Occurrence Of Adverse Events Research Articles

The impact of perceived stress on the prognosis in patients undergoing percutaneous coronary intervention.

To assess the impact of perceived stress levels in patients undergoing percutaneous coronary intervention (PCI) on the occurrence of major adverse cardiovascular events (MACEs) within a 6-month follow-up period postprocedure. A cohort of 339 hospitalized patients with coronary heart disease undergoing initial PCI was prospectively enrolled in the Department of Cardiology at two branches of Zhongda Hospital Affiliated to Southeast University between January 2022 and July 2022. Baseline data including demographic and clinical characteristics, along with the Chinese Perceived Stress Scale (CPSS), were collected. The occurrence of MACE was evaluated at 3 and 6 months post-PCI. Kaplan-Meier survival analysis and Cox regression models were engaged to analyze the relationship between perceived stress and MACE within 6 months after PCI. MACE occurred in 16.22% (55/339) of patients during the 6 following months. High CPSS at baseline was significantly associated with an increasing risk of short-term MACE occurrence (HR: 6.48, 95% confidence interval: 2.98-14.11, P < 0.05). High perceived stress during the baseline period after PCI was significantly correlated with increased incidence of MACE within 6 months postprocedure. The perceived stress level could help to identify patients undergoing PCI at heightened risk of short-term MACE.

Postmarketing Safety Surveillance of Topiramate: A Signal Detection and Analysis Study Based on the FDA Adverse Event Reporting System Database.

This study aims to investigate the occurrence of adverse events associated with topiramate by analyzing data from the FDA Adverse Event Reporting System. The goal is to provide a basis for the safe clinical use of topiramate. Adverse event data from the FDA Adverse Event Reporting System, from its inception through the first quarter of 2024, were extracted. Signal detection was conducted using three methods: the reporting odds ratio, the medicines and healthcare products regulatory agency method, and the Bayesian confidence propagation neural network. Adverse events were statistically analyzed according to the preferred term and system organ class classifications from the Medical Dictionary for Regulatory Activities version 27.0. Positive signals were then compared against the drug label and the Important Medical Event list. A total of 12,168 adverse event reports involving topiramate as the primary suspect were analyzed, resulting in the extraction of 244 positive signals across 15 system organ classes. Among these, 21 signals were identified as serious adverse reactions not included in the drug label, encompassing 5 system organ classes. Notable signals included hypospadias, spina bifida, abortion spontaneous, renal tubular dysfunction, uveitis, retinal detachment, and choroidal effusion. Additionally, signals such as osmotic demyelination syndrome and Arnold-Chiari malformation were identified as requiring further monitoring. This study identified several unexpected and serious adverse reaction signals that align with previously reported cases. These findings underscore the need for ongoing study, focused attention, and vigilant monitoring during the clinical use of topiramate.

Therapeutic efficacy and safety of botulinum toxin A injection in plantar fasciitis: A systematic review and meta-analysis.

The purpose of this meta-analysis was to evaluate the therapeutic efficacy and safety of botulinum toxin A (BTA) injections for treatment of plantar fasciitis (PF). This review adhered to the PRISMA guidelines, conducting a comprehensive search of the PubMed, Web of Science, EMBASE, and Cochrane Library databases for eligible studies from their inception to December 30 2023. The inclusion criteria were limited to randomized controlled trials (RCTs) comparing BTA injections with control interventions in terms of pain reduction, functional improvement, or the occurrence of adverse events in treating patients with PF were extracted for meta-analysis. Relevant data were extracted using an electronic spreadsheet and analyzed with Stata 16.0 software. The quality of included studies was assessed using the Cochrane Collaboration's tool. A total of 655 studies were retrieved and subsequently screened. Seven RCTs, comprising 305 participants, met the eligibility criteria and were included in the meta-analysis. The pooled results indicated that BTA injections led to significant pain reduction only at 1-month posttreatment (SMD = -1.72, 95% CI [-3.10, -0.34], p = 0.01]) and sustained functional improvement over twelve months (SMD = 25.10, 95% CI [9.67, 40.53], p = 0.001) compared to the control group. There was no significant difference in the occurrence of adverse events between the BTA and control interventions (OR = 0.16, 95% CI [-1.00, 1.32], p = 0.79). This meta-analysis suggested that BTA injection could be an effective and safe therapeutic strategy for plantar fasciitis. However, further larger-scale, rigorously designed RCTs are needed to validate these findings and determine the optimal injection dosage and site for BTA in the treatment of plantar fasciitis.

