Latest ArticlesTo analyze the blood-absorbing components of Penthorum chinense Pursh using high-resolution ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and to systematically investigate the material basis and mechanism of its therapeutic effect on primary sclerosing cholangitis (PSC) by integrating network pharmacology and molecular docking.
High-resolution UPLC-MS/MS was employed to identify the blood-absorbing components of Penthorum chinense Pursh. Potential target proteins of these components were predicted using the Swiss Target Prediction database. Disease-related targets of PSC were retrieved from the Gene Expression Omnibus (GEO) database using the keyword "Primary sclerosing cholangitis." The intersection of component targets and disease targets was identified to obtain common targets. A protein-protein interaction (PPI) network was constructed using the Search Tool for the Retrieval of Interacting Genes/Proteins (STRING) database to screen for core targets. Gene Ontology (GO) functional enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were performed using the Metascape platform. Finally, molecular docking validation of key components with core targets was conducted using AutoDock Vina software.
A total of 174 blood-absorbing components were identified from Penthorum chinense Pursh, corresponding to 661 predicted component targets. 2 878 PSC-related disease targets were obtained, and 105 intersection targets were screened. PPI network analysis revealed core targets including RAC-alpha serine/threonine-protein kinase (AKT1), heat shock protein HSP 90-alpha (HSP90AA1), C-X-C chemokine receptor type 4 (CXCR4), tyrosine-protein kinase Lyn (LYN), and androgen receptor (AR). GO analysis indicated that Penthorum chinense Pursh may participate in inflammatory response and other processes by regulating molecular functions such as phosphotransferase activity on membrane rafts. KEGG enrichment analysis demonstrated that the intersecting targets were significantly enriched in pathways associated with the pathological mechanisms of PSC, including T helper 17 (Th17) cell differentiation and bile secretion. Molecular docking results demonstrated favorable binding stability between key components and core targets.
This study identified the blood-absorbing components of Penthorum chinense Pursh and preliminarily revealed its potential mechanism in treating PSC through a "multi component, multi target, multi pathway" synergistic approach, providing a scientific basis for the clinical application of Penthorum chinense Pursh in PSC treatment.
To evaluate the practice of pharmaceutical care in oncology clinical pharmacists after the implementation of the charging policy for pharmaceutical service.
The clinical data of patients who received paid pharmaceutical care in the oncology department of a tertiary hospital in Beijing from November 2024 to July 2025 were retrospectively analyzed, including monitoring content, monitoring drugs, monitoring type and intervention.
A total of 131 patients were enrolled, and the average number of monitored patients was 14.55 per month. A total of 361 pharmaceutical care suggestions were put forward, of which 154 (42.66%) were intervention suggestions, of which 207 (57.34%) were pharmaceutical evaluation recommendations. The main suggestions for intervention were: 42 suggestions for the treatment of adverse drug reactions (27.27%), 42 suggestions for the formulation/adjustment of medication regimens (27.27%), etc. The main recommendations included risk monitoring of adverse drug reactions (103 recommendations, 49.76%), medication education (67 recommendations, 32.37%), etc.
This study describes the initial practice after the implementation of the policy, which can provide a baseline for subsequent controlled studies and also provide a new idea for the implementation of the model of inpatient pharmaceutical care.
As an antimalarial drug, hydroxychloroquine has anti-inflammatory and immunomodulatory effects, and can treat rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and other diseases. Because of its potential to inhibit virus therapy, it is widely used during the period of novel coronavirus pneumonia. Hydroxychloroquine also has drug side effects, which can cause damage to multiple systems such as the nervous system, cardiovascular system, retina, digestive system, skin, and blood system. Its toxic mechanism is related to Cytochrome P450 3A4 (CYP3A4) enzyme metabolism, blocking inward rectifier K+current(IK1), interfering with photoreceptors and retinal pigment epithelial (RPE) cells, and other effects. This study provides a review of the toxic side effects and molecular mechanisms caused by the application of hydroxychloroquine, providing theoretical support for the study of its toxic effects and rational clinical use.
