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Problem. Congenital plasmodial infection (CPI) is a rare event, which has been little studied in Colombia. Objective. To measure the frequency of CPI and to describe the immune and histological characteristics in maternal blood and placentas when CPI occurs. Methodology. A cross-sectional study was carried out in northwest Colombia. A sample size of 39 unit analysis (a unit of analysis corresponds to the cord, placenta, and peripheral blood of a pregnant woman) was calculated using epidemiological and statistical parameters. Thick blood smear (TBS) and quantitative real-time polymerase chain reaction (qPCR) were used as diagnostic tests. Results and Conclusions. A total of 137 parturient women were studied. All cases of CPI were submicroscopic (TBS negative and qPCR positive) and asymptomatic infections. If the definition of CPI considers only detection of parasites in umbilical cord blood, regardless of what was found in peripheral or placental blood, the frequency of CPI was 27%. However, if that definition is stricter and includes simultaneous detection of parasites in maternal or placental blood with the same species, the frequency of CPI in this study was 13%.
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Objetivo: evaluar, con el protocolo de la Organización Mundial de la Salud (OMS) de 1998, la respuesta terapéutica antimalárica (RTA) y los eventos adversos (EA) en cuatro esquemas de tratamiento antiplasmodial en gestantes colombianas, con diagnóstico de malaria no complicada por P. vivax o por P. falciparum, según gota gruesa.Materiales y métodos: experimento controlado aleatorizado en paralelo. Se calculó un tamaño muestral de 60 pacientes con P. vivax y 30 con P. falciparum. Se evaluaron cuatro tratamientos: malaria vivax en cualquier trimestre de gestación tratada con cloroquina o con amodiaquina; malaria falciparum en trimestres 2 y 3, terapia tratada con artesunato-mefloquina o arteméter-lumefantrina. Se hizo seguimiento por 28 días. Se midió la proporción de falla terapéutica y de eventos adversos. Los grupos se comparan mediante análisis univariado. El protocolo del estudio fue registrado en el sitio: ClinicalTrials. gov bajo el registro: MGP-02. Resultados: se trataron 90 pacientes. La RTA fue adecuada en 97-100% de los casos de malaria vivax (variación del método de análisis) y en 100% de los casos con malaria falciparum. Los EA más comunes fueron dolor epigástrico, mareo, tinitus y visión borrosa. No hubo eventos adversos graves.Conclusiones: la cloroquina y la amodiaquina tienen igual respuesta terapéutica adecuada. Las combinaciones artesunato-mefloquina y arteméterlumefantrina no mostraron fallas terapéuticas. Se requieren estudios en otros lugares del país con los esquemas evaluados y con otros.
Objective: To assess, using the 1998 WHO protocol, adequate clinical and parasitological response (ACPR) and adverse events (AEs) to 4 antiplasmodial treatment regimens in pregnant Colombian women diagnosed with uncomplicated P. vivax or P. falciparum malaria on the basis of thick blood smear.Materials and methods: Parallel randomized controlled trial. The estimated sample size was 60 patients with P. vivax and 30 with P. falciparum. Four treatments were assessed: vivax malaria in any trimester treated with chloroquine or amodiaquine; falciparum malaria in second and third trimesters treated with artesunate-mefloquine or artemether-lumefantrine. Patients were followed for 28 days. Measurements included the proportion of therapeutic failures and of adverse events. Groups were compared using univariate analysis. The study protocol was registered in ClinicalTrials.gov under the Protocol Record MGP-02. Results: Overall, 90 patients were treated. ACPR was adequate in 97-100% of vivax cases (analytical method variation) and in 100% of falciparum cases. The most common AEs were epigastric pain, dizziness, tinnitus and blurred vision. There were no serious adverse events. Conclusions: Both chloroquine as well as amodiquine have similar adequate responses. No therapeutic failures were found for the combinations of artesunate-mefloquine and artemether-lumefantrine. Studies need to be done in other places of the country using the regimens assessed as well as others.
Assuntos
Adulto , Feminino , Amodiaquina , Cloroquina , Malária , Mefloquina , Plasmodium , Gravidez , ColômbiaRESUMO
Problema: solo conocemos tres informes para Colombia de la prueba diagnóstica de malaria NowICT Malaria Pf/Pv ® (NowICT); esos estudios tuvieron resultados de sensibilidad y especificidad muy diferentes. Objetivo: evaluar la capacidad diagnóstica de NowICT frente a la gota gruesa para el diagnóstico de infección plasmodial en sangres periférica materna, del cordón umbilical y placentaria. Metodología: diseño paralelo y enmascarado para evaluación de una prueba diagnóstica. El tamaño de la muestra se calculó con parámetros epidemiológicos y estadísticos y fue de 131 muestras desangre periférica materna; también se examinaron sendas muestras de sangre placentaria y de cordón umbilical. Resultados: se evaluaron en total 386 muestras. La sensibilidad de NowICT para P. vivax no alcanzó70% en ninguna de las fuentes (madre, placenta, cordón). La especificidad mínima fue de 99%. Los valores para P. falciparum no se calcularon porque los casos fueron pocos. Conclusión: Now ICT malaria Pf/Pv® no es una herramienta diagnóstica útil en Colombia porque su sensibilidad para P. vivax es muy deficiente y en el país esta especie es la que predomina en la generación de malaria en humanos. Esta interpretación concuerda con las conclusiones generales de la OMS sobre el estado de desarrollo de las pruebas diagnósticas rápidas para malaria.
Problem: To date, there are only three reports from Colombia about the malaria diagnostic testNow ICT Malaria Pf / Pv ® (NowICT). The results from these studies showed major differences insensitivity and specificity. Objective: To evaluate the diagnostic performance of NowICT compared to thick smear for the diagnosis of Plasmodium infection in matched blood samples from mothers (maternal peripheral blood), umbilical cord and placenta. Methods: We used a closed (blinded/masked) and parallel design for the evaluation of a diagnostic test. The sample size was calculated with statistical and epidemiological parameters; this consisted of 131 thick smears from maternal peripheral blood. Blood samples from placenta and umbilical cord were also studied (386 samples tested in total). Results: The sensitivity of Now ICT for detection of P.vivax was below 70% in any of the samples (maternal blood, placental blood or cord blood). The specificity was greater than 99%. Values for P. falciparum infection were not calculated since too few cases were detected. Conclusions: Now ICT Malaria Pf / Pv ® is not a useful diagnostic tool in Colombia since the sensitivity for the most frequent species in the country, P. vivax, is poor. This interpretation is consistent with the WHOs general conclusions about the state of development of rapid diagnostic tests for malaria.