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1.
Liver Int ; 40(2): 308-318, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31705834

RESUMO

BACKGROUND & AIMS: Currently, standard of care (SOC) treatment for NASH is limited to lifestyle modifications. Drug regimens are being evaluated currently. We assessed the impact of a short-term hypothetical treatment on clinical outcomes of NASH. METHODS: Markov models estimated differences in outcomes between SOC and 2 hypothetical NASH treatments (A and B). We modelled 10 000 50-year-old biopsy-proven NASH patients over lifetime horizon. Health states included NASH with fibrosis (F1-F3), cirrhosis, hepatocellular carcinoma, liver transplant and mortality. Fibrosis Regression Factor (FRF) variable modelled the probability of 1-3 stage fibrosis improvement with treatment. Annual probability of treatment (ATP) ranged from 10%-70%. Treatment success was defined as regression to fibrosis, whereas failure was defined as progression to stages beyond cirrhosis. In treatment-A, successful treatment was followed by a maintenance regimen which stopped disease progression. After a successful treatment-B, patients remained at risk of disease progression. Differences in outcomes were calculated between both treatments and SOC models. We conducted a probabilistic sensitivity analysis. RESULTS: At 10% to 70% ATP, treatment-A averts 353 to 782 liver transplants and 1277 to 2381 liver-related deaths relative to SOC. Treatment-B averts 129 to 437 liver transplants and 386 to 1043 liver-related deaths. Sensitivity analysis shows our model is robust in estimating liver-related mortality and LTs averted, but is sensitive when estimating QALYs gained. CONCLUSIONS: With a small annual probability of treatment and FRF = 1, a 2-year treatment followed by maintenance of histologic improvement for patients would be highly beneficial relative to short-term treatment alone.

2.
BMJ Open Gastroenterol ; 5(1): e000198, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29607054

RESUMO

Background: Hepatic fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) independently predicts mortality. Given liver biopsy's invasive nature, non-invasive method to assess hepatic steatosis and fibrosis provides NAFLD risk stratification algorithm in clinical practice. NAFLD fibrosis score (NFS) is simple and non-invasive predictive model recommended by American Association for the Study of Liver Disease (AASLD) Guideline to identify patients with NAFLD with fibrosis risk. The aim of this study is to assess long-term outcomes of subjects with significant non-alcoholic steatofibrosis (NASF) as established by ultrasound (US) and NFS. Methods: Used National Health and Nutrition Examination Survey (NHANES III) with National Death Index-linked Mortality Files. NAFLD diagnosis established by the presence of moderate to severe hepatic steatosis on US without other causes of chronic liver disease (alcohol consumption <20 gr/day, hepatitis B surface-antigen negative, anti-hepatitis C virus antibody negative, transferrin saturation <50%). Significant hepatic fibrosis was estimated by high NFS (>0.676) and calculated with previously published formula. Subjects with NAFLD and high NFS have significant NASF. Results: NHANES III included 20 050 adult participants. 2515 participants complete data and NAFLD with 5.1% (n=129) meeting criteria for significant SF. Subjects with significant SF were older, had higher body mass index, waist circumference and the homeostasis model assessment (HOMA) scores and higher rates of comorbidities (diabetes, congestive heart failure (CHF), stroke; all p<0.001). After median of 207 months of follow-up, overall mortality in NAFLD cohort was 30.0% (n=754). Crude mortality higher in subjects with significant SF (67.4% vs 28.0%, p<0.001). In multivariate survival analysis, predictors of overall mortality included significant SF (adjusted HR (aHR): 1.37; 95% CI 1.07 to 1.76, p=0.01), older age (aHR:1.08; 95% CI 1.07 to 1.09 per year), male gender (aHR:1.44; 95% CI 1.24 to 1.67), black race (aHR:1.24; 95% CI 1.04 to 1.48)), history of hypertension (aHR:1.40; 95% CI 1.20 to 1.64), diabetes (aHR:1.69; 95% CI 1.43 to 2.00), CHF (aHR:1.77; 95% CI 1.38 to 2.261), stroke (aHR:1.84; 95% CI 1.38 to 2.48) and smoking (aHR:1.74; 95% CI 1.47 to 2.07) (all p<0.02). Sensitivity analysis showed that the best association of SF with mortality is higher at NFS threshold of 0.80 (aHR:1.41; 95% CI 1.09 to 1.83, p=0.01). Conclusions: Significant NASF determined non-invasively is an independent predictor of mortality. These data should help clinicians to easily risk-stratify patients with NAFLD for close monitoring and treatment considerations in clinical trial setting.

