Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 36.133
Filtrar
1.
Bone Joint J ; 103-B(5): 916-922, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33934662

RESUMEN

AIMS: It can be extremely challenging to determine whether to perform reimplantation in patients who have contradictory serum inflammatory markers and frozen section results. We investigated whether patients with a positive frozen section at reimplantation were at a higher risk of reinfection despite normal ESR and CRP. METHODS: We retrospectively reviewed 163 consecutive patients with periprosthetic joint infections (PJIs) who had normal ESR and CRP results pre-reimplantation in our hospital from 2014 to 2018. Of these patients, 26 had positive frozen sections at reimplantation. The minimum follow-up time was two years unless reinfection occurred within this period. Univariable and multivariable logistic regression analyses were performed to identify the association between positive frozen sections and treatment failure. RESULTS: Treatment failure occurred in eight (30.77%) of the 26 PJI patients with positive frozen sections at reimplantation, compared with 13 (9.49%) of 137 patients with negative results. In the multivariate analysis, positive frozen section increased the risk of failure (odds ratio 4.70; 95% confidence interval (CI) 1.64 to 13.45). The mean number of months to reinfection was lower in the positive frozen section group than in the control group (p = 0.041). While there were nine (34.62%) patients with positive frozen section and 25 (18.25%) patients with negative frozen section who had prolonged antibiotic use (p = 0.042), the mean duration of antibiotic use was comparable in two groups. Synovial white blood cell count (p = 0.137) and polymorphonuclear leucocyte percentage (p = 0.454) were not associated with treatment failure in logistic regression model. CONCLUSION: Positive frozen section at reimplantation was independently associated with subsequent failure and earlier reinfection, despite normal ESR and CRP levels pre-reimplantation. Surgeons should be aware of the risk of treatment failure in patients with positive frozen sections and carefully consider benefits of reimplantation. Cite this article: Bone Joint J 2021;103-B(5):916-922.


Asunto(s)
Artroplastia de Reemplazo de Cadera/métodos , Artroplastia de Reemplazo de Rodilla/métodos , Sedimentación Sanguínea , Proteína C-Reactiva/análisis , Secciones por Congelación , Infecciones Relacionadas con Prótesis/cirugía , Biomarcadores/sangre , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reoperación , Estudios Retrospectivos , Riesgo , Insuficiencia del Tratamiento
2.
Medicine (Baltimore) ; 100(17): e25481, 2021 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-33907096

RESUMEN

ABSTRACT: Identifying predictors of inadequate response to methotrexate (MTX) in rheumatoid arthritis (RA) is key to move from a "trial and error" to a "personalized medicine" treatment approach where patients less likely to adequately respond to MTX monotherapy could start combination therapy at an earlier stage. This study aimed to identify potential predictors of inadequate response to MTX in RA patients naïve to disease modifying anti-rheumatic drugs.Data from a real-life cohort of newly diagnosed RA patients starting MTX (baseline, T0) as first-line therapy were analyzed. Outcomes, assessed after 6 months (T1), were defined as failure to achieve a disease activity score 28 (DAS28) low disease activity (LDA) or a good/moderate response to MTX, according to the European League Against Rheumatism (EULAR) response criteria. Logistic regression was used to assess the associations between baseline variables and the study outcomes.Overall, 294 patients (60.5% females, median age 54.5 years) with a median disease duration of 7.9 months were recruited. At T1, 47.3% of subjects failed to achieve LDA, and 29.3% did not have any EULAR-response. In multivariate analysis, significant associations were observed between no LDA and current smoking (adjusted odds ratio [adjOR] 1.79, P = .037), female gender (adjOR 1.68, P = .048), and higher DAS28 (adjOR 1.31, P = .013); and between no EULAR-response and current smoking (adjOR: 2.04, P = .019), age (adjOR: 0.72 per 10-years increases, P = .001), and higher erythrocyte sedimentation rate (adjOR: 0.49; P = .020). By contrast, there were no associations between past smoker status and study outcomes.In summary, in our real-life cohort of disease modifying anti-rheumatic drug naïve RA patients, current smoking habit independently predicts inadequate response to MTX. This, together with other independent predictors of response to treatment identified in our study, might assist with personalized monitoring in RA patients. Further studies are required to investigate whether smoking quitting strategies enhance the therapeutic response to MTX.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Metotrexato/uso terapéutico , Fumar/efectos adversos , Adulto , Femenino , Humanos , Quimioterapia de Inducción , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Insuficiencia del Tratamiento
3.
JAMA ; 325(13): 1277-1286, 2021 04 06.
Artículo en Inglés | MEDLINE | ID: mdl-33821899

