RESUMO
BACKGROUND: Coronary heart disease (CHD) is the leading cause of death worldwide, constituting a growing health and social burden. People with cardiometabolic disorders are more likely to develop CHD. Retinal image analysis is a novel and noninvasive method to assess microvascular function. We aim to investigate whether retinal images can be used for CHD risk estimation for people with cardiometabolic disorders. METHODS: We have conducted a case-control study at Shenzhen Traditional Chinese Medicine Hospital, where 188 CHD patients and 128 controls with cardiometabolic disorders were recruited. Retinal images were captured within two weeks of admission. The retinal characteristics were estimated by the automatic retinal imaging analysis (ARIA) algorithm. Risk estimation models were established for CHD patients using machine learning approaches. We divided CHD patients into a diabetes group and a non-diabetes group for sensitivity analysis. A ten-fold cross-validation method was used to validate the results. RESULTS: The sensitivity and specificity were 81.3% and 88.3%, respectively, with an accuracy of 85.4% for CHD risk estimation. The risk estimation model for CHD with diabetes performed better than the model for CHD without diabetes. CONCLUSIONS: The ARIA algorithm can be used as a risk assessment tool for CHD for people with cardiometabolic disorders.
RESUMO
OBJECTIVES: This multicenter, randomized, open-label, phase II trial evaluated the efficacy and safety of AEG35156 in addition to sorafenib in patients with advanced hepatocellular carcinoma (HCC), as compared with sorafenib alone. METHODS: Eligible patients were randomly assigned in a 2:1 ratio to receive AEG35156 (300 mg weekly intravenous infusion) in combination with sorafenib (400 mg twice daily orally) or sorafenib alone. The primary endpoint was progression-free survival (PFS). Other endpoints include overall survival (OS), objective response rates (ORR), and safety profile. RESULTS: A total of 51 patients were enrolled; of them, 48 were evaluable. At a median follow-up of 16.2 months, the median PFS and OS were 4.0 months (95% CI, 1.2-4.1) and 6.5 months (95% CI, 3.9-11.5) for combination arm, and 2.6 (95% CI, 1.2-5.4) and 5.4 months (95% CI, 4.3-11.2) for sorafenib arm. Patients who had the study treatment interrupted or had dose modifications according to protocol did significantly better, in terms of PFS and OS, than those who had no dose reduction in combination arm and those in sorafenib arm. The ORR based on Choi and RECIST criteria were 16.1% and 9.7% in combination arm, respectively. The ORR was 0 in control arm. One drug-related serious adverse event of hypersensitivity occurred in the combination arm, whereas 2 gastrointestinal serious adverse events in the sorafenib arm. CONCLUSION: AEG35156 in combination with sorafenib showed additional activity in terms of ORR and was well tolerated. The benefit on PFS is moderate but more apparent in the dose-reduced subgroups.