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.Comparison of Two Methods of LPS-Induced Two-Hit Acute Lung Injury Models and Analysis of Clinical Syndrome Characteristics in Chinese and Western Medicine
Guofeng CHEN ; Junqing LIANG ; Xu HE ; Xiaojia HUANG ; Ye LIN ; Jing SUN ; Yan LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(8):2340-2350
Objective To explore the efficacy of two lipopolysaccharide(LPS)two-hit methods in establishing an acute lung injury(ALI)mouse model and analyze the characteristics of this model within the context of both Western and traditional Chinese medicine(TCM).Methods Healthy male C57BL/6 mice were randomly divided into six groups:PBS instillation control group,PBS nebulization control group,instillation two-hit group,nebulization two-hit group I,nebulization two-hit group Ⅱ,and nebulization two-hit group Ⅲ.Using LPS as a stimulant,a"two-hit"approach was employed to establish an ALI mouse model.Body temperature,weight,pulse oximetric oxygen saturation(SpO2),lung tissue wet-to-dry weight ratio(W/D),levels of tumor necrosis factor(TNF-α),interleukin-1β(IL-1β),and myeloperoxidase(MPO)activity in lung tissue,as well as total protein concentration and white blood cell count in bronchoalveolar lavage fluid were measured.Through evaluating the consistency between TCM and Western medical syndromes,the classification,characteristics,modeling methods,advantages,and disadvantages of the two-hit ALI animal model were summarized and analyzed based on the clinical diagnostic criteria and syndrome characteristics of ALI in both TCM and Western medicine.Results Compared with the control group,the body temperature,weight,and SpO2 of model group decreased,W/D increased,levels of TNF-α,IL-1β,and MPO activity in lung tissue increased.The alveolar walls thickened with a large exudate of red blood cells.The total protein concentration and white blood cell count in bronchoalveolar lavage fluid significantly increased.The existing two-hit ALI animal model showed a high degree of consistency with Western medical diagnostic main symptoms.Conclusion Both methods of two-hit can prepare mouse ALI models,among which the nebulization two-hit Group Ⅲ showed more pronounced effects in simulating the pathological changes and clinical symptoms of ALI.
3.Study on the role of coatomer protein Ⅰ in apolipoprotein A-1-mediated cholesterol efflux from foam cells
Weitao HONG ; Feilong ZHANG ; Jie HUANG ; Yumin LIANG ; Gengji CHEN ; Xiaojia CHEN ; Weilie MA ; Hang DING ; Zhizhen ZHANG
Chongqing Medicine 2025;54(3):580-587
Objective To establish a human monocytic THP-1 macrophage-derived foam cell model and analyze the role of the α subunit of coatomer protein Ⅰ(α-COP)in apolipoprotein A-1(apoA-1)-mediated cholesterol efflux from foam cells.Methods THP-1 cells were induced to adhere using PMA(PMA group),followed by treatment with acetylated low-density lipoprotein(Ac-LDL)to generate macrophage-derived foam cells(Ac-LDL group).Subsequent incubation with apoA-1 formed the apoA-1 group.Cholesterol efflux rates mediated by apoA-1 and intracellular lipid accumulation were quantified through liquid scintillation counting and oil red O staining.The expression patterns of α-COP were systematically analyzed using quantitative real-time PCR(qPCR),Western blotting,and laser scanning confocal microscopy.THP-1 macrophage-derived foam cells mediated by apoA-1 were transduced with scrambled shRNA(Scr group)or α-COP-specific shRNA lentivirus(α-COP shRNA group)to assess the effects of α-COP knockdown on cholesterol efflux efficiency and total cellular cholesterol content.Subcellular localization of adipopoilin(ADFP)and cholesterol probe Fil-ipin Ⅲ staining patterns were visualized via laser scanning confocal microscopy.Bioinformatics analysis of α-COP expression profiles in carotid atherosclerotic plaques was performed using datasets from the GEO data-base.Results Compared with the Ac-LDL group,the cholesterol efflux rate in the apoA-1 group was signifi-cantly increased[(9.77±0.79)%vs.(2.74±0.37)%,P<0.001].Oil red O staining demonstrated reduced lipid accumulation in foam cells of the apoA-1 group compared with the Ac-LDL group.The relative mRNA expression level of α-COP in the apoA-1 group was significantly higher than that in the Ac-LDL group(P<0.001),with corresponding elevation in protein expression(P<0.001).Fluorescence intensity analysis re-vealed increased mean fluorescence intensity of α-COP in the apoA-1 group compared with the Ac-LDL group.Following α-COP knockdown by shRNA,the apoA-1-mediated cholesterol efflux rate was significantly de-creased(P<0.05)and total intracellular cholesterol levels were increased(P<0.001)in the α-COP shRNA group compared with the Scr group.The α-COP shRNA group exhibited enhanced red fluorescence intensity of ADFP(P<0.05)and increased blue fluorescence intensity of Filipin Ⅲ(P<0.01)compared with the Scr group.Database analysis indicated that α-COP mRNA expression was lower in carotid atherosclerotic plaques than in normal arterial tissues,with reduced expression in advanced-stage plaques compared with early-stage plaques(P<0.05).Conclusion α-COP participates in apoA-1-mediated cholesterol efflux from foam cells,and interference with α-COP expression results in reduced cholesterol efflux and increased intracellular lipid accumulation.
