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enquanto no grupo M foi de&#160;58&#44;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#44;16 anos&#44; e mostrou&#8208;se diferente entre os grupos &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;033&#41;&#46; No grupo NMG&#44; 23&#160;&#40;60&#44;5&#37;&#41; pacientes eram do sexo masculino&#44; e no grupo M foram&#160;sete&#160;&#40;46&#44;7&#37;&#41; &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;37&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">No s&#233;timo dia de tratamento &#40;D7&#41;&#44; 11&#44;4&#37; dos integrantes do grupo NMG e 33&#44;3&#37; do grupo&#160;M apresentaram QTc alargado&#46; No d&#233;cimo quarto dia &#40;D14&#41;&#44; 26&#44;6&#37; do grupo NMG apresentavam QTc alargado&#44; mas nenhum do grupo M&#46; A tend&#234;ncia se manteve no vig&#233;simo primeiro dia &#40;D21&#41;&#44; 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IC 95&#37;&#58; 0&#44;26&#160;a&#160;15&#44;93&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;5495&#41;&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">A &#250;nica diferen&#231;a significativa entre os grupos foi evidenciada no D7 de tratamento&#44; quando os pacientes tratados com miltefosina apresentaram mais frequentemente QTc<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>440 &#40;RR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;25&#59; IC&#160;95&#37;&#58;&#160;0&#44;07&#160;a&#160;0&#44;94&#41;&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;04 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabela 1</a>&#41;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Estudos anteriores j&#225; haviam mostrado que a miltefosina pode aumentar o intervalo QT durante o tratamento&#44; quando comparado como os valores basais&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">8</span></a> O prolongamento QT&#160;&#8805; 440&#160;ms traduz um aumento exagerado do potencial de a&#231;&#227;o&#44; levando a n&#227;o homogeneidade da matriz el&#233;trica ventricular&#44; favorecendo o aparecimento de fen&#244;menos de reentrada&#44; al&#233;m de favorecer despolariza&#231;&#245;es diast&#243;licas precoces e atividade &#8220;trigada&#8221;&#46; Esse prolongamento do QT se associa ao <span class="elsevierStyleItalic">Torsades de pointes</span>&#44; uma taquicardia ventricular polim&#243;rfica que pode exibir degenera&#231;&#227;o em fibrila&#231;&#227;o ventricular&#44; configurando o mecanismo arr&#237;tmico de morte s&#250;bita&#46;<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">3&#44;9</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Ao contr&#225;rio do esperado&#44; uma propor&#231;&#227;o maior de pacientes que fez uso de miltefosina apresentou QTc<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>440<span class="elsevierStyleHsp" style=""></span>ms no D7&#44; mas essa diferen&#231;a n&#227;o se manteve nas segunda e terceira semanas&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">O envelhecimento &#233; fator de altera&#231;&#245;es eletrocardiogr&#225;ficas&#44; e os pacientes do grupo M tinham maior m&#233;dia de idade&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a> Mas&#44; por outro lado&#44; essas altera&#231;&#245;es j&#225; estavam presentes no pr&#233;&#8208;tratamento&#44; o que nos leva a crer que a idade n&#227;o tenha tido papel determinante nas altera&#231;&#245;es&#46; Outra limita&#231;&#227;o &#233; a realiza&#231;&#227;o de m&#250;ltiplos testes&#44; que pode aumentar a taxa de erros do tipo&#160;1&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">11</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Diante do resultado que sugere cardiotoxicidade da M no contexto da atual tend&#234;ncia do tratamento da LTA com a associa&#231;&#227;o de subst&#226;ncias potencialmente cardiot&#243;xicas &#40;antimoniais&#44; anfotericina&#41;&#44; esse achado deve ser mais bem estudado em esquemas com combina&#231;&#245;es de f&#225;rmacos&#46; Este parece ser o primeiro estudo a evidenciar altera&#231;&#245;es de ECG da M ao longo do tratamento&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a> Esses achados&#44; entretanto&#44; t&#234;m car&#225;ter explorat&#243;rio e merecem ser confirmados por estudos com maior n&#250;mero de pacientes&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Suporte financeiro</span><p id="par0080" class="elsevierStylePara elsevierViewall">A Sociedade