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.Disease burden and changing trend in tracheal, bronchus, and lung cancer attributable to air pollution globally and in China and the United States from 1990 to 2021
Shoucai HU ; Chenglong YANG ; Lingling ZHANG ; Fu LI ; Yanan ZHANG ; Bin LIU ; Qingxin LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):97-104
Objective To systematically analyze the spatiotemporal distribution characteristics and epidemiological trends of tracheal, bronchus, and lung cancer (TBL) disease burden attributed to air pollution globally and in China and the United States from 1990 to 2021, and to assess the patterns of disease burden changes from 2022 to 2031 based on predictive models, providing a scientific basis for formulating targeted TBL prevention and control strategies. Methods Based on the Global Burden of Disease (GBD) 2021 database, we analyzed the disease burden data of TBL attributed to air pollution globally and in China and the United States from 1990 to 2021. R Studio 4.3.2 software was used to analyze the corresponding trends and the Bayesian age-period-cohort (BAPC) prediction model was used to predict the status of the disease burden of TBL attributed to air pollution in the world and in China and the United States from 2022 to 2031. Results In 2021, China had the highest number of deaths and disability-adjusted life years attributed to air pollution (211 400 patients and 4.8947 million person-years), followed by the United States (6 000 patients and 124 300 person-years). The age-standardized mortality rate (ASMR) and age-standardized disability-adjusted life years rate (ASDR) of TBL due to air pollution in the world and in China and the United States showed a decreasing trend. From 1990 to 2021, the ASMR and ASDR of TBL in China due to air pollution were much higher than those in the United States and the global average. In terms of gender, from 1990 to 2021, the disease burden of male patients with TBL attributed to air pollution was much higher than that of female patients. The BAPC prediction model showed that from 2022 to 2031, the ASMR and ASDR of TBL attributed to air pollution showed an upward trend globally, while they showed a downward trend in China and the United States. Conclusion Over the past 30 years, the air pollution-related TBL disease burden in the world and in China and the United States has continued to decline, but China's disease burden is still significantly higher than the global average. The disease burden in men far exceeds that in women, with men and the population aged ≥50 years being high-risk groups. In the future, the global disease trend may reverse and rise, while China and the United States are expected to continuously decline. However, precise prevention and control for high-risk groups remains a key challenge.
3.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.
4.The risk prediction models for anastomotic leakage after esophagectomy: A systematic review and meta-analysis
Yushuang SU ; Yan LI ; Hong GAO ; Zaichun PU ; Juan CHEN ; Mengting LIU ; Yaxie HE ; Bin HE ; Qin YANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):230-236
Objective To systematically evaluate the risk prediction models for anastomotic leakage (AL) in patients with esophageal cancer after surgery. Methods A computer-based search of PubMed, EMbase, Web of Science, Cochrane Library, Chinese Medical Journal Full-text Database, VIP, Wanfang, SinoMed and CNKI was conducted to collect studies on postoperative AL risk prediction model for esophageal cancer from their inception to October 1st, 2023. PROBAST tool was employed to evaluate the bias risk and applicability of the model, and Stata 15 software was utilized for meta-analysis. Results A total of 19 literatures were included covering 25 AL risk prediction models and 7373 patients. The area under the receiver operating characteristic curve (AUC) was 0.670-0.960. Among them, 23 prediction models had a good prediction performance (AUC>0.7); 13 models were tested for calibration of the model; 1 model was externally validated, and 10 models were internally validated. Meta-analysis showed that hypoproteinemia (OR=9.362), postoperative pulmonary complications (OR=7.427), poor incision healing (OR=5.330), anastomosis type (OR=2.965), preoperative history of thoracoabdominal surgery (OR=3.181), preoperative diabetes mellitus (OR=2.445), preoperative cardiovascular disease (OR=3.260), preoperative neoadjuvant therapy (OR=2.977), preoperative respiratory disease (OR=4.744), surgery method (OR=4.312), American Society of Anesthesiologists score (OR=2.424) were predictors for AL after esophageal cancer surgery. Conclusion At present, the prediction model of AL risk in patients with esophageal cancer after surgery is in the development stage, and the overall research quality needs to be improved.
