Iopromide safety assessment in a radiology department: A seven-year retrospective characterization of adverse events.

BACKGROUND: Since the mid-20th century, contrast agents have been widely used in radiology due to their ability to provide high-definition radiographic images and greater precision in diagnostic exams. Different types of contrast agents are used in image diagnosis, namely radiological media. Despite being considered safe, there are still uncertainties about their safety profile, interactions, and incidence of adverse drug reactions in real-world settings. OBJECTIVE: To characterise the pattern of adverse events, during 7 years, in a radiology unit. METHODS: We performed a retrospective observational and descriptive study at an Image Center in Portugal between August 2012 and October 2019. A total of 77,449 computed tomography (CT) were registered, and from those 15,640 cases of iopromide were used as a contrast agent. The authors have accessed, under the authorization, the data of adverse events and procedures after the event. RESULTS: Most of the hypersensitivity events were immediate or with a short time of onset, with the majority of cases developing events with skin involvement and mild degree, where the most common events were papules (n = 60), pruritus (n = 42), erythema (n = 27) and urticaria (n = 14). Severe events, including hypersensitivity, were mainly represented by vomiting (n = 11), stridor (n = 8), breathing difficulties (n = 7) and syncope (n = 3). Abdominal-pelvic CT exam presented a higher frequency of adverse events. CONCLUSION: Despite all the current information about iopromide usage, the utilization of this agent is not abstent of risks and its safety profile not fully established. Most frequent symptoms were local, as skin adverse events, including papules, pruritus and erythema. Common medications used to treat or control adverse events were frequently hydrocortisone, clemastine and methylprednisolone.

Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database.

INTRODUCTION: Opioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice. OBJECTIVE: This study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes. METHODS: Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2021 with an opioid drug as the suspected/interacting medicine were analyzed. Reporting odds ratios (RORs) for drug-ADR combinations were calculated, analyzed, and corrected for sex and drug utilization (expenditure) for the Dutch population. RESULTS: A total of 8769 reports were analyzed. Tramadol was the opioid with the most reports during the period (n = 2746), while oxycodone or tramadol had the highest number of reports per year in the study period. The most reported ADRs from opioid use were nausea, followed by dizziness and vomiting, independent of sex, and all of them were more often reported in women. Vomiting associated with tramadol (ROR females/males = 2.17) was significantly higher in women. Buprenorphine was responsible for most ADRs when corrected for expenditure, with high RORs observed with application site hypersensitivity, application site reaction, and application site rash. Fentanyl gave rise to most of the reports of ADRs concerning abuse, misuse, and medication errors. CONCLUSION: Patients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS.

Are consumers ready to take part in the Pharmacovigilance System?--a Portuguese preliminary study concerning ADR reporting.

BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.

Fatores preditivos de morbidade e mortalidade no trauma hepático / Predictive factors of morbidity and mortality in hepatic trauma

OBJETIVO: Identificar os fatores preditivos de complicações e mortalidade em doentes operados com trauma hepático. MÉTODO: Estudo retrospectivo de 638 pacientes tratados no período de 1990 a 2003, identificando estatisticamente parâmetros epidemiológicos, fisiológicos e anatômicos associados com maior morbidade e mortalidade. RESULTADOS: Trauma penetrante foi o mecanismo mais freqüente. A instabilidade hemodinâmica esteve presente em 21,1 por cento das vítimas e o Índice de Gravidade das Lesões anatômicas (ISS) médio foi de 20,7. A maioria das lesões hepáticas foi grau III. A morbidade foi de 50,4 por cento, sendo as complicações relacionadas ao fígado mais freqüentes: sangramento persistente (9,8 por cento), abscesso intraperitoneal (3,8 por cento) e fístula biliar (3 por cento). As complicações não hepáticas ocorreram em 273 pacientes (42,8 por cento). A mortalidade foi de 22,1 por cento (141 casos) decorrente principalmente de sangramento persistente e sepse. As vítimas fatais apresentaram-se com pior índice fisiológico na admissão, com lesões hepáticas mais complexas e índices anatômicos mais graves quando comparadas aos sobreviventes. CONCLUSÃO: Os fatores preditivos de ocorrência de complicações hepáticas foram: idade maior que 60 anos, instabilidade hemodinâmica ou alteração de parâmetros fisiológicos na admissão, presença de lesões hepáticas complexas (grau > III) e índices anatômicos de gravidade de lesão abdominal (ATI) ou em outros segmentos corpóreos (ISS) elevados (= 25). Todas estas variáveis, mais a presença de lesões associadas abdominais e não abdominais e o mecanismo de trauma fechado foram preditivas de ocorrência de complicações não-hepáticas. Todos os fatores estudados, exceto a presença de lesões associadas abdominais, foram preditivos para a evolução a óbito.

