1.Study on the role definition of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs
Juan ZHAO ; Li GONG ; Jie SHEN ; Huiyao YANG ; Bin LIAO
China Pharmacy 2026;37(3):294-298
OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs, and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research. METHODS Combined with relevant regulations such as the Good Clinical Practice (GCP) (2020 Edition), and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital, this study systematically sorted out full-time pharmacists’ roles and functions in early-phase clinical trials of antineoplastic drugs, and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists. RESULTS & CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs, including providing pharmaceutical support for protocol design, implementing whole-process standardized management of clinical trial drugs, ensuring medication safety for clinical trial subjects/participants, conducting quality control throughout the clinical trial process, and serving as a bridge for interdisciplinary collaboration and communication. Currently, there are challenges in this field in China, such as unclear roles, an imperfect capacity building system, and insufficient regulatory support. This paper proposes that by establishing a standardized role framework, clarifying the core responsibilities and authorities of full-time pharmacists, and leveraging cutting-edge technologies to provide comprehensive support for their roles, so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.
2.Research progress on polydopamine in the treatment of oral diseases
LU Xiangxiang ; JIANG Zhen ; XING Aili ; ZHAO Bin ; SUN Bin
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(3):302-3014
Due to the moist environment in the mouth, there are many challenges that arise, such as difficult biofilm removal, short drug retention time, and low tissue repair efficiency, while treating dental caries, periodontal disease, and other oral diseases. As a biomimetic biomaterial, polydopamine (PDA) possesses multifunctional properties, including mussel-inspired adhesion and stimuli-responsive drug release. PDA adhesion properties originate from its surface catechol and amino functional groups, which maintain strong wettability in aqueous environments. With smart responsiveness encompassing photothermal, pH, and enzymatic stimuli, PDA enables controlled drug release under specific conditions. Additionally, PDA exhibits antibacterial, anti-inflammatory, and osteoblast-promoting functions, thus demonstrating significant application potential in the treatment of oral diseases. In hard tissue therapies, specifically for dental caries, PDA promotes enamel remineralization by inducing hydroxyapatite crystal growth and enhances dentin collagen mineralization through Ca2+ chelation while inhibiting cariogenic bacteria. In mandibular defect repair, functionalized PDA coatings on bone implants facilitate mesenchymal stem cell adhesion and differentiation, activate osteogenic signaling pathways, and synergistically promote vascularization to improve bone-implant integration. For soft tissue treatments, specifically for periodontitis, PDA alleviates alveolar bone resorption via antibacterial and anti-inflammatory effects coupled with osteoclast inhibition. In denture stomatitis management, PDA’s strong wet adhesion prolongs drug retention, while its photothermal effect and reactive oxygen generation provide both broad-spectrum antibacterial activity and wound healing promotion. This review summarizes PDA’s synthesis mechanisms and biological functions, with an emphasis on its therapeutic applications in oral diseases, providing innovative strategies for oral healthcare.
3.Risk Factors Analysis and Predictive Model Construction for Acute Kidney Injury Following Amphotericin B Deoxycholate Use in Hospitalized Patients
Hao XIE ; Yixun SHI ; Zhiqing XU ; Minquan LI ; Xiaoli DU ; Gang CHEN ; Bin ZHAO
Medical Journal of Peking Union Medical College Hospital 2026;17(2):429-437
To investigate the risk factors for acute kidney injury (AKI) following the use of amphotericin B deoxycholate and to develop a predictive model to guide clinical monitoring and intervention. A retrospective analysis was conducted on hospitalized patients who received amphotericin B deoxycholate between January 2014 and September 2024. Patients were divided into a training set and a validation set. Demographic data, laboratory findings, and medication orders were collected. Based on the occurrence of AKI during treatment and within 7 days after discontinuation, patients were classified into an AKI group and a non-AKI group. Univariate analysis was used to screen for potential risk factors, multivariate logistic regression was employed to construct a predictive model, and model performance was evaluated using the area under the receiver operating characteristic curve (AUC) and the Hosmer-Lemeshow test. The training set included 473 patients, comprising 255 males (53.91%) and 218 females (46.09%), with a median age of 52(35, 62) years. The AKI group consisted of 191 cases (40.38%), and the non-AKI group consisted of 282 cases (59.62%). The validation set included 114 patients, comprising 80 males (70.18%) and 34 females (29.82%), with a median age of 43.5 (31.0, 58.5) years. The AKI group consisted of 42 cases (36.84%), and the non-AKI group consisted of 72 cases (63.16%). Univariate analysis revealed statistically significant differences between the two groups in 23 factors (all Admission to the ICU, elevated serum creatinine at admission, and comorbid cardiac insufficiency as potential risk factors for AKI, while prophylactic use of diphenhydramine/promethazine or sodium bicarbonate showed a protective association. A predictive model with good discrimina-tion and calibration was developed, which may provide a basis for early identification of high-risk patients and timely adjustment of treatment strategies in clinical practice.
