1.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
2.Research advances in the mechanism of clemastine regulating oligodendrocytes and remyelination
Xiaojuan ZHANG ; Yao CHEN ; Chao ZHANG ; Binbin TANG ; Xianjun CHEN
Journal of Chongqing Medical University 2025;50(10):1323-1328
Oligodendrocytes(OLs)play a crucial role in the central nervous system,and the myelin sheath formed by them is essential for maintaining the normal function of the nervous system.Damage to the myelin sheath can trigger various nervous system diseases,which seriously affect the quality of life of patients.Clemastine,a traditional antihistamine,has shown certain potential in"repurposing old drugs"in recent years and can promote the repair of myelin sheath.This article summarizes the role of clemastine in regulating the differentiation,maturation,senescence,and apoptosis of OLs at multiple levels by acting on receptors on the OL membrane and regulat-ing the key signaling pathways in cells and epigenetic modifications in the nucleus.A deeper understanding of the mechanism of action of clemastine in OLs can help to provide new targets and new approaches for drug treatment of myelin-degenerative diseases.
3.Relationship between screening myopia and physical fitness index in college freshmen without majoring in public safety administration
Chinese Journal of School Health 2025;46(3):431-434
Objective:
To explore the relationship between visual acuity and physical fitness of university freshmen, so as to provide reference for myopia prevention and control for freshmen.
Methods:
From October to November 2022, 2 160 college freshman without majoring in public safety administration, selected from Guangxi Police College in 2022 by using the stratified cluster random sampling method, were reviewed for the results of visual acuity test and physical fitness scores. The physical fitness indices were evaluated by using the Z scores of physical fitness test scores, and the strength of association between the level of physical fitness index and myopia was analyzed by using Logistic regression model.
Results:
Among 2 160 college freshman without majoring in public safety administration, 917 (42.5%) students were diagnosed screening myopia, including 66 (3.1%) cases of high myopia, 383 (17.7%) cases of moderate myopia and 468 (21.7%) cases of mild myopia. The differences in the distribution of visual acuity tests among students with different physical fitness indices, body mass index, and gender were statistically significant ( Z/H=54.50, 49.53, 15.51, P <0.01). Low level and low middle level physical fitness indices were associated with screening myopia among freshmen[ OR (95% CI )=2.81(1.93-4.08),1.87(1.38-2.54)], and low level physical fitness indexes were associated with high myopia [ OR (95% CI )=7.22(2.33-22.32)] ( P <0.01).
Conclusions
Screening myopia among college freshman without majoring in public safety administration is related to physical fitness, and low level and low middle level physical fitness index are risk factors for myopia. Improving the level of physical fitness might be effective in preventing myopia.
4.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
5.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
6.Incidence rates and high-risk factors of different typies of patient-ventilator asynchrony under assisted mechanical ventilation
Qimin CHEN ; Jiaoyangzi LIU ; Jia YUAN ; Dehua HE ; Ming LIU ; Caixue PAN ; Ying LIU ; Yan TANG ; Xu LIU ; Xianjun CHEN ; Chuan XIAO ; Shuwen LI ; Wei LI ; Daixiu GAO ; Feng SHEN
The Journal of Practical Medicine 2025;41(10):1509-1516
Objective To investigate the incidence and types of patient-ventilator asynchrony(PVA)in mechanically ventilated patients within the intensive care unit(ICU),and to identify associated high-risk factors,thereby providing a basis for reducing PVA,enhancing mechanical ventilation efficiency,and refining ventilation strategies.Methods A prospective observational study was conducted among patients admitted to the general ICU of the Affiliated Hospital of Guizhou Medical University from October to December 2024 who were receiving mechanical ventilation.Inclusion criteria were as follows:age ≥18 years and mechanical ventilation duration ≥12 hours.Exclusion criteria included complete controlled mechanical ventilation,palliative care or do-not-resuscitate status,and lack of informed consent.Senior respiratory therapists performed daily bedside observations of ventilator waveforms for 10~15 minutes