RESUMEN
Some nutraceuticals have been studied as supportive treatment for fighting upper respiratory tract infection and middle ear disease. Our study aims at evaluating the effect of a specific oral supplementation in the treatment of pediatric otits media. The subjects were randomly assigned by the physician (single-blinded study) to one of three groups: Control Group (CG), Treatment Group 1 (TG1), or Treatment Group 2 (TG2). Both TG were treated with Flogostop Duo (for 20 days-TG1 or 30 days-TG2) in combination with the standard treatment, while CG underwent standard treatment only. The standard treatment was nasal aerosol with Fluticasone and Mucolytic, and nasal washing with hypertonic solution. All patients were analyzed by otoscopy, impedance, fibroscopy, and pure auditory test at the baseline (T0), after 20 days (T1) and 35 days (T2). 120 children were included in the study, 40 in the CG, 40 in the TG1, and 40 in the TG2. Both TG1 and TG2 presented statistically significant differences with respect to controls in otoscopy, impedance, fibroscopy, and PTA at T2. The otoscopy improved at T2 with statistically significant value only in TG2. The impedance and fibroscopy improved at T1 both in TG1 and TG2 compared to CG. A statistically significant improvement was observed in TG2 at T2 in comparison to both CG and TG1. Statistically significant differences were observed in PTA at T2 only compared with controls. This study confirmed the efficacy of nutraceutical as supporting therapy in the upper respiratory tract infection in children. In particular, the supplement containing Boswellia serrata and Bromelain, which are molecules with strong anti-inflammatory and pain-control capacities, could add the benefit without the adverse effects which are related to NSAID use.
RESUMEN
Oral supplements (OS) support the immune system in fighting upper airways infection. This study aimed to analyze the effect of Difensil Immuno (DI) on the recurrence of tonsillitis and fever in children. A multicentric randomized clinical trial was conducted. One-hundred and twenty children with chronic tonsillitis were randomly assigned to group A, B or control. Patients in group A were treated with 10 mL of DI for 90 consecutive days, patients in group B underwent treatment with 15 mL of DI for 45 consecutive days. The following data were collected at baseline (T0), T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results. One-way ANOVA was used to analyze within and between variances. Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2. However, T1 variances were more consistent in group A than in group B. All patients in the study groups improved their clinical outcomes. No statistically significant variances were observed in blood parameters both at T1 and T2. Our results suggest that children treated with DI had fewer episodes of tonsillitis and fever and a reduction in their tonsillar volume.
Asunto(s)
Adyuvantes Inmunológicos/administración & dosificación , Adyuvantes Inmunológicos/farmacología , Suplementos Dietéticos , Sistema Inmunológico/inmunología , Prevención Secundaria , Tonsilitis/inmunología , Tonsilitis/terapia , Niño , Preescolar , Femenino , Fiebre/prevención & control , Galactanos , Humanos , Lactobacillus acidophilus , Masculino , Sambucus nigra , Selenio , Índice de Severidad de la Enfermedad , Tonsilitis/prevención & control , Resultado del Tratamiento , Vitaminas , ZincRESUMEN
OBJECTIVE: The primary objective of this study was to evaluate the health-related quality of life (HRQOL) in lower-risk, transfusion-dependent patients with myelodysplastic syndromes (MDS) treated with deferasirox. A secondary objective was to investigate the relationship between HRQOL, serum ferritin levels and transfusion dependency. PATIENTS AND METHODS: This was a prospective multicentre study enrolling 159 patients, of whom 152 received at least one dose of deferasirox. HRQOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) at baseline and then at 3, 6, 9 and 12â months. Primary analysis was performed estimating mean HRQOL scores over time by a linear mixed model on selected scales. RESULTS: The median age of treated patients was 72â years (range 24-87â years). No statistically significant changes over time were found in mean scores for global health status/quality of life (p=0.564), physical functioning (p=0.409) and fatigue (p=0.471) scales. Also, no significant changes were found for constipation (p=0.292), diarrhoea (p=0.815) and nausea and vomiting (p=0.643). Serum ferritin levels were not associated with HRQOL outcomes. A higher patient-reported baseline pain severity was an independent predictive factor of an earlier achievement of transfusion independence with a HR of 1.032 (99% CI 1.004 to 1.060; p=0.003). CONCLUSIONS: HRQOL of transfusion-dependent patients with MDS receiving deferasirox therapy remains stable over time. HRQOL assessment might also provide important predictive information on treatment outcomes. TRIAL REGISTRATION NUMBER: NCT00469560.
