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.Methodological establishment of red blood cell lysis method for handling Rh typing double group samples
Lu LI ; Bin WANG ; Junjie WEI ; Xiaolin SUN ; Haiyun LIU ; Weixin WU ; Yinze ZHANG
Chinese Journal of Blood Transfusion 2026;39(1):114-117
Objective: To establish an accurate and rapid typing method for Rh typing of samples from patients who have received recent blood transfusions by utilizing the difference in osmotic fragility between fresh and old red blood cells. Methods: A lysing solution suitable for destroying old RBCs was prepared. Sixty-one samples collected in our hospital in 2024 with Rh typing of double groups were treated with the lysing solution to remove the old allogeneic red blood cells while preserving the patient's own fresh red blood cells, followed by repeat Rh typing tests. Results: For 61 samples with Rh typing in double groups, 41 were accurately detected identified through the red blood cell lysis method, yielding an identification rate of 67.21%. No significant difference was observed compared to the detection rate of the commonly used capillary centrifugation modified method (χ
=0.103, P>0.05). Conclusion: The red blood cell lysis method provides a novel and rapid experimental approach for clinical use in processing Rh-typed samples that are of double groups, thereby offering a basis for Rh compatibility blood transfusion.
3.Effect of bone metabolic markers on sarcopenia in elderly patients with type 2 diabetes mellitus
Yamei WANG ; Bin ZHONG ; Xiaoqian CHEN ; Haiyan SHANGGUAN ; Jie LI
Journal of Public Health and Preventive Medicine 2026;37(1):126-129
Objective To investigate the effect of bone metabolic markers on sarcopenia in elderly patients with type 2 diabetes mellitus (T2DM). Methods A total of 412 patients with T2DM in the department of endocrinology of Nanjing Central Hospital from May 2020 to June 2025 were selected as the research subjects. According to Asian Working Group for Sarcopenia (AWGS) in 2019, these patients were evaluated for skeletal muscle mass index (ASMI), muscle strength, and muscle function, and were divided into a sarcopenia group (84 cases) and a non-sarcopenia group (328 cases). The glucolipid metabolic indexes were detected in both groups of patients, and the bone metabolic markers were evaluated, including procollagen type 1 N-terminal peptide (P1NP), beta-C-terminal telopeptide of type 1 collagen (β-CTX), and 25-hydroxy vitamin D [25-(OH)D]. The factors influencing the occurrence of sarcopenia in T2DM patients were analyzed by logistic regression analysis, and the diagnostic values of bone metabolic markers on sarcopenia in patients with T2DM were assessed by ROC curve. Results The levels of P1NP and 25-(OH)D were lower, while β-CTX level was higher in the sarcopenia group compared to the non-sarcopenia group, with statistical differences (P<0.05). After logistic correlation analysis, it was found that P1NP, β-CTX and 25-(OH)D were all influencing factors for the occurrence of sarcopenia in T2DM patients. ROC curve analysis suggested that combined detection of PINP, β-CTX, and 25-(OH)D had higher diagnostic value, with an area under the curve up to 0.805. Conclusion The abnormal expression of bone metabolic markers is associated with the increased risk of sarcopenia in patients with T2DM. The detection of serum bone metabolic markers expression level is of certain significance for the assessment of diabetes-related sarcopenia.
