Multicenter prospective study on the burden of rotavirus gastroenteritis in children less than 3 years of age in Spain.

BACKGROUND: Rotavirus is acknowledged as an important cause of paediatric gastroenteritis worldwide. In Spain, comprehensive data on the burden of rotavirus disease was lacking. METHODS: A prospective, multicenter, observational study was carried out, during the winter season, from October to April 2014 in selected areas of Spain (Catalonia, Basque Country, Andalusia) to estimate the frequency and characteristics of acute gastroenteritis (AGE) and rotavirus gastroenteritis (RVGE) in children ≤3 years of age seeking medical care in primary care and emergency department centres. RESULTS: Of the 1087 episodes of AGE registered, 33.89 % were RVGE positive. The estimated incidence of RVGE, was 40.3 (95 % CI 36.1-44.8) episodes per 10,000 child-months in children ≤ 3 years of age and the 5-month (December-April) seasonal RVGE incidence rate was 2.01 [1.81-2.24] per 100 children. No vaccination and attending a day care centre were the main risk factors for RV infection. RVGE infected children presented more frequently with fever (63.9 % vs. 45.1 %, p = 0.009), vomiting (61.2 % vs. 44.3 %, p = 0.015), suffered more dehydration, and were hospitalised and went to the emergency room more often (41.7 % vs. 15.7 %, p <0.001) than non-RVGE infected ones. Children were usually more tired (77.5 % vs. 54.2 %, p <0.001), tearful, (47.2 % vs. 34.8 %, p <0.001), and easily irritated (76.5 % vs. 59.8 %, p <0.001), and parents were more concerned (41.7 % vs. 15.7 %, p <0.001) and suffered more working rhythm disturbances (39.0 % vs. 22.9 %, p <0.001). The cost for families of RVGE cases was significantly higher than the cost of non-RVGE infected ones (47.3 vs 36.7 euros, p = 0.011). Vaccinated children suffered less clinical symptoms and no hospitalization. Therefore, vaccination decreases the psychosocial stressors caused by the disease in the family. CONCLUSIONS: Rotavirus infections are responsible for a substantial proportion of AGE cases in children ≤3 years of age in Spain attended at primary care visits. RVGE episodes are associated with greater clinical severity, greater alterations in the child´s behaviour, and higher parental distress. The outcomes of the present study recommend that routine rotavirus vaccination in infants ≤3 years of age could considerably reduce the serious burden of this potentially serious childhood disease.

Nicotine gum, 2 and 4 mg, for nicotine dependence. A double-blind placebo-controlled trial within a behavior modification support program.

The effectiveness of nicotine gum in combination with a behavior modification program was studied. The nicotine dependence of participating smokers (N = 322) was assessed. One hundred sixty-eight smokers were labeled as high nicotine dependent and 154 as moderate to low dependent. In a randomized double-blind procedure, the high-dependent smokers were given gum containing 4 mg of nicotine (87) or 2 mg of nicotine (81) and the smokers with medium or low dependence were given gum containing 2 mg (76) or a placebo gum (78). The smokers were also randomized to familiarizing themselves with the medication a week before quit day (112) or to regular use, that is starting gum use on the quit day (122). In the high-dependent group, sustained and chemically verified nonsmoking rates at 6 weeks, 1 year, and 2 years were, respectively, 60%, 39%, and 34% in the subjects given the 4-mg dose compared with 41%, 16%, and 16% for those using the 2-mg dose. In the group with medium or low dependence, the success rates at the same time periods were 70%, 49%, and 39% for the subjects given the 2-mg dose and 38%, 22%, and 17% for those given placebo gum. The differences in success rates were significant at least at the p < 0.02% level for all comparisons. Familiarizing with the gum as compared with regular use gave fewer reports of side effects, 15% vs 34%, p < 0.001. A trend toward better success rates at 6 weeks, although not statistically significant, was observed for the familiarization group, 61% vs 52%. The study shows that high nicotine-dependent smokers need higher doses of nicotine replacement, in this case the 4-mg dose rather than the 2-mg dose, whereas 2 mg is superior to placebo among less dependent smokers. These results compare favorably with those reported from the more recent nicotine patch therapy.

Estudio multicéntrico comparativo sobre tolerancia y eficacia de terfenadina vs. placebo en urticaria crónica / Comparative multicenter study on the tolerance and efficacy of terfenadine vs. placebo in chronic urticaria

La terfenadina es un nuevo bloqueador específico de los receptores H1 periféricos. Diversos estudios clínicos realizados en los Estados Unidos y Europa han demostrado su eficacia en el tratamiento de la urticaria y la rinitis alérgica, así como la ausencia de efecto sedante, incluso cuando se administra conjuntamente con tranquilizantes o alcohol. El objetivo de nuestro estudio fue una evaluación comparativa de la tolerancia y eficacia de terfenadina y placebo, en el tratamiento de urticaria crónica, en pacientes latinoamericanos