ABSTRACT
Abstract Introduction: A combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis. Objective: To evaluate safety and efficacy of desloratadine plus prednisolone in the treatment of acute symptoms of children (2-12 years) with allergic rhinitis, and to compare it to dexchlorpheniramine plus betamethasone. Methods: Children with moderate/severe persistent allergic rhinitis and symptomatic (nasal symptoms score [0-12] ≥ 6) were allocated in a double-blind, randomized fashion to receive dexchlorpheniramine plus betamethasone (n = 105; three daily doses) or desloratadine plus prednisolone (n = 105; single dose followed by two of placebo) for 7 days. At the beginning and end of the evaluation, the following were obtained: nasal symptoms score, extra nasal symptoms score, peak nasal inspiratory flow, blood biochemistry, and electrocardiogram. Ninety-six children of the dexchlorpheniramine plus betamethasone group and 98 of the desloratadine plus prednisolone group completed the protocol. Results: The two groups were similar regarding initial and final nasal symptoms scores, extra nasal symptoms scores and peak nasal inspiratory flow. A drop of 76.4% and 79.1% for nasal symptoms score, 86.0% and 79.2% for extra nasal symptoms score, as well as an increase of 25.2% and 24.3% for peak nasal inspiratory flow occurred for those treated with desloratadine plus prednisolone and dexchlorpheniramine plus betamethasone, respectively. There were no significant changes in blood chemistry. Sinus tachycardia was the most frequent electrocardiogram change, but with no clinical significance. Drowsiness was reported significantly more often among those of dexchlorpheniramine plus betamethasone group (17.14% × 8.57%, respectively). Conclusion: The desloratadine plus prednisolone combination was able to effectively control acute symptoms of rhinitis in children, improving symptoms and nasal function. Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action, but with a lower incidence of adverse events and higher dosing convenience.
Resumo Introdução: A associação entre anti-histamínicos e corticosteroides orais é frequentemente empregada no tratamento de sintomas agudos de rinite alérgica. Objetivo: Avaliar a segurança e eficácia da associação desloratadina + prednisolona no tratamento de sintomas agudos de crianças (2-12 anos) com rinite alérgica e compará-las com as da associação dexclorfeniramina + betametasona. Método: Crianças com rinite alérgica persistente moderada/grave e sintomáticas (escore de sintomas nasais [0-12] ≥ 6) foram alocadas de modo duplo-cego e randômico para receber dexclorfeniramina + betametasona (n = 105; três doses diárias) ou desloratadina + prednisolona (n = 105; dose única seguida por duas de placebo) por 7 dias. No início e no fim da avaliação foram obtidos: escore de sintomas nasais, escore de sintomas extranasais, pico de fluxo inspiratório nasal, bioquímica sanguínea e eletrocardiograma. Do total, 96 crianças do grupo dexclorfeniramina + betametasona e 98 do grupo desloratadina + prednisolona concluíram o protocolo. Resultados: Os dois grupos foram iguais com relação ao escore de sintomas nasais, escore de sintomas nasais extranasais e pico de fluxo inspiratório nasal iniciais e finais. Observou-se queda de 76,4% e 79,1% nos escores para escore de sintomas nasais, de 86,0% e 79,2% para escore de sintomas extranasais, assim como incremento de 25,2% e de 24,3% para o pico de fluxo inspiratório nasal para os grupos desloratadina + prednisolona e dexclorfeniramina + betametasona, respectivamente. Não houve alterações significativas da bioquímica sanguínea. Taquicardia sinusal foi a alteração do eletrocardiograma mais encontrada, mas sem significância clínica. Sonolência foi significantemente mais referida entre os tratados com dexclorfeniramina + betametasona do que entre os desloratadina + prednisolona (8,57% × 17,14%, respectivamente). Conclusão: A associação desloratadina + prednisolona foi capaz de controlar efetivamente os sintomas agudos de rinite em crianças, melhorou sintomas e a função nasal. Na comparação com a associação dexclorfeniramina + betametasona, demonstrou ação clínica semelhante, mas com menor incidência de eventos adversos e maior comodidade posológica.
