1.Predictive model for severe adverse reaction associated with bevacizumab based on the global trigger tool and machine learning
Yongfei FU ; Xin LONG ; Hongzhen XU ; Jian TANG ; Xiangqing LI ; Yucheng LONG ; Dong QIN
China Pharmacy 2026;37(4):497-503
OBJECTIVE To confirm trigger items for adverse drug reaction (ADR) induced by bevacizumab, to identify and analyze the occurrence of related ADR, and to establish a predictive model for severe adverse reaction (SAR) caused by this drug. METHODS Based on the global trigger tool (GTT) theory, and referencing the GTT White Paper, drug package inserts and relevant literature, trigger items for bevacizumab-related ADR were confirmed using a single-round Delphi method. Utilizing these established items, electronic medical records of relevant patients at Guilin People’s Hospital from January 2020 to September 2024 were actively screened via the China Hospital Pharmacovigilance System. Pharmacists then identified and tallied the occurrence of bevacizumab-induced ADR. Data from patients with any positive trigger item served as the study subjects (divided into training and test sets at a ratio of 7∶3), candidate feature variables were selected from 39 related variables using the Boruta algorithm, and the multivariable Logistic regression analysis was performed with the occurrence of SAR as the dependent variable. Based on these candidate features, Logistic Regression, Extreme Gradient Boosting, Light Gradient Boosting Machine, Random Forest, and Categorical Boosting models were constructed. Model performance was evaluated using metrics including the area under the curve (AUC) of receiver operating characteristic curve and recall rate. The Shapley Additive exPlanations (SHAP) method was applied to analyze and interpret the contribution of each variable. A nomogram was constructed based on the optimal model. RESULTS A total of 38 trigger items for active monitoring of bevacizumab-related ADR were determined, comprising 17 laboratory indicators, 13 clinical manifestations, and 8 intervention measures. In total, 483 patients with positive trigger items were included, and 318 patients with bevacizumab-induced ADR were identified, including 83 SARs. The positive predictive values for the trigger items and cases were 43.57% (708/1 625) and 63.84% (318/483), respectively. Bevacizumab-induced ADR involved 7 systems/organs, with the hematological system being the most frequently involved (64.15%). The Boruta algorithm selected 7 vari ables: serum potassium, hematocrit, albumin-to-globulin ratio, prealbumin, hypertension history, age and red blood cell count. Multivariable Logistic regression showed that elevated serum potassium levels were associated with a decreased risk of bevacizumab-induced SAR (OR=0.234, P =0.002), while a history of hypertension (OR=2.642, P =0.006) and increased age (OR=1.040, P =0.025) were associated with an increased risk. The Logistic Regression model demonstrated superior performance with higher AUC, F1 score and recall rate (0.761, 0.447, 0.607), compared to other models. SHAP evaluation results indicated that variables such as serum potassium, hematocrit, and age ranked highest in importance. CONCLUSIONS Totally 38 trigger entries have been successfully identified for active screening of bevacizumab-related ADR. Elevated serum potassium levels are a protective factor against bevacizumab-induced SAR, whereas the hypertension history and increased age are risk factors. The Logistic Regression model is the optimal predictive model.
2.Exploration on the Diagnosis and Treatment of Esophageal Carcinoma from the Perspective of "Failure of Spleen and Kidney Warming,Internal Accumulation of Phlegm-Toxin" Based on Lipid Metabolism Disorder-Mediated Tumor Microenvironmental Imbalance
Shangfeng YUE ; Jiafan CHEN-YUAN ; Xuyang LIU ; Yaxing LI ; Hongzhen YIN ; Shaobo HU ; Ying SU ; Jie LI
Journal of Traditional Chinese Medicine 2026;67(15):1613-1617
Based on the modern understanding that lipid metabolism disorders mediate tumor microenvironmental imbalance in esophageal carcinoma, this paper proposes that failure of spleen and kidney warming and internal accumulation of phlegm-toxin constitute the core pathogenesis of esophageal carcinoma. Deficiency of spleen and kidney yang qi serves as the root cause, while impaired transformation and transportation of lipids and the accumulation of phlegm-toxin represent the superficial manifestations. Phlegm originates from the transformation of lipids, while toxin arises from and attaches to phlegm. Their interaction forms a sticky and persistent pathological state that runs throughout the entire disease process. The evolution of pathogenesis follows a dynamic and progressive pattern. In the early stage, failure of spleen and kidney warming and dysfunction of lipid metabolism mediate abnormalities in a lipid-enriched microenvironment; in the middle stage, lipid turbidity condenses into phlegm, and phlegm-toxin stasis promotes the formation of an inflammatory and hypercoagulable microenvironment; in the late stage, dysfunction of the sanjiao (三焦) warming function and impaired qi transformation lead to an imbalance in the hypoxic and metabolically dysfunctional microenvironment. Accordingly, a staged therapeutic approach is proposed, including warming the kidney and strengthening the spleen, transforming phlegm and resolving toxin, and warming and unblocking the sanjiao. By regulating lipid metabolism to restore tumor microenvironmental homeostasis, this approach provides a new theore-tical perspective and practical strategy for the intervention of esophageal cancer progression through traditional Chinese medicine.
