|  | | | | Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India | | | Autor(es): | SUNDAR, Shyam(*) et al.
(*) Department of Medicine, Institute of Medical Sciences, Banaras Hindu University - India | | Instituição: | Massachusetts Medical Society | | País: | Waltham/MA, USA | | Publicação/Editora: | N Engl J Med 2010;362:504-12. | | Data da publicação: | 11/02/2010 | | Número de Páginas: | 9 | | Veiculação no PEC: | 10/03/2010 16h15 | | Resumo: | Background: Some 50% of patients with visceral leishmaniasis (kala-azar) worldwide live in the Indian state of Bihar. Liposomal amphotericin B is an effective treatment when administered in short courses. We wanted to determine whether the efficacy of a single infusion of liposomal amphotericin B was inferior to conventional parenteral therapy, consisting of 15 alternate-day infusions of amphotericin B deoxycholate.
Methods: In this open-label study, we randomly assigned 412 patients in a 3:1 ratio to receive either liposomal amphotericin B (liposomal-therapy group) or amphotericin B deoxycholate (conventional-therapy group). Liposomal amphotericin B (at a dose of 10 mg per kilogram of body weight) was given once, and patients were discharged home 24 hours later. Amphotericin B deoxycholate, which was administered in 15 infusions of 1 mg per kilogram, was given every other day during a 29-day hospitalization. We determined the cure rate 6 months after treatment.
Results: A total of 410 patients — 304 of 304 patients (100%) in the liposomal-therapy group and 106 of 108 patients (98%) in the conventional-therapy group — had apparent cure responses at day 30. Cure rates at 6 months were similar in the two groups: 95.7% (95% confidence interval [CI], 93.4 to 97.9) in the liposomal-therapy group and 96.3% (95% CI, 92.6 to 99.9) in the conventional-therapy group. Adverse events in the liposomal-therapy group were infusion-related fever or rigors (in 40%) and increased anemia or thrombocytopenia (in 2%); such events in the conventional-therapy group were fever or rigors (in 64%), increased anemia (in 19%), and hypokalemia (in 2%). Nephrotoxicity or hepatotoxicity developed in no more than 1% of patients in each group.
Conclusions: A single infusion of liposomal amphotericin B was not inferior to and was less expensive than conventional therapy with amphotericin B deoxycholate. | | Arquivo para Download: | | PEC-SBI_Parasit Clin_Single-Dose Liposomal Amphotericin B.pdf | | Links Relacionados: | | http://content.nejm.org/cgi/content/full/362/6/504 |
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