Subject(s)
Humans , Male , Female , Child, Preschool , Child , Prednisolone/administration & dosage , Loratadine/analogs & derivatives , Rhinitis, Allergic/drug therapy , Glucocorticoids/administration & dosage , Time Factors , Severity of Illness Index , Betamethasone/administration & dosage , Betamethasone/adverse effects , Prednisolone/adverse effects , Peak Expiratory Flow Rate , Double-Blind Method , Reproducibility of Results , Treatment Outcome , Loratadine/administration & dosage , Loratadine/adverse effects , Statistics, Nonparametric , Histamine H1 Antagonists, Non-Sedating/administration & dosage , Histamine H1 Antagonists, Non-Sedating/adverse effects , Drug Combinations , Glucocorticoids/adverse effectsABSTRACT
INTRODUCTION: Uremic pruritus is common among dialysis patients. Effective treatments are not readily available. Early evidence with antihistamines and gabapentin indicate variable effects. OBJECTIVE: To compare the efficacy and side effects of gabapentin and desloratadine in patients with dialysis pruritus. METHODS: Prospective, open-label, cross-over clinical trial in 22 patients on chronic hemodialysis with sustained pruritus over a period of at least 60 days. After a one-week run-in period, we assigned patients to three weeks of either gabapentin 300 mg thrice weekly or desloratadine 5 mg thrice weekly. After a one-week washout period, each patient crossed-over to the alternate regimen for three more weeks. The primary endpoint of the study was the change in the visual analogue pruritus score (VAS). RESULTS: Nineteen subjects completed the two treatment blocks and were available for analysis. VAS scores decreased with both treatments (5.95 to 4.6 with gabapentin, p = 0.07; 5.89 to 3.4 with desloratadine, p = 0.004), but only desloratadine reached statistical significance. There were no differences when comparing the final pruritus score with gabapentin and desloratadine (4.6 versus 3.4, p = 0.16) Excessive sedation was common with gabapentin. Desloratadine was well tolerated. CONCLUSION: Desloratadine provides significant relief of uremic pruritus compared with no therapy. gabapentin has marginal efficacy. Desloratadine is better tolerated than gabapentin.
INTRODUÇÃO: Prurido urêmico é comum entre pacientes em diálise. Tratamentos eficazes não estão disponíveis até o momento. Provas recentes com anti-histamínicos e gabapentina indicam vários efeitos. OBJETIVO: Comparar a eficiência e os efeitos colaterais da gabapentina e da desloratadina em pacientes com prurido na diálise. MÉTODOS: Estudo prospectivo, aberto e comparativo com 22 pacientes em hemodiálise crônica com prurido constante durante um período de pelo menos 60 dias. Após uma semana, submetemos os pacientes a três semanas de gabapentina 300 mg, três vezes por semana, ou desloratadina 5 mg três vezes por semana. Após um período de eliminação de uma semana, os pacientes trocaram de regime por mais três semanas. O objetivo primário do estudo foi a mudança na escala visual analógica (EVA) de prurido. RESULTADOS: Dezenove indivíduos completaram os dois tratamentos e foram submetidos à análise. Os escores da EVA caíram com ambos os tratamentos (5,95 para 4,6 com gabapentina, p = 0,07; 5,89 para 3,4 com desloratadina, p = 0,004), mas somente a desloratadina teve significância estatística. Nenhuma diferença foi observada ao comparar o escore final do prurido com gabapentina e desloratadina (4,6 versus 3,4, p = 0,16). Excesso de sedação foi comum com gabapentina. A desloratadina teve alto nível de tolerância. CONCLUSÃO: A desloratadina dá alívio significante do prurido urêmico quando comparada a nenhum tratamento. A gabapentina tem eficiência marginal. A desloratadina tem maior nível de tolerância em relação à gabapentina.
Subject(s)
Humans , Middle Aged , Amines/therapeutic use , Cyclohexanecarboxylic Acids/therapeutic use , Histamine H1 Antagonists, Non-Sedating/therapeutic use , Loratadine/analogs & derivatives , Pruritus/drug therapy , Renal Dialysis , gamma-Aminobutyric Acid/therapeutic use , Amines/adverse effects , Cross-Over Studies , Cyclohexanecarboxylic Acids/adverse effects , Histamine H1 Antagonists, Non-Sedating/adverse effects , Loratadine/adverse effects , Loratadine/therapeutic use , Prospective Studies , Pruritus/etiology , Renal Dialysis/adverse effects , Uremia/complications , Uremia/therapy , gamma-Aminobutyric Acid/adverse effectsABSTRACT
BACKGROUND: Histamine is the major mediator of allergic reactions. Newer H1 antihistaminics like levocetirizine, fexofenadine, and desloratadine are used in the treatment of seasonal and perennial allergic rhinitis and urticaria. The ability to block the cutaneous response to intradermal histamine is used to evaluate the potential of antihistamines. AIMS: To compare the potency, onset, and duration of action of the commonly used antihistamines-levocetirizine, fexofenadine, and desloratadine. METHODS: Thirty volunteers were given three single doses of levocetirizine, fexofenadine and desloratadine at weekly intervals. A pretest was performed by using the intradermal histamine prick test. After administration of the drugs, the intradermal test was repeated at (1/2), 1, 2, 3, 6 and 24 h, and the sizes of the wheal were measured. The mean values were taken and were compared by using Levene's t-test. RESULTS: At 30 min, fexofenadine showed a statistically significant suppression of wheal size compared to levocetirizine and desloratadine. Two and three hours after administration, levocetirizine and fexofenadine showed statistically significant inhibition of wheal size while only levocetirizine had this effect after six hours when compared to desloratadine. Desloratadine showed greater inhibition of wheal size at the end of 24 h when compared to levocetirizine and fexofenadine but this was not statistically significant. CONCLUSIONS: Fexofenadine had the earliest onset of action while levocetirizine showed maximum inhibition of wheal response after three and six hours.