RESUMEN

Importance: Aspirin and cyclooxygenase 2 (COX-2) inhibitors have been associated with a reduced risk of colorectal polyps and cancer in observational and randomized studies. The effect of celecoxib, a COX-2 inhibitor, as treatment for nonmetastatic colon cancer is unknown. Objective: To determine if the addition of celecoxib to adjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) improves disease-free survival in patients with stage III colon cancer. Design, Setting, and Participants: Cancer and Leukemia Group B (Alliance)/Southwest Oncology Group 80702 was a 2 × 2 factorial design, phase 3 trial conducted at 654 community and academic centers throughout the United States and Canada. A total of 2526 patients with stage III colon cancer were enrolled between June 2010 and November 2015 and were followed up through August 10, 2020. Interventions: Patients were randomized to receive adjuvant FOLFOX (every 2 weeks) for 3 vs 6 months with or without 3 years of celecoxib (400 mg orally daily; n = 1263) vs placebo (n = 1261). This report focuses on the results of the celecoxib randomization. Main Outcomes and Measures: The primary end point was disease-free survival, measured from the time of randomization until documented recurrence or death from any cause. Secondary end points included overall survival, adverse events, and cardiovascular-specific events. Results: Of the 2526 patients who were randomized (mean [SD] age, 61.0 years [11 years]; 1134 women [44.9%]), 2524 were included in the primary analysis. Adherence with protocol treatment, defined as receiving celecoxib or placebo for more than 2.75 years or continuing treatment until recurrence, death, or unacceptable adverse events, was 70.8% for patients treated with celecoxib and 69.9% for patients treated with placebo. A total of 337 patients randomized to celecoxib and 363 to placebo experienced disease recurrence or died, and with 6 years' median follow-up, the 3-year disease-free survival was 76.3% for celecoxib-treated patients vs 73.4% for placebo-treated patients (hazard ratio [HR] for disease recurrence or death, 0.89; 95% CI, 0.76-1.03; P = .12). The effect of celecoxib treatment on disease-free survival did not vary significantly according to assigned duration of adjuvant chemotherapy (P for interaction = .61). Five-year overall survival was 84.3% for celecoxib vs 81.6% for placebo (HR for death, 0.86; 95% CI, 0.72-1.04; P = .13). Hypertension (any grade) occurred while treated with FOLFOX in 14.6% of patients in the celecoxib group vs 10.9% of patients in the placebo group, and a grade 2 or higher increase in creatinine levels occurred after completion of FOLFOX in 1.7% vs 0.5% of patients, respectively. Conclusions and Relevance: Among patients with stage III colon cancer, the addition of celecoxib for 3 years, compared with placebo, to standard adjuvant chemotherapy did not significantly improve disease-free survival. Trial Registration: ClinicalTrials.gov Identifier: NCT01150045.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Celecoxib/uso terapéutico , Quimioterapia Adyuvante , Neoplasias del Colon/tratamiento farmacológico , Inhibidores de la Ciclooxigenasa 2/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Celecoxib/efectos adversos , Neoplasias del Colon/cirugía , Inhibidores de la Ciclooxigenasa 2/efectos adversos , Supervivencia sin Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/prevención & control , Estadificación de Neoplasias , Cooperación del Paciente , Modelos de Riesgos Proporcionales , Prevención Secundaria , Tasa de Supervivencia , Insuficiencia del Tratamiento , Adulto Joven
4.
Int J Mol Sci ; 22(6)2021 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-33809601

RESUMEN

Recurrent implantation failure (RIF) refers to the occurrence of more than two failed in vitro fertilization-embryo transfers (IVF-ETs) in the same individual. RIF can occur for many reasons, including embryo characteristics, immunological factors, and coagulation factors. Genetics can also contribute to RIF, with some single-nucleotide variants (SNVs) reported to be associated with RIF occurrence. We examined SNVs in a long non-coding RNA, homeobox (HOX) transcript antisense RNA (HOTAIR), which is known to affect cancer development. HOTAIR regulates epigenetic outcomes through histone modifications and chromatin remodeling. We recruited 155 female RIF patients and 330 healthy controls, and genotyped HOTAIR SNVs, including rs4759314, rs920778, rs7958904, and rs1899663, in all participants. Differences in these SNVs were compared between the patient and control groups. We identified significant differences in the occurrence of heterozygous genotypes and the dominant expression model for the rs1899663 and rs7958904 SNVs between RIF patients and control subjects. These HOTAIR variants were associated with serum hemoglobin (Hgb), luteinizing hormone (LH), total cholesterol (T. chol), and blood urea nitrogen (BUN) levels, as assessed by analysis of variance (ANOVA). We analyzed the four HOTAIR SNVs and found significant differences in haplotype patterns between RIF patients and healthy controls. The results of this study showed that HOTAIR is not only associated with the development of cancer but also with pregnancy-associated diseases. This study represents the first report showing that HOTAIR is correlated with RIF.


Asunto(s)
Fertilización In Vitro , Estudios de Asociación Genética , Predisposición Genética a la Enfermedad , Polimorfismo de Nucleótido Simple/genética , ARN Largo no Codificante/genética , Adulto , Estudios de Casos y Controles , Femenino , Frecuencia de los Genes/genética , Humanos , Desequilibrio de Ligamiento/genética , Recurrencia , Insuficiencia del Tratamiento
5.
Wiad Lek ; 74(3 cz 2): 669-673, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33843632

RESUMEN

OBJECTIVE: The aim: To analyze molecular epidemiology features of M. tuberculosis in Kyiv oblast; and to identify the safest mode of TB treatment, which will allow clinicians to minimize the risk of drug-resistant strains nosocomial transmission. PATIENTS AND METHODS: Materials and methods: 55 isolates of M. tuberculosis were collected in January-April, 2018 from 31 patients with new cases and 24 patients with re-treatment cases of sputum culture-positive pulmonary TB, in Kyiv oblast, Ukraine. DNA samples extracted from all the isolates were used for 15-loci MIRU-VNTR molecular typing with further M. tuberculosis strains comparison by means of MIRU-VNTRplus web tool (http://www.miru-vntrplus.org). RESULTS: Results: Phylogenetic tree that reflects strains interrelationship reveals four main clusters, the largest of which spans 34 isolates. The presence of two big subclusters with 10 and 7 identical genotypes inside the largest cluster strongly suggests their tight epidemiologic relationship. Smaller clusters consist of five (Harlem), three (URAL), and two unidentified isolates. 10 singletons were detected, among which LAM, URAL and Cameroon lineages were identified; in these cases, epidemiological connection was presumably ruled out. CONCLUSION: Conclusions: High clustering level of isolates of M. tuberculosis suggests possible contact between patients from whom these isolates were obtained. Predominance of Beijing family in the clusters is associated with high DR-TB level, at least in eastern European countries. Similarity of the clusters isolated from different patients in a household or a hospital suggests high probability of recent disease transmission. Clustering genotypes from households and hospital wards can be a surrogate criterion of infection control effectiveness.


