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.Role of chloride ions in the prognosis of patients with decompensated cirrhosis
Tian MENG ; Ouyang JING ; Chang HONG ; Yang JIN ; Liu MIN ; Yuping WANG ; Zhaofeng CHEN
Journal of Chongqing Medical University 2025;50(3):367-375
Objective:To investigate the prognostic value of serum chloride ion concentration in critically ill or clinically stable pa-tients with decompensated cirrhosis.Methods:A retrospective study was conducted among the patients with decompensated cirrhosis who attended the intensive care unit(ICU)and Department of Gastroenterology,The First Hospital of Lanzhou University,from Janu-ary 2017 to January 2022,and the patients were divided into ICU cohort and Gastroenterology cohort.The outcome event for the ICU cohort was in-hospital death.A logistic regression analysis was used to investigate the association between serum chloride levels and ICU mortality rate;the receiver operating characteristic(ROC)curve was plotted and the area under the ROC curve(AUC)was calcu-lated to assess the value of blood chloride level in predicting ICU mortality rate.The patients in the Gastroenterology cohort were fol-lowed up with the outcome event of all-cause mortality rate,and the Cox regression analysis and the Kaplan-Meier analysis were used to investigate the value of blood chloride level in predicting mortality rate.Results:In the ICU cohort,serum chloride ion was signifi-cantly associated with in-hospital mortality in the ICU(odds ratio=0.934,95%CI=0.871-0.993,P=0.035),and blood chlorine had an AUC of 0.687 in predicting in-hospital mortality in the ICU.In the Gastroenterology cohort,serum chloride ion concentration was sig-nificantly associated with mortality rate in the subgroup with a Child-Pugh score of<10(hazard ratio=0.906,95%CI=0.822-0.997,P=0.043),and hypochloremia was associated with a lower survival rate.Conclusion:Hypochloremia is associated with the increase in mortality rate in patients with decompensated cirrhosis.
3.Survey on current status of"Perioperative Infection Control"initiative monitoring indicators in 138 medical institutions in Guizhou Province
Yao YAO ; Yan XU ; Xia MU ; Tingxiu YANG ; Lan TANG ; Liyuan CHEN ; Guiqin DU ; Jing LI ; Zhaofeng JING ; Liming WANG ; Qin WU ; Qingyang ZHAO ; Yufei ZHANG ; Min HE ; Ximin FAN
Chinese Journal of Nosocomiology 2025;35(20):3068-3073
OBJECTIVE To investigate the current status of monitoring indicators related to the"Perioperative In-fection Control"in medical institutions above the secondary level in Guizhou Province,and to delve into the imple-mentation of key measures for infection prevention and control during the perioperative period for patients under-going surgical operations.METHODS Based on the"Implementation Plan for the'Perioperative Infection Control'Initiative in Guizhou Province",a"Case Investigation Form on Key Measures for Infection Prevention and Control During the Perioperative Period for Patients Undergoing Surgical Operation"was developed.A total of 138 medi-cal institutions participated in the case investigation,and a total of 2 128 cases were investigated.RESULTS The overall monitoring indicators for the"Perioperative Infection Control"initiative in the 138 medical institutions a-bove the secondary level in Guizhou Province were at a relatively low level.The skin cleansing compliance rate was 80.32%,the hair removal compliance rate was 16.43%,the prophylactic antibacterial drug administration rate within 0.5-1 hour before surgery was 55.94%and the antibacterial drug discontinuation rate within 24 hours after prophylactic medication for type Ⅰ incision surgeries was 56.48%.The hair removal compliance rate was higher in tertiary medical institutions(19.21%)than in secondary medical institutions(14.34%)(P=0.039).The distri-bution of the four monitoring indicators varied in clinical departments and surgery types,with statistically signifi-cant differences(P<0.05).The preferred method for surgical site skin cleansing in medical institutions across the province was local wiping,primarily with clean water(57.21%).The primary method for hair removal was razors(68.82%),and hair removal on the day of surgery was most common(61.75%).CONCLUSIONS Conduc-ting a survey on the current status of"Perioperative Infection Control"initiative monitoring indicators in medi-cal institutions in Guizhou Province helps to understand the implementation of key measures for perioperative in-fection prevention and control and set intervention targets,thus providing references for establishing a dynam-ic monitoring indicator change mechanism.