Stereotactic Percutaneous Electrochemotherapy as a New Minimal Invasive Treatment Modality for Primary and Secondary Liver Malignancies

Background and Objectives: To report on the first results of safety, efficacy, and outcome of CT-navigated stereotactic percutaneous electrochemotherapy (SpECT) in patients with primary and secondary liver malignancies. Methods: This retrospective study included 23 consecutive lesions in 22 patients who underwent SpECT for primary and secondary malignant liver lesions with locally curative intention. The endpoints were primary technique efficacy (PTE), local tumor progression (LTP), time to progression (TTP), and occurrence of adverse events. Results: The mean maximum diameter of the treated lesions was 42 mm (range: 16 mm–72 mm). Eight lesions were hepatocellular carcinoma (34.8%), five lesions were colorectal liver metastases (21.7%), three lesions were cholangiocellular carcinoma (13.0%), and the other seven lesions were liver metastases from different primary cancers (30.4%). PTE was achieved for 22 lesions (95.7%). The mean follow-up time was 15 months (0–39 months). No LTP was observed. In six patients (27.3%), hepatic tumor progression was observed during follow-up with a mean TTP of 3.8 months (2–8 months). In 10 procedures (43.5%), minor complications (1 CIRSE Grade 2) and side effects occurred, but no major complications were observed. Conclusions: SpECT seems to be a safe and effective new local treatment modality for primary and secondary liver malignancies.

A real-world pharmacovigilance study of Sorafenib based on the FDA Adverse Event Reporting System

AimsThe primary objective of this study was to closely monitor and identify adverse events (AEs) associated with Sorafenib, a pharmacological therapeutic agent used to treat hepatocellular carcinoma, renal cell carcinoma, and thyroid cancer. The ultimate goal was to optimize patient safety and provide evidence-based guidance for the appropriate use of this drug.MethodsReports from the FDA Adverse Event Reporting System (FAERS) database were comprehensively collected and analyzed, covering the first quarter of 2004 to the first quarter of 2024. Disproportionality analysis was performed using robust algorithms for effective data mining to quantify the signals associated with Sorafenib-related AEs.ResultsIn total, we identifued 18,624 patients (82,857 AEs in the Sorafenib population) from the collected reports and examined, the occurrence of Sorafenib-induced AEs in 26 organ systems. The study results revealed the presence of the expected AEs, including Diarrhoea, Palmar-plantar erythrodysaesthesia syndrome, Hepatocellular carcinoma, Fatigue, and Rash, which was consistent with the information provided in the drug insert. In addition, unexpected significant AEs, such as Gait inability, Palmoplantar keratoderma and Hyperkeratosis were observed at the preferred term (PT) level. These findings suggest the potential occurrence of adverse reactions not currently documented in drug descriptions.ConclusionThis study successfully detected new and unforeseen signals associated with Sorafenib-related AEs related to Sorafenib administration, providing important insights into the complex correlations between AEs and Sorafenib use. The results of this study emphasize the critical importance of continuous and vigilant surveillance for the timely identification and effective management of AEs to improve the overall patient safety and wellbeing in the context of Sorafenib therapy.

