FIXED-DOSE COMBINATION VERSUS SEPARATE ANTITUBERCULOSIS FORMULATIONS IN PULMONARY TUBERCULOSIS PATIENTS: EVALUATION OF EFFECTIVENESS AND SAFETY

Objective: This study aimed to compare the effectiveness and safety of fixed dose combination (FDC) versus separate (separate formulation [SF])antituberculosis (TB) formulations in patients with bacteriologically confirmed pulmonary TB.Methods: Data were collected retrospectively from patient records, which included all newly diagnosed bacteriologically confirmed pulmonaryTB patients treated with first category FDC or SF between January 2014 and January 2017 at the Dr. Esnawan Antariksa Hospital. The efficacy ofthe formulations was determined according to acid-fast bacilli (AFB) sputum smear conversion at the end of the intensive phase (month 2), after6 months of therapy, and after the extended treatment phase (month 3). Adverse drug reactions (ADRs) during treatments were recorded as safetyoutcomes. Chi-square tests were used to analyze the differences between the groups.Results: On comparing patients treated with FDC (n=33) and SF (n=30), rates of sputum conversions did not differ significantly after 2 months(83.3% vs. 78.7%, p=0.693) and the intensive phase was extended by 1 month for patients with conversion failures at this time point. One of sevenpatients in the FDC group did not achieve sputum conversion during the extended phase and was recorded as a medication failure. At the end ofcontinuation phase, all other subjects achieved sputum conversion. The overall frequencies of ADRs were not significantly higher in the FDC groupthan that in the SF group (36.4% vs. 23.3%, p=0.260).Conclusion: No differences in effectiveness and safety profiles were identified between first category FDC and separate anti TB formulations

QUALITATIVE REVIEW OF ANTIBIOTIC USE FOR NEONATAL SEPSIS

Objective: The aim of this study is to evaluate the antibiotic use in neonates with sepsis.Methods: An observational retrospective study was conducted using medical records of neonates diagnosed with early-/late-onset sepsis who wereprescribed antibiotics and who were treated in the neonatal intensive care unit (NICU) at the Dr. Cipto Mangunkusumo Hospital between January 1 andDecember 31, 2015. Patient records were screened for antibiotic use; qualitative analyses were performed using the Gyssens algorithm. Concordanceof empirical antibiotic prescriptions with subsequent blood culture and sensitivity tests was evaluated.Results: A total of 176 sepsis cases included 80 and 96 neonates with normal and low birth weights (LBWs), respectively. Ampicillinsulbactam+gentamycin, which is indicated in local guidelines as the first-line antibiotic combination for neonatal sepsis, was most frequentlyprescribed. In the normal birth weight group, appropriate antibiotic use (Gyssens Category I) was found in 89.7% of cases, whereas Gyssens Category V(no indication) was found in 4.54% of cases. In the LBW group, 88.1% and 6.2% of cases were included in Gyssens Categories I and V, respectively.Only 17.5% and 13.5% cultured blood specimens from normal and LBW groups, respectively, yielded positive results; the most commonly identifiedbacteria were Acinetobacter baumannii and Klebsiella pneumonia. All isolates were resistant to ampicillin-sulbactam; only 7.4% were sensitive togentamicin.Conclusion: Antibiotic use for neonatal sepsis in NICU in this study can be considered appropriate, suggesting proper implementation of antimicrobialguidelines. However, high rates of resistance to the first-line antibiotics for neonatal sepsis are concerning