virais , Animais , Cavalos , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Doença Equina Africana/diagnóstico , Doença Equina Africana/epidemiologia , Doença Equina Africana/prevenção & controle , Orbivirus/genética , Anticorpos NeutralizantesRESUMO
In September 2022, more than 50 years after its eradication from Spain, Sheep pox virus was confirmed by laboratory analysis in sheep showing characteristic lesions. This was the start of an outbreak that lasted 9 months and infected 30 farms dispersed over two different areas, Andalusia and Castilla-La Mancha. Early after the initial confirmation, an active surveillance based on clinical inspection with laboratory confirmation of sheep with clinical signs was started in restricted areas. This allowed the confirmation of Sheep pox in 22 out of 28 suspected farms, where limited numbers of sheep with mainly erythema and papules were found, indicative of early detection. Nevertheless, to improve active surveillance and stop the outbreak, clinical inspection was reinforced by laboratory analysis in all inspected farms, even when no clinically diseased sheep were detected. Although more than 35,000 oral swabs from 335 farms were analysed by real-time PCR in pools of five, only two out of six reported outbreaks in this period were detected by laboratory analysis before clinical signs were observed. Furthermore, additional insights were gained from the extensive laboratory surveillance performed on samples collected under field conditions. No evidence of Sheep pox virus infection was found in goats. Oral swabs proved to be the sample of choice for early detection in the absence of scabs and could be tested in pools of five without extensive loss in sensitivity; serology by ELISA was not useful in outbreak detection. Finally, a non-infectious genome of the virus could be detected months after cleaning and disinfection; thus, real-time PCR results should be interpreted with caution in sentinel animals during repopulation. In conclusion, the outbreak of Sheep pox virus in Spain showed that active clinical inspection with laboratory confirmation of clinically diseased sheep via oral swab testing proved a sensitive method for detection of infected farms, providing insights in laboratory surveillance that will be helpful for other countries confronted with Sheep pox outbreaks.
Assuntos
Capripoxvirus , Surtos de Doenças , Infecções por Poxviridae , Doenças dos Ovinos , Animais , Espanha/epidemiologia , Surtos de Doenças/veterinária , Ovinos , Infecções por Poxviridae/veterinária , Infecções por Poxviridae/epidemiologia , Infecções por Poxviridae/diagnóstico , Infecções por Poxviridae/virologia , Doenças dos Ovinos/epidemiologia , Doenças dos Ovinos/virologia , Doenças dos Ovinos/diagnóstico , Capripoxvirus/genética , Capripoxvirus/isolamento & purificação , Cabras , Reação em Cadeia da Polimerase em Tempo Real/veterinária , Fazendas , Monitoramento Epidemiológico/veterináriaRESUMO
PURPOSE: Our objectives were to analyze the use of complementary and alternative medicine (CAM) in cancer patients and to describe the incidence and characteristics of interactions between CAM and antineoplastic agents. METHODS: We performed an observational study in cancer outpatients at a university hospital. Variables were collected through a 22-item questionnaire. Potential interactions between CAM and antineoplastic agents were analyzed using the Lexicomp®, the About Herbs®, and the summary of product characteristics. Mechanism of action, reliability, and the potential clinical effect of interactions were analyzed. RESULTS: The study population comprised 937 patients, of whom 65% used CAM (70.6% herbal products, 25.8% dietary supplements, and 3.6% homeopathy). Female sex, younger age, and breast cancer were associated with more frequent use of CAM. The primary source of information about CAM was friends and family (43.5%). A total of 335 (57.1%) patients did not tell their doctor that they took CAM. The five most common CAM were chamomile, green tea, pennyroyal mint, linden, and rooibos. At least one interaction between CAM and antineoplastic agents was reported by 65.0% of CAM users (33.9% of all patients). Depending on the mechanism of action, 80% of CAM diminished the metabolism of the antineoplastic agents. CONCLUSION: Our results reveal a high incidence of interactions between CAM and antineoplastic agents. The most frequent CAM were herbal products. Family and friends were the primary sources of information that led patients to start taking CAM, and more than half of the patients did not tell their doctor that they were taking CAM.