Statistical and Clustering Analysis of Safety Profiles of FDA-Approved Protein Kinase Inhibitors

Protein kinases are vital regulators in cell biology, modifying protein functions through phosphorylation. Protein kinase inhibitors (PKIs), which impede these kinases’ activities, have broadened their therapeutic scope from cancer treatment to autoimmune and viral diseases. Despite their clinical success, challenges such as drug resistance and tolerability of adverse events persist. This article used the Protein Kinase Inhibitor Database (PKIDB) and major pharmacovigilance databases to assess the adverse events (AEs) linked to FDA-approved protein kinase inhibitors. Methods were adopted to statistically identify outliers and construct a prototypical profile to generalize AE occurrences. A total of 66 inhibitors were analyzed, revealing substantial variability in the safety profiles. Cluster analysis identified distinct patterns of AEs based on kinase target classes, highlighting the importance of tailored therapeutic approaches. Statistical methods such as Tukey’s fences were used to identify drugs with unusual safety profiles, offering insights into both frequent and rare severe reactions. Real-world evidence complements clinical trial data, capturing AEs that might not be fully identified pre-approval.

Age-related characteristics of sedation in pediatric patients and their correlated adverse events: a cohort study

ObjectiveThe objective of this research was to examine the features and potential hazards of sedation in children of varying ages. Additionally, the study aimed to comprehend these variations to enhance the safety and efficacy of clinical applications.MethodsA retrospective analysis was conducted on case data involving pediatric patients who underwent imaging procedures in outpatient settings and necessitated procedural sedation from 2022 to 2024. The research participants were categorized into three age groups: ≤1 year, 1–3 years, and 3–12 years. The primary sedative agents administered were oral midazolam in conjunction with intranasal dexmedetomidine. We examined the effects of sedation and the occurrence of adverse events across various age groups. Additionally, we applied multivariate logistic regression to identify factors linked to these adverse events.ResultsThe study observed 2,194 children, with 879 (40.1%) being ≤1-year-old. The ≤1-year-old group achieved faster sleep onset at 18.7 ± 0.3 min, with no significant variance in awakening time and length of stay among the groups. The incidence of adverse events varied significantly by age, with the highest rate of 12.2% in the ≤1-year-old group and the lowest rate of 9.7% in the 3–12-year-old group. Multivariate analysis revealed age as an independent factor affecting adverse event occurrence, with a relative risk ratio (AOR) of 2.21 (95% CI: 1.31–3.75) for delayed awakening in children ≤1-year-old, 15.03 (95% CI: 1.92–117.61) for hypoglycemia, and a relative risk ratio (AOR) of 4.58 (95% CI: 2.22–9.42) for receiving a significant intervention.ConclusionsSignificant variations in sedation reactions and adverse events were observed across the different age groups. Specifically, children aged ≤1 year exhibited a higher susceptibility to adverse events such as delayed awakening and hypoglycemia. Clinical Trial Registrationchictr.org.cn identifier (ChiCTR2400082774).

Wearable equipment-based telemedical management via multiparameter monitoring on cardiovascular outcomes in elderly patients with chronic coronary heart disease: an open-labelled, randomised, controlled trial

BackgroundThe prevalence of chronic coronary heart diseases (CHDs) increases with age in the elderly, which represents one of the top-ranked causes of death and disease burden.MethodsThis study aimed to investigate...

A prospective study on the enhancement of surgical safety in robotic surgery: The BirdView camera system.

To investigate the surgical safety and benefits of using the BirdView camera system with a wide field of view in robotic surgery for rectal cancer in a prospective clinical study. This study included 20 consecutive patients who underwent robotic surgery at our institution between the years 2022 and 2023. The primary endpoint was perioperative safety, which was defined as the occurrence of adverse events, including other organ injuries and malfunctions, caused by the BirdView camera system. There were no injuries to any other organs caused by the console surgeon or assistant forceps during surgery. Surgical adverse events occurred in five cases (atelectasis, paralytic ileus, and anastomotic leakage) during the postoperative course. There were no cases of device failure or damage to the surrounding organs, including peritoneal heat damage. We believe that the BirdView system could be valuable in improving the safety of robotic surgery by enabling the observation of blind spots, thus preventing harm to other organs.