Asunto(s)
Mycobacterium tuberculosis , Tuberculosis Resistente a Múltiples Medicamentos , Genotipo , Humanos , Repeticiones de Minisatélite , Epidemiología Molecular , Mycobacterium tuberculosis/genética , Filogenia , Insuficiencia del Tratamiento , Tuberculosis Resistente a Múltiples Medicamentos/tratamiento farmacológico , Tuberculosis Resistente a Múltiples Medicamentos/epidemiología , Ucrania
6.
Medicine (Baltimore) ; 100(17): e25708, 2021 Apr 30.
Artículo en Inglés | MEDLINE | ID: mdl-33907153

RESUMEN

ABSTRACT: The aim of this study was to evaluate the risk factors related to osteosynthesis failure in patients with concomitant ipsilateral femoral neck and shaft fractures, including old age; smoking habit; comminuted fragments; infra-isthmus fracture; angular malreduction; unsatisfactory reduction (fracture gap >5 mm); and treatment with single construct.Patients over the age of 20 with concomitant ipsilateral femoral neck and shaft fractures diagnosed at a level one medical center between 2003 and 2019 were included. Treatment modalities included single construct with/without an antirotational screw for the neck and dual constructs. Radiographic outcomes were assessed from anteroposterior and lateral hip radiographs at follow-up. Fisher exact test was used to analyze categorical variables. The presence of avascular necrosis of the femoral head, delayed union, atrophic or hypertrophic nonunion of the femoral shaft fracture, and loss of reduction were identified as factors related to treatment failure.A total of 22 patients were included in this study. The average age was 58.5 years, and the majority was male (68.2%). The minimum radiographic follow-up duration was 12 months, and the median follow-up time was 12 (interquartile range 12-24) months.Femoral neck osteosynthesis failed in 3 patients, whereas femoral shaft osteosynthesis failed in 12 patients. Fisher exact test demonstrated the failure of femoral shaft osteosynthesis was significantly more frequent in the single-construct cohort in 16 infra-isthmus femoral fracture cases (P = .034).In ipsilateral femoral neck and infra-isthmus shaft fractures, it is better to treat the neck and shaft fractures with separate implants (dual constructs).In a dual-construct cohort, separate plate fixation of the femoral shaft achieved a better result in terms of bone union than retrograde nailing of the shaft (bone union rate: 4/8 vs 0/2).


Asunto(s)
Fracturas del Fémur , Fracturas del Cuello Femoral , Fijación Intramedular de Fracturas , Fijadores Internos , Complicaciones Posoperatorias , Cuidados Posteriores/métodos , Femenino , Fracturas del Fémur/diagnóstico , Fracturas del Fémur/epidemiología , Fracturas del Fémur/cirugía , Fracturas del Cuello Femoral/diagnóstico , Fracturas del Cuello Femoral/epidemiología , Fracturas del Cuello Femoral/cirugía , Fijación Intramedular de Fracturas/efectos adversos , Fijación Intramedular de Fracturas/instrumentación , Fijación Intramedular de Fracturas/métodos , Fracturas Conminutas/diagnóstico , Fracturas Conminutas/epidemiología , Fracturas Conminutas/cirugía , Humanos , Fijadores Internos/normas , Fijadores Internos/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Radiografía/métodos , Estudios Retrospectivos , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Factores de Riesgo , Taiwán/epidemiología , Insuficiencia del Tratamiento
7.
Medicine (Baltimore) ; 100(14): e25375, 2021 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-33832123

RESUMEN

RATIONALE: Alveolar capillary dysplasia with misalignment of the pulmonary veins (ACD/MPV) is a rare congenital malformation in neonates that results in severe respiratory distress and pulmonary hypertension. ACD/MPV is caused by mutations in the FOXF1 gene. Herein, a new case of a girl with ACD/MPV carrying a novel pathogenic variant of FOXF1 was reported. PATIENT CONCERNS: A 3-month-old Chinese girl was admitted to the hospital presenting a complaint of cyanosis for 10 days and respiratory distress for 2 days. The history of foreign body inhalation was denied. DIAGNOSES: Blood routine, liver and kidney function, electrolytes, type B natriuretic peptide, electrocardiogram, cardiac computed tomography (CT), and echocardiography were done after admission. Dysplasia of the alveolar and the left upper pulmonary vein was displayed through cardiac CT. Echocardiography showed atrial septal defect, tricuspid valve malformation, and pulmonary hypertension. Sequence analysis of FOXF1 from genomic deoxyribonucleic acid (DNA) revealed that the patient was heterozygous for a novel missense variant (c.418 C>T, p.Pro140Gly). Furthermore, genetic analysis of both parents confirmed the de novo occurrence of the variant. Conservation analysis showed that the locus was highly conserved across species. Then, ACD/MPV was a clinical diagnosis. INTERVENTIONS: After admission, nasal catheter oxygen inhalation, cefazoxime sodium, furosemide diuretic, milrinone lactate, and Bosentan were given to the patient. OUTCOMES: After 6 days of hospitalization, the patient's condition did not improved, the parents gave up treatment and discharged. The patient died half a month after discharge. LESSONS: ACD/MPV is a rare congenital malformation with a poor prognosis. A new de novo mutation of FOXF1 was found in our case. Non-invasive methods such as DNA sequencing and FOXF1 analysis are helpful in the clinical diagnosis of ACD/MPV especially in early infants with respiratory distress and pulmonary hypertension.


