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1.
Rev. Soc. Bras. Med. Trop ; 54: e0514-2020, 2021. tab, graf
Article in English | LILACS | ID: biblio-1155581

ABSTRACT

Abstract A 31-year-old male patient developed an ulcer on the glans penis that evolved for three months without healing. We diagnosed it as leishmaniasis using polymerase chain reaction. No immunosuppression or associated diseases were observed. The patient was treated with meglumine antimoniate that cured the lesion in a month post-treatment. Here, we report this case of cutaneous leishmaniasis lesion at the unusual location of glans penis in an immunocompetent individual. The lesion likely developed due to the bite of a vector, highlighting the need for considering cutaneous leishmaniasis among differential diagnosis of sexually transmitted diseases in areas endemic for leishmaniasis.


Subject(s)
Humans , Male , Adult , Organometallic Compounds/therapeutic use , Leishmaniasis, Cutaneous/diagnosis , Leishmaniasis, Cutaneous/drug therapy , Antiprotozoal Agents/therapeutic use , Brazil , Polymerase Chain Reaction , Meglumine Antimoniate/therapeutic use , Genitalia , Meglumine/therapeutic use
2.
Arq. bras. med. vet. zootec. (Online) ; 72(4): 1085-1092, July-Aug. 2020. tab
Article in English | LILACS, VETINDEX | ID: biblio-1139937

ABSTRACT

The aim of this study was to evaluate the effects of flunixin meglumine administration on pregnancy rates and luteal phase characteristics in bovine embryo recipients at the moment of embryo transfer. In experiment 1, in vitro produced embryos were transferred to 184 females divided as control and treated group (recipients treated with 1.1mg/kg flunixin meglumine). In experiment 2, 22 females were divided as control group; group 2 (animals submitted to a reproductive tract manipulation similar to an embryo transfer on the 7th day after estrous); and group 3 (females submitted to a manipulation and treatment with 1.1mg/kg flunixin meglumine). In experiment 1 no difference was observed between control and treated groups (40.2% and 44.6%, respectively) for pregnancy rates. In experiment 2 no difference was observed on the length of luteal phase between groups, however, animals in group 2 presented lower plasma progesterone concentrations than the control group and group 3. Therefore, we concluded that although the administration of flunixin meglumine at the moment of embryo transfer inhibited the reduction plasma progesterone concentrations, it was not effective in increasing pregnancy rates of bovine recipients.(AU)


O objetivo deste estudo foi avaliar os efeitos da administração de flunixina meglumina sobre as taxas de prenhez e características da fase lútea da receptora no momento da transferência de embriões em bovinos. No experimento 1, embriões produzidos in vitro foram transferidos para 184 fêmeas, divididas em grupos controle e tratado (tratados com 1,1mg/kg de flunixina meglumina). No experimento 2, 22 fêmeas foram divididas em grupo controle (n=7); grupo 2 (n=8; animais submetidos à manipulação do trato reprodutivo semelhante à transferência de embriões no sétimo dia pós-cio); e grupo 3 (n=7; fêmeas submetidas à manipulação e ao tratamento com 1,1mg/kg de flunixina meglumina). No experimento 1, não foi observada diferença nos grupos controle e tratado (40,2% e 44,6%, respectivamente) para as taxas de prenhez. No experimento 2, não houve diferença na extensão da fase lútea entre os grupos, entretanto os animais do grupo 2 apresentaram concentrações plasmáticas de progesterona mais baixas que o grupo controle e o grupo 3. Portanto, conclui-se que a administração de flunixina meglumina no momento da transferência de embriões inibiu a redução das concentrações plasmáticas de progesterona, no entanto não foi eficaz para aumentar as taxas de prenhez de receptoras em bovinos.(AU)


Subject(s)
Animals , Female , Pregnancy , Cattle , Pregnancy Rate , Embryo Culture Techniques/veterinary , Luteal Phase/physiology , Meglumine , Progesterone , In Vitro Techniques/veterinary
3.
Rev. Soc. Bras. Med. Trop ; 52: e20180272, 2019. tab, graf
Article in English | LILACS | ID: biblio-1041550

ABSTRACT

Abstract INTRODUCTION: Visceral leishmaniasis (VL) is fatal if not diagnosed and treated. This study aimed to estimate the cost-effectiveness of diagnostic-therapeutic alternatives for VL in Brazil. METHODS: A decision model estimated the life expectancy and costs of six diagnostic-therapeutic strategies. RESULTS: IT LEISH + liposomal amphotericin B emerged the best option, presenting lower costs and higher effectiveness. DAT-LPC + liposomal amphotericin B showed an incremental cost-effectiveness ratio of US$ 326.31 per life year. CONCLUSIONS: These findings indicate the feasibility of incorporating DAT and designating liposomal amphotericin B as the first-line drug for VL in Brazil.


