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1.
Osteoporos Int ; 30(2): 391-402, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30178159

RESUMEN

An innovative, non-ionizing technique to diagnose osteoporosis on lumbar spine and femoral neck was evaluated through a multicenter study involving 1914 women. The proposed method showed significant agreement with reference gold standard method and, therefore, a potential for early osteoporosis diagnoses and possibly improved patient management. INTRODUCTION: To assess precision (i.e., short term intra-operator precision) and diagnostic accuracy of an innovative non-ionizing technique, REMS (Radiofrequency Echographic Multi Spectrometry), in comparison with the clinical gold standard reference DXA (dual X-ray absorptiometry), through an observational multicenter clinical study. METHODS: In a multicenter cross-sectional observational study, a total of 1914 postmenopausal women (51-70 years) underwent spinal (n = 1553) and/or femoral (n = 1637) DXA, according to their medical prescription, and echographic scan of the same anatomical sites performed with the REMS approach. All the medical reports (DXA and REMS) were carefully checked to identify possible errors that could have caused inaccurate measurements: erroneous REMS reports were excluded, whereas erroneous DXA reports were re-analyzed where possible and otherwise excluded before assessing REMS accuracy. REMS precision was independently assessed. RESULTS: In the spinal group, quality assessment on medical reports produced the exclusion of 280 patients because of REMS errors and 78 patients because of DXA errors, whereas 296 DXA reports were re-analyzed and corrected. Analogously, in the femoral group there were 205 exclusions for REMS errors, 59 exclusions for DXA errors, and 217 re-analyzed DXA reports. In the resulting dataset (n = 1195 for spine, n = 1373 for femur) REMS outcome showed a good agreement with DXA: the average difference in bone mineral density (BMD, bias ± 2SD) was -0.004 ± 0.088 g/cm2 for spine and - 0.006 ± 0.076 g/cm2 for femur. Linear regression showed also that the two methods were well correlated: standard error of the estimate (SEE) was 5.3% for spine and 5.8% for femur. REMS precision, expressed as RMS-CV, was 0.38% for spine and 0.32% for femur. CONCLUSIONS: The REMS approach can be used for non-ionizing osteoporosis diagnosis directly on lumbar spine and femoral neck with a good level of accuracy and precision. However, a more rigorous operator training is needed to limit the erroneous acquisitions and to ensure the full clinical practicability.


Asunto(s)
Cuello Femoral/diagnóstico por imagen , Vértebras Lumbares/diagnóstico por imagen , Osteoporosis Posmenopáusica/diagnóstico por imagen , Absorciometría de Fotón/métodos , Anciano , Densidad Ósea/fisiología , Estudios Transversales , Femenino , Cuello Femoral/fisiopatología , Humanos , Vértebras Lumbares/fisiopatología , Persona de Mediana Edad , Osteoporosis Posmenopáusica/fisiopatología , Reproducibilidad de los Resultados , Ultrasonografía/métodos
2.
Reumatismo ; 71(1): 24-30, 2019 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-30932440

RESUMEN

We performed a retrospective analysis to evaluate the survival on first line biologic drug of rheumatoid arthritis (RA) patients with potential occult HBV infection (pOBI). We analysed longitudinal data of 486 consecutive RA patients starting a first biological drug in a time frame from 1st January 2008 to 31st December 2014. Demographic and disease related characteristics were collected at baseline and at the last observation visit. Baseline serological markers of HBV infection and causes of treatment discontinuation were also recorded. Primary endpoint was the influence of pOBI on drug survival, estimated by Kaplan-Meier life table analysis. Estimates hazard ratios (HRs) of drug discontinuation, adjusted for disease characteristics, biological drug class and HBcAb status were computed by Cox-regression models. The retention rate was significantly lower in pOBI positive patients (58.2%) when compared to pOBI negative ones (67.8%) and this data was confirmed also when only discontinuation due to ineffectiveness was considered (pOBI positive 66.4% vs pOBI negative 75.3%, long rank 7.93, p=0.005). Cox regression models showed a significant association between HBcAb-neg (HR 0.58, 0.41-0.84), higher ESR-DAS28 at baseline (HR 1.07, 1.03-1.11) or RF/ACPA-neg (HR 1.46, 1.04-2.06) and drug discontinuation. Occult HBV infection seems to influence negatively the effectiveness of biological therapies in RA patients.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Hepatitis B/complicaciones , Inmunosupresores/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Abatacept/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Citrulinación , ADN Viral/sangre , Etanercept/uso terapéutico , Femenino , Glucocorticoides/uso terapéutico , Antígenos del Núcleo de la Hepatitis B/sangre , Virus de la Hepatitis B/genética , Virus de la Hepatitis B/inmunología , Humanos , Estimación de Kaplan-Meier , Masculino , Metotrexato/uso terapéutico , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos
3.
Reumatismo ; 69(1): 30-39, 2017 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-28535619