Asunto(s)
Factores de Transcripción Forkhead/genética , Síndrome de Circulación Fetal Persistente/diagnóstico , Síndrome de Circulación Fetal Persistente/genética , Alveolos Pulmonares/anomalías , Venas Pulmonares/anomalías , Ecocardiografía/métodos , Resultado Fatal , Femenino , Defectos del Tabique Interatrial/diagnóstico por imagen , Defectos del Tabique Interatrial/genética , Heterocigoto , Humanos , Hipertensión Pulmonar/diagnóstico por imagen , Hipertensión Pulmonar/genética , Lactante , Mutación Missense , Terapia por Inhalación de Oxígeno/métodos , Síndrome de Circulación Fetal Persistente/tratamiento farmacológico , Análisis de Secuencia/métodos , Insuficiencia del Tratamiento , Válvula Tricúspide/anomalías , Válvula Tricúspide/diagnóstico por imagen
8.
Vasc Health Risk Manag ; 17: 111-121, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33854321

RESUMEN

Autogenous radial-cephalic direct wrist arteriovenous fistula (RC-AVF) in the non-dominant arm is the gold standard for dialysis vascular access. However, the RC-AVF non-maturation rate is significant (≃ 40%) due to an increasingly elderly and comorbid population incidence. A detailed identification of the biological cascade underlying arteriovenous fistula (AVF) maturation could be the key to clinical research aimed at identify the group of patients at risk of primary AVF failure. Currently, careful post-operative monitoring remains the most crucial aspect to overcome the problem of impaired maturation. Up to 80% of patients with immature RC-AVF have problems potentially solvable with early endovascular or surgical correction. Physical examination by experienced practitioners in conjunction with duplex ultrasound examination (DUS) can identify physical signs of non-maturation, understand the underlying cause, and drive for a tailored early planning to treat the complication. New approaches for the early assessment of AVF maturation are under study. Techniques to promote RC-AVF maturation performed through the administration of pre-or peri-operative drugs have missed up to now to prove an efficacy in improving fistula success. The new techniques tested after surgery appear to hold future promise for improving fistula maturation.


Asunto(s)
Derivación Arteriovenosa Quirúrgica , Oclusión de Injerto Vascular/diagnóstico , Examen Físico , Arteria Radial/cirugía , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular , Venas/cirugía , Muñeca/irrigación sanguínea , Derivación Arteriovenosa Quirúrgica/efectos adversos , Diagnóstico Precoz , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Humanos , Valor Predictivo de las Pruebas , Arteria Radial/diagnóstico por imagen , Arteria Radial/fisiopatología , Diálisis Renal , Factores de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento , Venas/diagnóstico por imagen , Venas/fisiopatología
9.
Cochrane Database Syst Rev ; 3: CD010172, 2021 03 04.
Artículo en Inglés | MEDLINE | ID: mdl-33661521

RESUMEN

BACKGROUND: High-flow nasal cannulae (HFNC) deliver high flows of blended humidified air and oxygen via wide-bore nasal cannulae and may be useful in providing respiratory support for adults experiencing acute respiratory failure, or at risk of acute respiratory failure, in the intensive care unit (ICU). This is an update of an earlier version of the review. OBJECTIVES: To assess the effectiveness of HFNC compared to standard oxygen therapy, or non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV), for respiratory support in adults in the ICU. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane COVID-19 Register (17 April 2020), clinical trial registers (6 April 2020) and conducted forward and backward citation searches. SELECTION CRITERIA: We included randomized controlled studies (RCTs) with a parallel-group or cross-over design comparing HFNC use versus other types of non-invasive respiratory support (standard oxygen therapy via nasal cannulae or mask; or NIV or NIPPV which included continuous positive airway pressure and bilevel positive airway pressure) in adults admitted to the ICU. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. MAIN RESULTS: We included 31 studies (22 parallel-group and nine cross-over designs) with 5136 participants; this update included 20 new studies. Twenty-one studies compared HFNC with standard oxygen therapy, and 13 compared HFNC with NIV or NIPPV; three studies included both comparisons. We found 51 ongoing studies (estimated 12,807 participants), and 19 studies awaiting classification for which we could not ascertain study eligibility information. In 18 studies, treatment was initiated after extubation. In the remaining studies, participants were not previously mechanically ventilated. HFNC versus standard oxygen therapy HFNC may lead to less treatment failure as indicated by escalation to alternative types of oxygen therapy (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.45 to 0.86; 15 studies, 3044 participants; low-certainty evidence). HFNC probably makes little or no difference in mortality when compared with standard oxygen therapy (RR 0.96, 95% CI 0.82 to 1.11; 11 studies, 2673 participants; moderate-certainty evidence). HFNC probably results in little or no difference to cases of pneumonia (RR 0.72, 95% CI 0.48 to 1.09; 4 studies, 1057 participants; moderate-certainty evidence), and we were uncertain of its effect on nasal mucosa or skin trauma (RR 3.66, 95% CI 0.43 to 31.48; 2 studies, 617 participants; very low-certainty evidence). We found low-certainty evidence that HFNC may make little or no difference to the length of ICU stay according to the type of respiratory support used (MD 0.12 days, 95% CI -0.03 to 0.27; 7 studies, 1014 participants). We are uncertain whether HFNC made any difference to the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) within 24 hours of treatment (MD 10.34 mmHg, 95% CI -17.31 to 38; 5 studies, 600 participants; very low-certainty evidence). We are uncertain whether HFNC made any difference to short-term comfort (MD 0.31, 95% CI -0.60 to 1.22; 4 studies, 662 participants, very low-certainty evidence), or to long-term comfort (MD 0.59, 95% CI -2.29 to 3.47; 2 studies, 445 participants, very low-certainty evidence). HFNC versus NIV or NIPPV We found no evidence of a difference between groups in treatment failure when HFNC were used post-extubation or without prior use of mechanical ventilation (RR 0.98, 95% CI 0.78 to 1.22; 5 studies, 1758 participants; low-certainty evidence), or in-hospital mortality (RR 0.92, 95% CI 0.64 to 1.31; 5 studies, 1758 participants; low-certainty evidence). We are very uncertain about the effect of using HFNC on incidence of pneumonia (RR 0.51, 95% CI 0.17 to 1.52; 3 studies, 1750 participants; very low-certainty evidence), and HFNC may result in little or no difference to barotrauma (RR 1.15, 95% CI 0.42 to 3.14; 1 study, 830 participants; low-certainty evidence). HFNC may make little or no difference to the length of ICU stay (MD -0.72 days, 95% CI -2.85 to 1.42; 2 studies, 246 participants; low-certainty evidence). The ratio of PaO2/FiO2 may be lower up to 24 hours with HFNC use (MD -58.10 mmHg, 95% CI -71.68 to -44.51; 3 studies, 1086 participants; low-certainty evidence). We are uncertain whether HFNC improved short-term comfort when measured using comfort scores (MD 1.33, 95% CI 0.74 to 1.92; 2 studies, 258 participants) and responses to questionnaires (RR 1.30, 95% CI 1.10 to 1.53; 1 study, 168 participants); evidence for short-term comfort was very low certainty. No studies reported on nasal mucosa or skin trauma. AUTHORS' CONCLUSIONS: HFNC may lead to less treatment failure when compared to standard oxygen therapy, but probably makes little or no difference to treatment failure when compared to NIV or NIPPV. For most other review outcomes, we found no evidence of a difference in effect. However, the evidence was often of low or very low certainty. We found a large number of ongoing studies; including these in future updates could increase the certainty or may alter the direction of these effects.


