DOI: 10.36347/sjams.2020.v08i12.045

Pages: 2922-2927

Background: Globally out of 600,000 cases of rifampicin-resistant tuberculosis about 190,000 people died from multidrug-resistant tuberculosis. New class of anti TB drug bedaquiline (BDQ) has shown efficacy in pre-extremely drug resistant (pre XDR) and extremely drug resistant (xdr) patients. Objectives: 1. To evaluate tolerability of bedaquiline in combination with background regimen (BR) for treatment of preXDR and XDR TB and observing incidence of subjects with emergence of type of adverse events in the form (mild, serious and required discontinuation of bedaquiline, 2. To observe the adverse reactions of bedaquiline for 14 days after starting bedaquiline, 3. To assess the factors (comorbidity) responsible for causing increase in adverse reactions or event for bedaquiline, 4. To assess clinical outcome at end of 14 days (at the end of first 2 weeks of bedaquiline therapy) in form of favourable and unfavourable clinical response. Material and Methods: This observational study was carried out in Department of Respiratory Medicine Dr. Vasant rao Pawar Medical College and tertiary health care institute with the duration of study from April 2019 to December 2019 with sample size 50. All patients aged > 18 years with pulmonary Tb with preXDR and XDR which were admitted at DR-TB ward in tertiary health care centre were evaluated. After complete pretreatment evaluation, according to RNTCP guideline, all patients started bedaquiline to all pre XDR and XDR patients. Tablets were given with food. Intake of bedaquiline and BR was supervised with direct observation and patients were monitored for 14 days (daily). Patients were assessed for adverse events, vital signs, ECG and clinically and were assessed daily for any adverse reactions for 14 days. All events were recorded, ECGs of all patients were taken at alternate days and sputum of all patients was sent for culture. Statistical analysis: Measurements were expressed as means and standard deviations for continuous ........