Detection of sivelestat and its metabolite in small volumes of plasma from Chinese ALI/ARDS patients with SIRS via high-throughput UPLC-MS/MS: A pharmacokinetic study.

In this study, we developed a sensitive and efficient analytical approach combining a 96-well plate-based protein precipitation strategy with ultra-performance liquid chromatography electrospray ionization tandem mass spectrometry (UPLC-MS/MS) in order to assess the pharmacokinetic (PK) properties of sivelestat and its metabolite XW-IMP-A in samples of plasma from ALI/ARDS patients with SIRS. The samples were separated via gradient elution with a C18 column (Phenomenex Kinetex, C18, 2.6 µm, 100 Å, 50 × 2.1 mm) using 0.1 % formic acid aqueous solution (A) and acetonitrile-methanol (1:1, V:V) (B) as a mobile phase at a 0.6 mL/min flow rate. UPLC-MS/MS spectra were generated in positive ion mode, and multiple reaction monitoring (MRM) was used to detect the following transitions: m/z 435.1 → 360.0 for sivelestat, m/z 469.0 → 394.0 for sivelestat-IS, m/z 351.0 → 276.0 for XW-IMP-A, and m/z 384.9 → 310.0 for XW-IMP-A-IS. This assay was run for 2.5 min in total, and achieved lowest limit of quantitation values of 2.0 ng/mL and 0.5 ng/mL for sivelestat and XW-IMP-A, respectively, while remaining highly linear from 2-500 ng/mL for sivelestat (r2 ≥ 0.9900) and from 0.5-125 ng/mL for XW-IMP-A (r2 ≥ 0.9900). These validated data were consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) acceptance criteria. In addition, this method was successfully applied to the steady-state PK evaluation of ALI/ARDS patients with SIRS.

Clinical characteristics of re-positive COVID-19 patients in Huangshi, China: A retrospective cohort study.

A cluster of patients with coronavirus disease 2019 (COVID-19) underwent repeated positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA tests after they were discharged from the hospital. We referred to them as re-positive (RP) patients in this study. We aimed to describe the clinical characteristics of these patients in a retrospective cohort study. After being treated for COVID-19, the patients underwent 14 days of quarantine following their discharge from the Huangshi Hospital of Traditional Chinese Medicine and the Huangshi Hospital of Youse. Two additional sequential SARS-CoV-2 RNA tests were performed at the end of quarantine. The median age of the 368 patients was 51 years, and 184 (50%) patients were female. A total of 23 RP patients were observed at follow-up. Using multivariate Cox regression analysis, risk factors associated with RP included a higher ratio of lymphocyte/white blood cell on admission (adjusted HR 7.038; 95% CI, 1.911-25.932; P = 0.0034), lower peak temperature during hospitalization (adjusted HR, 0.203; 95% CI, 0.093-0.443; P<0.0001), and the presence of comorbidities, particularly hypertension or chronic diseases in the respiratory system (adjusted HR, 3.883; 95% CI, 1.468-10.273; P = 0.0063). Antivirus treatment with arbidol was associated with a lower likelihood of re-positive outcomes (adjusted HR, 0.178; 95% CI, 0.045-0.709; P = 0.0144).

Mental Health Outcomes in Perinatal Women During the Remission Phase of COVID-19 in China.

BACKGROUND: Since the middle of March, the COVID-19 outbreak has been well contained in China. The prevention and control measures for the outbreak have been downgraded to a normalized level. However, until now, the change in level of psychological health amongst perinatal women during the remission phase of the COVID-19 outbreak has not been investigated in China. The aim of this current study was to assess the symptoms of anxiety, depression, insomnia and quality of life (QOL) in perinatal women and to identify potential risk factors associated with these symptoms. METHODS: This was a cross-sectional, hospital-based survey conducted between March 25th till June 5th, 2020 in southern China. Convenient sampling method was adopted. Women's anxiety, depression, insomnia symptoms and QOL was examined through standardized measurements. Multivariate logistic regression and Analysis of Covariance (ANCOVA) was conducted for the same. RESULTS: A total of 625 perinatal women completed the study; of them, 195 women (31.2%, 95%CI=27.56%-34.84%) reported anxiety, 120 (19.2%, 95%CI=16.10%-22.30%) reported depression, and 87 (13.9%, 95%CI=11.20%-16.64%) experienced symptoms of insomnia. Previous adverse experiences during pregnancy was a significant risk factor for anxiety (OR=1.628, 95%CI=1.069-2.480, P=0.023), depression (OR=1.853, 95%CI=1.153-2.977, P=0.011), and insomnia (OR=2.160, 95%CI=1.290-3.616, P=0.003). Participants having infected friends/families/colleagues were more likely to report anxiety (OR=2.195, 95%CI=1.245-3.871, P=0.007) and depression (OR=2.666, 95%CI=1.482-4.794, P=0.001). Those women whose regular check-ups were severely interrupted by the COVID-19 were also more likely to experience symptoms of anxiety (OR=2.935, 95%CI=1.701-5.062, P<0.001) and insomnia (OR=2.195, 95%CI=1.098-4.390, P=0.026). CONCLUSION: The COVID-19 pandemic does affect the mental health and well being of perinatal women. Increased attention should be paid to women who have infected friends/families/colleagues and those with previous adverse experiences during pregnancy. Coping strategies that relieve psychological stress during the COVID-19 outbreak should be provided to prevent adverse outcomes for women and their infants.