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Background: Hepatitis B Virus (HBV) remains a major global health challenge, with significant morbidity and mortality associated with chronic infections. Methods: This study examines the epidemiology, screening, and risk factors associated with HBV in Romania, focusing on a comprehensive national screening program, LIVE(RO)2, involving 320,000 individuals (majority of them considered vulnerable population). A questionnaire was used to collect information on the potential risk factors for HBV transmission. Results: The overall prevalence rate of HBV chronic infection among all the participants tested was 1.67% (confidence interval: 1.63-1.72%), with significant differences (p = 0.0001) between participants from the main geographical regions of residence (North-East 1.89%, South 1.38%, South-East 2.06%, and South-West 1.54%). Male persons aged 30-49 or 60-69 years old, from the rural and Eastern parts of Romania and non-Romanian ethnia, with a low level of education, unvaccinated, not married, unemployed, with family members with hepatitis, with personal histories of blood or blood product transfusion, surgical interventions, tattooing, hospitalizations, imprisonment, haemodialysis, unsafe sexual contacts, or with sexual transmitted infectious diseases were risk factors associated with HBsAg seropositivity. Conclusions: Our findings highlight significant demographic and epidemiological patterns of reduced HBV prevalence even in vulnerable persons, as well as modified risk factors and the impact of socio-economic factors.
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Hepatitis B , Tamizaje Masivo , Poblaciones Vulnerables , Humanos , Persona de Mediana Edad , Masculino , Femenino , Adulto , Prevalencia , Factores de Riesgo , Rumanía/epidemiología , Anciano , Hepatitis B/epidemiología , Hepatitis B Crónica/epidemiología , Adulto Joven , Derivación y Consulta , Virus de la Hepatitis B/inmunología , Virus de la Hepatitis B/aislamiento & purificación , Encuestas y Cuestionarios , AdolescenteRESUMEN
BACKGROUND: The global burden of hepatitis D virus (HDV) infection represents a major medical challenge and a public health crisis worldwide. However, there is a lack of accurate data on the epidemiology and risk factors for HDV. Hepatitis B virus (HBV) and HDV coinfection causes the most severe form of viral hepatitis, leading to a higher cumulative incidence of liver-related events compared with HBV monoinfection, including the need for liver transplantation and death. AIM: To investigate the epidemiology, natural history, risk factors and clinical management of HBV and HDV coinfection in Romanian patients. METHODS: This prospective study was conducted between January and July 2022 in six tertiary gastroenterology and hepatology referral centres in Romania. All consecutive adults admitted for any gastroenterology diagnosis who were HBV-positive were enrolled. Patients with acute hepatitis or incomplete data were excluded. Of the 25390 individuals who presented with any type of gastroenterology diagnosis during the study period, 963 met the inclusion criteria. Testing for anti-HDV antibodies and HDV RNA was performed for all participants. Demographic and risk factor data were collected by investigators using medical charts and patient questionnaires. All data were stored in an anonymized online database during the study. RESULTS: The prevalence of HBV was 3.8%; among these patients, the prevalence of HBV/HDV coinfection was 33.1%. The median age of the study population was 54.0 years, and it consisted of 55.1% men. A higher prevalence of HBV/HDV coinfection was observed in patients 50-69 years old. Patients with HBV/HDV coinfection were significantly older than those with HBV monoinfection (P = 0.03). Multivariate multiple regression analysis identified female gender (P = 0.0006), imprisonment (P < 0.0001), older age at diagnosis (P = 0.01) and sexual contact with persons with known viral hepatitis (P = 0.0003) as significant risk factors for HDV. CONCLUSION: This study shows that HDV infection among those with HBV remains endemic in Romania and updates our understanding of HDV epidemiology and associated risk factors. It emphasizes the need for systematic screening for HDV infection and collaborative initiatives for controlling and preventing HBV and HDV infection.
