Fatores de risco para a ocorrência das úlceras plantares decorrente da hanseníase de acordo com a árvore de decisão / Risk factors for plantar ulcers from leprosy according to the decision tree

Objective:To identify the risk factors for plantar ulcers in patients with leprosy.Methods:This is an epidemiological, observational, cross-sectional and analytical study. The population was composed of leprosy cases reported from 2005 to 2016. Pearson's Chi-square test or Fisher's exact test andMann-Whitney test were used for the univariate analysis, with a statistical significance of 5% (p < 0.05). In the multivariate analysis, a decision tree was elaborated using the CHAID algorithm. Results:Clinical form, degree of physical incapacity at discharge, affected nerve and the lack of insoles or adapted footwear before appearing to ulcer are risk factors for plantar ulcer. Conclusion:the need for an early diagnosis of leprosy was highlighted, as well as the efficient association of non-drug interventions with disability prevention techniques and the use of accommodating insoles and/or special shoes.

Objetivo:Identificar os fatores de risco para a ocorrência das úlceras plantares em pacientes com hanseníase. Métodos:Trata-se de um estudo epidemiológico, do tipo observacional, transversal e analítico. A população foi composta pelos casos de hanseníase notificados no período de 2005 a 2016. Para a análise univariada foram utilizados os testes Qui-quadrado de Pearson ou teste exato de Fisher e teste de Mann-Whitney, com significância estatística de 5% (p < 0,05). Na análise multivariada, foi elaborada árvore de decisão utilizando o algoritmo CHAID. Resultados: A forma clínica, grau de incapacidade física na alta, nervo acometido e o não uso de palmilhas ou calçado adaptado antes de surgir a úlcera são fatores de risco para a ocorrência de úlcera plantar. Conclusão:evidenciou a necessidade do diagnóstico precoce da hanseníase, como também da eficiente associação das intervenções medicamentosas e não medicamentosas por meio das técnicas de prevenção de incapacidade e uso de palmilhas acomodativas e/ou calçados especiais

Comparación de la técnica serológica ML flow y frotis cutáneas para evaluar la carga bacteriana en pacientes nuevos diagnosticados de Lepra / No disponible

Introducción: La técnica ML Flow es un ensayo inmunocromatográfico que detecta anticuerpos de tipo IgM glicolípido fenólico-I (PGL-1) M. leprae específico. Además de los frotis cutáneos teñidos mediante Ziehl-Neelsen puede ser útil en la clasificación de los pacientes de lepra para administrar el correspondiente tratamiento farmacológico. Objetivo: Este estudio revisa la relación entre los niveles de anticuerpos detectables mediante la técnica serológica semi-cuantitativa ML Flow y la carga bacteriana cuantificada mediante frotis cutáneo. Pacientes y métodos: Se obtuvieron frotis cutáneos de 135 pacientes nuevos diagnosticados de lepra en un servicio dermatológico de referencia en Brasil (registrados como índice bacteriológico – IB) y un resultado con el ML Flow (registrado cuantitativa y semi-cuantitativamente) en el momento de ser admitidos al estudio. Se calcularon la regresión logística y concordancia (índice kappa). Resultados: Los frotis cutáneos resultaron positivos en el 35.9% de los pacientes y el 57% de los pacientes eran seropositivos para el PGL-1. De entre los seropositivos, el 41.6% presentaban 5 o menos de 5 lesiones y el 65.8% presentaba la implicación de más de un nervio periférico. Los frotis resultaron positivos en sólo tres casos seronegativos (5.6%) y negativos en el 41.9% de pacientes seropositivos. Los pacientes con un IB+4 presentaban un OR de 3.3 de ser seropositivos en comparación con los de IB más bajo. Conclusiones: Hay una correlación entre el test serológico y los frotis cutáneos. Por tanto, un test ML Flow puede resultar útil para la clasificación clínica de la lepra, además de los frotis cutáneos que requieren una infraestructura de laboratorio y personal con experiencia (AU)