RESUMEN

Osteoporosis and fractures are common and invalidating consequences of chronic glucorticoid (GC) treatment. Reliable information regarding the epidemiology of GC induced osteoporosis (GIOP) comes exclusively from the placebo group of randomized clinical trials while observational studies are generally lacking data on the real prevalence of vertebral fractures, GC dosage and primary diagnosis. The objective of this study was to evaluate the prevalence and incidence of osteoporotic fractures and to identify their major determinants (primary disease, GC dosage, bone mineral density, risk factors, specific treatment for GIOP) in a large cohort of consecutive patients aged >21 years, on chronic treatment with GC (≥5 mg prednisone - PN - equivalent) and attending rheumatology centers located all over Italy. Glucocorticoid Induced OsTeoporosis TOol (GIOTTO) is a national multicenter cross-sectional and longitudinal observational study. 553 patients suffering from Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Connective Tissue Diseases (CTDs) and in chronic treatment with GCs were enrolled. Osteoporotic BMD values (T score <-2.5) were observed in 28%, 38% and 35% of patients with CTDs, PMR or RA at the lumbar spine, and in 18%, 29% and 26% at the femoral neck, respectively. Before GC treatment, prevalent clinical fractures were reported by 12%, 37% and 17% of patients with CTDs, PMR, or RA, respectively. New clinical fragility fractures during GC treatment were reported by 12%, 10% and 23% of CTDs, PMR and RA patients, respectively. Vertebral fractures were the prevailing type of fragility fracture. More than 30% of patients had recurrence of fracture. An average of 80% of patients were in supplementation with calcium and/or vitamin D during treatment with GCs. Respectively, 64%, 80%, and 72% of the CTDs, PMR and RA patients were on pharmacological treatment for GIOP, almost exclusively with bisphosphonates. The GIOTTO study might provide relevant contributions to clinical practice, in particular by highlighting and quantifying in real life the prevalence of GIOP and relative fractures, the frequency of the main risk factors, and the currently sub-optimal prevention. Moreover, these results emphasize the importance of the underlying rheumatic disease on the risk of GIOP associated fractures.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Glucocorticoides/efectos adversos , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/prevención & control , Enfermedades Reumáticas/tratamiento farmacológico , Vitamina D/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Artritis Reumatoide/tratamiento farmacológico , Estudios Transversales , Femenino , Glucocorticoides/administración & dosificación , Humanos , Incidencia , Italia/epidemiología , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Fracturas Osteoporóticas/diagnóstico , Polimialgia Reumática/tratamiento farmacológico , Prevalencia , Factores de Riesgo , Resultado del Tratamiento
4.
Reumatismo ; 68(4): 188-194, 2016 Dec 31.
Artículo en Inglés | MEDLINE | ID: mdl-28299917

RESUMEN

The study aimed to assess in a population of subjects with rheumatoid arthritis (RA) treated with methotrexate (MTX) how the initial approach to the treatment influenced subsequent disability. We performed a cross-sectional analysis of data collected during the baseline visit of the MARI study, a multicenter observational study on patients with RA on treatment with MTX for at least 12 months. Subjects who fulfilled the Health Assessment Questionnaire (HAQ) were included in the evaluation. For every patient we retrospectively evaluated the disease duration, the duration of symptoms before the diagnosis, the time elapsed before first MTX treatment, the initial MTX dose, and the concomitant medications in the first six months of therapy. Disability was defined as a DI-HAQ score ≥1. The study population included 1015 subjects. Patients with a DI-HAQ score ≥1 had a longer duration of symptoms before diagnosis, a higher delay in treatment initiation, a lower initial dose of MTX and a more frequent co-treatment with symptomatic drugs. Disability was found less frequently in subjects treated with other concomitant disease modifying anti-rheumatic drugs (DMARDs) but not with biological agents. Logistic regression analysis identified as significant predictors of disability: older age, female sex, a longer time to complete diagnosis, a delay in starting MTX treatment higher than 6 months, and a concomitant treatment with symptomatic drugs, while a combination therapy with other DMARDs was associated with a lower risk of disability. A late diagnosis and a delay in starting a treatment with MTX are associated with poorer functional outcomes in patients with RA.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Metotrexato/uso terapéutico , Adulto , Anciano , Estudios Transversales , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
5.
Reumatismo ; 66(3): 224-32, 2014 Nov 06.
Artículo en Inglés | MEDLINE | ID: mdl-25376957

