作者: Shyam Sundar Shyam Sundar , Anup Singh Anup Singh , Madhukar Rai Madhukar Rai , VK Prajapati , AK Singh
DOI: 10.1093/CID/CIS474
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摘要: Background. Miltefosine is the only oral drug available for treatment of Indian visceral leishmaniasis (VL), which was shown to have an efficacy 94% in a phase III trial subcontinent. Its unrestricted use has raised concern about its continued effectiveness. This study evaluates and safety miltefosine VL after decade India. Methods. An open-label, noncomparative performed 567 patients received (50 mg weighing <25 kg, 100 divided doses those ≥25 2.5 per kg aged <12 years, daily 28 days) directly observed manner. Patients were followed up 6 months see response therapy. Results. At end initial cure rate 97.5% (intention treat), final 90.3%. The overall death 0.9% (5 567), 2 deaths related toxicity. Gastrointestinal intolerance frequent (64.5%). interrupted 9 (1.5%) because drug-associated adverse events. Conclusions. As compared that led registration ago, there substantial increase failure