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Journal of Pediatric Gastroenterology... Sep 2023Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly utilized procedure in pediatric populations. A lack of dedicated pediatric research has led...
OBJECTIVES
Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly utilized procedure in pediatric populations. A lack of dedicated pediatric research has led endoscopists to extrapolate adult risk factors and preventative strategies to children. The aim of this multisite, retrospective study was to identify risks for adverse events, procedure failure, and prolonged courses in pediatric patients undergoing ERCP.
METHODS
Pediatric patients who had an ERCP at one of our academic centers were identified by query of their electronic medical records. Pre-procedure and post-procedure data were collected with ERCP-related adverse events defined according to the consensus criteria developed by Cotton et al 2010.
RESULTS
Between January 2004 and January 2021, 287 children had a total of 716 ERCPs. The procedure success rate was 95.5% with no mortality and an adverse event rate of 12.7%. Younger age was associated with increased case complexity, increased adverse events, and an increased rate of repeat ERCP. Case complexity score correlated with increased procedure time ( P < 0.001) and increased adverse events (tau 0.24, P < 0.01); stent removal and pancreatic stenting were more likely to precede an adverse event. Pancreatitis, pancreatic divisum, and pancreatic stricture/stenosis were associated with increased adverse events and rates of repeat ERCP.
CONCLUSIONS
Pediatric ERCP adverse event rates are higher than adults. The complexity grading system proposed by the Cotton et al appears to have applicability to pediatric patients. Young age and interventions affecting the pancreatic duct are associated with adverse ERCP outcomes in pediatrics.
Topics: Adult; Humans; Child; Cholangiopancreatography, Endoscopic Retrograde; Retrospective Studies; Pancreatitis; Pancreas; Pediatrics
PubMed: 37399144
DOI: 10.1097/MPG.0000000000003875 -
Clinical Genitourinary Cancer Feb 2024Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in...
INTRODUCTION
Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big dataset.
MATERIAL AND METHODS
We downloaded AE datasets of IPI + NIVO and CAB + NIVO from the Food and Drug Administration Adverse Event Reporting System database. We used the Medical Dictionary for Regulatory Activities to treat each AE as a preferred term and grouped it into the System Organ Class (SOC). We performed logistic regression analyses to compare IPI + NIVO and CAB + NIVO.
RESULTS
The incidence rates of 7 types of toxicities were higher for CAB + NIVO than for IPI + NIVO. On the other hand, the incidence rates of 3 types of toxicities were higher for IPI + NIVO than for CAB + NIVO. Serious AEs were higher in patients receiving IPI + NIVO.
CONCLUSION
Our findings suggest that both combination therapies presented a disproportionate distribution of toxicities in several SOC. These findings may help clinicians select suitable therapy for the individual and improve the safety profile in patients with advanced renal cell carcinoma receiving NIVO + IPI and NIVO + CAB in a real-world setting.
Topics: Humans; Nivolumab; Ipilimumab; Carcinoma, Renal Cell; Antineoplastic Combined Chemotherapy Protocols; Kidney Neoplasms; Anilides; Pyridines
PubMed: 37813699
DOI: 10.1016/j.clgc.2023.09.003 -
BMC Pharmacology & Toxicology Jan 2024Previous pharmacovigilance studies and a retroactive review of cancer clinical trial studies identified that women were more likely to experience drug adverse events...
BACKGROUND
Previous pharmacovigilance studies and a retroactive review of cancer clinical trial studies identified that women were more likely to experience drug adverse events (i.e., any unintended effects of medication), and men were more likely to experience adverse events that resulted in hospitalization or death. These sex-biased adverse events (SBAEs) are due to many factors not entirely understood, including differences in body mass, hormones, pharmacokinetics, and liver drug metabolism enzymes and transporters.
METHODS
We first identified drugs associated with SBAEs from the FDA Adverse Event Reporting System (FAERS) database. Next, we evaluated sex-specific gene expression of the known drug targets and metabolism enzymes for those SBAE-associated drugs. We also constructed sex-specific tissue gene-regulatory networks to determine if these known drug targets and metabolism enzymes from the SBAE-associated drugs had sex-specific gene-regulatory network properties and predicted regulatory relationships.
RESULTS
We identified liver-specific gene-regulatory differences for drug metabolism genes between males and females, which could explain observed sex differences in pharmacokinetics and pharmacodynamics. In addition, we found that ~ 85% of SBAE-associated drug targets had sex-biased gene expression or were core genes of sex- and tissue-specific network communities, significantly higher than randomly selected drug targets. Lastly, we provide the sex-biased drug-adverse event pairs, drug targets, and drug metabolism enzymes as a resource for the research community.
CONCLUSIONS
Overall, we provide evidence that many SBAEs are associated with drug targets and drug metabolism genes that are differentially expressed and regulated between males and females. These SBAE-associated drug metabolism enzymes and drug targets may be useful for future studies seeking to explain or predict SBAEs.
Topics: Humans; Male; Female; Gene Expression Regulation; Liver; Pharmacovigilance; Gene Expression
PubMed: 38167211
DOI: 10.1186/s40360-023-00727-1 -
World Journal of Gastrointestinal... Mar 2024We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor (ICI) and the occurrence of immune-related...