4.Adra2a Regulates LPS-Induced Inflammation in Hepatocytes of Lbp-/- Mice via the MAPK Signaling Pathway
Sai LIU ; Bin FU ; Sidi LI ; Zhida CHEN ; Yue ZHANG ; Zhongkun GUO ; Yongan WANG ; Kezhou WANG
Laboratory Animal and Comparative Medicine 2026;46(2):212-221
ObjectiveTo investigate the mechanism by which adrenoceptor alpha 2A (Adra2a) regulates lipopolysaccharide (LPS)-induced inflammation in primary hepatocytes from lipopolysaccharide-binding protein (LBP) knockout mice (Lbp-/-). MethodsPrimary hepatocytes from C57BL/6J and Lbp-/- mice were isolated using a two-step perfusion method. An in vitro inflammatory model was established by LPS stimulation, and an in vivo inflammatory mouse model was established by intraperitoneal injection of LPS. The in vitro experiments were grouped as follows: Control group, LPS group, BRL+LPS group, OE-NC+LPS group, and OE-Adra2a+LPS group. The Control group served as the blank control. The LPS group involved stimulating primary hepatocytes with LPS. The BRL+LPS group involved pretreating primary hepatocytes with BRL-44408 maleate followed by LPS stimulation. The OE-NC+LPS group involved transfecting primary hepatocytes with an empty vector followed by LPS stimulation. The OE-Adra2a+LPS group involved transfecting primary hepatocytes with a lentivirus overexpressing Adra2a, followed by LPS stimulation. The in vivo experimental groups were divided into Control', LPS', BRL+LPS', OE-NC+LPS', and OE-Adra2a+LPS' groups. The Control' group served as the blank control. The LPS' group received intraperitoneal injection of LPS. The BRL+LPS' group received intraperitoneal injection of BRL-44408 maleate for pretreatment, followed by LPS injection. The OE-NC+LPS' group received intraperitoneal injection of empty vector for pretreatment, followed by LPS injection. The OE-Adra2a+LPS' group received intraperitoneal injection of a lentivirus overexpressing Adra2a for pretreatment, followed by LPS injection. Cell viability after Adra2a inhibition and overexpression was assessed via the Cell Counting Kit-8 (CCK-8) assay. RT-qPCR measured changes in gene expression levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) after Adra2a inhibition and overexpression. Western blotting was performed to detect Adra2a protein expression and phosphorylation levels of extracellular signal-regulated kinase 1/2 (ERK1/2), p38 mitogen-activated protein kinase, and c-Jun N-terminal kinase (JNK) following LPS stimulation. ResultsIn vitro experiments revealed that LPS stimulation significantly decreased Adra2a protein expression in primary hepatocytes from C57BL/6J mice compared to the Control group (P<0.05), whereas it increased in primary hepatocytes from Lbp-/- mice (P<0.001). Compared to the LPS group, the BRL+LPS group exhibited significantly increased cell viability (P<0.01), reduced TNF-α, IL-6, and IL-1β gene transcription levels (P<0.01, P<0.001, P<0.001), and decreased phosphorylation levels of MAPK signaling pathway-related proteins ERK1/2, p38, and JNK (P<0.01, P<0.001, P<0.001). Compared with the OE-NC+LPS group, the OE-Adra2a+LPS group showed significantly decreased cell viability (P<0.001), increased gene transcription levels of TNF-α, IL-6, and IL-1β genes (P<0.001, P<0.01, P<0.001), and elevated phosphorylation levels of MAPK signaling pathway-related proteins ERK1/2, p38, and JNK (P<0.001, P<0.01, P<0.001). In vivo experiments showed that, compared with the LPS' group, the BRL+LPS' group exhibited significantly reduced phosphorylation levels of MAPK signaling pathway-related proteins ERK1/2, p38, and JNK (P<0.001, P<0.01, P<0.01). In the OE-Adra2a+LPS' group, the phosphorylation levels of ERK1/2, p38, and JNK were significantly elevated compared to the OE-NC+LPS' group (P<0.01, P<0.001, P<0.01). ConclusionLPS stimulation can cause a significant increase in Adra2a protein expression in primary hepatocytes of Lbp-/- mice. Adra2a protein can regulate the level of LPS-induced inflammation in primary hepatocytes of Lbp-/- mice through the MAPK signaling pathway.