To investigate the trends of the disease burden attributable to high body mass index (BMI) globally and in China from 1990 to 2021, to provide evidence for obesity prevention and control strategies.
Based on the Global Burden of Disease (GBD) 2021 database, data on high BMI-related deaths, disability-adjusted life years (DALYs), age-standardized mortality rates, and age-standardized DALYs rates globally and in China from 1990 to 2021 were extracted. The Joinpoint software was used to calculate the average annual percentage change (AAPC) of age-standardized mortality rates and DALYs. Disease burden ranking were performed using the GBD Compare tool.
Globally, deaths attributable to high BMI increased from 1.4595 million to 3.7091 million (increase of 154.13%, AAPC=0.29%, P<0.001); in China, from 0.1420 million to 0.5756 million (increase of 305.23%, AAPC=1.12%, P<0.001). Males showed higher increases than in females in both. Globally, the number of DALYs increased from 48.0421 million person-years to 128.5201 million person-years (increase of 167.52%), while in China, it increased from 5.4339 million person-years to 20.8652 million person-years (increase of 283.9%). For China, the top five diseases for mortality rates and DALYs rates attributable to high BMI were ischemic heart disease, hypertensive heart disease, diabetes, stroke, and chronic kidney disease. Alzheimer's disease showed an AAPC of 9.87% (P<0.001) for age-standardized mortality rate, rising from the 17th to the 6th place.
From 1990 to 2021, disease burden attributable to high BMI significantly increased globally and in China, with China’s growth rate far exceeding the global average. Comprehensive life-cycle obesity prevention and control should be strengthened, with special focus on high-burden diseases such as cardiovascular diseases, diabetes, and cancers. New directions for prevention and control of stroke and Alzheimer’s disease should be emphasized.
To analyze the developmental status and core characteristics of new drug registration clinical trials in China, and to forecast future trends, thereby providing references for the research and development (R&D) layout of the pharmaceutical industry and the optimization of relevant policies.
Based on public data from the Annual Drug Evaluation Report and the Annual Report on the Progress of Clinical Trials for New Drug Registration in China published by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) from 2020 to 2024, a comprehensive analysis was conducted on the growth in the number of clinical trials, drug types, distribution of indications, implementation efficiency, and progress in key areas.
In 2024, the total number of registered clinical trials reached 4 900, a record high. The proportion of Phase Ⅱ and Phase Ⅲ trials increased steadily, indicating continuous optimization of R&D efficiency. Clinical trials for chemical drugs and biological products were concentrated in the anti-tumor field, while trials for traditional Chinese medicine focused primarily on respiratory and digestive system diseases. Trials in key areas such as cell and gene therapy, drugs for rare diseases, and pediatric medications showed significant growth.
New drug clinical trials in China are demonstrating trends towards greater efficiency, innovation, and internationalization. Future efforts should focus on policy guidance and technological innovation to further optimize resource allocation, overcome homogeneous competition, and promote the high-quality development of the pharmaceutical industry.
Metabolic dysfunction-associated steatohepatitis (MASH) has become a research hotspot for new drug development in the field of liver diseases. Given the complex pathogenesis of MASH, coupled with constraints in disease understanding and therapeutic options, clinical trials are required to involve liver biopsies and prolonged monitoring of clinical outcomes, thereby contributing to the difficulties in drug development. To accelerate the R&D process, an increasing number of new methods and technologies are being developed and explored for application in clinical development of MASH therapeutic drugs. This paper introduces the progress of new methods such as non-invasive tests, optimized clinical trial designs, and artificial intelligence technologies in MASH clinical development, and discusses the challenges encountered in their application to clinical trials.
To develop a clinical trial management system (CTMS) to realize full-process review and management of clinical trial projects, research team management, document management, subject management, drug sample management, free medical order management and quality management.
Within the framework of the existing hospital information system, we collaborated with the hospital information center and a commercial software company to design and develop a full-process intelligent information system for clinical trials. Based on WebService, the system was connected to the hospital information system through standardized application programming interfaces (APIs), with the establishment of standard data dictionaries and governance rules to achieve secure data exchange between heterogeneous systems.