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(1) Background: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a tool designed to measure disability in accordance with the International Classification of Functioning, Disability and Health. Measuring disability is becoming increasingly important due to its high prevalence, which continues to rise. Rehabilitation interventions can reduce disability and enhance functioning. (2) Objective: The present study aims to assess the impact of rehabilitation interventions on reducing disability, as measured by the WHODAS 2.0 questionnaire. It also seeks to identify which specific rehabilitation interventions are more effective and to explore other disability assessment questionnaires. (3) Methods: Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) methodology, we conducted a systematic review, with the protocol registered with the identifier CRD42023495309, focused on "WHODAS" and "rehabilitation" using PubMed and Web of Science electronic databases. (4) Results: We identified 18 articles from various regions encompassing patients with various health conditions, related to stroke, the cardiovascular system (cardiovascular disease, chronic heart failure), the pulmonary system (chronic obstructive pulmonary disease), the neurologic system (Parkinson's disease, cerebral palsy, neurodegenerative disease), the musculoskeletal system (orthopaedic surgery), cancer, and chronic pain, and among frail elderly. These patients have received a wide range of rehabilitation interventions: from conventional therapy to virtual reality, robot-assisted arm training, exergaming, and telerehabilitation. (5) Discussion and Conclusions: A wide range of rehabilitation techniques can effectively improve disability with various comorbidities, offering numerous benefits. The WHODAS 2.0 questionnaire proves to be an efficient and reliable tool for measuring disability, and scores have a tendency to decrease after rehabilitation.
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BACKGROUND: Sarcopenia is a syndrome characteristic in elderly patients and is also associated with a significant proportion of chronic disorders such as inflammatory bowel disease (IBD). In this case, it can lead to a worse prognosis of the disease and a decreased quality of life. STUDY AIM: This study aims to identify the best ways to diagnose sarcopenia in patients with IBD, establish its impact on the course of the disease, and find preventive methods to counteract the effects of sarcopenia in the outcome of patients with IBD and, therefore, minimize disabilities and increase the health-related quality of life (HRQoL). MATERIAL AND METHODS: A systematic review with the Prospero registration number CRD42023398886 was performed in PubMed and Web of Science databases, evaluating all original articles published in the last 10 years (clinical trials and randomized control trials) that describe sarcopenia and IBD in the human adult population. RESULTS: From the 16 articles that were included, 5 articles defined sarcopenia by the skeletal muscle index (SMI) and reported data regarding its correlation with body composition: BMI; visceral fat (VF); subcutaneous fat (SC); and VF/SC index. Other articles evaluated the link between sarcopenia and the total psoas muscle area, thigh circumference, calf circumference, subjective global assessment, hand grip strength, and appendicular SMI, alongside inflammatory markers such as IL-6 and C-reactive protein, level of disability, malnutrition, frailty, resistance training alone and in combination with whey protein, and infliximab treatment. DISCUSSIONS AND CONCLUSIONS: There is a great heterogeneity regarding the assessment criteria and methods used to diagnose sarcopenia due to the variability of population characteristics, both anthropometric and socio-cultural, alongside the high variability in the cut-offs. Therefore, any method which identifies sarcopenia in IBD patients, thus enabling intervention, may provide good results for patient quality of life and outcomes.
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The negative consequences of microgravity for the human body are central aspects of space travel that raise health problems. Altered functions of the same systems and treatment options are common points of spaceflight physiology, age-related diseases, and oral medicine. This work emphasizes the convergence of knowledge between pathophysiological changes brought on by aging, physiological reactions to microgravity exposure, and non-pharmacological and non-invasive treatment methods that can be used in spaceflight. Sarcopenia, peripheral nerves alterations, neuromotor plaque in the masticatory muscles, lingual, labial, and buccal weakness, nociplastic pain in oral mucosal diseases, and microgravity, as well as soft tissue changes and pathologies related to chewing and swallowing, corticomotor neuroplasticity of tongue, and swallowing biomechanics, are of particular interest to us. Neurologic disease and other pathologies such as recovery from post-stroke dysphagia, nociplastic pain in glossodynia, sleep bruxism, and obstructive sleep apnea have been studied and, in some cases, successfully treated with non-invasive direct and transcranial magnetic stimulation (TMS) methods in recent decades. An interdisciplinary team from medical specialties, engineering, and biophysics propose an exploratory study based on the parallelism of ageing and space physiology, along with experiment scenarios considering TMS and non-invasive direct methods.
