1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Study on the current status and influencing factors of maximum tongue pressure in cardiac surgery inpatients based on a random forest model
Aimin SHAO ; Yilei ZHU ; Haiou XIA ; Jun ZHONG ; Run HUANG
Chinese Journal of Practical Nursing 2025;41(8):620-627
Objective:To investigate the current status of maximum tongue pressure (MTP) in cardiac surgery inpatients and analyze its influencing factors, providing a basis for developing personalized nursing measures for high-risk groups.Methods:This cross-sectional study used a convenience sampling method to select cardiac surgery inpatients at Zhongshan Hospital, Fudan University, from January 2022 to April 2023. General and clinical data questionnaires, a swallowing tongue muscle evaluation training device, and a hand dynamometer were used for data collection. The random forest model and Lasso regression were employed to identify key influencing factors, and multiple linear regression was used to analyze the factors affecting MTP.Results:A total of 501 cardiac surgery inpatients meeting the inclusion and exclusion criteria were enrolled, including 308 males and 193 females, with a mean age of (56.94 ± 14.02) years. The mean MTP was (45.92 ± 9.57) kPa. When the lambda (λ) value was 0.181, the model achieved the best fit, identifying 10 key influencing factors in descending order of importance: age, handgrip strength, gender, BMI, N-terminal pro-B-type natriuretic peptide (NT-proBNP), glomerular filtration rate, cardiac function grade, hemoglobin, history of stroke, and history of atrial fibrillation. Age, handgrip strength, low-level BMI, NT-proBNP, and history of stroke were determined as significant factors influencing MTP in cardiac surgery inpatients ( R2 = 0.324, F = 24.92, P<0.05). Conclusions:Nurses should pay close attention to the tongue muscle strength of cardiac surgery inpatients. Early assessment of MTP is essential for older patients, those with low handgrip strength, low BMI, elevated NT-proBNP, or a history of stroke. Targeted early identification and pre-rehabilitation measures should be implemented for patients with weakened tongue muscle strength.
3.Continuous radiofrequency versus high-voltage,long-duration pulsed radiofrequency of ganglia impar for the treatment of perineal pain in patients with rectal cancer:a clinical study
Bo ZHONG ; Taomei ZHANG ; Zhiqiang WANG ; Ping TAO ; Huaiming WANG ; Aimin ZHANG
Journal of Interventional Radiology 2025;34(2):154-159
Objective To evaluate the efficacy and safety of DSA-guided continuous radiofrequency ablation(CRF)and high-voltage,long-duration pulsed radiofrequency(HL-PRF)of ganglia impar in treating perineal pain in patients with rectal cancer.Methods This study is a single-center,randomized,active-controlled,double-blind trial that included 57 rectal cancer patients with perineal pain.At a 1∶1 ratio,the patients were randomly divided into CRF group(n=28)and HL-PRF group(n=29).The primary outcome indicators were the pain numerical rating scale(NRS)scores determined at the preoperative(T0),postoperative 24 h(T1),one week(T2),one month(T3),3 months(T4)and 6 months(T5)time-points.The secondary outcome indicators included the sitting time at T0,T1,T2,T3,T4 and T5 time-points,the 9-item patient health questionnaire(PHQ-9)score,the pittsburgh sleep quality index(PSQI)score,the postoperative oral morphine dosage,and the incidence of perineal numbness.Results Compared with the value at T0 time-point,in both groups the NRS score,PHQ-9 score and PSQI score at T1-T5 time-points were significantly decreased,while the sitting time become remarkably increased(all P<0.05).No statistically significant differences in postoperative oral morphine dosage and incidence of perineal numbness existed between the two groups(both P>0.05).There were no statistically significant differences in NRS score,PHQ-9 score and PSQI score,sitting time and oral morphine dosage at T1,T2,T3 time-points between CRF group and HL-PRF group(all P>0.05),while at T4 and T5 time-points the NRS score,PHQ-9 score and PSQI score in HL-PRF group were significantly higher than those in CRF group(all P<0.05),and the sitting time in HL-PRF group was strikingly lower than that in CRF group(P<0.05).Conclusion Both CRF and HL-PRF of ganglion impar can alleviate perineal pain in patients with advanced rectal cancer and improve the quality of life of patients.CRF is superior to HL-PRF in the long-term efficacy.
