1.Multidimensional Innovation for medical-rehabilitation integration
Bin LIAN ; Lin ZHOU ; Qinfeng WU ; Jiajia WANG ; Wei LU ; Guoen FANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(1):40-44
ObjectiveTo conduct a theoretical study on the medical-rehabilitation integration. MethodsStarting from the background, objectives and content of the medical-rehabilitation integration, this study analyzed its innovative points from the dimensions of conceptual innovation, organizational innovation, model innovation and technological innovation. Results and ConclusionThe medical-rehabilitation integration is an innovation in medical services that takes conceptual innovation as the forerunner, organizational innovation as the foundation, model innovation as the carrier and technological innovation as the core.
2.Clinical Observation on 45 Cases of Chronic Obstructive Pulmonary Disease in the Stable Phase with Qi Deficiency,Blood Stasis and Phlegm Obstruction Syndrome with Auxiliary Treated with Jinwei Guben Decoction (金卫固本汤) Combined with Bailing Capsule (百令胶囊)
Deyu KONG ; Xudong ZHENG ; Huimin ZHOU ; Ruitao WANG ; Benzhang ZHAO ; Jianjun WU
Journal of Traditional Chinese Medicine 2025;66(4):367-375
ObjectiveTo observe the clinical efficacy of modified Jinwei Guben Decoction (金卫固本汤, MJGD) combined with Bailing Capsule (百令胶囊, BC) in the treatment of chronic obstructive pulmonary disease (COPD) patients in the stable stage with qi deficiency, blood stasis and phlegm obstruction syndrome, in addition to conventional western medicine treatment. MethodsA total of 102 patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome were included in the study. According to the patients'preferences, they were divided into treatment group (49 cases) and control group (53 cases). The control group received conventional western medicine treatment, while the treatment group was given MJGD (1 dose daily) combined with BC (2.0 g each time, three times a day) additionally. The treatment period was 3 months, and the patients were followed up for 1 year after the treatment. The acute exacerbation frequency (mild, moderate, severe) before treatment, during treatment, at 6-month follow-up, and at 1-year follow-up was compared between groups. Additionally, the lung function indicators such as FEV1, FEV1%pred, FVC, and FEV1/FVC ratio, traditional Chinese medicine (TCM) syndrome scores, modified British Medical Research Council (mMRC) dyspnea scale, and the COPD Assessment Test (CAT) scores before and after treatment were compared. A logistic regression model was constructed to analyze the impact of MJGD combined with BC on clinical efficacy. ResultsFour patients dropped out from the treatment group and eight from the control group, leaving 45 patients of each group for statistical analysis. The number of mild and moderate acute exacerbations in the treatment group was lower than that in the control group during the treatment period, at 6-month follow-up and within 1 year of follow-up (P<0.05) .The number of severe acute exacerbations was only lower in the treatment group than in the control group at 6-month follow-up (P<0.05). Compared with that before treatment, the number of acute exacerbations of all degrees in the treatment group was significantly reduced within 1 year of follow-up (P<0.05),while only the number of mild acute exacerbations in the control group was significantly reduced within 1 year of follow-up (P<0.05). The treatment group showed significant improvement in FEV1 and FEV1%pred and FEV1/FEV, while the control group showed a significant decline in FEV1 and FVC (P<0.05). After treatment, both groups showed significant reductions in TCM syndrome scores, including coughing, sputum, wheezing, chest tightness, shortness of breath, and fatigue, as well as mMRC and CAT scores (P<0.05), with the treatment group having significantly lower scores than the control group (P<0.05). The overall clinical effective rate of in the treatment group was 93.33% (42/45), significantly higher than that of the control group, 75.56% (34/45, P<0.05). Multivariate logistic regression analysis showed that the use of MJGD combined with BC (OR = 4.68, 95%CI: 1.15 - 19.09, P = 0.03) was positively correlated with clinical efficacy. ConclusionsIn addition to conventional western medicine treatment, the combination of MJGD and BC can reduce the frequency of acute exacerbations, delay the decline of lung function, improve clinical symptoms, and significantly enhance the clinical efficacy in patients with stable COPD and qi deficiency, blood stasis, and phlegm obstruction syndrome.