between 08:00 and 12:00.PVA was diagnosed based on pressure-time and flow-time waveforms,with the types of PVA being recorded.Demographic and clinical data,including age,sex,body mass index(BMI),primary diagnosis,comorbidities,APACHEⅡ score at ICU admission,blood gas analysis,ventila-tion mode and parameters,analgesia and sedation status,duration of mechanical ventilation,and length of ICU stay,were collected.The incidence and types of PVA during the observation period were analyzed.Univariate and multivariate logistic regression analyses were performed to identify high-risk factors for PVA.Clinical outcomes were compared between patients with and without PVA.Results A total of 105 patients and 453 episodes of assisted mechanical ventilation waveforms were analyzed.Among these,60.95%(64/105)experienced at least one episode of PVA.Of the 453 ventilation waveforms assessed,35.76%(162/453)demonstrated PVA.The types of PVA,ranked by incidence,were as follows:cycling mismatch(12.58%,57/453),double triggering(11.92%,54/453),ineffective triggering(9.49%,43/453),flow starvation(5.30%,24/453),and exhalation flow limitation(1.77%,8/453).The incidence of PVA varied significantly across different ventilation modes:45.7%in volume-assist/control ventilation(V-A/C),38.1%in pressure-assist/control ventilation(P-A/C),42.9%in synchronized intermittent mandatory ventilation(SIMV),and 16.7%in pressure support ventilation(PSV)(P<0.001).Multi-variate logistic regression analysis revealed that the mechanical ventilation mode[reference:PSV;V-A/C:OR=4.687,95%CI:2.140~10.263,P<0.001;P-A/C:OR=2.922,95%CI:1.489~5.734,P=0.002;SIMV:OR=4.682,95%CI:1.758~12.466,P=0.002]and actual respiratory rate(OR=1.07,95%CI:1.016~1.127,P=0.011)were significant high-risk factors for PVA.Patients with PVA had a significantly longer duration of mechanical ventilation[8.21(5.35,13.91)days vs.3.00(1.96,5.71)days,P<0.001]compared to those without PVA.Conclusions PVA is commonly observed in ICU patients receiving assisted invasive mechanical ventilation,with cycling mismatch,double triggering,and ineffective triggering being the most prevalent types.The incidence of PVA tends to be lower when using the PSV mode.Clinically,real-time monitoring of patient-ventilator synchrony via ventilator waveforms,along with the optimization of ventilator modes and parameters,should be employed to minimize the occurrence of PVA and enhance the efficiency of mechanical ventilation.
7.TLC Identification,HPLC Fingerprint and Multi-components Quantitative Analysis of Spatholobus suberectus
Li LI ; Yi LUO ; Huasheng SU ; Ying MO ; Xianjun TAN ; Xinyi CHEN
Herald of Medicine 2025;44(3):459-465
Objective To establish TLC identification method,HPLC fingerprint,chemical pattern recognition,and multi-components quantitative analysis methods of Spatholobus suberectus,and identify the quality of 16 batches of Spatholobus su-berectus from different origins.Methods The TLC method was used to identify Spatholobus suberectus qualitatively.HPLC fin-gerprint of Spatholobus suberectus was established.The quality of Spatholobus suberectus was evaluated by chemical pattern recogni-tion technologies,and the contents of Gallocatechin,protocatechuic acid,catechin,epigallocatechin and fermononetin were deter-mined by HPLC.Results TLC method of Spatholobus suberectus was established.Ten common peaks were identified in 16 bat-ches of Spatholobus suberectus,and 6 components were identified by reference substances.The similarity of fingerprint was 0.769-0.990,indicating good similarity.The samples were divided into 3 groups by cluster analysis.Results of the principal component a-nalysis showed that the top 3 samples in the list of comprehensive scores were S16、S1 1、S14.Marker compounds that cause the quality difference of Spatholobus suberectus were screened out through the orthogonal partial least squares discriminant analysis,which were fermononetin,peaks 7 and epigallocatechin.Gallocatechin,protocatechuic acid,catechin,epigallocatechin,and ferm-ononetin had a good linearity in the concentration range(r>0.999).The content determination analysis showed that there were sig-nificant differences in the contents of the 5 index components among Spatholobus suberectus from different origins.Conclusion The established TLC and HPLC fingerprints of Spatholobus suberectus were stable and reliable,and the HPLC method for multiple active components method provides scientific support for improving the quality control method of Spatholobus suberectus.
