Effect of Food on the Pharmacokinetics of Tenofovir Amibufenamide: A Phase I, Randomized, Open-Label, Two-Period Crossover Trial in Healthy Adult Subjects.

Purpose: Tenofovir amibufenamide (TMF) is a novel nucleotide reverse transcriptase inhibitor. The aim of this study was to investigate the effect of food on the single-dose pharmacokinetic properties of TMF.

Patients And Methods: In this open-label, randomized, crossover study, after an overnight fast, eligible subjects received a single 25 mg dose of TMF tablet, either under fasted conditions or following consumption of a high-fat, high-calorie meal, followed by a two-week washout period.

A single-dose, randomized, open-labeled, parallel-group study comparing the pharmacokinetics, pharmacodynamics and safety of leuprolide acetate microspheres 3.75 mg and Enantone 3.75 mg in healthy male subjects.

Leuprolide acetate microspheres developed by Shanghai Livzon Pharmaceutical Co., Ltd. (T) have been marketed in China for more than 10 years, benefiting a large number of patients, and will continue to play an important role in China.

Relationship between the consumption of wholegrain and nonalcoholic fatty liver disease: The TCLSIH cohort study.

Background & Aims: Wholegrain contributes a range of beneficial nutrients and is considered to play a role in the prevention of chronic diseases, but evidence of their influence on nonalcoholic fatty liver disease (NAFLD) is limited. We conducted this study to investigate the prospective association between daily wholegrain consumption and NAFLD in the general population.

Methods: This prospective cohort study included a total of 14,968 (42.

Changes of Beclin-1 and ULK1 in retina of mice model in oxygen-inducedretinopathy.

Purpose: To observe the expression differences and potential effects of autophagy-related Beclin1 (mammalian Atg6) and Uncoordinated-51 like kinase 1 (ULK1) in the oxygen-induced retinopathy (OIR) model.

Materials And Methods: Thirty-three C57BL/6 mice in OIR model group were exposed to 75 ​± ​0.5% oxygen from postnatal day-of-life 7 (P7) to P12, and were then brought into normal room environment (relative hypoxia stage) and raised to P17.

Association between edible mushrooms consumption and handgrip strength: A large-scale population based on the TCLSIH cohort study.

Background & Aims: Edible mushrooms can be referred to as a "super food" and are recommended as a valuable constituent of the daily diet. Animal studies have suggested that mushroom intake can increase muscle endurance due to its abundant nutrients, and anti-inflammatory properties. However, no studies have explored the association between edible mushrooms consumption and muscle strength in the general population.

Green tea consumption and risk of depressive symptoms: Results from the TCLSIH Cohort Study.

Background: The prospective studies on the effect of particular type of tea consumption, especially green tea, on depressive symptoms are limited.

Objective: The aim of this study is to investigate the prospective association between green tea consumption and depressive symptoms in a large general adult population.

Methods: This prospective cohort study investigated 7524 participants aged 25 to 90 years from May 2013 to December 2018 and they were free of cardiovascular disease, cancer, and depressive symptoms at baseline.

Polysaccharide from Scutellaria barbata D. Don attenuates inflammatory response and microbial dysbiosis in ulcerative colitis mice.

This study aimed to evaluate the effect of polysaccharides from Scutellaria barbata D. Don (PSB) on dextran sodium sulfate (DSS)-induced ulcerative colitis (UC) in C57BL/6 mice. PSB was isolated, and its chemical composition was preliminarily identified.

Immune Checkpoint Inhibitors and Survival Outcomes in Brain Metastasis: A Time Series-Based Meta-Analysis.

Immune checkpoint inhibitors (ICIs) have shown potential to improve the prognosis of patients with brain metastasis (BM) caused by advanced cancers. However, controversies still exist in regard to its survival benefits. In the present work, a time series-based meta-analysis based on the phase I/II/III trials and observational studies were performed to investigate the differences in mortality of ICI-treated BM patients.

Nigella A ameliorates inflammation and intestinal flora imbalance in DSS induced colitis mice.