3.Structure, content and data standardization of rehabilitation medical records
Yaru YANG ; Zhuoying QIU ; Di CHEN ; Zhongyan WANG ; Meng ZHANG ; Shiyong WU ; Yaoguang ZHANG ; Xiaoxie LIU ; Yanyan YANG ; Bin ZENG ; Mouwang ZHOU ; Yuxiao XIE ; Guangxu XU ; Jiejiao ZHENG ; Mingsheng ZHANG ; Xiangming YE ; Jian YANG ; Na AN ; Yuanjun DONG ; Xiaojia XIN ; Xiangxia REN ; Ye LIU ; Yifan TIAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(1):21-32
ObjectiveTo elucidate the critical role of rehabilitation medical records (including electronic records) in rehabilitation medicine's clinical practice and management, comprehensively analyzed the structure, core content and data standards of rehabilitation medical records, to develop a standardized medical record data architecture and core dataset suitable for rehabilitation medicine and to explore the application of rehabilitation data in performance evaluation and payment. MethodsBased on the regulatory documents Basic Specifications for Medical Record Writing and Basic Specifications for Electronic Medical Records (Trial) issued by National Health Commission of China, and referencing the World Health Organization (WHO) Family of International Classifications (WHO-FICs) classifications, International Classification of Diseases (ICD-10/ICD-11), International Classification of Functioning, Disability and Health (ICF), and International Classification of Health Interventions (ICHI Beta-3), this study constructed the data architecture, core content and data standards for rehabilitation medical records. Furthermore, it explored the application of rehabilitation record summary sheets (home page) data in rehabilitation medical statistics and payment methods, including Diagnosis-related Groups (DRG), Diagnosis-Intervention Packet (DIP) and Case Mix Index. ResultsThis study proposed a systematic standard framework for rehabilitation medical records, covering key components such as patient demographics, rehabilitation diagnosis, functional assessment, rehabilitation treatment prescriptions, progress evaluations and discharge summaries. The research analyzed the systematic application methods and data standards of ICD-10/ICD-11, ICF and ICHI Beta-3 in the fields of medical record terminology, coding and assessment. Constructing a standardized data structure and data standards for rehabilitation medical records can significantly improve the quality of data reporting based on the medical record summary sheet, thereby enhancing the quality control of rehabilitation services, effectively supporting the optimization of rehabilitation medical insurance payment mechanisms, and contributing to the establishment of rehabilitation medical performance evaluation and payment based on DRG and DIP. ConclusionStructured rehabilitation records and data standardization are crucial tools for quality control in rehabilitation. Systematically applying the three reference classifications of the WHO-FICs, and aligning with national medical record and electronic health record specifications, facilitate the development of a standardized rehabilitation record architecture and core dataset. Standardizing rehabilitation care pathways based on the ICF methodology, and developing ICF- and ICD-11-based rehabilitation assessment tools, auxiliary diagnostic and therapeutic systems, and supporting terminology and coding systems, can effectively enhance the quality of rehabilitation records and enable interoperability and sharing of rehabilitation data with other medical data, ultimately improving the quality and safety of rehabilitation services.