Introduction. The ML Flow test is an immunochromatographic assay that detects IgM antibodies against M. leprae-specific anti-phenolic glycolipid I (PGL-I). In addition to slit skin smears stained by the Ziehl-Neelsen technique, it can be helpful in the operational classification of leprosy patients for treatment purposes. Objective. This work studied the relationship between antibody levels as detected by semi-quantitative ML Flow serologic test and bacterial load as quantified by slit skin smear. Patients and methods. 135 patients with newly detected leprosy at the reference service in Sanitary Dermatology in Brazil had slit skin smears (registered as bacillary index – BI) and an ML Flow test (registered qualitatively and semi-quantitatively) performed at admission. A logistic regression and agreement measures (kappa index) were calculated. Results. Slit skin smears were positive in 35.9% of patients and 57% of patients were seropositive for PGL-1 antibodies. Among the seropositive patients, 41.6% had five or fewer skin lesions, and 65.8% had more than one peripheral nerve involved. Slit skin smears were positive in only three seronegative patients (5.6%), and negative in 41.9% of seropositive patients. Patients with a BI of 4had an OR of 3.3 for being seropositive in comparison to those with a low BI. Conclusions. There is a correlation between serologic test and slit skin smear results. Therefore, an ML Flow test may become a useful tool in the clinical classification of leprosy, besides slit skin smears, which require a proper laboratory infrastructure and experienced personnel (AU)

A comparison of ML Flow serology and slit skin smears to assess the bacterial load in newly diagnosed leprosy patients in Brazil.

INTRODUCTION: The ML Flow test is an immunochromatographic assay that detects IgM antibodies against M. leprae-specific anti-phenolic glycolipid I (PGL-I). In addition to slit skin smears stained by the Ziehl-Neelsen technique, it can be helpful in the operational classification of leprosy patients for treatment purposes. OBJECTIVE: This work studied the relationship between antibody levels as detected by semi-quantitative ML Flow serologic test and bacterial load as quantified by slit skin smear. PATIENTS AND METHODS: 135 patients with newly detected leprosy at the reference service in Sanitary Dermatology in Brazil had slit skin smears (registered as bacillary index - BI) and an ML Flow test (registered qualitatively and semi-quantitatively) performed at admission. A logistic regression and agreement measures (kappa index) were calculated. RESULTS: Slit skin smears were positive in 35.9% of patients and 57% of patients were seropositive for PGL-1 antibodies. Among the seropositive patients, 416% had five or fewer skin lesions, and 65.8% had more than one peripheral nerve involved. Slit skin smears were positive in only three seronegative patients (5.6%), and negative in 41.9% of seropositive patients. Patients with a BI of 4 + had an OR of 33 for being seropositive in comparison to those with a low BI. CONCLUSIONS: There is a correlation between serologic test and slit skin smear results. Therefore, an ML Flow test may become a useful tool in the clinical classification of leprosy, besides slit skin smears, which require a proper laboratory infrastructure and experienced personnel.

The result patterns of ML Flow and ELISA (PGL-I) serologic tests in leprosy-endemic and non-endemic areas.

ML Flow and anti-PGL-I ELISA are serological tests that detect IgM antibodies against the phenolic glycolipid I (PGL-I), specific to Mycobacterium leprae. To evaluate the outcomes of ML Flow and ELISA (PGL-I) serological tests in leprosy-endemic areas in comparison to non-endemic ones, a total of 351 volunteers from Brazil and Chile were examined, including leprosy patients, healthy controls and others affected by other infectious or non-infectious diseases that are common differential diagnoses for leprosy. The ELISA cut-off point was established using the ROC Curve method (>or= 0.157). In endemic areas, 70% of leprosy patients present positive ML Flow results and 53.3% were ELISA-positive. In non-endemic areas, ML Flow was negative in all the subjects tested and ELISA was positive in 4 volunteers. ML Flow is faster and more easily performed and, therefore, a more adequate test for use in basic, primary-level health care centers. ELISA requires trained personnel, in addition to a more complex laboratory infrastructure.

Association of the ML Flow serologic test to slit skin smear.

A descriptive, exploratory study was conducted analyzing the association of covariables in the results of the ML Flow serological test and slit skin smear. A total of 60 leprosy cases diagnosed at the state Sanitary Dermatology Referral Center were investigated. Slit skin smear samples were collected from four sites and the results were expressed by the bacillary index. ML Flow was registered in both qualitative and semi-quantitative terms. Cohen's kappa coefficient was used to study the agreement with Landis and Koch's observer criteria for interpretation. For statistical analysis, the logistic regression model and Kruskal-Wallis test were used. ML Flow showed a strong association with slit skin smear results, since a gradual increase in BI was accompanied by a semi-quantitative rise in antibody levels measured by ML Flow, with 100% positivity in cases presenting a positive slit skin smear. Given its strong correlation to slit skin smear, the results of this study provide evidence that the ML Flow test could be a valuable auxiliary tool in the classification and treatment of leprosy patients.