Asunto(s)
Cuidados Críticos/métodos , Intubación/métodos , Terapia por Inhalación de Oxígeno/métodos , Insuficiencia Respiratoria/terapia , Enfermedad Aguda , Adulto , Barotrauma/epidemiología , Sesgo , Mortalidad Hospitalaria , Humanos , Intubación/efectos adversos , Intubación/instrumentación , Tiempo de Internación , Máscaras , Mucosa Nasal/lesiones , Ventilación no Invasiva/métodos , Terapia por Inhalación de Oxígeno/efectos adversos , Terapia por Inhalación de Oxígeno/instrumentación , Medición de Resultados Informados por el Paciente , Neumonía/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial/efectos adversos , Insuficiencia del Tratamiento
10.
N Engl J Med ; 384(9): 808-817, 2021 03 04.
Artículo en Inglés | MEDLINE | ID: mdl-33657293

RESUMEN

BACKGROUND: Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. Preclinical studies provide support for an antiinflammatory role of albumin, but confirmatory large-scale clinical trials are lacking. Whether targeting a serum albumin level of 30 g per liter or greater in these patients with repeated daily infusions of 20% human albumin solution, as compared with standard care, would reduce the incidences of infection, kidney dysfunction, and death is unknown. METHODS: We conducted a randomized, multicenter, open-label, parallel-group trial involving hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment. Patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. Treatment commenced within 3 days after admission. The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment. RESULTS: A total of 777 patients underwent randomization, and alcohol was reported to be a cause of cirrhosis in most of these patients. A median total infusion of albumin of 200 g (interquartile range, 140 to 280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared with a median of 20 g (interquartile range, 0 to 120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% confidence interval [CI], 127 to 158.2). The percentage of patients with a primary end-point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]) (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P = 0.87). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference (hazard ratio, 1.04; 95% CI, 0.81 to 1.35). More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group. CONCLUSIONS: In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom. (Funded by the Health Innovation Challenge Fund; ATTIRE EudraCT number, 2014-002300-24; ISRCT number, N14174793.).


Asunto(s)
Albúminas/uso terapéutico , Cirrosis Hepática/terapia , Albúmina Sérica , Adulto , Albúminas/administración & dosificación , Albúminas/efectos adversos , Ascitis/etiología , Ascitis/terapia , Femenino , Hospitalización , Humanos , Infusiones Intravenosas , Cirrosis Hepática/sangre , Cirrosis Hepática/complicaciones , Cirrosis Hepática/mortalidad , Cirrosis Hepática Alcohólica/sangre , Cirrosis Hepática Alcohólica/terapia , Masculino , Persona de Mediana Edad , Edema Pulmonar/etiología , Insuficiencia del Tratamiento
11.
JAMA ; 325(14): 1426-1435, 2021 04 13.
Artículo en Inglés | MEDLINE | ID: mdl-33662102

RESUMEN

Importance: Ivermectin is widely prescribed as a potential treatment for COVID-19 despite uncertainty about its clinical benefit. Objective: To determine whether ivermectin is an efficacious treatment for mild COVID-19. Design, Setting, and Participants: Double-blind, randomized trial conducted at a single site in Cali, Colombia. Potential study participants were identified by simple random sampling from the state's health department electronic database of patients with symptomatic, laboratory-confirmed COVID-19 during the study period. A total of 476 adult patients with mild disease and symptoms for 7 days or fewer (at home or hospitalized) were enrolled between July 15 and November 30, 2020, and followed up through December 21, 2020. Intervention: Patients were randomized to receive ivermectin, 300 µg/kg of body weight per day for 5 days (n = 200) or placebo (n = 200). Main Outcomes and Measures: Primary outcome was time to resolution of symptoms within a 21-day follow-up period. Solicited adverse events and serious adverse events were also collected. Results: Among 400 patients who were randomized in the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the trial. The median time to resolution of symptoms was 10 days (IQR, 9-13) in the ivermectin group compared with 12 days (IQR, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95% CI, 0.87 to 1.32]; P = .53 by log-rank test). By day 21, 82% in the ivermectin group and 79% in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 104 patients (52%) given ivermectin and 111 (56%) who received placebo. The most common serious adverse event was multiorgan failure, occurring in 4 patients (2 in each group). Conclusion and Relevance: Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms. The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT04405843.