4.Survey on current status of"Perioperative Infection Control"initiative monitoring indicators in 138 medical institutions in Guizhou Province
Yao YAO ; Yan XU ; Xia MU ; Tingxiu YANG ; Lan TANG ; Liyuan CHEN ; Guiqin DU ; Jing LI ; Zhaofeng JING ; Liming WANG ; Qin WU ; Qingyang ZHAO ; Yufei ZHANG ; Min HE ; Ximin FAN
Chinese Journal of Nosocomiology 2025;35(20):3068-3073
OBJECTIVE To investigate the current status of monitoring indicators related to the"Perioperative In-fection Control"in medical institutions above the secondary level in Guizhou Province,and to delve into the imple-mentation of key measures for infection prevention and control during the perioperative period for patients under-going surgical operations.METHODS Based on the"Implementation Plan for the'Perioperative Infection Control'Initiative in Guizhou Province",a"Case Investigation Form on Key Measures for Infection Prevention and Control During the Perioperative Period for Patients Undergoing Surgical Operation"was developed.A total of 138 medi-cal institutions participated in the case investigation,and a total of 2 128 cases were investigated.RESULTS The overall monitoring indicators for the"Perioperative Infection Control"initiative in the 138 medical institutions a-bove the secondary level in Guizhou Province were at a relatively low level.The skin cleansing compliance rate was 80.32%,the hair removal compliance rate was 16.43%,the prophylactic antibacterial drug administration rate within 0.5-1 hour before surgery was 55.94%and the antibacterial drug discontinuation rate within 24 hours after prophylactic medication for type Ⅰ incision surgeries was 56.48%.The hair removal compliance rate was higher in tertiary medical institutions(19.21%)than in secondary medical institutions(14.34%)(P=0.039).The distri-bution of the four monitoring indicators varied in clinical departments and surgery types,with statistically signifi-cant differences(P<0.05).The preferred method for surgical site skin cleansing in medical institutions across the province was local wiping,primarily with clean water(57.21%).The primary method for hair removal was razors(68.82%),and hair removal on the day of surgery was most common(61.75%).CONCLUSIONS Conduc-ting a survey on the current status of"Perioperative Infection Control"initiative monitoring indicators in medi-cal institutions in Guizhou Province helps to understand the implementation of key measures for perioperative in-fection prevention and control and set intervention targets,thus providing references for establishing a dynam-ic monitoring indicator change mechanism.
