RESUMO

INTRODUCCIÓN: la cepa atenuada 638 Vibrio cholerae O1 El Tor, Ogawa, ha demostrado ser bien tolerada e inmunogénica por vía oral en estudios realizados en voluntarios sanos. OBJETIVO: se evaluó la protección conferida contra el cólera, en un ensayo clínico de reto, para el escalado tecnológico y farmacéutico de este candidato vacunal como ingrediente activo a escala industrial. MÉTODOS: en el estudio participaron 21 voluntarios sanos, 12 de ellos recibieron el candidato vacunal, y 9 ingirieron un placebo; 28 d después, todos recibieron una dosis infectante de una cepa virulenta de V.cholerae. RESULTADOS: la diarrea se registró en 7 de los 9 placebos, mientras que ninguno de los voluntarios vacunados presentó diarrea. Los voluntarios placebos del grupo sanguíneo O, tuvieron diarreas con mayor frecuencia e intensidad. Todos los voluntarios en el grupo placebo excretaron V. cholerae mientras que solo 3 (25 por ciento) de los 12 vacunados la excretaron. CONCLUSIONES: en este modelo de ensayo de reto, la cepa 638 demostró proteger contra la diarrea producida por una cepa virulenta de V. cholerae.

INTRODUCTION: live attenuated oral Vibrio cholerae O1 El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVE: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHOD: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25 percent) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain.

Assuntos

RESUMO

INTRODUCTION: live attenuated oral Vibrio cholerae Ol El Tor, Ogawa strain 638 has demonstrated to be well tolerated and immunogenic when administrated orally in studies carried out in healthy volunteers. OBJECTIVES: to evaluate the protection against cholera infection in a challenge clinical trial, for the technological and pharmaceutical scale-up of this vaccinal candidate as active ingredient at industrial level. METHODS: a total of 21 healthy volunteers were involved in this trial; the vaccine candidate was administered to 12 of them and the remaining nine were given the placebo. Twenty eight days later, all of them received an infective dose of a V. cholerae virulent strain. RESULTS: diarrheas were observed in 7 out of 9 placebos whereas not a single vaccinated volunteer showed diarrheas. More frequent and intense loose stools were found in the placebo volunteers with O-blood group. All volunteers in he placebo group excreted V. cholerae, but only three (25%) out of the 12 vaccinated volunteers did so. CONCLUSION: in this challenge clinical trial model, the 638 strain proved to protect people against the diarrhea caused by a virulent V. cholerae strain.

Assuntos

RESUMO

En Cuba, entre el 1ero. de enero de 1986 y el 30 de abril de 2007 nacieron 280 niños hijos de madres VIH+. De ellos solo 22 (7,8 por ciento) nacieron con edad gestacional menor de 37 semanas y solo uno (4,5 por ciento) presentó una enterocolitis necrosante. En el presente artículo se describe un episodio de esta enfermedad en un niño prematuro hijo de padres VIH+, supuestamente asociado al uso profiláctico de zidovudina en las madres seropositivas por la posibilidad de producir toxicidad mitocondrial en el feto. Con el tratamiento quirúrgico empleado, la evolución del niño fue favorable. El caso presentado constituye una evidencia que el personal médico debe tener en cuenta para el cuidado y diagnóstico de estos pacientes.

In Cuba, from January 1, 1986 to April 30, 2007 were born 280 children from HIV+ mothers. Only 22 (7, 8 percent) had a gestational age under 37 weeks and only one (4, 5 percent) presented with a necrotizing enterocolitis. In present paper we describe an episode of this disease in a premature baby son of HIV+ parents, supposedly associated with prophylactic use of Zidovudine in seropositive mothers by possibility to produce mitochondria toxicity in fetus. This case is an evidence that family physician must to assess for care and diagnosis of these patients.

Assuntos

RESUMO

HIV infection affected 0.06% of the Cuban population and AIDS associated tuberculosis (TB) represented 4.4% of cases in 2004. The objective of this study was to determine the survival of AIDS patients with TB. 167 individuals of both sexes and ages between 15 and 60 years old were studied; all of them were diagnosed in the Havana's Tropical Medicine Institute "Pedro Kourí", Cuba, between January 1st 1997 and May 31st 2005. The Kaplan-Meier's method and the Long-rank test were used for the survival, and the Cox's multivariate method to identify the variables associated with mortality by means of SPSS 9.0. 78 individuals of the total died at the end of study, 71.8% belonged to the pre highly active antiretroviral therapy (HAART) era and 28.2% to the later period. From all deceased cases due to TB, 82.1% were diagnosed in the pre HAART era. The median survival was 41 months (CI=20-62). TB diagnosis in the pre HAART period, TB not being the first disease indicator of AIDS, suffering from candidiasis of esophagus before TB and a LTCD4+ count < 200 at the diagnosis of TB, were all independently associated with mortality. This study demonstrated the positive impact of HAART in the survival of Cuban AIDS patients with TB and also identified advanced immunodepression and opportunistic infections as predictors of mortality.

