PURPOSE: Management of MDR-TB is a challenge as the treatment requires prolonged administration of second line ATT which is expensive and toxic. Adverse effects of these drugs lead to significant morbidity in patients.
METHODS: A retrospective analysis of patients with MDR-TB admitted over a period of one year was done. All were given individualized in-hospital, directly observed, treatment with second line ATT. The ADR were noted and their severity was graded as per the modified common toxicity criteria (of NIH, DCTD, DHHS 1998). Interventions done for the management of the adverse effects were not included in the study.
RESULTS: 110 (65 males, 55 females, mean age 48±26 years) HIV seronegative patients were reviewed. ADR were observed in 93/110 (85.4%) viz, gastritis (73/93,78.5%), pruritis (26/93,28%), injection site abscess (23/93,24.7%), bodyache/arthralgia (15/93,16.12%), hypothyroidism (12/93,12.9%), headache (10/93,10.7%), ototoxicity (9/93,9.7%), hyperuricemia (9/93,9.7%), acne/rash (8/93,8.6%), giddiness (4/93,4.3%), gynaecomastia (2/93,2.1%), skin pigmentation (2/93,2.1%), psychosis (1/93,1%). No ADR were seen in 17/110 (15.4%). Majority of the patients had more than one ADR at a time. The odds for the onset of ADR were significantly higher in 4–6 months as compared to first 3 months of ATT (79/93 vs 9/93, Odds Ratio = 8.77, 95% CI= 4.15–18.52, P= 0.000). Grade I ADR were seen in 79/93 (85%), grade II in 13/93 (14%), grade III in 1/93 (1%) while grade IV in none. Sputum conversion within 6 months of start of treatment was seen in 85/110 (77.3%) while 25/110 (22.7%) took more time to convert and were given extended intensive phase.
CONCLUSION: Gastritis was the most frequently occurring ADR. Onset of ADR were highest in 4–6 months of the therapy. Majority of the patients had grade I ADR while grade II ADR were mainly seen among those on extended intensive phase. This could possibly lead to decreased compliance among patients on second line ATT.
CLINICAL IMPLICATIONS: It is important for clinicians to promptly recognize adverse drug reactions to the ATT and manage them as per their severity. Failing which, there will be failure of treatment.
DISCLOSURE: Dr Jaya Kala, No Financial Disclosure Information; No Product/Research Disclosure Information