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J Pain Res ; 13: 537-545, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32210609


Background: Studies have shown that interferon-beta (IFN-ß) treatment is associated with headaches in patients with multiple sclerosis (MS). Headaches can affect quality of life and overall function of patients with MS. We examined the frequency, relationships, patterns, and characteristics of headaches in response to IFN-ß in patients with relapsing-remitting multiple sclerosis (RRMS). Patients and Methods: This study was a prospective, longitudinal analysis with 1-year follow-up. The study comprised 796 patients with RRMS treated with IFN-ß (mean age 30.84±8.98 years) at 5 tertiary referral center outpatient clinics in Egypt between January 2015 and December 2017. Headaches were diagnosed according to the International Classification of Headache Disorders ICHD-3 (beta version), and data were collected through an interviewer-administered Arabic-language-validated questionnaire with an addendum specifically designed to investigate the temporal relationship between commencement of interferon treatment, and headache onset and characteristics. Results: Two hundred seventy-six patients had pre-existing headaches, and 356 experienced de novo headaches. Of 122 patients who experienced headaches before IFN-ß treatment, 55 reported headaches that worsened following onset of IFN-ß treatment. In patients with post-IFN-ß headaches, 329 had headaches that persisted for >3 months, 51 had chronic headaches, and 278 had episodic headaches, and 216 of these patients required preventive therapies. Univariate analysis showed a >6- and an approximately 5-fold increased risk of headache among those treated with intramuscular (IM) INF-ß-1a (OR 6.51; 95% CI: 3.73-10.01; P-value <0.0001) and 44 µg of SC INF-ß-1a (OR 5.44; 95% CI: 3.15-9.37; P-value <0.0001), respectively, compared with that in patients who received 22 µg of SC INF-ß-1a. Conclusion: Interferon-ß therapy aggravated pre-existing headaches and caused primary headaches in patients with MS. Headache risk was greater following treatment with IM INF-ß-1a and 44 µg SC INF-ß-1a.

BMJ Open ; 7(10): e017321, 2017 Oct 30.
Artículo en Inglés | MEDLINE | ID: mdl-29084796


INTRODUCTION: Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country. METHODS AND ANALYSIS: This pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group. ETHICS AND DISSEMINATION: Ethics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02402855; pre-results.

Motivación , Aceptación de la Atención de Salud , Complicaciones del Embarazo/prevención & control , Resultado del Embarazo , Atención Prenatal/economía , Clase Social , Adulto , Femenino , Feto , Francia , Edad Gestacional , Humanos , Salud del Lactante/economía , Recién Nacido , Salud Materna/economía , Embarazo , Complicaciones del Embarazo/economía , Derivación y Consulta , Proyectos de Investigación , Poblaciones Vulnerables , Adulto Joven