Assuntos

RESUMO

En Cuba el VIH infecta al 0,06% de la población y la tuberculosis (TB) asociada al SIDA representó el 4,4% de los casos en el año 2004. El objetivo de este estudio fue determinar la supervivencia de los enfermos con SIDA y TB. Se estudiaron 167 individuos de ambos sexos, con edades comprendidas entre 15 y 60 años, diagnosticados en el Instituto de Medicina Tropical “Pedro Kourí” de La Habana, Cuba, entre el 1º de enero de 1997 y el 31 de mayo del 2005. Se utilizó el método de Kaplan-Meier y la prueba de Log-rank para la supervivencia, un modelo multivariado de Cox para identificar las variables asociadas con la mortalidad mediante SPSS 9.0. De los 167 individuos 78 fallecieron, el 71,8% perteneció a la era-pre Tratamiento Antirretroviral de Alta Eficacia (TARVAE) y el 28,2% al periodo posterior. Del total de fallecidos por TB (39), el 82,1% se diagnosticó en la etapa pre-TARVAE. La mediana de supervivencia fue 41 meses (IC=20-62). Se asociaron de forma independiente con la mortalidad las categorías: diagnóstico de TB en la etapa pre-TARVAE, no ser la TB la primera enfermedad indicadora de SIDA, padecer candidiasis oroesofágica antes de la TB y menos de 200 LTCD4+ en el diagnóstico de la TB. Se demostró el impacto positivo del TARVAE en la supervivencia de los enfermos SIDA con TB en Cuba, y se identificaron la inmunodepresión avanzada y las enfermedades oportunistas como predictores de mortalidad.

Assuntos

Assuntos

RESUMO

Vertical transmission of HIV infection constitutes one of the most sensitive pillars of the current pandemic of this disease. This article carries out a report of the nine Cuban children who acquired this way the infection and died between 1986 and 2006. Prophylactic management of the cases and the clinical and anatomic pathological manifestations of those in whom autopsy was performed are described. The average gestational age was of 37.6 weeks, four of the pregnancies were captured late. Six children were born by caesarean section and in all transmission were presumably intrauterine. The average birth weight was 2786 grams. Four mother-sibling binomial received prophylaxis with AZT. The autopsy was carried out only in 4 children.

Assuntos

RESUMO

Vertical transmission of HIV infection constitutes one of the most sensitive pillars of the current pandemic of this disease. This article carries out a report of the nine Cuban children who acquired this way the infection and died between 1986 and 2006. Prophylactic management of the cases and the clinical and anatomic pathological manifestations of those in whom autopsy was performed are described. The average gestational age was of 37.6 weeks, four of the pregnancies were captured late. Six children were born by caesarean section and in all transmission were presumably intrauterine. The average birth weight was 2786 grams. Four mother-sibling binomial received prophylaxis with AZT. The autopsy was carried out only in 4 children.

Assuntos

RESUMO

Fundamento: Hay más de 40 millones de afectados en el mundo por el VIH/SIDA; han muerto alrededor de 20 millones de personas desde los inicios de la epidemia. Hay mayores tasas de mortalidad y menor supervivencia en los enfermos con tuberculosis (TB) e infección por el VIH-I. Particularmente, en Cuba no existen estudios previos que aborden la supervivencia en individuos coinfectados por VIH/TB. Métodos: Estudio observacional de una serie de 72 casos con TB y SIDA antes de generalizada la terapia antirretroviral de alta eficacia (TARVAE). Se describen variables clínicas e inmunológicas que se relacionan con la supervivencia a los tres años del diagnóstico de la TB y con el riesgo de muerte. Utilizamos el método de Kaplan-Meier y de riesgos proporcionales de Cox. Resultados: El 69.4% de los enfermos habían fallecido a los tres años del diagnóstico de la TB. La media del recuento de LTCD4+ resultó significativamente inferior en los muertos: 126 células por mm³ (p < 0.0001). El 44.4% de los casos cumplió los criterios de muerte por TB. La mediana de supervivencia global fue de 10 meses. Tener LTCD4 + < a 200 células y padecer candidiasis profunda previo a la TB, se asoció independientemente con el riesgo de muerte. Conclusiones: En ausencia de TARVAE, las infecciones oportunistas y el deterioro inmunológico en los individuos con SIDA y TB se relacionaron con un mayor riesgo de muerte.

