INTRODUCTION IgA deficiency is a primary immunodeficiency predominantly due to an antibody defect, for which there is no replacement therapy. Treatment consists of prevention and treatment of infections and other associated conditions. Given the immunomodulatory and regulatory properties of the redox balance of ozone therapy in infectious and inflammatory conditions, evaluation of its effect on IgA deficiency is of interest.
OBJECTIVE Assess the benefits and possible adverse effects of ozone treatment in patients with IgA deficiency.
METHODS A monocentric randomized controlled phase 2 clinical trial (RPCEC 00000236) was carried out, after approval by the Institutional Ethics Committee of the Roberto Rodríguez Fernández Provincial General Teaching Hospital in Morón, Ciego de Ávila Province, Cuba. Included were 40 patients aged 5–50 years, distributed in 2 groups of 20, after agreeing to participate and signing informed consent. The experimental group received 2 cycles of ozone by rectal insufflation for 20 days (5 times a week for 4 weeks each cycle) with a 3-month interval between cycles, for a total of 40 doses, with age-adjusted dose ranges. The control group was treated with leukocyte transfer factor (Hebertrans), 1 U per m<sup>2</sup> of body surface area subcutaneously, once weekly for 12 weeks. Frequency of appearance and severity of clinical symptoms and signs of associated diseases, serum immunoglobulin concentrations and balance of pro-oxidant and antioxidant biomarkers were recorded at treatment initiation and one month after treatment completion. Therapeutic response was defined as complete, partial, stable disease or progressive disease. Descriptive statistics and significance were calculated to compare groups and assess effect size.
RESULTS One month after treatment completion, 70% of patients in the experimental group experienced significant increases in IgG
(p = 0.000) and IgM (p = 0.033). The experimental group also displayed decreased pro-oxidation biomarkers, glutathione modulation and increased antioxidant enzymes, with reduced oxidative stress; none of these occurred in the control group. Complete therapeutic response was achieved in 85% of patients in the experimental group and only 45% in the control group. Mild, transient adverse events were reported in both groups.
CONCLUSIONS Ozone therapy by rectal insufflation is a suitable therapeutic option for treating IgA deficiency because it produces antioxidant and immunomodulatory effects and is feasible, safe and minimally invasive.
KEYWORDS Ozone therapy, IgA deficiency, primary immunodeficiency, oxidative stress, antioxidants, pro-oxidants, Cuba
CONTRIBUTION OF THIS RESEARCH This paper introduces in Cuba a new treatment a for IgA deficiency, with immunomodulatory and antioxidant effects offering substantial clinical benefits to patients with this immunodeficiency.
INTRODUCCIÓN La anemia constituye el principal problema nutricional en los niños preescolares cubanos. Tal situación estimuló la realización de intervenciones de salud por parte de las autoridades sanitarias cubanas con el propósito de prevenir y controlar la enfermedad. En 2008 se estableció una estrategia nacional integral que proporcionó atención particular a las provincias orientales del país, por constituir la región con los más grandes desafíos en los determinantes sociales de salud.
OBJETIVO Determinar la prevalencia de anemia en los niños de 6 a 59 meses en las cinco provincias orientales de Cuba en tres años diferentes dentro de una década, así como estudiar la asociación de la anemia con los factores epidemiológicos y nutricionales, para evaluar el impacto del Plan Integral Cubano para la Prevención y el Control de la Anemia por Deficiencia de Hierro en Cuba.
MÉTODOS Se realizaron estudios de corte transversal en muestras representativas de la población de los niños con 6 a 59 meses, residentes en las provincias orientales del país, en los años 2005, 2008 y 2011. Se midió el nivel de hemoglobina para diagnosticar la anemia (hemoglobina menor de 110 g/L) y los resultados se relacionaron con variables independientes tales como la edad, el sexo, el área de residencia (urbana o rural), la asistencia a círculos infantiles [guarderías para niños entre 1 y 5 años de edad, pertenecientes al Sistema Nacional de Educación de Cuba —Eds.], el peso al nacer, la historia de lactancia materna, así como la anemia materna durante el embarazo. Se calcularon las frecuencias de distribución, las comparaciones se evaluaron mediante la prueba de χ2 y los Odds Ratio (OR) con intervalos de confianza (IC) del 95%.