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Síndrome de Boca Ardiente , Ingravidez , Humanos , Ingravidez/efectos adversos , Investigación Dental , Envejecimiento , DolorRESUMEN
AIM: We evaluated the safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for their use with other glucose-lowering drugs and drugs for the treatment of type 2 diabetes mellitus (T2DM), in a standard-of-care regimen with maximum tolerated doses, and, respectively, when compared with metformin. METHODS: We conducted a retrospective, observational study on 405 patients that were seen in the outpatient clinic of the N Paulescu National Institute for Diabetes Mellitus, Bucharest, Romania, in 2019. Their demographics, metabolic parameters, and medication safety were evaluated at three follow-up visits, from baseline, six months, and twelve months. RESULTS: Both SGLT-2is and GLP-1 RAs are safe regarding creatinine, eGFR, urea, GOT, and GPT upon the comparison of the data from the six- and twelve-month visits with the initial visit, and also the twelve-month visit with the six-month visit. Moreover, when comparing SGLT-2is and GLP-1 RAs with metformin, there are safety data only for urea. CONCLUSIONS: In this retrospective analysis, both SGLT-2is and GLP-1 RAs, when used in conjunction with other glucose-lowering, blood-pressure-lowering, and lipid-lowering medications, appeared to be safe for the management of T2DM.
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BackgroundThe World Health Organization European Action Plan 2020 targets for the elimination of viral hepatitis are that > 75% of eligible individuals with chronic hepatitis B (HBV) or hepatitis C (HCV) are treated, of whom > 90% achieve viral suppression.AimTo report the results from a pilot sentinel surveillance to monitor chronic HBV and HCV treatment uptake and outcomes in 2019.MethodsWe undertook retrospective enhanced data collection on patients with a confirmed chronic HBV or HCV infection presenting at one of seven clinics in three countries (Croatia, Romania and Spain) for the first time between 1 January 2019 and 30 June 2019. Clinical records were reviewed from date of first attendance to 31 December 2019 and data on sociodemographics, clinical history, laboratory results, treatment and treatment outcomes were collected. Treatment eligibility, uptake and case outcome were assessed.ResultsOf 229 individuals with chronic HBV infection, treatment status was reported for 203 (89%). Of the 80 individuals reported as eligible for treatment, 51% (41/80) were treated of whom 89% (33/37) had achieved viral suppression. Of 240 individuals with chronic HCV infection, treatment status was reported for 231 (96%). Of 231 eligible individuals, 77% (179/231) were treated, the majority of whom had received direct acting antivirals (99%, 174/176) and had achieved sustained virological response (98%, 165/169).ConclusionTreatment targets for global elimination were missed for HBV but not for HCV. A wider European implementation of sentinel surveillance with a representative sample of sites could help monitor progress towards achieving hepatitis control targets.