Mining and analysis of adverse event signals of trastuzumab deruxtecan via real-world data of FDA adverse event reporting system database from 2019 to 2023

ABSTRACT Background Trastuzumab deruxtecan (T-DXd) is a novel generation antibody-drug conjugate. However, current evidence for the safety of T-DXd is mostly limited to clinical trials. It resulted in inability to timely update the adverse event (AE) for drug. Therefore, we mine and analyze AE signals caused by T-DXd based on the FAERS database, and to provide reference for the safe use of drug in clinical practice and reduce the occurrence of AE. Research design and methods This study analyzed real-world data on AEs associated with T-DXd reported in the FAERS database from December 2019 to December 2023, and the reporting odds ratio, proportional report ratio, bayesian confidence propagation neural network and multi-item gamma Poisson shrinker methods were combined to identify and evaluate reports, which can reduce the number of false positive and false negative signals with good sensitivity. Results A total of 4651 AE reports of T-DXd as the ‘primary suspect’ were collected. The median time to onset of T-DXd -related AEs was 25 days. The proportion of serious AEs was 69.40%. Hospitalization (25.67%) and death (24.19%) accounted for the highest occurrence frequency of clinical serious outcomes. The top three AE in both occurrence frequency and signal intensity were interstitial lung disease. We also found twelve kinds of potential novel danger signals not recorded in the drug lable, such as ascites, sepsis, pneumocystis jirovecii pneumonia, and gastroenteritis listeria, which need further attention and verification in clinical practice. Conclusion The results of this study indicate the importance of timely mining and updating information of adverse drug reactions. Drug evaluation should be performed well before using T-DXd, and during treatment, the indexes of pulmonary, bone marrow hematopoietic and cardiac function should be closely monitored, timely intervention measures should be taken to avoid related injury caused by AEs.

ACE inhibitors versus angiotensin receptor-neprilysin inhibitors for HFrEF management: A prospective cohort study from Indonesia

Previous studies have reported that angiotensin receptor-neprilysin inhibitors (ARNI) are superior to angiotensin-converting enzyme inhibitors (ACEI) in treating heart failure with reduced ejection fraction (HFrEF). Unfortunately, previously published studies predominantly focused on Western populations, while the data remains insufficient in developing countries. The aim of this study was to compare the efficacies of ARNI and ACEI on patients with HFrEF in Indonesia. A prospective cohort study was conducted among heart failure patients at Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia. Both ACEI and ARNI each consisted of 40 subjects receiving standard treatment for heart failure. Left ventricular ejection fraction (LVEF), quality of life (QoL), suppression of tumorigenicity 2 (ST2), and troponin T were measured upon admission and at the end of the follow-up. In addition, the occurrence of major adverse cardiac events (MACE) was observed during 6 months of follow-up. Paired t-test was used to compare the outcomes of ACEI and ARNI. The results revealed that KKCQ score and LVEF were improved in both ARNI and ACEI groups (each with p&lt;0.001). A higher KCCQ overall score was observed in the ARNI group in contrast to the ACEI group (p=0.01). ARNI demonstrated superior results in improving the ejection fraction as compared with ACEI (p=0.001). Troponin T and ST2 levels exhibited no significant difference between the two groups (p=0.07 and 0.286, respectively). MACE-associated mortality (p=0.696) and rehospitalization (p=0.955) were identical between both groups. In conclusion, ARNI was more efficacious than ACEI in improving the quality of life and left ventricular ejection fraction of patients with HFrEF. However, the efficacy was not significantly different in reducing the risk of MACE.

Safety observations in neuroblastoma patients undergoing 18F-mFBG PET.