8.Incidence rates and high-risk factors of different typies of patient-ventilator asynchrony under assisted mechanical ventilation
Qimin CHEN ; Jiaoyangzi LIU ; Jia YUAN ; Dehua HE ; Ming LIU ; Caixue PAN ; Ying LIU ; Yan TANG ; Xu LIU ; Xianjun CHEN ; Chuan XIAO ; Shuwen LI ; Wei LI ; Daixiu GAO ; Feng SHEN
The Journal of Practical Medicine 2025;41(10):1509-1516
Objective To investigate the incidence and types of patient-ventilator asynchrony(PVA)in mechanically ventilated patients within the intensive care unit(ICU),and to identify associated high-risk factors,thereby providing a basis for reducing PVA,enhancing mechanical ventilation efficiency,and refining ventilation strategies.Methods A prospective observational study was conducted among patients admitted to the general ICU of the Affiliated Hospital of Guizhou Medical University from October to December 2024 who were receiving mechanical ventilation.Inclusion criteria were as follows:age ≥18 years and mechanical ventilation duration ≥12 hours.Exclusion criteria included complete controlled mechanical ventilation,palliative care or do-not-resuscitate status,and lack of informed consent.Senior respiratory therapists performed daily bedside observations of ventilator waveforms for 10~15 minutes between 08:00 and 12:00.PVA was diagnosed based on pressure-time and flow-time waveforms,with the types of PVA being recorded.Demographic and clinical data,including age,sex,body mass index(BMI),primary diagnosis,comorbidities,APACHEⅡ score at ICU admission,blood gas analysis,ventila-tion mode and parameters,analgesia and sedation status,duration of mechanical ventilation,and length of ICU stay,were collected.The incidence and types of PVA during the observation period were analyzed.Univariate and multivariate logistic regression analyses were performed to identify high-risk factors for PVA.Clinical outcomes were compared between patients with and without PVA.Results A total of 105 patients and 453 episodes of assisted mechanical ventilation waveforms were analyzed.Among these,60.95%(64/105)experienced at least one episode of PVA.Of the 453 ventilation waveforms assessed,35.76%(162/453)demonstrated PVA.The types of PVA,ranked by incidence,were as follows:cycling mismatch(12.58%,57/453),double triggering(11.92%,54/453),ineffective triggering(9.49%,43/453),flow starvation(5.30%,24/453),and exhalation flow limitation(1.77%,8/453).The incidence of PVA varied significantly across different ventilation modes:45.7%in volume-assist/control ventilation(V-A/C),38.1%in pressure-assist/control ventilation(P-A/C),42.9%in synchronized intermittent mandatory ventilation(SIMV),and 16.7%in pressure support ventilation(PSV)(P<0.001).Multi-variate logistic regression analysis revealed that the mechanical ventilation mode[reference:PSV;V-A/C:OR=4.687,95%CI:2.140~10.263,P<0.001;P-A/C:OR=2.922,95%CI:1.489~5.734,P=0.002;SIMV:OR=4.682,95%CI:1.758~12.466,P=0.002]and actual respiratory rate(OR=1.07,95%CI:1.016~1.127,P=0.011)were significant high-risk factors for PVA.Patients with PVA had a significantly longer duration of mechanical ventilation[8.21(5.35,13.91)days vs.3.00(1.96,5.71)days,P<0.001]compared to those without PVA.Conclusions PVA is commonly observed in ICU patients receiving assisted invasive mechanical ventilation,with cycling mismatch,double triggering,and ineffective triggering being the most prevalent types.The incidence of PVA tends to be lower when using the PSV mode.Clinically,real-time monitoring of patient-ventilator synchrony via ventilator waveforms,along with the optimization of ventilator modes and parameters,should be employed to minimize the occurrence of PVA and enhance the efficiency of mechanical ventilation.