Subject(s)
Humans , Amphotericin B/economics , Cost-Benefit Analysis/statistics & numerical data , Leishmaniasis, Visceral/economics , Meglumine/economics , Antiprotozoal Agents/economics , Brazil , Coombs Test/economics , Amphotericin B/administration & dosage , Sensitivity and Specificity , Fluorescent Antibody Technique, Indirect/economics , Leishmaniasis, Visceral/diagnosis , Leishmaniasis, Visceral/drug therapy , Meglumine/administration & dosage , Antiprotozoal Agents/administration & dosage
4.
Rev. Soc. Bras. Med. Trop ; 51(3): 393-396, Apr.-June 2018. tab, graf
Article in English | LILACS | ID: biblio-957422

ABSTRACT

Abstract Visceral leishmaniasis is a systemic disease that is potentially severe and endemic in Brazil. It clinically manifests as fever, weight loss, swelling, hepatosplenomegaly, paleness, and edema. In this study, we discuss a case of a 1-year-old child diagnosed with refractory visceral leishmaniasis after being treated with liposomal amphotericin B in two distinct occasions. Considering the persistent clinical features and weak response to conventional treatment, a combination therapy with liposomal amphotericin B (ambisome), n-methylglucamine antimoniate (glucantime), and pentamidine isethionate was initiated, and response to treatment was good.


Subject(s)
Humans , Male , Infant , Organometallic Compounds/administration & dosage , Pentamidine/administration & dosage , Amphotericin B/administration & dosage , Leishmaniasis, Visceral/drug therapy , Meglumine/administration & dosage , Antiprotozoal Agents/administration & dosage , Drug Therapy, Combination , Meglumine Antimoniate
5.
Mem. Inst. Oswaldo Cruz ; 113(2): 71-79, Feb. 2018. tab, graf
Article in English | LILACS | ID: biblio-894896

ABSTRACT

BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed. FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result. CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.


Subject(s)
Humans , Injections, Intralesional/adverse effects , Leishmaniasis, Cutaneous/drug therapy , Meglumine , Antiprotozoal Agents/administration & dosage , Clinical Protocols/standards , Reproducibility of Results
6.
Brasília; CONITEC; jan. 2018. ilus, tab.
Non-conventional in Portuguese | LILACS, BRISA | ID: biblio-905632