Nigella A, also named Sieboldianoside A, has been extracted from many kinds of Traditional Chinese Medicine (TCM), such as Nigella glandulifera, Stauntonia chinensis DC., and the leaves of Acanthopanax sieboldianus. Nigella A exhibited potential analgesic, anti-inflammatory, anti-tumor, and antioxidant activities.

Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions.

Purpose: This study compares the pharmacokinetic and safety profiles between a new generic and a branded reference formulation of amitriptyline hydrochloride tablets, and assesses the bioequivalence of the two products in healthy Chinese volunteers to obtain sufficient evidence for the marketing approval of the generic drug.

Materials And Methods: A randomized, open-label, two-period crossover study (clinicaltrials.gov, NCT03646526) was conducted under both fasting and fed conditions in healthy Chinese volunteers (24 subjects/condition).

Development and Application of a LC-MS/MS Method for Simultaneous Quantification of Four First-Line Antituberculosis Drugs in Human Serum.

A simple, rapid, and sensitive liquid chromatography (LC)/mass spectrometry (MS) method was established and validated for simultaneous quantitation of pyrazinamide, isoniazid, rifampicin, and ethambutol in human blood sample. Samples were pretreated by a single-step precipitation with acetonitrile. Chromatographic separation was achieved on XSelecT HSS T3 column by gradient elution with a total run time of 5.

Derivation and Validation of a Risk Prediction Model for Vancomycin-Associated Acute Kidney Injury in Chinese Population.

Background: Vancomycin is the standard therapy for methicillin-resistant (MRSA) infection; however, nephrotoxicity happened with a high incidence of 15%~40%. Weighting the risk before receiving vancomycin treatment facilitates timely prevention of nephrotoxicity, but no standardized strategy exists for this purpose.

Methods: A retrospective cohort study was performed.

Anti-breast cancer and toxicity studies of total secondary saponin from Anemone raddeana Rhizome on MCF-7 cells via ROS generation and PI3K/AKT/mTOR inactivation.

Ethnopharmacological Relevance: The rhizome of Anemone raddeana Regel (A. raddeana) is a famous traditional Chinese medicine (TCM) recorded in Chinese Pharmacopoeia for the treatment of carbuncle and swelling. Carbuncle swollen is an explanation of tumor in the theory of TCM and softening and resolving hard mass effects are one of the important pharmacological activities of A.

Anti-colitic effects of Physalin B on dextran sodium sulfate-induced BALB/c mice by suppressing multiple inflammatory signaling pathways.

Ethnopharmacological Relevance: Physalin B is one of the main active withanolide existed in Physalis alkekengi L. var. franchetii (Mast.

Effects of Tenofovir on the Single-Dose Pharmacokinetics of Intravenous Morinidazole in Healthy Chinese Subjects.

The effects of multiple-dose administration of tenofovir disoproxil fumarate (TDF) on the pharmacokinetics of morinidazole (MOR) were compared in healthy subjects. MOR exposure was similar, with an area under the curve from 0 h to infinity (AUC) treatment ratio for MOR+TDF/MOR of 1.01 (90% confidence interval, 0.

Pharmacokinetics and Tolerability of Single and Multiple Intravenous Doses of Cefotetan Disodium in Healthy Chinese Volunteers.

Background: Cefotetan is highly stable to penicillinase and cephalosporin produced by gram-negative bacteria, and it has strong antimicrobial activity against most gram-negative bacteria, some anaerobic bacteria and streptococcus. The objective of this study was to evaluate the pharmacokinetic profile and tolerability of single and multiple intravenous doses of cefotetan disodium in healthy Chinese volunteers.

Methods: In this single-center, open-label, dose-escalating study, subjects were randomized to receive a single dose of cefotetan disodium 0.

Potential Cytotoxicity, Pharmacokinetics, and Excretion Properties of Sapindoside B from the Seeds of Nigella sativa var. hispidula.

The seeds of var. are widely used in food preparation by the Uighur people in western China. Recently, series of oleanane triterpenoid saponins were extracted from the seeds of var.

A Phase I Comparative Pharmacokinetic and Safety Study of Two Intravenous Formulations of Vinorelbine in Patients With Advanced Non-Small Cell Lung Cancer.