9.Efficacy analysis of endoscopic endonasal and craniotomy surgery in the treatment of craniopharyngioma Based on QST Classification
Chunlin ZHANG ; Changzhen JIANG ; Jun FU ; Zhicheng WANG ; Jianyu ZHU ; Wenjian FAN ; Xianjun CHEN ; Wanhai LI ; Wenwei LUO ; Wenpei CHEN ; Jinsheng HUANG ; Xiaorong YAN
Chinese Journal of Nervous and Mental Diseases 2025;51(2):72-81
Objective This study aims to explore the efficacy and complication rates of the transcranial approach(TCA)and extended endoscopic endonasal approach(EEEA)for the treatment of craniopharyngiomas based on the QST classification,providing a scientific reference for clinical decision-making on surgical approach.Methods A total of 151 patients who underwent craniopharyngioma surgery at our center from January 2018 to December 2023 were enrolled.The patients were categorized into Q-CP(suprasellar type),S-CP(infundibular type),and T-CP(tuberal type)according to the QST classification.Systematic collection and analysis were performed on the outcomes of TCA and EEEA treatments,respectively.The differences in effectiveness between the two approaches were evaluated based on the QST classification.Results The improvement rate of visual symptoms was overall higher in the EEEA group than in the TCA group(59.1%vs.36.5%,P=0.006),and the visual deterioration rate was lower(3.0%vs.14.1%,P=0.006).However,the incidence of cerebrospinal fluid leakage was higher in the EEEA group(15.2%vs.3.5%,χ2=4.986,P=0.026).The incidence of postoperative seizures(8.2%vs.0,P=0.019),brain contusions(10.6%vs.0,P=0.005),and subdural hematoma(9.4%vs.0%,P=0.01)was higher in the TCA group.For patients with Q-CP type,the EEEA group had a higher rate of total tumor resection(92.9%vs.65.2%,P=0.025)and a lower recurrence rate(3.6%vs.21.7%,P=0.047),with shorter hospital stays and lower postoperative costs.The TCA group had higher intraoperative blood loss in this type(300 mL vs.200 mL,Z=-2.261,P=0.024).For S-CP type patients,the EEEA group showed a higher rate of total tumor resection(91.3%vs.74.2%)and a lower recurrence rate(0 vs.12.9%,P=0.031),with lower postoperative hospital costs.In T-CP type,due to the deeper location,EEEA showed limitations in protecting hypothalamic function and the TCA group had a better postoperative hypothalamic function score(P=0.035).Conclusion Based on QST classification,EEEA has advantages in Q-CP and S-CP types and is recommended as the preferred surgical procedure;In the T-CP type,TCA surgery is more helpful in protecting hypothalamic function.
10.TLC Identification,HPLC Fingerprint and Multi-components Quantitative Analysis of Spatholobus suberectus
Li LI ; Yi LUO ; Huasheng SU ; Ying MO ; Xianjun TAN ; Xinyi CHEN
Herald of Medicine 2025;44(3):459-465
Objective To establish TLC identification method,HPLC fingerprint,chemical pattern recognition,and multi-components quantitative analysis methods of Spatholobus suberectus,and identify the quality of 16 batches of Spatholobus su-berectus from different origins.Methods The TLC method was used to identify Spatholobus suberectus qualitatively.HPLC fin-gerprint of Spatholobus suberectus was established.The quality of Spatholobus suberectus was evaluated by chemical pattern recogni-tion technologies,and the contents of Gallocatechin,protocatechuic acid,catechin,epigallocatechin and fermononetin were deter-mined by HPLC.Results TLC method of Spatholobus suberectus was established.Ten common peaks were identified in 16 bat-ches of Spatholobus suberectus,and 6 components were identified by reference substances.The similarity of fingerprint was 0.769-0.990,indicating good similarity.The samples were divided into 3 groups by cluster analysis.Results of the principal component a-nalysis showed that the top 3 samples in the list of comprehensive scores were S16、S1 1、S14.Marker compounds that cause the quality difference of Spatholobus suberectus were screened out through the orthogonal partial least squares discriminant analysis,which were fermononetin,peaks 7 and epigallocatechin.Gallocatechin,protocatechuic acid,catechin,epigallocatechin,and ferm-ononetin had a good linearity in the concentration range(r>0.999).The content determination analysis showed that there were sig-nificant differences in the contents of the 5 index components among Spatholobus suberectus from different origins.Conclusion The established TLC and HPLC fingerprints of Spatholobus suberectus were stable and reliable,and the HPLC method for multiple active components method provides scientific support for improving the quality control method of Spatholobus suberectus.


Result Analysis
Print
Save
E-mail