Adverse Drug Reactions (ADR) necessitatingmodification of multi-drug therapy (MDT) inHansen’s disease: a retrospective study fromKerala, India

摘要

Objective: To assess the frequency and type of adverse drug reactions (ADR) thatnecessitated modification of multi-drug therapy (MDT) in Hansen’s disease, withemphasis to find out the interval between initiation of MDT and the occurrenceof ADR.Design: A retrospective analysis of case records of patients diagnosed withHansen’s disease (HD) and registered for MDT in a tertiary care institution between2010 and 2015. Clinical details and laboratory data were collected using a proforma.Results: One hundred and ninety-six patients were registered for treatment duringthe study period. We analysed 150 records that met the inclusion criteria. Thirty-sixamong them (24%) had ADR that needed modification of MDT. The most commonADR was haemolytic anemia (19 patients; 12·7%) followed by hepatitis (14 patients;9·3%). The most serious ADR was agranulocytosis (three patients; 2%). Adverseeffects were more common (72%) during the initial 2 months of MDT compared tolater months. (P ? 0·004).Conclusion: Nearly a quarter of the patients started on MDT for Hansen’s diseaseneeded its stoppage and subsequent modification due to ADR. Haemolytic anemiaand hepatitis were the most frequent adverse events. 72% of the ADR events occurredduring the initial two months of MDT which points to the need for more frequentmonitoring of the haemogram and liver function tests during the initial months oftreatment.