Background: Infection due to HIV/AIDS affects more than 40 million people worldwide; around 20 million have succumbed since the epidemy began. There are higher mortality rates and shortened survival in those affected by tuberculosis (TB) and HIV-I. In Cuba, there are no previous studies regarding the survival of patients coinfected by HIV/TB. Methods: Observational study of a series of 72 cases infected by TB and AIDS before the widespread use of highly active anti-retroviral therapy (HAART); we describe the clinical and immunological variables associated to three year survival from the diagnosis of TB/AIDS and to the risk of death. Survival analyses were done by the Kaplan-Meier method and the log-rank test to determine the survival function according to categories of the variables included. Cox's proportional hazards was used to determine the independent association of each variable with the risk of death. Results: 51.4% of patients were dead one year and 69.4%, three years after the diagnosis of TB. Mean CD4+T lymphocyte counts were significantly lower in the deceased, 126 cells/mm³ (p < 0.0001); 44.4% fulfilled the criteria of death caused by TB. Mean survival was 10 months; survival was higher in those patients with TB as the first condition indicative of AIDS, in those who were not AIDS before TB, in those not having previous deep candidiasis, when CD4 + T lymphocyte counts > 200/mm³, in those with a reactive tuberculin skin test and when smears from sputum were negative to acid fast bacilli. The risk of death was independently associated to CD4 + T lymphocyte counts < 200/mm³, and having deep candidiasis before TB. Conclusions: In the absence of HA ART, opportunistic infections and immunologic impairment in patients with AIDS and TB are related to lower survival rates and increased risk of death.

RESUMO

Objetivo: Caracterizar dos grupos de enfermos con SIDA y tuberculosis (TB) diagnosticados antes y después de generalizada la terapia antirretrovirai de alta eficacia (TARVAE) en Cuba. Métodos: Diseño descriptivo y correlacional en dos series de casos en 149 enfermos con SIDA y TB: serie I, 72 casos (enero 1997-marzo 2001, antes de la TARVAE); serie II, 77 casos (mayo 2001-julio 2004, después de la TARVAE). Todos los casos fueron egresados del Instituto de Medicina Tropical "Pedro Kourí" de La Habana, Cuba. Se evaluaron variables demográficas, clínicas, microbiológicas e inmunológicas por revisión de expedientes clínicos. Resultados principales y conclusiones: Predominó el sexo masculino en ambas series; la edad media varió de los 30 a los 33 años. El 58.3% y el 57.1% de los casos de ambas series clasificaba como enfermo SIDA en el momento de la TB, ésta fue la primera enfermedad indicadora del síndrome en el 64.9% de los casos en la serie II, 48.6% en el resto. En la serie II, el 54.5% de los enfermos tuvieron un recuento de LTCD4+ < 200 células, indicando mejor estado inmunológico respecto a la serie I (76.4%). El estado clínico de la TB fue semejante en ambos grupos; en la serie II, hubo mayor frecuencia de fiebre de origen desconocido (92.2%), diaforesis nocturna (64.9%), disnea (14.3%) y linfadenopatías regionales (27.3%). La localización pulmonar fue la más frecuente en ambas series (79.2 y 75.35%); en 9 casos de la serie II se diagnosticó TB diseminada (11.7%). Las formas radiológicas más frecuentes fueron el infiltrado inflamatorio difuso de las bases, la mediastinal y la TB con radiografía negativa; en la serie II, hubo lesiones cavitarías (7.8%) y apicales (14.3%), pero menos afectación de las bases (18.2% vs 36.1%); no hubo correlación entre el recuento promedio de LTCD4+ y las formas clínicas y radiológicas de la TB. En la serie II resultó inferior la frecuencia de baciloscopías y cultivos de esputos positivos y superior la de Mantoux reactivos (32.9%) y exámenes anatomohistológicos positivos (16.9%).

Objective: Analysis of groups of patients with the acquired immunodeficiency syndrome (AIDS) and tuberculosis (TB) diagnosed before and after the use of highly active antiretroviral therapy (HAART) in Cuba. Methods: Chart analysis of 149 cases with AIDS and TB. Series I, 72 cases (January 1997-March 2001, before HAART). Series II, 77 cases (May 2001-June 2004, after HAART); all the patients were discharged from the "Instituto de Medicina Tropical 'Pedro Kourí" in Havana, Cuba. Results and conclusions: There was a predominance of young (30-33ys) males in both series; 58.3% and 57.1% of cases classified as AIDS at the appearance of TB; TB was the first indicator of AIDS in 64.9% of cases in Series II; 54.5% of cases in Series II and 36.4% in Series I had < 200 CD4 + TL cells, probably related to better immunologic status. Clinical profile was similar; fever of uknown origin, nocturnal sweats, dyspnea and regional lymphadenopathies were more frequent in Series II. Amongst TB cases, pulmonary disease was more frequent (79.2% and 75.3%, respectively); 9 cases (11.7%) of Series II had disseminated TB. Diffuse basal and mediastinal shadows and negative chest X rays were more frequent; there was no correlation between the counts of CD4+ TL cells and the clinical and radiological forms of TB. Series II had a lower invadence of positive sputum smears and positive cultures and a higher incidence of positive intradermal reaction to tuberculin and positive tissue diagnoses for TB.