Asunto(s)
Benzoatos/uso terapéutico , Quelantes del Hierro/uso terapéutico , Síndromes Mielodisplásicos/tratamiento farmacológico , Síndromes Mielodisplásicos/psicología , Calidad de Vida , Reacción a la Transfusión , Triazoles/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Benzoatos/administración & dosificación , Deferasirox , Femenino , Humanos , Quelantes del Hierro/administración & dosificación , Masculino , Persona de Mediana Edad , Síndromes Mielodisplásicos/metabolismo , Estudios Prospectivos , Resultado del Tratamiento , Triazoles/administración & dosificación , Adulto JovenRESUMEN
BACKGROUND: In the absence of randomized, controlled trial data to support iron chelation therapy in transfusion-dependent patients with myelodysplastic syndromes (MDS), continued evidence from large prospective clinical trials evaluating the efficacy and safety of iron chelation therapy in this patient population is warranted. METHODS: The safety and efficacy of deferasirox was examined in a prospective, open-label, single-arm, multicenter trial of transfusion-dependent patients with International Prognostic Scoring System low- or intermediate-1-risk MDS and evidence of transfusion-related iron overload. The effects of deferasirox therapy on hematological response and disease progression were also examined. RESULTS: Of 159 participants enrolled from 37 Italian centers, 152 received ≥1 dose of deferasirox (initiated at 10-20 mg/kg/day and titrated as appropriate), and 68 completed the study. Of 84 patients who discontinued deferasirox therapy, 22 died during the trial, and 28 withdrew due to an adverse event (AE). Fourteen treatment-related grade 3 AEs occurred in 11 patients, whereas no grade 4 or 5 drug-related AEs were reported. Significant risks for dropout were a higher serum ferritin level at baseline, a higher MDS-Specific Comorbidity Index, and a shorter diagnosis-enrollment interval. Median serum ferritin level fell from 1966 ng/mL to 1475 ng/mL (P < 0.0001). The cumulative incidence of transfusion independence, adjusted for death and disease progression, was 2.6%, 12.3%, and 15.5% after 6, 9, and 12 months, respectively. CONCLUSIONS: Deferasirox therapy in transfusion-dependent patients with MDS was moderately well tolerated and effectively lowered serum ferritin levels. Positive hematological responses were observed, and a subset of patients achieved transfusion independence.
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Benzoatos/uso terapéutico , Transfusión Sanguínea , Quelantes del Hierro/uso terapéutico , Sobrecarga de Hierro/tratamiento farmacológico , Sobrecarga de Hierro/etiología , Síndromes Mielodisplásicos/complicaciones , Síndromes Mielodisplásicos/terapia , Triazoles/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Benzoatos/efectos adversos , Deferasirox , Femenino , Ferritinas/sangre , Humanos , Quelantes del Hierro/efectos adversos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Reacción a la Transfusión , Resultado del Tratamiento , Triazoles/efectos adversos , Adulto JovenRESUMEN
Myelodysplastic syndromes (MDSs) are characterized by ineffective hematopoiesis that results in peripheral cytopenias. Anemia is the most common symptom of MDS and the majority of patients become transfusion-dependent with the risk of iron overload, which may lead to cardiac, hepatic and endocrine complications. Deferasirox is an orally available iron chelator administered once-daily in transfusion-dependent patients with various chronic anemias. Its efficacy has been established in controlled clinical trials. In the present study, we describe our experience with 55 consecutive MDS patients [International Prognostic Scoring System risk score of low (n=32) or intermediate-1 (n=23)] treated with deferasirox in a routine clinical setting following Consensus Guidelines on Iron Chelation Therapy. According to WHO classifications, patients had refractory anemia (n=30), refractory anemia with ringed sideroblasts (n=16), refractory cytopenia with multilineage dysplasia (n=8) or refractory cytopenia with multilineage dysplasia and ringed sideroblasts (n=1). The median monthly transfusion requirement at baseline was 3 units. Patients received a starting dosage of 10 mg/kg/day, subsequently titrated according to serum ferritin (SF) levels which were measured monthly. Safety assessment included monitoring of liver and renal parameters and recording adverse events (AE) during treatment. At the baseline, the mean ± SD SF level was 2,362±172 ng/ml and after 24 months, the mean ± SD decrease in SF was 1,679±209 ng/ml. Sixteen patients had sustained hematological improvement meeting International Working Group 2006 criteria. One patient became transfusion-independent. No severe AE were reported. In conclusion, deferasirox therapy was effective and safe in reducing transfusional iron overload and it reduces transfusion requirement in a subset of patients.