Hepatobiliary Disease Research Articles

The effects of photoactivated ciprofloxacin and bile acids on biofilms on bile duct catheters

ObjectivesThis study examined the potential of a novel photoactivatable ciprofloxacin to act against bacterial infections and microbiomes related to biliary diseases. It also evaluated treatment by combining the impact of bile acids and antibiotics on biofilms. Innovative strategies were evaluated to address the elusive bile duct microbiome resulting in biofilm-related infections linked to biliary catheters. The healthy biliary system is considered sterile, but bile microbiomes can occur in disease, and these correlate with hepatobiliary diseases. Causes include biofilms that form on internal-external biliary drainage catheters. These biliary catheters were used to noninvasively study the otherwise elusive bile microbiome for a pilot study. MethodsA new photoactivatable antibiotic was tested for efficacy against human-derived pathogenic bacterial isolates – Salmonella enterica and Escherichia coli – and catheter-derived bile duct microbiomes. In addition, the effect of bile acids on the antibiotic treatment of biofilms was quantified using crystal violet staining, confocal laser scanning microscopy, and biofilm image analysis. Two novel approaches for targeting biliary biofilms were tested. ResultsA photoactivated antibiotic based on ciprofloxacin showed efficacy in preventing biofilm formation and reducing bacterial viability without harming eukaryotic cells. Furthermore, combination treatment of antibiotics with bile acids, such as ursodesoxycholic acid, mildly influenced biofilm biomass but reduced bacterial survival within biofilms. ConclusionBile acids, in addition to their endocrine and paracrine functions, may enhance antibiotic killing of bacterial biofilms compared with antibiotics alone. These approaches hold promise for treating biliary infections such as cholangitis.

Drug regulation of microRNA

The scientific review provides the mechanisms of drug regulation of microRNA in the human body. To write the article, information was searched using Scopus, Web of Science, MEDLINE, PubMed, Google Scholar, Embase, Global Health, The Cochrane Library databases. To restore the reduced functional activity of microRNAs, replacement therapy is used, with modified synthetic analogs of endogenous microRNAs, and drugs that enhance the production of the body’s own microRNAs. The authors state that numerous studies have confirmed the effectiveness of miRNA replacement therapy. It is known that there are several groups of drugs among miRNA inhibitors: anti-miRNA oligonucleotides, miRNA traps, miRNA mimics that prevent miRNA binding; peptide nucleic acids, small-molecule inhibitors. The authors suggest that the expression of drug-metabolizing enzymes is controlled by nuclear receptors and transcription factors, epigenetic regulation such as DNA methylation and histone acetylation, and post-translational modification. It is emphasized that ursodeoxycholic acid modulates the expression of some miRNAs. It is known that probiotic bacteria can modulate the expression level of miRNA genes. The use of probiotics is accompanied by a change in the expression of nume­rous genes of the body involved in the regulation of the inflammatory response, allergic reactions, metabolism and other biological processes. Thus, modern science is intensively studying the potential of using drugs that restore miRNA content or inhibit miRNA acti­vity for the therapy of miRNA-dependent conditions. The results of scientific research confirmed the therapeutic effect of ursodeoxycholic acid and probiotic preparations due to the effect on the acti­vity of miRNA generation in hepatobiliary diseases. Therefore, the introduction into clinical practice of drugs than can modulate the content and expression of specific miRNAs will certainly open new perspectives in the treatment of patients with hepatobiliary diseases.

Comparative Analysis of Microbial Species and Multidrug Resistance Patterns in Acute Cholangitis Patients with Cholecystectomy: A Single-Center Study.