4.
Medicine (Baltimore) ; 96(7): e5914, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28207507

RESUMO

Patient-reported outcomes (PROs) such as quality of life and work productivity are important for measuring patient's experience. We assessed PROs during and after treatment of hepatitis C virus (HCV) patients.Data were obtained from a phase 3 open label study of sofosbuvir and ribavirin (SOF + RBV) with and without interferon (IFN). Patients completed 4 PRO assessment instruments (SF-36, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire- HCV, Work Productivity and Activity-Specific Health Problem) before, during, and after treatment.A total of 533 patients with chronic HCV were enrolled; 28.9% treatment-naïve, 23.1% cirrhotic, 219 received IFN + SOF + RBV and 314 received IFN-free SOF + RBV. At baseline, there were no differences in PROs between the IFN-free and IFN-containing treatment arms (all P > 0.05). During treatment, patients receiving IFN + SOF + RBV had a substantial impairment in their PROs (up to -24.4% by treatment week 12, up to -8.3% at week 4 post-treatment). The PRO decrements seen in the SOF + RBV arm were smaller in magnitude (up to -7.1% by treatment week 12), and all returned to baseline or improved by post-treatment week 4. By 12 weeks after treatment cessation, patients who achieved sustained viral response-12 showed some improvement of PRO scores regardless of the regimen (up to +7.1%, P < 0.0001) or previous treatment experience. In multivariate analysis, the use of IFN was independently associated with lower PROs.IFN-based regimens have a profoundly negative impact to PROs. By contrast, the impact of RBV on these PROs is relatively modest. Achieving HCV cure is associated with improvement of most of the PRO scores.


Assuntos
Antivirais/uso terapêutico , Hepatite C Crônica/tratamento farmacológico , Interferons/uso terapêutico , Ribavirina/uso terapêutico , Sofosbuvir/uso terapêutico , Adulto , Feminino , Hepatite C Crônica/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Resultado do Tratamento , Desempenho Profissional
5.
J Clin Gastroenterol ; 51(3): 254-260, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27332747

RESUMO

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is one of the leading causes of chronic liver disease worldwide with tremendous clinical burden. The economic burden of NAFLD is not well studied. GOAL: To assess the economic burden of NAFLD. STUDY: Medicare beneficiaries (January 1, 2010 to December 31, 2010) with NAFLD diagnosis by International Classification of Diseases, Ninth Revision codes in the absence of other liver diseases were selected. Inpatient and outpatient resource utilization parameters were total charges and total provider payments. NAFLD patients with compensated cirrhosis (CC) were compared with decompensated cirrhosis (DC). RESULTS: A total of 976 inpatients and 4742 outpatients with NAFLD were included-87% were white, 36% male, 30% had cardiovascular disease (CVD) or metabolic syndrome conditions, and 12% had cirrhosis. For inpatients, median total hospital charge was $36,289. NAFLD patients with cirrhosis had higher charges and payments than noncirrhotic NAFLD patients ($61,151 vs. $33,863 and $18,804 vs. $10,146, P<0.001). Compared with CC, NAFLD patients with DC had higher charges and payments (P<0.02). For outpatients, median total charge was $9,011. NAFLD patients with cirrhosis had higher charges and payments than noncirrhotic NAFLD patients ($12,049 vs. $8,830 and $2,586 vs. $1,734, P<0.001). Compared with CC, DC patients had higher total charges ($15,187 vs. $10,379, P=0.04). In multivariate analysis, variables associated with increased inpatient resource utilization were inpatient mortality, DC, and CVD; for outpatients, having CVD, obesity, and hypertension (all P<0.001). CONCLUSIONS: NAFLD is associated with significant economic burden to Medicare. Presence of cirrhosis and CVD are associated with increased resource utilization.


