1.Right ventricular-pulmonary artery connection for palliative treatment of pulmonary atresia with ventricular septal defect in children: A single-center retrospective study
Shuai ZHANG ; Jianrui MA ; Hailong QIU ; Xinjian YAN ; Wen XIE ; Qiushi REN ; Juemin YU ; Tianyu CHEN ; Yong ZHANG ; Xiaohua LI ; Furong LIU ; Shusheng WEN ; Jian ZHUANG ; Qiang GAO ; Jianzheng CEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):366-371
Objective To compare the benefits and drawbacks of primary patch expansion versus pericardial tube right ventricular-pulmonary artery connection in patients diagnosed with pulmonary atresia with ventricular septal defect (PA/VSD). Methods A retrospective study was conducted on patients diagnosed with PA/VSD who underwent primary right ventricular-pulmonary artery connection surgery at our center between 2010 and 2020. Patients were categorized into two groups based on the type of right ventricular-pulmonary artery connection: a pericardial tube group and a patch expansion group. Clinical data and imaging findings were compared between the two groups. Results A total of 51 patients were included in the study, comprising 31 males and 20 females, with a median age of 12.57 (4.57, 49.67) months. The pericardial tube group included 19 patients with a median age of 17.17 (7.33, 49.67) months, while the patch expansion group consisted of 32 patients with a median age of 8.58 (3.57, 52.72) months. In both groups, the diameter of pulmonary artery, McGoon index, and Nakata index significantly increased after treatment (P<0.001). However, the pericardial tube group exhibited a longer extracorporeal circulation time (P<0.001). The reoperation rate was notably high, with 74.51% of patients requiring further surgical intervention, including 26 (81.25%) patients in the patch expansion group and 12 (63.16%) patients in the pericardial tube group. No statistical differences were observed in long-term cure rates or mortality between the two groups (P>0.005). Conclusion In patients with PA/VSD, both patch expansion and pericardial tube right ventricular-pulmonary artery connection serve as effective initial palliative treatment strategies that promote pulmonary vessel development and provide a favorable foundation for subsequent radical operations. However, compared to the pericardial tube approach, the patch expansion technique is simpler to perform and preserves some intrinsic potential for pulmonary artery development, making it the preferred procedure.
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.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.Short-term results of valve-in-valve transcatheter aortic valve implantation in patients with degenerated bioprosthesis
Xu HAN ; Linjie YANG ; Chen HUANG ; Xiaohua ZHU ; Gongcheng HUANG ; Jing XU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):977-982
Objective To summarize the short-term results of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) in the treatment of bioprosthetic valve failure after aortic valve replacement. Methods We reviewed the clinical data of patients who underwent ViV-TAVI from 2021 to 2022 in the First Affiliated Hospital of Zhengzhou University. The valve function was evaluated by echocardiography before operation, immediately after operation and 3 months after operation. The all-cause death and main complications during hospitalization were analyzed. Results A total of 13 patients were enrolled, including 8 males and 5 females with a mean age of (65.9±8.5) years, and the interval time between aortic valve replacement and ViV-TAVI was (8.5±3.4) years. The Society of Thoracic Surgeons mortality risk score was 10.3%±3.2%. None of the 13 patients had abnormal valve function after operation. The mean transvalvular pressure gradient of aortic valve was decreased (P<0.001), the peak flow velocity of aortic valve was decreased (P<0.001), and the left ventricular ejection fraction was not changed significantly (P=0.480). There were slight perivalvular leakage in 2 patients and slight valve regurgitation in 3 patients. Three months after operation, the mean transvalvular pressure difference and peak flow velocity of aortic valve in 12 patients were significantly decreased compared with those before operation (P≤0.001). Conclusion This study demonstrates that ViV-TAVI for the treatment of bioprosthetic valve failure after aortic valve replacement is associated with favorable clinical and functional cardiovascular benefits, the short-term results are satisfactory.