4.Study on the current status and influencing factors of maximum tongue pressure in cardiac surgery inpatients based on a random forest model
Aimin SHAO ; Yilei ZHU ; Haiou XIA ; Jun ZHONG ; Run HUANG
Chinese Journal of Practical Nursing 2025;41(8):620-627
Objective:To investigate the current status of maximum tongue pressure (MTP) in cardiac surgery inpatients and analyze its influencing factors, providing a basis for developing personalized nursing measures for high-risk groups.Methods:This cross-sectional study used a convenience sampling method to select cardiac surgery inpatients at Zhongshan Hospital, Fudan University, from January 2022 to April 2023. General and clinical data questionnaires, a swallowing tongue muscle evaluation training device, and a hand dynamometer were used for data collection. The random forest model and Lasso regression were employed to identify key influencing factors, and multiple linear regression was used to analyze the factors affecting MTP.Results:A total of 501 cardiac surgery inpatients meeting the inclusion and exclusion criteria were enrolled, including 308 males and 193 females, with a mean age of (56.94 ± 14.02) years. The mean MTP was (45.92 ± 9.57) kPa. When the lambda (λ) value was 0.181, the model achieved the best fit, identifying 10 key influencing factors in descending order of importance: age, handgrip strength, gender, BMI, N-terminal pro-B-type natriuretic peptide (NT-proBNP), glomerular filtration rate, cardiac function grade, hemoglobin, history of stroke, and history of atrial fibrillation. Age, handgrip strength, low-level BMI, NT-proBNP, and history of stroke were determined as significant factors influencing MTP in cardiac surgery inpatients ( R2 = 0.324, F = 24.92, P<0.05). Conclusions:Nurses should pay close attention to the tongue muscle strength of cardiac surgery inpatients. Early assessment of MTP is essential for older patients, those with low handgrip strength, low BMI, elevated NT-proBNP, or a history of stroke. Targeted early identification and pre-rehabilitation measures should be implemented for patients with weakened tongue muscle strength.
5.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
6.Value of cardiac MRI in evaluation of left atrial function in the postoperative tetralogy of Fallot and pulmonary stenosis patients
Yanyan MA ; Rongzhen OUYANG ; Liwei HU ; Aimin SUN ; Qian WANG ; Chen GUO ; Yumin ZHONG
Chinese Journal of Radiology 2023;57(4):404-409
Objective:To explore the value of cardiac MRI (CMRI) in evaluating left atrial function in patients with postoperative tetralogy of Fallot (rTOF) and postoperative pulmonary stenosis (rPS).Methods:Totally 67 pediatric patients (49 with rTOF, 18 with rPS) with preserved left ventricular ejection fraction (EF) were recruited between January 2019 and October 2021 in Shanghai Children′s Medical Center, School of Medicine, Shanghai Jiao Tong University. Thirty-three healthy volunteers, matched in gender and age, were included as controls from July 2017 to August 2018. Left atrial EF, strain and strain rate of three phases (reservoir, conduit and pump), left atrial volume (maximum volume index, minimum volume index and pre-atrial contraction volume index) were measured with corresponding cardiac function analysis software. Then, the differences in these parameters were analyzed between the three groups by ANOVA or Kruskal-Wallis test with post hoc comparison and Bonferroni correction.Results:Compared with controls, patients with rTOF had lower reservoir function parameters (EF, strain and strain rate), conduit EF, conduit strain, and left atrial maximum volume index ( P<0.05), but higher pump EF ( P<0.05). In patients with rPS, only the reservoir strain rate decreased compared with controls ( P<0.05), and the remaining data showed no significant difference ( P>0.05). The reservoir and conduit EF and strain in patients with rPS were higher than those in patients with rTOF ( P<0.05). Conclusions:In patients with rTOF and rPS, left atrial function has changed despite the preservation of left ventricular EF, which may be an early marker of left ventricular diastolic dysfunction. In children with rTOF, left atrial reservoir and conduit functions decreased while the pump function increased. The reservoir and pump functions in rPS were better than those in rTOF. In addition, CMRI can detect left atrial dysfunction early before it enlarged.
