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.Research progress on protective effect of hydrogen molecule and its products on lung transplantation
Menggen LIU ; Peizhi LIU ; Hongtao TANG ; Heng HUANG ; Dong TIAN
Organ Transplantation 2023;14(2):300-
Ischemia-reperfusion injury after lung transplantation is the main cause of primary graft dysfunction, which will subsequently reduce the function of lung allograft and lower the overall survival rate of lung transplant recipients. As a physiological regulatory molecule, hydrogen molecule has the functions of anti-inflammation, easing oxidative stress, alleviating direct cell injury and mitigating epithelial edema. Recent studies have demonstrated that hydrogen molecule and its products (hydrogen and hydrogen-rich solution) could significantly mitigate ischemia-reperfusion injury and postoperative complications after lung transplantation. In this article, the protective effect and exact mechanism of hydrogen molecule and its products in lung transplantation were reviewed, aiming to provide theoretical basis for the application of hydrogen molecule and its products as a novel treatment for lung transplantation-related complications, enhance the overall prognosis and improve the quality of life of lung transplant recipients
4.Association between inflammation, body mass index, and long-term outcomes in patients after percutaneous coronary intervention: A large cohort study.
Guyu ZENG ; Deshan YUAN ; Sida JIA ; Peizhi WANG ; Liu RU ; Tianyu LI ; Ce ZHANG ; Xueyan ZHAO ; Song LEI ; Lijian GAO ; Jue CHEN ; Yuejin YANG ; Shubin QIAO ; Runlin GAO ; Xu BO ; Jinqing YUAN
Chinese Medical Journal 2023;136(14):1738-1740
5.A modified mouse model of orthotopic left lung transplantation based on "pendulum" anastomosis of the reverse-view plane (with video demonstration)
Caihan LI ; Heng HUANG ; Junjie WANG ; Hongtao TANG ; Ye WU ; Senlin HOU ; Peizhi LIU ; Wan YANG ; Tingting CHEN ; Shengxuan ZHANG ; Siyi FU ; Yujie ZUO ; Junjie YANG ; Haoji YAN ; Dong TIAN
Organ Transplantation 2022;13(5):634-
Objective To modify the mouse model of orthotopic left lung transplantation from different perspectives, aiming to establish a simpler, faster and stabler mouse model of lung transplantation. Methods Based on preliminary modified rat model of orthotopic left lung transplantation established by our team, varying extent of modifications were made regarding the tracheal intubation, cannula preparation and anastomosis procedures of orthotopic left lung transplantation in the recipient mice. Orthotopic left lung transplantation in 40 mice were performed by an operator with microsurgical experience. The dissection of the recipient's hilar structure was carried out at the plane of the hilar clamp model within the reverse-view, and the three branches (left main bronchus, pulmonary artery and pulmonary vein) of the pulmonary hilum were anastomosed in turn by the "pendulum" anastomosis method. The operation time of each procedure was recorded. The recipient mice were sacrificed at postoperative 2 weeks, and the incidence of postoperative complications was recorded. Results Lung transplantation was successfully completed in 40 mice, with no bronchial and vascular tearing or twisting, and no bleeding at the anastomosis site. The overall cardiopulmonary procurement time was (10.7±1.5) min, cannula preparation time was (16.2±1.5) min, cold ischemia time was (25.1±2.4) min, warm ischemia time was (19.4±1.6) min, and the total operation time was (57.2±2.9) min, respectively. During the follow-up from 6 to 14 days after surgery, one recipient mouse died of pleural effusion, probably caused by infection. No pneumothorax, thrombosis or atelectasis was found in the remaining recipient mice during postoperative follow-up. Conclusions The modified mouse model of orthotopic left lung transplantation based on "pendulum" anastomosis of the reverse-view plane possesses multiple advantages of short operation time, high success rate and few complications, which is expected to become an alternative model of studying pathological changes after lung transplantation and worthy of further application.