Assuntos
Assistência Ambulatorial/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Cirrose Hepática , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Idoso , Assistência Ambulatorial/economia , Feminino , Recursos em Saúde , Hospitalização/economia , Humanos , Benefícios do Seguro , Masculino , Medicare , Hepatopatia Gordurosa não Alcoólica/economia , Estados Unidos/epidemiologia
6.
Clin Gastroenterol Hepatol ; 15(5): 759-766.e5, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-27464590

RESUMO

BACKGROUND & AIMS: Chronic liver (CLD) is a major public health concern. We assessed its effects on quality of life and work productivity, as well as its economic burden in the United States. METHODS: We performed a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS; 2004-2013). We extracted participants' sociodemographic parameters and medical histories. Subjects with CLD were identified based on Clinical Classification Software codes. MEPS participants were compared between those with and without CLD, and then between employed and unemployed patients with CLD. Outcomes were quality-of-life scores, employment, and health care use. RESULTS: We collected data from 230,406 adult participants (age, ≥18 y) in the MEPS; 1846 had current CLD (36.7% with viral hepatitis and 5.3% with liver cancer). Individuals with CLD were less likely to be employed (44.7% vs 69.6% patients without CLD), were not working owing to illness/disability (30.5% vs 6.6% without CLD), lost more work because of disability (10.2 vs 3.4 d without CLD), and had more health care use, producing greater health care expenses ($19,390 vs $5567/y without CLD) (all P < .0001). Patients with CLD also had more comorbidities and worse self-reported general and mental health status, and reported more health-related limitations in their daily activities than individuals without CLD (all P < .0001). They also indicated more psychologic distress and depressive symptoms and had a lower quality of life and health utility scores (P < .0001). In multivariate analysis, after adjustment for sociodemographic factors and comorbidities, the presence of CLD was an important predictor of unemployment (odds ratio, 0.60; 95% confidence interval, 0.50-0.70), annual health care expenditure (ß = $9503 ± $2028), and impairment in all aspects of health-related quality of life (all P < .0001). In patients with CLD, the presence of liver cancer had the most profound impact on health care expenditures (ß = $17,278 ± $5726/y) and physical health (ß = -7.2 ± 1.7 for SF-12 physical component) (all P < .005). CONCLUSIONS: In a cross-sectional analysis of MEPS participants, we associated CLD with large economic and quality-of-life burdens.


Assuntos
Custos de Cuidados de Saúde , Gastos em Saúde , Hepatopatias/economia , Hepatopatias/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica/economia , Doença Crônica/epidemiologia , Estudos Transversais , Eficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Estados Unidos/epidemiologia , Adulto Jovem
7.
Undersea Hyperb Med ; 43(3): 217-23, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27416689

RESUMO

INTRODUCTION: Changes in visual acuity are a known side effect of hyperbaric oxygen (HBO2). We conducted a quality improvement initiative to better quantify visual change risk and to identify possible risk factors. METHODS: Vision was checked weekly in a clinical HBO2 population by Snellen eye chart. Visual acuity change was defined as Snellen test worsened to 20/40 or greater or by loss of 2 lines. RESULTS: Of 85 patients treated from January 2013 to February 2015 with 10 HBO2 sessions and ≥ 2 weeks of visual acuity testing, 53 (62%) were male. All were treated for UHMS-approved indications. A total of 34 patients (40%) had no change in visual acuity, 27 (32%) had a 1-line change, and 24 (28%) had at least a 2-line worsening in visual acuity. The number of sessions for those with at least a 2-line change was 36 ± 15 (15-60). A 2-line change occurred at similar rates for monoplace and multiplace patients (29% and 32%, respectively), but monoplace patients more frequently reached 20/40 or worse (32% vs. 18%). Seven of 11 patients with existing cataracts had ≥ 2 line change, as did six of 14 patients (43%) with a history of head/neck radiation. CONCLUSIONS: In this retrospective review of quality improvement data, 28% of patients had a 2-line change in visual acuity by Snellen exam after treat-ment with HBO2. Further study of possible risk factors, including chamber type, is warranted.