3.Exploration on the Diagnosis and Treatment of Esophageal Carcinoma from the Perspective of "Failure of Spleen and Kidney Warming,Internal Accumulation of Phlegm-Toxin" Based on Lipid Metabolism Disorder-Mediated Tumor Microenvironmental Imbalance
Shangfeng YUE ; Jiafan CHEN-YUAN ; Xuyang LIU ; Yaxing LI ; Hongzhen YIN ; Shaobo HU ; Ying SU ; Jie LI
Journal of Traditional Chinese Medicine 2026;67(15):1613-1617
Based on the modern understanding that lipid metabolism disorders mediate tumor microenvironmental imbalance in esophageal carcinoma, this paper proposes that failure of spleen and kidney warming and internal accumulation of phlegm-toxin constitute the core pathogenesis of esophageal carcinoma. Deficiency of spleen and kidney yang qi serves as the root cause, while impaired transformation and transportation of lipids and the accumulation of phlegm-toxin represent the superficial manifestations. Phlegm originates from the transformation of lipids, while toxin arises from and attaches to phlegm. Their interaction forms a sticky and persistent pathological state that runs throughout the entire disease process. The evolution of pathogenesis follows a dynamic and progressive pattern. In the early stage, failure of spleen and kidney warming and dysfunction of lipid metabolism mediate abnormalities in a lipid-enriched microenvironment; in the middle stage, lipid turbidity condenses into phlegm, and phlegm-toxin stasis promotes the formation of an inflammatory and hypercoagulable microenvironment; in the late stage, dysfunction of the sanjiao (三焦) warming function and impaired qi transformation lead to an imbalance in the hypoxic and metabolically dysfunctional microenvironment. Accordingly, a staged therapeutic approach is proposed, including warming the kidney and strengthening the spleen, transforming phlegm and resolving toxin, and warming and unblocking the sanjiao. By regulating lipid metabolism to restore tumor microenvironmental homeostasis, this approach provides a new theore-tical perspective and practical strategy for the intervention of esophageal cancer progression through traditional Chinese medicine.
4.Exploration on the mechanism of lung cancer treatment from the perspective of phlegm pathogen theory based on inflammatory-metabolic-immune microenvironment
Yuanjiafan CHEN ; Yaxing LI ; Shaobo HU ; Hongzhen YIN ; Chongyang QU ; Shuzhen DUAN ; Yinghua LI ; Jie LI
International Journal of Traditional Chinese Medicine 2025;47(10):1341-1346
The tumor microenvironment (TME) is the cellular milieu in which tumor cells thrive, comprising interacting cells and associated factors that form a complex network of interactions, directly or indirectly influencing the initiation, progression, and metastasis of lung cancer. Through TCM pattern identification, it has been observed thatphlegm-pathogen is closely associated with disorder in the inflammatory-metabolic-immune microenvironments of lung cancer. This involves three key pathological mechanisms: "phlegm-stasis complicated by toxin, qi deficiency with exuberant phlegm, and phlegm-pathogen impairing healthy qi". Molecular mechanism studies have revealed that phlegm-resolving agents can extensively modulate multiple targets or pathways, thereby remodeling the inflammatory-metabolic-immune microenvironments of lung cancer. Consequently, a comprehensive therapeutic strategy integrating "resolving phlegm, dispelling stasis, and detoxifying; supplementing qi, warming yang, and resolving phlegm; and reinforcing healthy qi, tonifying the lung, and eliminating phlegm" is essential to reshape the lung cancer TME and enhance antitumor efficacy.
