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.The efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis and its impact on the immune function of diseased children
Youjia SUN ; Guijuan ZHOU ; Yuee JIA ; Haixia LI ; Xue FANG
Immunological Journal 2025;41(5):356-361
Objective To investigate the efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis(IM)and its impact on the immune function of diseased children.Methods Totally 120 diseased children with IM accepted by our hospital from February 2022 to August 2024 were stochastically assigned into a treatment group and a monotherapy group.The monotherapy group received treatment with ganciclovir,while the treatment group received treatment with spleen aminopeptide in addition to the monotherapy group.The efficacy,symptom improvement time,serum inflammatory factors,immune indicators,and biochemical indicators before and after treatment were compared between the two groups.Results The efficacy of the treatment group was better than that of the monotherapy group,and the symptom relief time was shorter than that of the monotherapy group(P<0.05).After treatment,the serum amyloid A,TNF-α,IL-6,procalcitonin,CD3+T,CD8+T,lactate dehydrogenase,alanine aminotransferase,EBV-DNA,creatine kinase,and white blood cell count in both groups decreased,while CD4+T and CD4+T/CD8+T increased.The amplitude of the treatment group was greater than that of the monotherapy group(P<0.05).Conclusion The combination of ganciclovir and spleen aminopeptide in treating IM is beneficial for enhancing the immune function of T lymphocytes of diseased children,alleviating inflammatory reactions,improving biochemical indicators,and enhancing efficacy.
3.The efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis and its impact on the immune function of diseased children
Youjia SUN ; Guijuan ZHOU ; Yuee JIA ; Haixia LI ; Xue FANG
Immunological Journal 2025;41(5):356-361
Objective To investigate the efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis(IM)and its impact on the immune function of diseased children.Methods Totally 120 diseased children with IM accepted by our hospital from February 2022 to August 2024 were stochastically assigned into a treatment group and a monotherapy group.The monotherapy group received treatment with ganciclovir,while the treatment group received treatment with spleen aminopeptide in addition to the monotherapy group.The efficacy,symptom improvement time,serum inflammatory factors,immune indicators,and biochemical indicators before and after treatment were compared between the two groups.Results The efficacy of the treatment group was better than that of the monotherapy group,and the symptom relief time was shorter than that of the monotherapy group(P<0.05).After treatment,the serum amyloid A,TNF-α,IL-6,procalcitonin,CD3+T,CD8+T,lactate dehydrogenase,alanine aminotransferase,EBV-DNA,creatine kinase,and white blood cell count in both groups decreased,while CD4+T and CD4+T/CD8+T increased.The amplitude of the treatment group was greater than that of the monotherapy group(P<0.05).Conclusion The combination of ganciclovir and spleen aminopeptide in treating IM is beneficial for enhancing the immune function of T lymphocytes of diseased children,alleviating inflammatory reactions,improving biochemical indicators,and enhancing efficacy.
4.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.
5.Development of the Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with Inflammatory Bowel Disease and its reliability and validity
Qianyi WANG ; Weidong SHEN ; Lihua ZHAO ; Min WANG ; Yuee QIN ; Yuanyuan PENG ; Rongrong LI ; Guozhen SUN ; Jufen PU
Chinese Journal of Modern Nursing 2024;30(4):461-468
Objective:To develop the Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with Inflammatory Bowel Disease (IBD), and test its reliability and validity.Methods:Guided by the theory of knowledge, attitude, and practice, a preliminary draft of the scale was formed through literature review, Delphi expert consultation, and pre-survey. From May to August 2022, convenience sampling was used to select 200 IBD patients who visited the Gastroenterology Clinic of three ClassⅢ Grade A comprehensive hospitals in Jiangsu Province as the research subject for a questionnaire survey. The critical ratio method, correlation analysis method, internal consistency method, commonality and factor loadings were used for item analysis of the scale. Exploratory factor analysis, content validity index, and internal consistency reliability were applied to test the reliability and validity of the scale.Results:A total of 200 questionnaires were distributed, and 181 valid questionnaires were collected, with an effective response rate of 90.50% (181/200). The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD included three dimensions of knowledge, attitude and practice, with a total of 21 items. The content validity index at the scale level was 0.917, and the content validity index at the item level ranged from 0.833 to 1.000. Exploratory factor analysis extracted three common factors, with a cumulative variance contribution rate of 74.197%. The Cronbach's α coefficient of the total scale was 0.951, and the coefficients of each dimension were 0.914 to 0.942. The test-retest reliability coefficient of the total scale was 0.918, and the test-retest reliability coefficients of each dimension ranged from 0.737 to 0.833.Conclusions:The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD has good reliability and validity, which can help medical and nursing staff evaluate patients' understanding and acceptance of microbial transplantation, so as to provide a basis for personalized communication in shared decision making between doctors and patients.
7.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.
8.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.
9.The roles of ubiquitin-proteasome inhibitor in atherosclerosis
Haimei FAN ; Yuee SHEN ; Kun LI ; Ruihong SUN
International Journal of Cerebrovascular Diseases 2012;20(5):389-393
Atherosclerosis (AS) is a common underlying disease that hazard to human health.It is closely associated with stroke,hypertension,coronary artery disease,and diabetes.AS on the premise of vascular intimnal injury,excessive smooth muscle cell proliferation,inflammatory cell infiltration,oxidative stress,apoptosis and other mschanisms participate together.In eucaryotic organisms,most proteins are degraded by ubiquitin-proteasome system (UPS).An increasing number of evidence indicates that UPS is associated with the occurrenee and development of AS and complications.This article reviews the relationship between.UPS and AS,as well as the effect of ubiquitin-proteasome inhibitor on AS.
10.Advancement on thrombolytic characteristic, function and clinical application of different fibrinolytic enzymes.
Yuee SUN ; Weidong WANG ; Chao LI
China Journal of Chinese Materia Medica 2010;35(6):794-798
Cardio-cerebral vascular diseases endanger people's health very seriously. Thrombolytic therapy is effective in curing thrombotic diseases at present. Microorganism is an important source of thrombolytic drug. Plasminogen activators are widely used as thrombolytic drugs clinically, while they are still exists some defects. This article analyzed research and development status of kinds of thrombolytic drugs from microorganisms, and evaluated their clinical efficacy and safety, aiming at showing the direction to search new and effective thrombolytic drugs and prevent and treat thromboembolic disease.
Bacteria
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enzymology
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Clinical Protocols
;
classification
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Drug Discovery
;
methods
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Drug Therapy, Combination
;
methods
;
Fibrinolytic Agents
;
chemical synthesis
;
isolation & purification
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supply & distribution
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therapeutic use
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Humans
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Plasminogen Activators
;
supply & distribution
;
therapeutic use
;
Thromboembolism
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drug therapy
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Thrombolytic Therapy
;
methods
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Thrombosis
;
drug therapy
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Urokinase-Type Plasminogen Activator
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isolation & purification
;
therapeutic use
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Viruses
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chemistry
;
enzymology

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