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.
4.Application of 18F-FDG PET/CT in diagnosis of Adrenal Lymphoma
Xiaobei DUAN ; Xiangmeng CHEN ; Weiqiang ZOU ; Binhao HUANG ; Yuee WU ; Lixia SUN
Chinese Journal of Medical Imaging 2016;24(12):919-923
Purpose To explore the 18F-FDG PET/CT imaging features of adrenal lymphoma and to improve the diagnosis of this disease.Materials and Methods A total of 13 cases with pathology-proven adrenal lymphoma and PET/CT examinationfrom December 2012 to March 2016 were retrospectively reviewed,The contents including the extent,shape,size and density of the adrenal lymphoma as well as the SUVmax value and affected lymph gland were recorded.The region of interesting (ROI) was delineated with the SUVmax value being calculated,which was compared with pathological diagnosis.Results All 13 cases were non-Hodgkins lymphoma,12 of which were secondary lymphoma,with the other case being primary lymphoma.Nine cases were diffuse large B-cell lymphoma (DLBCL);2 cases were mantle cell lymphoma;2 cases were NK/T-cell lymphoma.In 10 cases there were bilateral adrenal involvement,and unilateral involvement in 3 casesincluding on 2 the left and 1 on the right.A total of 23 adrenal glands were involved,with soft masses in 13,soft nodules in 8 and adrenal thickening in 2.The lesions were well-defined in 10 cases.In 3 cases there were cystic changes or necrosis.No hemorrhage,calcification or fat was identified.Extra-adrenal involvement was discovered in 9 cases.Lymphadenopathy was seen in 10 cases involving the neck,mediastinum and retroperitoneum.Adrenal lesions showed intense FDG uptake on PET/CT with SUVmax ranging from 5.7 to 30.8 and mean SUVmax of 15.8±8.9.Conclusion Most of the adrenal lymphoma cases were diffuse large B-cell non-Hodgkin's lymphoma.The features of PET/CT include bilateral involvement,well-defined soft tissue mass with intense FDG uptake.PET/CT can differentiate primary and secondary adrenal lymphoma and help with treatment planning.
5.Biological toxicity of heavy metals to Caenorhabditis elegans
Yuee HUANG ; Nan ZHANG ; Yuxin JIANG ; Wei GUO ; Chaopin LI
Chinese Journal of Schistosomiasis Control 2015;(3):290-294
Objective To evaluate the biological toxicity of heavy metals by using Caenorhabditis elegans. Methods The C. elegans at L4 stage were exposed to CdCl2 CrCl3 As2O3 PbCl2 HgCl2 with low concentrations and M9 buffer the control group for 72 h respectively and the effects of heavy metals with different concentrations on the survival time and reproduction of C. elegans were evaluated. Results After exposure to 2.5 10μmol/L HgCl2 and PbCl2 10μmol/L CdCl2 and 50μmol/L CrCl3 for 72 h respectively the life spans and survival curves of the C. elegans were different from those in the control group the differences were statistically significant all P<0.05 . After exposure to CdCl2 CrCl3 As2O3 PbCl2 and HgCl2 with the con?centrations of 2.5 50 100μmol/L for 72 h respectively the generational time and brood size of C. elegans were all different from those in the control group all P<0.01 . Among the 5 heavy metals at low concentrations the reproduction toxicity of Hg was bigger than Pb Cd Cr and the toxicity of As was the weakest. Conclusion Heavy metal exposure can affect the life span and reproductive toxicity of C. elegans.
6.Effects of acupuncture on PI3K/Akt/mTOR signaling pathway in rats with premature ovarian failure.
Yimin ZHANG ; Bin YU ; Jia CHEN ; Zhisheng ZHAO ; Wang JIALI ; Fasen HUANG ; Yuee LIN ; Mengwei WANG ; Yupei ZHANG ; Bo WEI
Chinese Acupuncture & Moxibustion 2015;35(1):53-58
OBJECTIVETo explore the effects of acupuncture and medication on PI3K/Akt/mTOR signaling pathway in rats with premature ovarian failure.
