{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T22:20:02Z","timestamp":1792794002549,"version":"4.5.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2020,9,7]],"date-time":"2020-09-07T00:00:00Z","timestamp":1599436800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006507","name":"FIOCRUZ","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006507","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Ministry of Health from Brazil","id":[{"id":"https:\/\/ror.org\/02y7p0749","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The treatment of cutaneous leishmaniasis (CL) in Brazil using pentavalent antimony (Sbv) is associated with a high rate of failure. Miltefosine has proven efficacy for CL caused by L. braziliensis, with a cure rate (CR) of 75%. A combined treatment with granulocyte macrophage colony-stimulating factor (GM-CSF) and miltefosine could increase CR and decrease healing time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized, double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M + GM) vs miltefosine and placebo (M + P) vs Sbv in 133 patients with CL caused by L. braziliensis in Bahia, Brazil.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The final CR at 180 days after the initiation of treatment was 44.4% in the Sbv group, 76.6% in the M + P group (P = .003 vs Sbv), and 75.6% in the M + GM group (P = .004 vs Sbv). The median healing time for cure was 102 days for the Sbv group and 60 days for both miltefosine groups (P = .0009). During the 6-month follow-up period, 4 relapses were documented: 1 in the Sbv group, 1 in the M + P group, and 2 in the M + GM group. Mild adverse events occurred in 65% of patients from the Sbv group, 76% and 79% from the M + P and M + GM groups respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Miltefosine is more effective than Sbv for the treatment of CL caused by L. braziliensis in Brazil and accelerates the healing time. Association with GM-CSF does not improve therapeutic outcome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT03023111.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaa1337","type":"journal-article","created":{"date-parts":[[2020,9,3]],"date-time":"2020-09-03T07:11:24Z","timestamp":1599117084000},"page":"e2465-e2469","source":"Crossref","is-referenced-by-count":21,"title":["A Double-blind, Randomized Trial to Evaluate Miltefosine and Topical Granulocyte Macrophage Colony-stimulating Factor in the Treatment of Cutaneous Leishmaniasis Caused by\n                    <i>Leishmania braziliensis<\/i>\n                    in Brazil"],"prefix":"10.1093","volume":"73","author":[{"given":"Paulo R L","family":"Machado","sequence":"first","affiliation":[{"name":"Servi\u00e7o de Imunologia, Hospital Universit\u00e1rio Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil"},{"name":"Instituto Nacional de Ci\u00eancia e Tecnologia em Doen\u00e7as Tropicais, Minist\u00e9rio da Ci\u00eancia, Tecnologia, Inova\u00e7\u00f5es e Comunica\u00e7\u00f5es, Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico, Bras\u00edlia, DF, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernanda V O","family":"Prates","sequence":"additional","affiliation":[{"name":"Servi\u00e7o de Imunologia, Hospital Universit\u00e1rio Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil"},{"name":"Instituto Nacional de Ci\u00eancia e Tecnologia em Doen\u00e7as Tropicais, Minist\u00e9rio da Ci\u00eancia, Tecnologia, Inova\u00e7\u00f5es e Comunica\u00e7\u00f5es, Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico, Bras\u00edlia, DF, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viviane","family":"Boaventura","sequence":"additional","affiliation":[{"name":"Instituto Gon\u00e7alo Moniz, Funda\u00e7\u00e3o Oswaldo Cruz, Bahia, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tain\u00e3","family":"Lago","sequence":"additional","affiliation":[{"name":"Servi\u00e7o de Imunologia, Hospital Universit\u00e1rio Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luiz H","family":"Guimar\u00e3es","sequence":"additional","affiliation":[{"name":"Universidade Federal do Sul da Bahia, Teixeira de Freitas, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert","family":"Schriefer","sequence":"additional","affiliation":[{"name":"Servi\u00e7o de Imunologia, Hospital Universit\u00e1rio Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, 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