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Hepatitis B Crónica , Hepatitis B , Hepatitis C Crónica , Hepatitis C , Humanos , Hepatitis B Crónica/diagnóstico , Hepatitis B Crónica/tratamiento farmacológico , Hepatitis B Crónica/epidemiología , Antivirales/uso terapéutico , Vigilancia de Guardia , Estudios Retrospectivos , Hepatitis C Crónica/diagnóstico , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/epidemiología , Hepatitis C/epidemiología , Hepacivirus , Resultado del Tratamiento , Hepatitis B/epidemiología , Virus de la Hepatitis BRESUMEN
Metabolic syndrome (MetS) is characterized by an association of cardiovascular and diabetes mellitus type 2 risk factors. Although the definition of MetS slightly differs depending on the society that described it, its central diagnostic criteria include impaired fasting glucose, low HDL-cholesterol, elevated triglycerides levels and high blood pressure. Insulin resistance (IR) is believed to be the main cause of MetS and is connected to the level of visceral or intra-abdominal adipose tissue, which could be assessed either by calculating body mass index or by measuring waist circumference. Most recent studies revealed that IR may also be present in non-obese patients, and considered visceral adiposity to be the main effector of MetS' pathology. Visceral adiposity is strongly linked with hepatic fatty infiltration also known as non-alcoholic fatty liver disease (NAFLD), therefore, the level of fatty acids in the hepatic parenchyma is indirectly linked with MetS, being both a cause and a consequence of this syndrome. Taking into consideration the present pandemic of obesity and its tendency to drift towards a progressively earlier onset due to the Western lifestyle, it leads to an increased NAFLD incidence. Novel therapeutic resources are lifestyle intervention with physical activity, Mediterranean diet, or therapeutic surgical respective metabolic and bariatric surgery or drugs such as SGLT-2i, GLP-1 Ra or vitamin E. NAFLD early diagnosis is important due to its easily available diagnostic tools such as non-invasive tools: clinical and laboratory variables (serum biomarkers): AST to platelet ratio index, fibrosis-4, NAFLD Fibrosis Score, BARD Score, fibro test, enhanced liver fibrosis; imaging-based biomarkers: Controlled attenuation parameter, magnetic resonance imaging proton-density fat fraction, transient elastography (TE) or vibration controlled TE, acoustic radiation force impulse imaging, shear wave elastography, magnetic resonance elastography; and the possibility to prevent its complications, respectively, fibrosis, hepato-cellular carcinoma or liver cirrhosis which can develop into end-stage liver disease.
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BACKGROUND: Film-forming substances, such as natural polysaccharides (NP) and pea proteins (PP), act as a protective barrier for treating various gastrointestinal conditions. We assessed the efficacy and safety of a novel therapeutic of natural origin (NTN) containing NP and PP for symptomatic treatment of lactose intolerance. METHODS: In this multicenter, randomized, double-blind, parallel-group study, patients with lactose intolerance received NTN (n = 30) or placebo (n = 30) for 7 days, then the alternate treatment for 7 days. Patients rated their gastrointestinal symptoms using a 7-point Likert scale. The lactose hydrogen breath test was used to assess exhaled hydrogen. RESULTS: NTN as primary or crossover treatment significantly improved patient-reported symptoms of bloating, distension, and abdominal pain. Abdominal pain also improved under primary treatment with placebo. Primary treatment with NTN, but not placebo, normalized mean exhaled hydrogen levels. In the group allocated initially to placebo, crossover to NTN attenuated the increase in hydrogen production. No treatment-related adverse effects were reported in either group. CONCLUSIONS: Subjective improvements in bloating, distension, and abdominal pain with NTN were supported by objective evidence of hydrogen production normalization. NTN appears to be a useful alternative to lactose avoidance or enzyme replacement in patients with lactose intolerance.
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The continuous variability of SARS-CoV-2 and the rapid waning of specific antibodies threatens the efficacy of COVID-19 vaccines. We aimed to evaluate antibody kinetics one year after SARS-CoV-2 vaccination with an mRNA vaccine in healthcare workers (HCW), with or without a booster. A marked decline in anti-Spike(S)/Receptor Binding Domain (RBD) antibody levels was registered during the first eight months post-vaccination, followed by a transitory increase after the booster. At three months post-booster an increased antibody level was maintained only in HCW vaccinated after a prior infection, who also developed a higher and long-lasting level of anti-S IgA antibodies. Still, IgG anti-nucleocapsid (NCP) fades five months post-SARS-CoV-2 infection. Despite the decline in antibodies one-year post-vaccination, 68.2% of HCW preserved the neutralization capacity against the ancestral variant, with a decrease of only 17.08% in the neutralizing capacity against the Omicron variant. Nevertheless, breakthrough infections were present in 6.65% of all participants, without any correlation with the previous level of anti-S/RBD IgG. Protection against the ancestral and Omicron variants is maintained at least three months after a booster in HCW, possibly reflecting a continuous antigenic stimulation in the professional setting.