4.A panel study on effects of short-term exposure to ambient particulate matter and nitrogen dioxide on serum reproductive hormones in healthy adults
Yan FANG ; Xinghou HE ; Erlu ZHAO ; Bin ZHANG ; Yutong ZHU ; Tong WANG ; Xiaoming SONG ; Hongbing XU ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(6):709-716
Background Air pollution has widespread adverse health effects on human health, but research on its impact on reproductive health and related physiological mechanisms remains insufficient. Objective To investigate the associations between short-term exposure to particulate matter and nitrogen dioxide (NO2) and serum levels of anti-Müllerian hormone (AMH) and testosterone in healthy adults. Methods A total of 152 healthy adults were recruited for a panel study, undergoing four follow-up visits from September 2019 to January 2020. Basic demographic information and serum samples were collected. Reproductive hormone levels were measured by enzyme-linked immunosorbent assay kits. Concurrently, environmental data in the study area were monitored, including fine particulate matter (PM2.5), black carbon (BC), NO2, particle number concentrations in the 5-560 nm size fraction (PNC5_560), and meteorological variables. Linear mixed-effects models were constructed to estimate the effects of short-term exposure to these particulate matter on serum reproductive hormone levels. Results The participants had an average age of (23.9±2.4) years, with 102 women. For each interquartile range (IQR) increment in pollutant moving average concentrations, PM2.5, PNC5_25, PNC100_560, BC, and NO2 were associated with relative decreases in female serum AMH levels by 10.2%-16.9%, 46.2%-58.0%, 16.9%-21.2%, 14.8%-26.5%, and 11.3%-17.6%, respectively. These negative associations were stronger in females with waist-to-hip ratio > 0.76 and physical activity levels ≤ 1217 metabolic equivalents (MET) min per week. Similarly, in males, an IQR increase in the same pollutants was associated with relative decreases in serum free testosterone by 11.1%-17.2%, 35.2%, 10.5%-18.9%, 18.7%-24.2%, and 10.3%-26.0%, respectively. These effects were more pronounce in male with a waist-to-hip ratios > 0.81 and physical activity levels ≤ 1498 MET-min per week. Conclusion Short-term exposure to particulate matter and NO2 may reduce serum levels of AMH and testosterone in healthy adults. Furthermore, these adverse effects appears to be stronger in adults with higher waist-to-hip ratios.
5.Experimental study on the method of establishing a pig left lung orthotopic transplantation model
Heng ZHAO ; Jinteng FENG ; Shan GAO ; Rui ZHAO ; Hongyi WANG ; Ye SUN ; Yixing LI ; Haotian BAI ; Runyi TAO ; Bin HE ; Zhiyu WANG ; Yanpeng ZHANG ; Borui SUN ; Shuo LI ; Guangjian ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(08):1275-1281
Objective To explore the method for establishing a pig left lung orthotopic transplantation model. Methods A total of 4 male Yorkshire pigs weighing (40.0±2.5) kg underwent surgical procedures, including anesthesia, tracheal intubation, donor lung procurement, and recipient lung transplantation. Histological morphology and blood gas analysis of the transplanted lungs were assessed 2 hours after reperfusion to evaluate the histological changes and function of the transplanted lungs. Results The pigs underwent left lung in situ transplantation, effectively simulating conditions relevant to human lung transplantation. Two hours after the transplantation, arterial blood gas analysis showed that arterial partial pressure of oxygen was 155.4-178.6 mm Hg, arterial partial pressure of carbon dioxide was 53.1-62.4 mm Hg, and the oxygenation index was 310.8-357.2 mm Hg. Hematoxylin and eosin staining indicated a low degree of pulmonary edema and minimal cellular infiltration. Conclusion The pig left lung orthotopic transplantation model possesses strong operability and stability. Researchers can replicate this model according to the described methods and further conduct basic research and explore clinical translational applications.