We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor (ICI) and the occurrence of immune-related adverse events (irAEs). The predictive potential of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in determining ICI effectiveness has been extensively investigated, while limited research has been conducted on predicting irAEs. Furthermore, the combined model incorporating NLR and PLR, either with each other or in conjunction with additional markers such as carcinoembryonic antigen, exhibits superior predictive capabilities compared to individual markers alone. NLR and PLR are promising markers for clinical applications. Forthcoming models ought to incorporate established efficacious models and newly identified ones, thereby constituting a multifactor composite model. Furthermore, efforts should be made to explore effective clinical application approaches that enhance the predictive accuracy and efficiency.
PubMed: 38577447
DOI: 10.4251/wjgo.v16.i3.577 -
The Journal of International Medical... Dec 2023To examine the use of platelet-rich plasma (PRP) for treatment of pilonidal disease (PD) and thus provide a reference for clinical application.
OBJECTIVE
To examine the use of platelet-rich plasma (PRP) for treatment of pilonidal disease (PD) and thus provide a reference for clinical application.
METHODS
A systematic review of PubMed and the Cochrane Library was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We considered all studies that reported the use of PRP for treatment of PD. Extracted data included the first author's name, year of publication, study type, number of included patients, inclusion and exclusion criteria, interventions, anesthesia, application of PRP (source, preparation, dose, and operation), antibiotics, follow-up time, therapeutic outcomes, and adverse events.
RESULTS
In total, eight randomized controlled trials and one prospective cohort study involving 809 patients were included. PRP reduced pain, accelerated healing, and reduced adverse events. The application of combined minimally invasive surgery achieved better results. However, overfilling of the wound with PRP in minimally invasive surgeries was shown to potentially increase the risk of adverse events.
CONCLUSION
PRP can be used as an adjuvant treatment in PD surgery to improve the therapeutic effect and reduce adverse events. The optimal combination of PRP and various factors is an important direction of future research. INPLASY2023100070.
Topics: Humans; Prospective Studies; Treatment Outcome; Platelet-Rich Plasma; Pain; Anesthesia; Randomized Controlled Trials as Topic
PubMed: 38141657
DOI: 10.1177/03000605231216590 -
BioRxiv : the Preprint Server For... Nov 2023Previous pharmacovigilance studies and a retroactive review of cancer clinical trial studies identified that women were more likely to experience drug adverse events...
BACKGROUND
Previous pharmacovigilance studies and a retroactive review of cancer clinical trial studies identified that women were more likely to experience drug adverse events (i.e., any unintended effects of medication), and men were more likely to experience adverse events that resulted in hospitalization or death. These sex-biased adverse events (SBAEs) are due to many factors not entirely understood, including differences in body mass, hormones, pharmacokinetics, and liver drug metabolism enzymes and transporters.
METHODS
We first identified drugs associated with SBAEs from the FDA Adverse Event Reporting System (FAERS) database. Next, we evaluated sex-specific gene expression of the known drug targets and metabolism enzymes for those SBAE-associated drugs. We also constructed sex-specific tissue gene-regulatory networks to determine if these known drug targets and metabolism enzymes from the SBAE-associated drugs had sex-specific gene-regulatory network properties and predicted regulatory relationships.
RESULTS
We identified liver-specific gene-regulatory differences for drug metabolism genes between males and females, which could explain observed sex differences in pharmacokinetics and pharmacodynamics. In addition, we found that ~85% of SBAE-associated drug targets had sex-biased gene expression or were core genes of sex- and tissue-specific network communities, significantly higher than randomly selected drug targets. Lastly, we provide the sex-biased drug-adverse event pairs, drug targets, and drug metabolism enzymes as a resource for the research community.
CONCLUSIONS
Overall, we provide evidence that many SBAEs are associated with drug targets and drug metabolism genes that are differentially expressed and regulated between males and females. These SBAE-associated drug metabolism enzymes and drug targets may be useful for future studies seeking to explain or predict SBAEs.
PubMed: 37362157
DOI: 10.1101/2023.05.23.541950 -
Expert Opinion on Drug Safety Jul 2024Our research aimed to identify previously undocumented adverse events (AEs) in the gemcitabine drug insert with the goal of informing clinical practice.
BACKGROUND
Our research aimed to identify previously undocumented adverse events (AEs) in the gemcitabine drug insert with the goal of informing clinical practice.
METHODS
We extracted adverse events associated with gemcitabine use through 2023 using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayesian Geometric Mean) were employed to detect new AE signals. AEs were considered positive signals only if they were detected by all four algorithms.
RESULTS
From 2014 to 2023, a total of 42,360 AEs were reported in 14,905 individuals following gemcitabine use. These AEs totaled 437 preferred terms (PTs) across 20 system organ classes (SOCs). We identified unexpected AEs related to the ocular disorders, the nervous system, and the ear and the labyrinth. The ocular organ system will present with retinopathy, purtscher retinopathy, choroidal effusion, amaurosis, necrotizing scleritis, etc. The nervous system may experience reversible posterior encephalopathy syndrome, cerebellar syndrome, cauda equina syndrome, athetosis, transverse myelitis, etc. The ears and labyrinth may exhibit ototoxicity.