RESUMEN

The paper reports the results from the observational retrospective-prospective RUBINO study conducted in Italy to assess the safety of rituximab in the treatment of rheumatoid arthritis (RA) in routine clinical practice. The percentage of patients who manifested at least one grade 3 or 4 adverse event (AE) assessed by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v.3) during the observation period (primary objective) was evaluated. The percentage of patients manifesting a severe AE (SAE), clinical response to rituximab treatment, clinical remission according to disease activity score for 28 joints (DAS28) criteria, markers of disease and quality of life were also assessed. Fifty-three Italian rheumatology centers took part in the study. Patients with a diagnosis of RA and inadequate response to anti-tumor necrosis factor b (anti-TNFa) drugs were enrolled. Participating patients had previously received at least one cycle of rituximab, and treatment was still ongoing at the time of recruitment. Out of 205 patients enrolled, 60% manifested no form of AE, 14.2% had at least one grade 3 or 4 AE, and 11.2% patients reported an SAE. The overall percentage of patients manifesting AEs (40%) was lower compared to the DANCER (81% and 85%), REFLEX (85%) and RESET (85% and 69%) studies, but higher than that observed in the CERERRA registry (from 10.2% to 13.9%). This difference may be due to the shorter observation period applied in the CERERRA registry (only 12 months) compared to the RUBINO study (up to 3 years). All parameters of RA activity (erythrocyte sedimentation rate, C-reactive protein, health assessment questionnaire score, DAS28) improved significantly during the study.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Rituximab/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antirreumáticos/efectos adversos , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Rituximab/efectos adversos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adulto Joven
6.
Reumatismo ; 65(5): 240-7, 2013 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-24399187

RESUMEN

Systemic sclerosis (scleroderma) is a disease of unknown cause, the hallmark of which is induration of the skin. This bad condition of the skin influences negatively the quality of life of patients with scleroderma. The aim of the study was to verify the efficacy of two formulations, specifically designed to wash, moisturize and soothe the scleroderma skin. An independent, randomized, double blind, controlled trial was conducted in the Department of Rheumatology of "A. Galateo" Hospital in San Cesario di Lecce. Forty-six women affected by scleroderma, and treated with Iloprost every month, were divided into two groups: group 1 followed a specific treatment with cleansing formulation only, group 2 followed a combined treatment with the cleansing solution and the moisturizing solution. In addition, a third group was evaluated: 14 women, who did not undergo intravenous Iloprost therapy, were treated simultaneously with the cleansing formulation and the moisturizing formulation. The three treatments lasted for 4 weeks. Reduction in trans epidermal water loss (TEWL), increase in moisturization of the stratum corneum, reduction in Skin Score and improvement in quality of life were assessed. Very significant improvement in quality of life occurred in each group. Group 2 obtained very significant improvement in hydration and reduction in skin score and TEWL. The study showed that the daily use of both formulations proved to be effective in washing, hydrating and soothing the skin of patients with scleroderma, especially in association with Iloprost therapy.


Asunto(s)
Esclerodermia Sistémica/complicaciones , Crema para la Piel/uso terapéutico , Enfermedades de la Piel/tratamiento farmacológico , Enfermedades de la Piel/etiología , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad
7.
Reumatismo ; 65(3): 113-20, 2013 Jul 23.
Artículo en Inglés | MEDLINE | ID: mdl-23884026

RESUMEN

Vitamin D deficiency is very common in patients with rheumatoid arthritis (RA). Aim of this study was to evaluate the prevalence of vitamin D deficiency among the different Italian regions and whether these variations are associated with different severity of the disease. The study includes 581 consecutive RA patients (464 women), not taking vitamin D supplements, from 22 Italian rheumatology centres uniformly distributed across Italy. Together with parameters of disease activity (disease activity score 28), functional impairment (activities of daily living and health assessment questionnaire disability index) and mean sun exposure time, all patients had serum 25-hydroxyvitamin D (25OHD) measured in a centralized laboratory. Vitamin D deficiency (25OHD level <20 ng/mL) was very frequent among RA patients; its prevalence was 60%, 52% and 38% in southern, central and northern Italy, respectively. Mean disease activity and disability scores were worse in southern regions of Italy. These scores were inversely related to 25OHD levels and this correlation remained statistically significant after adjusting for both body mass index (BMI) and sun exposure time. However, disease severity remained significantly higher in southern regions versus central-northern Italy after adjustment also for serum 25OHD levels, age and BMI. In RA Italian patients there are significant regional differences in the prevalence of vitamin D deficiency explained by different BMI, and sun exposure time, and inversely associated with disease activity and disability scores.


