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.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.
3.Effectiveness of extensively hydrolyzed formula in treating feeding intolerance in preterm infants
Hanshu YU ; Ruizhen SUN ; Yanling YANG ; Yuehua SU ; Zhongying FU
Chinese Journal of Child Health Care 2024;32(4):456-459
【Objective】 To analyze the effect of extensively hydrolyzed formula(eHF) in the treatment of feeding intolerance in preterm infants and the effect on hospital infection, in order to provide reference for the clinical treatment of feeding intolerance in preterm infants. 【Methods】 A total of 208 cases of preterm infants with feeding intolerance diagnosed and treated in Shandong Heze Municipal Hospital from April 2017 to February 2020 were selected into the clinical trial for eligibility assessment, then were randomly assigned into study group(n=100) and control group(n=100) after screening and exclusion. Children in the control group were fed with standard preterm formula, while children in the study group were fed with eHF. Feeding tolerance indicators, including daily milk intake, time to meconium evacuation, time to full gastrointestinal nutrition, total gastric residual counts(GRV1) in the 7-d period after resumption of breastfeeding, ratio of all-day gastric residual counts/all-day estimated milk intake after resumption of breastfeeding(GRV2) were compared between the two groups, and growth indicators(body weight growth rate, head dimension growth rate), complication incidence [necrotizing enterocolitis(NEC), pathological jaundice, positive fecal occult blood or blood in stool] and incidence of hospital-acquired infections. 【Results】 The daily milk intake(t=5.037) of the study group was higher than that of the control group, and the time of foetal excretion(t=9.217), the time to reach full gastrointestinal nutrition(t=15.833), GRV1(t=6.737), GRV2(t=9.956) were lower than those of the control group, and the differences were all statistically significant(P<0.05). The rate of weight gain(t=2.454) and head dimension growth(t=5.469) in the study group was significantly higher than those of the control group(P<0.05). The incidence of the three complications of NEC, pathological jaundice and positive fecal occult blood or blood in stool(χ2=4.310) and the incidence of hospital infections(χ2=4.688) were significantly lower in the study group than in the control group(P<0.05). 【Conclusions】 Compared with the standard formula milk for preterm infants, eHF can significantly improve the feeding intolerance of preterm infants, promote growth and development, and reduce the occurrence of hospital-acquired infections. Therefore, eHF can be widely used in clinic for preterm infants with feeding intolerance.
4.Efficacy of low extra-abdominal aortic block in cesarean section for placenta accreta spectrum disorders and its effect on the expression of MDA and SOD.
Ruizhen LI ; Moothoosamy SOMASODIRAN ; Tao SUN ; Chunxia CHEN ; Mailian LONG ; Dabao XU
Journal of Central South University(Medical Sciences) 2022;47(8):1129-1135
OBJECTIVES:
Placenta accreta spectrum disorders (PAS) refers to a group of abnormalities in placental adhesion and invasion, which may lead to serious complications such as intractable postpartum hemorrhage. The use of low-level extra-abdominal aortic temporary block during cesarean section may reduce intraoperative bleeding in patients with PAS, but it may also cause ischemia-reperfusion injury. In this study, we intend to investigate the efficacy of low extra-abdominal aortic block in cesarean section for placental implantation disease and its effect on malondialdehyde (MDA) level and superoxide dismutase (SOD) activity, and analyze the severity of ischemia-reperfusion injury caused by them.
METHODS:
Pregnant women with invasive placenta accreta spectrum disorders who delivered in the Department of Obstetrics and Gynecology of the Third Xiangya Hospital of Central South University from July 2017 to July 2021, were selected, and they were divided into 2 groups. Group A consisted of those who underwent low extra-abdominal aortic block during cesarean section (n=15) and group B consisted of those who did not undergo extra-abdominal aortic block (n=15). The intraoperative bleeding, blood transfusion, hysterectomy and complication rate, postoperative hospital stay and hospitalization expenses were compared between the 2 groups to analyze the efficacy of abdominal aortic block. The biochemical indexes related to ischemia-reperfusion, MDA content and total superoxide dismutase (T-SOD) activity, were measured at the corresponding time points in both groups. The time points of each test were: in group A, before the block of the low extra-abdominal aorta after delivery (A0), 0 h (A1, when the myometrium was started to be sutured), 0.5 h (A2), 2 h (A3), and 4 h (A4) after the open block; in group B, after delivery of the fetus (B0), 0 h (B1), 0.5 h (B2), 2 h (B3), and 4 h (B4) after the myometrium was started to be sutured. Total duration of abdominal aortic block in group A was also recorded. Both groups were observed for sings of edema, ischemia, necrosis and infection in the limbs after surgery. The severity of ischemia-reperfusion injury caused by abdominal aortic block were determined by detecting the relevant biochemical indexes at different moments of reperfusion.