ABSTRACT

CONTEXTO: A polineuropatia amiloidótica familiar relacionada à transtirretina (PAF-TTR) é uma doença genética neurodegenerativa progressiva altamente incapacitante, irreversível e fatal. As manifestações clínicas são variadas, mas a principal disfunção é uma polineuropatia sensório-motora e autonômica progressiva e irreversível. O tratamento envolve medidas para aliviar sintomas e, em casos selecionados, o transplante hepático. No Brasil, estima-se que existam 4.800 pacientes com esta condição. TECNOLOGIA: Tafamidis meglumina (Vyndaqel®). INDICAÇÃO: Tratamento da amiloidose associada à transtirretina em pacientes adultos com polineuropatia sintomática em estágio inicial e não submetidos a transplante hepático. PERGUNTA: O uso de tafamidis é eficaz, seguro e custo-efetivo no tratamento da polineuropatia amiloidótica familiar relacionada à transtirretina em pacientes com estágio inicial da doença? EVIDÊNCIAS CIENTÍFICAS: O demandante apresentou sete artigos sobre o medicamento e uma busca complementar para este relatório identificou mais um. De todos os estudos selecionados, apenas um foi ensaio clínico randomizado, controlado por placebo, duplo-cego, sem limitações metodológicas importantes. Entretanto, houve perda de mais de 20% da amostra, com impactos no poder estatístico. Análise por intenção de tratar não demonstrou benefício em escalas de sintomas neurológicos e qualidade de vida. Análise por protocolo e de desfechos secundários, houve benefício com o uso do tafamidis (proporção de pacientes sem progressão neurológica definida pela NIS-LL de 60,0% para intervenção e 38,1% para placebo, p = 0,041; diferença de média no escore de qualidade de vida TQOL foi de 0,1 pontos no grupo intervenção e de 8,9 no grupo placebo, p = 0,045). Demais artigos não foram considerados. AVALIAÇÃO ECONÔMICA: Custo-utilidade cujo comparador foi ausência de tratamento. O uso de tafamidis resultou em ganhos em qualidade de vida (QALY de 6,48 para 9,01, incremento de 2,54) e em anos de vida (de 10,05 para 13,28, incremento de 3,24), com uma razão de custoutilidade incremental de R$ 974.617/QALY e de R$ 763.609/ano de vida salvo. Modelo apresentado possui crítica em sua validade interna, como ausência de descrição clara dos parâmetros utilizados para população em estudo e dos detalhes da análise de microssimulação; ausência de descrição sobre avaliação de incerteza estocástica (variabilidade); pressupostos utilizados para determinação de eficácia do medicamento e progressão da doença (afetando qualidade de vida e sobrevida) e falta de dados para determinar a incerteza paramétrica do modelo (validade externa limitada). AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: Necessidade de R$ 18,9 milhões no primeiro ano após a incorporação e de R$ 397,5 milhões em cinco anos. Estimativa com validade questionada. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram identificados 4 medicamentos em desenvolvimento clínico para o tratamento da PAF-TTR (fase 2 ou 3): diflunial (Dolobid®), tolcapona (Tasmar®), Oligonucleotídeo fosfotiorato específico da transtirretina (Inotersen®; ISIS TTR Rx; ISIS-GSK1 Rx; IONIS-TTRRx) e Oligoleucleotídeo de siRNA de cadeia dupla sintético dirigido contra mRNA de transtirretina (Patisiran®; ALN-TTR02). CONSIDERAÇÕES: Baixa confiança na evidência do uso do tafamidis na PAF-TTR, baseada em análise secundária de um único ensaio clínico com desfecho que não é crítico para a tomada de decisão clínica. Eficácia comparativa com outras opções terapêuticas não foi avaliada. Análise econômica com validade questionável. Impacto orçamentário com custo significativo. RECOMENDAÇÃO PRELIMINAR: O Plenário, em sua 57ª reunião ordinária (05/07/2017), recomendou a incorporação no SUS do tafamidis meglumina para tratamento da amiloidose associada à transtirretina em pacientes adultos com polineuropatia sintomática em estágio inicial e não submetidos a transplante hepático. CONSULTA PÚBLICA: Foram recebidas 70 contribuições técnico-científicas e 764 sobre experiência ou opinião. Na 61ª reunião ordinária, após apreciação das contribuições, o plenário da CONITEC considerou contundente a necessidade de retomar a análise do tema incluindo as evidências apresentadas pela contribuição contrária. Na 62ª reunião ordinária, após apreciação das evidências trazidas pela contribuição contrária, o plenário entendeu que não houve nova informação, mantendo recomendação inicial. RECOMENDAÇÃO FINAL: Os membros da CONITEC presentes na 62ª reunião ordinária, no dia 07 de dezembro de 2017, deliberaram, por unanimidade, por recomendar a incorporação no SUS do tafamidis meglumina para tratamento da amiloidose associada à transtirretina em pacientes adultos com polineuropatia amiloidótica familiar sintomática em estágio inicial e não submetidos a transplante hepático, mediante negociação de preço e Protocolo Clínico e Diretrizes Terapêuticas do Ministério da Saúde. Foi assinado o Registro de Deliberação nº 320/2017. A recomendação será encaminhada para decisão do Secretário da SCTIE. DECISÃO: Incorporar o tafamidis meglumina para pacientes adultos com polineuropatia sintomática em estágio inicial e não submetidos a transplante hepático, mediante negociação de preço e Protocolo Clínico e Diretrizes Terapêuticas do Ministério da Saúde, no âmbito do Sistema Único de Saúde ­ SUS. A decisão foi dada pela Portaria SCTIE-MS nº 02 publicada no Diário Oficial da União (DOU) nº 13, de 18 de janeiro de 2018, pág. 56.(AU)


Subject(s)
Humans , Amyloid Neuropathies, Familial/drug therapy , Meglumine/analogs & derivatives , Prealbumin/genetics , Brazil , Cost-Benefit Analysis/economics , Technology Assessment, Biomedical , Unified Health System
7.
Article in English | WPRIM | ID: wpr-773604

ABSTRACT

Analysis errors can occur in the desorbing process of ginkgo diterpene lactone meglumine injection (GDMI) by a conventional analysis method, due to several factors, such as easily crystallized samples, solvent volatility, time-consuming sample pre-processing, fixed method, and offline analysis. Based on risk management, near-infrared (NIR) and mid-infrared (MIR) spectroscopy techniques were introduced to solve the above problems with the advantage of timely analysis and non-destructive nature towards samples. The objective of the present study was to identify the feasibility of using NIR or MIR spectroscopy techniques to increase the analysis accuracy of samples from the desorbing process of GDMI. Quantitative models of NIR and MIR were established based on partial least square method and the performances were calculated. Compared to NIR model, MIR model showed greater accuracy and applicability for the analysis of the GDMI desorbing solutions. The relative errors of the concentrations of Ginkgolide A (GA) and Ginkgolide B (GB) were 2.40% and 2.89%, respectively, which were less than 5.00%. The research demonstrated the potential of the MIR spectroscopy technique for the rapid and non-destructive quantitative analysis of the concentrations of GA and GB.