BACKGROUND: The aim of this study was to evaluate predictive factors of morbidity and mortality in patients operated on for liver trauma. METHODS: Six hundred thirty eight patients were studied from 1990 to 2003 regarding their epidemiologic, physiologic and anatomic data and the predictive values associated with complications and death were statistically analyzed. RESULTS: Penetrating trauma was the most frequent mechanism of trauma. Hemodynamic instability occurred in 21.1 percent of the victims and mean Injury Severity Score (ISS) was 20.7. Most liver injuries were grade III. Morbidity was 50.4 percent and the most common liver related complications were: persistent bleeding (9.8 percent); intraperitoneal abscess (3.8 percent) and biliary fistula (3 percent). Complications not related to the liver occurred in 273 patients (42.8 percent). Mortality was 22.1 percent (141 cases), and it occurred mainly due to persistent bleeding and sepsis. Fatal victims were more unstable during admission, with worst physiological status, more complex liver injuries and higher anatomical scores when in comparison with the other patients. CONCLUSION: We found that the predictive factors for liver complications were: age higher than 60 years-old, hemodynamic instability and altered physiological status during admission, complex liver injuries (grade > III), and higher anatomical scores (Abdominal Trauma Index and ISS = 25). All these variables, and the existence of associated abdominal and extra-abdominal injuries, and blunt mechanism of trauma were predictive of the occurrence of liver unrelated complications. All the studied factors, except for associated abdominal injuries, were predictive of death.

Vitamina A em asmáticos / Vitamin A in asthmatics

Objetivo: investigar hipovitaminose A em crianças asmáticas; a presença de asma e rinite alérgica nos familiares delas, e a frequência de rinite alérgica e sinisite em crianças com asma. Métdos: estudo transversal e controlado com 110 crianças de 2 a 6 anos, pacientes dos ambulatórios de Pediatria, Imunologia e Pneumologia Pediátrica da Universidade de Santo Amaro, no período de agosto de 1999 a outubro de 2000. Estudaram-se três grupos: asmáticos com pneumonia anterior (1), asmáticos sem pneumonia anterior (2) e controlo (3). Foram prenchidos os inquéritos de frequência de consumo, com atenção especial aos alimentos fintes de vitamina A. Realizaram-se as dosagens de vitamina A pelo método de cromatografia líquida de alta resolução. Para se estudar as associações entre as variáveis, foram utilizados o teste qui-quadrado, o G de Cochtan, o teste t e análise de variância, considerando-se significante p <- 0,05. Resultados: a intensidade da asma influenciou o crescimento (indicador estatura/idade). Não houve diferença na frequência ou intensidade das asma, de rinite e de sinusite entre os grupos de crianças asmáticas. A comparação dos níveis séricos de vitamina A entre os grupos não mostrou diferença significante. Apenas no grupo de pacientes asmáticos foram encontradas crianças com níveis séricos de vitamina A inferiores aos estabelecidos pela Organização Mundial da Saúde. Da população total estudada, 20 por cento apresentava nível sérico de vitamina A próximo ao limite da normalidade. Conclusões: apesar de não haver significância estatística, só froam encontradas crianças com níveis baixos de vitamina A no grupo de asmáticos, o que sugere a importância de outros trabalhos sobre o assunto.

Glutaraldehyde-preserved bovine pericardium for the repair of diaphragmatic defects due to extensive metastatic liver resection.

Closure of diaphragmatic defects, regardless of their cause, can often be achieved by direct suture. However, when a large defect secondary to tissue destruction has been observed, direct closure is likely to be difficult. The glutaraldehyde-preserved bovine pericardium is a biological material with high resistance and allows for easy surgical manipulation. This case report shows the use of these prostheses applied in a patient after massive diaphragm resection due to hepatectomy by colon metastasis invasion in the diaphragm muscle. To replace diaphragm muscle, the glutaraldehyde-preserved bovine pericardium prostheses showed a good result even after four laparotomies.

Evoluçäo do carcinoma mamário: novos parâmetros imunopatológicos de avaliaçäo; estudo experimental em camundongos (MuMT), III. Líquido ascítico / Course of breast carcinoma: new immunopathological parameters of evaluation; experimental study in mice (MuMT), III. Ascitic fluid

Cem camundongos Swiss fêmeas inoculados por via intraperitonial com células tumorais de MuMT (carcinoma de Ehrlich, forma ascítica) e sacrificados diariamente, em grupos de cinco animais, durante os 20 dias de experimentaçäo. A formaçäo do líquido ascítico foi constatada a partir do 3§ dia (0,28 ml), aumentando para 0,48 ml no 6§ dia, e atingindo o máximo de 15,28 ml próximo ao 20§ dia (morte dos animais). A proporçäo de células tumorais variou acentuadamente no decorrer dos 20 dias da experimentaçäo. As células encontradas no 2§ dia se apresentaram 95% lisadas e as células íntegras inexistentes. Ao contrário, no fim da experimentaçäo constatou-se 6% de células lisadas e 85% de células íntegras. Nos primeiros dias a lise predominante foi a de tipo citotóxico, desencadeada pelas plaquetas, linfócitos T e monócitos. Entre o 6§ e 10§ dia a lise foi devida aos granulócitos. A lise por mecanismo näo citotóxico foi inversa ao porcentual de polimorfonucleares neutrófilos, diminuindo de 80% nos primeros 12 dias para 33% no 18§ dia