6.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
7.Effects of a multidisciplinary integrated weight management intervention in Beilun District
XU Chunxia ; Ding Yajun ; YUAN Yunyun ; ZHOU Yachun ; PAN Xiaohua ; ZHANG Jingjing ; CHEN Lili
Journal of Preventive Medicine 2025;37(11):1103-1107,1112
Objective:
To evaluate the effects of a multidisciplinary weight management intervention, so as to provide a reference for the formulation of overweight and obesity intervention measures.
Methods:
From April to September 2025, overweight and obese residents aged 18-60 years who participated in a weight loss competition at the Health Management Center of Beilun People's Hospital in Ningbo City were selected as study subjects. They were divided into a control group and an intervention group. The control group received conventional weight management, while the intervention group received the multidisciplinary integrated weight management in addition to the conventional weight management, for a total intervention period of 8 weeks. Weight, body mass index (BMI), waist circumference, hip circumference, waist-to-hip ratio, fasting blood glucose (FBG), triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and blood pressure were collected before and after the intervention through physical examinations and laboratory tests. The generalized estimating equations (GEE) method was employed to analyze the differences in indicators between the two groups before and after the intervention.
Results:
The control group comprised 241 participants, including 161 females (66.80%), with a mean age of (35.66±7.80) years. The intervention group consisted of 127 participants, including 86 females (67.72%), with a mean age of (36.80±7.05) years. No statistically significant differences were observed between the two groups at baseline in terms of age, gender, weight, BMI, or waist-to-hip ratio (all P>0.05). Results from the GEE analysis indicated significant interactions between group and time for weight, BMI, waist circumference, and hip circumference (all P<0.05) with greater reductions in these parameters observed in the intervention group compared to the control group before and after the intervention. Similarly, significant interactions between group and time were observed for FBG, TG, TC, and LDL-C (all P<0.05), with the intervention group demonstrating larger decreases in these markers compared to the control group. However, no statistically significant interactions between group and time were observed for waist-to-hip ratio, HDL-C, systolic blood pressure, and diastolic blood pressure (all P>0.05). Following the intervention, a weight loss exceeding 10% was achieved by 13 participants (5.39%) in the control group and 62 participants (48.82%) in the intervention group. The proportion of individuals with a weight loss exceeding 10% was significantly higher in the intervention group compared to the control group (P<0.05).
Conclusion
Compared to conventional weight management, multidisciplinary integrated weight management demonstrated greater efficacy in improving weight-related indicators and blood glucose, blood lipids, and enhancing weight loss outcomes among overweight and obese residents.
8.Effect of laparoscopic salpingectomy on ovarian reserve function and serum neuropeptide Y and cortisol in patients with ectopic pregnancy
Rong SHI ; Xianfang ZHENG ; Qun TAO ; Junmo CHEN ; Xiaohua GE
The Journal of Practical Medicine 2024;40(6):801-806
Objective To explore the effect of laparoscopic salpingectomy on ovarian reserve function and serum neuropeptide Y(NPY)and cortisol(Cor)in patients with ectopic pregnancy.Methods 82 patients with ectopic pregnancy who had visited Chaohu Hospital Affiliated to Anhui Medical University from June 2018 to June 2021 were randomly divided into two groups,with 41 in each group.The control group underwent laparoscopic salpingostomy and suturing for embryo retrieval,while the study group underwent laparoscopic salpingectomy.Surgical duration,intraoperative blood loss,time to postsurgical mobilization,length of hospital stay,serum NPY and Cor levels,antral follicle count(AFC),indexes for peak flow velocity and resistance of ovarian artery were compared between the two groups.Follow-up was conducted for two years after surgery,and the success rate of pregnancy and the ectopic pregnancy rate were recorded.Results The surgical duration in the study group was shorter than that in the control group(P<0.05).The differences in serum NPY and Cor values between the two groups immediately after surgery and at postoperative week one were not statistically significant(P>0.05).At postoperative months1 and 6,the peak flow velocity of the affected ovary was lower in the study group than in the control group,whereas the resistance index was higher(P<0.05).At postoperative month 6,both groups showed an increase in peak flow velocity and a decrease in resistance index(P<0.05).There were no statistically signifi-cant differences in AFC and the success rate of pregnancy between the two groups postoperatively(P>0.05).The ectopic pregnancy rate in the study group was lower than that in the control group(P<0.05).Conclusion As compared with laparoscopic salpingostomy,laparoscopic salpingectomy for ectopic pregnancy can also preserve postoperative ovarian antral follicle count(AFC),and it has greater advantage in reducing the risk of recurrent ectopic pregnancy after surgery.