Assuntos
Oxigenação Hiperbárica/efeitos adversos , Miopia/etiologia , Melhoria de Qualidade , Acuidade Visual , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Miopia/diagnóstico , Estudos Retrospectivos , Fatores de Risco , Testes Visuais
8.
Health Qual Life Outcomes ; 14: 18, 2016 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-26860700

RESUMO

BACKGROUND: NAFLD impacts patient reported outcomes (PROs). Our aim was to assess the impact of NAFLD on patients' HRQOL. METHODS: National Health and Nutrition Examination Survey (NHANES) 2001-2011 data were used to identify adult patients with NAFLD [Fatty Liver Index (FLI) > 60 in absence of other liver disease and excessive alcohol >20 g/day for men, >10 g/day for women]. Patients with other chronic diseases (ex. HIV, cancer, end-stage kidney disease) were excluded. Subjects without any of these conditions were healthy controls. HCV RNA (+) patients were HCV-controls. All patients completed NHANES HRQOL-4 questionnaire. Linear regression determined the association between NAFLD and HRQOL components adjusting for age, gender, race, and BMI. RESULTS: Participants with complete data were included (n = 9661); 3333 NAFLD (age 51 years and BMI 34 kg/m(2)); 346 HCV+ (age 49 years; BMI 27 kg/m(2)) and 5982 healthy controls (age 48 years and BMI 26 kg/m(2)). The proportion of subjects rating their health as "fair" or "poor" in descending order were HCV controls (30 %) NAFLD (20 %) and healthy controls (10 %) (p < 0.001). HRQOL-4 components scores 2-4 were lowest for HCV, followed by NAFLD and then healthy controls (p-values p = 0.011 to < .0001). After adjustment for age, gender, race, and BMI, NAFLD patients were 18-20 % more likely to report days when their physical health wasn't good or were unable to perform daily activities as a result (p < .0001). CONCLUSIONS: NAFLD causes impairment of HRQOL. As NAFLD is becoming the most important cause of CLD, its clinical and PRO impact must be assessed.


Assuntos
Adaptação Psicológica , Falência Renal Crônica/psicologia , Hepatopatia Gordurosa não Alcoólica/psicologia , Qualidade de Vida/psicologia , Fatores Etários , Atitude Frente a Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Fatores Sexuais , Inquéritos e Questionários , Estados Unidos
9.
Undersea Hyperb Med ; 43(7): 835-840, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28777521

RESUMO

Although Raynaud's phenomenon is a well-known consequence of exposure to cold, neither its incidence in recreational divers nor case reports in that population have been reported in the medical literature. We present a case report of the initial manifestation of primary Raynaud's phenomenon during a warm-water scuba dive. A healthy 18-year-old Caucasian male made four open-circuit compressed air scuba dives over two days in the Florida Keys to a maximum depth of 90 feet. After two of those dives, he noted painless, blue discoloration on three digits of his left hand, unaccompanied by sensory changes, which resolved within an hour of surfacing. During a fitness-to-dive evaluation one week later, his physical examination was normal. No skin discoloration, neurological symptoms or changes to pulse or blood pressure were noted with temperature or positional provocation. Laboratory testing was normal. However, arterial Doppler measurements were severely diminished in all digits of both upper extremities with temperature provocation, and continued to be diminished five minutes after immersion, suggesting Raynaud's phenomenon.


