Cuiyun Li
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View article: The effectiveness of a multi-dimensional intervention model combining cognitive behavioral therapy and social support in hospitalized depressed patients
The effectiveness of a multi-dimensional intervention model combining cognitive behavioral therapy and social support in hospitalized depressed patients Open
Background Depression management in hospitalized patients with moderate-to-severe major depressive disorder (MDD) often relies on pharmacotherapy, with limited integration of psychosocial interventions. This study introduces a novel multid…
View article: A de novo variant of RERE was identified in a patient with neurodevelopmental disorder, enuresis and scoliosis
A de novo variant of RERE was identified in a patient with neurodevelopmental disorder, enuresis and scoliosis Open
The RERE-related disorders are featured by neurodevelopmental problems with or without anomalies of the eyes, heart, kidneys, and genitourinary tract and hearing loss. Previous studies have revealed that the diagnosis of this disease was b…
View article: Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial
Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial Open
Objective To evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men. Methods This randomized, double-blind, parallel three-arm, single-dose Phase I clinica…
View article: [Cardiofaciocutaneous syndrome caused by microdeletion of chromosome 19p13.3: a case report and literature review].
[Cardiofaciocutaneous syndrome caused by microdeletion of chromosome 19p13.3: a case report and literature review]. Open
This article reports a child with cardioaciocutaneous syndrome (CFCS) caused by a rare microdeletion of chromosome 19p13.3, and a literature review is conducted. The child had unusual facies, short stature, delayed mental and motor develop…
View article: Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls
Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls Open
This study evaluated the safety and pharmacokinetics (PK) of a single dose of leritrelvir, a novel inhibitor of 3-chymotrypsin-like cysteine protease (3CLpro), in patients with hepatic impairment versus healthy participants with normal hep…
View article: Safety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients
Safety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients Open
Background and Aims Freethiadine is a novel hepatitis B virus capsid assembly modulator. Herein, we report the safety, tolerability, pharmacokinetics and 28‐day antiviral activities of freethiadine. Methods The study consisted of two parts…
View article: Distinguishing functional and structural MRI abnormalities between bipolar and unipolar depression
Distinguishing functional and structural MRI abnormalities between bipolar and unipolar depression Open
Background This study aims to investigate the underlying characteristics of spontaneous brain activity by analyzing the volumes of the hippocampus and parahippocampal gyrus, as well as the fractional amplitude of low-frequency fluctuation …
View article: Safety, tolerability, pharmacokinetics and pharmacodynamics of a novel farnesoid X receptor (FXR) agonist-TQA3526 in healthy Chinese volunteers: a double-blind, randomized, placebo-controlled, dose-escalation, food effect phase I study
Safety, tolerability, pharmacokinetics and pharmacodynamics of a novel farnesoid X receptor (FXR) agonist-TQA3526 in healthy Chinese volunteers: a double-blind, randomized, placebo-controlled, dose-escalation, food effect phase I study Open
Background: TQA3526 is a novel farnesoid X receptor agonist developed to treat non-alcoholic steatohepatitis (NASH) or primary biliary cholangitis (PBC). This study aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and pha…
View article: Safety, tolerability and pharmacokinetics of forsythin in healthy subjects: a double-blinded, placebo-controlled single-dose and multiple-dose escalation and food effect study
Safety, tolerability and pharmacokinetics of forsythin in healthy subjects: a double-blinded, placebo-controlled single-dose and multiple-dose escalation and food effect study Open
The safety and PK profiles of forsythin support further evaluation of its efficacy in individuals with the common cold or influenza.
View article: Characterization of amiodarone action on currents in hERG-T618 gain-of-function mutations
Characterization of amiodarone action on currents in hERG-T618 gain-of-function mutations Open
The purpose of this study was to determine the effect of amiodarone (Ami) on hERG-T618I currents in HEK293 cells. A transient transfection method was used to transfer hERG-T618I and hERG wild-type (WT) channel plasmids into HEK293 cells. A…
View article: Safety, pharmacokinetics and pharmacodynamics of a novel γ-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment
Safety, pharmacokinetics and pharmacodynamics of a novel γ-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment Open
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04145596).Key MessageHSK3486 at an IV bolus dose of 0.4 mg/kg and a maintenance infusion of 0.4 mg/kg/h was safe and well tolerated by all mild or moderate hepatic impair…
View article: Neurodevelopmental disorders and anti-epileptic treatment in a patient with a SATB1 mutation: A case report
Neurodevelopmental disorders and anti-epileptic treatment in a patient with a SATB1 mutation: A case report Open
SATB1 variants causing developmental delay with dysmorphic facies and dental anomalies have been reported in a small cohort. Most patients present epilepsy as a main clinical feature in neurodevelopmental disorders; however, its treatment …
View article: A Reference‐Scaled Average Bioequivalence Study of Azithromycin Tablets Manufactured in China and the United States: An Open‐Label, Randomized, Single‐Dose, 3‐Way Crossover Study in Healthy Chinese Subjects Under Fasted and Fed Conditions
A Reference‐Scaled Average Bioequivalence Study of Azithromycin Tablets Manufactured in China and the United States: An Open‐Label, Randomized, Single‐Dose, 3‐Way Crossover Study in Healthy Chinese Subjects Under Fasted and Fed Conditions Open
Azithromycin (Zithromax) is an azalide antibiotic that binds to the 50S ribosomal subunit of the susceptible organism and thereby interferes with its protein synthesis. An open‐label, randomized, single‐dose, 3‐way crossover bioequivalence…
View article: Molecular Spectrum, Ethnic and Geographical Distribution of Thalassemia in the Southern Area of Hainan, China