6.Effects of gene polymorphisms on the efficacy of tofacitinib combined with iguratimod in the treatment of moderate-to-severe rheumatoid arthritis
Jun SHI ; Yang ZHAO ; Rongxue HU ; Shanshan LIU ; Bin JIA ; Jianping XU ; Peihua TIAN
China Pharmacy 2026;37(17):2286-2291
OBJECTIVE To investigate the effects of MIR149 rs2292832 and MIR499 rs3746444 gene polymorphisms on the efficacy of tofacitinib combined with iguratimod in the treatment of moderate‑to‑severe rheumatoid arthritis (RA), to provide genetic reference for individualized treatment of moderate‑to‑severe RA patients.METHODS This was a prospective cohort study, and patients were grouped according to genotyping results. A total of 320 patients with moderate-to-severe RA diagnosed in the department of immunology of our hospital between January 2023 and January 2024 were enrolled. All patients received standardized treatment with tofacitinib (5 mg twice daily) combined with iguratimod (25 mg twice daily) for 24 weeks treatment course. Clinical efficacy outcomes, including American College of Rheumatology (ACR) 20/50/70 responses, disease activity score‑28 based on C‑reactive protein (DAS28-CRP), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), were compared among patients with different genotypes. Combined-genotype analysis and multivariate Logistic regression analysis were also performed.RESULTS The MIR149 rs2292832 CC-genotype patients exhibited significantly higher ACR20, ACR50 and ACR70 response rates (88.90%, 67.78%, 45.56%) than those carrying CT- and TT-genotypes ( P <0.05). After 24 weeks treatment, the reductions in DAS28‑CRP, ESR and CRP were significantly greater in CC‑genotype patients than in CT‑ and TT‑genotype patients ( P <0.05), and the 24‑week DAS28‑CRP was significantly lower in the CC‑genotype patients than in CT‑ and TT‑genotype patients ( P <0.05). The MIR499 rs3746444 GG-genotype showed significantly higher ACR20, ACR50 and ACR70 response rates (91.46%, 73.17%, 52.44%) than those carrying AG‑ and AA‑genotypes ( P <0.05). After 24 weeks of treatment, the reductions in DAS28‑CRP, ESR and CRP were significantly greater in GG‑genotype patients than in AG- and AA-genotype patients and the 24‑weeks DAS28‑CRP was significantly lower in the GG‑genotype patients than in AG- and AA-genotype patients ( P <0.05). Among the nine combined‑genotyps, the CC+GG genotype yielded the best treatment response. The MIR149 rs2292832 CC and MIR499 rs3746444 GG genotypes were independent predictors of clinical remission ( P <0.01), whereas baseline DAS28‑CRP ≥ 6.5 served as a negative predictor of clinical remission ( P <0.05).CONCLUSIONS Gene polymorphisms of MIR149 rs2292832 and MIR499 rs3746444 significantly influence the therapeutic effect of tofacitinib combined with iguratimod in patients with moderate-to-severe RA. Patients carrying CC and GG genotypes achieve better treatment responses.
7.Proteomic Profiling of Qi-blood Deficiency vs Damp-heat Syndrome in Colorectal Cancer: Therapeutic Targeting by Astragaloside IV-berberine
Zhao-Huan LI ; Jing-Wen ZHAO ; Xin ZHANG ; Jian-Jin GUO ; Jie XU ; Zeng-Qiang YANG ; Hao TU ; Min ZOU ; Ming-Bin GUI ; Feng GAO
Progress in Biochemistry and Biophysics 2026;53(9):2462-2479
ObjectiveColorectal cancer (CRC) is a highly heterogeneous malignancy, and traditional Chinese medicine (TCM) syndrome differentiation is widely used in its clinical management. However, the biological basis underlying different TCM syndromes remains insufficiently understood. This study aimed to investigate the proteomic differences between qi-blood deficiency syndrome (QBDS) and damp-heat syndrome (DHS) in CRC patients and to establish a “syndrome-differential protein-herbal component” network for exploring potential molecular mechanisms and therapeutic targets associated with syndrome-specific treatment strategies. MethodsTumor tissue samples were collected from 10 patients with pathologically confirmed CRC, including 5 patients diagnosed with QBDS and 5 with DHS according to standardized TCM syndrome differentiation criteria. Tandem mass tag (TMT)-based quantitative proteomics was employed to identify differentially expressed proteins (DEPs) between the two syndrome groups. Functional enrichment analyses, including Gene Ontology (GO) annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analyses, were performed to characterize the biological functions and signaling pathways associated with the identified DEPs. Least absolute shrinkage and selection operator (LASSO) regression analysis was further applied to screen key