4.Effect of Acupuncture with the Method of Soothing the Liver and Regulating the Mind on the TLR4/NF-κB Pathway in the Hippocampus of Lipopolysaccharide-Induced Depression Model Mice
Bingxin WU ; Yi ZHOU ; Sibo HAN ; Xichang HUANG ; Junye MA ; Baile NING ; Shanze WANG ; Wenbin FU
Journal of Traditional Chinese Medicine 2025;66(5):526-531
ObjectiveTo explore the potential mechanism of acupuncture with the method of soothing the liver and regulating the mind in improving depressive disorder. MethodsEighteen C57BL/6J mice were randomly divided into blank group, model group, and acupuncture group, with 6 mice in each group. The model group and the acupuncture group were subjected to depression induction by intraperitoneal injection of lipopolysaccharide (LPS), while the blank group received an equal volume of normal saline once daily for seven consecutive days. Concurrently, the acupuncture group received "soothing the liver and regulating the mind" acupuncture intervention starting from the first day of modeling, once daily for 14 days; whereas the blank group and the model group were only restrained without acupuncture. The sucrose preference test was used to assess sucrose preference rate, the open-field test to measure center stay time and total travel distance, and the forced swim test to evaluate immobility time. Hematoxylin-eosin (HE) staining was performed to observe hippocampal morphological changes. Enzyme-linked immunosorbent assay (ELISA) was used to detect levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) in hippocampal tissue. Western blot analysis was conducted to examine the protein expression levels of Toll-like receptor 4 (TLR4) and nuclear factor-κB (NF-κB) in the hippocampus. ResultsCompared to the blank group, the model group showed a significant reduction in sucrose preference rate, center stay time, and total travel distance, along with a significant increase in immobility time in the forced swim test, hippocampal IL-1β, IL-6, and TNF-α levels, as well as TLR4 and NF-κB protein expression (P<0.01), and the histological examination revealed blurred hippocampal neuronal boundaries, loose arrangement, and some neurons exhibiting nuclear pyknosis and deep staining. Compared to the model group, the acupuncture group demonstrated a significant increase in sucrose preference rate, center stay time, and total travel distance, along with a significant reduction in immobility time in the forced swim test, hippocampal IL-1β, IL-6, and TNF-α levels, and TLR4 and NF-κB protein expression (P<0.01), and the histological analysis showed that hippocampal neurons in the acupuncture group were more tightly arranged, with reduced nuclear pyknosis and deep staining. ConclusionAcupuncture with the "soothing the liver and regulating the mind" method can significantly improve depression-like behavior, potentially by inhibiting the hippocampal TLR4/NF-κB signaling pathway and alleviating inflammatory responses.
5.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
6.Clinical Efficacy of Jinwei Pingchuan Decoction in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Phlegm-heat Obstruction in Lung Syndrome
Xudong ZHENG ; Deyu KONG ; Benzhang ZHAO ; Huimin ZHOU ; Ruitao WANG ; Jianjun WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):125-133
ObjectiveTo study the effect of Jinwei Pingchuan decoction combined with conventional Western medicine on the number of acute exacerbations, lung function, and clinical symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) with phlegm-heat obstruction in lung syndrome. MethodsA non-randomized controlled trial was conducted to include 60 patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. Patients were divided into a treatment group and a control group based on whether they received Jinwei Pingchuan decoction, with 30 patients in each group. The treatment group received Jinwei Pingchuan decoction combined with conventional Western medicine therapy, while the control group received conventional Western medicine therapy alone. Both groups received treatment for 7 days. The number of acute exacerbations and lung function indices were followed up and recorded before treatment and three months after treatment. The following outcomes were observed before and after treatment: the number of acute exacerbations, lung function indices (forced expiratory volume in one second [FEV1], percentage of predicted value [FEV1%pred], forced vital capacity [FVC], and FEV1/FVC ratio), the degree of acute exacerbation, TCM syndrome score, COPD assessment test (CAT) score, modified British Medical Research Council Dyspnea Questionnaire (mMRC) score, C-reactive protein (CRP), and white blood cell (WBC) count. ResultsAfter 3 months of follow-up, the treatment group showed a significant reduction in the number of acute exacerbations compared with the pre-treatment values (P<0.05). After treatment, the treatment group had fewer acute exacerbations than the control group (P<0.05). The degree of acute exacerbation in the treatment group improved significantly compared with the pre-treatment values (P<0.05). After treatment, the degree of acute exacerbation in the treatment group was improved compared to the control group (P<0.05). Regarding lung function, FEV1, FEV1%pred, FVC, and FEV1/FVC ratio increased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar improvements were observed in the control group (P<0.05). After treatment, FEV1 and FVC were higher in the treatment group than the control group (P<0.05). Regarding TCM syndrome scores, the scores for individual symptoms such as wheezing, cough, expectoration, chest tightness, shortness of breath, and fatigue, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, fatigue, and palpitation, as well as the total score, also decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for wheezing, cough, chest tightness, shortness of breath, and the total score than the control group (P<0.05). Regarding the CAT score, the scores for cough, expectoration, chest tightness, climbing stairs, going out, activity, and energy, as well as the total score, decreased significantly in the treatment group compared with the pre-treatment values (P<0.05). In the control group, the scores for cough, expectoration, chest tightness, sleep, energy, and the total score decreased (P<0.05). After treatment, the treatment group showed significantly lower scores for cough, expectoration, chest tightness, activity, and going out than the control group (P<0.05). Regarding the mMRC score, CRP level, and WBC count, all these parameters decreased significantly in the treatment group compared with the pre-treatment values (P<0.05), and similar reductions were observed in the control group (P<0.05). ConclusionJinwei Pingchuan decoction can reduce the number of acute exacerbations and the degree of acute exacerbation in patients with acute exacerbation of COPD with phlegm-heat obstruction in lung syndrome. It also improves lung function and symptoms such as cough and chest tightness, thereby enhancing the quality of life of patients.