5.Effect and Mechanisms of Bushen Tongluo Prescription on Pulmonary Fibrosis via Inhibiting Macrophage Polarization Through Wnt3a/β-catenin Signaling Pathway
Yanxia LIANG ; Xuelian YU ; Wenwen WANG ; Guangsen LI ; Hongfei XING ; Maorong FAN ; Bin YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):112-123
ObjectiveThis study aimed to investigate whether Bushen Tongluo prescription inhibits macrophage polarization by regulating the Wnt3a/β-catenin signaling pathway, thereby reducing epithelial-mesenchymal transition and excessive extracellular matrix deposition, in order to elucidate the anti-pulmonary fibrosis mechanisms of Bushen Tongluo prescription and provide a new theoretical basis for the clinical treatment of pulmonary fibrosis. MethodsFifty male Sprague-Dawley (SD) rats were randomly divided into a blank group, model group, pirfenidone group, and high- and low-dose Bushen Tongluo prescription groups. Except for the blank group, the pulmonary fibrosis model was established by intratracheal instillation of bleomycin. Intervention was initiated on day 28 after modeling. The high- and low-dose Bushen Tongluo prescription groups were administered Bushen Tongluo prescription at doses of 30.88, 15.44 g·kg-1, respectively, by intragastric gavage. The pirfenidone group was administered pirfenidone capsules at 110 mg·kg-1 by intragastric gavage. The blank and model groups were given an equal volume of normal saline by gavage, once daily for 90 days. After treatment, the level of transforming growth factor-β1 (TGF-β1) in bronchoalveolar lavage fluid (BALF) was detected by enzyme-linked immunosorbent assay (ELISA). Morphological changes in lung tissue and the collagen volume fraction were compared. The protein distribution and expression of E-cadherin, cytokeratin 19, α-smooth muscle actin (α-SMA), vimentin, collagen type Ⅰ (Col Ⅰ), and collagen type Ⅲ (Col Ⅲ) in lung tissue were detected by immunohistochemistry. The protein distribution and expression of CD68, arginase-1 (Arg-1), inducible nitric oxide synthase (iNOS), Wnt3a, and β-catenin in lung tissue were detected by immunofluorescence. The protein expression of Wnt3a and β-catenin in lung tissue was detected by Western blot, and the mRNA expression of Wnt3a and β-catenin was detected by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). ResultsCompared with the blank group, a large number of inflammatory cells infiltrated the airway walls, alveolar spaces, and interstitial tissue in the model group, with obvious fibrous tissue hyperplasia. The level of TGF-β1 in BALF was significantly increased. The protein expression of E-cadherin and cytokeratin 19 in lung tissue was decreased, whereas the protein expression of α-SMA, Vimentin, Wnt3a, β-catenin, Col Ⅰ, and Col Ⅲ was increased. The fluorescence-positive area ratios of CD68, Arg-1, iNOS, Wnt3a, and β-catenin in lung tissue were increased. The protein and mRNA expression levels of Wnt3a and β-catenin in lung tissue were significantly increased (P<0.01). Compared with the model group, all treatment groups showed varying degrees of improvement in inflammatory cell infiltration and fibrous tissue hyperplasia in the airway walls, alveolar spaces, and interstitial tissue, decreased TGF-β1 levels in BALF, increased protein expression of E-cadherin and cytokeratin 19 in lung tissue, decreased protein expression of α-SMA, Vimentin, Col Ⅰ, and Col Ⅲ, decreased fluorescence-positive area ratios of CD68, Arg-1, iNOS, Wnt3a, and β-catenin in lung tissue, and decreased protein and mRNA expression levels of Wnt3a and β-catenin in lung tissue (P<0.05, P<0.01). ConclusionBushen Tongluo prescription can improve bleomycin-induced pulmonary fibrosis in rats by inhibiting epithelial-mesenchymal transition and reducing excessive extracellular matrix deposition. The mechanism may be related to inhibition of the Wnt3a/β-catenin signaling pathway and the macrophage polarization mediated by this pathway.
6.Research advances in STING agonist-based antibody-drug conjugates
Jing ZHANG ; Depeng LI ; Bin YU ; Zhiyu LI ; Jinlei BIAN
Journal of China Pharmaceutical University 2026;57(1):19-27
Immune-stimulating antibody drug conjugate (ISAC) can not only effectively solve the defects of stimulator of interferon genes (STING) agonists by coupling antibodies with STING agonists through the targeting of antibodies, but also play a synergistic role with antibodies to further improve the efficacy of STING agonists. This review first provides a concise overview of the current research landscape of ISACs and STING agonists, systematically elaborates on evolving trends in STING agonist development, and subsequently summarizes the mechanistic advances in STING ISAC research. Special emphasis is placed on representative STING ISAC candidates in preclinical/clinical development. Finally, the future directions of STING ISACs are critically discussed with perspectives and recommendations, aiming to provide theoretical insights and practical guidance for future investigations.