Asunto(s)
Artritis Reumatoide/complicaciones , Deficiencia de Vitamina D/epidemiología , Deficiencia de Vitamina D/etiología , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Prevalencia , Índice de Severidad de la Enfermedad
8.
ESMO Open ; 7(6): 100629, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36399953

RESUMEN

BACKGROUND: Evaluation of health-related quality of life (HR-QoL) among cancer patients has gained an increasing importance and is now a key determinant of anticancer treatments' value. HR-QoL has been assessed in trials testing cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) in breast cancer (BC), using various questionnaires at different timepoints. HR-QoL reports from BC patients treated with CDK4/6i in the real-world setting are also available. METHODS: We systematically reviewed the literature, searching for full-length articles, and selected conference abstracts reporting data on HR-QoL in BC patients at any stage and of any molecular subtype treated with abemaciclib, palbociclib or ribociclib. RESULTS: A total of 533 full-length articles and 143 abstracts were retrieved. After screening for eligibility, 38 records were included (31 clinical trials; 7 real-world reports). Assessment methods were heterogeneous across studies in terms of questionnaires, evaluation timepoints and endpoints. Overall, adding CDK4/6i to endocrine therapy did not worsen patients' HR-QoL, with a positive trend towards pain improvement. Gastrointestinal scores (diarrhea, nausea and appetite loss) statistically favored the control arm among metastatic BC patients receiving abemaciclib, whereas they were superimposable in the early setting. The combination of palbociclib and endocrine therapy showed similar HR-QoL outcomes compared with endocrine therapy alone, but determined better scores compared with chemotherapy. HR-QoL was specifically assessed in premenopausal patients treated with ribociclib, showing similar scores compared with postmenopausal patients. CONCLUSIONS: Despite methodological heterogeneity does not allow a proper comparison, HR-QoL was generally maintained with CDK4/6i. However, differences between abemaciclib, palbociclib and ribociclib exist and mainly rely on the distinct safety profiles of the compounds. These differences should be acknowledged and taken into account in the clinical practice.


Asunto(s)
Neoplasias de la Mama , Inhibidores de Proteínas Quinasas , Calidad de Vida , Femenino , Humanos , Aminopiridinas/farmacología , Aminopiridinas/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Quinasa 4 Dependiente de la Ciclina/antagonistas & inhibidores , Quinasa 6 Dependiente de la Ciclina/antagonistas & inhibidores , Inhibidores de Proteínas Quinasas/uso terapéutico
9.
Musculoskelet Surg ; 105(1): 49-59, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32026381

RESUMEN

PURPOSE: To evaluate the outcomes of vertebral stabilisation after acute traumatic thoracolumbar fractures, correlating the outcome with patient clinical data, type and location of fracture, presence of neurological damage, timing of surgical intervention and number of instrumented levels. The results have been evaluated also through the AO classification and AOSIS score. METHODS: Retrospective analysis of 101 patients with traumatic thoracolumbar injuries from T3 to L5 operated 2011-2016 by posterior or antero-posterior fixation. The demographic data, trauma dynamics, number and type of fractures, associated lesions, timing of surgery, hospital stay, AOSIS score, RKA, SF-36 and ODI scores, pre- and post-operative neurological condition (ASIA grade), possible complications and re-interventions were evaluated for each patient. RESULTS: Fractures mainly involved the region between T11 and L2. The probability of medullary involvement increases with the increase in severity of the main fracture type with no relation with the vertebral region. Type B and C fractures were common in the thoracic region and rare in the thoracolumbar junction. ODI and SF-36 scores were significantly better in patients with a lower AOSIS score, specifically in lesions classified as type A, amyelic and with no comorbidity. No difference was found in the clinical scores between thoracic, thoracolumbar and lumbar fractures, nor between male and female patients. None of the 10 patients with ASIA A lesion at presentation achieved any degree of recovery: 50% of them had a thoracic lesion. Re-intervention rate was 15%. Hospital stay was significantly higher in patients with type C fractures, and complication rate was on average 14% (7% in type A fractures, 16% in B and 25% in C). CONCLUSIONS: This study confirmed the validity of the posterior approach in the surgical treatment of thoracolumbar fractures. Outcomes and complication risks are related to fracture severity. Surgical treatment can be recommended even with an AOSIS score of two or three. The combined antero-posterior approach could be useful in cases with LSC > 8, especially in the thoracolumbar region. The degree of neurological recovery depends on fracture type, location, ASIA score and presence of comorbidities. Early intervention in myelic patients allows for a better prognosis. Level of evidence III retrospective case series.