Asunto(s)
/tratamiento farmacológico , Ivermectina/uso terapéutico , Adulto , Anciano , Antiinfecciosos/efectos adversos , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Ivermectina/efectos adversos , Masculino , Persona de Mediana Edad , Gravedad del Paciente , Factores de Tiempo , Insuficiencia del Tratamiento
12.
Medicine (Baltimore) ; 100(12): e25274, 2021 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-33761730

RESUMEN

ABSTRACT: To investigate the influencing factors of fracture nonunion after intramedullary nailing for subtrochanteric fractures and to construct a risk assessment model.Based on the multicenter retrospective analysis of 251 patients, all patients were divided into modeling group and verification group. In the modeling group, postoperative fracture nonunion rate, general data, fracture-related factors, surgical reduction-related factors, mechanical and biological factors were calculated, and the influencing factors of fracture nonunion were screened by univariate analysis. Logistic regression model was used for multifactor analysis to construct the risk assessment model. Based on the logistic regression model, the risk prediction model was constructed by drawing the Nomogram diagram. Through the verification group, the influencing factors were evaluated again, and the differentiation and calibration of the model were evaluated. The calibration degree was evaluated by Hosmer-Lemeshow test, goodness of fit test, and calibration curve. The discriminant degree was evaluated by the receiver operating characteristic curve.Fracture nonunion occurred in 34 of 149 patients in the modeling group. Among the 14 potential influencing factors, univariate analysis and logistic regression analysis showed that postoperative hip varus, intramedullary nail fixation failure, and reduction of fracture with large incision were the risk factors of fracture nonunion. The medial cortex fracture was seen reduced on X-Ray was a protective factor for fracture nonunion, and a regression equation was established. Based on the logistic regression model, the Nomogram diagram is drawn. Twenty-four cases of fracture nonunion occurred in the verification group. The area under the receiver operating characteristic curve was area under curve =0.883 > 0.7, indicating that there was a moderate differentiation to evaluate the occurrence of fracture nonunion after operation. The goodness of fit test: the Hosmers-Lemeshow test (X2 = 2.921, P = .712 > .05) showed that the model had a good calibration.After intramedullary nailing of subtrochanteric fracture, hip varus, failure of intramedullary nail fixation and wide surgical dissection are the risk factors of fracture nonunion, and the postoperative reduction of medial cortex fracture is protective factor.National key research and development projects: 2016YFC0105806.


Asunto(s)
Coxa Vara , Fijación Intramedular de Fracturas , Fracturas no Consolidadas , Fracturas de Cadera/cirugía , Complicaciones Posoperatorias , Medición de Riesgo , Anciano , Clavos Ortopédicos , Coxa Vara/diagnóstico , Coxa Vara/epidemiología , Femenino , Fijación Intramedular de Fracturas/efectos adversos , Fijación Intramedular de Fracturas/instrumentación , Fijación Intramedular de Fracturas/métodos , Fracturas no Consolidadas/diagnóstico , Fracturas no Consolidadas/epidemiología , Fracturas no Consolidadas/etiología , Fracturas de Cadera/diagnóstico , Humanos , Complicaciones Intraoperatorias/diagnóstico , Complicaciones Intraoperatorias/epidemiología , Masculino , Evaluación de Resultado en la Atención de Salud , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Radiografía/métodos , Estudios Retrospectivos , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Factores de Riesgo , Insuficiencia del Tratamiento
13.
Zhonghua Wai Ke Za Zhi ; 59(3): 196-202, 2021 Mar 01.
Artículo en Chino | MEDLINE | ID: mdl-33685053

RESUMEN

Objective: To evaluate the safety and efficacy of stent-assisted coil embolization in patients with recurrent intracranial bifurcation aneurysms,after initial simple coiling or microsurgical clipping. Methods: Clinical data of 20 patients with recurrent intracranial bifurcation aneurysms who initially underwent simple coiling or surgical clipping and subsequently re-treated by stent-assisted coiling embolization at the Radiology Intervention Department of Huashan Hospital between March 2009 and November 2019 were collected and analyzed retrospectively.There were 9 males and 11 females,with a median age of 55.5 years (range:33 to 71 years),including 17 aneurysms initially treated with simple coiling and 3 treated with surgical clipping.All cases were re-treated with stent-assisted coiling,15 using a single stent and 5 employing two stents in a Y-configuration.Peri-and post-operative complications and outcomes were evaluated.Mann-Whitney U tests were performed to compare the follow-up duration between initial treatment and re-treatment.Student's t tests were used to compare the parent artery angles before re-treatment, after re-treatment and at the last follow-up. The parent artery angle was defined using the proximal main trunk and the stented branch. Results: Immediate complete occlusion (Raymond Ⅰ) was achieved in 18 aneurysms (90.0%) while 2 aneurysms (10.0%) had a residual neck (Raymond Ⅱ).The median follow-up time(M(QR)) was 8.5(16.3)months,which had no significantly different from the initial treatment follow-up duration (15.5(27.0)months)(U=157.7,P=0.25). During the follow-up period,2 aneurysms (10.0%) with immediate post-operative residual necks recanalized again,including 1 aneurysm re-treated with the Y-configuration stent.Symptomatic thromboembolic complications occurred in 6 patients,including 4 re-treated with the Y-configuration stent.No peri-operative hemorrhagic complications occurred,along with no operation-related permanent disability or death. The parent artery angle increased significantly from pre-operative(90.1±21.1)°to post-operative and the last follow-up ((115.4±28.9)° and (132.6±26.8)°);t=5.14,P<0.01;t=7.78,P<0.01). Conclusion: For recurrent intracranial bifurcation aneurysms after initial surgical clipping or simple coiling,stent assisted coil embolization is proved to be safe and can decrease recurrence rate.


