Efficacy and Tolerability of Miltefosin for Childhood in Visceral leishmaniasis
Abstract
Introduction: Bangladesh is a kala-azar endemic country. Previously Visceral leishmaniasis was treated with intravenous
Sodium stibogluconate. But it was hazardous for the patients and associated with many adverse effects. So, doctors were
searching for an oral antileishmanial drug. Miltefosin is an oral anticancer drug, but has an excellent antileishmanial
activity. Objective: To see the effectiveness and tolerability of Miltefosin for childhood Visceral leishmaniasis.
Materials and Methods: This is a prospective type of descriptive study. Study setting and period: Department of
Pediatrics, Rajshahi Medical College & Hospital. Rajshahi during September 2011 to February 2012. Study population:
Patients of Visceral leishmaniasis admitted in Pediatrics department, Rajshahi Medical College & Hospital. Sample size:
Forty four (44) Patients of Visceral leishmaniasis admitted in Pediatrics department, Rajshahi Medical College &
Hospital. Results: 86.4% patients of childhood Visceral leishmaniasis were cured (evidenced by absence of LD body in
splenic aspirate) with Oral Miltefosin at a dose of 2.5mg/kg/day in two divided dose in the morning and evening after meal
for 28 days. 65.9% became afebrile in 1-6 days, 20.5% in 7-10 days and 13.6% in >10 days. Mean weight of the patients
was increased from 22.5 kg to 23.2 kg. Very few adverse effects were noted. Most of them were gastrointestinal symptoms
like, nausea (29.5%), vomiting (22.7%), diarrhea (18.2%) and 11.4% patients showed transient elevation of serum
transaminases. But no patient needed to discontinue the treatment with Miltefosin. Conclusion: This study indicates that
Miltefosin is safe, well tolerable and highly effective for childhood Visceral leishmaniasis.
Keywords
Otitis media
Adenoid hypertrophy
Adenoiditis
Tympanometry
Introduction
Visceral leishmaniasis (VL) or Kala-azar is a human disease caused by hemoflagellate protozoal parasite of leishmania species (Leishmania donovani) and transmitted to human by the sand fly (Phlebotomus argentipes) bites. Leishmania is distributed worldwide and 12million people are estimated to be infected with about 500,000 new cases every year', 90% of which occurs in India, Nepal, Bangladesh, Sudan and Brazil? Approximately 50% of these patients are children’. In India 40% of patients are aged <13 years; in Sudan, 65% are aged <15years and in Brazil, 60% of patients are aged <5 years’. Furthermore, Visceral leishmaniasis is an opportunistic infection in HIV. Bangladesh is a Kala-azar endemic country. At present Kala-azar cases are reported from 139 upazilas in 45 districts of Bangladesh. On an average 10,000 cases are detected and treated annually’. Present estimated prevalence is 45,000 cases. The present prevalence rate is 2.9/10,000 population in Bangladesh.” Of them most are from Mymenshingh, Pabna, Tangail, Jamalpur and Rajshahi districts. Cardinal clinical feature of Kala-azar are: History of fever more than two weeks, residing/traveling in endemic area, splenomegaly, weight loss, anemia. Disease is confirmed by demonstration of LD body from splenic aspirate, bone marrow, buffy coat, lymph node biopsy etc. Associated laboratory changes are: Hematological changes like- Anemia, Raised ESR, Leucopenia, Thrombocytopenia, Positive ICT for Kala-azar and Biochemical changes like- Increased Serum bilirubin, raised SGOT & SGPT, Decreased Serum albumin, increased blood urea and creatinine etc. Death occurs in >90% of patients without specific anti-leishmanial treatment.