RESUMEN
OBJECTIVES: Hyoid expansion is a novel procedure that was developed to widen and stabilize the lateral walls of the hypopharynx in order to improve obstructive sleep apnea. This study was conducted to evaluate the safety, efficacy and feasibility of hyoid expansion. STUDY DESIGN: A prospective, non-randomized multicenter pilot study with a follow-up of 6 months was conducted. METHOD: An implantable device (the Air-Frame system) was used to surgically expand the hyoid bone. Subjective and objective outcome measures were evaluated. RESULTS: The procedure was successfully performed in all patients without technical adverse events. There were three clinical adverse events, and tolerance was good. Although there was a significant improvement in snoring and excessive daytime sleepiness, there was no objective improvement of the apnea-hypopnea index as measured by polysomnography. CONCLUSION: Hyoid expansion did not provide objective improvement of obstructive outcome measures in patients with obstructive sleep apnea syndrome.
Asunto(s)
Hueso Hioides/cirugía , Prótesis e Implantes , Apnea Obstructiva del Sueño/cirugía , Adulto , Trastornos de Somnolencia Excesiva/cirugía , Diseño de Equipo , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Polisomnografía , Complicaciones Posoperatorias/diagnóstico , Estudios Prospectivos , Apnea Obstructiva del Sueño/diagnóstico , Ronquido/cirugía , Instrumentos QuirúrgicosRESUMEN
BACKGROUND: When inhaling medication, it is essential that drug particles are delivered to all sites of lung inflammation, including the peripheral airways. The aim of this study was to assess the lung deposition and lung distribution of beclomethasone dipropionate (BDP)/formoterol (100/6 microg), both dissolved in hydrofluoroalkane (HFA) and delivered by pressurized metered dose inhaler (pMDI) in healthy subjects, asthmatic, and chronic obstructive pulmonary disease (COPD) patients, to investigate how the in vitro characteristics of the formulation translate into the in vivo performance in diseases with different airway obstruction. METHODS: Healthy volunteers (n = 8), persistent asthmatics (n = 8), and patients with stable COPD (n = 8) completed this open-label, single-dose parallel-group study. Each patient received one single treatment of four puffs of (99 m)Tc-labeled BDP/formoterol formulation. The correlation between particle size distribution of radioactivity and of the drugs in the radiolabeled formulation was validated. Intra- and extrapulmonary deposition, amount of exhaled drug, and the central to peripheral ratio (C/P) were calculated immediately after inhalation. Patients' lung function and pharmacokinetic parameters were also assessed up to 24 h post-dose. RESULTS: The average lung deposition of BDP/formoterol was 34.08 +/- 9.30% (relative to nominal dose) in healthy subjects, 30.86 +/- 8.89% in asthmatics, and 33.10 +/- 8.90% in COPD patients. Extrathoracic deposition was 53.48% +/- 8.95, 57.64% +/- 9.92 and 54.98% +/- 7.01, respectively. C/P ratios of 1.42 +/- 0.32 in healthy subjects, 1.96 +/- 0.43 in asthmatics, and 1.94 +/- 0.69 for COPD patients confirmed drug distribution to all regions of the lungs. Forced expiratory volume in 1 sec (FEV(1)) increased in all groups after BDP/formoterol inhalation, but was more evident in the patient groups. No significant correlation between baseline lung function and drug deposition was observed. Formoterol, BDP, and beclomethasone 17 monopropionate (B17MP) plasma profiles were comparable between groups. CONCLUSION: Inhalation of BDP/formoterol HFA (100/6 microg) produces high and homogeneous deposition of BDP and formoterol in the airways, regardless of pathophysiological condition.
Asunto(s)
Beclometasona/farmacocinética , Etanolaminas/farmacocinética , Pulmón/metabolismo , Administración por Inhalación , Adulto , Anciano , Antiinflamatorios/administración & dosificación , Antiinflamatorios/farmacocinética , Asma/tratamiento farmacológico , Beclometasona/administración & dosificación , Broncodilatadores/administración & dosificación , Broncodilatadores/farmacocinética , Estudios de Casos y Controles , Combinación de Medicamentos , Etanolaminas/administración & dosificación , Femenino , Volumen Espiratorio Forzado , Fumarato de Formoterol , Humanos , Masculino , Inhaladores de Dosis Medida , Persona de Mediana Edad , Tamaño de la Partícula , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Pruebas de Función Respiratoria , Distribución TisularRESUMEN
RATIONALE: The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices. OBJECTIVES: Our purpose was to compare the efficacy of both types of devices in patients with SDB. METHODS: A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval. MEASUREMENTS AND MAIN RESULTS: A total of 35 patients (29 males; age, 49 +/- 9 yr; apnea-hypopnea index [AHI], 13 +/- 11 events/h; body mass index, 28 +/- 4 kg/m(2)) completed the protocol. AHI was only reduced with the custom-made device (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001). CONCLUSIONS: In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.