RESUMEN
Iodine deficiency is a major cause of impaired mental development, goitre, and cretinism in many parts of the world. Because existing immunization programmes can be used to deliver oral iodized oil (OIO) to infants at risk, it was important to know whether OIO could adversely affect the antibody response to vaccines, such as trivalent oral poliovirus vaccine (OPV). A randomized, double-blind, placebo-controlled clinical trial was conducted in Subang, West Java, Indonesia, in which 617 eight-week-old infants received either OIO or a placebo (poppy-seed oil) during a routine visit for their first dose of OPV as part of the Expanded Programme on Immunization (EPI). The infants received two boosters of OPV at 4-week intervals after the first dose, and were followed up when 6 months old. Neutralizing antibody titres to poliovirus serotypes 1, 2, and 3 were compared in serum samples that were taken from 478 of these infants just before the first dose of OPV and at 6 months. It was found that oral iodized oil did not reduce the antibody responses to any of the three serotypes of OPV. These results indicate that oral iodine may safely be delivered to infants at the same time as oral poliovirus vaccine according to current EPI immunization schedules.
PIP: This is a randomized, placebo-controlled clinical trial on the effect of oral iodized oil (OIO) on the immune response to oral poliovirus vaccine (OPV). 617 8-week old infants were enrolled in the study conducted in Subang, West Java, Indonesia. Infants received either IOI--at which time they also received OPV and diphtheria-pertussis-tetanus vaccine--or a placebo (poppy seed oil) during their first Expanded Program on Immunization (EPI) contact for their first dose of OPV. After the first dose, 2 boosters of OPV were received by the infants at 4-week intervals, and there was a final follow-up evaluation when infants reached their 6th month. Serum samples were collected from each infant at enrolment and at follow-up. A total of 478 pairs of pre-immune and postimmune sera were collected for evaluation. Neutralizing antibody titers to poliovirus serotypes 1,2, and 3 were compared in serum samples. The range of measured neutralizing antibody activity was 0.01-14 IU for type 1, 0.05-49 IU for type 2, and 0.01-11 IU for type 3 poliovirus. After the immunization, 2 (0.4%), 1 (0.2%), and 16 (3.3%), respectively, of the infants had no detectable neutralizing antibodies to all 3 poliovirus serotypes. It was found that OIO did not reduce the antibody responses to any of the 3 serotypes of OPV but did improve infant survival in the same cohort. These findings indicate that oral iodine supplementation may be safely combined with the delivery of the first dose of OPV according to EPI schedules.
Asunto(s)
Anticuerpos Antivirales/sangre , Yodo/administración & dosificación , Vacuna Antipolio Oral/inmunología , Análisis de Varianza , Método Doble Ciego , Femenino , Humanos , Esquemas de Inmunización , Indonesia , Lactante , Masculino , Pruebas de Neutralización , Vacuna Antipolio Oral/administración & dosificaciónRESUMEN
Although reports suggest that infant mortality is increased during iodine deficiency, the effect of iodine supplementation on infant mortality is unknown. A double-masked, randomized, placebo-controlled, clinical trial of oral iodized oil was conducted in Subang, West Java, Indonesia to evaluate the effect of iodine supplementation on infant mortality. Infants were allocated to receive placebo or oral iodized oil (100 mg) at about 6 wk of age and were followed to 6 mo of age. Six hundred seventeen infants were enrolled in the study. Infant survival was apparently improved, as indicated by a 72% reduction in the risk of death during the first 2 mo of follow-up (P < 0.05) and a delay in the mean time to death among infants who died in the iodized oil group compared with infants who died in the placebo group (48 days vs. 17.5 d, P = 0.06). Other infant characteristics associated with reduced risk of death included weight-for-age at base line, consumption of solid foods, female gender and recent history of maternal iodine supplementation. Oral iodized oil supplementation had a stronger effect on the mortality of males compared with females. This study suggests that oral iodized oil supplementation of infants may reduce infant mortality in populations at risk for iodine deficiency.
Asunto(s)
Mortalidad Infantil , Yodo/deficiencia , Aceite Yodado/uso terapéutico , Administración Oral , Peso Corporal , Enfermedades Carenciales/terapia , Método Doble Ciego , Femenino , Humanos , Lactante , Masculino , Factores Sexuales , Análisis de SupervivenciaRESUMEN
The authors investigated the role of secondary immunologic response, virus serotype, age, and sex on the clinical manifestations of dengue fever in Puerto Rico. From surveillance data for 1990 and 1991, this study identified 3,926 laboratory-positive cases, including 889 for whom dengue immunologic status and symptoms could be ascertained. Of those, 622 cases were virologically confirmed, and 267 cases were serologically confirmed. More than 50% of all positive patients reported fever, chills, headache, eye pain, body pains, joint pains, nausea, vomiting, or skin rash. The frequency of reporting signs, symptoms, and hospitalization was significantly higher among persons with secondary infections diagnosed by serological methods. Only rash was more common among those with primary infections. Symptom reporting increased with age; body pains, joint pains, and rash were significantly more frequently reported by female patients. No significant difference in symptom frequency was found among the virologically confirmed cases, comparing primary and secondary cases or infections due to different serotypes. The data for serologically confirmed cases suggest that in Puerto Rico the manifestations of dengue fever are, as with dengue hemorrhagic fever in Asia, more prominent among those who are experiencing secondary infections, and this effect may be more marked in the younger age groups.
Asunto(s)
Virus del Dengue/aislamiento & purificación , Dengue/fisiopatología , Adolescente , Adulto , Factores de Edad , Niño , Preescolar , Dengue/epidemiología , Dengue/inmunología , Dengue/virología , Virus del Dengue/clasificación , Femenino , Humanos , Lactante , Modelos Logísticos , Masculino , Persona de Mediana Edad , Puerto Rico/epidemiología , Estudios Seroepidemiológicos , Serotipificación , Factores SexualesRESUMEN
The authors carried out an open noncomparative study to evaluate the anti-inflammatory therapeutic activity of piroxicam in 40 adult patients suffering from acute gout. The patients ranged in age from 28 to 68 years (the average age was 51.6 years) overall, 21 men and 19 women participated in the trial. All of the patients had their disease for more than one year and they were receiving treatment with Benziodarone, 100 mg per day when the drug was discontinued from clinical use in Brazil. All of these patients subsequently experienced aggravation of their disease and had an acute attack of gout. Each patient was given piroxicam, 40 mg, in a single dose on the first day and two divided doses of 20 mg for the following five days. The affected joints were: elbow, knee, ankle and hallux. Severity of pain at rest, severity of pain on movement, tenderness, swelling, redness, heat and restriction of movement were evaluated. By the sixth day of the trial, good or total remission was observed in all patients. Overall evaluation of efficacy showed excellent and good results in 81.6% of the patients. Tolerability was excellent and good in 92.5%. All adverse reactions that occurred during the use of piroxicam therapy were noted. Five patients showed mild side effects, such as pyrosis, nausea and headache, and two patients had severe side effects (skin rash, gastric disturbance) that necessitated withdrawal from therapy. Finally, statistical analysis demonstrates that piroxicam is highly efficacious in the treatment of acute gout.