5.Development and application of a healthcare quality evaluation system for national regional medical centers based on the structure-process-outcome Theory
Lizhong LIANG ; Hongzhen ZHOU ; Yan LI ; Tong LI ; Yingzhe LIU ; Hong LI ; Jie ZHENG ; Chao YANG
Modern Hospital 2025;25(11):1651-1655
Objective To develop a scientific,systematic,and operable healthcare quality evaluation system for Nation-al Regional Medical Centers(NRMCs),providing a theoretical basis and practical tool for objectively assessing their construction outcomes and guiding high-quality development.Methods Based on the classic"Structure-Process-Outcome"(SPO)quality management model,and aligned with national policy directives and the functional positioning of regional medical centers,a pre-liminary set of evaluation indicators was screened and an indicator system was constructed through literature review,policy analy-sis,and field investigations.Guangxi Hospital Division of The First Affiliated Hospital,Sun Yat-sen University was selected as the study subject,and cross-sectional data from March 2023 to June 2025 were collected for empirical application.Results A healthcare quality evaluation system for NRMCs was established,comprising 3 first-level dimensions(Structure Quality,Process Quality,Outcome Quality),10 second-level indicators,and 66 third-level indicators.This system covers multiple aspects,inclu-ding resource allocation,healthcare service efficiency,clinical practices,patient outcomes,and social benefits.Empirical results indicated that the center demonstrated a consistent upward trend in key indicators such as"Proportion of Discharged Patients Un-dergoing Level-4 Surgeries"(O1.2)and"DRG-CMI Value"(O2.1),while"Average Length of Hospital Stay"(P3.1)and"Cost Consumption Index"(O2.3)showed a steady decline.The indicator system effectively revealed the center's progress in en-hancing regional influence and operational efficiency.Conclusion The developed healthcare quality evaluation system is well-grounded in theory and practice,combining scientific rigor with policy relevance,and can serve as a decision-support tool for quality assessment and improvement in National Regional Medical Centers.
6.Impact of Postoperative Reduction Quality on Biomechanics of the Femoral Head Following Internal Fixation of Femoral Neck Fractures
Shixiong ZHANG ; Jianxiong MA ; Bin LU ; Ying WANG ; Aixian TIAN ; Lei SUN ; Zhe HAN ; Jiahui CHEN ; Jing DAI ; Haohao BAI ; Hongzhen JIN ; Jie ZHAO ; Pengfei LI ; Xinlong MA
Journal of Medical Biomechanics 2025;40(5):1144-1149
Objective To investigate the effect of postoperative reduction quality in femoral neck fracture internal fixation on mechanical properties of the femoral head from the perspective of trabecular bone biomechanics.Methods From patients who underwent hip replacement surgery for femoral neck fractures,a total of 26 femoral head slice specimens were obtained.The central axis of the primary compressive trabeculae was defined as the 0° group,with the intersection point of the primary compressive trabeculae and the femoral calcar serving as the center.By rotating the specimens to simulate different reduction angles,the cut femoral head slice specimens were randomly divided into five groups:-10°,-5°,0°,5°,and 10°,representing femoral heads with varying reduction qualities.The specimens were subjected to single compression load tests and fatigue load tests.The load was set from 70 N to 1 400 N,at a frequency of 1 Hz,with 10 000 cycles.Axial stiffness,displacement,and the number of collapse cycles were measured,to compare the biomechanical properties of femoral head specimens under different reduction qualities.Results There were differences in the axial stiffness,displacement,and number of collapse cycles among the femoral head specimens in different groups.Under 800 N load,the axial stiffness of 0° group was significantly greater than that of±10° groups(P<0.05).The axial stiffness of 0° group was also greater than that of the±5° groups,but the differences were not statistically significant(P>0.05).The axial stiffness of±5° groups was greater than that of±10° groups(P<0.05).0° group had a lower displacement than±5° groups and±10° groups.However,the differences in displacement between 0° group and±5° groups were not statistically significant(P>0.05),while the differences between the 0° group and±10° groups were statistically significant(P<0.05).The differences in displacement between±5° groups and±10° groups were also statistically significant(P<0.05).0° group had a significantly higher number of collapse cycles than±10° groups(P<0.05).The number of collapse cycles in 0° group was also higher than that in±5° groups,but the differences were not statistically significant(P>0.05).The number of collapse cycles in±5° groups was significantly higher than that±10° groups(P<0.05).Conclusions The quality of reduction after internal fixation of femoral neck fractures significantly affects the biomechanical properties of the femoral head.This study provides a scientific basis for optimizing treatment and postoperative management,aiming to improve clinical outcomes and patients' quality of life.
