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.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.
3.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.
4.Characteristics and lifestyles of patients with metabolic dysfunction-associated fatty liver disease based on the physical examination population
Haiqing GUO ; Mingliang LI ; Feng LIU ; Yali LIU ; Jing ZHANG
Journal of Clinical Hepatology 2025;41(6):1090-1096
ObjectiveTo screen for the patients with metabolic dysfunction-associated fatty liver disease (MAFLD) among the physical examination population, to observe the characteristics of MAFLD patients, and to compare the differences in lifestyle between the MAFLD population and the non-MAFLD population. MethodsA cross-sectional study was conducted among 6 206 individuals who underwent physical examination in a physical examination institution in Beijing from December 2015 to December 2019, and according to the new diagnostic criteria for MAFLD, the examination population was divided into MAFLD group and non-MAFLD group. Based on body mass index (BMI), the MAFLD group was further divided into lean MAFLD group (BMI<24 kg/m2) and non-lean MAFLD group (BMI ≥24 kg/m2). Related data were compared between groups, including demographic indicators, education level, work pressure, physical measurement indicators, and lifestyles such as sleep, diet, and exercise. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the chi-square test was used for comparison of categorical data between groups. ResultsOf all individuals in this study, 1 926 (31.1%) had MAFLD and 4 280 (68.9%) did not have MAFLD. Compared with the non-MAFLD group, the MAFLD group had significantly higher age (Z=-14.459, P<0.001), proportion of male patients (χ2=72.004, P<0.001), work pressure (χ2=7.744, P=0.005), body weight (Z=-43.508, P<0.001), BMI (Z=-47.621, P<0.001), waist circumference (Z=-48.515, P<0.001), hip circumference (Z=-42.121, P<0.001), and waist-hip ratio (Z=-43.535, P<0.001), as well as a significantly lower education level (χ2=33.583, P<0.001). In terms of behavior, the MAFLD group had a significantly shorter sleep time (χ2=5.820, P=0.016) and a significantly faster eating speed (χ2=74.476, P<0.001). In terms of diet, the patients in the MAFLD group consumed more high-sodium, high-sugar, and high-calorie diets (χ2=42.667, P<0.001) and low-fiber diet (χ2=4.367, P=0.008). In terms of exercise, the MAFLD group had a significantly higher proportion of patients without exercise habits (χ2=10.278, P=0.001). Further analysis showed that there were 202 individuals (10.5%) in the lean MAFLD group and 1 724 (89.5%) in the non-lean MAFLD group. Compared with the non-lean MAFLD group, the lean MAFLD group had significantly higher age (Z=3.368, P=0.001) and education level (χ2=9.647, P=0.002) and significantly lower proportion of male patients (χ2=27.664, P<0.001), body weight (Z=-18.483, P<0.001), BMI (Z=-23.286, P<0.001), waist circumference (Z=-18.565, P<0.001), and hip circumference (Z=-18.097, P<0.001), and in terms of behavior, the non-lean MAFLD group had a significantly faster eating speed (χ2=4.549, P=0.033). ConclusionThere is a relatively high prevalence rate of MAFLD among the physical examination population in Beijing, with a higher number of people with unhealthy lifestyles compared with the non-MAFLD population.
5.Expert consensus on clinical protocol for treating herpes zoster with fire needling.
Xiaodong WU ; Bin LI ; Baoyan LIU ; Lin HE ; Zhishun LIU ; Shixi HUANG ; Keyi HUI ; Hongxia LIU ; Yuxia CAO ; Shuxin WANG ; Zhe XU ; Cang ZHANG ; Jingsheng ZHAO ; Yali LIU ; Nanqi ZHAO ; Nan DING ; Jing HU
Chinese Acupuncture & Moxibustion 2025;45(12):1825-1832
The expert consensus on the clinical treatment of herpes zoster with fire needling was developed, and the commonly used fire needling treatment scheme verified by clinical research was selected to form a standardized diagnosis and treatment scheme for acute herpes zoster and postherpetic neuralgia (PHN), so as to answer the core problems in clinical application. The consensus focuses on patients with herpes zoster, and forms recommendations for 9 key clinical issues, covering simple fire needling and TCM comprehensive therapy based on fire needling, including fire needling combined with cupping, fire needling combined with Chinese herb, fire needling combined with cupping and Chinese herb, fire needling combined with filiform needling, fire needling combined with moxibustion, and provides specific recommendations and operational guidelines for various therapies.
Humans
;
Herpes Zoster/therapy*
;
Acupuncture Therapy/instrumentation*
;
Consensus
;
Clinical Protocols
6.Data Analysis of Characteristics of Congenital Endowment in Senile Dementia Patients Based on CHARLS
Lei LIU ; Yali WANG ; Huirong HUANG ; Ming DING ; Qing LIU ; Jing LI ; Saiyu ZHENG ; Lihui HE
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(5):1077-1083
Objective To investigate the characteristics and differences of congenital endowment in senile dementia population based on the theory of five circuits and six qi.Methods Based on the cross-sectional data of China Health and Retirement Longitudinal Survey(CHARLS)in 2018,the dementia status of the population aged 60 and above in China was evaluated by using the Mini-Mental State Examination(MMSE),and the five-circuit and six-qi features at birth in the senile dementia population were analyzed by descriptive statistics and Chi-square goodness-of-fit test.Results A total of 854 patients with senile dementia were included.The five-circuit and six-qi features at birth in the senile dementia population were as follows:most of them were born at the heavenly stem of Bing while the least at the heavenly stem of Ji and Geng(P<0.001),most of them were born at the earthly branch of Wei while the least at the earthly branch of Zi(P<0.001),most of them were born at the yearly circuit of excessive water circuit while the least at the yearly circuit of excessive gold circuit and deficient earth circuit(P<0.001),and most of the patients were born at sitan of taiyin damp-earth and zaiquan of taiyang cold-water while the least at sitan of jueyin wind-wood and zaiquan of shaoyang ministerial fire;no statistically significant differences were found in the dominant qi and guest qi(P>0.05);most of the patients were born in the year of combination of circuit and qi being Shunhua while the least in the year of combination of circuit and qi being same celestial correspondence(P<0.001),and the patients born in the year of Shunhua usually were frequently distributed in heavenly-stem and earthly-branch year of Jiawu(P<0.001).Conclusion There is a certain relationship between the congenital endowment at birth and the incidence of senile dementia in the population of senile dementia.The circuit-qi features at birth for the prevalence of senile dementia are the yearly circuit of excessive water circuit,sitan of taiyin damp-earth and zaiquan of taiyang cold-water,and the year of the combination of circuit and qi being Shunhua.The population born at the time with the above circuit-qi features are prone to suffer the injury of the kidneys,the heart,and the spleen,and then result into illness.