This study aimed to compare microbial species and multidrug resistance patterns in acute cholangitis patients with and without a history of cholecystectomy, highlighting potential differences We hypothesized that post-cholecystectomy patients would exhibit distinct microbial spectra and resistance patterns. Conducted at a western Romanian hospital specializing in gastroenterology and hepatobiliary diseases from 2020 to 2023, this retrospective study included 488 acute cholangitis patients, divided into groups based on their cholecystectomy history. Bile and blood samples were analyzed for microbial identification and antibiotic susceptibility using VITEK®2. Positive biliary cultures were found in 66% of patients. The cholecystectomy group showed a higher prevalence of multidrug-resistant organisms, with 74.4% exhibiting resistance compared to 31.5% in the non-cholecystectomy group (p < 0.001). Notable microbial differences included higher occurrences of Escherichia coli (40.2%) and Enterococcus spp. (32.4%) in the cholecystectomy group. Resistance to Piperacillin/Tazobactam and Penems was significantly higher in this group, with odds ratios of 3.25 (p < 0.001) and 2.80 (p = 0.001), respectively, for the development of multidrug-resistant (MDR) bacterial species. The study confirmed our hypothesis, revealing distinct microbial profiles and a higher prevalence of multidrug resistance in acute cholangitis post-cholecystectomy patients. These findings underscore the need for tailored antibiotic strategies in managing acute cholangitis in this patient demographic.

Hepatobiliary manifestations in patients with ulcerative colitis: a retrospective analysis.

Inflammatory bowel diseases (IBDs) are often associated with altered liver function tests (LFTs). There is little data on the relationship between abnormal LFT and IBD. Our study aimed to evaluate the prevalence and etiology of elevated LFT in patients with ulcerative colitis (UC) and to determine whether there is an association with clinical and demographic parameters. The clinical records of the Gastroenterology Outpatients Clinic at a single center were reviewed and screened for patients with UC from 2005 to 2014. In total, 263 patients were included. Patients with Crohn's disease (CD), colitis indeterminate, and colitis of other origins were excluded. Abnormal LFT and liver injuries were analyzed. A cohort of 182 patients was analyzed (114 males, 68 females; mean age = 50.2 ± 16.1 years). 58 patients had already been diagnosed with a hepatobiliary disorder. Patients with a known hepatobiliary disorder suffered from UC for a significantly longer duration. Elevated LFT in patients without known hepatobiliary disorders was 69.4%. Liver injury was found in 21.8%. A transient increase in abnormal LFT was shown in 59 patients (68.6%), a persistent increase was found in 27 patients (31.4%). Treatment with thiopurines was a risk factor for persistent elevated LFT (p = 0.029), steroids had a protective impact (p = 0.037). This study clearly highlights the importance of screening for hepatobiliary disorders and abnormal LFT in patients with UC, as the prevalence of hepatobiliary disorders and abnormal LFT is detected very often among this patient group.

A disproportionality analysis for assessing the safety of FLT3 inhibitors using the FDA Adverse Event Reporting System (FAERS).

This pharmacovigilance analysis was conducted to assess the safety signals of FMS-related tyrosine kinase 3 (FLT3) inhibitors in a real-world setting using the United States Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed adverse event (AE) reports related to FLT3 inhibitors submitted to the FAERS database from the first quarter of 2015 to the fourth quarter of 2022. Disproportionality analysis was used to identify AEs of FLT3 inhibitors in the FAERS database. A total of 55,393 AE reports were identified, of which 5938, 44,013, and 5442 were attributed to midostaurin, sorafenib, and gilteritinib, respectively, as primary suspects. Compared to the full database, significant safety signals at the system organ class level were observed for midostaurin (blood and lymphatic system disorders and hepatobiliary disorders), sorafenib (skin and subcutaneous tissue disorders and hepatobiliary disorders), and gilteritinib (investigations, blood and lymphatic system disorders, infections and infestations, and hepatobiliary disorders). All the drugs studied were associated with hepatobiliary disorders. The most prominent AEs associated with midostaurin, sorafenib, and gilteritinib were cytopenia, palmar-plantar erythrodysesthesia syndrome, and increased blast cell count, respectively. Compared with chemotherapy, midostaurin and gilteritinib showed a higher risk of electrocardiogram QT prolongation, gastrointestinal hemorrhage, cerebral hemorrhage, and increased white blood cell count. Gilteritinib had the highest overall death percentage (30.28%), whereas sorafenib had the lowest (23.06%). Mining AE signals using the FAERS database provides a method for analyzing the safety of FLT3 inhibitors in post-marketing. We found several significant AE signals that corresponded to previous studies; however, some AE signals were not mentioned in the drug instructions. Our study could provide a direction for follow-up real-world studies to verify the results further.