Asunto(s)
Fracturas de la Columna Vertebral , Vértebras Torácicas , Femenino , Fijación Interna de Fracturas , Humanos , Vértebras Lumbares/lesiones , Vértebras Lumbares/cirugía , Masculino , Periodo Posoperatorio , Estudios Retrospectivos , Fracturas de la Columna Vertebral/cirugía , Vértebras Torácicas/lesiones , Vértebras Torácicas/cirugía , Resultado del Tratamiento
10.
Osteoporos Int ; 21(8): 1323-30, 2010 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-19809775

RESUMEN

SUMMARY: A total of 507,671 people > or =65 experienced hip fractures between 2000 and 2005. In 2005, 94,471 people > or =65 were hospitalized due to hip fractures, corresponding to a 28.5% increase over 6 years. Most fractures occurred in patients > or =75 (82.9%; n = 420,890; +16% across 6 years), particularly in women (78.2%; n = 396,967). INTRODUCTION: We aimed to analyze incidence and costs of hip fractures in Italy over the last 6 years. METHODS: We analyzed the national hospitalization and DRG databases concerning fractures occurred in people > or =65 between 2000 and 2005. RESULTS: A total of 507,671 people > or =65 experienced hip fractures across 6 years, resulting in about 120,000 deaths. In year 2005 94,471 people aged > or =65 were hospitalized due to hip fractures, corresponding to a 28.5% increase over 6 years. The majority of hip fractures occurred in patients > or =75 (82.9%; n = 420,890; +16% across 6 years) and particularly in women (78.2%; n = 396,967). Among women, 84.2% of fractures (n = 334,223; +28.0% over 6 years) were experienced by patients > or =75, which is known to be the age group with the highest prevalence of osteoporosis, accounting for 68.6% of the overall observed increase in the total number of fractures. Hip fractures in men > or =75 increased by 33.1% (up to 16,540). Hospitalization costs increased across the six examined years (+36.1%) reaching 467 million euros in 2005, while rehabilitation costs rose up to 531 million in the same year. CONCLUSIONS: Hip fractures of the elderly are increasing and represent a major health problem in industrialized countries such as Italy.


Asunto(s)
Fracturas de Cadera/epidemiología , Fracturas Osteoporóticas/epidemiología , Distribución por Edad , Anciano , Grupos Diagnósticos Relacionados , Femenino , Costos de la Atención en Salud/estadística & datos numéricos , Fracturas de Cadera/rehabilitación , Hospitalización/estadística & datos numéricos , Hospitalización/tendencias , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Fracturas Osteoporóticas/rehabilitación , Distribución por Sexo
11.
Reumatismo ; 62(2): 113-8, 2010.
Artículo en Italiano | MEDLINE | ID: mdl-20657888

RESUMEN

OBJECTIVES: We aimed to analyze incidence and costs of hip fractures in Italy. METHODS: We analyzed the Italian Ministry of Health national hospitalization and DRGs databases concerning fractures occurred in people > or =65 between 2003 and 2005. We have estimated incidence and direct costs sustained by the National Health Service for hospitalization and treatment of hip fractures on the basis of the value of the Diagnosis Related Groups (DRGs) referring to hip fractures. The expenses of rehabilitation and indirect costs were based on regional estimations. RESULTS: Between 2003 and 2005 we registered almost 90,000 hospital admissions per year (corresponding to 75,000 patients) because of hip fractures in people aged > or =65. Women accounted for the majority of hospital admissions due to hip fractures (78.0%; n=214,519). Among women, 84.3% of fractures (n=180,861) occurred in patients > or =75, which is known to be the age group with the highest prevalence of osteoporosis. Hospitalizations of both men and women showed an increasing trend across all the examined period. Hospital costs increased up to 467 million euros in 2005, while rehabilitation costs rose up to 531 million in the same year. CONCLUSIONS: Hip fractures in the Italian population are increasing and represent a major public health challenge.


Asunto(s)
Costos de la Atención en Salud , Fracturas de Cadera/economía , Fracturas de Cadera/epidemiología , Anciano , Grupos Diagnósticos Relacionados , Femenino , Fracturas de Cadera/etiología , Humanos , Incidencia , Italia/epidemiología , Tiempo de Internación/economía , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Osteoporosis/complicaciones , Admisión del Paciente/economía , Admisión del Paciente/estadística & datos numéricos , Prevalencia , Estudios Retrospectivos , Factores de Riesgo
12.
Curr Med Res Opin ; 6(9): 598-605, 1980.
Artículo en Inglés | MEDLINE | ID: mdl-7408527