Limited safety data have been published on fluorine-18 (18F) meta-fluorobenzylguanidine (mFBG), a new PET radiopharmaceutical for imaging neural crest and neuroendocrine tumors. As part of a prospective clinical trial, safety data in patients with neuroblastoma were collected and analyzed. Between April 2015 and January 2022, 27 patients with neuroblastoma underwent 18F-mFBG PET imaging as part of an ongoing single-center phase 1/2 trial (NCT02348749). Pre- and postinjection safety assessments were performed, including vital sign measurement and observation for occurrence of adverse events (AEs). mFBG administration resulted in no significant changes in measured vital signs. Two subjects had transient, grade 1 facial flushing shortly after the administration, which resolved within a few minutes. Neither subject had a clinically significant change in pulse or blood pressure on postadministration measurements. In this investigation of the potential clinical utility of mFBG PET imaging, no significant adverse safety signals were noted. Two mild, self-limited AEs were observed, without associated changes in vital signs. No grade 2 or higher AEs were noted. The findings are consistent with a favorable safety profile for mFBG in the target population of patients with neuroblastoma.

Clinical characteristics and in-hospital event rate of chronic obstructive pulmonary disease patients with concurrent acute myocardial infarction

This study was to investigate the clinical features of chronic obstructive pulmonary disease (COPD) patients with concurrent acute myocardial infarction (AMI) and analyze the occurrence of in-hospital adverse events. Patients with AMI who were admitted to Beijing Chaoyang Hospital from January 2019 to August 2023 were retrospectively collected. All patients were divided into COPD with concurrent AMI group and simple AMI group according to whether they were with concurrent COPD. All patients received interventional treatment for AMI. The clinical features and the occurrence of in-hospital adverse events were compared between the two groups. A total of 183 AMI patients aged (65.6±13.6) years were enrolled, including 142 males (77.6%). There were 94 patients (51.4%) in simple AMI group and 89 patients (48.6%) in COPD with concurrent AMI group, respectively. Patients in COPD with concurrent AMI group were older, had higher Killip grade, rate of smoking and previous percutaneous coronary intervention history, creatinine and B-type natriuretic peptide levels, and lower albumin, hemoglobin, low-density lipoprotein cholesterol, white blood cell count and cardiac troponin I than those of simple AMI group (all P<0.05). There were no significant differences in echocardiographic parameters between the two groups (all P>0.05). The proportion of β-blockers, angiotensin-converting enzyme inhibitors/angiotensin-blockers used in COPD with concurrent AMI group was lower (P<0.05). Patients in COPD with concurrent AMI group had longer length of hospital stay than those in simple AMI group (P=0.028). The incidence of primary endpoint events in COPD with concurrent AMI group was higher than that in simple AMI group (27.0% vs 18.0%, P=0.002). The current study indicates that COPD patients with concurrent AMI have longer length of hospital stay and higher incidence of in-hospital events, which are worthy of significant attention in clinical practice.

Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.

Utilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation. A national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3). At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI -2.17 to -0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self-management. A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.

Efficacy and safety of the glucagon receptor antagonist volagidemab in type-1 diabetes: A systematic review and meta-analysis.

The glucagon receptor antagonist (GRA) volagidemab is the first-in-class fully human monoclonal antibody that inhibits glucagon receptor. GRA can improve glycemia by reducing endogenous glucose production and reduce risks of diabetic ketoacidosis by suppressing ketogenesis. This systematic review and meta-analysis analyzed the efficacy and safety of volagidemab in type-1 diabetes (T1D). Electronic databases were searched for randomized controlled trials (RCTs) involving T1D patients receiving volagidemab. The primary outcome was to evaluate changes in total daily dose (TDD) of insulin. The secondary outcomes were to evaluate changes in measures of glycemia, hypoglycemia, and adverse events. Data from 3 RCTs (98 patients) were analyzed. Volagidemab (70mg/week) was associated with a significant reduction in TDD of insulin requirement (mean difference [MD]: -8.45 units/day (95% confidence interval [CI]: [-12.09, -4.81]); I2=83%; p<0.01) and average blood glucose (MD: -21.42mg/dL (95% CI: [-37.10, -5.74]); I2=88%; p<0.01), compared to placebo. Volagidemab use was associated with a significant increase in time in range (blood glucose: 70-180mg/dL) (MD: 10.93% (95% CI: [6.69, 15.17]); I2=55%; p<0.01) and significant reduction in time above range (blood glucose >180mg/dL) (MD: -11.93% (95% CI: [-14.71, -9.15]); I2=6%; p<0.01) without any impact on time below range (blood glucose <70mg/dL) (MD: 0.14% (95% CI: [-0.56, 0.84]); I2=0%; p=0.70), compared to placebo. Occurrence of treatment-emergent adverse events (odds ratio [OR]: 0.96 (95% CI: [0.36, 2.56]); I2=8%; p=0.94) and hypoglycemia (OR: 0.56 (95% CI: [0.11, 2.89]); I2=0%; p=0.49) were similar among volagidemab users as compared to placebo. Short-term volagidemab use was associated with significant reduction in insulin requirement along with improvement in glycemia.

Immune checkpoint inhibitor rechallenge after immune-related adverse events: a retrospective study from VigiBase update in 2024 looking for emergent safety signals

ObjectivesLimited information is available on the safety of a rechallenge with an immune checkpoint inhibitor (ICI) after occurrence of an immune-related adverse event (irAE). We aim to identify potential emergent...

Inflammation Biomarker-Driven Vertical Visualization Model for Predicting Long-Term Prognosis in Unstable Angina Pectoris Patients with Angiographically Intermediate Coronary Lesions.

Angina, a prevalent manifestation of coronary artery disease, is primarily associated with inflammation, an established contributor to the pathogenesis of atherosclerosis and acute coronary syndromes (ACS). Various inflammatory markers are employed in clinical practice to predict patient prognosis and optimize clinical decision-making in the management of ACS. This study investigated the prognostic significance of integrating commonly used, easily repeatable inflammatory biomarkers within a multimodal preoperative prediction model in patients presenting with unstable Angina Pectoris (UAP) and intermediate coronary lesions. This retrospective analysis included patients diagnosed with UAP and intermediate coronary lesions (50%-70% stenosis) who underwent coronary angiography at our hospital between January 2019 and June 2021. The assessed outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCEs). The Boruta algorithm was applied to identify potential risk factors and develop a prognostic multimodal model. A total of 773 patients were enrolled and divided into a training cohort (n=463) and validation cohort (n=310). A nomogram was constructed to predict the probability of MACCE-free survival based on five clinical features: diabetes mellitus, current smoking, history of myocardial infarction, neutrophil-to-lymphocyte ratio, and fasting blood glucose. In the training cohort, the area under the curve values for the nomogram at 24, 32, and 40 months were 0.669, 0.707, and 0.718, respectively, while those in the validation cohort were 0.613, 0.612 and 0.630, respectively. The model demonstrated good calibration in both cohorts with predicted outcomes aligning well with actual results at all time points up to 40 months. Furthermore, decision curve analysis showed significant clinical utility of the model across the specified time intervals. The developed preoperative prognostic model visually illustrates the association among inflammation, blood glucose level, established risk factors, and long-term MACCEs in UAP patients with intermediate coronary lesions.

Analysis of perioperative complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms

Objective: To investigate the perioperative adverse events and complications of flow-diverter devices in the treatment of unruptured intracranial aneurysms. Methods: This is a retrospective case series study. The clinical and imaging data of 174 patients with unruptured intracranial aneurysms treated with flow-diverter devices in the Department of Neurointervention, Department of Neurology, the First Medical Center of Chinese People's Liberation Army General Hospital from January 2020 to January 2024 were retrospectively analyzed. There were 63 males and 111 females, with an age of (53.9±11.4) years (range:23 to 76 years).The occurrence, development and outcome of perioperative complications and related adverse events during treatment were collected and analyzed. The degree of aneurysm embolization was evaluated using the O'Kelly-Marotta (OKM) grading system,with OKM grade C and D as successful occlusion. Results: A total of 187 flow-diverter devices (from 7 different brands) were implanted in 174 patients (with 294 aneurysms). Of these, 151 cases involved standalone stent embolization, 26 cases involved stent embolization combined with coil assistance, and 5 cases involved the use of two flow-diverter devices simultaneously. Twenty-nine cases (16.7%,29/174) suffered intraoperative adverse events, including 10 cases of poor stents deployment, 3 cases of stents migration into the aneurysm sac, 1 cases of abnormal guidewire movement, 4 cases of ischemic events. Complications occurred in 10 patients (5.7%, 10/174), and neurological deficits occurred in 5 patients (2.9%, 5/174). A total of 129 patients completed follow-up for more than 12 months after surgery. There were 117 aneurysms with OKM grade D and 22 with OKM grade C, showing a satisfactory healing rate of 77.7% (139/179). Conclusion: The effect of flow-diverter devices in the treatment of intracranial aneurysms is satisfactory, but complications and adverse events cannot be ignored, especially the relatively high incidence of perioperative adverse events, which requires neurointerventional physicians to be vigilant.

