Artigo Original/Original Article
Reacções adversas aos antibacilares em doentes internados: Gravidade e factores de risco
Adverse reactions to antituberculosis drugs in in-hospital patients: Severity and risk factors
Ana Sofia Vilariça1,
, Nelson Diogo2, Mota André2, Jaime Pina3
Corresponding author
anasofia.vilarica@gmail.com
Serviço de Pneumologia III, Hospital de Pulido Valente, Centro Hospitalar Lisboa Norte, Lisboa, Alameda das Linhas de Torres, 117, 1769-001 Lisboa.
Serviço de Pneumologia III, Hospital de Pulido Valente, Centro Hospitalar Lisboa Norte, Lisboa, Alameda das Linhas de Torres, 117, 1769-001 Lisboa.
1 Interna do Internato Complementar de Pneumologia/Resident, Pulmonology
2 Assistente Hospitalar Graduado de Pneumologia/Specialist, Consultant, Pulmonology
3 Chefe de Serviço Hospitalar de Pneumologia e Director do Serviço de Pneumologia III do Hospital de Pulido Valente, Lisboa/Head, Hospital Pulmonology Unit and Director, Pulmonolgy Unit III, Hospital de Pulido Valente, Lisbon
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=> "2" "identificador" => "af0010" ] 2 => array:3 [ "entidad" => "Chefe de Serviço Hospitalar de Pneumologia e Director do Serviço de Pneumologia III do Hospital de Pulido Valente, Lisboa/Head, Hospital Pulmonology Unit and Director, Pulmonolgy Unit III, Hospital de Pulido Valente, Lisbon" "etiqueta" => "3" "identificador" => "af0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cr0005" "etiqueta" => "*" "correspondencia" => "Serviço de Pneumologia III, Hospital de Pulido Valente, Centro Hospitalar Lisboa Norte, Lisboa, Alameda das Linhas de Torres, 117, 1769-001 Lisboa." ] ] ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Adverse reactions to antituberculosis drugs in in-hospital patients: Severity and risk factors" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2009-07-31" "fechaAceptado" => "2009-11-05" "PalabrasClave" => array:2 [ "pt" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palavras-chave" "identificador" => "xpalclavsec570164" "palabras" => array:4 [ 0 => "Tuberculose" 1 => "reacção adversa (RA)" 2 => "antibacilares" 3 => "infecção VIH" ] ] ] "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key-words" "identificador" => "xpalclavsec570165" "palabras" => array:4 [ 0 => "Tuberculosis" 1 => "adverse reaction (AR)" 2 => "antituberculosis drug" 3 => "HIV infection" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "pt" => array:2 [ "titulo" => "Resumo" "resumen" => "<span id="as0005" class="elsevierStyleSection elsevierViewall"><p id="sp0005" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Introdução:</span> Atendendo às características do <span class="elsevierStyleItalic">Mycobacterium tuberculosis</span> (MT), o tratamento da tuberculose (TB) é feito com uma associação de vários fármacos, por um período de tempo alargado (≥ a 6 meses), cada um com potencial para provocar reacções adversas (RA). Estas podem acompanhar-se de significativa morbilidade e comprometer o tratamento da TB.</p><p id="sp0010" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Objectivos:</span> Determinar a incidência, a gravidade e os factores de risco das principais RA induzidas pelos antibacilares, em doentes internados com TB em tratamento.</p><p id="sp0015" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Material e métodos:</span> Análise retrospectiva dos registos clínicos dos doentes internados no Serviço de Pneumologia III do Hospital de Pulido Valente com tuberculose activa, medicados com antibacilares, durante o período de Abril de 1999 a Julho de 2007. Foram registadas as RA que resultaram em modificação ou descontinuação do tratamento ou que foram a causa de internamento.</p><p id="sp0020" class="elsevierStyleSimplePara elsevierViewall">As características demográficas e os dados clínicos dos doentes foram usados como variáveis independentes. A relação entre variáveis independentes e a frequência e gravidade das RA foi feita através de uma análise multivariada, utilizando um modelo de regressão logística. Os dados foram analisados pelo teste t de <span class="elsevierStyleItalic">Student</span>, <span class="elsevierStyleItalic">one-way</span> ANOVA e regressão logística. A aplicação utilizada para a análise estatística foi o programa SPSS (Statistical Package for the Social Sciences), versão 15.0.</p><p id="sp0025" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Resultados:</span> Dos 1400 doentes internados e tratados por TB activa entre 1999 e 2007, 175 doentes (12,5%), 118 homens e 57 mulheres, apresentaram pelo menos uma RA induzida pelos antibacilares, num total de 192 eventos. A hepatotoxicidade foi a RA mais prevalente (83/47,4%), seguindo-se a reacção cutânea (55/31,4%) e a intolerância gastrintestinal (24/13,7%). Em 76 doentes (43,4%) as RA causaram o prolongamento do internamento. Constatou-se que a demora média do grupo de doentes com RA foi de 58,4 dias. Esta demora média apresentou diferenças estatisticamente significativas (p<span class="elsevierStyleHsp" style=""></span>< 0,001) em relação à demora média dos doentes sem RA, que foi de 26 dias. Os fármacos mais implicados foram a isoniazida (62,2%) e a rifampicina (51,9%). Dos 134 casos em que foi possível caracterizar a gravidade das RA, em 106 casos (79%) houve necessidade de suspensão do fármaco. A relação causal fármaco-RA foi definitiva em 23 casos (17%). Dos 13 doentes (9,6%) que faleceram, em 6 (4,4%) a RA esteve directamente implicada na causa de morte.</p><p id="sp0030" class="elsevierStyleSimplePara elsevierViewall">A ocorrência de qualquer RA foi associada ao alcoolismo (risco relativo [RR] de 3,0; 95% de intervalo confiança [IC], 1,1-7,9) e aos níveis de CD4 < 350 células/mm <span class="elsevierStyleSup">3</span> ([RR] de 2,6; [IC], 1,4-5).