Subject(s)
Chemistry, Pharmaceutical , Methods , Reference Standards , Drug Compounding , Reference Standards , Drugs, Chinese Herbal , Chemistry , Reference Standards , Ginkgolides , Chemistry , Reference Standards , Injections , Lactones , Least-Squares Analysis , Meglumine , Chemistry , Reference Standards , Reproducibility of Results , Risk Management , Spectrophotometry, Infrared , Reference Standards
8.
Article in English | WPRIM | ID: wpr-812393

ABSTRACT

Analysis errors can occur in the desorbing process of ginkgo diterpene lactone meglumine injection (GDMI) by a conventional analysis method, due to several factors, such as easily crystallized samples, solvent volatility, time-consuming sample pre-processing, fixed method, and offline analysis. Based on risk management, near-infrared (NIR) and mid-infrared (MIR) spectroscopy techniques were introduced to solve the above problems with the advantage of timely analysis and non-destructive nature towards samples. The objective of the present study was to identify the feasibility of using NIR or MIR spectroscopy techniques to increase the analysis accuracy of samples from the desorbing process of GDMI. Quantitative models of NIR and MIR were established based on partial least square method and the performances were calculated. Compared to NIR model, MIR model showed greater accuracy and applicability for the analysis of the GDMI desorbing solutions. The relative errors of the concentrations of Ginkgolide A (GA) and Ginkgolide B (GB) were 2.40% and 2.89%, respectively, which were less than 5.00%. The research demonstrated the potential of the MIR spectroscopy technique for the rapid and non-destructive quantitative analysis of the concentrations of GA and GB.


Subject(s)
Chemistry, Pharmaceutical , Methods , Reference Standards , Drug Compounding , Reference Standards , Drugs, Chinese Herbal , Chemistry , Reference Standards , Ginkgolides , Chemistry , Reference Standards , Injections , Lactones , Least-Squares Analysis , Meglumine , Chemistry , Reference Standards , Reproducibility of Results , Risk Management , Spectrophotometry, Infrared , Reference Standards
9.
Article in English | WPRIM | ID: wpr-715455

ABSTRACT

OBJECTIVE: To intra-individually compare 3T magnetic resonance (MR) images obtained with one dose gadoterate meglumine to 1.5T MR using conventional double dose for assessment of chronic myocardial infarction. MATERIALS AND METHODS: Sixteen patients diagnosed with chronic myocardial infarctions were examined on single-dose 3T MR within two weeks after undergoing double-dose 1.5T MR. Representative short-axis images were acquired at three points after administration of gadoterate meglumine. Contrast-to-noise ratios between infarcted and normal myocardium (CNRinfarct-normal) and between infarct and left ventricular cavity (CNRinfarct-LVC) were calculated and compared intra-individually at each temporal scan. Additionally, two independent readers assessed relative infarct size semi-automatically and inter-observer reproducibility was evaluated using intraclass correlation coefficient. RESULTS: While higher CNRinfarct-normal was revealed at single-dose 3T at only 10 minutes scan (p = 0.047), the CNRinfarct-LVC was higher at single-dose 3T MR at each temporal scan (all, p 0.05). However, inter-observer reproducibility was higher at single-dose 3T MR (all, p < 0.05). CONCLUSION: Single-dose 3T MR is as effective as double-dose 1.5T MR for delineation of infarcted myocardium while being superior in detection of infarcted myocardium from the blood cavity, and provides better reproducibility for infarct size quantification.


Subject(s)
Gadolinium , Humans , Magnetic Resonance Imaging , Meglumine , Myocardial Infarction , Myocardium
10.
Rio de Janeiro; s.n; 2018. xiv, 142 p. ilus.
Thesis in Portuguese | LILACS | ID: biblio-1047177

ABSTRACT

Esta tese porpõe uma nova abordagem para o tratamento da leishmaniose tegumentar com o antimoniato de N-metilglucamina (antimoniato de meglumina - AM) associado a dois derivados oxiranos. O estudo foi conduzido em modelo murino de infecção in vitro e in vivo por Leishmania (Leishmania) amazonensis. Na primeira etapa do estudo foram descritas alterações histológicas causadas por epoxi-α-lapachona, epoximetil-lausona e AM em camundongos BALB/c não infectados, bem como a predição de algumas de suas propriedades farmacocinéticas. Os resultados indicaram que tanto os oxiranos quanto o antimoniato de meglumina induzem alterações histopatológicas nos órgãos analisados. O epoximetil-lausona foi o mais tóxico para o tecido pulmonar, enquanto os danos mais graves no coração foram causados pelo epoxi-α-lapachona. O AM causou alterações leves a moderadas nos tecidos cardíacos e pulmonares, mas sem qualquer efeito detectado nos tecidos cerebrais. Na segunda etapa foi necessário avaliar a eficácia do epoximetil-lausona sobre a infecção de macrófagos e camundongos BALB/c infectados por L.(L.) amazonensis. Em amastigotas intracelulares, o IC50 do epoximetil-lausona foi ligeiramente superior ao do AM (7,41 ± 0,2 e 4,43 ± 0,25 µM, respectivamente), sendo o efeito mais evidente após 48 horas de exposição (18 vezes e 7,4 vezes inferiores, respectivamente).