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After almost 50 years of data analysis, screening for colorectal cancer has proven to be an effective tool in reducing colorectal cancer mortality. However, implementing the optimal strategy represents a challenge for many healthcare facilities around the world. There is much discussion regarding how screening should be done, the optimal tools that should be used, and the proper timing for screening procedures. Another essential step is to maintain the adherence of patients to screening programs. Also, the recommendation for lowering the age to initiate screening is in progress, as there is an increase in colorectal incidence in people born after 1970.
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Colonoscopía , Neoplasias Colorrectales , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Atención a la Salud , Detección Precoz del Cáncer , Humanos , Incidencia , Tamizaje MasivoRESUMEN
Immunotherapy has revolutionized cancer treatment. Immune checkpoint inhibitors (ICIs) including antibodies targeting cytotoxic T lymphocyte associated antigen-4 and programmed cell death 1 have been shown to be effective in the treatment of certain types of cancer. The benefit of these therapies is to prolong life expectancy in the case of metastatic malignancies. Rheumatic adverse events are not very common. In the present study, 9 patients were monitored between November 2018 and January 2020. The oncologist, who identified the occurrence of rheumatic toxicities after the treatment with ICIs, evaluated the patients. Only oncological patients with rheumatic manifestations after the start of immunotherapy were included. Toxicity grading was performed by both the oncologist and the rheumatologist, on a scale from 1 to 5 (1, mild; 2, moderate; 3, severe; 4, life-threatening; 5, death related to toxicity). The results showed that rheumatoid factor, which was sampled in each patient, was negative in all cases. Patients were treated with nonsteroidal anti-inflammatory drugs or prednisone depending on the severity of the adverse events. The results varied with the severity of the adverse events. In conclusion, as the number of patients treated with ICIs increases, so will the number of patients presenting with immune-related adverse events (irAEs). The collaboration between oncologists and rheumatologists should be intimate to provide optimal treatment to patients. Musculoskeletal manifestations secondary to ICIs are slightly different from other rheumatologically conditions making diagnosis, treatment and monitoring difficult. Thus, irAEs are new and challenging for oncologists, thus understanding of the pathogenesis and clinical characteristics must be improved for better treatment guidelines.
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Background: Emerging evidence suggests that patients with metabolic (dysfunction) associated fatty liver disease (MAFLD) are prone to severe forms of coronavirus disease (COVID-19), especially those with underlying liver fibrosis. The aim of our study is to assess the association of an increased FIB-4 score with COVID-19 disease prognosis. Methods: We performed a prospective study on hospitalized patients with known type II diabetes mellitus (T2DM) and confirmed COVID-19, with imaging evidence of liver steatosis within the last year or known diagnosis of MAFLD. All individuals were screened for liver fibrosis with a FIB-4 index. We evaluated the link between FIB-4 and disease prognosis. Results: Of 138 participants, 91.3% had MAFLD and 21.5% patients had a high risk of fibrosis. In the latter group of patients, the number of severe forms of disease, the hospital stay length, the rate of ICU admissions and the number of deaths reported registered a statistically significant increase. The independent predictors for developing severe forms of COVID-19 were obesity (odds ratio (OR), 3.24; 95% confidence interval (CI), p = 0.003), higher values of ferritin (OR-1.9; 95% CI, 1.17-8.29, p = 0.031) and of FIB-4 ≥ 3.25 (OR-4.89; 95% CI, 1.34-12.3, p = 0.02). Conclusions: Patients with high scores of FIB-4 have poor clinical outcomes and liver fibrosis may have a relevant prognostic role. Although the link between liver fibrosis and the prognosis of COVD-19 needs to be evaluated in further studies, screening for liver fibrosis with FIB-4 index, particularly in patients at risk, such as those with T2DM, will make a huge contribution to patient risk stratification.