</p><p id="sp0035" class="elsevierStyleSimplePara elsevierViewall">No modelo preditivo, as reacções hepáticas foram associadas à ocorrência de hepatites virais B e/ou C ([RR] de 2,5; [IC], 1,2-5,1) e aos níveis de CD4 < 350 células/mm<span class="elsevierStyleSup">3</span> ([RR] de 5,5; [IC], 1,6-18,6).</p><p id="sp0040" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Conclusões:</span> Os antibacilares estão associados a um número significativo de RA que podem condicionar grande morbilidade, prolongamento do internamento e mesmo alguma mortalidade. Os nossos resultados mostram que o alcoolismo e os níveis de CD4 <<span class="elsevierStyleHsp" style=""></span>350 células/mm<span class="elsevierStyleSup">3</span> foram significativamente associados a um elevado risco de ocorrência de qualquer RA e que as hepatites B e C e os níveis de CD4 < 350 células/mm<span class="elsevierStyleSup">3</span> foram associados, também de forma significativa, ao risco de RA hepáticas.</p><p id="sp0045" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Rev Port Pneumol 2010; XVI (3): 431-451</span></p></span>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="as0010" class="elsevierStyleSection elsevierViewall"><p id="sp0050" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Introduction:</span> Given <span class="elsevierStyleItalic">Mycobacterium tuberculosis</span>’s characteristics, the treatment of tuberculosis (TB) infection is administered over a long period of time (for six months or more) with a combination of several drugs which could cause adverse reactions (AR). These can cause significant morbidity and compromise tuberculosis treatment regimens.</p><p id="sp0055" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Aim:</span> To determine the incidence and severity of and risk factors for major adverse reactions to antituberculosis drugs in in-hospital patients treated for active tuberculosis.</p><p id="sp0060" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Methods:</span> Retrospective analysis of clinical records of patients admitted to Pulido Valente Hospital (Pulmonology Unit III) with active TB treated with anti tuberculosis agents April 1999 to July 2007. Adverse reactions resulting in modification or discontinuation of treatment or hospital admission were recorded.</p><p id="sp0065" class="elsevierStyleSimplePara elsevierViewall">Patients’ demographic characteristics and clinical data were used as independent variables. The relationship between independent variables and the frequency and severity of AR was studied using multivariate analysis using a logistic regression model. The data were analysed using the Student t test, one-way ANOVA and logistic regression. Statistical analysis was performed using the SPSS (Statistical Package for the Social Sciences) version 15.0.</p><p id="sp0070" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Results:</span> We recorded 1400 in-hospital patients treated for active TB 1999 to 2007, of which 175 patients (12.5%), 118 male and 57 female, had at least one AR induced by antituberculosis agents, to a total of 192 events. Hepatotoxicity was the most prevalent AR (83/47.4%), followed by skin reactions (55/31.4%) and gastrointestinal intolerance (24/13.7%). In 76 patients (43.4%) AR caused prolonged hospital stay. Statistically significant differences (<span class="elsevierStyleItalic">p</span><<span class="elsevierStyleHsp" style=""></span>0.001) were observed in the average hospital stay (58.4<span class="elsevierStyleHsp" style=""></span>days for patients with AR and 26 days for patients without AR). Isoniazid (62.2%) and rifampicin (51.9%) were the most frequently implicated drugs. It was possible to characterise the AR severity in 134 cases. In 106 cases (79%) AR resulted in discontinuation of the drug. The relationship between drug and AR was definitive in 23 cases (17%). Of the 13 patients (9.6%) who died, AR was directly implicated in the cause of death in six (4.4%). AR were associated with alcoholism (relative risk [RR] 3.0; 95% confidence interval [CI] 1.1-7.9) and CD4 levels <<span class="elsevierStyleHsp" style=""></span>350 cells/mm<span class="elsevierStyleSup">3</span> (RR 2.6; CI 1.4-5). In the predictive model, hepatic reactions were associated with viral hepatitis B and/or C (RR 2.5, CI; 1.2-5.1) and that CD4 levels <<span class="elsevierStyleHsp" style=""></span>350 cells/mm<span class="elsevierStyleSup">3</span> (RR 5.5; CI 1.6-18.6).</p><p id="sp0075" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Conclusions:</span> Antituberculosis drugs are associated with a significant number of AR that can cause significant morbidity, prolonged hospital stay and even death. Our results show that alcoholism and levels of CD4 <<span class="elsevierStyleHsp" style=""></span>350 cells/mm<span class="elsevierStyleSup">3</span> were significantly associated with a high risk of AR and hepatitis B and C and levels of CD4 <<span class="elsevierStyleHsp" style=""></span>350 cells/mm<span class="elsevierStyleSup">3</span> were also significantly associated with hepatotoxicity.</p><p id="sp0080" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleBold">Rev Port Pneumol 2010; XVI (3): 431-451</span></p></span>" ] ] "lecturaRecomendada" => array:1 [ 0 => array:3 [ "vista" => "all" "titulo" => "<span class="elsevierStyleSectionTitle" id="st0025">Bibliografia/Bibliography</span>" "seccion" => array:1 [ 0 => array:2 [ "vista" => "all" "bibliografiaReferencia" => array:23 [ 0 => array:3 [ "identificador" => "bb0005" "etiqueta" => "1." 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Article information
ISSN: 08732159Original language: Portuguese
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