7.Surveillance of bacterial resistance in Liuzhou Workers'Hospital,Guangxi from 2020 to 2022
Mengwei LI ; Liuhua WEI ; Guolan LUO ; Hongzhen ZHU ; Shengzhang LIN ; Likun CHEN ; Lijun JIANG ; Haixia WANG
Chinese Journal of Infection and Chemotherapy 2025;25(2):195-202
Objective To understand the changing profiles of antimicrobial susceptibility of the bacterial strains isolated from patients at Liuzhou Workers'Hospital in Guangxi from 2020 to 2022.Methods The bacteria were isolated,identified,and underwent antimicrobial susceptibility testing using VITEK 2 Compact,disk diffusion method,or E-test.The results were interpreted according to the breakpoints recommended by CLSI M100 32nd Edition in 2022.The data were analyzed using WHONET 5.6 software.Results A total of 26 254 nonduplicate strains were collected from 2020 to 2022,including Gram-positive bacteria(27.9%)and gram-negative bacteria(72.1%).The prevalence of methicillin-resistant strains was 20.0%in SS.aureus(MRSA),and 72.2%in coagulase-negative Staphylococcus(MRCNS).Methicillin-resistant staphylococcal strains were more resistant to most antimicrobial agents than methicillin-susceptible strains(MSSA and MSCNS).None of the staphylococcal strains was resistant to vancomycin,linezolid or tigecycline.Enterococcus faecium strains showed higher resistance rates to most antimicrobial agents than Enterococcus faecalis.None of enterococcal strains was resistant to vancomycin.A few enterococcal strains were resistant to linezolid.Overall,691 strains of the non-meningitis Streptococcus pneumoniae were isolated from children and 123 strains were isolated from adults.The prevalence of penicillin-resistant SS.pneumoniae(PRSP)was 0.4%in the strains from children and 1.6%in the strains from adults.None of S.pneumoniae strains was intermediate to penicillin.The prevalence of carbapenem-resistant Klebsiella pneumoniae(CRKpn)was 1.2%,1.2%,and 13.8%in 2020,2021,and 2022,respectively.The prevalence of carbapenem-resistant P.aeruginosa(CRPae)and carbapenem-resistant Acinetobacter baumannii(CRAba)was 10.7%and 68.4%in 2020,17.5%and 75.2%in 2021,14.3%and 77.3%in 2022,respectively.About 84.6%of the 1 269 strains of Haemophilus influenzae were isolated from children and 15.4%isolated from adults.The prevalence of beta-lactamase-producing strains was 39.4%in the isolates from children and 46.8%in the isolates from adults.The β-lactamase-producing H.influenzae was resistant to ampicillin.Furthermore,some β-lactamase-nonproducing ampicillin-resistant(BLNAR)H.influenzae strains(27.0%)were also identified.Conclusions Antimicrobial resistance is still serious in this hospital,especially high prevalence of carbapenem-resistant organisms(CRO).Hospital infection prevention and control measures,antibiotic stewardship,and proactive CRO screening should be strengthened.More clinical specimens should be collected for suspected infections.Antimicrobial treatment should be prescribed empirically in time and adjusted when the results of antimicrobial susceptibility testing are available.