7.High glucose inhibition of miR-126-5p promotes renal tubular epithelial cell injury
Qiong JIANG ; Ting YANG ; Zhaofei LI ; Yan ZHOU ; Qingchun LI ; Xiaohui CHEN ; Mingjie HE ; Aimin ZHONG
Journal of Chinese Physician 2023;25(12):1829-1834
Objective:To explore the differential expression profile of miRN in the development of diabetes nephropathy (DN), and further explore the mechanism of miR-126-5p involved in high glucose induced injury of renal tubular epithelial cells.Methods:Firstly, we downloaded existing chip data from the Gene Expression Integrated Database (GEO) and used GEO2R, miRanda, gene ontology (GO) analysis, and Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis to mine differential miRNAs. Subsequently, a high glucose induced HK-2 cell injury model was used and divided into three groups: high glucose model group, si-HOTAIR group, and si HOTAIR+ miR-126-5p inhibitor group. The three groups of cells were sequentially transfected with siRNA-NC, siRNA-HOTAIR, and siRNA-HOTAIR+ miR-126-5p mimic, and cultured in a medium containing 60 mmol/L glucose. Flow cytometry was used to detect changes in apoptosis levels in each group, while cell counting kit-8 (CCK-8) was used to detect changes in cell proliferation.Results:Through data mining analysis using GEO, it was found that compared to ordinary mice, DN mice had 74 upregulated miRNAs and 80 downregulated miRNAs in their kidney tissue. Enrichment analysis results showed that miRNAs could target signaling pathways such as Wnt, PKG, MAPK, and Rap1, and miR-126-5p was significantly downregulated. In the high glucose induced HK-2 cell injury model, the experimental results showed that the inhibitory effect on cell proliferation activity was more significant at a high glucose concentration of 60 mmol/L ( P<0.05); High glucose stimulation significantly reduced the expression of miR-126-5p ( P<0.05). The results of flow cytometry showed that compared with the high glucose model group, the apoptosis rate of the si-HOTAIR group significantly decreased ( P<0.05), while the apoptosis rate of the si-HOTAIR+ miR-126-5p inhibitor group significantly increased ( P<0.05). The CCK-8 experiment showed that compared with the high glucose model group, the cell viability of the si-HOTAIR group significantly increased ( P<0.05); The cell viability of the si-HOTAIR+ miR-126-5p inhibitor group was inhibited ( P<0.05). Conclusions:miR-126-5p can inhibit high glucose induced apoptosis in HK-2 cells and protect them.
8.A neonate with Smith-Lemli-Opitz syndrome caused by DHCR7 gene compound heterozygous variations
Ming LING ; Chijuan ZHONG ; Furong HUANG ; Jun XU ; Menghua ZHAO ; Li HUANG ; Aimin ZHANG
Chinese Journal of Perinatal Medicine 2022;25(2):146-149
This article reported a male neonate with Smith-Lemli-Opitz syndrome (SLOS) caused by DHCR7 gene compound heterozygous variations. The patient presented with multiple malformations and feeding difficulties after birth and was transferred to the First Affiliated Hospital of Hunan Normal University (Hunan Provincial People's Hospital) from a local hospital eight days later. Physical examination found general scleredema, scalp defects, short penis, urinary tract malformation, bilateral syndactyly of the second and third toes, and low serum cholesterol. Whole-exome and Sanger sequencing indicated a compound heterozygous mutation in the DHCR7 gene, c.852C>A(p.F284L), and a de novo mutation of c.820_825del(p.N274_V275del). SLOS is rare in the Asian populations and prone to missed diagnosis and misdiagnosis with difficulty in clinical management. The possibility of SLOS should be considered for newborns with multiple malformations and low serum cholesterol.
