{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T21:22:11Z","timestamp":1780435331056,"version":"3.54.1"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,5,2]],"date-time":"2023-05-02T00:00:00Z","timestamp":1682985600000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,5,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Post\u2013kala-azar dermal leishmaniasis (PKDL) is a dermal complication of visceral leishmaniasis. Oral miltefosine (MF) is the first-line treatment for PKDL patients in South Asia. This study assessed the safety and effectiveness of MF therapy after 12 months of follow-up to explore more precise data.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this observational study, 300 confirmed PKDL patients were enrolled. MF with the usual dose was administered to all patients for 12 weeks and followed up for 1 year. Clinical evolution was recorded systematically by photographs at screening and at 12 weeks, 6 months, and 12 months after treatment onset. Definitive cure consisted of disappearance of skin lesions with a negative PCR at 12 weeks or with &amp;gt;70% of lesions, disappearing or fading at 12-month follow-up. Patients with reappearing clinical features and any positive diagnostics of PKDL during the follow-up were considered as nonresponsive.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 300 patients, 286 (95.3%) completed 12 weeks of treatment. The per-protocol cure rate at 12 months was 97%, but 7 patients relapsed and 51 (17%) were lost to 12-month follow-up, resulting in a final cure rate of only 76%. Eye-related adverse events were noted in 11 (3.7%) patients and resolved in most (72.7%) within 12 months. Unfortunately, 3 patients had persistent partial vision loss. Mild to moderate gastrointestinal side effects were seen in 28% patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Moderate effectiveness of MF was observed in the present study. A significant number of patients developed ocular complications, and thus MF for treatment for PKDL should be suspended and replaced with a safer alternative regimen.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofad231","type":"journal-article","created":{"date-parts":[[2023,5,2]],"date-time":"2023-05-02T09:03:31Z","timestamp":1683018211000},"source":"Crossref","is-referenced-by-count":20,"title":["Safety and Effectiveness of Miltefosine in Post\u2013Kala-Azar Dermal Leishmaniasis: An Observational Study"],"prefix":"10.1093","volume":"10","author":[{"given":"Shyam","family":"Sundar","sequence":"first","affiliation":[{"name":"Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University , Varanasi , India"},{"name":"Department of Clinical Medicine, Kala-azar Medical Research Center , Muzaffarpur , India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jitendra","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University , Varanasi , India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anju","family":"Dinkar","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University , Varanasi , India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neha","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Florida , Jacksonville, Florida , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,5,2]]},"reference":[{"key":"2023052401070428700_ofad231-B1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0007173","article-title":"The safety and efficacy of miltefosine 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