A real-world disproportionality analysis of cyclosporine from the FDA Adverse Event Reporting System (FAERS) database.

Cyclosporine is an immunosuppressant used to prevent organ rejection in kidney, liver, and heart allogeneic transplants. This study aimed to assess the safety of cyclosporine through the analysis of adverse events (AEs) related to cyclosporine in the US Food and Drug Administration Adverse Event Reporting System (FAERS). To detect AEs associated with cyclosporine, a pharmacovigilance analysis was conducted using four algorithms on the FAERS database: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM). A statistical analysis was performed on data extracted from the FAERS database, covering 19,582 case reports spanning from 2013 to 2022. Among these cases, 3,911 AEs were identified, with 476 linked to cyclosporine as the primary suspected drug. Cyclosporin-induced AEs targeted 27 System Organ Classes (SOCs). Notably, the highest case at the SOC level included eye disorders, injury, poisoning, and procedural complications, as well as immune system disorders, all of which are listed on the cyclosporine label. Furthermore, we discovered novel potential AEs associated with hepatobiliary disorders, among others. Moreover, unexpected adverse drug reactions (ADRs), such as biliary anastomosis complication and spermatozoa progressive motility decrease, were identified. Importantly, these newly identified ADRs were not mentioned on the cyclosporine label, which were involved in injury, poisoning, and procedural complications, and investigations at the SOC level. The study used pharmacovigilance analysis of FAERS database to identify new and unexpected potential ADRs relating to cyclosporine, which can provide safety tips for the safe use of cyclosporine.

Evaluation of urinary C-reactive protein as an early detection biomarker for pancreatic ductal adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) is one of the leading causes of cancer-related death worldwide. Up to now, no specific screening or diagnostic tests are available for early PDAC detection. As a result, most patients are diagnosed with advanced or metastatic disease, which leads to a poor prognosis. In this study, we aimed to evaluate the diagnostic value of urinary CRP (uCRP) alone and in combination with our previously established urine biomarker panel (REG1B, LYVE1 and TFF1) for early detection of PDAC. A total of 534 urine samples from multiple centres were analysed: 93 from healthy individuals, 265 from patients with benign hepatobiliary diseases and 176 from PDAC patients. The uCRP and the urinary biomarker panel were assessed using commercial ELISA assays, while plasma CA19-9 and blood CRP (bCRP) were measured using Roche Cobas platform. Multiple logistic regression and nonparametric Kruskal-Wallis test were used for statistical analysis. An internal validation approach was applied, and the validated AUC estimators were reported to ensure accuracy. A significant difference was observed in the medians of uCRP between healthy and benign controls and PDAC sample groups (p < 0.001). uCRP levels were not dependent on gender and age, as well as cancer stage. When uCRP was combined with the urinary biomarker panel, it achieved AUCs of 0.878 (95% CI: 0.802-0.931), 0.798 (95% CI: 0.738-0.859) and 0.813 (95% CI: 0.758-0.869) in healthy vs PDAC, benign vs PDAC and healthy and benign vs PDAC sample groups, respectively. However, adding plasma CA19-9 to the urinary biomarker panel yielded a better performance, with AUCs of 0.978 (95% CI: 0.959-0.996), 0.911 (95% CI: 0.873-0.949) and 0.919 (95% CI: 0.883-0.955) in the healthy vs PDAC, benign vs PDAC and healthy and benign vs PDAC comparisons, respectively. In conclusion, we show that measuring CRP in urine is a feasible analytical method, and that uCRP could potentially be a promising biomarker in various diseases including other cancer types.