4.Comparison of Two Methods of LPS-Induced Two-Hit Acute Lung Injury Models and Analysis of Clinical Syndrome Characteristics in Chinese and Western Medicine
Guofeng CHEN ; Junqing LIANG ; Xu HE ; Xiaojia HUANG ; Ye LIN ; Jing SUN ; Yan LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(8):2340-2350
Objective To explore the efficacy of two lipopolysaccharide(LPS)two-hit methods in establishing an acute lung injury(ALI)mouse model and analyze the characteristics of this model within the context of both Western and traditional Chinese medicine(TCM).Methods Healthy male C57BL/6 mice were randomly divided into six groups:PBS instillation control group,PBS nebulization control group,instillation two-hit group,nebulization two-hit group I,nebulization two-hit group Ⅱ,and nebulization two-hit group Ⅲ.Using LPS as a stimulant,a"two-hit"approach was employed to establish an ALI mouse model.Body temperature,weight,pulse oximetric oxygen saturation(SpO2),lung tissue wet-to-dry weight ratio(W/D),levels of tumor necrosis factor(TNF-α),interleukin-1β(IL-1β),and myeloperoxidase(MPO)activity in lung tissue,as well as total protein concentration and white blood cell count in bronchoalveolar lavage fluid were measured.Through evaluating the consistency between TCM and Western medical syndromes,the classification,characteristics,modeling methods,advantages,and disadvantages of the two-hit ALI animal model were summarized and analyzed based on the clinical diagnostic criteria and syndrome characteristics of ALI in both TCM and Western medicine.Results Compared with the control group,the body temperature,weight,and SpO2 of model group decreased,W/D increased,levels of TNF-α,IL-1β,and MPO activity in lung tissue increased.The alveolar walls thickened with a large exudate of red blood cells.The total protein concentration and white blood cell count in bronchoalveolar lavage fluid significantly increased.The existing two-hit ALI animal model showed a high degree of consistency with Western medical diagnostic main symptoms.Conclusion Both methods of two-hit can prepare mouse ALI models,among which the nebulization two-hit Group Ⅲ showed more pronounced effects in simulating the pathological changes and clinical symptoms of ALI.
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.A systematic review of efficacy,safety and acceptability of pharmacological treatment of mixed states in bipolar disorder
Xiaojia HUANG ; Leping HUANG ; Yuncheng ZHU ; Ni ZHOU ; Jun CHEN ; Daihui PENG ; Yiru FANG ; Zuowei WANG
Chinese Journal of Nervous and Mental Diseases 2024;50(11):681-687
To evaluate the efficacy,safety and acceptability of different drugs in the treatment of mixed states in bipolar disorder using the Cochrane systematic review method. The results showed that for the treatment of bipolar depression with mixed features,there is evidence to support the efficacy of lurasidone and quetiapine. Lurasidone has low metabolic and sedative side effects,and can be used in children and adolescents with bipolar depression with mixed features. Quetiapine has balanced anti-depressant and anti-manic effects,with low risk of phase transition. There is evidence to support the efficacy of olanzapine in the treatment of bipolar manic with mixed features. However,it is necessary to balance the efficacy and side effects of olanzapine,and pay attention to the risk of phase transition. For mixed episode in Bipolar disorder,aripiprazole had most research evidence. Aripiprazole has fewer side effects on metabolism and prolactin,and can be used in children with bipolar disorder. Valproate and lithium are recommended by experts for the treatment of mixed state in bipolar disorder. The inconsistency between current studies is still significant,and high-quality randomized controlled trials are urgently needed to provide more comprehensive evidence-based support for the treatment of mixed states in bipolar disorder.
7.Qualitative research on post competence of nursing staff in large surface ships
Anhua QIAO ; Xiaojia HUANG ; Fei PENG ; Liandi GAO ; Jingjing WANG ; Xiedong SHEN
Journal of Navy Medicine 2024;45(2):125-129
Objective To explore the characteristic elements of post competence of nursing staff in large surface ships medical support,and to provide reference for the special training within military hospital and training for dispatched nursing staff.Methods Sixteen medical people who have carried out the large surface ship medical support were selected as research objects using the purposive sampling method.One-to-one semi-structured interviews were performed.The Colaizzi phenomenological analysis was used to carefully sort out and analyze the obtained data and summarize the theme.Results The core competency characteristics of nursing staff during the large surface ships medical support were extracted,including four elements:professional knowledge of common diseases on ships,professional nursing skills on ships,rescue professional ability in ships,and military quality.Conclusion It is essential to construct nursing staff training,system based on the core competencies of large surface ships medical support,and to reserve military nursing talents in daily training,so as to complete medical support tasks with high standards.