Brasileira de Dermatologia&#44; por meio da Funaderme e da Funda&#231;&#227;o de Apoio &#224; Pesquisa do Distrito Federal &#40;FAP&#8208;DF&#41;&#44; n&#250;mero&#160;0193&#46;001447&#47;2016&#44; agradece pelo apoio financeiro&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Contribui&#231;&#227;o dos autores</span><p id="par0085" class="elsevierStylePara elsevierViewall">Daniel Holanda Barroso&#58; Escreveu o manuscrito an&#225;lise dos dados&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Ciro Martins Gomes&#58; Revisou o manuscrito&#59; realizou exames de biologia molecular e analisou os dados&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Ant&#244;nia Marilene da Silva&#58; Escreveu o manuscrito e analisou os dados cardiol&#243;gicos&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Raimunda Nonata Ribeiro Sampaio&#58; Analisou os dados&#59; escreveu e revisou o manuscrito&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflito de interesses</span><p id="par0105" class="elsevierStylePara elsevierViewall">Nenhum&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Como citar este artigo&#58; Barroso DH&#44; Gomes CM&#44; Silva AM&#44; Sampaio RNR&#46; Comparison of cardiotoxicity between N&#8208;methyl&#8208;glucamine and miltefosine in the treatment of American cutaneous leishmaniasis&#46; An Bras Dermatol&#46; 2021&#59;96&#58;502&#8211;4&#46;</p>"
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Carta ‐ Investigação
Comparação da cardiotoxicidade entre N‐metil‐glucamina e miltefosina no tratamento da leishmaniose tegumentar americana
Daniel Holanda Barrosoa,
Corresponding author
Danielhbarroso@unb.br

Autor para correspondência.
, Ciro Martins Gomesa, Antônia Marilene da Silvaa, Raimunda Nonata Ribeiro Sampaioa,b
a Universidade de Brasília, Brasília, DF, Brazil
b Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF , Brazil
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">A N&#8208;metil&#8208;glucamina &#40;NMG&#41; constitui a primeira op&#231;&#227;o terap&#234;utica para a leishmaniose tegumentar americana &#40;LTA&#41;&#44; mas causa muitos efeitos adversos&#46; Uma das complica&#231;&#245;es mais graves e temidas &#233; a morte s&#250;bita&#44; causada por altera&#231;&#245;es eletrofisiol&#243;gicas card&#237;acas associadas no eletrocardiograma &#40;ECG&#41; ao prolongamento do QT corrigido pela f&#243;rmula de Bazeett &#40;QTc&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">1&#8211;3</span></a>A toxicidade dos antimoniais&#44; a ocorr&#234;ncias de recidivas da doen&#231;a e a resist&#234;ncia a essas subst&#226;ncias estimularam a busca por outros f&#225;rmacos ou esquemas terap&#234;uticos mais eficazes para o tratamento da LTA&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a> Dessa situa&#231;&#227;o surgiu a miltefosina &#40;hexadecilfosfocolina&#41;&#44; que se mostrou efetiva contra v&#225;rias esp&#233;cies de <span class="elsevierStyleItalic">Leishmania</span> e outros protozo&#225;rios&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">5&#44;6</span></a> O medicamento ativa o mecanismo de morte celular programada&#44; inibindo a s&#237;ntese de fosfatidilcolina&#44; importante para a s&#237;ntese e integridade da membrana celular&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">5</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Esse medicamento tem potencial teratog&#234;nico&#44; o que requer controle da natalidade durante a gesta&#231;&#227;o e at&#233; dois meses ap&#243;s o tratamento&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Realizou&#8208;se um estudo de coorte retrospectivo em dados dos registros de ECG de pacientes tratados para LTA &#40;20<span class="elsevierStyleHsp" style=""></span>mg SbV&#47;kg&#47;dia durante 20 dias para leishmaniose cut&#226;nea e 30 dias para a leishmaniose mucosa&#41; ou miltefosina &#40;1&#44;3 a 2<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;dia &#8211; duas c&#225;psulas por dia por 28 dias&#41;&#44; acompanhados com ECG semanal em Servi&#231;o de Dermatologia entre&#160;2008 e&#160;2013&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Os crit&#233;rios de inclus&#227;o foram pacientes tratados para LTA com idade entre 18 e 85 anos&#44; sem uso de quaisquer outras medica&#231;&#245;es no momento e que n&#227;o tivessem sido tratados para LTA nos &#250;ltimos&#160;seis&#160;meses&#46; Os crit&#233;rios de exclus&#227;o foram gestantes&#44; portadores