title: Magnitude of unresponsiveness to sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar.
abstract: BACKGROUND
  The Indian government proposes to eliminate kala-azar, which has been a serious public health problem in Bihar. This study aimed to assess the magnitude of unresponsiveness to sodium stibogluconate in the treatment of new cases of visceral leishmaniasis and to identify the associated factors.
  
  
  METHODS
  Patients with clinically and parasitologically confirmed visceral leishmaniasis (n = 182) who had received no prior treatment, were enrolled for the study. The patients were treated with sodium stibogluconate (20 mg/kg body weight; upper limit 850 mg), intramuscularly for 30 days. The vital parameters and side-effects, if any, were monitored. Patients who developed toxicity during treatment were excluded from the study but were given rescue treatment with liposomal amphotericin B. All patients who completed the treatment were followed up for 6 months.
  
  
  RESULTS
  Unresponsiveness to sodium stibogluconate at the end of treatment was 43%. It was higher in women (48%) compared to men (40%). A significant association was observed between unresponsiveness and level of endemicity (p = 0.0002), large spleen size (p = 0.04) and immune response (migration inhibition factor) (p = 0.00002). At the end of 6 months' follow up, 27% of patients relapsed, giving a total unresponsiveness rate of 58%.
  
  
  CONCLUSIONS
  Unresponsiveness to sodium stibogluconate is a serious problem in the management of patients with visceral leishmaniasis. In patients with factors associated with nonresponse to sodium stibogluconate, alternative drugs such as miltefosine or amphotericin B should be considered as first-line drugs.
authors.affiliation: Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Agamkuan, Patna 800007, Bihar, India. dirrmris@sancharnet.in
authors.forename: V N R
authors.initials: VN
authors.lastname: Das
authors.forename: A
authors.initials: A
authors.lastname: Ranjan
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Bimal
authors.forename: N A
authors.initials: NA
authors.lastname: Siddique
authors.forename: K
authors.initials: K
authors.lastname: Pandey
authors.forename: Nawin
authors.initials: N
authors.lastname: Kumar
authors.forename: Neena
authors.initials: N
authors.lastname: Verma
authors.forename: V P
authors.initials: VP
authors.lastname: Singh
authors.forename: P K
authors.initials: PK
authors.lastname: Sinha
authors.forename: S K
authors.initials: SK
authors.lastname: Bhattacharya
mesh_terms: D000666:Amphotericin B / Q000627:therapeutic use; D000818:Animals; D000967:Antimony Sodium Gluconate / Q000494:pharmacology / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007194:India; D007893:Leishmania donovani / Q000187:drug effects*; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D010767:Phosphorylcholine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine; D000666:Amphotericin B; D000967:Antimony Sodium Gluconate