5.A Retrospective Study of Rescue Injuries and Agonal Injuries in 640 Death Cases
Xuanyi LI ; Guoli LV ; Wen YANG ; Chunlei WU ; Xiaoshan LIU ; Bin LUO ; Xinbiao LIAO ; Erwen HUANG
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(1):81-87
ObjectiveTo clearly identify the difference between rescue injuries and agonal injuries and to avoid duplicate identifications and misidentifications. MethodsBased on the forensic pathological data of 5 923 cases of death cause identification from 2013 to 2022 in Sun Yat-sen University Forensic Identification Center and Guangzhou Tianhe District Branch of Guangzhou Public Security Bureau, this study retrospectively studied the characteristics of rescue injuries and agonal injuries seen in cause of death identification and their influence on cause of death identification. ResultsAmong all the 5 923 cases, 640 cases were found to have rescue injuries or agonal injuries, and 624 cases received treatment, of which 609 cases were found to have rescue injuries (97.60%), 44 cases were found to have agonal injuries, and 13 cases were found to have both types of injuries. Among the 640 cases, 441 were male and 199 were female. The age of death was discontinuously distributed from 0 to 95 years old. The leading cause of death was disease, followed by mechanical injury and asphyxia. The main manifestations of rescue injuries were rib and sternum fractures, soft tissue injuries in the prechest area or face, and pericardial rupture. The most common injuries in agonal stage were falling after unconsciousness, inhalation of foreign body in respiratory tract or multiple violent injuries. Among the 640 cases, 19 cases were repeatedly identified, including 15 cases of rescue injuries, 6 cases of agonal injuries, and 2 cases of both types of injuries. Compared with the cases where neither type of injuries was detected, the repeated identification rate of treatment injuries and agonal injuries was significantly increased (χ²=4.04, P=0.044; χ²=43.49, P<0.001). Among the 640 cases, 11 cases (1.72%) were misidentified as the initial injuries in the first identification, and 13 cases had combined rescue injuries or agonal injuries that were involved in death. ConclusionsBy elucidating the epidemiological characteristics of the two types of injuries, this study proved that the two types of injuries were associated with higher rates of repeated identification and misidentification, which provided a reference for reducing repeated identification and misidentification and improving the accuracy of cause of death identification.
6.Role of amino acid metabolism in autoimmune hepatitis and related therapeutic targets
Peipei GUO ; Yang XU ; Jiaqi SHI ; Yang WU ; Lixia LU ; Bin LI ; Xiaohui YU
Journal of Clinical Hepatology 2025;41(3):547-551
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease. The pathogenesis of AIH remains unclear, but it is mainly autoimmune injury caused by the breakdown of autoimmune tolerance due to the abnormal activation of the immune system, while the specific molecular mechanism remains unknown. Recent studies have shown that abnormal amino acid metabolism plays an important role in the development and progression of AIH. This article reviews the research advances in amino acid metabolic reprogramming in AIH, in order to provide a theoretical basis for amino acid metabolism as a new target for the clinical diagnosis and treatment of AIH.
7.Changes in the body shape and ergonomic compatibility for functional dimensions of desks and chairs for students in Harbin during 2010-2024
Chinese Journal of School Health 2025;46(3):315-320
Objective:
To analyze the change trends in the body shape indicators and proportions of students in Harbin from 2010 to 2024, and to investigate ergonomic compatibility of functional dimensions of school desks and chairs with current student shape indicators, so as to provide a reference for revising furniture standards of desks and chairs.
Methods:
Between September and November of both 2010 and 2024, a combination of convenience sampling and stratified cluster random sampling was conducted across three districts in Harbin, yielding samples of 6 590 and 6 252 students, respectively. Anthropometric shape indicators cluding height, sitting height, crus length, and thigh length-and their proportional changes were compared over the 15-year period. The 2024 data were compared with current standard functional dimensions of school furniture. The statistical analysis incorporated t-test and Mann-Whitney U- test.
Results:
From 2010 to 2024, average height increased by 1.8 cm for boys and 1.5 cm for girls; sitting height increased by 1.5 cm for both genders; crus length increased by 0.3 cm for boys and 0.4 cm for girls; and thigh length increased by 0.5 cm for both genders. The ratios of sitting height to height, and sitting height to leg length increased by less than 0.1 . The difference between desk chair height and 1/3 sitting height ranged from 0.4-0.8 cm. Among students matched with size 0 desks and chairs, 22.0% had a desk to chair height difference less than 0, indicating that the desk to chair height difference might be insufficient for taller students. The differences between seat height and fibular height ranged from -1.4 to 1.1 cm; and the differences between seat depth and buttock popliteal length ranged from -9.8 to 3.4 cm. Among obese students, the differences between seat width and 1/2 hip circumference ranged from -20.5 to -8.7 cm, while it ranged from -12.2 to -3.8 cm among non obese students.