RESUMEN

Twenty in-patients with rheumatoid arthritis took part in a double-blind, crossover clinical trial to compare the effectiveness and tolerance of 400 mg indoprofen with 1000 mg aspirin each given 3-times a day for 1 week, with an interval of 2 days during which patients received an indistinguishable placebo. At the start and at the end of each treatment period several subjective and objective indices were measured. Both indoprofen and aspirin to remable improvement in patient conditions, with no significant differences between drugs in overall pain, number of swollen joints, grip strength and functional index. Indoprofen, however, was significantly superior to aspirin with regard to the number of painful joints (p < 0.01), duration of morning stiffness (p < 0.05) and articular index (p < 0.05). Moreover, both patients' and investigators' opinion of overall response favoured indoprofen. Small but significant decreases were recorded in ertythrocyte sedimentation rate and seromucoid levels in both treatment periods. Adverse reactions, mainly as gastric pyrosis and/or gastralgia, occurred in 6 patients while on aspirin, in 2 while on indoprofen, and in a further 2 while on both drugs. No statistically significant changes were observed in safety laboratory tests.


Asunto(s)
Artritis Reumatoide/tratamiento farmacológico , Aspirina/uso terapéutico , Indoprofeno/uso terapéutico , Fenilpropionatos/uso terapéutico , Adulto , Anciano , Aspirina/efectos adversos , Aspirina/sangre , Método Doble Ciego , Femenino , Humanos , Indoprofeno/efectos adversos , Indoprofeno/sangre , Masculino , Persona de Mediana Edad
13.
Adv Exp Med Biol ; 478: 419-20, 2000.
Artículo en Inglés | MEDLINE | ID: mdl-11065111

RESUMEN

The relation between mother's diet and breast milk composition is still an open question. An important issue is whether mothers who are breast feeding modify, respect to before lactation, food intake to satisfy the increased requirements.


Asunto(s)
Alimentación con Biberón , Lactancia Materna , Dieta/normas , Ingestión de Alimentos , Femenino , Humanos , Lactante , Recién Nacido , Leche Humana/química , Encuestas y Cuestionarios
14.
Int J Clin Pharmacol Res ; 20(3-4): 61-4, 2000.
Artículo en Inglés | MEDLINE | ID: mdl-11314239

RESUMEN

Steroid therapy is the third most common cause of osteoporosis, after loss of gonad function and senescence. The aim of the present study was to evaluate the protective action of clodronate on bone mass loss induced by steroid therapy. Sixty patients with bronchial asthma receiving either fluticasone (250 mg x 4/day) or beclomethasone (250 mg x 4/day) inhaled corticosteroid treatment were enrolled. Half the patients received combination treatment with clodronate (100 mg i.m./14 days), for a total period of 12 months. All patients were evaluated at baseline and at the end of treatment for bone mineral density (BMD) and calcium/phosphor metabolism parameters (kalemia, kaluria, phosphoremia, phosphaturia, alkaline phosphatase and hydroxyprolinuria over a 24-h period). The results of this preliminary study confirm the protective influence of clodronate on bone mass loss, as documented by the increment in mean values in BMD reported at the end of treatment compared with baseline values.


Asunto(s)
Androstadienos/efectos adversos , Asma/tratamiento farmacológico , Beclometasona/efectos adversos , Ácido Clodrónico/uso terapéutico , Osteoporosis/prevención & control , Administración por Inhalación , Anciano , Androstadienos/uso terapéutico , Antiasmáticos/efectos adversos , Antiasmáticos/uso terapéutico , Asma/fisiopatología , Beclometasona/uso terapéutico , Densidad Ósea/efectos de los fármacos , Enfermedad Crónica/tratamiento farmacológico , Fluticasona , Humanos , Bombas de Infusión , Masculino , Persona de Mediana Edad , Osteoporosis/inducido químicamente
15.
Minerva Med ; 71(50): 3655-63, 1980 Dec 15.
Artículo en Italiano | MEDLINE | ID: mdl-6161325

