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1.
Artigo em Russo | MEDLINE | ID: mdl-25345629

RESUMO

UNLABELLED: Multiple sclerosis (MS) is a chronic autoimmune demyelinating disorder of the central nervous system. Nowadays some disease-modifying drugs (DMD) in the Russian Federation (RF) are biosimilars. Their full spectrum of tolerability and efficacy is to be determined. Here we present results of two retrospective-prospective studies on efficacy and safety of a biosimilar interferon beta-1a (genfaxon) in treatment of MS in the RF. AIMS: determination of safety and efficacy profile of genfaxon in a routine neurological practice in the RF. MATERIALS AND METHODS: Trials were performed in 18 MS centers in the RF. A total of 649 patients aged from 18 to 68 years with the EDSS score no more than 6.0 were treated with genfaxon for 12 months. The first group was comprised of 'naïve' patients without previous history of DMD administration. There were patients in the second group which have already received some of DMD. Statistical analysis was performed with the help of significance criteria (χ-square), t-criteria of Student for analysis of independent samplings. RESULTS: There were no serious adverse events during the period of the study. "Naïve" patients had significantly lower number of adverse events, than patients with previous history of DMD usage. Efficacy results were comparable with results published for the Rebif. CONCLUSIONS: Data, received from the studies show equal efficacy and tolerability of genfaxon compared with original DMD Rebif.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Interferon beta-1a/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adolescente , Adulto , Medicamentos Biossimilares/efeitos adversos , Feminino , Humanos , Interferon beta-1a/efeitos adversos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Federação Russa , Resultado do Tratamento , Adulto Jovem
2.
J Perinatol ; 34(1): 33-8, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24071904

RESUMO

OBJECTIVE: To reduce exposure to hyperoxia and its associated morbidities in preterm neonates. STUDY DESIGN: A multidisciplinary group was established to evaluate oxygen exposure in our neonatal intensive care unit. Infants were assigned target saturation ranges and signal extraction technology implemented to temporally quantify achievement of these ranges. The outcomes bronchopulmonary dysplasia/death, retinopathy of prematurity (ROP)/death, severe ROP and ROP requiring surgery were compared in a pre- versus post-intervention evaluation using multivariate analyses. RESULT: A total of 304 very low birth weight pre-initiative infants were compared with 396 post-initiative infants. Multivariate analyses revealed decreased odds of severe ROP (adjusted odds ratio (OR): 0.41; 95% confidence interval (CI): 0.24-0.72) and ROP requiring surgery (adjusted OR 0.31; 95% CI: 0.17-0.59) post-initiative. No differences in death were observed. CONCLUSION: Significant reductions in severe ROP and ROP requiring surgery were observed after staff education and implementation of new technology to quantify success in achieving targeted saturations and reinforce principles and practices.


Assuntos
Hiperóxia/terapia , Oxigênio/sangue , Displasia Broncopulmonar/prevenção & controle , Feminino , Humanos , Hiperóxia/sangue , Hiperóxia/complicações , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Masculino , Oximetria , Retinopatia da Prematuridade/prevenção & controle
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