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.Establishment and Validation of A Prediction Model for the Occurrence of Acute Kidney Disease in Patients with Liver Cirrhosis
Jing OUYANG ; Hong CHANG ; Mengjiao YANG ; Meng ZHANG ; Meng TIAN ; Ya ZHENG ; Yuping WANG ; Zhaofeng CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(1):89-98
7.Exploration of the effects of Yushen Yangluan decoction on improving ovarian reserve function in mice based on the HIF-1α/VEGFA signaling pathway
Jiami HUANG ; Linjin XIA ; Zhaofeng ZHANG ; Yushun ZHONG ; Yanyan MAO ; Jing DU ; Tingting ZHANG
Chinese Journal of Reproduction and Contraception 2024;44(11):1156-1163
Objective:To observe the effect of the Yushen Yangluan decoction on ovarian reserve function in mice with diminished ovarian reserve (DOR) and to explore its mechanism of action based on the hypoxia-inducible factor (HIF)-1α/vascular endothelial growth factor A (VEGFA) signaling pathway.Methods:Mechanism analysis was conducted using artificial intelligence-based network pharmacology. Fifty 6-week-old female C57BL/6 mice were randomly divided into five groups according to body weight, with 10 mice in each group. The groups were as follows: control group, model group, low-dose Traditional Chinese Medicine (TCM) group, medium-dose TCM group, and high-dose TCM group. Hematoxylin-eosin staining was used to observe the number of antral follicles in the ovaries, enzyme-linked immunosorbent assay was employed to detect serum hormone levels, and TdT-mediated dUTP nick end labeling (TUNEL) was used to assess apoptosis in ovarian granulosa cells. Immunohistochemistry (IHC) was performed to detect ovarian expression of HIF-1α, and Western blotting was used to measure the protein expressional levels of HIF-1α, VEGFA, and B-cell lymphoma-2 (BCL2) in the ovaries.Results:After treating DOR model mice with the Yushen Yangluan decoction at low, medium, and high dosages, the ovarian antral follicle count of the mice in the TCM groups was all higher than that in the model group ( P=0.024, P<0.001, P<0.001), the follicle-simulating hormone level was lower than that in the model group ( P=0.003, P<0.001, P<0.001), and the serum anti-Müllerian hormone level in the medium-and high-dose TCM groups was higher than that in the model group ( P=0.001, P<0.001). Network pharmacology and molecular docking suggested that the formula may influence the HIF signaling pathway through core targets such as HIF-1α, BCL2 and VEGFA. TUNEL assays indicated that the apoptosis rate of ovarian granulosa cells in the low-, medium-, and high-dose TCM groups was significantly lower than that in the model group ( P=0.017, P=0.003, P<0.001). Immunohistochemistry results showed that the expression level of HIF-1α in the granulosa cells of the follicles in the low-, medium- and high-dose TCM groups was significantly higher than that in the model group ( P=0.008, P<0.001, P<0.001). Western blotting analysis indicated that the protein expression level of HIF-1α in medium-, and high-dose TCM groups was significantly higher than that in the model group ( P=0.004, P<0.001), and the protein expression levels of VEGFA and BCL2 in low-, medium-, and high-dose TCM groups were significantly higher than those in the model group ( P=0.003, P=0.002, P=0.001; P=0.029, P=0.007, P=0.001). Conclusion:The Yushen Yangluan decoction may exert its therapeutic effect by inhibiting apoptosis of ovarian granulosa cells through the HIF-1α/VEGFA signaling pathway.
8.Exploration of the effects of Yushen Yangluan decoction on improving ovarian reserve function in mice based on the HIF-1α/VEGFA signaling pathway
Jiami HUANG ; Linjin XIA ; Zhaofeng ZHANG ; Yushun ZHONG ; Yanyan MAO ; Jing DU ; Tingting ZHANG
Chinese Journal of Reproduction and Contraception 2024;44(11):1156-1163
