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We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18–55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86–90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95–60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms (p = 0.006), with no fatalities or grade four AEs. TURKOVAC was non-inferior to CoronaVac in terms of efficacy and demonstrated a good safety and tolerability profile. [ABSTRACT FROM AUTHOR]

Background. The gut-liver axis is one of the most emphasized topics in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Intestinal microbiota dysbiosis has been shown to be a predictor of disease severity and progression to fatty liver disease. Therefore, research addressing gut-based therapies has become popular. Objectives. To investigate the effect of lactulose and polyethylene glycol 3350 (PEG 3350) in mice with induced obesity and NAFLD at a non-diarrheal dose. Materials and methods. Thirty-six C57BL/6J male mice were divided into 6 groups. The first 2 groups (n = 6 each) were used as an induced obesity model (group A) and NAFLD model (group B) for 8 weeks. The remaining 24 animals were categorized into control diet group, high-fat diet (HFD) group, HFD + lactulose group, and HFD + PEG 3350 group. Serum and liver tissue samples were obtained for biochemical and histopathological analyses, respectively. Results. The HFD + lactulose treatment group displayed a significant decrease in liver weight (1.3 (1.3-- 1.4) kg compared to 1.8 (1.6--1.9) kg) and NAFLD activity score (NAS) (1.5 (1.0--3.0) compared to 5.0 (4.0--5.0), respectively; p = 0.0043, p = 0.0021) when compared with the HFD group. However, a decrease in body weight (35.0 (34.6--36.0) kg compared to 40.9 (34.7--41.9) kg) and hepatosteatosis (HS) rate (33.3% compared to 100.0%) were not statistically significant (p = 0.1796, p = 0.0606, respectively). The HFD + PEG 3350 treatment group showed a statistically significant decrease in body weight (32.4 (30.2--33.9) kg compared to 40.9 (34.7--41.9) kg), liver weight (1.5 (1.3--1.5) kg compared to 1.8 (1.6--1.9) kg), HS rate (16.7% compared to 100.0%) and NAS (0.5 (0.0--1.0) compared to 5.0 (4.0--5.0); p = 0.0086, p = 0.0086, p = 0.0151, and p = 0.0021, respectively) when compared with the HFD group. Conclusions. We demonstrated that non-diarrheal dose of lactulose and PEG 3350 reduced hepatic inflammation in mice with induced NAFLD. It was also observed that PEG 3350 decreased HS and body weight. We believe these mechanisms can be utilized as novel therapeutic approaches in NAFLD in prospective human studies. [ABSTRACT FROM AUTHOR]

Objective: The fibrosis stage during diagnosis and the response to ursodeoxycholic acid in the 1st year of treatment are considered to be prognostic indicators in primary biliary cholangitis (PBC). Determining these indicators with non-invasive models can enable the risk of liver failure to be monitored with continuous variables from the moment of diagnosis. The aim of this study was to evaluate the diagnostic performance of non-invasive models for determining the prognostic indicators in patients with PBC. Materials and Methods: Data from patients with PBC were screened retrospectively. Patients were divided into early (≤2) and advanced (≥3) fibrosis groups. In addition, treatment response status according to the Paris-II criteria and liver failure risk (LFR) according to the UK-PBC score were determined. The S-Index consisting of gamma-glutamyltransferase (GGT), platelets (PLT), and albumin, (S-index: 1000×GGT÷[PLT×Albumın2]), other non-invasive models were calculated. The diagnostic effectiveness of noninvasive indicators to determine the fibrosis stage, response to treatment, and low LFR was analyzed. Results: Fifty-three patients were included in the study. The overall mean age at diagnosis was 49.6±13.6 years and 86.8% of the patients (n=46) were female. The S-Index was able to determine fibrosis stage, treatment responded, and patients with low LFR (AUC: 0.747, 0.823, and 0.752; p=0.006, <0.001, and 0.0007, respectively). Furthermore, S-Index found to superior to other noninvasive indicators in terms diagnosis of prognostic indicators of PBC. Conclusion: S-index is a practical and inexpensive non-invasive model that can identify liver fibrosis and treatment response in patients with PBC. It can be used as a continuous variable prognostic model in PBC. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Familial Mediterranean fever (FMF) is a monogenic inherited periodic fever syndrome presenting with episodes of self-limiting fever and inflammation of serosal membranes. Besides the findings in the diagnostic criteria, musculoskeletal findings can also be seen in FMF patients attacks. In this study, we aim to reveal the frequency and genotype association of musculoskeletal manifestations in children with FMF. METHODS: The patients diagnosed with FMF between January 1, 2017 and June 1, 2019, and followed for at least six months in our pediatric rheumatology clinic were included in this study. Musculoskeletal manifestations of patients were enrolled. The patients were grouped according to the "Mediterranean Fever" (MEFV) gene variants. Musculoskeletal manifestations of the patients were compared between the groups. RESULTS: The study group included 634 children with FMF (336 female and 298 male, F/M: 1.13/1). The clinical manifestations of patients in the attack period were as follows: 99% of the patients had a fever, 87.3% had abdominal pain, 20.7% had chest pain, 11.3% had vomiting, 10.7% had erysipelas like erythema, and 9.3% had a headache. The musculoskeletal symptoms were accompanied by 58.6% (n=372) of the patients during the attack period. The most common musculoskeletal manifestation was found as arthralgia (32.6%, n=206). Also, the other musculoskeletal manifestations were as follows during attacks: arthritis in 23.7% (n=150), myalgia in 20.5% (n=130), exertional leg pain in 6.5% (n=41), and protracted febrile myalgia in 1% (n=7) of the patients. It was observed that the musculoskeletal manifestations were significantly higher in patients with homozygous M694V variants in exon-10 (p=0.017). The musculoskeletal manifestations were more common in the attack periods of patients carrying the M694V variant in at least one allele (p=0.019). CONCLUSION: We found that the musculoskeletal manifestations were accompanied in more than half of patients with FMF. M694V variant was found as a risk factor for emerging musculoskeletal manifestations. [ABSTRACT FROM AUTHOR]