Comportamento dos testes sorológicos ML Flow e ELISA (PGL-I) em áreas endêmica e não endêmica de hanseníase / The result patterns of ML Flow and ELISA (PGL-I) serologic tests in leprosy-endemic and non-endemic areas

O ML Flow e o ELISA PGL-I são testes sorológicos que detectam anticorpos IgM contra o glicolipídio fenólico I específico do Mycobacterium leprae. Para avaliar o comportamento destes testes em áreas endêmica e não endêmica para hanseníase foram estudados 351 voluntários no Brasil e no Chile, incluindo pacientes com hanseníase, controles sadios, portadores de outras doenças infecciosas, não infecciosas e dermatoses que fazem diagnóstico diferencial com hanseníase. O ponto de corte do ELISA foi estabelecido pelo método da Curva ROC (> 0,157). Em área endêmica, o ML Flow apresentou resultados positivos em 70 por cento dos pacientes com hanseníase; o ELISA foi positivo em 53,3%. Em área não endêmica, o ML Flow foi negativo em todos os voluntários testados; o ELISA foi positivo em 4 voluntários. O ML Flow é um ensaio mais rápido, facilmente aplicável e, portanto, mais adequado para ser utilizado na Atenção Básica; o ELISA necessita, alem de uma infra-estrutura de laboratório adequada, pessoal treinado e especializado em sua execução.

ML Flow and anti-PGL-I ELISA are serological tests that detect IgM antibodies against the phenolic glycolipid I (PGL-I), specific to Mycobacterium leprae. To evaluate the outcomes of ML Flow and ELISA (PGL-I) serological tests in leprosy-endemic areas in comparison to non-endemic ones, a total of 351 volunteers from Brazil and Chile were examined, including leprosy patients, healthy controls and others affected by other infectious or non-infectious diseases that are common differential diagnoses for leprosy. The ELISA cut-off point was established using the ROC Curve method (> 0.157). In endemic areas, 70% of leprosy patients present positive ML Flow results and 53.3% were ELISA-positive. In non-endemic areas, ML Flow was negative in all the subjects tested and ELISA was positive in 4 volunteers. ML Flow is faster and more easily performed and, therefore, a more adequate test for use in basic, primary-level health care centers. ELISA requires trained personnel, in addition to a more complex laboratory infrastructure.

Associação do teste sorológico ML Flow com a baciloscopia / Association of the ML Flow serologic test to slit skin smear

Realizou-se estudo descritivo e exploratório relacionando as covariáveis aos resultados do teste sorológico ML Flow e baciloscopia. Foram estudados 60 casos novos de hanseníase diagnosticados no Centro de Referência em Dermatologia Sanitária. Para a baciloscopia, foi utilizada a coleta de esfregaço dérmico em quatro sítios, sendo o resultado expresso pelo índice bacilocópico. O ML Flow foi registrado de modo qualitativo e semi-quantitativo. Para o estudo da concordância, foi utilizado o índice de Kappa e, para sua interpretação, os critérios de Landis e Koch. Para análise estatística foram realizados a regressão logística e o teste de Kruskal-Wallis. O ML Flow mostrou forte associação com a baciloscopia, observou-se que o aumento gradativo do índice baciloscópico foi acompanhado pelo aumento semi-quantitativo dos níveis de anticorpos medidos pelo ML Flow, tendo sido positivo em 100% dos casos com baciloscopia positiva. Os resultados deste estudo evidenciaram que o ML Flow, por estar fortemente correlacionado à bacilocopia, poderá tornar-se um valioso instrumento auxiliar na classificação e alocação dos pacientes para fins de tratamento.

A descriptive, exploratory study was conducted analyzing the association of covariables in the results of the ML Flow serological test and slit skin smear. A total of 60 leprosy cases diagnosed at the state Sanitary Dermatology Referral Center were investigated. Slit skin smear samples were collected from four sites and the results were expressed by the bacillary index. ML Flow was registered in both qualitative and semi-quantitative terms. Cohen's kappa coefficient was used to study the agreement with Landis and Koch's observer criteria for interpretation. For statistical analysis, the logistic regression model and Kruskal-Wallis test were used. ML Flow showed a strong association with slit skin smear results, since a gradual increase in BI was accompanied by a semi-quantitative rise in antibody levels measured by ML Flow, with 100% positivity in cases presenting a positive slit skin smear. Given its strong correlation to slit skin smear, the results of this study provide evidence that the ML Flow test could be a valuable auxiliary tool in the classification and treatment of leprosy patients.