Os promastigotas também foram afetados pelo composto, porém o IC50 foi seis vezes maior (45,45 ± 5,0µM), indicando sua especificidade sobre os amastigotas intracelulares. A análise de citotoxicidade revelou que o epoximetil-lausona tem um efeito menor (1,7 ×) comparado ao AM (40,05 ± 3,0 e 24,14 ± 2,6 µM). O tratamento com três doses do epoximetil-lausona reduziu a lesão da pata dos animais infectados em 27 %, enquanto a redução obtida com o AM chegou a 31% nas doses baixa e intermediária, e 64% com a dose mais alta, comparado ao grupo controle. Alterações ultraestruturais detectadas nos amastigotas da lesão constataram comprometimento da integridade dos parasitos. Na etapa final deste estudo foi demonstrado o efeito do tratamento com o AM associado aos oxiranos epoxi-α-lapachona e epoximetil-lausona sobre a infecção experimental in vitro e in vivo. Os compostos foram testados individualmente e em combinações, seguindo as razões: 3:1; 1:1 e 1:3 (p/v) sobre macrófagos infectados. Todos os compostos, assim como suas combinações mostraram índices endocíticos muito inferiores ao grupo controle, sendo as maiores reduções obtidas nas razões de 3:1. O tratamento de camundongos BALB/c com os compostos individualmente e combinados nas mesmas razões levou a reduções significativas das lesões. O melhor efeito das combinações foi observado nas razões de 3:1. Os resultados indicaram que a associação do AM com os oxiranos produz um incremento no efeito leishmanicida, e pode ser considerada uma nova abordagem para o tratamento da leishmaniose cutânea. (AU)


Subject(s)
Humans , Leishmaniasis, Cutaneous , Drug Therapy, Combination , Ethylene Oxide , Meglumine , Antimony
11.
Mem. Inst. Oswaldo Cruz ; 112(12): 838-843, Dec. 2017. tab, graf
Article in English | LILACS | ID: biblio-894858

ABSTRACT

BACKGROUND American tegumentary leishmaniasis (ATL) is a non-lethal parasitic disease that presents with cutaneous (CL) and mucosal (ML) clinical forms. ATL treatment aims at healing the lesions and preventing the development of the late mucosal form. Systemic meglumine antimoniate (MA) therapy with 10-20 mg Sb5+/kg/day is the first choice of treatment. However, alternative therapies using 5 mg Sb5+/kg/day or intralesional (IL) MA are the usual regimens at the National Institute of Infectious Diseases (NIID), Rio de Janeiro, Brazil. OBJECTIVES To evaluate lethality and the incidence of relapse and development of late ML in CL patients treated at NIID from 2001 until 2013. METHODS Data were recovered from records of all ATL patients diagnosed during that period. FINDINGS Out of 777 patients, 753 were treated with MA (96.9%). Of those, 89.1% received alternative therapy of 9.9% IL and 79.2% systemic 5 mg Sb5+/kg/day. Some patients required 1-3 additional courses of treatment, thus making a total of 997 courses; 85.2% of them were subjected to alternative therapies. Lethality was 0.1%, relapse incidence 5.8%, and late ML incidence 0.25%. As a final outcome for the 777 patients, 95.9% were cured, 0.1% died and 4.0% were not able to follow-up. MAIN CONCLUSIONS Alternative MA schedules resulted in low lethality without increase of relapse or late ML incidence.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Leishmaniasis, Cutaneous/mortality , Leishmaniasis, Cutaneous/drug therapy , Meglumine/administration & dosage , Organometallic Compounds/administration & dosage , Injections, Intralesional/methods , Treatment Outcome
12.
Rev. Soc. Bras. Med. Trop ; 50(4): 478-482, July-Aug. 2017. tab
Article in English | LILACS | ID: biblio-896990

ABSTRACT

Abstract INTRODUCTION: The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. METHODS: The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. RESULTS: The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. CONCLUSIONS: This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained.