OBJECTIVE: There are many instruments to measure disease activity in ulcerative colitis. While determining clinical activity according to these instruments, many clinical and laboratory parameters are needed to be followed. Determination of disease activity with non-invasive and objective inflammatory indicators may be a practical and objective way. CRP/Albumin ratio (CAR) is an inflammatory marker that is considered to have prognostic value in various cancers, sepsis and acute pancreatitis. In this study, we aim to investigate diagnostic performance CAR in determining the clinical severity of ulcerative colitis. METHODS: Between November 2011 and February 2017, hospital records and follow-up cards of patients with ulcerative colitis were reviewed retrospectively. One hundred forty-nine patients were included in this study. Patient's demographic data, laboratory values, clinical disease activity, according to Truelove & Witts criteria and endoscopic activity according to the Mayo sub-score and treatments, were recorded. Diagnostic performance of CAR analyzed to determine the clinical severity. RESULTS: Of the patients included in this study, 99 (62%) were male, and 50 (38%) were female. Mean age was 45.22±14 years. When patients were grouped into remission, mild, moderate and severe disease according to disease activity, there was a statistically significant difference between CRP, CAR, erythrocyte sedimentation rate (ESR) and albumin levels (p=0.001; p<0.05). Area under the curve (AUC) values for the diagnosis of severe disease were 0.941, 0.931, 0.888 and 0.883 for CAR, CRP, ESR and albumin levels, respectively. Cut-off value to determine severe disease for CAR was 0.6 (sensitivity: 88.9%, specificity of 90.3%, positive predictive value (PPV) 85.1%, negative predictive value (NPV) 92.8%, AUC: 0.941, p<0.001). CONCLUSION: There was a significant relationship between CAR, CRP, ESR and albumin levels and clinical disease severity in patients with ulcerative colitis. CAR is a cheap and practical marker for the diagnosis of acute severe ulcerative colitis. [ABSTRACT FROM AUTHOR]

OBJECTIVE: In this study, we aimed to investigate the presence of subclinical atherosclerosis by measuring epicardial fat thickness (EFT) and carotid intima-media thickness (cIMT), evaluate low-level inflammation with high-sensitivity C-reactive protein (hsCRP), and evaluate whether there is a relationship among lipid profile, atherogenic indices, and hsCRP with these subclinical atherosclerosis markers in patients with celiac disease (CD). METHODS: After exclusion and inclusion criteria were applied, 31 patients with CD (24 female, mean age: 39.4±12.3 years) and 32 healthy controls (21 female, mean age: 39.5±4.4 years), totally 63 cases, were recruited. Subclinical atherosclerosis was evaluated with EFT by transthoracic echocardiography and cIMT by ultrasonography. Inflammatory markers including erythrocyte sedimentation rate (ESR), hsCRP, and lipid profile were recorded. Also, atherogenic indices were calculated: Castelli risk index I and II (TG/HDL-c and LDL-c/HDL-c, respectively), atherogenic index of plasma (AIP; logarithm TG/HDL-c), non-HDL-c (TG-HDL-c), and atherogenic coefficient (AC; non-HDL-c/HDL-c). RESULTS: EFT was significantly higher in the CD group (0.49±0.10 vs. 0.49±0.09; p-value: 0.02). Although cIMT was higher in the patient group, it did not reach statistical significance (0.51±0.08, 0.47±0.08; p-value: 0.10). HDL cholesterol level was found to be significantly lower (42.0±8.8 vs. 50.0±13.7; p-value: 0.01), and the plasma atherogenic index was found to be significantly higher in the patient group (0.98±0.50 vs. 0.62±0.64; p-value: 0.02). hsCRP (3.51±3.18 vs. 1.92±1.40; p-value: 0.02) and ESR (17.2±12.8 with 9.7±3.1; p-value: 0.01) were found to be significantly higher in the CD group. Although there was a significant positive correlation between EFT and hsCRP (r: 0.453; p-value: 0.01), there was a significant negative correlation between cIMT and HDL-cholesterol (-0.339; p-value: 0.05), and a significant positive correlation with the other components of the atherogenic index was found. CONCLUSION: The risk of atherosclerosis has been increased in patients with CD. Chronic inflammation may be responsible for this increase along with atherogenic indices. [ABSTRACT FROM AUTHOR]

