Clinical treatment outcomes of tuberculosis treated with the basic regimen recommended by the Brazilian National Ministry of Health using fixed-dose combination tablets in the greater metropolitan area of Goiânia, Brazil

J Bras Pneumol. 2013 Jan-Feb;39(1):76-83. doi: 10.1590/s1806-37132013000100011.
[Article in English, Portuguese]

Abstract

Objective: To describe the rates of cure, treatment failure, and treatment abandonment obtained with the basic regimen recommended by the Brazilian National Ministry of Health (rifampin, isoniazid, pyrazinamide, and ethambutol for two months, followed by isoniazid and rifampin for four months) involving the use of fixed-dose combination tablets (self-administered treatment), as well as to describe adverse events and their potential impact on treatment outcomes.

Methods: This was a descriptive study based on prospective data obtained from the medical records of tuberculosis patients (> 18 years of age) treated with the basic regimen at either of two primary health care facilities in the greater metropolitan area of Goiânia, Brazil.

Results: The study sample comprised 40 tuberculosis patients. The rate of cure was 67.5%, the rate of treatment abandonment was 17.5%, and there were no cases of treatment failure. Of the 40 patients in the sample, 19 (47%) reported adverse reactions, which were mild and moderate, respectively, in 87% and 13% of the cases. It was not necessary to alter the regimen or discontinue the treatment in any of the cases evaluated.

Conclusions: The rate of cure obtained with the self-administered, fixed-dose combination tablet form of the new basic regimen was similar to the historical rates of cure obtained with the previous regimen. The rate of treatment abandonment in our sample was much higher than that considered appropriate (up to 5%).

OBJETIVO:: Descrever as taxas de cura, falência e abandono do tratamento da tuberculose com o esquema básico preconizado pelo Ministério da Saúde - tratamento com rifampicina, isoniazida, pirazinamida e etambutol por dois meses seguido de isoniazida e rifampicina por quatro meses - utilizando comprimidos em dose fixa combinada em regime autoadministrado e descrever os eventos adversos e seus possíveis impactos nos desfechos do tratamento.

MÉTODOS:: Estudo descritivo utilizando dados coletados prospectivamente dos prontuários médicos de pacientes com tuberculose (idade ≥ 18 anos) tratados com o esquema básico em duas unidades básicas de saúde da região metropolitana de Goiânia, GO.

RESULTADOS:: A amostra foi composta por 40 pacientes com tuberculose. A taxa de cura foi de 67,5%, a taxa de abandono foi de 17,5%, e não ocorreram casos de falência. Nessa amostra, 19 pacientes (47%) relataram reações adversas aos medicamentos. Essas foram leves e moderadas, respectivamente, em 87% e 13% dos casos. Em nenhum caso houve necessidade de mudança do esquema ou suspensão do tratamento.

CONCLUSÕES:: A taxa de cura do esquema básico com o uso de comprimidos em dose fixa combinada sob regime autoadministrado foi semelhante às taxas históricas do esquema anterior. A taxa de abandono, na amostra estudada, foi muito acima da taxa preconizada como adequada (até 5%).

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antitubercular Agents / adverse effects
  • Antitubercular Agents / therapeutic use*
  • Brazil
  • Drug Therapy, Combination / methods
  • Ethambutol / adverse effects
  • Ethambutol / therapeutic use
  • Female
  • Humans
  • Isoniazid / adverse effects
  • Isoniazid / therapeutic use
  • Male
  • National Health Programs / standards
  • Patient Compliance / statistics & numerical data*
  • Prospective Studies
  • Pyrazinamide / adverse effects
  • Pyrazinamide / therapeutic use
  • Rifampin / adverse effects
  • Rifampin / therapeutic use
  • Self Administration / methods
  • Treatment Failure
  • Treatment Outcome
  • Tuberculosis / drug therapy*
  • Tuberculosis, Pulmonary / drug therapy
  • Urban Population
  • Young Adult

Substances

  • Antitubercular Agents
  • Pyrazinamide
  • Ethambutol
  • Isoniazid
  • Rifampin