Subject(s)
Humans , Health Care Costs/statistics & numerical data , Leishmaniasis, Visceral/drug therapy , Antiprotozoal Agents/economics , Organometallic Compounds/economics , Organometallic Compounds/therapeutic use , Brazil , Amphotericin B/economics , Amphotericin B/therapeutic use , Clinical Protocols , Deoxycholic Acid/economics , Deoxycholic Acid/therapeutic use , Drug Combinations , Meglumine Antimoniate , Leishmaniasis, Visceral/economics , Meglumine/economics , Meglumine/therapeutic use , Antiprotozoal Agents/therapeutic use
13.
Rev. Soc. Bras. Med. Trop ; 50(2): 269-272, Mar.-Apr. 2017. tab, graf
Article in English | LILACS | ID: biblio-842839

ABSTRACT

Abstract Although New World cutaneous leishmaniasis is not itself a life-threatening disease, its treatment with systemic antimonials can cause toxicity that can be dangerous to some patients. Intralesional meglumine antimoniate provides a viable, less toxic alternative. Herein, we describe an alternative treatment with subcutaneous intralesional injections of meglumine antimoniate into large periarticular lesions of three patients with cutaneous leishmaniasis and comorbidities. This treatment was safe, successful, and well tolerated. This case series suggests that intralesional meglumine antimoniate is an effective therapy for cutaneous leishmaniasis, even with periarticular lesions. This hypothesis should be tested in controlled clinical trials.


Subject(s)
Humans , Male , Female , Aged , Organometallic Compounds/administration & dosage , Leishmaniasis, Cutaneous/drug therapy , Meglumine/administration & dosage , Antiprotozoal Agents/administration & dosage , Time Factors , Severity of Illness Index , Injections, Intralesional , Treatment Outcome , Meglumine , Middle Aged
14.
An. bras. dermatol ; 92(2): 268-269, Mar.-Apr. 2017. graf
Article in English | LILACS | ID: biblio-838041

ABSTRACT

Abstract: Periungual and paronychia-like skin lesions can mimic various diseases, setting up a diagnostic challenge that invariably requires correlation with complementary tests. We report a case of an ulcerated tumor of the nailfold diagnosed as leishmaniasis. Although paronychia-like cutaneous leishmaniasis is a rare variant, its epidemiological relevance in Brazil should prompt dermatologists to include it as a plausible diagnosis thus leading to correct work up and treatment.


Subject(s)
Humans , Male , Young Adult , Leishmaniasis, Cutaneous/pathology , Brazil , Leishmaniasis, Cutaneous/drug therapy , Meglumine/analogs & derivatives , Meglumine/therapeutic use , Antimony/therapeutic use , Antineoplastic Agents/therapeutic use
16.
Rev. Soc. Bras. Med. Trop ; 50(1): 67-74, Jan.-Feb. 2017. tab, graf
Article in English | LILACS | ID: biblio-842815

ABSTRACT

ABSTRACT INTRODUCTION Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. RESULTS In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. CONCLUSIONS N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL.


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Organometallic Compounds/therapeutic use , Amphotericin B/therapeutic use , Deoxycholic Acid/therapeutic use , Leishmaniasis, Visceral/drug therapy , Meglumine/therapeutic use , Antiprotozoal Agents/therapeutic use , Organometallic Compounds/adverse effects , Pilot Projects , Amphotericin B/adverse effects , Treatment Outcome , Deoxycholic Acid/adverse effects , Drug Combinations , Meglumine Antimoniate , Meglumine/adverse effects , Antiprotozoal Agents/adverse effects
17.
MedUNAB ; 20(2): 165-173, 2017.
Article in Spanish | LILACS | ID: biblio-964001

ABSTRACT

Introducción: La leishmaniasis es una de las enfermedades reemergentes de mayor importancia en salud pública, causa grandes costos y puede generar discapacidad. Objetivo: Evaluar el costo y la efectividad obtenida con el tratamiento de primera línea para leishmaniasis cutánea en los municipios de Otanche y Puerto Boyacá, Boyacá durante 2013-2014. Metodología: Estudio longitudinal retrospectivo de tipo descriptivo, se tomaron 86 pacientes que cumplían con los criterios de inclusión; se realizó un análisis de las características sociodemográficas, la efectividad del manejo de la patología con antimoniato de meglumina, los efectos adversos y los costos institucionales de los pacientes. Resultados: Se observó que los más afectados fueron los pacientes de 0 a 14 años, de género masculino (57%) y procedentes de zonas rurales. Las zonas corporales más comprometidas fueron los miembros superiores. El municipio de Otanche atendió el 86% de los pacientes reportados y en promedio el costo por paciente fue de 258,664 pesos. El municipio de Puerto Boyacá reportó el 14% de los casos y el costo promedio por paciente fue de 290,307 pesos; con una diferencia en costos por paciente de 31,643 entre los municipios. Conclusiones: Cuando la administración del medicamento se hace siguiendo las dosis recomendadas, la efectividad se encuentra alrededor del 90%. Los pacientes que recibieron dosis superiores a la indicada obtuvieron un mayor porcentaje de curación, sin embargo, no es necesario sobredosificar a los pacientes y elevar los costos para mejorar la curación. Los pacientes que recibieron dosis subterapéuticas generaron más costos debido a que es necesario brindarles servicios médicos de mayor complejidad. [Abril-Sánchez LR, Pachón-Abril E, Picón-Jaimes YA. Pacientes con leishmaniasis cutánea tratados con antimoniato de meglumina en 2 municipios de Boyacá, Colombia 2013-2014. MedUNAB 2017; 20(2): 165-173].