de doen&#231;a renal ou hep&#225;tica cr&#244;nicas&#44; cardiopatias graves ou outras doen&#231;as ou uso de subst&#226;ncias que pudessem interferir no ECG&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Os pacientes inclu&#237;dos foram divididos em dois grupos&#58; 1&#160;&#8211;&#160;tratados com NMG&#59; 2&#160;&#8211;&#160;tratados com miltefosina &#40;M&#41;&#46; Foram comparados nos grupos o risco relativo e o percentual de altera&#231;&#245;es no EGC durante o tratamento &#40;ritmo e frequ&#234;ncia card&#237;aca&#44; onda&#160;P&#44; complexo QRS&#44; intervalo de risco relativo <span class="elsevierStyleSup">RR</span>&#44; presen&#231;a ou aus&#234;ncia de arritmias e intervalo QTc&#41;&#46; Foi adotada para a frequ&#234;ncia card&#237;aca a faixa de normalidade entre 60 bpm e 100 bpm&#44; e o limite para o QTc de 440<span class="elsevierStyleHsp" style=""></span>ms para ambos os sexos &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabela 1</a>&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">7</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">As vari&#225;veis foram expressas em frequ&#234;ncia&#44; e a compara&#231;&#227;o entre os grupos foi feita pelo uso do teste de Qui&#8208;Quadrado ou pelo teste exato de Fisher quando mais de 20&#37; das caselas apresentaram frequ&#234;ncia esperada inferior a 5&#46; Considerou&#8208;se significativo p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;05&#46; Empregou&#8208;se um modelo multivariado e RR com intervalo de confian&#231;a &#40;IC&#41; de&#160;95&#37;&#44; calculados para analisar a intensidade da associa&#231;&#227;o entre cada vari&#225;vel independente e a propor&#231;&#227;o de efeitos adversos&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Foram analisados os prontu&#225;rios de&#160;111&#160;pacientes com recupera&#231;&#227;o dos dados epidemiol&#243;gicos e eletrocardiogr&#225;ficos de&#160;53&#160;indiv&#237;duos&#44; dos quais 38&#160;foram tratados com NMG e 15&#160;com M&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">A m&#233;dia de idade no grupo NMG foi de 48&#44;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>16&#44;29 anos&#44; enquanto no grupo M foi de&#160;58&#44;4<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>9&#44;16 anos&#44; e mostrou&#8208;se diferente entre os grupos &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;033&#41;&#46; No grupo NMG&#44; 23&#160;&#40;60&#44;5&#37;&#41; pacientes eram do sexo masculino&#44; e no grupo M foram&#160;sete&#160;&#40;46&#44;7&#37;&#41; &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;37&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">No s&#233;timo dia de tratamento &#40;D7&#41;&#44; 11&#44;4&#37; dos integrantes do grupo NMG e 33&#44;3&#37; do grupo&#160;M apresentaram QTc alargado&#46; No d&#233;cimo quarto dia &#40;D14&#41;&#44; 26&#44;6&#37; do grupo NMG apresentavam QTc alargado&#44; mas nenhum do grupo M&#46; A tend&#234;ncia se manteve no vig&#233;simo primeiro dia &#40;D21&#41;&#44; j&#225; que 35&#44;3&#37; do grupo NMG apresentaram QTc alterado enquanto n&#227;o houve altera&#231;&#245;es no grupo M&#46; Quanto &#224; frequ&#234;ncia card&#237;aca&#44; 28&#44;9&#37; dos pacientes do grupo NMG e 26&#44;6&#37; do grupo MTF apresentaram bradicardia durante o tratamento&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Antes do tratamento&#44;&#160;16&#160;&#40;21&#37;&#41; pacientes do grupo NMG e 37&#44;5&#37; do grupo da M apresentavam bradicardia &#40;RR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;59&#59; IC 95&#37;&#58;&#160;0&#44;17&#160;a&#160;1&#44;99&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;44&#41;&#46; O QTc encontrava&#8208;se alargado em&#160;13&#44;51&#37; do grupo NMG e em 6&#44;66&#37; do grupo M &#40;RR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>2&#44;02&#59; IC 95&#37;&#58; 0&#44;26&#160;a&#160;15&#44;93&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;5495&#41;&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">A &#250;nica diferen&#231;a significativa entre os grupos foi evidenciada no D7 de tratamento&#44; quando os pacientes tratados com miltefosina apresentaram mais frequentemente QTc<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>440 &#40;RR<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;25&#59; IC&#160;95&#37;&#58;&#160;0&#44;07&#160;a&#160;0&#44;94&#41;&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;04 