8.Optimization of clinical target volume delineation for prostate cancer radiotherapy based on prostate bed occurrence patterns in prostate-specific membrane antigen positron emission tomography
Huan ZHANG ; Xin QI ; Xuhe LIAO ; Cheng CHEN ; Jingyun WU ; Jianhua ZHANG ; Yan FAN ; Xianshu GAO ; Hongzhen LI
Chinese Journal of Radiological Medicine and Protection 2025;45(10):966-972
Objective:To explore the optimization potential of clinical target volume (CTV) delineation proposed in the guidelines of the Oncology Group (RTOG), the Francophone Group of Urological Radiotherapy (GFRU), and the European Society for Radiotherapy and Oncology (ESTRO) based on prostate bed local occurrence patterns after radical prostatectomy identified using prostate-specific membrane antigen positron emission tomography (PSMA PET).Methods:A retrospective analysis was conducted on patients with local prostate bed recurrence after radical prostatectomy who underwent PSMA PET at the Department of Nuclear Medicine, Peking University First Hospital from September 2021 to February 2024. The central point of each recurrence was marked. A six-zone method was established based on prostate bed anatomy and the characteristics of cross-sectional imaging. Then, the positional relationships (within or outside) were recorded with respect to recurrences and CTV defined by the RTOG, GFRU, and ESTRO (CTV RTOG, CTV GFRU, and CTV ESTRO), followed the analysis of the recurrence rates and distribution characteristics of various zones. Results:A total of 63 patients with prostate bed recurrence after radical prostatectomy were enrolled in this study, including 97 recurrences. The recurrence rates in the six zones were as follows: 10% of zone 1, 22% of zone 2, 29% of zone 3, 2% of zone 4, 12% of zone 5a, 18% of zone 5b, and 7% of zone 6. Among these zones, zones 2 and 3 showed the highest and second-highest recurrence rates, respectively. CTV GFRU and CTV ESTRO completely covered zones 2 and 3, while CTV RTOG covered zone 2 completely and zone 3 partially. Zone 4, characterized by a low recurrence rate, was not covered by CTV GFRU and CTV ESTRO but was entirely covered by CTV RTOG. Zone 5a, with a recurrence rate of 12%, was completely covered by CTV RTOG but was partially covered by CTV GFRU and CTV ESTRO. The range of 1.3 cm in front of the posterior wall of the bladder covered all recurrences in zone 5a. Conclusions:For CTV delineation of the prostate cancer surgical bed, zone 4, the anterior half of the bladder above the pubic symphysis midpoint, should be contracted due to the low recurrence rate in this zone. In contrast, the anterior boundary above the pubic symphysis midpoint should extend to 1.3 cm in front of the posterior wall of the bladder to completely cover the recurrence zones.
9.Radiotherapy for undifferentiated spindle cell sarcoma of the prostate: a case report
Yuyang ZHAO ; Hongzhen LI ; Wei YU ; Huan ZHANG ; Shuai HU ; Xuhe LIAO ; Xin QI
Chinese Journal of Urology 2025;46(10):788-790
Undifferentiated spindle cell sarcoma of the prostate is clinically rare. This article reports a case of a 29-year-old male who presented on February 7,2022,with a two-week history of localized pain in the perineal area and spermatic cord. The diagnosis of prostatic undifferentiated spindle cell sarcoma was confirmed by imaging studies and prostate needle biopsy pathology. After consultation by the urologic oncology multidisciplinary team and considering the patient's preference,a treatment plan of radical radiotherapy combined with chemotherapy,immunotherapy,and targeted therapy was adopted,Partial stereotactic body radiotherapy(P-SBRT)was delivered to the tumor center with a total dose of 74.4 Gy,combined with cisplatin and pembrolizumab. Lung metastasis progression occurred 1.5 months after radiotherapy,and treatment was switched to a combination of pirarubicin,ifosfamide,pembrolizumab,and bevacizumab. After 39 months of follow-up,the disease remained well-controlled with preserved organ function and long-term survival. This case,utilizing a multidisciplinary comprehensive diagnosis and treatment model,provides a reference for organ-preserving non-surgical management in patients with prostate soft tissue sarcoma.
10.Advances in prostate-rectum spacer application for prostate cancer radiotherapy: a comprehensive review
Qinghua PENG ; Xin QI ; Hongzhen LI
Chinese Journal of Urology 2025;46(10):796-800
Globally,prostate cancer is the second most common malignant tumor in men. Radiotherapy is a radical treatment modality for prostate cancer,with efficacy comparable to radical prostatectomy. During radiotherapy delivery,as tumors in the peripheral zone of the prostate which are adjacent to the anterior rectal wall,delivering curative doses to the prostate inevitably results in irradiation of the anterior rectal wall. This carries a certain probability of causing related complications and adversely affecting patients' quality of life. The prostate-rectum spacer(or isolation device)is perineally implanted between the prostate and rectum to create a physical separation,increasing the distance between them. This reduces rectal radiation dose during radiotherapy and consequently lowers the incidence of rectal adverse reactions. Currently,commonly used prostate-rectum spacers include polyethylene glycol hydrogels,hyaluronic acid hydrogels,and balloon spacers. Substantial clinical evidence has confirmed the safety and efficacy of prostate-rectum spacers,strongly supporting their use in prostate cancer radiotherapy. However,existing technologies still face several challenges,including inadequate separation force provided by the spacer material,procedural complexity during implantation,compression-induced injuries to adjacent tissues,and suboptimal visualization under current imaging modalities. Future efforts must establish quality standards,optimize image-guided implantation,develop novel materials,evaluate long-term biocompatibility to enhance clinical deployment,and mitigate rectal complication risks.

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