RESUMEN
Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, observational study conducted in 25 centres and 15 countries in five continents.428 culture-confirmed MDR-TB cases were analysed (61.5% male; 22.1% HIV-positive, 45.6% XDR-TB). MDR-TB cases were admitted to hospital for a median (interquartile range (IQR)) 179 (92-280) days and exposed to bedaquiline for 168 (86-180) days. Treatment regimens included, among others, linezolid, moxifloxacin, clofazimine and carbapenems (82.0%, 58.4%, 52.6% and 15.3% of cases, respectively).Sputum smear and culture conversion rates in MDR-TB cases were 63.6% and 30.1%, respectively at 30â days, 81.1% and 56.7%, respectively at 60â days; 85.5% and 80.5%, respectively at 90â days and 88.7% and 91.2%, respectively at the end of treatment. The median (IQR) time to smear and culture conversion was 34 (30-60) days and 60 (33-90) days. Out of 247 culture-confirmed MDR-TB cases completing treatment, 71.3% achieved success (62.4% cured; 8.9% completed treatment), 13.4% died, 7.3% defaulted and 7.7% failed. Bedaquiline was interrupted due to adverse events in 5.8% of cases. A single case died, having electrocardiographic abnormalities that were probably non-bedaquiline related.Bedaquiline-containing regimens achieved high conversion and success rates under different nonexperimental conditions.
Asunto(s)
Antituberculosos/uso terapéutico , Diarilquinolinas/uso terapéutico , Tuberculosis Extensivamente Resistente a Drogas/tratamiento farmacológico , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , Adulto , Carbapenémicos/uso terapéutico , Clofazimina/uso terapéutico , Estudios de Cohortes , Quimioterapia Combinada , Femenino , Infecciones por VIH/complicaciones , Humanos , Linezolid/uso terapéutico , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Estudios Retrospectivos , Esputo/metabolismo , Resultado del TratamientoRESUMEN
In patients with COPD non-naïve to rehabilitation we tested the feasibility, adherence and satisfaction of a home-based reinforcement telerehabilitation program (TRP). Outcomes were compared with a standard outpatient rehabilitation program (ORP). Then 18 TRP patients underwent 28 sessions of strength exercises (60 min) and cycle training (40 min) using a satellite platform provided telemonitoring, tele-prescription, video-assistance and phone-calls, patients were equipped with an oximeter, steps-counter, bicycle, remote control and interactive TV software. 18 matched ORP, retrospectively identified from our hospital ORP database, were used as controls. At baseline and end of program, the 6-min walking test (6MWT), Medical Research Council (MRC) scale and Saint George's Respiratory Questionnaire (SGRQ) were administered. In TRP only, we assessed platform use, incremental exercise, steps walked/day and patient satisfaction. TRP patients completed all sessions without side effects, used the remote control 1,394 ± 2,329 times being in the 84% of the cases satisfied with the service. In 22% of the cases patients found the technology unfriendly. Each health-professional performed 46 ± 65 actions, 14.6 ± 2.12 phone calls and 1 ± 1.67 videoconference sessions per patient. TRP patients increased physical activity (3,412 vs. 1,863 steps/day, p = 0.0002). Both programs produced significant (all, p < 0.01) gains in 6MWT [meters, TRP +34.22 ± 50.79; ORP +33.61 ± 39.25], dyspnea [TRP - 0.72 ± 0.89; ORP - 0.94 ± 0.53] and SGRQ [TRP - 6.9 ± 9.96, ORP - 9.9 ± 12.92] without between-group differences. In conclusion, TRP is feasible and well accepted by patients, although sometimes technology was perceived as difficult. It seems to improve walking capacity, dyspnea, quality of life and daily physical activity. Future RCTs will demonstrate cost-effectiveness.