6.The effects of salidroside on cognitive function and expression of inflammatory factor in diabetic rats
Na LIU ; Xiao WANG ; Li MENG ; Peizhi WANG ; Mingwei WANG
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2018;25(3):233-236
Objective To observe the effect of salidroside on the cognitive dysfunction of rats with diabetes induced by streptozotocin (STZ) and to explore its related mechanisms. Methods According to the random number table method, 45 Sprague-Dawley (SD) rats were divided into three groups: the normal control, diabetic model and salidroside groups, 15 rats in each group. The diabetic rat model was established by intra-peritoneal injection of 60 mg/kg STZ (72 hours after STZ injection, the caudal venous blood glucose was measured by a glucose meter, if the glucose level reached >16.7 mmol/L , the model was regarded as a successful one). The rats in the normal control group were injected with equal volume of citrate buffer. After model making, the salidroside group was treated with salidrosidec 15 mg/kg by intragastric administration; the normal control group and the diabetic model group were given the same volume of normal saline for gavage, 1 times a day. Morris water maze was used to test cognitive function in rats after consecutive four weeks of treatment, and the blood glucose levels of rats in various groups were detected at the onset and the end of the experiment; the protein expression and contents of tumor necrosis factor-α (TNF-α) and intedeukin-6 (IL-6) in hippocampus were detected by enzyme linked immunosorbent assay (ELISA) and Western Blot analysis. Results Compared with the normal control group, the escape latency in diabetic model group was significantly prolonged (seconds: 62.54±7.67 vs. 19.37±4.23), the time in target quadrant was shortened (seconds:18.76±4.75 vs. 43.09±8.09), the number of crossing platform was also obviously reduced (frequency: 2.26±0.57 vs. 6.84±1.56), blood glucose levels were significantly higher (mmol/L: 24.27±3.69 vs. 6.95±1.52), protein expressions and contents of TNF-α and IL-6 in hippocampus were markedly increased [TNF-α (μg/L): 482.09±45.72 vs. 92.53±14.84, IL-6 (μg/L): 8.26±1.14 vs. 3.03±0.48; TNF-α protein (A value): 0.61±0.15 vs. 0.25±0.04, IL-6 protein (A value): 0.53±0.11 vs. 0.12±0.03, all P < 0.05]. Compared with the diabetic model group, the escape latency in salidroside group was significantly shortened (seconds: 38.07±5.84 vs. 62.54±7.67), the time in target quadrant was prolonged (seconds: 31.29±5.61 vs. 18.76±4.75), the number of crossing platform was also significantly increased (frequency: 4.72±1.24 vs. 2.26±0.57), blood glucose levels were obviously lowered (mmol/L: 18.34±2.75 vs. 24.27±3.69), protein content and expression of TNF-α and IL-6 in hippocampus were remarkably decreased [TNF-α (μg/L): 328.46±39.33 vs. 482.09±45.72, IL-6 (μg/L): 6.09±0.97 vs. 8.26±1.14; TNF-α protein (A value):0.47±0.09 vs. 0.61±0.15, IL-6 protein (A value): 0.28±0.06 vs. 0.53±0.11, all P < 0.05]. Conclusion Salidroside can ameliorate the cognitive impairment in STZ-induced diabetic rats, and its mechanism may be closely related to the reduction of the hippocampal inflammatory response and blood glucose level of diabetic rats.
7.Effectiveness analysis of fine nursing care on quality of nursing of critically ill patients with stroke
Peizhi WANG ; Guining DAI ; Li LIU ; Yingzhi LI ; Li MENG
Chinese Journal of Practical Nursing 2016;32(13):1027-1030
Objective To investigate the effectiveness analysis of fine nursing care on quality of nursing of critically ill patients with stroke. Methods The control group who came from the neurology department of our hospital between February and April in 2015 were given the routine care. The test group who came from the neurology department of our hospital between May and July in 2015 were given the fine nursing care. The quality of nursing and satisfaction of the relatives of patients were compared. Results In the test group, unqualified rates of nursing quality was 8.8%(81/924) and satisfaction of the relatives of patient was 90.9% (229/252); In the control group, unqualified rates of nursing quality was 22.5%(183/814) and satisfaction of the relatives of patient was 82.0%(182/222).There were significant differences between two teams (χ2=63.191, 8.096, P<0.01 or 0.05). Conclusions Fine nursing care can significantly improve the quality of nursing, improve the nurse-patient relationship and improve satisfaction of the relatives of patients.