Molecular Spectrum, Ethnic and Geographical Distribution of Thalassemia in the Southern Area of Hainan, China Open
Background Thalassemia is one of the most common genetic diseases in southern China. Accurate population frequency data regarding the occurrence and distribution of thalassemia are important for designing appropriate prevention strategies …
View article: First-In-Human Study on Pharmacokinetics, Safety, and Tolerability of Single and Multiple Escalating Doses of Hepenofovir, a Novel Hepatic Targeting Prodrug of Tenofovir in Healthy Chinese Subjects
First-In-Human Study on Pharmacokinetics, Safety, and Tolerability of Single and Multiple Escalating Doses of Hepenofovir, a Novel Hepatic Targeting Prodrug of Tenofovir in Healthy Chinese Subjects Open
Objective: Hepenofovir, a novel hepatic targeting prodrug of tenofovir, has been developed for the treatment of chronic hepatitis B (CHB). This is a first-in-human study to evaluate the pharmacokinetics (PK) and tolerability of single and …
View article: A Class of Shark‐Derived Single‐Domain Antibodies can Broadly Neutralize SARS‐Related Coronaviruses and the Structural Basis of Neutralization and Omicron Escape
A Class of Shark‐Derived Single‐Domain Antibodies can Broadly Neutralize SARS‐Related Coronaviruses and the Structural Basis of Neutralization and Omicron Escape Open
The identification of a novel class of shark‐derived single domain antibodies, named vnarbodies that show picomolar affinities binding to the receptor binding domain (RBD) of Wuhan and Alpha, Beta, Kappa, Delta, Delta‐plus, and Lambda vari…
View article: Regulatory emotional self-efficacy and psychological distress among medical students: multiple mediating roles of interpersonal adaptation and self-acceptance
Regulatory emotional self-efficacy and psychological distress among medical students: multiple mediating roles of interpersonal adaptation and self-acceptance Open
Background Psychological distress (depression, anxiety and stress) is more common among medical students than in the general population, and is an important cause of insomnia, internet addiction, substance abuse, decreased academic perform…
View article: Effects of Kangdaxin on myocardial fibrosis in heart failure with preserved ejection fraction rats
Effects of Kangdaxin on myocardial fibrosis in heart failure with preserved ejection fraction rats Open
Kangdaxin oral liquid has protective effect on heart in HFpEF rats, which can reduce the protein expression of TGF-β1 in the heart tissue of HFpEF rats. This may be a possible mechanism to inhibit myocardial fibrosis and improve cardiac di…
View article: Regulatory Emotional Self-efficacy and Psychological Distress among Medical Students:Multiple Mediating Roles of Interpersonal Adaptation and Self-acceptance
Regulatory Emotional Self-efficacy and Psychological Distress among Medical Students:Multiple Mediating Roles of Interpersonal Adaptation and Self-acceptance Open
Background Psychological distress (depression, anxiety and stress) is more common among medical students than in the general population, and is an important cause of insomnia, internet addiction, substance abuse, decreased academic perform…
View article: Safety, Tolerability and Pharmacokinetics of the Serotonin 5-HT6 Receptor Antagonist, HEC30654, in Healthy Chinese Subjects
Safety, Tolerability and Pharmacokinetics of the Serotonin 5-HT6 Receptor Antagonist, HEC30654, in Healthy Chinese Subjects Open
Background and Objective: HEC30654 is a selective 5-HT6 receptor antagonist that was safe and well-tolerated in preclinical models of Alzheimer’s disease. The objective of this double-blind, randomized, placebo-controlled clinical trial wa…
View article: Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial
Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial Open
Hepatitis B virus capsid assembly modulators (HBV CAMs) are promising, clinically validated therapeutic agents for the treatment of chronic hepatitis B (CHB). The safety, tolerability, and pharmacokinetic (PK) profiles of GST-HG141, a nove…
View article: A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects
A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects Open
Objective: To evaluate the tolerance, variability, and pharmacokinetics (PK) of QX001S, a biosimilar for ustekinumab, in healthy Chinese men. Methods: One hundred and seventy-eight healthy men were recruited in this randomized, double-blin…
View article: Clinical importance of the distribution of pulmonary artery embolism in acute pulmonary embolism
Clinical importance of the distribution of pulmonary artery embolism in acute pulmonary embolism Open
Objective To explore the clinical importance of the distribution of pulmonary artery embolism in acute pulmonary embolism (APE). Methods Sixty-four patients with APE were classified into mixed-type and distal-type pulmonary embolism groups…
View article: A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects
A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects Open
Objective: This study explored the bioequivalence of a proposed biosimilar HOT-3010 vs. its reference product (adalimumab) among healthy Chinese male subjects. The study also investigated the tolerance, immunogenicity, and pharmacokinetics…
View article: The relationships between negative emotions and latent classes of smartphone addiction
The relationships between negative emotions and latent classes of smartphone addiction Open
The relationships between negative emotions and smartphone addiction has been tested through the literature. However, most of the studies applied variable-centered approaches. The heterogeneity of smartphone addiction severity has not been…
View article: Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study
Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study Open
The primary objective of this randomized, double‐blind, parallel‐controlled study (from December 2016 to October 2018) was to evaluate pharmacokinetic (PK) equivalence of adalimumab biosimilar HLX03 and reference adalimumab in healthy volu…
View article: A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men
A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men Open
Objective: The study aimed to explore the bioequivalence of a proposed biosimilar BAT1806 to its reference products marketed in the EU and US (RoActemra-EU and Actemra-US) among healthy Chinese men. The tolerance, immunogenicity, and pharm…