title: A prospective, observational study of adverse reactions to drug regimen for multi-drug resistant pulmonary tuberculosis in central India.
abstract: OBJECTIVE
  1) To assess the adverse drug reactions (ADRs) of second-line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR-TB) in central India on the basis of causality, severity and avoidability scales. 2) To investigate the relationship of MDR-TB (primary or secondary) and the presence of diabetes mellitus (DM) with mean smear conversion time.
  
  
  METHODS
  A prospective, observational study was carried out on diagnosed multidrug-resistant tuberculosis patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January 2012 to December 2012 with a follow-up of nine months. Encountered ADRs were noted along with the time of sputum conversion.
  
  
  RESULTS
  Total 64 ADRs were reported in 55 patients out of total 110 patients (n=110). As per the Naranjo causality assessment of ADRs, seven patients had definite, 45 had probable, and 3 had possible causal relation with drugs of DOTS-Plus regimen. As per the Hartwig's severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being definitely avoidable, 26 possibly avoidable, 23 not avoidable and three not evaluable. Mean sputum smear conversion time was significantly higher in patients with a secondary type than that of primary type of MDR TB and in patients with DM than those without DM.
  
  
  CONCLUSIONS
  ADRs were common in patients of MDR-TB on DOTs-Plus drug regimen. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regimen compared to DOTS regimen in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and clinical parameters and instituting appropriate measures.
authors.affiliation: Department of Pharmacology, Government Medical College, Nagpur, India-440003.
authors.forename: Rohan
authors.initials: R
authors.lastname: Hire
authors.affiliation: Department of Pharmacology, Government Medical College, Nagpur, India-440003.
authors.forename: A S
authors.initials: AS
authors.lastname: Kale
authors.affiliation: Department of Pharmacology, Government Medical College, Nagpur, India-440003.
authors.forename: G N
authors.initials: GN
authors.lastname: Dakhale
authors.affiliation: Department of Pharmacology, Government Medical College, Nagpur, India-440003.
authors.forename: Nilesh
authors.initials: N
authors.lastname: Gaikwad