ABSTRACT
The purpose of this study was to compare the safety and efficacy of cetirizine plus pseudoephedrine (C+P) with loratadine plus pseudoephedrine (L+P) in the treatment of perennial allergic rhinitis. This was a double blind, randomized, parallel trial with an active control. Subjects aged 12 to 70 years with perennial allergic rhinitis for at least 2 years were enrolled and randomized to receive either of the active study medications plus a placebo resembling the other, twice daily for 4 weeks. Nasal total symptom scale (NTSS) including sneezing, rhinorrhea, nasal itching and nasal stuffiness is evaluated by subjects daily and at baseline, 2 weeks, and 4 weeks by the investigator as efficacy measurement. A total of 51 eligible patients were enrolled and 45 patients completed the treatment course. Both groups had significant reductions in NTSS after 4 weeks of treatment as assessed by the subjects, but there was no significant difference between the two groups (mean +/- SD) reduction of 4.25 +/- 2.45 with C+P vs. 3.52 +/- 2.41 with L+P, p = 0.215. As assessed by the investigator, sneezing was significantly better at 2 weeks (-1.13 vs. -0.52, p = 0.028) and nasal congestion at 4 weeks (-1.71 vs. -1.19, p = 0.031) in subjects treated with C+P compared to those treated with L+P. There were 37 treatment-related adverse events (5 in 4 subjects in the C+P group and 32 in 16 subjects in the L+P group). It was concluded that both cetirizine plus pseudoephedrine and loratadine plus pseudoephedrine are efficacious for perennial allergic rhinitis in Taiwanese subjects. Relief of sneezing and nasal congestion may be marginally better with the cetirizine preparation, which also seemed to be slightly better tolerated, although the incidence of side effects did not differ significantly.
Subject(s)
Adolescent , Adult , Aged , Cetirizine/administration & dosage , Child , Double-Blind Method , Drug Therapy, Combination , Ephedrine/administration & dosage , Female , Humans , Loratadine/administration & dosage , Male , Middle Aged , Rhinitis, Allergic, Perennial/complications , Sneezing/drug effects , Taiwan , Treatment OutcomeABSTRACT
The present study was undertaken to evaluate Midazolam as a Paediatric conscious sedative agent for a routine Indian dental setup and to compare its efficacy and safety when administered by intranasal and intramuscular routes, at a dosage of 0.2 mg/kg body weight. The present study was accomplished in two phases: Phase 1: Preliminary dose finding pilot study on 10 children. Phase 2: Single dose, randomized parallel clinical trial on 40 children between the ages of 2 and 5 years. These children were randomly assigned to two groups consisting of 20 subjects each. Group M, received Midazolam intramuscularly, while Group N received Midazolam intranasally. Both the intranasal and intramuscular groups showed highly significant decrease in crying levels, motor movements and sensory perception levels, post-sedation (P P < 0.001). Midazolam could be safely and successfully employed by intranasal and intramuscular routes for Paediatric conscious sedation in a routine dental setup with basic facilities at a dosage of 0.2 mg/ kg body weight. Whenever the clinical situation warrants a faster action, peak and recovery, the intranasal route should be the obvious choice.
Subject(s)
Administration, Intranasal , Anesthesia Recovery Period , Anesthesia, Dental , Body Weight , Child Behavior/drug effects , Child, Preschool , Conscious Sedation/methods , Cough/chemically induced , Crying , Female , Hiccup/chemically induced , Humans , Hypnotics and Sedatives/administration & dosage , Injections, Intramuscular , Male , Midazolam/administration & dosage , Motor Activity/drug effects , Pilot Projects , Safety , Single-Blind Method , Sneezing/drug effects , Time Factors , Wakefulness/drug effectsABSTRACT
O estudo teve como objetivo avaliar a tolerabilidade, a eficácia clínica e a segurança do uso da cetirizina (CTZ) no tratamento da rinite alérgica perene. O estudo foi comparativo contra placebo (PLB), duplo-cego, randomizado, cruzado. Os pacientes receberam um período de 15 dias com CTZ (10 mg em dose única di ria), seguido de outro período de 15 dias com PLB, ou vice-versa de acordo com lista de aleatorizaçäo. Setenta e dois pacientes foram admitidos e 52 deles completaram os dois períodos de tratamento previstos. A CTZ mostrou superioridade nos seguintes sintomas de rinite alérgica: coriza, obstruçäo nasal, crises de espirro, prurido nasal e conjuntivite. O sintoma tosse näo foi modificado por qualquer dos tratamentos. Os sinais físicos de rinite alérgica, como coloraçäo da mucosa, hipertrofia de cornetos, secreçäo nasal e inflamaçäo faríngea, mantiveram-se inalterados com os dois tratamentos. O mesmo ocorreu com os sinais vitais: pressäo arterial, frequência cardíaca, frequência respiratória e peso. Durante o período de tratamento com a CTZ foram observados eventos adversos em sete pacientes (12,3 por cento) e no período PLB foram observados eventos adversos em oito pacientes (14 por cento). Os eventos adversos mais frequentes no período de tratamento com CTZ foram sonolência e aumento subjetivo de peso (nÝo confirmado ao exame físico); no período PLB foram tontura, aumento de apetite e cefaléia. Durante o período de tratamento com a CTZ nove pacientes interromperam o tratamento, sendo oito pacientes por abandono ou falta de colaboraçäo do paciente e um por evento adverso (urticária ao frio näo controlada). Durante o período PLB 11 pacientes interromperam o tratamento, sendo dez pacientes por abandono ou falta de colaboraçäo do paciente e um por evento adverso (tontura e calafrios). Concluímos que a CTZ se mostrou clinicamente superior ao PLB em efic cia, proporcionando alívio dos sintomas da rinite alérgica perene e sintomas conjuntivais. A incidência de eventos adversos com CTZ nÝo diferiu da observada com PLB. A cetirizina é um anti-histamínico eficaz e bem tolerado, com posologia cômoda em relaçäo aos anti-histamínicos clássicos, podendo ser utilizada para tratamento da rinite alérgica.