Asunto(s)
Embolización Terapéutica , Aneurisma Intracraneal , Stents , Adulto , Anciano , Angiografía Cerebral , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/instrumentación , Femenino , Estudios de Seguimiento , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Masculino , Persona de Mediana Edad , Recurrencia , Reoperación , Estudios Retrospectivos , Grapado Quirúrgico/efectos adversos , Grapado Quirúrgico/instrumentación , Insuficiencia del Tratamiento , Resultado del Tratamiento
14.
JAMA ; 325(17): 1731-1743, 2021 05 04.
Artículo en Inglés | MEDLINE | ID: mdl-33764378

RESUMEN

Importance: High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. Objective: To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone. Design, Setting, and Participants: Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200). Interventions: Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). Main Outcomes and Measures: The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay. Results: Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99). Conclusions and Relevance: Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation. Trial Registration: ClinicalTrials.gov Identifier: NCT04502576.


Asunto(s)
/complicaciones , Intubación Intratraqueal/estadística & datos numéricos , Ventilación no Invasiva/instrumentación , Terapia por Inhalación de Oxígeno/métodos , Insuficiencia Respiratoria/terapia , Anciano , /terapia , Femenino , Mortalidad Hospitalaria , Humanos , Hipoxia/etiología , Masculino , Persona de Mediana Edad , Ventilación no Invasiva/métodos , Insuficiencia Respiratoria/etiología , Insuficiencia del Tratamiento
15.
Nat Commun ; 12(1): 1967, 2021 03 30.
Artículo en Inglés | MEDLINE | ID: mdl-33785743

RESUMEN

Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.


Asunto(s)
Antivirales/administración & dosificación , Interleucinas/administración & dosificación , Polietilenglicoles/administración & dosificación , Adulto , Anciano , Femenino , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , /fisiología , Método Simple Ciego , Insuficiencia del Tratamiento , Esparcimiento de Virus/efectos de los fármacos , Adulto Joven
16.
Int Heart J ; 62(2): 329-336, 2021 Mar 30.
Artículo en Inglés | MEDLINE | ID: mdl-33731518

RESUMEN

The reasons of residual left ventricular outflow tract (LVOT) obstruction following alcohol septal ablation (ASA) remain unclear, and outcomes of myectomy following failed ASA remain underreported.Thirteen symptomatic patients (10 women, a median age of 60.0 years) who underwent septal myectomy following failed ASA were reviewed. The patients were followed up for a median of 6 months. The clinical characteristics and outcomes of these patients were analyzed and were compared with those of 178 patients who underwent isolated myectomy without previous ASA at our institution during the same period.In the first ASA procedure, the median number of septal perforator arteries injected was 1.0 with the median value of peak creatine kinase following ablation of 978.5 U/L.Uncontrollable extent and location of infarcted myocardium caused by ablation and mitral subvalvular anomalies were found in four (30.8%) and seven (53.8%) patients, respectively. No operative or follow-up deaths occurred. The median maximum LVOT gradients fell from preoperative 112.0 to 8.5 mmHg at follow-up (P < 0.001). Compared with controls, patients with failed ASA had a higher proportion of mitral subvalvular anomalies (53.8% versus 13.5%, P = 0.001) and developed a higher incidence of complete atrioventricular block following myectomy (15.4% versus 1.7%, P = 0.038).Low institutional or operator experience with ablation, uncontrollable extent and location of infarcted myocardium caused by ablation, and mitral subvalvular anomalies may be reasons for failed ASA. Surgical myectomy for the treatment of residual LVOT obstruction after unsuccessful ASA may be associated with favorable results.


Asunto(s)
Técnicas de Ablación/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Etanol/farmacología , Tabiques Cardíacos/cirugía , Obstrucción del Flujo Ventricular Externo/terapia , Adulto , Anciano , Femenino , Estudios de Seguimiento , Frecuencia Cardíaca/fisiología , Tabiques Cardíacos/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Insuficiencia del Tratamiento , Obstrucción del Flujo Ventricular Externo/diagnóstico , Obstrucción del Flujo Ventricular Externo/fisiopatología
17.
Anticancer Res ; 41(3): 1655-1662, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33788762

RESUMEN

BACKGROUND/AIM: Our previous study revealed the association between extracellular water-to-total body water ratio (ECW/TBW) and the therapeutic durability of chemotherapy and/or immune checkpoint inhibitors in advanced lung cancer. We retrospectively examined the usefulness of ECW/TBW in detecting frailty compared to other bioelectrical impedance (BIA) parameters in a larger number of patients. PATIENTS AND METHODS: Lung cancer patients underwent BIA before anti-cancer therapy at our hospital between June 1, 2018 and July 31, 2020. RESULTS: Of 99 patients, 26 were assigned to ECW/TBW≥0.4 (higher group: HG) and 57 to ECW/TBW<0.4 (lower group: LG). ECW/TBW increased significantly with performance deterioration and ageing. HG patients had significantly shorter time-to-treatment failure (TTF) than LG patients. In patients with performance status 0-1, those in the HG had shorter TTF than those in the LG. ECW/TBW was the only independent predictor of TTF according to multivariate analysis. CONCLUSION: ECW/TBW is an objective biomarker for detecting frailty among lung cancer patients.