Transcriptome changes of liver fluke Opisthorchis viverrini in diabetic hamsters.

A recent study in hamsters showed that infection with the liver fluke Opisthorchis viverrini in diabetic hosts worsens the severity of hepatobiliary disease. However, the effects of diabetes on the worm's phenotype and gene expression pattern remain unknown. This study investigated the impact of diabetes on the global gene expression and development of O. viverrini in diabetic hamsters. Parasitological parameters were assessed, and mRNA sequencing with bioinformatic analysis was performed. The study revealed that worm establishment rates in diabetic hamsters were directly correlated with fasting plasma glucose levels. Interestingly, worms collected from diabetic hosts exhibited stunted growth and reduced egg production. Transcriptomic analysis revealed significant alterations in gene expression, with 4314 and 567 differentially expressed genes at 21- and 35-days post-infection, respectively. Gene ontology enrichment analysis highlighted changes in biological processes related to stress response, metabolism, and cellular organization. Notably, genes associated with parasite virulence, including granulin, tetraspanins, and thioredoxins, showed significant upregulation in diabetic hosts. These findings demonstrate the profound impact of host diabetic status on O. viverrini development and gene expression, providing insights into the complex interplay between host metabolism and parasite biology, including molecular adaptations of O. viverrini in hosts. This study contributes to our understanding of opisthorchiasis in the context of metabolic disorders and may inform future strategies for disease management in diabetic human populations.

Comparison of single and combination risk factors in pancreatic ductal adenocarcinoma with control and benign hepatobiliary disease groups

Comparison of single and combination risk factors in pancreatic ductal adenocarcinoma with control and benign hepatobiliary disease groups

A review of the botany, phytochemistry, pharmacology, synthetic biology and comprehensive utilization of Silybum marianum.

Silybum marianum (L.) Gaertn, a herbaceous plant with a long history in traditional medicine for the treatment of hepatobiliary diseases, particularly in Europe, which has attracted attention for its remarkable therapeutic effect. This review systematically summarizes the research progress in the botany, phytochemistry, pharmacology, comprehensive utilization and synthetic biology of S. marianum. Up to now, more than 20 types of flavonolignan components have been isolated from S. marianum. In addition, the rearch on fatty acids and triterpenoids is also constantly improving. Among them, silybin is the most active compound in flavonolignans components. Its pharmacological effects in vivo and in vitro include anti-inflammatory, antioxidant, anti-tumour, hypoglycaemic, neuroprotective and immunoregulatory properties. The use of coniferyl alcohol and taxifolin as substrates to produce silybin and isosilybin under the action of enzyme catalysis is the commonly used biosynthetic pathway of silymarin, which provides support for a comprehensive analysis of the synthetic pathway of silymarin. In addition to medicinal use, the extracts of plants also have broad application prospects in the production of food, healthcare products, cosmetics and other aspects. In addition, the chemical composition, pharmacological mechanism and synthetic biology of S. marianum need to be further studied, which is very important for its clinical efficacy and resource development.

Autoimmune hepatobiliary disease -up to date

Autoimmune hepatobiliary disease -up to date

Profile of Liver Elevated Enzymes in People Living with HIV Followed at the Protestant Hospital of Garoua-Boulai, East Region, Cameroon

Background: Human immunodeficiency virus (HIV) infection associated with Highly Active Antiretroviral Treatment (HAART) is considered a cause of many hepatobiliary disorders, including elevated liver enzymes, hepatomegaly, and fatty liver. Aim: To highlight Liver Elevated Enzymes (LEE) in people living with HIV (PLHIV) under HAART treatment. Methods: This study was cross-sectional and done between June 2022 to August 2022. Participants were PLHIV, adults over 21 years old, followed at the Protestant Hospital of Garoua Boulai. Venous blood was collected from each participant Alanine aminotransferase (ALT), and aspartate aminotransferase (AST), were measured with a spectrophotometer. SPSS version 23.0. Was used to express proportions and adjusted odds ratios to identify risk factors. Results: Overall, 131 participants were included in this analysis, all were HIV type 1, and 30% of participants have LEE. Of the 131 patients investigated, we found 69.6% of LEE with HBs Ag and 27.5% of this group found with Antibody HCV. A logistic regression analysis did not show any significant (p&lt;0.05) association between LEE with socio-demographic and clinical variables. Conclusion: This study shows that the occurrence of LEE is independently influenced by multiple risk factors.