RESUMEN

LE cells, ds-DNA antibodies (radioimmunoassay), antinuclear antibodies (ANA) by indirect immunofluorescence (IFI) and anti-ENA antibodies have been sought in 150 clinical cases observed over a 5-year period in the Rheumatology Division of Bari University. For the latter, three parallel techniques were adopted on each serum, each completed by RNA-sensitivity assay for the demonstration of anti-RNP, i.e. IFI, passive haemoagglutination (PHA) and controimmunoelectrophoresis (CIE). The series included systemic lupus erythematodes (SLE), 30 cases; rheumatoid arthritis (RA), 30 cases; progressive systemic sclerosis (PSS), 12 cases; unclassified connective tissue disease (UCTD), 8 cases; mixed connective tissue disease (MCTD), 7 cases; Sjögren's syndrome (SS), 4 cases; dermatomyositis (DM), 3 cases; overlap syndromes (PSS-SLE, SS-SLE), 2 cases; rheumatological and internal miscellanea, 54 cases, LE cells and ds-DNA antibodies were found exclusively in SLE; the anti-ENA were found in various groups of diseases, while the anti-RNP were only demonstrated in the 7 MCTD and in some SLE. Of the three techniques for demonstrating anti-ENA, the PHA proved most sensitive and CIE most specific, whereas IFI was considered most suitable for clinical screening. The clinical aspects of the 7 MCTD faithfully followed the disease picture described by Sharp, but some overlap-syndromes and the unclassified connective tissue diseases did not present anti-RNP. It is also pointed out that nephropathy is not rare in MCTD and that the clinical course of the disease is not always benign. To conclude, it is considered that MCTD merits nosographic autonomy, but further investigations are recommended for more exact nosographical typing of connective tissue diseases.


Asunto(s)
Enfermedad Mixta del Tejido Conjuntivo/diagnóstico , Anticuerpos/análisis , Anticuerpos Antinucleares/análisis , Artritis Reumatoide/inmunología , Enfermedades del Tejido Conjuntivo/inmunología , Contrainmunoelectroforesis , Dermatomiositis/inmunología , Técnica del Anticuerpo Fluorescente , Humanos , Inmunoensayo , Lupus Eritematoso Sistémico/inmunología , Enfermedad Mixta del Tejido Conjuntivo/clasificación , Enfermedad Mixta del Tejido Conjuntivo/inmunología , Neutrófilos , Enfermedades Reumáticas/inmunología , Ribonucleoproteínas , Síndrome de Sjögren/inmunología , Panencefalitis Esclerosante Subaguda/inmunología
16.
Int J Tissue React ; 25(2): 73-8, 2003.
Artículo en Inglés | MEDLINE | ID: mdl-14518596

RESUMEN

The aim of the present study was to determine the safety and efficacy of combined therapy with raloxifene (RLX) and clodronate (CLD) in postmenopausal women. We enrolled 45 women with postmenopausal osteoporosis. The patients were randomly assigned to two different therapeutic groups: RLX 60 mg/day (n = 23) and RLX 60 mg/day plus CLD 100 mg intramuscularly (i.m.) once every 10 days (n = 22); 1 g of calcium and 800 IU of vitamin D3 were also given daily to both groups. Lumbar and femoral bone mineral density (BMD) were assessed at baseline and after 12 months of therapy using the dual X-ray absorptiometry technique (Norland XR36). We measured the bone turnover markers NTx and CTx, bone alkaline phosphatase (BAP) and osteocalcin at baseline and after 12 months of therapy. Our data demonstrate that 1 year of combined RLX+CLD therapy induced a higher increase in lumbar BMD than treatment with RLX alone as well as a major decrease in bone resorption markers, suggesting an additive effect of CLD on bone mass and inhibition of bone turnover. Furthermore, after 1 year of therapy levels of bone formation markers (osteocalcin and BAP) had increased in both groups, but the increase in osteocalcin and BAP was significantly higher in the RLX+CLD treated group, suggesting that, in addition to its inhibitory effects on resorption, CLD might also have stimulatory effects on mature osteoblast activity.


Asunto(s)
Densidad Ósea/efectos de los fármacos , Remodelación Ósea/fisiología , Ácido Clodrónico/uso terapéutico , Osteoporosis Posmenopáusica/tratamiento farmacológico , Clorhidrato de Raloxifeno/uso terapéutico , Absorciometría de Fotón , Anciano , Biomarcadores/sangre , Remodelación Ósea/efectos de los fármacos , Resorción Ósea/tratamiento farmacológico , Resorción Ósea/fisiopatología , Colecalciferol/farmacología , Ácido Clodrónico/administración & dosificación , Ácido Clodrónico/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Osteoporosis Posmenopáusica/fisiopatología , Clorhidrato de Raloxifeno/administración & dosificación , Clorhidrato de Raloxifeno/efectos adversos , Moduladores Selectivos de los Receptores de Estrógeno/efectos adversos , Moduladores Selectivos de los Receptores de Estrógeno/uso terapéutico
17.
Reumatismo ; 53(4): 309-311, 2001.
Artículo en Italiano | MEDLINE | ID: mdl-12089625

RESUMEN

We studied the case of a male patient aged 43 affected by post-traumatic chronic osteomyelitis with frequent relapses. Having supposed an insufficiency of the arterial and venous microcirculation in perilesional bone and soft tissue we decided for a therapy with iloprost and antibacterial drugs. After 15 months of treatment the patient hasn't showed any clinically evident relapsing episodes and we have not reported any side effects related to the therapy.

