Latest ArticlesTo establish an ultra performance liquid chromatography (UPLC) method for determining the concentration of pazopanib in human serum.
Carbamazepine was used as an internal standard (IS), and acetonitrile as a protein precipitant. Separation was performed on an Agilent InfinityLab Poroshell 120 EC-C18 column (2.1 x 50 mm, 1.9 μm) with a mobile phase of 0.1% aqueous formic acid-acetonitrile solution in gradient elution mode. The flow rate was 0.25 mL·min-1, detection wavelength was 268 nm, column temperature was 40 ℃, and injection volume was 25 μL. The specificity of the method, the standard curve and the lower limit of quantification, the accuracy and precision and the stability of the sample were investigated.
Under the established chromatographic conditions, the analyte and internal standard exhibited satisfactory separation without interference from endogenous substances. Pazopanib demonstrated good linearity within the concentration range of 0.5-100 μg·mL-1. The standard curve was y=63.37×10-2x-0.49×10-2 (r2=0.999 9) and the lower limit of quantification can reach 0.25 μg·mL-1. The relative standard deviations (RSD) for both intra-day. and inter-day precision were less than 12.02%, with extraction recovery rates exceeding 86.44%. Stability was good, with RSD below than 8.80%.
The established UPLC method is simple, selective, sensitive, accurate, and reliable for determining pazopanib in human serum.
To establish a radiation injury model using primary human lung fibroblasts and screen for key genes driving radiation-induced pulmonary fibrosis through transcriptome sequencing, thereby elucidating their potential mechanisms and providing new therapeutic targets and strategies for the clinical prevention and treatment of radiotherapy-induced lung injury.
Primary human lung fibroblasts were isolated by collagenase digestion and serially passaged. Cell purity was confirmed by flow cytometry prior to establishing an in vitro radiation model. Transcriptome analysis was performed based on qualified sequencing data. DESeq2 was used for differential expression analysis to identify upregulated genes, which were subsequently validated. Protein-protein interactions (PPI) among the differentially expressed gene sets were predicted using the String database and visualized using the igraph package. Finally, functional and pathway enrichment analyses of the core genes were performed via gene ontology (GO), Kyoto encyclopedia of genes and genomes (KEGG) and gene set enrichment analysis (GSEA) using the clusterProfiler software.
All samples met the quality control standards. Transcriptome analysis identified three significantly upregulated key differentially expressed genes: sulfatase 1 (SULF1), sulfatase 2 (SULF2), and oligodendrocyte myelin glycoprotein (OMG). These findings were consistently validated in a public dataset. PPI network analysis constructed with Cytoscape revealed that SULF1 occupied a central hub position within the network, exhibiting a strong connection with SULF2, and both directly interacted with OMG. GSEA indicated that SULF1/2 and OMG were significantly enriched in pathways related to DNA function, glutathione transferase activity, and neuroimmune regulation. These results suggested that SULF1/2 and OMG may function in radiation-induced lung injury by participating in processes such as DNA damage response, oxidative stress, and neuroimmune interactions.
SULF1, SULF2 and OMG are key molecules in human lung fibroblasts responding to radiation injury and may drive the progression of radiation-induced lung injury through multiple pathways. As potential therapeutic targets, they provide a novel theoretical basis for the clinical prevention and treatment of radiotherapy-induced lung injury.
To evaluate and analyze quality assessment tools for informed consent and provide a reference for selecting appropriate tools.
A systematic search was conducted in Chinese and English databases, including CNKI, VIP, Wanfang, PubMed, Web of Science, and Embase, covering the period from database inception to July 23, 2025. Basic information on the included studies and assessment tools was extracted, and the dimensions covered by the tools as well as their reliability and validity were summarized.
A total of 23 articles and 18 informed consent quality assessment tools were included. The evaluations primarily focused on levels of understanding, information provision, and therapeutic misconception. The information content commonly addressed study objectives, study duration, procedural steps, risks and inconveniences, and potential benefits.
Although numerous quality assessment tools for informed consent are available, many lack sufficient validation in terms of reliability and validity. Future research should prioritize the validation and refinement of existing tools while developing or introducing culturally adapted assessment instruments.
Narsoplimab was first approved by the U.S. Food and Drug Administration (FDA) on December 24,2025, for the management of thrombotic microangiopathy following hematopoietic stem cell transplantation (TA-TMA) in children aged 2 years and older and adults. As a serious complication of hematopoietic stem cell transplantation (HSCT), TA-TMA is characterized by high mortality. TA-TMA is associated with endothelial injury and can activate the complement agglutinin pathway, where mannose-binding agglutinin-related serine protease-2 (MASP-2) is a key enzyme. Narsoplimab is a humanized monoclonal antibody that specifically binds to and inhibits MASP-2, thereby reducing complement activation in damaged tissues without compromising the beneficial role of complement in anti-infection. Multiple real-world studies have demonstrated a high response rate. This article provides an overview of the mechanism of action, pharmacodynamics, pharmacokinetics, clinical studies, and safety profile of Narsoplimab.