RESULTS:
The intraoperative bleeding and blood transfusion in group A were less than those in group B, and the difference was statistically significant (P<0.05). There was no significant difference in postoperative hospital stay and hospitalization expenses between the 2 groups (P>0.05). Surgical complications: in group A, the uterus was preserved in all cases, there was 1 bladder injury and 2 pelvic infections; while in group B, there was 1 hysterectomy, 3 bladder injuries, and 3 pelvic infections. Changes in T-SOD and MDA values: compared with A0 before block, the MDA level was significantly elevated in blood at time points A1, A2, and A3, while SOD activity was significantly decreased (P<0.05), and the 2 observed indexes basically returned to A1 level (ischemic period) at 4 h after open block (A4). There was no significant difference in the changes of T-SOD and MDA in group B (P>0.05). Comparison of T-SOD and MDA levels between group A and B: the difference of the 2 indexes was not statistically significant between A0 and B0 (P>0.05), MDA level was not statistically significant between A1 and B1, T-SOD activity at A1 was lower than B1, the difference was statistically significant, at the rest of the same time point, MDA level in group A were higher than that in group B, T-SOD activity in group A were lower than that in group B, the difference was statistically significant (P<0.05). No postoperative limb edema, ischemia, necrosis, or infection occurred in both groups.
CONCLUSIONS
Low-level extra-abdominal aortic block effectively reduces bleeding and transfusion during cesarean section for placenta accreta spectrum disorders, resulting in a transient MDA elevation and a decrease of SOD activity, which means causing transient ischemia-reperfusion injury without complications such as limb edema, ischemia, necrosis, and infection.
Aorta, Abdominal/surgery*
;
Cesarean Section
;
Female
;
Humans
;
Ischemia
;
Necrosis
;
Pelvic Infection
;
Placenta/metabolism*
;
Placenta Accreta/surgery*
;
Pregnancy
;
Reperfusion Injury
;
Superoxide Dismutase/metabolism*
5.Regulation of crop agronomic traits and abiotic stress responses by brassinosteroids: a review.
Liming WANG ; Ruizhen YANG ; Jiaqiang SUN
Chinese Journal of Biotechnology 2022;38(1):34-49
Plant adaptation to adverse environment depends on transmitting the external stress signals into internal signaling pathways, and thus forming a variety of stress response mechanisms during evolution. Brassinosteroids (BRs) is a steroid hormone and widely involved in plant growth, development and stress response. BR is perceived by cell surface receptors, including the receptor brassinosteroid-insensitive 1 (BRI1) and the co-receptor BRI1-associated-kinase 1 (BAK1), which in turn trigger a signaling cascade that leads to the inhibition of BIN2 and activation of BES1/BZR1 transcription factors. BES1/BZR1 can directly regulate the expression of thousands of downstream responsive genes. Studies in the model plant Arabidopsis thaliana have shown that members of BR biosynthesis and signal transduction pathways, particularly protein kinase BIN2 and its downstream transcription factors BES1/BZR1, can be extensively regulated by a variety of environmental factors. In this paper, we summarize recent progresses on how BR biosynthesis and signal transduction are regulated by complex environmental factors, as well as how BR and environmental factors co-regulate crop agronomic traits, cold and salt stress responses.
Arabidopsis/metabolism*
;
Brassinosteroids/pharmacology*
;
DNA-Binding Proteins/metabolism*
;
Gene Expression Regulation, Plant
;
Stress, Physiological
6.Effect of macrophages on the differentiation of mouse induced pluripotent stem cells into hepatic progenitor cells
Tiantian GONG ; Shaogang HUANG ; Ruizhen SUN ; Jingling SHEN ; Qiuming LI ; Lei LEI ; Zhiyan SHAN
Journal of Clinical Hepatology 2021;37(4):852-856
ObjectiveTo investigate the effect of macrophages (MCs) on the differentiation of mouse induced pluripotent stem cells (iPSCs) into hepatic progenitor cells (HPCs). MethodsA total of 24 C57BL/6N mice were used to obtain MCs by peritoneal irrigation, and the supernatant was collected to obtain the conditioned medium of MCs (MC-CDM). Activin A, bone morphogenetic protein 4, and fibroblast growth factor were used to induce the differentiation of mouse iPSCs into HPCs. The differentiation of HPCs were randomly divided into control group (normal medium) and experimental group (MC group; use of MC-CDM medium on day 5 of induction). Morphology, immunofluorescence assay, and Western blot were used to compare the morphology of HPCs and the expression of related proteins between the control group and the MC group. The t-test was used for comparison of continuous data between two groups. ResultsHPCs derived from iPSCs were established in vitro, and HPCs had the potential to differentiate into hepatocytes. Immunofluorescence assay showed that compared with the D12 control group, the D12 MC group had a significant increase in the protein expression of the HPC-specific protein CK19 (0.901±0.072 vs 0.686±0.097, t=-3.093, P<0.05). Western blot showed that compared with the D12 control group, the D12 MC group had a significant increase in the protein expression of the HPC-related protein CK19 (1.922±0.103 vs 1.448±0.012, t =-7.881, P <005), as well as a significant increase in the protein expression of the autophagy-related protein LC3 (1.392±0.042 vs 1.101±0048, t =-5.978, P<005). ConclusionMCs can promote the differentiation of mouse iPSCs into HPCs, possibly by increasing the autophagy level of HPCs.