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabela 1</a>&#41;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Estudos anteriores j&#225; haviam mostrado que a miltefosina pode aumentar o intervalo QT durante o tratamento&#44; quando comparado como os valores basais&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">8</span></a> O prolongamento QT&#160;&#8805; 440&#160;ms traduz um aumento exagerado do potencial de a&#231;&#227;o&#44; levando a n&#227;o homogeneidade da matriz el&#233;trica ventricular&#44; favorecendo o aparecimento de fen&#244;menos de reentrada&#44; al&#233;m de favorecer despolariza&#231;&#245;es diast&#243;licas precoces e atividade &#8220;trigada&#8221;&#46; Esse prolongamento do QT se associa ao <span class="elsevierStyleItalic">Torsades de pointes</span>&#44; uma taquicardia ventricular polim&#243;rfica que pode exibir degenera&#231;&#227;o em fibrila&#231;&#227;o ventricular&#44; configurando o mecanismo arr&#237;tmico de morte s&#250;bita&#46;<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">3&#44;9</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Ao contr&#225;rio do esperado&#44; uma propor&#231;&#227;o maior de pacientes que fez uso de miltefosina apresentou QTc<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>440<span class="elsevierStyleHsp" style=""></span>ms no D7&#44; mas essa diferen&#231;a n&#227;o se manteve nas segunda e terceira semanas&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">O envelhecimento &#233; fator de altera&#231;&#245;es eletrocardiogr&#225;ficas&#44; e os pacientes do grupo M tinham maior m&#233;dia de idade&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">10</span></a> Mas&#44; por outro lado&#44; essas altera&#231;&#245;es j&#225; estavam presentes no pr&#233;&#8208;tratamento&#44; o que nos leva a crer que a idade n&#227;o tenha tido papel determinante nas altera&#231;&#245;es&#46; Outra limita&#231;&#227;o &#233; a realiza&#231;&#227;o de m&#250;ltiplos testes&#44; que pode aumentar a taxa de erros do tipo&#160;1&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">11</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Diante do resultado que sugere cardiotoxicidade da M no contexto da atual tend&#234;ncia do tratamento da LTA com a associa&#231;&#227;o de subst&#226;ncias potencialmente cardiot&#243;xicas &#40;antimoniais&#44; anfotericina&#41;&#44; esse achado deve ser mais bem estudado em esquemas com combina&#231;&#245;es de f&#225;rmacos&#46; Este parece ser o primeiro estudo a evidenciar altera&#231;&#245;es de ECG da M ao longo do tratamento&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">4</span></a> Esses achados&#44; entretanto&#44; t&#234;m car&#225;ter explorat&#243;rio e merecem ser confirmados por estudos com maior n&#250;mero de pacientes&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Suporte financeiro</span><p id="par0080" class="elsevierStylePara elsevierViewall">A Sociedade Brasileira de Dermatologia&#44; por meio da Funaderme e da Funda&#231;&#227;o de Apoio &#224; Pesquisa do Distrito Federal &#40;FAP&#8208;DF&#41;&#44; n&#250;mero&#160;0193&#46;001447&#47;2016&#44; agradece pelo apoio financeiro&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Contribui&#231;&#227;o dos autores</span><p id="par0085" class="elsevierStylePara elsevierViewall">Daniel Holanda Barroso&#58; Escreveu o manuscrito an&#225;lise dos dados&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Ciro Martins Gomes&#58; Revisou o manuscrito&#59; realizou exames de biologia molecular e analisou os dados&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Ant&#244;nia Marilene da Silva&#58; Escreveu o manuscrito e analisou os dados cardiol&#243;gicos&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Raimunda Nonata Ribeiro Sampaio&#58; Analisou os dados&#59; escreveu e revisou o manuscrito&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflito de interesses</span><p id="par0105" class="elsevierStylePara elsevierViewall">Nenhum&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Como citar este artigo&#58; Barroso DH&#44; Gomes CM&#44; Silva AM&#44; Sampaio RNR&#46; Comparison of cardiotoxicity between N&#8208;methyl&#8208;glucamine and miltefosine in the treatment of American cutaneous leishmaniasis&#46; An Bras Dermatol&#46; 2021&#59;96&#58;502&#8211;4&#46;</p>"
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ISSN: 26662752
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