Conclusion
Current furniture standards basically satisfy hygienic requirements; however, in the case of exceptionally tall and obese students, ergonomic accommodations such as adaptive seating allocation or personalized adjustments are recommended to meet hygienic requirements.
8.Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
Li GONG ; Bin LIAO ; Jie SHEN ; Juan ZHAO ; Yi GONG ; Xiaoxiao LU ; Huiyao YANG ; Sha LI ; Yongsheng LI
Cancer Research on Prevention and Treatment 2025;52(5):347-354
Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.
9.Transurethral blue laser treatment of bladder stones: a report of 2 cases
Fuchao DING ; Tong LI ; Bin CHU ; Lin YANG
Journal of Modern Urology 2025;30(3):255-256
Objective: To report the clinical data of two patients with prostatic hyperplasia and bladder uric acid stones,so as to provide reference for clinical practice. Methods: Clinical data of two patients successfully undergoing blue laser lithotripsy in Department of Urology,Zhenba County People's Hospital were retrospectively analyzed,including clinical manifestations,surgical methods,treatment outcomes and complications. Results: Both patients sought medical care due to progressive dysuria or hematuria.B ultrasound and magnetic resonance imaging confirmed bladder calculi and prostatic hyperplasia.One patient also had large blood clots in the bladder cavity.Both patients received transurethral blue laser prostate vaporization + transurethral bladder stone holmium laser lithotripsy.The stone surface was dark yellow,with no obvious pores,fine particles or spike protrusion.Blue laser produced an “ablative” phenomenon similar to vaporization,and then stones became smaller and fragmented.The lithotripsy lasted for 11 min and 8 min,respectively.There were multiple bladder mucosal injuries due to constant drift of stones during operation.Stone composition analysis suggested uric acid stones.After 3 months of follow-up,both patients had smooth postoperative urination,good urine control,and no stone recurrence. Conclusion: Blue laser can be applied to crush uric acid stones,and the bladder mucosa should be protected during lithotripsy.
10.Treatment of Psoriasis from ''Fuyu'' Theory
Jiaqi LI ; Bobiao NING ; Ningxin ZHANG ; Bin YANG ; Ping SONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):39-48
Psoriasis is a chronic inflammatory skin disease with a polygenic genetic background. Its etiology remains unclear, and its pathogenesis is complex and refractory, collectively posing significant challenges in its treatment and greatly affecting the physical and mental health of patients. With the advantages of multi-target and multi-pathway treatment, traditional Chinese medicine has shown unique efficacy and value in the diagnosis and treatment of psoriasis. Modern doctors have a lot of discussion on psoriasis, and most of them tend to treat the disease by solving disorders of the blood system. They think that the disease is closely related to the "heat in the blood". Combining the clinical characteristics and accompanying symptoms of psoriasis, this article traced the causes of "heat in the blood" in psoriasis and believed that multiple internal and external factors have prevented the smooth circulation of Qi. Yang Qi Fuyu (stagnation) and transformation into heat and toxicity is the source of "heat in the blood" in psoriasis. Furthermore, it was proposed that "Fuyu" is the core pathogenesis of psoriasis. The etiology of "Fuyu" is complex, such as external wind and cold pathogens, emotional injuries, internal accumulation of dampness, and deficiency of healthy Qi, all of which can disrupt the ascending and descending movement of Qi, impede the circulation of Qi and fluids, close the pores and skin texture, and subsequently lead to stagnation. Based on the above understanding, "resolving stagnation" is crucial for treating the disease. Many doctors have explored the treatment ideas of psoriasis from the perspectives of dispelling wind, warming cold, regulating Qi, eliminating dampness, tonifying deficiency, and external treatment, aiming to remove the causes, promote the circulation of Qi and fluids, and resolve stagnation and heat. Clinical studies have shown that the therapies can relieve clinical symptoms, reduce recurrence rate, and improve quality of life, which also have good safety in the treatment of psoriasis. This article discussed the treatment of psoriasis from the perspective of "Fuyu", enriching the understanding of TCM regarding the etiology and pathogenesis of psoriasis. It is aiming to serve as an effective supplement to the "treating by solving disorders of the blood system" approach and provide a reference for clinical diagnosis and treatment of psoriasis.


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