Asunto(s)
Composición Corporal , Agua Corporal/metabolismo , Espacio Extracelular/metabolismo , Fragilidad/metabolismo , Neoplasias Pulmonares/metabolismo , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores , Impedancia Eléctrica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Insuficiencia del Tratamiento
18.
Anticancer Res ; 41(3): 1671-1676, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33788764

RESUMEN

BACKGROUND/AIM: This study aimed to investigate the efficacy of first-line gemcitabine monotherapy for metastatic breast cancer (MBC) and its effect on health-related quality of life (HRQoL) compared with treatment of physician's choice (TPC). PATIENTS AND METHODS: We enrolled 96 patients into the first-line gemcitabine group (n=47) or other treatment of physician's choice (TPC) group (n=49) from May 2010 to April 2013. HRQoL was evaluated every 4 weeks. RESULTS: There was no significant difference in the median time to treatment failure (5.3 vs. 4.6 months, hazard ratio=0.87, p=0.546) and the incidence rates of grade 3/4 haematological toxicity (10.6% vs. 8.1%, p=0.677) and grade 3/4 non-haematological toxicity (4.2% vs. 8.1%, p=0.429) between the gemcitabine and TPC groups. Changes in HRQoL from baseline to 12 weeks were not significantly different. CONCLUSION: Gemcitabine achieves similar efficacy and HRQoL benefit to other chemotherapy and can be used as first-line treatment for MBC.


Asunto(s)
Neoplasias de la Mama/tratamiento farmacológico , Desoxicitidina/análogos & derivados , Adulto , Anciano , Neoplasias de la Mama/patología , Neoplasias de la Mama/psicología , Desoxicitidina/efectos adversos , Desoxicitidina/uso terapéutico , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Médicos , Estudios Prospectivos , Calidad de Vida , Insuficiencia del Tratamiento
19.
Eur J Endocrinol ; 184(5): 667-676, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33667193

RESUMEN

Objective: The objectives of our study were to analyze the influence of age on the survival of patients with RAIR-DTC and to determine their prognostic factors according to age. Methods: This single-center, retrospective study enrolled 155 patients diagnosed with RAIR-DTC. The primary end point was overall survival (OS) according to different cutoff (45, 55, 65, 75 years). Secondary endpoints were progression free survival (PFS) and prognostic factors in patients under and over 65 years. Results: Median OS after RAIR diagnosis was 8.2 years (95% IC: 5.3-9.6). There was no difference according to age with a 65 (P = 0.47) and 55 years old cutoff (P = 0.28). Median OS improved significantly before 45 years old (P = 0.0043). After 75 years old, median OS significantly decreased (P = 0.0008). Median PFS was 2.1 years (95% CI: 0.8-3) in patients < 65 years old, and 1 year in patients ≥ 65 years old (95% CI: 0.8-1.55) with no statistical difference (P = 0.22). There was no impact of age on PFS with any cutoff. In both groups, progressive disease despite 131I treatment reduced OS. In patients < 65 years old, an interval of less than 3 years between the initial diagnosis and the diagnosis of RAIR metastatic disease was predictive of poor survival. In patients > 65 years old, the presence of a mediastinum metastasis was a significant factor for mortality (HR: 4.55, 95% CI: 2.27-9.09). Conclusion: In RAIR-DTC patients, a cut-off age of 65 years old was not a significant predictive factor of survival. Forty-five and 75-years-old cutoff were predictive for OS but not PFS.


Asunto(s)
Adenocarcinoma/mortalidad , Adenocarcinoma/radioterapia , Envejecimiento/fisiología , Radioisótopos de Yodo/uso terapéutico , Neoplasias de la Tiroides/mortalidad , Neoplasias de la Tiroides/radioterapia , Adenocarcinoma/diagnóstico , Adenocarcinoma/patología , Factores de Edad , Anciano , Progresión de la Enfermedad , Femenino , Francia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Retrospectivos , Análisis de Supervivencia , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/patología , Insuficiencia del Tratamiento , Resultado del Tratamiento
20.
JAMA ; 325(11): 1061-1073, 2021 03 16.
Artículo en Inglés | MEDLINE | ID: mdl-33724323

RESUMEN

Importance: Atrial fibrillation (AF) is the most common heart rhythm disturbance, continues to increase in incidence, and results in significant morbidity and mortality. The marine omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D have been reported to have both benefits and risks with respect to incident AF, but large-scale, long-term randomized trial data are lacking. Objective: To test the effects of long-term administration of marine omega-3 fatty acids and vitamin D on incident AF. Design, Setting, and Participants: An ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017. Interventions: Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). Main Outcomes and Measures: The primary outcome was incident AF confirmed by medical record review. Results: Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39). Conclusions and Relevance: Among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF. Trial Registration: ClinicalTrials.gov Identifiers: NCT02178410; NCT01169259.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Colecalciferol/uso terapéutico , Suplementos Dietéticos , Ácidos Docosahexaenoicos/uso terapéutico , Ácido Eicosapentaenoico/uso terapéutico , Vitaminas/uso terapéutico , Anciano , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Insuficiencia del Tratamiento , Deficiencia de Vitamina D/tratamiento farmacológico
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...