Indocyanine green fluorescence in gastrointestinal surgery: Appraisal of current evidence.

Applying indocyanine green (ICG) fluorescence in surgery has created a new dimension of navigation surgery to advance in various disciplines. The research in this field is nascent and fragmented, necessitating academic efforts to gain a comprehensive understanding. The present review aims to integrate diverse perspectives and recent advances in its application in gastrointestinal surgery. The relevant articles were selected by using the appropriate keyword search in PubMed. The angiography and cholangiography property of ICG fluorescence is helpful in various hepatobiliary disorders. In gastroesophageal and colorectal surgery, the lymphangiography and angiography property of ICG is applied to evaluate bowel vascularity and guide lymphadenectomy. The lack of objective parameters to assess ICG fluorescence has been the primary limitation when ICG is used to evaluate bowel perfusion. The optimum dose and timing of ICG administration need to be standardized in some new application areas in gastrointestinal surgery. Binding tumor-specific ligands with fluorophores can potentially widen the fluorescence application to detect primary and metastatic gastrointestinal tumors. The narrative review outlines prior contributions, limitations, and research opportunities for future studies across gastrointestinal sub-specialty. The findings of the present review would be helpful for scholars and practitioners to explore and progress in this exciting domain of gastrointestinal surgery.

Estimation of hematological parameters and lipid profile of coronary artery disease patients with Helicobacter pylori

Helicobacter pylori infection causes generally gastric illnesses, however from the beginning of 1994, a few researchers have detailed a relationship of H. pylori with other systemic manifestations are outside stomach include various extra gastric appearances, for e.g., neurological, dermatological, hematologic, visual, cardiovascular, metabolic, hypersensitive, and hepatobiliary diseases. In this study, blood parameters, lipid profile, and fasting glucose were measured for patients with coronary artery disease with H. pylori, and the relationship of H. pylori with lipids, which is considered a risk factor for coronary artery disease, was measured. 150 people participated in the current study, and they were divided into three groups: The first group had arterial disease. coronary artery disease with H. pylori 50 people, the second group had coronary artery disease without H. pylori 50 people, the third group the control group 50 people. The samples were obtained from the heart center in Nasiriyah. Risk factors were taken into account: which included age, gender, smoking status, high blood pressure, and diabetes. In the first group, the number of males was 28 (56%) and females 22 (44%) with an average age of 72.60 ± 18.97, the second group had a number of males 33 (66%) and females 17 (34%) with an average age of 71.70 ± 21.06, the third group the number of males was 28 (56%) and females 22 (44%) with an average age of 55.44 ± 18.53.

Cholestasis in neonates with fetal growth restriction

Background: Neonatal Cholestasis (NC) is a sign of hepatobiliary disorder due to various etiologies. In the neonatal intensive care unit (NICU) extensive evaluvation is done to rule out treatable causes. Neonates with fetal growth retardation (FGR) have an increased incidence of cholestasis. Aim: To determine the prevalence, management, additional healthcare cost and outcome of cholestasis in neonates born with FGR. Methods: Retrospective review of all neonates admitted to the NICU at Valley Children’s Hospital, from January 1, 2021 to December 31, 2022 was done. Data of the infants with FGR was collected. Results: Of 2850 infants admitted in the 2-year period, 42 had a birth weight of less than 10th percentile, of which 19 developed cholestasis (45%). 12 of the 19 infants were preterm infants and 7 were term infants. Average gestational age at birth was 31.6 and average direct bilirubin of 5.2 mg/dL. The average length of stay was 54 days Of the 19 infants who developed NC, 8 were discharged on ursodiol and followed up in gastroenterology clinic. 17 showed resolution of NC within 6 months of discharge. Some infants underwent extensive work-up. Costs for the work-up added up to an average of $8,920. Conclusion: Prognosis for NC in the FGR neonates appears to be good with resolution in our study population within the first year of life. Hence, it may be safe to monitor these neonates with outpatient followup with early limited evaluation until complete resolution of cholestasis.

