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 irector, Pulmonolgy Unit III, Hospital de Pulido Valente, Lisbon
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"PalabrasClave" => array:2 [ "pt" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palavras-chaves" "identificador" => "xpalclavsec160803" "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" => "xpalclavsec160802" "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 class="elsevierStyleSectionTitle">Introdução</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">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> <span class="elsevierStyleSectionTitle">Objectivos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Determinar a incidência, a gravidade e os factores de risco das principais RA induzidas pelos antibacilares, em doentes internados com TB em tratamento.</p> <span class="elsevierStyleSectionTitle">Material e métodos</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">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. 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> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">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 doen tes (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><<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. 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/ mm3 ([RR] de 2,6 ; [IC], 1,4–5). 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> <span class="elsevierStyleSectionTitle">Conclusões</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">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 <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>" ] "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">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> <span class="elsevierStyleSectionTitle">Aim</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">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> <span class="elsevierStyleSectionTitle">Methods</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">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="spar0110" 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> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">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 (p<0.001) were observed in the average hospital stay (58.4 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 <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 <350 cells/mm<span class="elsevierStyleSup">3</span> (RR 5.5; CI 1.6–18.6).</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">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 <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 <350 cells/mm<span class="elsevierStyleSup">3</span> were also significantly associated with hepatotoxicity.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "Bibliografia/Bibliography" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:23 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1." "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Tratamento da tuberculose latente, revisão das normas, Sociedade Portuguesa de Pneumologia." ] ] ] 1 => array:3 [ "identificador" => "bib2" "etiqueta" => "2." 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ISSN: 21735115Original language: Portuguese
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