7.Exploration of nursing development mode at a research hospital
Hongying PI ; Junyan GUO ; Ruizhen LI ; Tingting SUN ; Yanshuang CHENG ; Chang WEI
Chinese Journal of Hospital Administration 2016;(1):64-67
This article described the background,concept,characteristic and objective of the research-based nursing,systematically introducing the main measures including management mechanism, nursing service,nursing staff training,and nursing scientific development.Other areas covered include innovation management mechanism,updating service philosophy,improving nursing staff training,and constructing scientific research platform.
8.Disinfection efficacy of different disinfectants on dental unit waterlines
Ying XU ; Hongmei WU ; Ying YE ; Ning GU ; Jianrong YANG ; Zhida SUN ; Ruizhen LIANG
Chinese Journal of Infection Control 2015;(1):23-26
Objective To compare the disinfection efficacy of different disinfectants on dental unit waterlines (DUWLs). Methods 18 sets of DUWLs were randomly divided into 4 groups,and disinfected or treated with hydrogen peroxide (H2 O2 )disinfectant,sodium hypochlorite (NaClO)disinfectant,hydrogen peroxide silver ion disinfectant(Sanosil),and distilled water (DW)respectively.Water specimens from triple syringes and high-speed handpieces were taken,bacterial count before and after disinfection were compared.Results Before disinfection,no significant differences in bacterial counts were found among four groups (all P >0.05),bacterial counts of DUWLs of all groups severely exceeded the standard(all>3 000 CFU/mL).After disinfection,except DW group,bacterial counts of DUWLs of the other groups declined dramat-ically (all <100 CFU/mL),bacterial count after disinfection were all obviously lower than before disinfection (all P <0.001 ).One week after disinfection,bacterial counts among three disinfectant groups in different time periods were statisti-cally different (triple syringes:Day1—Day5,all P <0.05;high-speed handpieces:Day2,Day3 and Day5,all P <0.05). Day3 after disinfection of triple syringes by H2 O2 and NaClO,Day4 after disinfection of high-speed handpieces by H2 O2 and NaClO,and Day5 of triple syringes and high-speed handpieces by Sanosil all exceeded the standard of Center for Disease Control and Prevention of America.One week after disinfection,bacterial counts of three disinfection groups all exceeded or approximated to that before disinfection.Conclusion Three types of disinfectants can all effectively reduce bacterial load in DUWLs.Compared with other disinfectants,Sanosil has advantage of inhibiting bacterial growth after disinfection.
9.Automated breast volume imaging with color doppler ultrasound in evaluating effect of neoadjuvant chemotherapy for breast cancer
Jianna SUN ; Ruizhen LUO ; Lingjun KONG ; Feng GAO ; Hua XU ; Hongyu SONG ; Mei HUANG
Chinese Journal of Clinical Oncology 2014;(14):913-916
Objective: To explore automatic breast full volume imaging (ABVS) and color doppler ultrasound (CDFI) for breast cancer neoadjuvant chemotherapy (NCT) in the evaluation of curative effect. Methods:The application of a CDFI and ABVS 42 cases of breast cancer patients receiving NCT lesions imaging characteristics before and after observation and analysis. Results:ABVS from coronal distribution and audio-visual change according to the primary tumor, and CDFI images showing the primary tumors and blood flow changes within all have significant difference in patients with complete remission after NCT (P<0.01);ABVS from coronal distri-bution and audio-visual change according to the primary tumor, and CDFI showed lesions in blood flow changes, etc. in patients with the absence of change and easing some lesions have no significant difference (P>0.05). Conclusion:We use ABVS and CDFI for breast cancer before and after the NCT curative effect evaluation of great clinical significance and value.
10.The development and implementation of hospital-community Interactive nursing mode for patients with diabetes
Mei LI ; Ruizhen XU ; Tao SUN ; Suxia CHEN ; Shaoru SU ; Junying ZHAI ; Zhenzhen ZHANG
Chinese Journal of Nursing 2009;44(8):703-704
This paper introduces the development and implementation of hospital-community interactive nursing mode for patients with diabetes. The interactive mode between community and hospital,specialist nurses and community nurses,as well as patients and nurses was formed to provide timely,convenient,continuous and whole-process nursing care for diabetic patients through the setting up and services of hespital-based diabetes care team,two-way transfer center between hospital and commu-nity,hospital-based education and community-based visit team,community-based self-management group as well as green chan-nel of priority treatment,inspection and hospitalization for diabetic patients. The implementation of the interactive mode achieved good effect and was approved by the patients. The patient satisfaction rate was 96.5%.

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