Biliary Ascariasis Causing Obstructive Jaundice: A Case Report on ERCP-Assisted Management

BACKGROUND: Biliary tract disorders are predominantly caused by cholelithiasis (gallstones). However, in regions endemic for parasitic infestations, or areas with poor hygiene and sanitation, hepatobiliary disorders may be due to an underlying worm infestation. THE CASE A 55-year-old female from Skardu, Pakistan, an Ascariasis-endemic area, presented to a tertiary care hospital with right hypochondrial pain and jaundice. Her condition did not respond to conservative treatment. Ultrasound (USG) and Magnetic Resonance Cholangiopancreatography (MRCP) identified multiple worms obstructing the common bile duct. Subsequently, an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure was performed, successfully retrieving the worms and achieving complete ductal clearance. The patient was discharged with oral anthelmintics and made a full recovery. CONCLUSION: This case underscores the importance of considering biliary ascariasis as a differential diagnosis for obstructive jaundice in endemic regions. MRCP emerges as a valuable diagnostic tool, providing a non-invasive and precise way to identify worm infestations of the biliary system. It effectively reduces the dependence on ERCP and its associated risks, reserving ERCP for therapeutic interventions. Equipping local healthcare centers in Ascariasis-endemic regions with the necessary resources to diagnose and treat these conditions is essential for mitigating patient suffering. This may lessen the need for travel to larger hospitals, minimising physical and financial inconveniences to the patient while also decreasing the burden on tertiary care hospitals.

Profiles of biliary microbiota in biliary obstruction patients with Clonorchis sinensis infection.

Clonorchis sinensis (C. sinensis) is a epidemiologically significant food-borne parasite, causing several hepatobiliary diseases. Biliary microbiota community structure might be influenced by infection with pathogens. However, the biliary microbiome of biliary obstruction patients infected with C. sinensis is still an unexplored aspect. A total of 50 biliary obstruction patients were enrolled, including 24 infected with C. sinensis and 26 non-infected subjects. The bile samples were collected by Endoscopic Retrograde Cholangiopancretography. Biliary microbiota alteration was analyzed through high-throughput 16S ribosomal RNA (rRNA) gene sequencing. Our findings revealed that there was significant increase in both richness and diversity, as well as changes in the taxonomic composition of the biliary microbiota of C. sinensis infected patients. At the phylum level, C. sinensis infection induced Proteobacteria increased and Firmicutes reduced. At the genus level, the relative abundance of Pseudomonas and Staphylococcus increased significantly, while Enterococcus decreased prominently in infected groups (P < 0.05). The PICRUSt analysis further showed remarkably different metabolic pathways between the two groups. C. sinensis infection could modify the biliary microbiota, increasing the abundance and changing the phylogenetic composition of bacterial in biliary obstruction patients. This study may help deepen the understanding of the host-biliary microbiota interplay with C. sinensis infection on the background of biliary obstruction and provide new insights into understanding the pathogenesis of clonorchiasis.