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COVID-19 , Diabetes Mellitus Tipo 2 , Enfermedad del Hígado Graso no Alcohólico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Humanos , Pronóstico , Estudios Prospectivos , SARS-CoV-2RESUMEN
Breast cancer remains the most common cause of morbidity and mortality by cancer in females worldwide, even though it is largely preventable through population screening. Despite notable progress in the last years in the EU, breast cancer screening programs still maintain wide variations among countries and socio-economic groups. This statistical review aimed to investigate the breast cancer-related health gaps in Romanian women compared to the average EU female population after 10 years of accession (2007-2016). We evaluated breast cancer-related deaths, age-standardized mortality rates and contribution of breast cancer to life expectancy. Trends and percentage changes were compared between Romania and EU-27 for breast cancer, all cancer and all causes of mortality. We found a higher increase of breast cancer deaths in Romania, an increasing trend of mortality (opposite to EU) and a contribution to life expectancy at birth that increased gradually from 0.45 to 0 48 years. All these health gaps compared to EU are aggravated by the fact that no population screening for breast cancer is organized in the country. The opportunities for organizing such a program are consistent, but they should be increased in the future, in order to control the health gap between Romania and EU.
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Background and Objectives: Despite being largely preventable, cervical cancer mortality still remains an important public health problem globally, in Europe, and in Romania. The European Union member states are urged to implement systematic, population-based screenings for cervical cancer, but the programs developed by the countries remain very heterogeneous. This study aimed to investigate the differences in cervix cancer mortality between Romania and EU and within Romania over the last two decades and to reveal the major sources of inequalities and the policy implications. Materials and Methods: We analyzed the number of deaths and the mortality rates by cervical cancer, standardized using the direct method, over two decades (2001-2016 for the EU, and 2001-2019 for the national and sub-national analyses). Trends, mortality reduction over the years, and mortality differences at the beginning and end of the time interval have been calculated for the EU and Romania, at national and sub-national levels (rural-urban and regions). Results: Our results revealed differences in cervical cancer mortality between Romania and EU and within Romania (among regions and rural-urban areas). These differences used to be very high in the past and are still persisting. Conclusions: The country should revisit its national cervical cancer screening program, which has been implemented for many years, but with a very limited participation rate. Due to the similar problems existing in Central-Eastern Europe, targeted support from the EU for the members from this geographical area could contribute to the minimization of differences in cervical cancer mortality among the EU members.
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Neoplasias del Cuello Uterino , Detección Precoz del Cáncer , Femenino , Humanos , Políticas , Rumanía/epidemiología , Población RuralRESUMEN
Liver cirrhosis (LC) is an important cause of mortality. Access to liver transplantation (LT) has significantly improved the prognosis of LC. A rigorous pre-transplant cardiac evaluation is mandatory, since cardiac dysfunction is considered the main cause of mortality after LT. Notwithstanding, the most updated pre-LT evaluation guidelines provide only an algorithm for the evaluation of major cardiovascular diseases, with no specific recommendations concerning cirrhotic cardiomyopathy (CCM), which is linked to various complications in LC, especially the development of heart failure after invasive procedures and surgical interventions, including LT. CCM is characterized by a cardiac dysfunction that includes systolic and/or diastolic dysfunction and/or electrophysiological abnormalities, in the absence of other known cardiac diseases. The role of the novel methods, tissue Doppler imaging and speckle tracking echocardiography, might be essential in the early detection of cardiac dysfunction, with prognosis implications in LC. All these new methods were only recently included in the CCM diagnosis algorithm. This review summarizes the old and novel techniques used for the diagnosis of CCM, with their diagnosis and prognostic role. It also highlights the strengths and the weaknesses of the new provided CCM diagnostic consensus, and proposes a step-by- step novel diagnostic algorithm, in order to better detect cardiac dysfunction.cirrhotic cardiomyopathy.