7.Impact of social capital, adverse childhood experiences and depressive symptoms on suicidal behavior among vocational high school students
YU Bin, YAN Jingyan, CHEN Xinguang, GUO Yan, LI Fang, YAN Hong, XIAO Chenchang
Chinese Journal of School Health 2026;47(4):506-511
Objective:
To explore the nonlinear dynamic effects of social capital, adverse childhood experiences (ACEs) and depressive symptoms on suicidal behavior among vocational high school students, so as to provide theoretical basis and practical references for formulating suicide prevention strategies.
Methods:
A convenience sampling method was employed to include 668 students from a vocational high school from Wuhan in March 2023. Social capital was used as the asymmetry variable, while ACEs and depressive symptoms were used as bifurcation variables, a cusp catastrophe model was constructed to analyze the nonlinear changes in suicidal behavior among vocational high school students, and its fit was compared with linear and Logistic regression models.
Results:
Among students in the health vocational high school in Wuhan, only suicidal ideation accounted for 8.5%, only suicide attempt for 18.6%, neither accounted for 31.9%, and both for 41.0%. Gender, left behind experience, family economic status, parental parenting styles, depressive symptoms, social capital, and ACEs were all related factors influencing suicidal behavior among vocational high school students ( χ 2/H=19.03, 13.33, 21.11, 46.70, 144.38, 24.61, 118.77, all P <0.05). Violin plots showed a bimodal distribution of suicidal behavior, indicating nonlinear variation characteristics. The cusp catastrophe model results showed that social capital was negatively correlated with suicidal behavior, but the relationship was bifurcated by ACEs ( α social capital = -0.006 , β ACEs =0.075) and depressive symptoms ( α social capital =-0.013, β depressive =0.028) (all P <0.05). When both ACEs and depressive symptoms coexisted, the impact of ACEs was stronger ( β ACEs =0.077, β depressive =0.014) (both P <0.05). The cusp catastrophe model fitted ( R 2=0.886, 0.881, 0.882) better than the linear ( R 2=0.258, 0.219, 0.258) and Logistic regression models ( R 2= 0.242, 0.211 , 0.176). Gender stratified analysis results showed that bifurcation effect of ACEs was stronger in males than in females( β boys =0.224, β girls =0.086); in females, both ACEs and depressive symptoms had a bifurcation effect, with the former showing a stronger effect ( β ACEs =0.062, β depressive =0.015) (all P <0.05).
Conclusions
Suicidal behavior among vocational high school students exhibits nonlinear characteristics. Improving social capital to reducing ACEs and depressive symptoms may contribute to decreasing adolescent suicidal behaviors.
8.Construction of an index system for assessment of schistosomiasis transmission risk following natural disasters
Jingye SHANG ; Chenghang YU ; Zisong WU ; Xianhong MENG ; Huirong XU ; Chaofu WANG ; Bin ZHENG ; Shizhu LI ; Yang LIU
Chinese Journal of Schistosomiasis Control 2026;38(1):60-68
Objective To construct an index system for assessment of schistosomiasis transmission risk following natural disasters such as rainstorms, floods, earthquakes, mudslides, and landslides, so as to provide insights into rapid identification of schistosomiasis transmission risk post-disasters and formulation of targeted schistosomiasis control strategies. Methods An initial framework for the index system for assessment of schistosomiasis transmission risk following natural disasters was drafted through literature review, brainstorming, and focus group discussions. Two rounds of expert correspondence consultations were conducted using the Delphi method to refine and finalize the system, and the degrees of expert activeness, authority and endorse ment, and consensus were evaluated. In addition, the weights of each index were calculated using the analytic hierarchy process. Results A total of 18 experts participated in the consultation. The expert positive coefficients were 100.00% and 94.44% for two rounds of consultations, with authority coefficients of 0.92 and 0.94, respectively. The coefficients of coordination on the index importance, rationality and operability were 0.209, 0.185, 0.222 and 0.407, 0.214, 0.257 for two rounds of consultations, respectively, and all consistency