Assuntos
Antineoplásicos , Neoplasias da Mama , Terapias Complementares , Humanos , Feminino , Reprodutibilidade dos Testes , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Suplementos Nutricionais , Inquéritos e QuestionáriosRESUMO
Objective: The management of cardiotoxicity concerning the use of oral antineoplastic agents (OAAs) is a challenge for healthcare professionals. Our objective was to create a comprehensive medication management guide with dose adjustment recommendations on OAAs concerning cardiotoxic and lipid metabolic adverse events (AEs) to assist healthcare professionals when prescribing OAAs. Materials and methods: A review of the available information on all dose adjustments necessary to safely prescribe and dispense OAAs concerning cardiotoxicity was conducted. In January 2023, we identified all OAAs authorized by the European Medicines Agency (EMA). For each drug, the latest summary of product characteristics (SPC) approved by the EMA and the tertiary data source Lexicomp® were reviewed. Cardiotoxic AEs were recorded, namely, QT interval prolongation, decrease in left ventricular ejection fraction (LVEF), imbalances in blood pressure (hypertension and hypotension), alterations in heart rate (tachycardia and bradycardia), and thrombosis. Any available dose adjustment recommendations in case of an occurrence of these adverse events were collected. Results: In all, 93 different OAAs had been approved by the EMA and were reviewed. Among them, 51.6% have recognized cardiotoxic AEs and 10.8% can cause alterations in lipid metabolism. A total of 27 (29.0%) OAAs had specific recommendations regarding QT prolongation; 88.9% were listed in the SPC and 59.3% in Lexicomp®. Eight OAAs (9.68%) have reported a decrease in LVEF, and four of these drugs, namely, encorafenib, lorlatinib, ripretinib, and sunitinib, have specific management recommendations. Almost half (49.5%) of currently approved OAAs can potentially alter blood pressure; 34 (36.6%) of them have been reported to cause hypertension and 12 (12.9%) are related to hypotension. Tachycardia and/or bradycardia are associated with 22.6% and 8.6% of the evaluated drugs, respectively. Regarding thrombosis, 30 (32.3%) of the drugs analyzed included the appearance of a thrombus as a possible AE. Conclusions: More than half of the OAAs can produce cardiotoxic effects, with the most frequent being blood pressure alteration and QT interval prolongation with a non-depreciable incidence of LV dysfunction or thrombosis. Before starting the treatment, it is necessary to stratify baseline cardiovascular risk, plan a surveillance schedule, and consider referral to cardio-oncology units.
RESUMO
INTRODUCTION AND HYPOTHESIS: This study was conducted to evaluate the effects of an alternative model of birth (AMB) on the incidence of assisted vaginal delivery (AVD) and perineal trauma (PT). METHODS: One hundred ninety-nine women with epidural anesthesia were randomized to a traditional model of birth (TMB) (n = 96) or AMB (n = 103). Women in TMB pushed immediately after complete dilatation and delivered in lithotomy position. In AMB, women followed a postural changes protocol while they delayed pushing and used a specific lateral position for delivery. RESULTS: AMB was associated with a significant reduction in AVD compared with TMB (19.8% vs 42.1%, p<0.001). TMB was strongly associated with AVD (OR = 4.49; p< 0.05), which, in turn, was significantly associated with nulliparity (OR = 5.52; p<0.005) and fetal head unengaged at full dilatation (OR = 5.35; p<0.05). AMB significantly increased the intact perineum rate compared with TMB (40.3% vs 12.2%, p<0.001). Episiotomy rate was significantly reduced in AMB (21.0% vs 51.4%, p<0.001). CONCLUSION: A combination of postural changes during the passive expulsive phase of labor and lateral position during active pushing time is associated with reductions in AVD and PT.
Assuntos
Lacerações/prevenção & controle , Parto , Posicionamento do Paciente , Períneo/lesões , Adulto , Analgesia Epidural , Episiotomia/estatística & dados numéricos , Extração Obstétrica/estatística & dados numéricos , Feminino , Humanos , Apresentação no Trabalho de Parto , Segunda Fase do Trabalho de Parto , Modelos Logísticos , Análise Multivariada , Contração Muscular , Razão de Chances , Paridade , GravidezRESUMO
Background: Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. Our objective was to design and implement an app for remote monitoring and communication with IMID patients. Methods: A multidisciplinary group was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, descriptive study of available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we offered the app to IMID patients who initiated a new biological therapy. The inclusion period was from December 2020 to August 2021. We performed an observational, longitudinal study to assess the app's impact on medication safety, communication, satisfaction, and usability. Results: We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 85 patients were installed with the app. The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. Conclusions: We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals.
Assuntos
Aplicativos Móveis , Telemedicina , Seguimentos , Humanos , Estudos Longitudinais , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Oral antineoplastic agents (OAAs) are high-risk drugs that may increase the risk of bleeding, difficulty in wound healing, or produce alterations in coagulation and/or platelet aggregation. These aspects had to be highly considered throughout the entire perioperative process. Our aim was to create a comprehensive management medication guide based on reconciliation and dose adjustment recommendations for OAAs in patients undergoing a surgical intervention. RESEARCH DESIGN AND METHODS: We analyzed all OAAs approved by the EMA in November 2020. We assessed data related to dose adjustment, drug reconciliation, coagulation disturbances, or anticoagulant interactions from the FDA and EMA summary of product characteristics. RESULTS: We analyzed 67 OAAs. We identified that 51 (76.2%) OAAs can produce alteration in the platelet count, 12 (17.9%) affect the wound healing and recovery process, and 32 (47.8%) require control and monitoring in case of combination with anticoagulants. Only 13 (19.4%) OAAs, most of them antiangiogenics, have specific recommendations for temporary suspension before surgery. CONCLUSIONS: Most OAAs require perioperative monitoring. This review can serve as an easy (simple, effective) tool to help healthcare professionals involved in patient care to manage OAAs during the perioperative process.