Introduction: Leishmaniasis is one of the most important reemerging diseases in public health and causes great costs and may generate a disability. Objective: To evaluate the cost and effectiveness obtained with the first line treatment for tegumentary leishmaniasis in the municipalities of Otanche and Puerto Boyaca, Boyaca during 2013 and 2014. Methodology: This is a retrospective longitudinal study of descriptive type. 86 patients who fulfilled the inclusion criteria were taken into account. Ananalys is of the sociodemographic characteristics, the effectiveness of the management of the pathology with meglumine antimoniate, the adverse effects and the institutional costs of the patients was carried out. Results: It was observed that the most affected with this disease were male patients (57%) from 0 to 14 years old and from rural areas. The most compromised body areas were the superior limbs. The municipality of Otanche treated 86% of the patients who were reported, and on average the cost per patient was $258,664 (Colombian pesos). The municipality of Puerto Boyacá reported 14% of the cases and the average cost per patient was 290,307 pesos; the difference in cost among the municipalities per patient was 31,643 pesos. Conclusions: The effectiveness rate when the administration of the drug is done following the recommended doses is around 90%. Patients who were treated with a higher dose than the indicated one obtained a higher percentage of curing; however, it is not necessary to dose patients and raise costs to improve curing. Patients who were treated with subtherapeutic doses generated more costs due to the need to provide them with more complex medical services. [Abril-Sánchez LR, Pachón-Abril E, Picón- Jaimes YA. Patients with Tegumentary Leishmaniasis Treated with Meglumine Antimoniate in 2 Municipalities of Boyaca, Colombia from 2013 to 2014. MedUNAB 2017; 20(2): 165-173].


Introdução: A leishmaniose é uma das doenças de maior importância que ressurge em saúde pública, causa grandes custos e pode gerar incapacidade. Objetivo: Avaliar o custo e a eficácia obtidos com o tratamento de primeira linha para leishmaniose cutânea nos municípios de Otanche e Puerto Boyacá, Boyacá, durante 2013-2014. Metodologia: Estudo longitudinal retrospectivo de tipo descritivo, foram atendidos 86 pacientes que preencheram aos critérios de inclusão; para o estudo se fez uma análise das características socio demográficas, da efetividade do manejo da patologia com antimonato de meglumina, dos efeitos adversos e os custos institucionais dos pacientes. Resultados: Observou-se que os mais afetados foram os pacientes de 0 a 14 anos de idade, masculino (57%) e os das áreas rurais. As áreas do corpo mais comprometidas foram os membros superiores. O município de Otanche tratou 86% dos pacientes relatados e, em média, o custo por paciente foi de 258.664 pesos. O município de Puerto Boyacá reportou 14% dos casos e o custo médio por paciente foi de 290.307 pesos; com uma diferença de custos por paciente de 31.643 entre os municípios. Conclusões: Quando a administração da medicação é feita seguindo as doses recomendadas, a eficácia aproximada é de 90%. O paciente que receberam maior dosagem que a indicada obtiveram maior porcentagem de cura, no entanto, não é necessário administrar maiores quantidades e aumentar os custos para melhorar a cicatrização. Os pacientes que receberam doses subterapêuticas geraram mais custos devido à necessidade de fornecer serviços médicos muito mais complexos. [Abril-Sánchez LR, Pachón-Abril E, Picón-Jaimes YA. Pacientes com leishmaniose cutânea tratados com antimonato de meglumina em 2 municípios de Boyacá, Colômbia 2013-2014. MedUNAB 2017; 20(2): 165-173].