7.Study on meal preferences of school aged children based on discrete choice experiment
Chinese Journal of School Health 2025;46(1):45-49
Objective:
To explore the relative importance of different food attributes and levels in food decision making of school aged children, and to understand their meal preferences, so as to provide the evidence for formulating precise intervention strategies for dietary behaviours of school aged children.
Methods:
From May to June 2024, a total of 854 children aged 11 to 15 years old were selected from 2 middle schools (each school in urban and rural areas) in both Hubei Province and Anhui Province by stratified cluster random sampling method to conduct a D-optimal discrete choice experiment. The mixed Logit model was used to analyze children s preference for meal attributes and different levels, and to calculate the relative importance (RI) of attributes and willingness to pay (WTP) in meal choices.
Results:
The included five food attributes had statistical significance on meal choice of school aged children ( P <0.05). The relative importance of food attributes affecting the meal choices of school aged children in descending order were dining mode ( RI =31.26%), food varieties ( RI =30.56%), cooking method( RI =23.84%), taste( RI =8.06%) and price ( RI =6.27%). Among them, school aged children preferred home cooked meals ( β =0.74) (WTP=86.3 yuan),varied foods(grain/tubers+vegetables+fish, meat, eggs and beans) ( β =0.61) (WTP=71.9 yuan), fried/roasted cooking ( β =0.51) and spicy taste ( β =0.33).Price was negatively correlated with meal choices( β =-0.01) ( P <0.05). Based on residential area and body mass index (BMI), the stratified analysis showed that dining mode was highest in the relative importance for rural children with overweight and obese children ( RI =31.28%,34.17%), both of whom preferred home cooked meals ( β =0.76, 0.91), and meals containing fish, meat, eggs and beans with grain/tubers or grain/tubers and vegetables in terms of food choice (area: β =0.53, 0.53 ; BMI: β =0.55, 0.56) ( P <0.05).
Conclusions
School aged children have different preferences for different attributes of meals. The quality of school meals should be improved,the cost of buying healthy meals should be reduced,targeted family health education should be carried out,and healthy cooking methods should be advocated.
8.Combined anterior and posterior miniscrews increase apical root resorption of maxillary incisors in protrusion and premolar extraction cases
Zhizun WANG ; Li MEI ; Zhenxing TANG ; Dong WU ; Yue ZHOU ; Ehab A. ABDULGHANI ; Yuan LI ; Wei ZHENG ; Yu LI
The Korean Journal of Orthodontics 2025;55(1):26-36
Objective:
Miniscrews are commonly utilized as temporary anchorage devices (TADs) in cases of maxillary protrusion and premolar extraction. This study aimed to investigate the effects and potential side effects of two conventional miniscrew configurations on the maxillary incisors.
Methods:
Eighty-two adult patients with maxillary dentoalveolar protrusion who had undergone bilateral first premolar extraction were retrospectively divided into three groups: non-TAD, two posterior miniscrews only (P-TADs), and two anterior and two posterior miniscrews combined (AP-TADs). Cone-beam computed tomography was used to evaluate the maxillary central incisors (U1).
