Adverse reactions to antituberculosis drugs in Manguinhos, Rio de Janeiro, Brazil

OBJECTIVES: This study aimed to characterize and estimate the frequency of adverse reactions to antituberculosis drugs in the population treated at the Centro de Saúde Escola Germano Sinval Faria, a primary health care clinic in Manguinhos, Rio de Janeiro City, and to explore the relationship between adverse drug reactions and some of the patients' demographic and health characteristics. METHODS: This descriptive study was conducted via patient record review of incident cases between 2004 and 2008. RESULTS: Of the 176 patients studied, 41.5% developed one or more adverse reactions to antituberculosis drugs, totaling 126 occurrences. The rate of adverse reactions to antituberculosis drugs was higher among women, patients aged 50 years or older, those with four or more comorbidities, and those who used five or more drugs. Of the total reactions, 71.4% were mild. The organ systems most affected were as follows: the gastrointestinal tract (29.4%), the skin and appendages (21.4%), and the central and peripheral nervous systems (14.3%). Of the patients who experienced adverse reactions to antituberculosis drugs, 65.8% received no drug treatment for their adverse reactions, and 4.1% had one of the antituberculosis drugs suspended because of adverse reactions. "Probable reactions" (75%) predominated over "possible reactions" (24%). In the study sample, 64.3% of the reactions occurred during the first two months of treatment, and most (92.6%) of the reactions were ascribed to the combination of rifampicin + isoniazid + pyrazinamide (Regimen I). A high dropout rate from tuberculosis treatment (24.4%) was also observed. CONCLUSION: This study suggests a high rate of adverse reactions to antituberculosis drugs.

Reações adversas a medicamentos e abandono ao tratamento da tuberculose / Adverse drug reactions and abandonment to tuberculosis treatment

Introdução: A tuberculose é a doença que mais mata no mundo. No país, ela constitui a 4ª causa de mortalidade por doenças infecciosas, com cerca de 6 mil óbitos/ano. Esses óbitos são atribuídos principalmente ao uso irregular e ao abandono da farmacoterapia. No entanto, a tuberculose é curável em praticamente 100 por cento dos casos, desde que o regime terapêutico, preconizado pelo MS, seja cumprido corretamente. Os medicamentos são eficazes, mas podem ocasionar reações adversas e aumentar a proporção de pacientes que abandonam o tratamento.Objetivos: Caracterizar as reações adversas aos medicamentos (RAMs) antituberculose segundo a gravidade, causalidade e sistema-órgão afetado e analisar a sua relação com oabandono do tratamento da TB nos casos novos atendidos no Centro de Saúde Escola Germano Sinval Faria, Rio de Janeiro. Metodologia: Estudo de coorte retrospectivo, com revisão de prontuários de cento e setenta e seis pacientes considerados casos novos de tuberculose pulmonar, moradoresdo Complexo de Manguinhos, RJ, atendidos no Centro de Saúde Escola Germano Sinval Faria (CSEGSF / ENSP / Fiocruz-RJ), no período de janeiro de 2004 a dezembro de 2008. Foram excluídos: os indivíduos não considerados casos novos de tuberculosepulmonar; acometidos por outros tipos de tuberculose. Foi realizada análise descritiva dos casos e análise estratificada, segundo o desfecho do tratamento...

Background: Tuberculosis (TB) is the main cause of deaths worldwide. In Brazil, it is the fourth leading cause of mortality from infectious diseases, with about 6,000 deaths a year. These deaths are mainly attributed to irregular use and abandonment pharmacotherapy. However, tuberculosis is curable in almost 100% of cases, provided the regimen, as recommended by Ministry of Health of Brazil, is completed correctly. The drugs are effective but can cause adverse reactions (ADRs) and increase theproportion of patients who discontinue treatment. Objectives: Characterize adverse reactions to antituberculosis drugs, according to the causality, seriousness, and system-organ affected and analyze its relationship with theabandonment of TB treatment in incident cases seen at the Health Center Germano Sinval Faria, Rio de Janeiro.Methods: Retrospective cohort study with chart review of one hundred seventy-six patients considered incident cases of pulmonary tuberculosis, residents of the Complexo de Manguinhos, RJ, attended at the Health Center Germano Sinval Faria (CSEGSF /ENSP / Fiocruz-RJ) in the period from January 2004 to December 2008. We excluded: individuals not considered incident cases of pulmonary tuberculosis and affected by other types of tuberculosis. A descriptive analysis of cases and stratified analysis according to treatment outcome was carried out...