Subject(s)
Leishmaniasis, Cutaneous , Cost Efficiency Analysis , Drug Costs , Cost of Illness , Neglected Diseases , Meglumine
18.
Rev. Fed. Argent. Soc. Otorrinolaringol ; 24(2): 58-62, 2017. ilus, tab
Article in Spanish | LILACS | ID: biblio-908139

ABSTRACT

La leishmaniasis es una zoonosis parasitaria causada por protozoos. Puede afectar la piel y las mucosas o presentarse como una enfermedad visceral. La variedad mucocutánea conduce a la destrucción parcial o completa de las membranas mucosas de la nariz, las fauces y la faringe. Aproximadamente un 90% de los casos con afectación mucocutánea se producen en Brasil, Bolivia y Perú. En nuestro país afecta en forma endémica a las provincias del norte desde principios del siglo XX. Se relata el caso de un paciente de 53 años con odinodisfagia de aproximadamente 6 meses de evolución, asociado a formaciones granulomatosas medio- faciales, en el que se diagnosticó leishmaniasis cutaneomucosa mediante el rescate de amastigotes en muestras tomadas de lesiones de paladar blando para estudio anatomopatológico con tinción de Giemsa. Se realizó tratamiento con meglumina antimoniato con buena evolución clínica a partir de los quince días de instaurado el mismo.


Leishmaniasis is a parasitic zoonosis caused by protozoa. It can affect skin, mucous membranes or presented as visceral disease. Mucocutaneous variety leads to partial or complete destruction of the mucous membranes of the nose, mouth and pharynx. Approximately, 90% of cases with mucocutaneous involvement occurs in Brazil, Bolivia and Peru. In our country it affects endemic to the northern provinces since the beginning of the century. The case of a 53-year-old patient with odinodisphagia of approximately 6 months of evolution, associated with mid-facial granulomatous formations in which cutaneomucous leishmaniasis was diagnosed by rescue of amastigotes in samples taken from lesions of soft palate for anatomopathological study with Staining of Giemsa. Treatment with meglumina antimonia was carried out with good clinical evolution from the fifteen days of the same establishment.


A leishmaniose é uma zoonose parasitária causada por protozoários. Ele pode afectar a pele e membranas mucosas ou presente como doença visceral. variedade mucocutânea conduz à destruição parcial ou completa das membranas mucosas do nariz, boca e faringe. Aproximadamente 90% dos casos com envolvimento mucocutânea ocorrem no Brasil, Bolívia e Peru. Em nosso país que afeta endêmica para as províncias do norte, desde o início do século XX. O caso de um odinodisfagia 53 anos, aproximadamente, 6 meses evolução associada com formações granulomatosas mediofaciais em que a leishmaniose mucocutânea foi diagnosticada por resgatar amastigotas em amostras tomadas a partir de lesões do palato mole para estudo histopatológico contou Giemsa. O tratamento foi realizado com antimoniato de meglumina com boa evolução clínica a partir de quinze dias introduzidas ele.


Subject(s)
Male , Humans , Middle Aged , Leishmaniasis, Mucocutaneous/diagnosis , Leishmaniasis, Mucocutaneous/drug therapy , Antimony/therapeutic use , Granulomatosis, Orofacial/diagnosis , Granulomatosis, Orofacial/therapy , Meglumine/therapeutic use
19.
Article in English | LILACS | ID: biblio-842780

ABSTRACT

ABSTRACT The authors report a case of disseminated cutaneous leishmaniasis caused by Leishmania (Viannia) braziliensis, in a 55 years old patient with 1,119 lesions distributed throughout the body. The patient resides in Sabáudia municipality, North of Paraná State, Southern Brazil, where there was no previous report of this form of leishmaniasis. Treatment with meglumine antimoniate was successful, although the diagnosis was made only five months later.


Subject(s)
Humans , Male , Middle Aged , Leishmania braziliensis , Leishmaniasis, Cutaneous/diagnosis , Antiprotozoal Agents/therapeutic use , Brazil , Leishmaniasis, Cutaneous/drug therapy , Meglumine/therapeutic use , Organometallic Compounds/therapeutic use
20.
Rev. Soc. Bras. Med. Trop ; 49(6): 774-776, Dec. 2016. graf
Article in English | LILACS | ID: biblio-1041383

ABSTRACT

Abstract INTRODUCTION: Intralesional treatment for cutaneous leishmaniasis has been applied for over 30 years at the Oswaldo Cruz Foundation, Rio de Janeiro, with good therapeutic results and without relevant systemic toxicity. METHODS Meglumine antimoniate was injected subcutaneously, using a long medium-caliber needle (for example, 30mm × 0.8mm); patients received 1-3 injections, with 15-day intervals. RESULTS The technique is described in detail sufficient to enable replication. CONCLUSIONS: The treatment of cutaneous leishmaniasis with intralesional meglumine antimoniate is a simple, effective, and safe technique, which may be used in basic healthcare settings.


Subject(s)
Humans , Organometallic Compounds/administration & dosage , Leishmaniasis, Cutaneous/drug therapy , Meglumine/administration & dosage , Antiprotozoal Agents/administration & dosage , Injections, Intralesional/standards , Meglumine Antimoniate
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