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INTRODUCTION: Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). METHODS: In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%-70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point), 0-3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). RESULTS: Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45-131]; P<0.001) and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27-72]; P<0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2-0.0]; P≤0.05). More patients achieved clinically meaningful improvements in TDI score (≥1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21-2.64]; P≤0.01). Improvements in SGRQ and CAT scores were similar between treatments. The incidence of AEs was similar with UMEC/VI (30%) and TIO (31%). CONCLUSION: UMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone.
Assuntos
Álcoois Benzílicos/administração & dosagem , Broncodilatadores/administração & dosagem , Clorobenzenos/administração & dosagem , Pulmão/efeitos dos fármacos , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quinuclidinas/administração & dosagem , Brometo de Tiotrópio/administração & dosagem , Idoso , Argentina , Álcoois Benzílicos/efeitos adversos , Broncodilatadores/efeitos adversos , Clorobenzenos/efeitos adversos , Substituição de Medicamentos , Europa (Continente) , Feminino , Volume Expiratório Forçado , Humanos , Análise de Intenção de Tratamento , Análise dos Mínimos Quadrados , Modelos Logísticos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Quinuclidinas/efeitos adversos , Recuperação de Função Fisiológica , África do Sul , Inquéritos e Questionários , Fatores de Tempo , Brometo de Tiotrópio/efeitos adversos , Resultado do Tratamento , Estados Unidos , Capacidade VitalRESUMO
BACKGROUND: The treatment of atrophic scars is difficult and dermal filler materials provide a simple alternative with immediate results. Esthélis® is an injectable non-animal crosslinked hyaluronic acid of Swiss origin characterized by a polydense cohesive matrix (CPM®) which produces a gel of uniform consistency with better biointegration to the tissues and a longer duration. OBJECTIVE: To evaluate Esthélis in the treatment of atrophic scars. PATIENTS AND METHODS: Twelve patients aged 18-56 years with facial atrophic scars caused by acne vulgaris, dog bite, piercing, basal cell carcinoma and leishmaniasis were treated with Esthélis. The injection technique was linear threading, serial puncture or a combination of both. Clinical efficacy was assessed independently by the authors and by patients immediately, one week and one month after the injection. Adverse events were registered. RESULTS: Authors described the results as moderate (27%), good (57%) and excellent (17%), immediately, one week and one month after the injection. Patients evaluated the cosmetic improvement as good (42%) or excellent (58%) one month after the treatment. Pain during the injection was described as slight or moderate. Only mild erythema was observed immediately after injection, which spontaneously resolved within few hours. CONCLUSION: Esthélis showed good or excellent results in most patients with atrophic scars, and these were perceived as even better when patients evaluated the cosmetic improvement. The best results were observed in patients with more deforming scars such as surgical scars or trauma.
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Carcinoma Basocelular/tratamento farmacológico , Clorobenzenos/uso terapêutico , Cicatriz/tratamento farmacológico , Sistemas de Liberação de Medicamentos , Face , Ácido Hialurônico/uso terapêutico , Sulfetos/uso terapêutico , Acne Vulgar/complicações , Acne Vulgar/patologia , Adulto , Atrofia , Carcinoma Basocelular/complicações , Carcinoma Basocelular/patologia , Clorobenzenos/efeitos adversos , Cicatriz/patologia , Cicatriz/cirurgia , Técnicas Cosméticas/efeitos adversos , Excipientes , Humanos , Ácido Hialurônico/efeitos adversos , Injeções , Pessoa de Meia-Idade , Punções , Sulfetos/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
Chromosome studies were done in 8 males and 18 females who were accidentally exposed for 4 work days (i.e., 8 hr/day) to vapors of ortho dichlorobenzene. The clinical symptoms in 10 individuals included headache, general malaise, dizziness, and nausea. All persons had variable degrees of mucosal irritations. Of the 1345 cells studied, 120 disclosed chromosomal aberrations (mean = 8.92%), whereas a control group of 11 healthy individuals revealed 19 cells with aberrations in 942 cells examined (mean = 2.02%). The main chromosomal alterations were 84 single breaks (6.25%) and 86 double breaks (6.39%). In the control group there were 2 single breaks (0.92%) and 10 double breaks (1.06%), with significant statistic values of P less than .001 for the exposed group. Other chromosomal aberrations were poliploidy and ring formation but these were not statistically significant. Chromosome studies conducted 6 months later in 15 persons of the exposed group disclosed a significant reduction of chromosomal aberrations, but these were still present as compared with the control group. Although definite chromosomal changes occurred, these alterations seemed to be reversible after several months, at least with an original 4-day exposure to the clastogen chemical.