tests were statistically significant (χ2 = 246.771 to 505.278, all P values < 0.001). Following two rounds of expert consultations, an index system consisting of 6 first-level indicators, 15 second-level indicators, and 49 third-level indicators was ultimately constructed. In terms of first-level indicators, “disaster situation”, “previous epidemics”, “healthcare guarantee”, “response capacity” and “emergency recovery” had the highest weights, each at 18.18%. Regarding second-level indicators, “Schistosoma japonicum infections in animals”, “S. japonicum infections in snails” and “medical treatment” had the highest weights, each at 7.35%. In terms of third-level indicators, ten items had the highest weights, including “identification of schistosomiasis cases”, “detection of S. japonicum infections in wild feces”, “detection of S. japonicum infections in snails”, “reserves of schistosomiasis diagnostic/testing reagents and consumables”, “reserves of chemotherapy agents for human and animal schistosomiasis”, “reserves of cercariacides”, “periodical surveillance on schistosomiasis”, “identification of schistosomiasis transmission risk and timely response”, “normal provision of diagnosis and treatment services” and “post-disaster schistosomiasis surveillance”, each at 2.40%. Conclusion A scientific, systematic, and practical index system has been constructed for assessment of schistosomiasis transmission risk following natural disasters, which may provide insights into rapid post-disaster identification of schistosomiasis transmission risk, formulation of targeted schistosomiasis control strategies and optimization of resource allocation.
9.Construction and Application of a Real-World Cohort of Community-Acquired Pneumonia Based on a Multimodal Large-Scale Traditional Chinese Medicine Big Data Platform
Zhichao WANG ; Xianmei ZHOU ; Fanchao FENG ; Mengqi WANG ; Xin WANG ; Bin KANG ; Xiaofan YU ; Xiaoxiao WANG ; Lei XIAO ; Juan LI ; Zhichao ZHANG ; Ye MA ; Yeqing JI ; Xin TONG ; Zhuoyue WU ; Jia LIU
Journal of Traditional Chinese Medicine 2026;67(9):961-965
This paper introduces a real-world cohort research model for community-acquired pneumonia (CAP) based on the Jiangsu Traditional Chinese Medicine (TCM) Dominant Diseases Diagnosis and Treatment Data Platform. Firstly, data cleaning is performed by standardizing diagnosis, symptoms, treatment and imaging, intelligently extracting unstructured information, and cleaning and constructing a standardized database. Secondly, for cohort establishment, CAP patients across the province are screened in accordance with CAP diagnostic criteria to build a high-quality disease-specific cohort. Lastly, in terms of protocol design, the characteristics of TCM research and the CAP disease profile are considered to determine appropriate inclusion and exclusion criteria, estimate sample size, define interventions, outcomes and economic evaluations, providing a reference for real-world TCM research on CAP.
10.Construction and Application of a Real-World Cohort of Community-Acquired Pneumonia Based on a Multimodal Large-Scale Traditional Chinese Medicine Big Data Platform
Zhichao WANG ; Xianmei ZHOU ; Fanchao FENG ; Mengqi WANG ; Xin WANG ; Bin KANG ; Xiaofan YU ; Xiaoxiao WANG ; Lei XIAO ; Juan LI ; Zhichao ZHANG ; Ye MA ; Yeqing JI ; Xin TONG ; Zhuoyue WU ; Jia LIU
Journal of Traditional Chinese Medicine 2026;67(9):961-965
This paper introduces a real-world cohort research model for community-acquired pneumonia (CAP) based on the Jiangsu Traditional Chinese Medicine (TCM) Dominant Diseases Diagnosis and Treatment Data Platform. Firstly, data cleaning is performed by standardizing diagnosis, symptoms, treatment and imaging, intelligently extracting unstructured information, and cleaning and constructing a standardized database. Secondly, for cohort establishment, CAP patients across the province are screened in accordance with CAP diagnostic criteria to build a high-quality disease-specific cohort. Lastly, in terms of protocol design, the characteristics of TCM research and the CAP disease profile are considered to determine appropriate inclusion and exclusion criteria, estimate sample size, define interventions, outcomes and economic evaluations, providing a reference for real-world TCM research on CAP.


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