syndrome-related proteins and construct a core protein prediction model. Subsequently, molecular docking was conducted to evaluate the binding affinities between representative herbal compounds, astragaloside IV and berberine, and the identified core proteins. Finally, cell counting kit-8 (CCK-8) assays were performed in HCT 116 and HT-29 colorectal cancer cell lines to validate the anti-proliferative activities of these compounds in vitro. ResultsA total of 44 DEPs were identified between QBDS and DHS tissues, including 21 upregulated and 23 downregulated proteins in the QBDS group relative to the DHS group. Functional enrichment analyses revealed that these proteins were primarily associated with antiviral immune responses, regulation of inflammatory signaling, NF‑κB signaling pathways, cholesterol metabolism, and other biological processes relevant to tumor progression and host immune regulation. LASSO regression analysis identified eight core proteins with potential syndrome-specific significance. Among them, ST7, GPCPD1, and PODXL were closely associated with QBDS, whereas FAT1, GRB7, KRT7, MAFF, and MMP8 were associated with DHS. Molecular docking demonstrated favorable interactions between astragaloside IV and QBDS-related proteins, with binding energies lower than -5 kcal/mol, indicating stable binding activity. Berberine exhibited even lower binding energies and stronger binding specificity toward DHS-related core proteins. In vitro experiments further confirmed that both compounds inhibited CRC cell proliferation, while berberine displayed significantly greater anti-proliferative efficacy. The lowest 48 h IC50 value of berberine reached 15.21 mg/L in CRC cells, indicating a stronger growth-inhibitory effect than astragaloside IV. ConclusionCRC patients with QBDS and DHS exhibit distinct proteomic characteristics, suggesting that different TCM syndromes possess unique molecular signatures. The identified core proteins may serve as potential biomarkers for syndrome differentiation, while astragaloside IV and berberine may exert therapeutic effects through targeting syndrome-specific molecular networks. These findings provide preliminary proteomic evidence supporting syndrome-guided precision integrative medicine in CRC and offer new insights into the biological basis of TCM syndrome differentiation and individualized therapeutic strategies.
8.A panel study on association of short-term air pollution exposure and peripheral blood microparticles in healthy adults
Bin ZHANG ; Xinghou HE ; Jiahui LIU ; Xuyang SHAN ; Yan FANG ; Huiying XU ; Erlu ZHAO ; Shengcong LIU ; Hongbing XU ; Jianping LI ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(1):1-7
Background Microparticles (MPs) are one of the main medium of inflammatory reaction with an important role in atherosclerotic progression. Studies on association of air pollution exposure and levels of peripheral blood MPs are limited among human. Objective To evaluate the effects of short-term exposure to air pollution on levels of peripheral blood MPs. Method A panel of 73 healthy adults was followed with 4 repeated follow-ups in Beijing, China, from November 2014 to January 2016. During each visit, we collected questionnaire information, fasting venous blood, urine, and exposures to fine particulate matter (PM2.5), black carbon, nitric oxide, nitrogen dioxide, nitrogen oxide, sulfur dioxide, carbon monoxide, and ozone. We used linear mixed-effect models to analyze associations of air pollution exposure with levels of total MPs (TMPs) and MPs derived from various cells. Stratified analysis was conducted by levels of C-reactive protein (CRP) and malondialdehyde (MDA). Results The results showed significant associations between air pollution exposure and peripheral blood TMPs at 2 h-6 d prior to the follow-ups (P<0.05), while no statistical associations were found for MPs derived from different cell types. Significant increases in TMPs of 7.8% (95%CI: 0.7%, 15.3%) and 14.3% (95%CI: 2.8%, 27.2%) were observed with each interquartile range (IQR) increase in PM2.5 (IQR=64.9 μg·m−3) at prior 18 h and NO (IQR=40.5 μg·m−3) at prior 48 h. Among participants with low levels of CRP and MDA, significantly positive associations were observed between air pollution exposure and levels of TMPs (P<0.05). Conclusion Short-term exposure to air pollution is significantly associated with increased levels of circulating MPs in healthy adults, and in people with lower systemic inflammation, peripheral blood MPs levels are more easily affected after exposure to air pollutants.
