Adverse effects of the new tuberculosis treatment regimen recommended by the Brazilian National Ministry of Health* Efeitos adversos causados pelo novo esquema de tratamento da tuberculose preconizado pelo Ministério da Saúde do Brasil

Objective: To determine the principal adverse effects of the tuberculosis treatment regimen recommended by the Brazilian Ministry of Health. Methods: A prospective descriptive study involving 79 tuberculosis patients treated at the Clinical Research Center of the Cassiano Antonio Moraes University Hospital, in the city of Vitoria, Brazil, between 2003 and 2006. The treatment regimen consisted of isoniazid, rifampicin, pyrazinamide and ethambutol for four months, followed by rifampicin and isoniazid for two months. During the treatment period, the patients were clinically evaluated every week and had a monthly medical visit. Results: The overall incidence of adverse effects was 83.54%. Articular/bone/muscle involvement was the most common, followed by skin involvement (24.94% and 22.09%, respectively). Adverse effects were more common in the second month of treatment (41.59%). Modification of the treatment regimen was unnecessary. One patient required concomitant medication to counter the adverse effects. The cure rate was 100%. Conclusions: The overall incidence of adverse effects related to the new treatment regimen recommended by the Brazilian Ministry of Health was high. However, none of those effects demanded a change in the regimen, which was effective in the patients evaluated.

[1]  Gary M Williams,et al.  Alteration of Liver Cell Function and Proliferation: Differentiation Between Adaptation and Toxicity , 2002, Toxicologic pathology.

[2]  W. Paul,et al.  Risk factors for hepatotoxicity associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: experience from three public health tuberculosis clinics. , 2002, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[3]  Mauro Gomes,et al.  Adverse effects of tuberculosis treatment: experience at an outpatient clinic of a teaching hospital in the city of São Paulo, Brazil. , 2008, Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia.

[4]  T. Schaberg,et al.  Risk factors for side-effects of isoniazid, rifampin and pyrazinamide in patients hospitalized for pulmonary tuberculosis. , 1996, The European respiratory journal.

[5]  D. Menzies,et al.  Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. , 2003, American journal of respiratory and critical care medicine.

[6]  A M Patel,et al.  Avoidance and Management of Adverse Reactions to Antituberculosis Drugs , 1995, Drug safety.

[7]  John L. Johnson,et al.  Shortening treatment in adults with noncavitary tuberculosis and 2-month culture conversion. , 2009, American journal of respiratory and critical care medicine.

[8]  M. Demedts,et al.  Aging and hepatotoxicity of isoniazid and rifampin in pulmonary tuberculosis. , 1995, American journal of respiratory and critical care medicine.

[9]  M. A. Steele,et al.  Toxic hepatitis with isoniazid and rifampin. A meta-analysis. , 1991, Chest.

[10]  J. Fitzgerald,et al.  Adverse drug reactions associated with first-line anti-tuberculosis drug regimens. , 2007, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[11]  J. Belaiche,et al.  Deleterious influence of pyrazinamide on the outcome of patients with fulminant or subfulminant liver failure during antituberculous treatment including isoniazid , 1995, Hepatology.

[12]  M. Conde,et al.  Defaulting from anti-tuberculosis treatment in a teaching hospital in Rio de Janeiro, Brazil. , 2004, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[13]  J. Leibold,et al.  THE OCULAR TOXICITY OF ETHAMBUTOL AND ITS RELATION TO DOSE * , 1966, Annals of the New York Academy of Sciences.

[14]  D. Snider,et al.  Isoniazid hepatitis among pregnant and postpartum Hispanic patients. , 1989, Public health reports.

[15]  M. Borek,et al.  Comparison of a four-drug fixed-dose combination regimen with a single tablet regimen in smear-positive pulmonary tuberculosis. , 2009, The International Journal of Tuberculosis and Lung Disease.

[16]  M. Manassero,et al.  Adverse effects of antituberculosis drugs causing changes in treatment. , 1982, Tubercle.