The system balanced development costs and functionality, and achieved good application effects. It integrated functions including project process, document management, drug sample management, subject management, free inspection and testing, and quality management, formed a medical database covering the entire project cycle of subjects, and ensured the authenticity and traceability of data.
This system fully leverages the advantages of joint development and informatization, improves the enrollment efficiency and implementation quality of clinical trials, and provides reference experience for other hospitals to implement integrated clinical trial management systems.
To address issues such as low efficiency and poor consistency in the submission of bioequivalence trial data under the Clinical Data Interchange Standards Consortium standards, this study aimed to develop a set of reusable standardized core data sets to improve data preparation efficiency and regulatory submission quality.
A systematic review of multiple approved BE trial projects was conducted, covering different trial designs, dosage forms, and study types. Common data structures and mapping rules were extracted through business analysis, and standardized data set templates covering both SDTM and ADaM layers were developed in strict accordance with CDISC standards.
This study summarized 274 SDTM and 338 ADaM data element-specific attributes applicable to bioequivalence trials. A set of standardized core data sets suitable for most BE trial scenarios was established and successfully applied in a two-formulation, two-period, two-sequence crossover BE study evaluating a gel patch.
The standardized dataset constructed in this study provides a preliminary framework for the standardization of BE trial data, which requires further validation through large-scale applications to clarify its applicability and robustness in enhancing the standardization level and work efficiency of BE trial data processing. It holds significant practical value for ensuring data quality and improving the success rate of submissions, while also serving as a referenceable example for the development of foundational datasets within the industry.
Currently, there are no approved adolescent weight management drugs in China, and there is a significant unmet medical need for adolescent weight management. With glucagon like peptide-1 receptor agonists (GLP-1 RA) design becoming a hot topic in the research and development of adolescent obesity, the number of communication and applications for clinical application in China has gradually increased. Combined with relevant problems encountered in the evaluation, we discussed the design and evaluation consideration for clinical trials of adolescent weight management, so as to improve the research and development and provide references for researchers.
To evaluate the effects of dapagliflozin tablets on metabolic and cardiovascular system in patients with chronic kidney disease (CKD).
CKD patients hospitalized in our institution who underwent coronary computed tomography angiography (CCTA) were divided into dapagliflozin group and non-dapagliflozin group according to treatment regimens. Levels of uric acid, creatinine, uric acid reduction rate, creatinine reduction rate and coronary artery calcium score (CACS) were compared between the two groups. Univariate and multivariate logistic regression analyses were performed to assess the independent risk factors of dapagliflozin on coronary artery calcification (CAC).
A total of 30 cases were included in dapagliflozin group, 60 cases were included in non-dapagliflozin group. After treatment, uric acid levels were (182.31±52.56) and (221.75±73.45) μmol·L-1, creatinine levels were (49.27±15.33) and (55.20±16.43) μmol·L-1, CACS were 0 (0, 0) and 0 (0, 28.93) points, uric acid reduction rates were (46.34±7.45)% and (25.81±4.56)%, creatinine reduction rates were (27.23±5.53)% and (9.12±2.46)%, and CAC incidence rates were 3.33% and 20.00% in the dapagliflozin group and non-dapagliflozin group, respectively. All the above indicators showed statistically significant differences between the two groups (all P<0.05). Multivariate logistic regression analysis showed that, after adjusting for confounding factors including sex, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), uric acid, total cholesterol, low-density lipoprotein cholesterol (LDL-C) and glycated hemoglobin (HbA1c), dapagliflozin remained an independent protective factor against CAC (OR=0.128, 95% CI: 0.03-0.62, P<0.05). The main adverse drug reactions of dapagliflozin group were mild genitourinary infection and postural hypotension; hypoglycemia and urinary tract infection were the main adverse drug reaction in non-dapagliflozin group. The total incidence of adverse drug reactions in dapagliflozin group and non-dapagliflozin group were 10.00% and 6.67%, respectively, with no significant difference in statistics (P>0.05), demonstrating good safety profile.
Dapagliflozin tablets can significantly reduce uric acid, creatinine and CACS levels in CKD patients, and may serve as a potential protective factor against coronary artery calcification.