Assuntos
Mergulho/efeitos adversos , Dedos , Doença de Raynaud/etiologia , Adolescente , Temperatura Baixa , Dedos/irrigação sanguínea , Humanos , Masculino , Fotopletismografia , Doença de Raynaud/diagnóstico
10.
Ann Hepatol ; 13(1): 84-90, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24378270

RESUMO

BACKGROUND AND AIM. Statins are commonly used medications for the treatment of dyslipidemia. Although there are reported cases of hepatotoxicity related to statins, very few are associated with severe course and liver failure. MATERIAL AND METHODS. We used the Third National Health and Nutrition Examination Survey (NHANES III)-mortality linked files to assess the association between statin use and liver-related mortality. Patients with established causes of liver disease (HCV RNA-positive, HBs-Ag-positive, NAFLD by hepatic ultrasound, iron overload and excessive alcohol use of > 20 g of alcohol per day with elevated liver enzymes) were excluded. RESULTS. Of all adult NHANES III participants enrolled in 1988-1994 (n = 20,050), 9,207 individuals had sufficient demographic, clinical and medical information making them eligible for this study (age 41.26 ± 0.38, 46.76% male, 76.67% Caucasian, BMI 26.39 ± 0.38, 16.99% had diabetes or insulin resistance, 16.97% had hypertension, 65.28% had dyslipidemia). Of the entire study cohort, 90 (1.25%) participants reported using statins at the time of the interview. Median mortality follow-up for the study cohort was 175.54 months. During this period, 1,330 individuals (11.25%) died with 26 (0.17%) being liver-related deaths. For the cohort using statins, there were 37 deaths (40.15%) after a median follow-up of 143.35 months. In fact, the top cause of death for statin users was cardiac related (16 cases, 33.62%). However, after adjusting for major demographic, clinical and metabolic confounders, statin use was not associated with cardiovascular deaths in males (Hazard Ratio, 0.79, 95% Confidence Interval, 0.30-2.13), but was associated with higher risk of cardiovascular deaths in females (odds ratio, 2.32, 95% confidence interval, 1.58-3.40). Furthermore, the rate of liver-related mortality was significantly lower (p = 0.0035) among statin users compared to non-statin users. CONCLUSIONS. After a decade of follow up, there was no association between statin use and liver-related mortality.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Hepatopatias/mortalidade , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Hipercolesterolemia/complicações , Hepatopatias/complicações , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Modelos de Riscos Proporcionais , Adulto Jovem
11.
J Clin Exp Hepatol ; 3(3): 181-5, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25755498

RESUMO

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a major cause of chronic liver disease. In smaller studies, sleep apnea has been previously associated with NAFLD. The aim of this study was to assess the prevalence and independent associations of sleep disorders in patients with NAFLD using recent population-based data. METHODS: Three cycles of the National Health and Nutrition Examination Survey (NHANES) conducted between 2005 and 2010 were used. The diagnosis of NAFLD was established as elevated liver enzymes in the absence of all other causes of chronic liver disease. Sleep disorders were diagnosed using sleep disorder questionnaires completed by NHANES participants, and included self-reported history of sleep apnea, insomnia, and restless leg syndrome. The prevalence of sleep disorders was compared between those with and without NAFLD. RESULTS: A total of 10,541 adult NHANES participants with complete demographic, clinical, and laboratory data were included. Of those, 15.0% had NAFLD and 7.2% reported having sleep disorders. Of those with sleep disorders, 64.7% reported history of sleep apnea, 16.0% had history of insomnia, and 4.0% had restless leg syndrome. Individuals with NAFLD were more likely to be male (53.8% vs. 45.7%, P < 0.0001), obese (50.1% vs. 33.4%, P < 0.0001) and had higher prevalence of sleep disorders (9.1% vs. 6.9%, P = 0.0118). In multivariate analysis, having any sleep disorder, sleep apnea and insomnia were all independently associated with NAFLD [OR (95% CI) = 1.40 (1.11-1.76), OR = 1.39 (0.98-1.97), and OR = 2.17 (1.19-3.95); respectively)]. CONCLUSIONS: This large population-based data suggests that NAFLD is associated with sleep disorders. Although the exact mechanism is unknown, this association is most likely through metabolic conditions associated with NAFLD.

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