Pharmacokinetics and bioequivalence studies of fluvoxamine maleate tablets in healthy Chinese subjects.

Fluvoxamine is a selective serotonin reuptake inhibitor commonly used for various types of depression. The purpose of this study was to evaluate the pharmacokinetics and bioequivalence of fluvoxamine maleate tablets orally on an empty stomach and after a meal in healthy adult Chinese subjects and to preliminarily evaluate their safety. A single-center, randomized, open-label, two-drug, two-period, crossover, single-dose trial protocol was designed. Sixty healthy Chinese participants were enrolled and randomly classified into fasting (n = 30) and fed groups (n = 30). Each week, subjects took fluvoxamine maleate tablets 50 mg orally once as a test preparation or as a reference preparation on an empty stomach/after meals. To evaluate the bioequivalence of test and reference tables, the concentration of fluvoxamine maleate in the plasma of the subjects at different time points after administration was detected by liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters including the maximum plasma drug concentration (Cmax ), the time to reach maximum concentration (Tmax ), the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t ) and the area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞ ) were calculated. Our data revealed that the 90% confidence intervals of the geometric mean ratio of the test or reference drugs for the Cmax , AUC0-t and AUC0-∞ fell within the acceptance range for bioequivalence (92.30-102.77%). The absorption, measured by AUC, did not show a significant difference between the two groups. There were no suspected serious adverse reactions or serious adverse events over the entire trial. Our results demonstrated that the test and reference tablets were bioequivalent under fasting and fed conditions.

Prognostic significance of preoperative skeletal muscle status in patients with gastric cancer after radical gastrectomy.

BACKGROUND AND OBJECTIVES: The association between skeletal muscle status and gastric cancer (GC) prognosis remains unclear. Here, we investigated the impact of the skeletal muscle index (SMI) on overall survival (OS) in GC patients after radical gastrectomy. METHODS AND STUDY DESIGN: We divided 178 patients into four groups: adult men, adult women, elderly men and elderly women. The SMI, calculated using CT images, of patients was graded using cutoff values of group-specific tertiles. Age, body mass index, SMI grade, Charlson comorbidity index, surgical method (total vs distal gastrectomy), tumor stage, and histological type and differentiation were included in Cox regression models to assess the primary outcome parameter of OS. A new prognostic score for 3- year OS was established by combining the SMI grade and tumor stage, and receiver operating characteristic (ROC) curve analyses were used to determine its predictive reliability. RESULTS: For groups with high, medium, and low SMI grades, the 3-year OS rates were 94.04, 79.08 and 59.09% and 86.09, 70.11 and 49.11% (p<0.001) in patients undergoing distal and total gastrectomy, respectively. In the multivariate analysis, low SMI (hazard ratio (HR) 1.82, 95% confidence interval (CI) 1.14-2.9), advanced stage (HR 2.89, 95% CI 1.43-5.83), and total gastrectomy (HR 1.69, 95% CI 0.95-3.01) were independent risk factors for OS (p<0.010). The areas under the ROC curves for the prognostic score were 0.77 (range 0.61-0.93) and 0.76 (range 0.65-0.86) in patients undergoing distal and total gastrectomy, respectively. CONCLUSIONS: The preoperative SMI was an independent prognostic factor for long-term survival in GC patients after radical gastrectomy.

Assessment of left ventricular systolic and diastolic function in type 2 diabetic patients and in type 2 diabetes mellitus with coronary heart disease by two-dimensional speckle-tracking / 解放军医学杂志

[Abstract] Objective To investigate the early changes of myocardial systolic and diastolic function in patients with type 2 diabetes mellitus (T2DM) and in patients with both T2DM and coronary heart disease (CAD). Methods A retrospective analysis was taken of 128 patients who were hospitalized for suspected CAD, underwent coronary angiography and received echocardiography between August 2015 and November 2017. In these patients, 32 patients with T2DM with normal coronary angiography (DM group), 66 patients with T2DM and CAD (DM+CAD group) and 30 patients with normal coronary angiography without DM (control group) were enrolled in the study. The two-dimensional speckle tracking strain technique was used to measure the global longitudinal peak strain (GLS) of the left ventricular myocardium, and peak systolic longitudinal strains (PSLS) of the basal segment, middle segment and apical segment of the three groups. The further results were compared and analyzed. Generalized linear regression analysis were taken to analyze the factors affecting left ventricular myocardial GLS in the DM patients. Results The interventricular septal (IVS), left ventricular posterior wall (LVPW) and left artrial dimension (LAD) were increased in the DM group and (DM+CAD group), with the E peak and E/A were decreased, compared with the control group. The peak value and E/e' value were higher in the DM+CAD group, compared with the DM group. Importantly, the left ventricular GLS of the DM group, and the DM+CAD group were significantly lower than that of the control group. Moreover, the left ventricular GLS, the basical, the middle and the apical segment PSLS were all significantly lower in the DM+CAD group, than the DM group. In addition, by generalized linear regression analysis, whether combination of coronary heart disease significantly affected GLS value in DM patients, including glycated hemoglobin levels, hypertension, and E/e' values. Conclusion The DM Patients or the patients of DM+CAD were both have left ventricular systolic and diastolic dysfunction in the early stage, even if the ejection fraction is normal. The left ventricular systolic and diastolic dysfunction is more obviously in the DM+CAD patients. The two-dimensional speckle-tracking strain can be used to evaluate left ventricular diastolic and systolic dysfunction in diabetic patients in the early stage.