The aim of this study was to compare the pharmacokinetics and safety between two vinorelbine formulations [a new oil-in-water emulsion formulation (ANX) versus a previously marketed solution formulation (Navelbine)] in Chinese patients with advanced non-small cell lung cancer (NSCLC). This was a single-center, randomized, open-label study. Eligible patients aged 18-70 years who had histologically or cytologically confirmed NSCLC were enrolled.

Pharmacokinetic/Pharmacodynamic Evaluation of Dexlansoprazole Infusion Injection Compared with Lansoprazole in Healthy Chinese Adults.

Background And Objective: This study was performed in healthy Chinese subjects to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of a novel injection formulation of dexlansoprazole in the context of single and multiple administration, compared with the original lansoprazole injection.

Methods: Helicobacter pylori-negative healthy volunteers were recruited, and 70 participants were enrolled into five dosing groups (seven males and seven females in each group), including 15 mg once daily (qd), 15 mg every 12 h (q12h), 30 mg qd and 30 mg q12h of dexlansoprazole treatment for 5 days, as well as 30 mg q12h of lansoprazole treatment for 5 days. Blood samples were collected at scheduled time spots postdose on day 1 (first dose) and day 5 (last dose).

Physalin B induces G2/M cell cycle arrest and apoptosis in A549 human non-small-cell lung cancer cells by altering mitochondrial function.

Physalin B (PB) is one of the major constituents of Physalis alkekengi var. franchetii, a well-known Chinese traditional herb. In this study, we demonstrated for the first time that PB exhibits significant antiproliferative and apoptotic activity in A549 human lung cancer cells in a concentration-dependent and time-dependent manner.

Downregulation of CPT2 promotes tumorigenesis and chemoresistance to cisplatin in hepatocellular carcinoma.

Background: Cancer cells often have characteristic changes in metabolism. Besides Warburg effect, abnormal lipid metabolism is also considered as one of the most typical metabolic symbols of cancer. Thus, understanding the mechanisms of cell metabolic reprogramming may provide a potential avenue for cancer treatment.

Ethnopharmacological uses, phytochemistry, biological activities, and therapeutic applications of Alpinia oxyphylla Miquel: A review.

Ethnopharmacological Usages: Fructus Alpiniae oxyphyllae (A. oxyphylla) is an important medicinal plant that is used not only as an edible fruit, but also as an important traditional medicine for benefiting cognitive performance and alleviating a wide spectrum of diseases. Such as; warming kidney, securing essence and arresting polyuria, as well as warming the spleen and stopping diarrhea and saliva.

Simultaneous pharmacokinetics and stability studies of physalins in rat plasma and intestinal bacteria culture media using liquid chromatography with mass spectrometry.

Physalins are the major steroidal constituent of Physalis plants and display a range of biological activities. For this study, a rapid and sensitive high-performance liquid chromatography with triple quadrupole mass spectrometry method was developed for the simultaneous quantification of six physalins. Specifically, it was for the quantification of physalin A, physalin B, physalin D, physalin G, 4,7-didehydroneophysalin B, and isophysalin B in rat plasma and rat intestinal bacteria.

Lenalidomide and the risk of serious infection in patients with multiple myeloma: a systematic review and meta-analysis.

The immunomodulatory drug lenalidomide is highly effective against newly diagnosed and relapsed/refractory multiple myeloma (MM), but serious and even fatal infections have been associated with its use. In this meta-analysis, we assessed the overall risk of infection to MM patients treated with lenalidomide. Eleven phase II or III clinical trials, comprising 3,210 subjects, were selected from the Embase, Pubmed, and Cochrane Library databases, from the Clinical Trial Registration website, and from meeting abstracts and virtual presentations at the American Society of Clinical Oncology.

Identification and quantitative analysis of physalin D and its metabolites in rat urine and feces by liquid chromatography with triple quadrupole time-of-flight mass spectrometry.

Physalin D is known to show extensive bioactivities. However, no excretion study has elucidated the excretion of physalin D and its metabolites. This study investigates the excretion of physalin D and its metabolites in rats.