Results:
The APTADs group had significantly greater U1 intrusion (1.99 ± 2.37 mm, n = 50) and less retroclination (1.70° ± 8.80°) compared to the P-TADs (–0.07 ± 1.65 mm and 9.45° ± 10.68°, n = 60) and non-TAD group (0.30 ± 1.61 mm and 1.91° ± 9.39°, n = 54).However, the AP-TADs group suffered from significantly greater apical root resorption (ARR) of U1 (2.69 ± 1.38 mm) than the P-TADs (1.63 ± 1.46 mm) and non-TAD group (0.89 ± 0.97 mm). Notably, the incidence of grade IV ARR was 16.6% in the AP-TADs group, significantly higher than the rates observed in the P-TADs (6.7%) and non-TAD (1.9%) groups. Multiple regression analysis revealed that after excluding tooth movement factors, the AP-TADs configuration resulted in an additional 0.5 mm of ARR compared with the P-TADs group.
Conclusions
In cases of maxillary protrusion and premolar extraction, the use of combined anterior and posterior miniscrews enhances incisor intrusion and minimizes torque loss of the maxillary incisors. However, this approach results in more severe ARR, likely due to the increased apical movement and composite force exerted.
9.Analgesic effect and mechanism of punicalagin on neuropathic pain in rats
Li WANG ; Ling ZHOU ; Chenglong WU
China Pharmacy 2025;36(10):1191-1196
OBJECTIVE To investigate the analgesic effect and potential mechanism of punicalagin on neuropathic pain (NP) rats based on the hypoxia-inducible factor-1α (HIF-1α)/nucleotide-binding domain leucine-rich repeat and pyrin domain-containing receptor 3 (NLRP3) signaling pathway. METHODS Male SD rats were randomly divided into sham operation group (18 rats) and modeling group (72 rats). NP rat model was established by chronic constriction injury (CCI) of sciatic nerve. The successfully modeled rats were divided into NP group, 2-methoxyestradiol group (HIF-1α antagonist 10 mg/kg), punicalagin group (300 mg/kg), and punicalagin+dimethyloxaloglycine group (punicalagin 300 mg/kg+HIF-1α agonist 175 mg/kg), with 18 rats in each group. Rats in each group were injected intraperitoneally and/or intragastrically with the corresponding solution or 1% dimethyl sulfoxide/normal saline, once a day, for 14 consecutive days. After the last administration, the mechanical withdrawal threshold (MWT), thermal withdrawal latency (TWL), the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and IL-6 in spinal cord tissue were detected; the morphological changes in the spinal dorsal horn were observed. Apoptosis rate of spinal dorsal horn neurons, the co-localization of NLRP3/ionized calcium binding adapter molecule 1 (Iba-1) (calculated by the number of NLRP3+/Iba-1+ cells) and the protein expressions of HIF-1α, NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC) and caspase-1 in spinal cord tissue were detected. RESULTS Compared with the sham operation group, neurofibril in spinal dorsal horn of rats in NP group was thickened and wound into knots, and vacuolar degeneration containing silver granules was observed; the MWT and TWL were reduced or shortened; the levels of TNF-α, IL-1β and IL-6 in spinal cord tissue, the apoptosis rate of spinal dorsal horn neurons, the number of NLRP3+/Iba-1+ cells, and protein expressions of HIF-1α, NLRP3, ASC and caspase-1 were significantly increased or up-regulated (P<0.05). Compared with the NP group, the above indexes were significantly improved in the 2-methoxyestradiol group and punicalagin group (P<0.05), while dimethyloxaloglycine could significantly reverse the improvement effect of punicalagin on the above indexes (P<0.05). CONCLUSIONS Punicalagin can relieve pain in NP rats, and its analgesic effect may be achieved by inhibiting HIF-1α/NLRP3 signaling pathway and blocking the activation of ma0o4e@163.com NLRP3 inflammasome in spinal dorsal horn microglia.
10.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.


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