Overdiagnosis of vaccine allergy: Skin testing and challenge at a public specialized unit (CRIE) in Rio de Janeiro, Brazil.

Background: Vaccination is an extremely safe public health intervention, but rare IgE-mediated adverse events must be identified to avoid the risk of anaphylaxis in the event of reexposure. However, using only clinical history to diagnose previous allergic reactions may lead to overdiagnosis of vaccine allergy and even to the use of medical exemptions as a subterfuge to mandatory vaccination. Methods: We conducted a retrospective study to describe the outcomes of patients with a history of vaccine or vaccine component allergy who were evaluated at our unit from 2011 to 2017. Data on allergy history, skin test results, vaccines prescribed, and adverse events were retrieved from the medical records at the Centro de Referência para Imunobiológicos Especiais (Reference Center of Special Immunobiologicals)-Fiocruz, in Rio de Janeiro, Brazil. Results: Of 34 adults with history of allergy to vaccine or vaccine components, 32 (94.1%) were successfully vaccinated without serious adverse events after our evaluation. In 12 patients (35%), the time elapsed between the allergy symptoms and evaluation in the Centro de Referência para Imunobiológicos Especiais-Fiocruz was more than 10 years. Conclusion: Specialized care and use of skin tests allowed safe vaccination of the majority of patients. An objective, systematic evaluation of a history of vaccine allergy can prevent its improper use to avoid mandatory vaccination and reduce missed opportunities for immunization.

Fully independent validation and updating of a clinical pharmacy prioritizing risk score in an infectious disease hospital ward.

AIMS: The aim of this study was to validate and update the risk score originally developed at Hospital de Clínicas de Porto Alegre, verifying its performance in an infectious disease population. METHODS: This is an observational study with consecutive selection of admission in a ward of participants with infectious diseases. Predictors were age, number of medications, intravenous drugs, potentially dangerous drugs, renal dysfunction, liver dysfunction, use of nasoenteral tube, nasogastric tube, gastrostomy feeding, jejunostomy feeding, oral enteral tube, total parenteral nutrition, cardiac or pulmonary dysfunction and immunosuppression. Outcome was defined as preventable prescription incidents by a clinical pharmacist. A GEE model was fit to make predictions each week. RESULTS: A total of 219 patients participated in the study, 79.25% of whom had prescription incidents in the first week of admission. Predictors of the updated model were number of drugs prescribed, number of intravenous drugs, use of tubes, truncated age at 36 years and week of hospitalization. The performance of the original model was poor. The updated model's discrimination and calibration were moderate (overall AUC 0.74). A calculator to apply the model is available at https://pedrobrasil.shinyapps.io/INDWELL/. CONCLUSION: The updated risk score enabled the user to make predictions at admission and throughout the weeks, allowing for a prioritized weekly update for clinical pharmacy intervention. The updated model has a moderate and satisfactory performance for infectious disease patients.

Development of a risk score to predict sudden death in patients with Chaga's heart disease.

BACKGROUND: Sudden death is the most frequent mechanism of death in patients with chronic Chaga's cardiopathy, regardless of the degree of myocardial involvement. We developed a model to predict the risk of sudden death in patients with chronic Chaga's cardiopathy. METHODS: We retrospectively evaluated 373 patients. The association between the risk factors for chronic Chaga's cardiopathy and sudden death was assessed using Cox proportional-hazards analysis, and a risk score was determined. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the predictive performance of the score and Kaplan Meier survival curves, which were stratified according to the score. RESULTS: During a mean follow-up period of 66±44months, 43 patients experienced sudden death. Four independent predictors were identified, each of which was assigned a number of points proportional to the following regression coefficients: QT-interval dispersion (3 points), syncope (2 points), ventricular extrasystoles (1 point), and severe dysfunction of the left ventricle (1 point). We calculated risk scores for each patient and defined three groups: low risk (0 to 2 points), intermediate (3 to 4 points), and high risk (>5 points). The mortality rates of the three groups were 1.5%, 25%, and 51%, respectively. The C statistic for the prediction score was 0.84, which demonstrated good clinical relevance of the model. CONCLUSION: This simple risk score predicted sudden death in patients with chronic Chaga's heart disease.

Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.