METHODSTen of fifty SPF-grade female SD rats were randomly selected into a normal group, and the remaining 40 rats were treated with intraperitoneal injection of cyclophospha mide (30 mg/kg) for consecutive 5 days to establish rat model of premature ovarian failure. Thirty five successful rat models were randomly divided into a model group (9 cases), a medication group (9 cases), an acupuncture group A (9 cases) and an acupuncture group B (8 cases). The rats in the model group and normal group did not receive any treatment. The rats in the medication group were treated with intragastric administration of diethylstil bestrol, once a day. The rats in the acupuncture group A and acupuncture group B were respectively treated with acupuncture at different acupoints, twice a day. All the treatment was given for 4 weeks. After the treatment, enzyme-linked immunosorbent assay (ELISA) was applied to test the levels of estradiol (E2), progesterone (P), follicle stimulating hormone (FSH) and luteotropic hormone (LH). The ovarian tissue sample was processed with hematoxylin eosin (HE) staining as well as RNA and protein extraction to test the mRNA expression of estrogen receptor alpha (ERalpha), estrogen receptor beta (ERP), phosphatidylinositol 3-kinase/serine/threonine kinase (PI3K), protein kinase B (Akt) and mammalian target of rapamycin (mTOR).
RESULTSHigh-dose short-term in- tervention of cyclophosphamide could establish rat model of premature ovarian failure with a successful rate of 87.5%. Compared with the normal group, the vaginal smear in the model group was featured with signs of estro gen deficiency, early-follicle reduction, structural damage to the follicle, and reducing number of mature follicles; the level of E2 was significantly reduced (P<0.05), levels of P, FSH and ILH were increased (all P<0.05), and mRNA expression of estrogen-related ERP3, PI3K, Akt and mTOR were all reduced (all P<0.05). Compared with the model group, the number of mature follicle was increased in the medication group and acupuncture groups, the levels of E2 was obviously increased (all P<0.05). level of FSH was reduced (all P<0.05), and mRNA expression of PI3K, Akt and mTOR all showed an increasing trend (all P<0.05). The differences of each index result between acupuncture groups and medication group were not significant (all P>0.05).
CONCLUSIONAcupuncture has certain advantage for the treatment of premature ovarian failure, which achieves similar therapeu tic effect as estrogen; the possible mechanism may be related to up-regulation of gene and protein expression in PI3K/Akt/mTOR signaling pathway.
Acupuncture Points ; Acupuncture Therapy ; Animals ; Estradiol ; blood ; Female ; Follicle Stimulating Hormone ; blood ; Humans ; Oncogene Protein v-akt ; genetics ; metabolism ; Phosphatidylinositol 3-Kinases ; genetics ; metabolism ; Primary Ovarian Insufficiency ; blood ; enzymology ; genetics ; therapy ; Progesterone ; blood ; Rats ; Rats, Sprague-Dawley ; Signal Transduction ; TOR Serine-Threonine Kinases ; genetics ; metabolism
7.Studies on pathogenesis in patients with uterine leiomyoma complicated by amyloidosis
Lixiang GUO ; Liang WANG ; Yuee LUO ; Xiaoliang LI ; Xiaochun LIU ; Shan HUANG ; Xuguo SUN
Tianjin Medical Journal 2015;(9):1006-1007,1008
Objective To investigate the pathogenesis in patients with uterine leiomyoma complicated by amyloidosis. Methods A total of 36 uterine leiomyoma patients were recruited in this study, and divided into two group by Congo red staining:amyloidosis group (n=6) and non-amyloidosis group (n=30). (1) Amyloidosis deposition was observed in amyloidosis group. (2) HE staining was used to compare changes of inflammatory cells in two groups. (3)PAS staining was used to observe polysaccharide difference in two groups. (4)Values of serum hemoglobin (HGB), white blood cell count (WBC), lymphocyte absolute value (LYM), neutrophil absolute value (NEU), total protein (TP), albumin (Alb) and prealbumin (PA) were com?pared between two groups. Results (1)Leiomyoma entity cells were negatively Congo red stained, while 5 out of 6 pseudo-capsule fiber deposition and 2 out of 6 blood vessel were positively Congo red stained. (2)Infiltrations of inflammatory cells were observed in two groups. (3) The PAS positive staining was found in amyloidosis deposition and non-amyloidosis deposi?tion groups. (4)There were no significant differences in HGB, WBC, NEU, LYM, TP, Alb and PA levels between two groups (P>0.05). Conclusion Metabolism changes resulted from cell function alterations in local micro-environment by uterine leiomyoma may be related to the formation of the amyloidosis.