9.Pre-operative risk assessment of hepatocellular carcinoma recurrence in liver transplant recipients by non-invasive detection of pre-existing genetic lesions
Suqin YANG ; Sunbin LING ; Jianhua LI ; Yan WANG ; Jiapei WANG ; Qiwei HUANG ; Fanming LIU ; Yiqi ZHUANG ; Yingyu ZHENG ; Rui WANG ; Zhe YANG ; Xiaoping ZHENG ; Kai WANG ; Zhikun LIU ; Jun CHEN ; Jianguo WANG ; Haiyang XIE ; Lin ZHOU ; Leiming CHEN ; Guoqiang CAO ; Dandan CHEN ; Junfang JI ; Bin ZHAO ; Chao JIANG ; Di LU ; Xuyong WEI ; Hangjin JIANG ; Qiaonan SHAN ; Hengbo SHI ; Yong-Zhen XU ; Shusen ZHENG ; Zhengxin WANG ; Shengda LIN ; Xiao XU
Clinical and Molecular Hepatology 2026;32(2):884-903
Background/Aims:
Liver transplantation (LT) following total hepatectomy is a life-saving treatment for hepatocellular carcinoma (HCC). The HCC recurrence after LT hinders the effectiveness of the procedure. The objective of this study is to develop a pre-operative risk stratification model based on a liquid biopsy.
Methods:
We conducted a comprehensive multi-omics study of 260 HCC patients from three centers, including clinical data, low-coverage whole-genome sequencing of cell-free DNA (cfDNA) from plasma, as well as whole-exome, single-nucleus RNA, and spatial transcriptomics from matched tumor and non-tumor tissues.
Results:
We identified cfDNA-derived copy number alteration (CNA) signatures associated with post-transplant recurrence. By integrating cfDNA-derived CNA profiles with single-cell transcriptomic data, we traced recurrence-associated cfDNA to a distinct subpopulation of malignant cells within the primary tumor. These cells were embedded in a pro-metastatic microenvironment of specialized endothelial subtypes and cancer-associated fibroblasts. Notably, most recurrence-associated lesions were detectable in cfDNA prior to liver transplantation (LT). Building on these insights, we developed the ZJU Criteria based on CNA fragments and tumor markers, a pre-LT risk prediction tool that integrates conventional clinical factors with cfDNA-derived CNA signatures, and validated it using internal and independent external cohorts.
Conclusion
Our findings suggest that post-transplant recurrence commonly originates from advanced subclones that emerge late during tumor evolution. The ZJU Criteria provides an accurate, non-invasive strategy that significantly improves pre-LT risk stratification and clinical decision-making for patients with HCC.
10.Application and prospect of artificial intelligence in screening and diagnosis of scoliosis
Chinese Journal of Tissue Engineering Research 2026;30(3):721-730
BACKGROUND:Scoliosis is a three-dimensional deformity characterized by lateral bending and rotation of the spine.Its onset age covers the entire life cycle,becoming an important health issue that threatens people's health.Artificial intelligence continues to advance with the development of computer science.At present,artificial intelligence has great potential for application in medical diagnosis and treatment,and is gradually being applied in screening and diagnosis of scoliosis.OBJECTIVE:To comprehensively review the application of artificial intelligence in screening and diagnosis of scoliosis,elaborate on the progress of its application in recent years from multiple aspects,and look forward to its innovative points,providing reference for the future trend of intelligence.METHODS:Search covered databases such as PubMed,IEEE Xplore,CNKI,and WanFang,using Chinese and English search terms such as"scoliosis,artificial intelligence,machine learning,screen,diagnosis."Boolean logic was used to optimize the search strategy.Articles directly related to the application of artificial intelligence in screening and diagnosis of scoliosis were included,and articles with weak correlation,outdated experimental design,or poor credibility were excluded.Finally,83 articles were included for analysis.RESULTS AND CONCLUSION:(1)Artificial intelligence has shown unique application value and development prospects in multiple fields such as early screening of scoliosis,chest X-ray screening,smartphone screening,X-ray diagnosis,CT and MRI diagnosis,and reconstruction of three-dimensional spinal images.(2)The application of artificial intelligence in the screening and diagnosis of scoliosis has improved efficiency,reduced misdiagnosis rates,and alleviated the burden on medical staff,facilitating early detection and diagnosis of scoliosis and safeguarding spinal health.


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