7.Biological and genetic characteristics of three hypervirulent Klebsiella pneumoniae strains causing liver abscess
Yuqi ZHANG ; Juan WANG ; Lei HAN ; Pu LI ; Wentao MA ; Chun ZHANG ; Yali LI ; Jing YUAN ; Jin’e LEI
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(6):885-894
[Objective] To understand the resistance mechanisms, virulence characteristics, and pathogenicity of hypervirulent Klebsiella pneumoniae (hvKp), which causes pyogenic liver abscess (PLA), and to provide related data for clinical treatment of infection caused by this type of bacteria. [Methods] We collected three strains of Klebsiella pneumoniae isolated from the liver abscess fluid of patients with liver abscesses in various departments of The First Affiliated Hospital of Xi’an Jiaotong University. The hypervirulent phenotypes were determined by the wire test, and drug sensitivity was assessed using the VITEK 2 compact automatic microbiological analyzer. Molecular characteristics such as podocarp serotypes, multi-locus sequence typing (MLST), virulence genes, and drug resistance genes were identified through whole-genome sequencing. Additionally, a mouse infection model was established to evaluate pathogenicity. [Results] The isolates were sticky, with mucous thread pulling length >5 mm, all of which exhibited high viscosity phenotypes. Except 146007, which is a multidrug-resistant bacterium, the other two strains had higher antibiotic sensitivity. Whole genome sequencing revealed that the isolates were of high-virulence type, carrying the toxin plasmid rmpADC/rmpA2, iron uptake system, bacterial hairs, secretion system, and other virulence factors. All the three isolates tested positive for rmpA/rmpA2 combined with iucA/iutA, indicating they could be classified as hvKp. Multiple resistance genes were detected, such as β-lactamase like bla
8.Research Progress in Blood Pressure Management after Aortic Dissection
Zhiyong LI ; Jing WANG ; Yali ZHOU ; Dong YUAN
Medical Journal of Peking Union Medical College Hospital 2024;15(4):904-910
Hypertension (HT) can induce aortic dissection (AD) by increasing the tension of the aortic wall and promoting tissue degradation, and continuous HT may increase the risk of aortic-related death. It is a significant factor in poor prognosis for AD and the most important controllable factor. Research has shown that blood pressure management after AD can reduce the incidence rate and mortality of AD, so controlling HT is an important goal and means of AD treatment. This article reviews the research progress on the impact of AD on blood pressure, the significance and methods of blood pressure management after AD, with the hope of providing reference for the treatment of AD patients and benefiting them.
9.Risk factors and predictive models for liver cancer after sustained virologic response in hepatitis C
Shanshan XU ; Lixia QIU ; Yali LIU ; Jing ZHANG
Journal of Clinical Hepatology 2024;40(6):1259-1263
Hepatitis C is one of the main causes of liver cancer.With the application of direct-acting antiviral agents,more than 95%of patients can achieve the eradication of hepatitis C virus and obtain sustained virologic response(SVR).Effective antiviral therapy can change the natural course of hepatitis C and reduce the risk of liver cancer;however,some patients are still affected by age,sex,liver fibrosis,diabetes,hepatic steatosis,alcohol consumption,and genetic factors and become the high-risk population of liver cancer.Therefore,it is needed to further clarify and improve the identification and prediction of high-risk populations of liver cancer after SVR of hepatitis C.This article reviews the risk factors and predictive models for liver cancer after SVR in patients with hepatitis C,in order to provide a basis for identifying the high-risk population of liver cancer after SVR of hepatitis C in clinical practice.
10.Experience in eliminating the mother-to-child transmission of hepatitis B virus in China
Yali LUO ; Wei WANG ; Yuchen PAN ; Jing JIANG ; Hanlong ZHENG ; Xueli WU ; Hui CHEN ; Shiben ZHU ; Jinlin HOU
Journal of Clinical Hepatology 2024;40(11):2145-2151
Reducing the mother-to-child transmission of hepatitis B virus(HBV)is crucial for achieving HBV elimination.Launched in July 2015 at the Great Hall of the People in Beijing,China,the"Zero Hepatitis B Mother-to-Child Transmission Project"(Shield Project)is a public welfare initiative integrating scientific prevention and applied research and aims to perform standardized management of pregnant women with hepatitis B using the mobile application of"Shield Project",in order to further reduce or eliminate the mother-to-child transmission of HBV.At present,the Shield Project has expanded nationwide,offering detailed implementation strategies,successful practices,and reliable data to support the global effort to eliminate the mother-to-child transmission of HBV.This article introduces the implementation strategies and outcomes of the Shield Project in four representative cases,in order to provide strong evidence for further understanding and preventing the mother-to-child transmission of HBV.

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