8.Development and application of a standard operating procedure for perioperative nursing cooperation in corneal collagen cross-linking surgery
Jiayi LI ; Weixin ZHENG ; Jingwen SONG ; Xiaojia ZHOU ; Ting WANG ; Lilian CAI ; Dandan GE ; Mengyi LONG ; Ping LI ; Ying WANG ; Wenmin HUANG
Modern Clinical Nursing 2024;23(10):66-72
Objective To establish a standard operating procedure(SOP)for perioperative nursing cooperation in the corneal collagen cross-linking surgery and explore the effect of clinical application in order to improve the quality and efficiency of the management in clinical practice.Methods A research team was established in October 2022 to construct a patient-orientated standard operating procedure for perioperation nursing cooperation in corneal collagen cross-linking surgery.With the before-after control method,170 patients who underwent single eye rapid epithelial-off corneal collagen cross-linking surgery between April 2022 and July 2023 were selected.Totally 85 case form April to October 2022 were assigned into a control group and 85 cases form November 2022 to July 2023 were assigned into a trial group.The control group received a routine perioperative nursing,while the trial group received the standard operating procedure(SOP)for perioperative nursing on the basis of the control group.The two groups were compared in terms of surgical duration,surgical connection duration,perioperative time,surgeon's satisfaction,nurse's job satisfaction and patient's satisfaction.Results The trial group had significantly shorter surgical duration,connection duration and perioperative duration than those of the control group(all P<0.001).The trial group showed significantly higher scores in satisfactions of doctor,nurse and patient in comparison with the control group(all P<0.001).Conclusion The SOP for perioperative nursing cooperation in the corneal collagen cross-linking surgery not only improve the efficiency among the medical team,work quality and services level,but also improve the satisfaction of doctors and patients towards the nursing care and enhance nurse's sense of identity with nursing work.
9.Development and application of a standard operating procedure for perioperative nursing cooperation in corneal collagen cross-linking surgery
Jiayi LI ; Weixin ZHENG ; Jingwen SONG ; Xiaojia ZHOU ; Ting WANG ; Lilian CAI ; Dandan GE ; Mengyi LONG ; Ping LI ; Ying WANG ; Wenmin HUANG
Modern Clinical Nursing 2024;23(10):66-72
Objective To establish a standard operating procedure(SOP)for perioperative nursing cooperation in the corneal collagen cross-linking surgery and explore the effect of clinical application in order to improve the quality and efficiency of the management in clinical practice.Methods A research team was established in October 2022 to construct a patient-orientated standard operating procedure for perioperation nursing cooperation in corneal collagen cross-linking surgery.With the before-after control method,170 patients who underwent single eye rapid epithelial-off corneal collagen cross-linking surgery between April 2022 and July 2023 were selected.Totally 85 case form April to October 2022 were assigned into a control group and 85 cases form November 2022 to July 2023 were assigned into a trial group.The control group received a routine perioperative nursing,while the trial group received the standard operating procedure(SOP)for perioperative nursing on the basis of the control group.The two groups were compared in terms of surgical duration,surgical connection duration,perioperative time,surgeon's satisfaction,nurse's job satisfaction and patient's satisfaction.Results The trial group had significantly shorter surgical duration,connection duration and perioperative duration than those of the control group(all P<0.001).The trial group showed significantly higher scores in satisfactions of doctor,nurse and patient in comparison with the control group(all P<0.001).Conclusion The SOP for perioperative nursing cooperation in the corneal collagen cross-linking surgery not only improve the efficiency among the medical team,work quality and services level,but also improve the satisfaction of doctors and patients towards the nursing care and enhance nurse's sense of identity with nursing work.
10.A systematic review of efficacy,safety and acceptability of pharmacological treatment of mixed states in bipolar disorder
Xiaojia HUANG ; Leping HUANG ; Yuncheng ZHU ; Ni ZHOU ; Jun CHEN ; Daihui PENG ; Yiru FANG ; Zuowei WANG
Chinese Journal of Nervous and Mental Diseases 2024;50(11):681-687
To evaluate the efficacy,safety and acceptability of different drugs in the treatment of mixed states in bipolar disorder using the Cochrane systematic review method. The results showed that for the treatment of bipolar depression with mixed features,there is evidence to support the efficacy of lurasidone and quetiapine. Lurasidone has low metabolic and sedative side effects,and can be used in children and adolescents with bipolar depression with mixed features. Quetiapine has balanced anti-depressant and anti-manic effects,with low risk of phase transition. There is evidence to support the efficacy of olanzapine in the treatment of bipolar manic with mixed features. However,it is necessary to balance the efficacy and side effects of olanzapine,and pay attention to the risk of phase transition. For mixed episode in Bipolar disorder,aripiprazole had most research evidence. Aripiprazole has fewer side effects on metabolism and prolactin,and can be used in children with bipolar disorder. Valproate and lithium are recommended by experts for the treatment of mixed state in bipolar disorder. The inconsistency between current studies is still significant,and high-quality randomized controlled trials are urgently needed to provide more comprehensive evidence-based support for the treatment of mixed states in bipolar disorder.

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