title: Treatment outcome of standardized regimen in patients with multidrug resistant tuberculosis.
abstract: OBJECTIVE
  To evaluate the treatment outcome of second line drugs used in directly observed treatment, short-course (DOTS)-Plus regimen under Revised National Tuberculosis Control Program (RNTCP).
  
  
  METHODS
  A prospective, observational study was carried out on multidrug resistant tuberculosis (MDR-TB) patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January to December 2009. Demographic details, symptoms, sputum examination and adverse drug reactions were recorded in a case record form. Patients were followed up for 24 months. The data were analysed by Fisher's exact test and paired student's 't' test.
  
  
  RESULTS
  Out of 130 patients, 51 (39%) were cured, 7 (5%) completed the treatment, 25 (19%) died, 30 (23%) defaulted and 17 (13%) failure. A significant increase in body weight (P < 0.0001) was observed at the end of the 24 months. Out of 89 patients with sputum culture conversion, majority (73) turned negative within first 3 months. Female gender (P < 0.05), conversion of sputum culture from positive to negative (P < 0.0001), and radiological improvement (P < 0.0001) were found to be positive predictors of a successful treatment outcome. While smoking habit (P < 0.05) and alcohol consumption (P < 0.05) were negative predictors of successful treatment outcome. Thirty five (26%) patients developed ADRs that required withdrawal of causal drug. The most common ADR was joint pain due to pyrazinamide (11) followed by neurological and psychiatric disturbances due to cycloserine (9).
  
  
  CONCLUSIONS
  The treatment outcome of standardized regimen in MDR-TB patients was low. The long duration of treatment and defaulters are major challenges for a successful outcome.
authors.affiliation: Department of Pharmacology, BJ Medical College, Ahmedabad, Gujarat, India.
authors.forename: Kalpesh
authors.initials: K
authors.lastname: Jain
authors.affiliation: Department of Pharmacology, BJ Medical College, Ahmedabad, Gujarat, India.
authors.forename: Mira
authors.initials: M
authors.lastname: Desai
authors.affiliation: Department of Tuberculosis and Chest Disease, Civil Hospital, Ahmedabad, Gujarat, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Solanki
authors.affiliation: Department of Pharmacology, BJ Medical College, Ahmedabad, Gujarat, India.
authors.forename: Ram Kumar
authors.initials: RK
authors.lastname: Dikshit
keywords: DOTS-Plus; India; MDR-TB; standardized regimen; treatment outcome