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Cardiomiopatías/diagnóstico , Cardiomiopatías/etiología , Cirrosis Hepática/complicaciones , Cirrosis Hepática/cirugía , Trasplante de Hígado , Humanos , PronósticoAsunto(s)
Antivirales/uso terapéutico , Bencimidazoles/uso terapéutico , Carcinoma Hepatocelular/epidemiología , Fluorenos/uso terapéutico , Hepatitis C/tratamiento farmacológico , Neoplasias Hepáticas/epidemiología , Ribavirina/uso terapéutico , Sofosbuvir/uso terapéutico , Carcinoma Hepatocelular/patología , Carcinoma Hepatocelular/virología , Hepacivirus , Hepatitis C/complicaciones , Hepatitis C/patología , Humanos , Cirrosis Hepática/tratamiento farmacológico , Cirrosis Hepática/patología , Cirrosis Hepática/virología , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/virología , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/virología , Estudios RetrospectivosRESUMEN
BACKGROUND AND AIMS: Elimination of hepatitis C worldwide is more feasible if micro-elimination screening strategies are adopted. We aimed to screen hepatitis C virus (HCV) in specific high-risk populations in certain sub-regions of Romania and link them to antiviral treatment. METHODS: A multicenter prospective study was conducted among the hospitalized or ambulatory adult patients from March 2019 to March 2020 in more than 20 medical institutions from 4 Romanian cities (Bucharest, Iasi, Timisoara, Cluj-Napoca). A rapid diagnostic test for HCV diagnosis was performed to all admitted patients and the positive ones were sent to gastroenterology departments for confirming the active infection, staging and treatment prescription. RESULTS: In total, 25,141 subjects signed the informed consent and were consequently enrolled into the study. The prevalence of anti-HCV antibodies was 1.39% (95%CI: 1.25-1.54) and increased with the number of risk factors presented by one subject. There was a positive association between the presence of anti-HCV antibodies and female gender (p<0.001), rural area of residence (p<0.001), advanced age (p<0.001), as well as a negative association with the education level (p<0.001). CONCLUSIONS: In a hospital-based screening micro-elimination program in Romania, HCV prevalence was lower than previously reported. This is a first step towards a cost-effective screening in a well-defined group of persons at risk and provides sufficient capacity to deliver access to HCV treatment and linkage to care in Romania.
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Programas de Detección Diagnóstica , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Hospitales , Adulto , Anciano , Antivirales/uso terapéutico , Biomarcadores/sangre , Femenino , Hepatitis C/tratamiento farmacológico , Hepatitis C/virología , Anticuerpos contra la Hepatitis C/sangre , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Prevalencia , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rumanía/epidemiologíaRESUMEN
BACKGROUND AND AIMS: Ledipasvir/Sofosbuvir (LDV/SOF) with or without Ribavirin (RBV) has shown good results in terms of efficacy and safety in clinical trials in advanced liver cirrhosis, but real-life data are still needed in order to confirm this profile. We investigated the efficacy and safety of LDV/SOF in a large Romanian population with liver cirrhosis and genotype 1b hepatitis C virus (HCV). METHODS: We analyzed a multicentric retrospective cohort enrolling 349 patients with decompensated liver cirrhosis due to HCV who received LDV/SOF±RBV 12/24 weeks (301/48). Patients were included between 2017-2018, all with genotype 1b. Main inclusion criteria were liver cirrhosis and detectable HCV RNA. The cases were followed-up monthly during therapy and 12 weeks after the end of therapy. RESULTS: The cohort included 60% females with a median age of 61, 16% interferon (IFN) pre-treated, 53% with comorbidities, 40/53/7 % with Child Pugh A/B/C, 4% with virus B co-infection and 8% with previously treated hepatocellular carcinoma. Mean initial MELD score was 11.92 (6.82÷ 24.5). Six patients were lost during follow-up. Sustained virologic response (SVR) in intention-to-treat was reported in 85.1%. Predictive factors of SVR in decompensated cirrhosis were female gender (p=0.01), advanced age (p<0.001), lower bilirubin levels (p=0.002) and lower CTP score (p=0.02). In patients with CTP score B or C low bilirubin levels (p=0.003), low INR (p<0.001), increased platelet count (p=0.04), low CTP score (p<0.001), lack of encephalopathy (p=0.02), serum albumin >3.5g/dl (p=0.002) predicted improvement of liver function. Serious adverse events were reported in 16/349 (4.6%), most of them due to severe liver decompensation (9/16). CONCLUSIONS: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR.