Left atrial appendage filling defects restricted to the early phase of cardiac computed tomography is significantly associated with ischemic stroke.

PURPOSE: To investigate the relationship between filling defects in the left atrial appendage restricted to the early phase of cardiac computed tomography (CCT), and ischemic stroke in patients with atrial fibrillation (AF). MATERIALS AND METHODS: A total of 152 patients with non-valvular AF were retrospectively enrolled and divided into two groups according to the stroke history, as confirmed by brain computed tomography (CT) or magnetic resonance imaging (MRI), as the non-stroke group (n = 89) and stroke group (n = 63), respectively. The numbers of patients with filling defects in the early phase of CCT images without thrombi were recorded. Morphological parameters of the LAA were measured for all participants. All patients with early-phase filling defects (n = 44) were assigned to two groups according to ischemic stroke history: the filling defects with stroke group (n = 28) and the filling defects without stroke group (n = 16). The clinical characteristics and LAA morphological parameters were compared. RESULTS: Univariate analysis showed that compared with the non-stroke group，LAA volume index and age were higher in the stroke group, and the ratio of early phase filling defect in LAA, hypertension and diabetes were also higher, in the meanwhile the LVEF and BMI were lower (P < 0.05).After adjusting confounding factors by the multivariate logistic regression analysis, filling defect was significantly related with stroke [odds ratio (OR): 4.339, 95% confidence interval (CI): 1.951-9.653, P = 0.000]. LAA morphological parameters were not significantly different between the filling defects with stroke group and the group without stroke. CONCLUSION: AF patients with LAA non-thrombotic filling defects in the early-phase of CCT had an increased risk of ischemic stroke compared to those without filling defects. This finding may help to optimize stroke risk stratification in patients with AF.

18F-FDG PET-CT Diagnosis of Tuberculosis in Celiac Lymph Nodes.

The special location of abdominal tuberculosis makes it difficult for biopsy, while its clinical and imaging characteristics make it indistinguishable from tumors. Here, we report a female patient that was initially misdiagnosed with pancreatic cancer, but eventually correctly diagnosed with tuberculosis in the celiac lymph nodes using 18F-FDG PET-CT. She was 38 years old. Her main complaint was "deep abdominal pain and discomfort for nearly a month", accompanied by nausea and vomiting. Diagnosis of pancreatic tumors or enlarged lymph nodes was initially made based on CT scan results. Abdominal MRI revealed enlarged lymph nodes. 18F-FDG PET-CT imaging revealed a soft-tissue mass about 2.8 cm in diameter in the hepatic hilar area with a maximum standardized uptake value (SUVmax) of 9.4, and delayed imaging measured the SUVmax at 12. Enhanced CT showed no vascular envelopment in the mass. Based on these results, the patient was diagnosed with tuberculosis in the celiac lymph nodes. Her tuberculin test was strongly positive. After 5 months of antituberculosis treatment, the mass had reduced to about 1.5 cm in diameter and SUVmax reduced to 8.1, as demonstrated by 18F-FDG PET-CT imaging. Abdominal lymph-node tuberculosis is easy to misdiagnose, but timely 18F-FDG PET-CT imaging combined with tuberculin testing may reduce misdiagnosis and mistreatment.

[Overview of CDISC standard and implementation in China].

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.

Statistical and graphical approaches for disproportionality analysis of spontaneously-reported adverse events in pharmacovigilance.

AIM: Combine disproportionality analysis with dynamically interactive graphics to understand spontaneously-reported adverse events in pharmacovigilance. METHODS: Four statistical methods, including Reporting Odds Ratio, Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker and Bayesian Confidence Propagation Neural Network that are used for computing disproportionality are described. Tree maps and other graphical techniques are used to display the disproportionality results. RESULTS: Spontaneously-reported adverse events in pharmacovigilance are collected from physicians, patients, or the medical literature by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. In order to identify potential safety-signals, disproportionality analysis methods compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database. Tree maps are employed to interactively display the adverse events for particular drugs and compare the adverse events among the drugs. CONCLUSION: Interactive graphical displays of disproportionality allow the analyst to quickly identify safety signals and perform additional follow-up analyses. Combining statistical methods with dynamically interactive graphics affords insights into the data inaccessible by traditional analysis methods.