8.Effect of traditional Chinese medicine composit Guben Yiliu III combined with gemcitabine on human pancreatic cancer xenograft in nude mice
Ju LIU ; Haili QIAN ; Zhijian XU ; Lisheng ZHANG ; Peizhi YE ; Aiping TIAN ; Hongli YANG
Acta Laboratorium Animalis Scientia Sinica 2014;(3):98-102
Objective To explore whether the Chinese medicine Guben Yiliu III can improve the effect of gemcit -abine on human pancreatic cancer xenograft in nude mice . Methods Nude mice with transplanted human pancreatic cancer were divided randomly into 4 groups: control group, gemcitabine treatment group , combined ( Guben Yiliu III +gemcitabine) group, and Guben Yiliu III group, 10 mice in each group.The gemcitabine group and combined group were treated with gemcitabine from the 8th day after transplantation in a dose of 100 mg/kg by i.p.injection, twice a week. Guben Yiliu III and combined groups were given the aqueous solution of Guben Yiliu III granules p .o.since the 8th day af-ter transplantation .Result The inhibition rate of transplanted tumor in the three treatment groups were 48.9% in the gemcitabine group , 68.9%in the combined group , and 28.0%in the Guben Yiliu III group .The combined group showed a significantly higher inhibition rate than the gemcitabine group (P<0.05).The gemcitabine group, combined group and Guben Yiliu III group showed a significantly slower growth rate than the control group .However, the combined treatment group showed a pronounced side effect and body weight loss than the other 3 groups .Conclusions The Chinese medicine Guben Yiliu III can improve the inhibitory effect of gemcitabine on nude mice with human pancreatic cancer xenograft in the auxilla of nude mice .
9.Polymorphisms in the interleukin-1 receptor-associated kinase 4 gene are associated withsusceptibility to severe sepsis
Chenling YAO ; Chenglong LIU ; Zhenju SONG ; Jun YIN ; Chaoyang TONG ; Peizhi HUANG
Chinese Journal of Emergency Medicine 2012;21(2):128-132
Objective To investigate the possible association of IRAK4 polymorphisms with susceptibility to and prognosis of severe sepsis.Methods A total of 192 patients hospitalized in emergency department of Zhongshan Hospital from February 2006 to December 2009,and another 192 healthy volunteers were enrolled in this case-control study.Patients were excluded if they had metastatic tumors,autoimmune diseases,AIDS or received immunosuppressive drugs.This study was approved by the ethical committee of Zhongshan Hospital,Fudan University.Sepsis patients were divided into survival group(n =124)and non-survival group(n =68)according to the 30-day mortality.Primer 3 software was used to design the PCR and sequencing primers.Genomic DNA was extracted from peripheral blood mononuclear cells.Seven tagSNPs were selected based on the data of Chinese Han in Beijing from the Hapmap projectand genotyped by direct sequencing.We used x2 analysis to evaluate the significance of differences in genotype and allele frequencies between different groups.Results The distributions of all tagSNPs were consistent with Hardy-Weinberg equilibrium.The allele and genotype frequencies of rs4251545(G/A)were significantly different between severe sepsis and healthy control groups(P =0.015,P =0.035,respectively).Carriers of the rs4251545A had a higher risk for severe sepsis compared with carriers of the rs4251545G(OR =1.69,95% CI:1.10-2.58).The allele and genotype frequencies of all SNPs were not significantly different between survivor group and non-survivor group.Conclusions These findings indicated that the variants in IRAK4 are significantly associated with severe sepsis susceptibility in the Chinese Han population.
10.Expression and purification of fusion protein CTP-SOD in Pichia pastoris and antioxidant capacity analysis.
Peizhi LI ; Junle REN ; Ting AN ; Yan LIU
Chinese Journal of Biotechnology 2010;26(3):324-329
Cytoplasmic transduction peptide (CTP) is a newly designed transduction peptide, by which special molecules can be carried out and localized into cytoplasmic compartment. Superoxide dismutase (SOD) is a protein that is difficult to go into cytoplasm. In this study, CTP-SOD fusion gene was amplified from human cDNA by PCR, and the active recombinant protein was successfully expressed in Pichia pastoris. HeLa cells pretreated with CTP-SOD showed a significantly improved survival against the pyrogallol-induced oxidative stress, suggesting CTP-SOD could cross the cell membrane more efficiently and protect cells from oxidative stress.
Antioxidants
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pharmacology
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Cytoplasm
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drug effects
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metabolism
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Genetic Vectors
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genetics
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HeLa Cells
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Humans
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Intracellular Signaling Peptides and Proteins
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genetics
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metabolism
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Oxidative Stress
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drug effects
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Pichia
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genetics
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metabolism
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Recombinant Fusion Proteins
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biosynthesis
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genetics
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pharmacology
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Signal Transduction
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drug effects
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physiology
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Superoxide Dismutase
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biosynthesis
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genetics
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metabolism

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