title: To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL).
abstract: BACKGROUND
  Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients.
  
  
  METHODS
  In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year.
  
  
  RESULTS
  A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups.
  
  
  CONCLUSIONS
  The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Vidya Nand
authors.initials: VN
authors.lastname: Rabi Das
authors.affiliation: Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Niyamat Ali
authors.initials: NA
authors.lastname: Siddiqui
authors.affiliation: Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.
authors.forename: Biplab
authors.initials: B
authors.lastname: Pal
authors.affiliation: Department of Biochemistry, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Chandra Shekhar
authors.initials: CS
authors.lastname: Lal
authors.affiliation: Department of Pathology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Neena
authors.initials: N
authors.lastname: Verma
authors.affiliation: Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Rakesh Bihari
authors.initials: RB
authors.lastname: Verma
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Dhirendra
authors.initials: D
authors.lastname: Kumar
authors.affiliation: Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Pradeep
authors.initials: P
authors.lastname: Das
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research), Agamkuan, Patna, Bihar, India.
authors.forename: Krishna
authors.initials: K
authors.lastname: Pandey
mesh_terms: D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage* / Q000009:adverse effects; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007891:Leishmania / Q000187:drug effects; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy* / Q000469:parasitology; D007898:Leishmaniasis, Visceral / Q000469:parasitology / Q000473:pathology; D008297:Male; D059208:Parasite Load; D051437:Renal Insufficiency / Q000139:chemically induced; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D000666:Amphotericin B