RESUMO
OBJECTIVE: To assess the effects of treatment with onabotulinumtoxinA (Botox, Allergan, Inc., Irvine, CA) on health-related quality of life (HRQoL) and headache impact in adults with chronic migraine (CM). METHODS: The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program (PREEMPT 1 and 2) included a 24-week, double-blind phase (2 12-week cycles) followed by a 32-week, open-label phase (3 cycles). Thirty-one injections of 5U each (155 U of onabotulinumtoxinA or placebo) were administered to fixed sites. An additional 40 U could be administered "following the pain." Prespecified analysis of headache impact (Headache Impact Test [HIT]-6) and HRQoL (Migraine-Specific Quality of Life Questionnaire v2.1 [MSQ]) assessments were performed. Because the studies were similar in design and did not notably differ in outcome, pooled results are presented here. RESULTS: A total of 1,384 subjects were included in the pooled analyses (onabotulinumtoxinA, n = 688; placebo, n = 696). Baseline mean total HIT-6 and MSQ v2.1 scores were comparable between groups; 93.1% were severely impacted based on HIT-6 scores ≥60. At 24 weeks, in comparison with placebo, onabotulinumtoxinA treatment significantly reduced HIT-6 scores and the proportion of patients with HIT-6 scores in the severe range at all timepoints including week 24 (p < 0.001). OnabotulinumtoxinA treatment significantly improved all domains of the MSQ v2.1 at 24 weeks (p < 0.001). CONCLUSIONS: Treatment of CM with onabotulinumtoxinA is associated with significant and clinically meaningful reductions in headache impact and improvements in HRQoL. CLASSIFICATION OF EVIDENCE: This study provides Class 1A evidence that onabotulinumtoxinA treatment reduces headache impact and improves HRQoL.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/psicologia , Fármacos Neuromusculares/uso terapêutico , Qualidade de Vida , Adolescente , Adulto , Idoso , Doença Crônica , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Medição da Dor , Testes Psicológicos , Resultado do Tratamento , Adulto JovemRESUMO
PURPOSE: We tested the hypothesis that weight for height, a simple index of nutritional status, is related to prognosis in childhood acute lymphoblastic leukemia (ALL). PATIENTS AND METHODS: The study population was composed of 78 children with ALL tested at one U.K. center on the same protocol (UKALL-X). Outcome measures were relapse/no relapse and time to first relapse. Influence of weight for height, expressed as standard deviation scores, was tested using survival analysis in a retrospective design. RESULTS: The weight-for-height standard deviation score had a significant influence on time until first relapse (log ranks test, p = 0.012), with the highest risk of early relapse in children at the lower end of the weight-for-height distribution. CONCLUSIONS: The results suggest that weight for height does have an influence on outcome in ALL, but the mechanism is unclear and the finding requires confirmation by larger scale prospective studies.