9.Characteristics of intestinal flora in female patients with type 2 diabetes mellitus and coronary heart disease
Aimin ZHANG ; Yu GAO ; Qitian SUN ; Min ZHONG ; Shan GAO ; Xiaoyan LIU ; Chang LIU ; Fengbiao JIN ; Jianqiu HE
Chinese Journal of Endocrinology and Metabolism 2022;38(2):100-104
Objective:To explore the characteristics of intestinal flora in female patients with type 2 diabetes mellitus (T2DM) with comorbid coronary heart disease.Methods:Female patients with T2DM from September 2019 to November 2020 were enrolled in this study and divided into 2 groups stratified by coronary heart disease: 22 patients with coronary heart disease(T2DM+ CHD group) and 49 patients with simple T2DM group(T2DM group). Thirty-one healthy females were selected as the normal control group(NC group). The abundance of intestinal flora, the difference in intestinal flora and its relationship with indicators such as glycosylated hemoglobin and fasting blood glucose was analyzed by the real-time fluorescent quantitative PCR detection technology in the three groups.Results:The abundance of Prevotella in the T2DM group was lower, and Roseburia inulinivorans and Faecalibacterium prausnitzii in the T2DM+ CHD group were lower, while Bacteroides and Enterococcus spp in the T2DM+ CHD group were higher compared with NC group, respectively( P<0.05). The abundance of Bacteroides and Enterococcus spp in the T2DM+ CHD group was lower than that in the T2DM group( P<0.05). Spearman correlation analysis showed that the abundance of Faecalibacterium prausnitzii and Eubacterium rectale was negatively correlated with obesity while abundance of Bacteroides and Enterococcus spp was positively correlated with HbA 1C and fasting blood glucose. The abundance of Bacteroides was positively correlated with TCH and TG(all P<0.05). Logistic regression analysis showed that Bacteroides and Enterococcus spp were independent influencing factor of the development of female patients with T2DM and CHD. Conclusion:Female T2DM and T2DM with CHD had intestinal flora imbalance, which was related to a variety of glucose and lipid metabolism indicators, and might be closely related to the occurrence of T2DM and CHD. Bacteroides and Enterococcus spp were independent influencing factors of the development of female patients with T2DM and CHD. Regulating the intestinal flora can provide ideas for the prevention and treatment of T2DM with CHD in female.
10.The value of cardiac MR dual-phase 3D whole heart imaging in evaluation of coronary artery in children
Rongzhen OUYANG ; Qian WANG ; Aimin SUN ; Yumin ZHONG
Chinese Journal of Radiology 2022;56(10):1076-1082
Objective:To investigate the value of whole-heart and volume-targeted balanced steady-state free precession(bSSFP) in the evaluation of coronary artery in children.Methods:Children with congenital heart disease and Kawasaki disease who underwent cardiac magnetic resonance imaging were retrospectively collected from January 2014 to December 2015, 197 cases(male: female 124∶73) were included according to the inclusion and exclusion criteria in this study. There were 189 cases of congenital heart disease and 8 Kawasaki disease, in which 23 cases had abnormal coronal arteries. Image quality of the coronary artery segments, the coronary artery origin and course, and coronary artery dimension in dual phase 3D bSSFP were analyzed. Chi-square test was used to evaluation the degree of accuracy and difference of coronal artery segments. T test was used to compare the diameter of left with right coronal artery in end systolic phase and mid to end diastolic phase.Results:Image quality was better in systolic phase than diastolic phase(3.9±0.5 and 3.5±0.7 respectively, P<0.001) for all cases. Combining the dual phases, the sensitivity, specificity and accuracy of dual phase 3D whole heart imaging in evaluating the coronal artery origin, course and shape was 100%. However, there was a little difference in revealing left anterior descending coronary artery, left circumflex artery and right coronary artery. There was significant difference in the clearly revealing the left anterior descending coronary artery and left circumflex artery( P<0.001). The left and right coronary artery dimension was larger in systolic phase than in mid-diastolic phase(left coronary artery 3.1±1.3 mm and 2.8±1.3 mm, respectively, right coronary artery(2.5±0.9) and(2.3±0.7)mm, respectively, P<0.001). Conclusion:Cardiac MR 3D bSSFP can retrospectively select coronary resting periods for optimal images, providing a more reliable imaging modality for the assessment of coronary arteries in children to make better clinical decision.

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