Brexpiprazole, a novel atypical antipsychotic drug, has therapeutic effects in the treatment and prevention of relapse of schizophrenia. It exerts its efficacy through partial agonism of dopamine D2 receptor and 5-hydroxytryptamine receptor 1A (5-HT1A), as well as antagonism of 5-HT2A receptor. In terms of pharmacokinetics, it features high oral bioavailability, a long half-life, and minimal influence of food on its absorption. Multiple clinical trials have confirmed its effectiveness in the acute treatment (2-4mg every day) and maintenance treatment (1-4mg every day) of schizophrenia. Regarding safety, common adverse reactions include akathisia and weight gain, with a relatively low risk of metabolic abnormalities. No systematic review of brexpiprazole has been published in China. This article conducts a systematic search for the first time and reviews it from aspects such as its mechanism of action, pharmacokinetic characteristics, clinical efficacy, and safety, providing a reference for rational clinical use.
Rheumatoid arthritis is a multifactorial autoimmune disease with an unknown etiology. In recent years, an increasing number of research findings have indicated that matrix metalloproteinase-3 (MMP-3) is most closely related to the pathogenesis of rheumatoid arthritis and is a key enzyme involved in joint destruction in patients with rheumatoid arthritis. A large number of studies have shown that traditional Chinese medicine can play a role in the prevention and treatment of rheumatoid arthritis by regulating the expression of MMP-3 in rheumatoid arthritis. This article explores the possible molecular mechanisms by which MMP-3 causes rheumatoid arthritis and systematically summarizes the literature on the regulation of MMP-3 by traditional Chinese medicine in the prevention and treatment of rheumatoid arthritis in recent years, with the aim of providing a theoretical basis for the research and clinical treatment of rheumatoid arthritis.
Novel drug research and development has high failure rate and “a narrow escape from death”, which needs to strike a balance between rapid progress, development risk and cost reduction and scientific decision-making, it is necessary to achieve "two early": eliminate drugs that may fail as early as possible with little investment, obtain key evidence as early as possible to enhance confidence in subsequent research and development, which is also known as "Quick win, fast fail" concept. Phase 0 clinical trial, as an early exploratory research tool, has the characteristics of low dose, short cycle, small number of subjects, and flexible application requirements. It is mainly used to rapidly evaluate the potential of drug candidates for further development, and more efficiently screen and develop potential drug candidates. The Phase 0 clinical trial strategy requires a variety of specific technologies and qualified personnel, including radiopharmaceutical labeling techniques, high-sensitivity analysis techniques, imaging techniques, pharmacokinetic and pharmacodynamic modeling, ethical review and subject recruitment, as well as multidisciplinary team collaboration and highly specialized research institutions. The effective integration and collaboration of these technologies and personnel is the key to the success of Phase 0 clinical trial. This paper mainly introduces the benefit-risk assessment strategy, required technologies, application requirements, and case analysis of the new paradigm for novel drug development incorporating phase 0 clinical trial.
Bone and joint diseases encompass conditions such as osteoporosis, osteoarthritis, rheumatoid arthritis, and gouty arthritis. With high prevalence rates and a significant burden of disability, they have become a major global public health issue. Current treatment approaches primarily rely on drug interventions and surgical procedures, with relatively limited options for comprehensive intervention strategies. Psoralea corylifolia L. (Buguzhi), a traditional Chinese medicinal herb, is rich in various flavonoid small-molecule compounds. Its multi-targeted, multi-step regulatory advantages have drawn significant attention in the prevention and treatment of bone and joint diseases. Existing evidence indicates that these compounds exhibit comprehensive effects including osteogenesis promotion, osteoclast inhibition, anti-inflammation, antioxidant activity, and metabolic regulation, However, its key active substances and functional networks have yet to be systematically elucidated. Based on this, this paper aims to systematically elucidate the pharmacological actions and molecular mechanisms of psoralen flavonoids in the treatment of osteoarthritis, with the goal of providing novel research perspectives and potential strategies for the clinical prevention and treatment of this condition. Furthermore, it explores the prospects for clinical translation and the primary challenges encountered.
The drug clinical trial institution serves as the management entity for the trial site and the responsible unit for protecting the rights and interests of the subjects. The investigator is responsible for the quality of clinical trials and the rights and safety of subjects at the clinical trial site. The depth and precision of quality management in both aspects determine the reliability of the trials data and the level of safety and rights protection for the subjects. This study introduced the quality management requirements and inspection focus of relevant regulations for drug clinical trial institutions and investigators from the perspective of inspection. Meanwhile, this study analyzed reasons and provided suggestions based on relevant risks identified during the inspection, with the aim of offering reference for conductors and supervisors of drug clinical trials.
Eliglustat is a first-line oral small molecule drug for the treatment of type 1 Gaucher disease, which can reduce the volume of spleen and liver, and improve anemia and thrombocytopenia. Eliglustat is mainly metabolized by cytochrome P450 2D6 (CYP2D6), and its systemic exposure is significantly affected by CYP2D6 phenotypes. The bioavailability is extremely low in CYP2D6 extensive metabolizers, resulting in the bioequivalence (BE) study results being easily affected by factors other than the preparation itself. This paper analyzed the potential risk factors in the BE study of eliglustat capsules from the aspects of molecular characteristics, biopharmaceutics, pharmacokinetics, food-drug interaction and genetic polymorphism of metabolic enzymes, so as to provide a practical reference for the BE study of the generic research and development of this variety.
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