9.Current status and management strategies of occupational disease hazards in Shantou City from 2019 to 2022
Shaofang LIN ; Xiaohua WU ; Chaoxin LIN ; Shaorong LIANG ; Jianzhong CHEN
China Occupational Medicine 2024;51(5):570-574
Objective To analyze the status of occupational disease hazards in Shantou City for 2019 to 2022 and propose corresponding management measures. Methods Technical reports on various occupational-disease-specific activities in Shantou City from 2019 to 2022 were collected and the data were comprehensively analyzed. Results Among the 3 066 enterprises surveyed in the 2020 occupational disease hazard investigation in Shantou City, occupational hazards were reported in 2 982 enterprises (accounting for 97.3%), with 2 955 being small and micro enterprises, accounted for 99.1%(2 955/2 982). The exposure rate of occupational hazards was 58.7% (42 894/73 054) among workers in the surveyed enterprises, with dust and noise exposure rates of 59.7% and 77.8%, respectively. The reported rate of occupational disease hazard projects by employers, regular detection rate of workplace occupational hazards, detection rate of occupational medical examination among workers, and occupational health training rate of key responsible personnel and occupational health management staff were 8.4%, 1.4%, 2.4%, and 4.3%, respectively. The results of occupational hazards monitoring of workplace in key industries from 2019 to 2022 showed that noise had the highest rate of exceeding national standards workplace, followed by silica dust, accounting for 34.2% and 13.8%, with the on-site exceedance rate of 32.2% and 10.0%, respectively. From 2019 to 2022, 31 suspected occupational disease cases were identified in key occupational disease monitoring, including 27 suspected cases of occupational pneumoconiosis and four suspected cases of occupational noise-induced deafness. Conclusion The workers in Shantou City have a high exposure rate to occupational hazards, and the occupational health management level of employers remains low, with noise and silica dust being the most severe occupational hazards. It is essential to improve technical support and service system development for occupational disease prevention and treatment, strengthen supervision and management in key industries and positions, explore occupational health assistance mechanisms for small and micro enterprises, and enforce employers' responsibility in occupational disease prevention to protect workers' occupational health and safety.
10.Effect of long-term frozen plasma on the detection of HBsAg by ELISA
Simin LIAN ; Xiaohua CHEN ; Shubo LIN ; Ziyue GUO ; Zebin XIAO
Chinese Journal of Blood Transfusion 2024;37(1):91-94
【Objective】 To evaluate the HBsAg detection results of HBsAg+ samples after 8 years refrigeration by ELISA and evaluate the effectiveness of the current storage policy of retained samples. 【Methods】 A total of 100 HBsAg+ plasma samples by ELISA from May 2014 to March 2015 and refrigerated at -20℃ were collected and retested for HBsAg using the same method after thawing in 2023. 【Results】 The HBsAg retest results of 100 plasma samples were all positive, with the concordance rate of 100%, though there was a significant decrease in the S/CO value after refrigeration(27.52 vs 19.03, P<0.05). 【Conclusion】 Long-term refrigeration can lead to a decrease in the S/CO value of HBsAg ELISA detection,but it does not affect the positive results.


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