Elimination of 1,3,7-trimethylxanthine in laboratory animals during the induction of fatty hepatosis

Liver pathologies play a significant role in changing the metabolism and clearance of a number of pharmacologically active substances, including 1,3,7-trimethylxanthine, which is explained by their influence on enzyme systems that regulate the biotransformation of exogenous biologically active substances. Currently, changes in caffeine clearance are being actively studied in various hepatobiliary disorders, especially those that are chronic, since it is precisely such pathologies, according to a number of researchers, that are characterized by the most predictable and stable change in the trimethylxanthine pharmacokinetic profile. The purpose of the study was to determine changes in serum caffeine levels when inducing fatty liver disease in laboratory animals (rats). The studies were carried out in the vivarium of the Department of Pharmacology and Toxicology of the Federal State Budgetary Educational Institution of Higher Education of St. Petersburg State University of Medicine. Laboratory animals from a previous series of experiments were selected for the study in order to further compare the “caffeine curves.” Fatty hepatosis was modeled using strontium sulfate according to the methodology developed at the Department of Pharmacology and Toxicology. Upon completion of induction, fatty hepatosis was confirmed based on clinical and biochemical signs. Based on the studies conducted, we can conclude that there are certain correlations. For example, in fatty hepatosis, the elimination of caffeine is not significantly slowed down with a characteristic long plateau (up to 8 hours after administration), turning into a smooth decrease in concentration. Experimental data can be used to create a database to assess the relationship between pharmacokinetics and the physiological state of animals. Similar experiments need to be carried out on other animal species, which will create a holistic picture and help in assessing pathologies for veterinary specialists.

A real-world analysis of safety profile of selexipag by using FDA adverse Event Reporting System (FAERS)

ABSTRACT Background The current investigation sought to conduct a real-world analysis of adverse events (AEs) associated with selexipag by utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods The Reporting Odds Ratios (ROR) and the Medicines Healthcare Products Regulatory Agency (MHRA) method were employed to assess the potential associations between selexipag and AEs. Case reports of adverse drug reaction (ADR) related to selexipag were systematically sourced from PubMed, Embase, and Web of Science databases. Results Our analysis identified 281 Preferred Terms (PTs) signals across 20 System Organ Classes (SOCs) were found to meet the screening threshold. The most common AEs were consistent with instructions, randomized controlled trials (RCTs), and case reports. Of significant note, unexpected AEs principally target SOCs of infections and infestations, blood and lymphatic system, renal and urinary disorders, hepatobiliary disorders, including pneumonia, metapneumovirus, decreased hemoglobin. transfusion, iron-deficiency anemia, dialysis hypotension, abnormal creatinine renal clearance, liver function test increased, hepatic function abnormal, hepatic enzyme increased. Within the pediatric population, unexpected signals such as pyrexia, pneumonia, and intussusception necessitate special precautionary measures. Conclusions The findings contribute valuable insights to clinical practice, reinforcing the importance of vigilant monitoring, and can be instrumental in guiding both therapeutic applications and safety assessments of this particular medication.

Evaluation of the positivity of the fecal occult blood test compared to the microscopic detection of red blood cells

Backgrounds: Fecal occult blood testing (FOBT) is commonly used in colorectal cancer screening programs. Many studies have compared different FOBT methods, but the correlation between traditional red cell microscopy and FOBT remains unclear. Objectives: 1) To evaluate the rate of positive FOBT in patients with different disease groups; 2) To compare the sensitivity and specificity of red blood cells detection in fresh stool by microscopy technique and FOBT. Materials and methods: This was a cross-sectional study involving 120 patients from Hue University of Medicine and Pharmacy Hospital who requested a stool test from 4/2021 to 4/2022. Fresh stool samples were examined for the presence of red blood cells using traditional microscopy and FOBT technique. Results: The overall positivity rate of FOBT was 20%, and in the group of gastrointestinal diseases (n = 24), clinical anemia (n = 21), hepatobiliary diseases (n = 26) and other diseases (n = 49), it was 37.5%, 23.8%, 11.5% and 14.3%, respectively. In comparison with the FOBT technique, microscopic RBC detection had a sensitivity of 33.3% and a specificity of 100%. Conclusions: A high rate of fecal occult blood tests was observed in patients with gastrointestinal disorders. Microscopic erythrocyte detection has low sensitivity and many disadvantages compared to the rapid test. This rapid test should be widely used in clinical practice to aid in the diagnosis of gastrointestinal bleeding Key words: fecal occult blood, microscopic detection, gastrointestinal bleeding.