CONCLUSION
Our study identified previously undetected signals following gemcitabine treatment, thereby providing new insights for future medication guidance.
Topics: Gemcitabine; Adverse Drug Reaction Reporting Systems; Humans; Deoxycytidine; United States; United States Food and Drug Administration; Bayes Theorem; Antimetabolites, Antineoplastic; Databases, Factual; Algorithms
PubMed: 37974405
DOI: 10.1080/14740338.2023.2284989 -
Revista Brasileira de Enfermagem 2023to analyze the incidence of preventable adverse events related to health care in adult patients admitted to public hospitals in Brazil. (Observational Study)
Observational Study
OBJECTIVES
to analyze the incidence of preventable adverse events related to health care in adult patients admitted to public hospitals in Brazil.
METHODS
observational, analytical, retrospective study based on medical records review.
RESULTS
medical records from 370 patients were evaluated, 58 of whom had at least one adverse event. The incidence of adverse events corresponded to 15.7%. Adverse events were predominantly related to healthcare-related infection (47.1%) and procedures (24.5%). Regarding the adverse event severity, 13.7% were considered mild, 51.0% moderate, and 35.3% severe. 99% of adverse events were classified as preventable. Patients admitted to the emergency room had a 3.73 times higher risk for adverse events.
CONCLUSIONS
this study's results indicate a high incidence of avoidable adverse events and highlight the need for interventions in care practice.
Topics: Adult; Humans; Retrospective Studies; Hospitalization; Emergency Service, Hospital; Hospitals, Public; Incidence; Medical Errors
PubMed: 37436233
DOI: 10.1590/0034-7167-2022-0025 -
Journal of Gastroenterology and... Feb 2024The association between proton-pump inhibitors (PPIs) and rhabdomyolysis were unclear. The aim of this study was to explore and systematically analyze the potential link...
BACKGROUND AND AIM
The association between proton-pump inhibitors (PPIs) and rhabdomyolysis were unclear. The aim of this study was to explore and systematically analyze the potential link between five PPIs and the rhabdomyolysis events using the FDA Adverse Event Reporting System (FAERS) database.
METHODS
Suspected rhabdomyolysis events associated with PPIs were identified by data mining with the reporting odds ratio (ROR), proportional reporting ratio (PRR), the information component (IC), and Empirical Bayes Geometric Mean (EBGM). Demographic information, drug administration, and outcomes of PPI-induced rhabdomyolysis events were also analyzed.
RESULTS
There were 3311 reports associated with PPI-induced rhabdomyolysis that were identified. After removing duplicates, 1899 cases were determined to contain complete patient demographic data. The average age was 65 ± 18 year and 57% were male. Omeprazole and pantoprazole had the same largest percentage of reports. Lansoprazole had the highest ROR index of 12.67, followed by esomeprazole (11.18), omeprazole (10.27), rabeprazole (10.06), and pantoprazole (9.24). PRR, IC, and EBGM showed similar patterns. This suggested that lansoprazole exhibited the strongest correlation with rhabdomyolysis. In rhabdomyolysis events, PPIs were mainly "concomitant" (>60%), and only a few cases were "primary suspects" (<15%). Rabeprazole showed the lowest death rate while lansoprazole showed the highest.
CONCLUSIONS
The study suggested that significant rhabdomyolysis signals were associated with PPIs. Further research should be performed in drug safety evaluation for a more comprehensive association.
Topics: Male; Humans; Middle Aged; Aged; Aged, 80 and over; Female; Proton Pump Inhibitors; Pantoprazole; Rabeprazole; Pharmacovigilance; Bayes Theorem; Omeprazole; Lansoprazole; Rhabdomyolysis
PubMed: 37961012
DOI: 10.1111/jgh.16411 -
Geriatric Nursing (New York, N.Y.) May 2024This study explored the status of adverse event reporting attitudes and its predictors among nursing staff in Chinese nursing homes. A cross-sectional study was...
This study explored the status of adverse event reporting attitudes and its predictors among nursing staff in Chinese nursing homes. A cross-sectional study was conducted with 475 nursing staff, and they completed sociodemographic and facility-related questionnaire, Incident Reporting Attitude Scale, Adverse Event Reporting Awareness Scale, and Nursing Home Survey on Patient Safety Culture. Univariate analysis and multiple linear regression models were performed. The mean score for adverse event reporting attitude was 125.87 (SD=15.35). The predictors included individual variables, such as education level (β=0.129, p = 0.001) and working years (β=-0.102, p = 0.007), and organizational variables, such as patient safety culture (β=0.503, p < 0.001) and adverse event reporting awareness (β=0.261, p < 0.001). These factors explained 35.3 % of total variance. Managers in nursing homes should strengthen team-targeted education and training for nursing staff with longer working years and lower educational backgrounds. Meanwhile, a simplified and non-punitive reporting system should be established to create positive safety management climate.
PubMed: 38788557
DOI: 10.1016/j.gerinurse.2024.05.015