Objective:To observe the effect of the Yushen Yangluan decoction on ovarian reserve function in mice with diminished ovarian reserve (DOR) and to explore its mechanism of action based on the hypoxia-inducible factor (HIF)-1α/vascular endothelial growth factor A (VEGFA) signaling pathway.Methods:Mechanism analysis was conducted using artificial intelligence-based network pharmacology. Fifty 6-week-old female C57BL/6 mice were randomly divided into five groups according to body weight, with 10 mice in each group. The groups were as follows: control group, model group, low-dose Traditional Chinese Medicine (TCM) group, medium-dose TCM group, and high-dose TCM group. Hematoxylin-eosin staining was used to observe the number of antral follicles in the ovaries, enzyme-linked immunosorbent assay was employed to detect serum hormone levels, and TdT-mediated dUTP nick end labeling (TUNEL) was used to assess apoptosis in ovarian granulosa cells. Immunohistochemistry (IHC) was performed to detect ovarian expression of HIF-1α, and Western blotting was used to measure the protein expressional levels of HIF-1α, VEGFA, and B-cell lymphoma-2 (BCL2) in the ovaries.Results:After treating DOR model mice with the Yushen Yangluan decoction at low, medium, and high dosages, the ovarian antral follicle count of the mice in the TCM groups was all higher than that in the model group ( P=0.024, P<0.001, P<0.001), the follicle-simulating hormone level was lower than that in the model group ( P=0.003, P<0.001, P<0.001), and the serum anti-Müllerian hormone level in the medium-and high-dose TCM groups was higher than that in the model group ( P=0.001, P<0.001). Network pharmacology and molecular docking suggested that the formula may influence the HIF signaling pathway through core targets such as HIF-1α, BCL2 and VEGFA. TUNEL assays indicated that the apoptosis rate of ovarian granulosa cells in the low-, medium-, and high-dose TCM groups was significantly lower than that in the model group ( P=0.017, P=0.003, P<0.001). Immunohistochemistry results showed that the expression level of HIF-1α in the granulosa cells of the follicles in the low-, medium- and high-dose TCM groups was significantly higher than that in the model group ( P=0.008, P<0.001, P<0.001). Western blotting analysis indicated that the protein expression level of HIF-1α in medium-, and high-dose TCM groups was significantly higher than that in the model group ( P=0.004, P<0.001), and the protein expression levels of VEGFA and BCL2 in low-, medium-, and high-dose TCM groups were significantly higher than those in the model group ( P=0.003, P=0.002, P=0.001; P=0.029, P=0.007, P=0.001). Conclusion:The Yushen Yangluan decoction may exert its therapeutic effect by inhibiting apoptosis of ovarian granulosa cells through the HIF-1α/VEGFA signaling pathway.
9.Research progress of the relationship between non-coding RNA and gestational diabetes mellitus
Weiqiang ZHU ; Zhaofeng ZHANG ; Min LI ; Jianhua XU ; Shangqing LIU ; Weijin ZHOU ; Jing DU
Chinese Journal of Reproduction and Contraception 2020;40(10):853-858
With the increase of obesity and type 2 diabetes, gestational diabetes mellitus (GDM) is growing public health problem worldwide. GDM is one of the most ubiquitous diseases affecting pregnancy outcomes in perinatal women, which increases the incidence of adverse outcomes such as miscarriage, macrosomia, premature birth and stillbirth. Non-coding RNA (ncRNA) plays an important role in regulating the occurrence and development of GDM, and it is also related to the occurrence of complications of GDM. NcRNA is a type of RNA that don't encode proteins, including long non-coding RNA (LncRNA), microRNA (miRNA) and circular RNA (circRNA). More and more studies show ncRNA contains abundant information. This review discusses the relationship between three kinds of ncRNA and GDM, in aim to provide theoretical basis for further research on gestational diabetes.
10.Research progress of the relationship between non-coding RNA and gestational diabetes mellitus
Weiqiang ZHU ; Zhaofeng ZHANG ; Min LI ; Jianhua XU ; Shangqing LIU ; Weijin ZHOU ; Jing DU
Chinese Journal of Reproduction and Contraception 2020;40(10):853-858
With the increase of obesity and type 2 diabetes, gestational diabetes mellitus (GDM) is growing public health problem worldwide. GDM is one of the most ubiquitous diseases affecting pregnancy outcomes in perinatal women, which increases the incidence of adverse outcomes such as miscarriage, macrosomia, premature birth and stillbirth. Non-coding RNA (ncRNA) plays an important role in regulating the occurrence and development of GDM, and it is also related to the occurrence of complications of GDM. NcRNA is a type of RNA that don't encode proteins, including long non-coding RNA (LncRNA), microRNA (miRNA) and circular RNA (circRNA). More and more studies show ncRNA contains abundant information. This review discusses the relationship between three kinds of ncRNA and GDM, in aim to provide theoretical basis for further research on gestational diabetes.

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