8.Effect of work flow optimization based on hospital information system on the nursing quality of infusion center
Chaoyan XU ; Na YU ; Fangyu LIN ; Yuee CHEN ; Xiaoyu LIANG ; Yanmei HUANG
Chinese Journal of Modern Nursing 2014;20(8):954-956
Objective To discuss the application value of work flow optimization based on hospital information system to shorten waiting time , improve nursing efficiency and ensure infusion safety in infusion center.Methods Process management combined with information technology was used to optimize the unreasonable work flow in infusion center .Self-designed questionnaire was used to compare the time between patients'arrival and leaving as well as the correct rate of nurses'transcription and typing of infusion cards before and after optimization .Results The average waiting time was ( 92.15 ±70.57 ) s before optimization and (64.34 ±37.59)s after, with statistically significant difference (Z=-6.704,P<0.01).The correct rate of transcription and typing of infusion cards improved from 96.5% to 99.3%, with statistically significant difference (χ2 =11.806 , P<0.01 ) .Conclusions The work flow optimization based on hospital information system can improve nurses'working efficiency, shorten patients'waiting time, reduce adverse incidence due to wrong transcription and typing of infusion cards and ensure the drug safety , so as to give patients effective and safe treatment and nursing in the infusion center .
9.Application of work flow rebuilt on intravenous infusion center
Chaoyan XU ; Yanmei HUANG ; Yuee CHEN ; Xiaoyu LIANG
Modern Clinical Nursing 2013;(11):60-64
Objective To explore the effect of intravenous infusion flow rebuilt on the patients’safety and nursing quality in intravenous infusion center.Methods Risk safety factors about intravenous infusion process in intravenous infusion center were analyzed and the work flow were rebuilt and optimized?The satisfaction rate,the reception time and the disinfection time for tourniquets were compared before and after work flow rebuilt.Results After work flow rebuilt,the satisfaction rate raised from 92?5%to 94?5%?There were significant differences among the reception time and the disinfection time for tourniquets before and after work flow rebuilt (all P<0?05)?After work flow rebuilt,both the reception time and the time for dealing with tourniquets are shorter than before. Conclusions The rebuilt work flow can make nurses work efficiently and enhance the patients’nursing quality?
10.Application of ‘incorrect cases’in medical statistics teaching
Jinquan WANG ; Hui YUAN ; Yuee HUANG ; Yuelong JIN ; Yingshui YAO
Chinese Journal of Medical Education Research 2013;(10):1030-1033
Objective To evaluate the application effect of‘incorrect cases’in medical statis-tics teaching. Methods The junior students (n=307)of clinical medicine were selected as research subjects by random cluster sampling. They were divided into the teaching improving group (n=151) who accepted case teaching and control group (n=156)who accepted traditional teaching. At the end of the term,the teaching effect was surveyed by questionnaires and compared between the two groups. Measurement data was analyzed by t test,enumeration data by χ2 test and ranked data by rank sum test. Results Students' interests of medical statistics and understanding the importance of the course in teaching improving group were significantly higher than that in control group (Z=-2.375,P=0.018;Z=-2.971,P=0.003). The proportion of students with learning difficulties in teaching improving group was obviously lower than that in control group (Z=-2.488,P=0.013). The satisfaction with theory and practical teaching in teaching improving group (84.10% and 88.74%,respectively)was significantly higher that in control group (73.08%and 71.79%,respectively)(χ2=5.530,P=0.013;χ2=13.841,P<0.001). Although no difference was observed in the test score between the two groups (t=1.230,P=0.220),knowledge of parameter estimation,hypothesis testing and science research design in teach-ing improving group was significantly higher than that in control group (χ2=6.829,P=0.009;χ2=5.835, P=0.016). Conclusions Application of ‘incorrect cases’in medical statistics teaching could arouse students' learning interests and improve clinical medical students' comprehensive analy sis ability of medical statistics.

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