BACKGROUND: Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy. METHODS: The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 µg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up. DISCUSSION: If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost. TRIAL REGISTRATION: Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).

A clinical adverse drug reaction prediction model for patients with chagas disease treated with benznidazole.

Benznidazole (BZN) is the main trypanocidal drug used to treat Chagas disease, and the evidence supporting the benefits of BZN use during the chronic phase of the disease will favor its use in millions of individuals. However, more than 30% of patients treated with BZN may suffer adverse drug reactions (ADRs), and the development of tools to identify those patients at risk is highly desirable. In the present study, we aimed to identify predictive factors for ADRs in Chagas disease patients treated with BZN. Among 195 patients included in the study, 48.7% experienced ADRs and 31.3% had ADRs that caused BZN treatment discontinuation. Overall ADRs and ADRs that caused BZN treatment discontinuation were more common among women and in those who graduated from elementary school. Overall ADRs were also less frequent among black individuals. Based on logistic regression analysis, female sex (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.5 to 5.4), graduation from elementary school (OR, 2.0; 95% CI, 1.1 to 3.8), and white (OR, 5.0; 95% CI, 1.0 to 24.1) and mulatto (OR, 5.6; 95% CI, 1.1 to 28.7) races were considered to predict overall ADRs, and female sex (OR, 2.3; 95% CI, 1.2 to 4.3) was considered to predict ADRs that caused BZN treatment discontinuation. Graduation from elementary school also presented a tendency to predict ADRs that caused BZN treatment discontinuation (OR, 1.8; 95% CI, 0.9 to 3.6). The logistic regression (LR) models to predict ADRs to BZN described in this study may become important tools to minimize ADRs and improve patients' compliance and thus assist physicians treating patients with Chagas disease with BZN.

Biodistribution of bone marrow mononuclear cells after intra-arterial or intravenous transplantation in subacute stroke patients.

AIMS: To assess the biodistribution of bone marrow mononuclear cells (BMMNC) delivered by different routes in patients with subacute middle cerebral artery ischemic stroke. PATIENTS & METHODS: This was a nonrandomized, open-label Phase I clinical trial. After bone marrow harvesting, BMMNCs were labeled with technetium-99m and intra-arterially or intravenously delivered together with the unlabeled cells. Scintigraphies were carried out at 2 and 24 h after cell transplantation. Clinical follow-up was continued for 6 months. RESULTS: Twelve patients were included, between 19 and 89 days after stroke, and received 1-5 × 10(8) BMMNCs. The intra-arterial group had greater radioactive counts in the liver and spleen and lower counts in the lungs at 2 and 24 h, while in the brain they were low and similar for both routes. CONCLUSION: BMMNC labeling with technetium-99m allowed imaging for up to 24 h after intra-arterial or intravenous injection in stroke patients.

Prevalence of psychoactive drug use among medical students in Rio de Janeiro.

BACKGROUND: Drug use and abuse may hamper learning capabilities and the development of technical skills in medical students and, therefore, the quality of care offered to patients. The aim of this investigation was to estimate the prevalence of psychoactive drug use among medical students of public universities in Rio de Janeiro, Brazil, and to identify characteristics associated with substance use. METHOD: This was a cross-sectional investigation designed to include all medical students of four universities. The final sample included 1,054 students. Patterns of licit and illicit drug use (at least once in lifetime drug use, drug use in the last 30 days (LTD) and CAGE) before and during medical school were assessed by a multiple-choice, self-administered anonymous questionnaire. RESULTS: Alcohol abuse was more prevalent among male students from higher income families. Alcohol LTD use was more prevalent among male students with college-educated parents. Tobacco, cannabis and inhalant lifetime use was more prevalent among males and tranquillizer use among females. Tobacco, cannabis and tranquillizer lifetime use was more prevalent among students with divorced or dead parents. Inhalant lifetime use was more prevalent among students from higher income families. Students who had college-educated, divorced or dead parents or evidenced tobacco, cocaine or inhalant lifetime use were more prevalent among cannabis users. Male students from higher income families had higher prevalence of cocaine lifetime use. CONCLUSION: Substance use in this group of medical students is not widespread compared to rates reported for developed countries. Preventive efforts should focus on alcohol and cannabis use by medical students.