18.
Reumatismo ; 56(4): 235-41, 2004.
Artículo en Italiano | MEDLINE | ID: mdl-15643475

RESUMEN

Diabetes mellitus and osteoporosis are chronic diseases with an elevated and growing incidence in the elderly. Recent epidemiological studies have demonstrated an elevated risk of hip, humerus and foot fractures in elder diabetic subjects. While type 1 diabetes is generally associated with a mild reduction in bone mineral density (BMD), type 2 diabetes, more prevalent in old subjects, is frequently linked to a normal or high BMD. Studies on experimental models of diabetes have suggested an altered bone structure that may help to explain the elevated risk of fractures observed in these animals and may as well help to explain the paradox of an incremented risk of fractures in type 2 diabetic elderly in the presence of normal or elevated BMD. In addition, diabetic elderly have an increased risk of falls, consequent at least in part to a poor vision, peripheral neuropathy, and weaken muscular performance. Diabetes may affect bone tissue by different mechanisms including obesity, hyperinsulinemia, deposit of advanced glycosilation end products in collagen fibre, reduced circulating levels of IGF-1, hypercalciuria, renal function impairment, microangiopathy and chronic inflammation. A better understanding of these mechanisms may help implement the prevention of fractures in the growing population of mature diabetics.


Asunto(s)
Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Osteoporosis/complicaciones , Accidentes por Caídas , Factores de Edad , Anciano , Anciano de 80 o más Años , Animales , Densidad Ósea , Diabetes Mellitus Experimental , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Femenino , Estudios de Seguimiento , Fracturas Óseas/etiología , Fracturas Óseas/prevención & control , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Masculino , Persona de Mediana Edad , Osteoporosis/etiología , Estudios Prospectivos , Ratas , Factores de Riesgo , Factores Sexuales , Factores de Tiempo
19.
Reumatismo ; 54(3): 251-6, 2002.
Artículo en Italiano | MEDLINE | ID: mdl-12404034

RESUMEN

OBJECTIVE: To evaluate if parenteral gold-therapy with Sodium gold thiosulfate is effective and safe for the treatment of rheumatoid arthritis we began an open, multicenter trial. METHODS: 126 rheumatoid arthritis patients were treated with Sodium gold thiosulfate for two years. Efficacy, quality of life, progression of joint damage, inflammatory parameters and side effects were evaluated. RESULTS: Gold salts reduced joint inflammation and improved subjective and objective symptoms, quality of life and activity of illness within 6 months. Side effects appeared in 13,8% of all cases and regressed, promptly, when gold therapy stopped. The poor efficacy caused the interruption and the change from the gold therapy to others disease-modifying anti-rheumatic drugs (DMRDs) in 17,8 % of the patients. CONCLUSIONS: The follow-up showed Sodium gold thiosulfate was effective in Rheumatoid Arthritis and the survival in therapy was of 77,8% to one year and of 68,4% to two years.


Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Tiosulfato Sódico de Oro/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/efectos adversos , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Progresión de la Enfermedad , Erupciones por Medicamentos/etiología , Femenino , Estudios de Seguimiento , Tiosulfato Sódico de Oro/administración & dosificación , Tiosulfato Sódico de Oro/efectos adversos , Humanos , Enfermedades Renales/inducido químicamente , Masculino , Persona de Mediana Edad , Calidad de Vida , Seguridad , Índice de Severidad de la Enfermedad
20.
G Ital Med Lav Ergon ; 25 Suppl(3): 241-2, 2003.
Artículo en Italiano | MEDLINE | ID: mdl-14979168

RESUMEN

The aim of the present study was to identify the way the occupational injuries with biological risk can happen in order to find the right measures of prevention and protection and to periodically verify their efficacy. The study started in January 1996 and ended in December 2001 and included 2750 subjects working in the sanitary field. A module (module A), was created to collect all the accident data. For every occupational injury with biological risk, a specific procedure is activated, including: Emergency Room, Sanitary Direction, Infective Diseases Division, Competent Physician. The injuries were classified, according to: sex, age, work qualify, division, object causing injury, modality, anatomical location, type of injury, working turn, and time phase. Most of the division underlined a higher risk the procedures that expose the subjects to accidental punctures with infected needle, such as injection therapy, blood tests, butterfly insertion and removal, etc. Old and bad attitudes, such as needle recapping are still used, even if the law is clear. None occupational injury showed serum conversion. It could be a consequence of the post exposition prophylaxis performed by the infectivologists and of the HBV prophylaxis.


Asunto(s)
Accidentes de Trabajo/estadística & datos numéricos , Personal de Salud , Humanos , Factores de Riesgo
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