Prognostic Value of Human Epididymis Protein 4 in Acute Myocardial Infarction.

To investigate the prognostic value of human epididymis protein 4 (HE4) in patients with acute myocardial infarction (AMI). A total of 212 consecutive patients diagnosed with AMI in the Department of Cardiovascular Medicine of Hunan Provincial People's Hospital from June 2020 to May 2021 were enrolled. We determined plasma HE4 levels at baseline. The patients were followed up regularly and the occurrence of major adverse cardiac events (MACE) was recorded after discharge. After a mean follow-up period of 242 (159-427) days, 67 patients had MACE. Multivariate Cox regression analysis showed that HE4 was an independent predictor of MACE in patients with AMI [HR = 1.004 (1.002-1.007), P = 0.002]. Kaplan-Meier survival curves showed that patients with HE4 levels > 532.9 pmol/L had higher MACE compared with patients with ≤ 532.9 pmol/L HE4 levels (HR=4.044, 95% CI 2.373-6.890, P <0.001). Receiver operating characteristic (ROC) curve analysis showed that the area under the curve (AUC) of HE4 for predicting MACE was 0.734 (95% CI: 0.669-0.792, P < 0.001). Human epididymis protein 4 (HE4) might be a novel biomarker for predicting the prognosis of patients with AMI.

Data Mining and Analysis for Iodinated Contrast Media Adverse Event Signals Based on the Food and Drug Administration Adverse Event Reporting System Database

BackgroundThe purpose of this study was to employ the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to mine and analyze adverse events related to iodinated contrast media (ICM), explore the characteristics of adverse events (AEs) including their occurrence and correlation strength between AEs and drugs, and to provide valuable insights for clinical use. MethodsThe FAERS database was queried, data from Q1 of 2004 to Q2 of 2023 were extracted, and AE reports targeting 5 ICMs as the primary suspects were collected. Data mining and analysis were carried out on relevant reports using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), while the standardized medical dictionary for regulatory activities (MedDRA) queries (SMQ) was used for systematic classification. ResultsA total of 11,155,106 AE reports were retrieved from FAERS, with 2,412 for ioversol, 2,001 for iohexol, 987 for iodixanol, 1,154 for iopamidol, and 3,835 for iopromide. ICM-induced AE occurrence targeted 21 system organ classes (SOCs). A total of 329 significant disproportionality Preferred terms (PTs) conforming to the 4 algorithms were simultaneously retained. The results revealed that the medium and strong adverse drug reaction (ADR) signals of the 5 ICMs largely focused on “respiratory, thoracic and mediastinal disorders,” “general disorders and administration site conditions,” “immune system disorders,” and “skin and subcutaneous tissue disorders.” Ioversol (log2ROR = 1.21, Padj = 0.034) and iopromide (log2ROR = 1.32, Padj = 0.004) were both correlated with a higher incidence of a significant ADR signal, namely throat irritation, particularly in females. In addition, ioversol and iopromide also suggested that toxic nephropathy (log2ROR = −2.47, Padj < 0.001) and hyperhidrosis (log2ROR = −1.22, Padj = 0.001) were significant ADR signals, especially in males, respectively. ConclusionsWhile the AE distribution of the 5 ICMs was consistent, there were variations in specific ADR signal characteristics, warranting further consideration and exploration.