RESUMO
BACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).
Assuntos
Antiprotozoários/administração & dosagem , Leishmaniose Cutânea/tratamento farmacológico , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem , Adolescente , Adulto , Idoso , Antiprotozoários/efeitos adversos , Brasil , Feminino , Humanos , Injeções Intralesionais , Leishmaniose Cutânea/fisiopatologia , Masculino , Meglumina/efeitos adversos , Antimoniato de Meglumina , Pessoa de Meia-Idade , Compostos Organometálicos/efeitos adversos , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Antiprotozoários/administração & dosagem , Protocolos Clínicos/normas , Injeções Intralesionais , Leishmaniose Cutânea/tratamento farmacológico , Meglumina/administração & dosagem , Compostos Organometálicos/administração & dosagem , Humanos , Injeções Intralesionais/efeitos adversos , Injeções Intralesionais/métodos , Antimoniato de Meglumina , Reprodutibilidade dos TestesRESUMO
INTRODUCTION: Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML. METHODS: This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015. RESULTS: The median age of patients was 63 years, and the median duration of the disease was 24 months. Seventeen patients received Sbv, while nine patients were treated with liposomal amphotericin B (AmB), and another nine patients were treated with fluconazole. Patients treated with AmB received a total median accumulated dose of 2550mg. The mean duration of azole use was 120 days, and the daily dose ranged from 450 to 900mg. At the three-month follow-up visit, the cure rate was 35%, 67%, and 22% for Sbv, AmB, and azole groups, respectively. At the six-month follow-up visit, the cure rates for Sbv, AmB, and azole groups were 71%, 78%, and 33%, respectively. CONCLUSIONS: There is a scarcity of effective ML treatment alternatives, and based on our observations, fluconazole is not a valid treatment option.
Assuntos
Anfotericina B/uso terapêutico , Antimônio/uso terapêutico , Antiprotozoários/uso terapêutico , Fluconazol/uso terapêutico , Leishmaniose Mucocutânea/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).
Assuntos
Humanos , Compostos Organometálicos/administração & dosagem , Leishmaniose Cutânea/tratamento farmacológico , /uso terapêutico , Injeções Intralesionais , Antiprotozoários/efeitos adversosRESUMO
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.
Assuntos
Humanos , Injeções Intralesionais/efeitos adversos , Leishmaniose Cutânea/tratamento farmacológico , Meglumina , Antiprotozoários/administração & dosagem , Protocolos Clínicos/normas , Reprodutibilidade dos TestesRESUMO
Abstract INTRODUCTION Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML. METHODS This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015. RESULTS The median age of patients was 63 years, and the median duration of the disease was 24 months. Seventeen patients received Sbv, while nine patients were treated with liposomal amphotericin B (AmB), and another nine patients were treated with fluconazole. Patients treated with AmB received a total median accumulated dose of 2550mg. The mean duration of azole use was 120 days, and the daily dose ranged from 450 to 900mg. At the three-month follow-up visit, the cure rate was 35%, 67%, and 22% for Sbv, AmB, and azole groups, respectively. At the six-month follow-up visit, the cure rates for Sbv, AmB, and azole groups were 71%, 78%, and 33%, respectively. CONCLUSIONS There is a scarcity of effective ML treatment alternatives, and based on our observations, fluconazole is not a valid treatment option.
Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso , Idoso de 80 Anos ou mais , Leishmaniose Mucocutânea/tratamento farmacológico , Fluconazol/uso terapêutico , Anfotericina B/uso terapêutico , Antimônio/uso terapêutico , Antiprotozoários/uso terapêutico , Índice de Gravidade de Doença , Resultado do Tratamento , Pessoa de Meia-IdadeRESUMO
A cetoacidose diabética (CAD) constitui um distúrbio endócrino caracterizado por acidose metabólica, cetose (pH arterial < 7,3 ou venoso < 7,25 e/ou HCO3- < 15mEq/L), hiperglicemia (> 200 mg/dL) e graus variados de desidratação em portadores de diabetes mellitus (DM). É motivo habitual de admissão em emergência ou Unidade de Terapia Intensiva pediátrica. É a causa mais frequente de morte em crianças e adolescentes com DM tipo 1. Resulta da deficiência de insulina e aumento dos níveis circulantes de hormônios contrarreguladores. A abordagem da CAD em pediatria não deve prescindir das particularidades existentes nessa população quando comparada à de adultos. Os principais fatores desencadeantes são as infecções e a omissão de insulina. A terapêutica na emergência visa a: corrigir a desidratação e os distúrbios eletrolíticos; reverter a cetose e a acidose; restabelecer a glicemia normal; evitar complicações; identificar e tratar a causa precipitante; e prevenir novos episódios. Este artigo atualiza sobre a CAD, tratando, em especial, sobre seus aspectos da fisiopatologia, diagnóstico, classificação, manifestações clínicas, abordagem terapêutica, complicações e profilaxia.
The diabetic ketoacidosis (DK) is an endocrine disorder characterized by metabolic acidosis and ketosis (arterial pH < 7,3 or venous pH < 7,25 and HCO3- < 15 mEq/L), hyperglycemia (higher than 200 mg/dL) and different degrees of dehydration in patients with Diabetes Mellitus (DM). It is a usual reason for admission in emergency services or pediatric ICU, as well as the most frequent cause of death in children and teenagers with type 1 DM. This pathology results from lack of insulin and elevation of counter-regulatory hormone levels. The DKs approach in pediatric patients must consider the singular characteristics of this age group. The main trigger factors are infections and omission of insulin. The therapeutic at the emergency aims to: correct the dehydration and electrolyte disturbances, ketosis, acidosis and hyperglycemia; avoid complications; identify and treat the trigger factors; and prevent new events. The aim of this review is to present updates on DK, dealing in particular with aspects of physiopathology, diagnosis, classification, clinical findings, therapeutic approach, complications and prophylaxis.
Assuntos
Humanos , Criança , Adolescente , Cetoacidose Diabética/diagnóstico , Cetoacidose Diabética/fisiopatologia , Diabetes Mellitus , Fatores de Risco , Cetoacidose Diabética/complicações , Cetoacidose Diabética/terapiaRESUMO
A cetoacidose diabética é a principal complicação aguda do Diabetes Mellitus (DM) e responsável por importante causa de morte, principalmente devido ao desenvolvimento de edema cerebral. É discutida neste trabalho a evolução clínica de um jovem de 10 anos de idade, diabético tipo I, admitido no Pronto Socorro do Hospital das Clínicas da UFMG com sintomatologia compatível com cetoacidose diabética, com melhora inicial dos padrões laboratoriais não acompanhada de melhora clínica.
The diabetic ketoacidosis is the main Diabetes Mellitus (DM) acute complication and responsible for an important cause of death, mainly due to the development of cerebral edema. This article reports a case of a 10 year old boy, previously diagnosed with DM I, admitted to the pediatric emergency of Hospital das Clínicas da UFMG with signs and symptoms compatible with diabetic ketoacidosis. Despite the initial improvement of laboratorial findings, there was not a significant clinical recovery. This scenery required new arrangements, like the use of sodium bicarbonate, which is not recommended by current consensus guidelines, considering that the patients venous pH was higher than 6,9.