Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2011
Prednisolone in Bell's palsy related to treatment start and age.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Axelsson Sara, Berg Thomas, Jonsson Lars, Engström Mats, Kanerva Mervi, Pitkäranta Anne, Stjernquist-Desatnik Anna
Аннотация
OBJECTIVE: To evaluate if treatment start and age are related to the outcome in Bell's palsy patients treated with prednisolone.
STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING: Sixteen otorhinolaryngologic centers in Sweden and 1 in Finland.
PATIENTS: Data were collected from the Scandinavian Bell's palsy study. A total of 829 patients were treated within 72 hours of onset of palsy. Follow-up was 12 months.
INTERVENTION: Patients were randomly assigned to treatment with placebo plus placebo (n = 206), prednisolone plus placebo (n = 210), valacyclovir plus placebo (n = 207), or prednisolone plus valacyclovir (n = 206).
MAIN OUTCOME MEASURES: Facial function was assessed with the Sunnybrook grading system, and complete recovery was defined as Sunnybrook = 100. Time from onset of palsy to treatment start was registered.
RESULTS: Patients treated with prednisolone within 24 hours and 25 to 48 hours had significantly higher complete recovery rates, 66% (103/156) and 76% (128/168), than patients given no prednisolone, 51% (77/152) and 58% (102/177) (p = 0.008 and p = 0.0003, respectively). For patients treated within 49 to 72 hours of palsy onset, there were no significant differences. Patients aged 40 years or older had significantly higher complete recovery rates if treated with prednisolone, whereas patients aged younger than 40 years did not differ with respect to prednisolone treatment. However, synkinesis was significantly less in patients younger than 40 years given prednisolone (p = 0.002).
CONCLUSION: Treatment with prednisolone within 48 hours of onset of palsy resulted in significantly higher complete recovery rates and less synkinesis compared with no prednisolone.
STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter trial.
SETTING: Sixteen otorhinolaryngologic centers in Sweden and 1 in Finland.
PATIENTS: Data were collected from the Scandinavian Bell's palsy study. A total of 829 patients were treated within 72 hours of onset of palsy. Follow-up was 12 months.
INTERVENTION: Patients were randomly assigned to treatment with placebo plus placebo (n = 206), prednisolone plus placebo (n = 210), valacyclovir plus placebo (n = 207), or prednisolone plus valacyclovir (n = 206).
MAIN OUTCOME MEASURES: Facial function was assessed with the Sunnybrook grading system, and complete recovery was defined as Sunnybrook = 100. Time from onset of palsy to treatment start was registered.
RESULTS: Patients treated with prednisolone within 24 hours and 25 to 48 hours had significantly higher complete recovery rates, 66% (103/156) and 76% (128/168), than patients given no prednisolone, 51% (77/152) and 58% (102/177) (p = 0.008 and p = 0.0003, respectively). For patients treated within 49 to 72 hours of palsy onset, there were no significant differences. Patients aged 40 years or older had significantly higher complete recovery rates if treated with prednisolone, whereas patients aged younger than 40 years did not differ with respect to prednisolone treatment. However, synkinesis was significantly less in patients younger than 40 years given prednisolone (p = 0.002).
CONCLUSION: Treatment with prednisolone within 48 hours of onset of palsy resulted in significantly higher complete recovery rates and less synkinesis compared with no prednisolone.
Предметные рубрики MeSH
AcyclovirAdolescentAdultAgedAntiviral AgentsBell PalsyDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleFinlandGlucocorticoidsHumansIntention to Treat AnalysisMaleMiddle AgedPrednisoloneProspective StudiesRecovery of FunctionSwedenTime FactorsTreatment OutcomeValacyclovirValine