RESULTADOS La prevalencia de anemia en la región estudiada disminuyó de 31.8% en 2005 a 26% en 2011; en la mayoría de los casos era leve (hemoglobina = 100-109 g/L). La prevalencia fue superior en los niños de 6 a 23 meses comparado con los que tenían de 24 a 59 meses. No se encontró diferencia significativa en la prevalencia de anemia entre niños y niñas. La prevalencia fue superior en las áreas rurales comparadas con las áreas urbanas en 2005 (p = 0.026) y en 2011
(p = 0.012). La asistencia a círculos infantiles constituyó un factor protector en los tres años estudiados. El bajo peso al nacer solo estuvo asociado con la anemia en 2011 (OR 1.74, IC 1.04-2.92). La prevalencia de la lactancia materna de forma exclusiva durante los seis primeros meses de vida se incrementó durante el período de estudio y la anemia se asoció con la no utilización de lactancia materna exclusiva en 2005 (OR 1.57, IC 1.05-2.34). La anemia materna al inicio y durante el embarazo fue un factor de riesgo significativo tanto en 2005 (OR 1.98, IC 1.27-3.10) como en 2011 (OR 1.43, IC 1.05-1.94).
CONCLUSIONES Aunque la prevalencia de anemia disminuyó paulatinamente durante el período del estudio, la enfermedad continúa siendo un problema de salud pública en Cuba, por lo que se deben mantener y fortalecer las medidas para su prevención y su control, tales como realizar intervenciones de salud sobre las mujeres en edad reproductiva, la alimentación exclusiva por lactancia materna durante los primeros seis meses de edad, estimular el cumplimiento de las recomendaciones de las normas cubanas para la alimentación complementaria de los niños hasta los dos años de edad, así como continuar la evaluación y la investigación de las causas de la anemia en los niños en edad preescolar.
PALABRAS CLAVE Anemia, niños, preescolar, infantes, lactancia materna, círculos infantiles, guarderías, Cuba
INTRODUCTION Anemia is the main nutritional problem in Cuban preschool children, prompting several interventions to prevent and control it. An enhanced national strategy was established in 2008, and particular attention paid to the eastern provinces, the region with greatest challenges in social determinants of health.
OBJECTIVE Determine anemia prevalence in children aged 6–59 months in Cuba’s five eastern provinces in three separate years within a decade, as well as association of anemia with epidemiological and nutritional factors, to assess impact of Cuba’s Comprehensive Plan for Prevention and Control of Iron-Deficiency Anemia in Cuba.
METHODS Cross-sectional studies of children aged 6–59 months (completed) were conducted in 2005, 2008 and 2011. Hemoglobin levels were measured to diagnose anemia (hemoglobin <110 g/L) and data were collected on independent variables such as age, sex, area of residence (urban or rural), daycare center enrollment, birth weight, breastfeeding history, and maternal anemia during pregnancy. Frequency distributions were created and comparisons tested with the chi square, and odds ratios calculated with 95% confidence intervals.
RESULTS Anemia prevalence in the region fell from 31.8% in 2005 to 26% in 2011; most of cases were mild (hemoglobin: 100–109 g/L). Prevalence was higher in children aged 6–23 months than in those aged 24–59 months throughout. No significant differences were found in anemia prevalence between boys and girls. Prevalence was higher in rural than in urban areas in 2005 (p = 0.026) and 2011 (p = 0.012). Daycare enrollment emerged as a protective factor in all three years. Low birth weight was associated with anemia only in 2011 (OR 1.74, CI 1.04–2.92). Prevalence of exclusive breastfeeding for six months increased over the study period; lack of breastfeeding was found to be associated with anemia in 2005 (OR 1.57, CI 1.05–2.34). Maternal anemia at onset of and during pregnancy was a significant risk factor in 2005 (OR 1.98, CI 1.27–3.10) and 2011 (OR 1.43, CI 1.05–1.94).
CONCLUSIONS Although anemia prevalence steadily decreased over the study period, it continues to be a public health problem in Cuba and anemia prevention and control measures should be maintained and strengthened: interventions for women of childbearing age, fostering exclusive breastfeeding of infants through their sixth month, and encouraging compliance with recommendations on complementary feeding per Cuba’s nutritional guidelines for children aged <2 years. Further evaluation is needed to identify the causes of anemia in the population of preschool children.
KEYWORDS Anemia, children, preschool, infants, breastfeeding, child daycare centers, Cuba