Background and Aim: The aim of the present study was to examine the etiology of hepatocellular carcinoma (HCC) by underlying cause and determine the characteristics and clinical features of patients with HCC., Materials and Methods: The study comprised 1802 HCC patients diagnosed and followed up by Liver Diseases Outpatient Clinics in 14 tertiary centers in Turkey between 2001 and 2020., Results: The mean age was 62.3±10.7 years, and 78% of them were males. Of the patients, 82% had cirrhosis. Hepatitis B virus (HBV) infection was the most common etiology (54%), followed by hepatitis C virus (HCV) infection (19%) and nonalcoholic fatty liver disease (NAFLD) (10%). Of the patients, 56% had a single lesion. Macrovascular invasion and extrahepatic spread were present in 15% and 12% of the patients, respectively. The median serum alpha-fetoprotein level was 25.4 ng/mL. In total, 39% of the patients fulfilled the Milan Criteria. When we compared the characteristics of patients diagnosed before and after January 2016, the proportion of NAFLD-related HCC cases increased after 2016, from 6.6% to 13.4%., Conclusion: Chronic HBV and HCV infections remain the main causes of HCC in Turkey. The importance of NAFLD as a cause of HCC is increasing., Competing Interests: The authors have no conflict of interest to declare., (© Copyright 2022 by Hepatology Forum.)

Objective: The fibrosis stage during diagnosis and the response to ursodeoxycholic acid in the 1 st year of treatment are considered to be prognostic indicators in primary biliary cholangitis (PBC). Determining these indicators with non-invasive models can enable the risk of liver failure to be monitored with continuous variables from the moment of diagnosis. The aim of this study was to evaluate the diagnostic performance of non-invasive models for determining the prognostic indicators in patients with PBC., Materials and Methods: Data from patients with PBC were screened retrospectively. Patients were divided into early (≤2) and advanced (≥3) fibrosis groups. In addition, treatment response status according to the Paris-II criteria and liver failure risk (LFR) according to the UK-PBC score were determined. The S-Index consisting of gamma-glutamyltransferase (GGT), platelets (PLT), and albumin, (S-index: 1000×GGT÷[PLT×Albumın2]), other non-invasive models were calculated. The diagnostic effectiveness of non-invasive indicators to determine the fibrosis stage, response to treatment, and low LFR was analyzed., Results: Fifty-three patients were included in the study. The overall mean age at diagnosis was 49.6±13.6 years and 86.8% of the patients ( n =46) were female. The S-Index was able to determine fibrosis stage, treatment responded, and patients with low LFR (AUC: 0.747, 0.823, and 0.752; p =0.006, <0.001, and 0.0007, respectively). Furthermore, S-Index found to superior to other non-invasive indicators in terms diagnosis of prognostic indicators of PBC., Conclusion: S-index is a practical and inexpensive non-invasive model that can identify liver fibrosis and treatment response in patients with PBC. It can be used as a continuous variable prognostic model in PBC., Competing Interests: Conflict of Interest: None declared., (Copyright: © 2021 by The Medical Bulletin of Sisli Etfal Hospital.)

Objective: There are many instruments to measure disease activity in ulcerative colitis. While determining clinical activity according to these instruments, many clinical and laboratory parameters are needed to be followed. Determination of disease activity with non-invasive and objective inflammatory indicators may be a practical and objective way. CRP/Albumin ratio (CAR) is an inflammatory marker that is considered to have prognostic value in various cancers, sepsis and acute pancreatitis. In this study, we aim to investigate diagnostic performance CAR in determining the clinical severity of ulcerative colitis., Methods: Between November 2011 and February 2017, hospital records and follow-up cards of patients with ulcerative colitis were reviewed retrospectively. One hundred forty-nine patients were included in this study. Patient's demographic data, laboratory values, clinical disease activity, according to Truelove & Witts criteria and endoscopic activity according to the Mayo sub-score and treatments, were recorded. Diagnostic performance of CAR analyzed to determine the clinical severity., Results: Of the patients included in this study, 99 (62%) were male, and 50 (38%) were female. Mean age was 45.22±14 years. When patients were grouped into remission, mild, moderate and severe disease according to disease activity, there was a statistically significant difference between CRP, CAR, erythrocyte sedimentation rate (ESR) and albumin levels (p=0.001; p<0.05). Area under the curve (AUC) values for the diagnosis of severe disease were 0.941, 0.931, 0.888 and 0.883 for CAR, CRP, ESR and albumin levels, respectively. Cut-off value to determine severe disease for CAR was 0.6 (sensitivity: 88.9%, specificity of 90.3%, positive predictive value (PPV) 85.1%, negative predictive value (NPV) 92.8%, AUC: 0.941, p<0.001)., Conclusion: There was a significant relationship between CAR, CRP, ESR and albumin levels and clinical disease severity in patients with ulcerative colitis. CAR is a cheap and practical marker for the diagnosis of acute severe ulcerative colitis., Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors., (Copyright: © 2020 by Istanbul Northern Anatolian Association of Public Hospitals.)