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.Exploring the mechanism of traditional Chinese medicine indirubin derivative E804 inhibiting the proliferation and migration of lung cancer A549 cells based on the Nrf2-HO-1/GPX4 pathway
Yujun YUAN ; Huahua CAO ; Min ZHAO ; Yuhui LUO ; Sumei ZHANG
Acta Universitatis Medicinalis Anhui 2024;59(2):331-335,343
Objective To investigate the effects of indirubatin derivative E804 on proliferation and migration of non-small cell lung cancer(NSCLC)A549 cells,and to elucidate the possible mechanism of Nrf2-HO-1/GPX4 pathway.Methods Lung cancer A549 cells were used as the cell model.The proliferation and migration of differ-ent specific inhibitors(Nec-1,CQ,Z-VAD,DFO,Fer-1 and Lip-1)in 0,10 μmol/L E804 and 10 μmol/L E804+groups were observed by MTT and cell scratch assay.The contents of reactive oxygen species(ROS)were de-tected by DCFH-DA fluorescence probe method,the contents of Fe2+were detected by colorimetric method,the contents of reduced glutathione(GSH)were detected by spectrophotometry,and the contents of malondialdehyde(MDA)were detected by micromethod.The expression levels of SLC7A11,Transferrin,GPX4,SLC40A1,Nrf2 and HO-1 were detected by Western blot in cells of 0,2.5,5 and 10 μmol/L E804 groups.Results Compared with the control group(0 μmol/L E804),2.5,5 and 10 μmol/L E804 significantly increased intracellular ROS,Fe2+and MDA levels,and decreased intracellular GSH content(P<0.01).Meanwhile,the expression levels of SLC7A11,GPX4,SLC40A1,Nrf2 and HO-1 significantly decreased(P<0.01),and the expression level of Transferrin increased(P<0.05).Compared with the 10 μmol/L E804 group alone,the apoptosis inhibitor(Z-VAD)group and the ferroptosis inhibitor(DFO,Fer-1 and Lip-1)group could significantly reverse the inhibition of proliferation and migration of A549 cells by 10 μmol/L E804(P<0.01).Conclution E804 can induce ferrop-tosis and inhibit the proliferation and migration of A549 cells,which may be related to the inhibition of Nrf2-HO-1/GPX4 pathway.
4.Investigation on influencing factors of blood indexes of interventional radiology workers
Lidong WANG ; Xiangjie NA ; Jie ZHAO ; Sumei SUN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(12):924-928
Objective:To analyze the influencing factors of blood indicators indexes of interventional radiology workers, and provide a theoretical basis for radiological occupational health monitoring, radiation protection monitoring and risk assessment.Methods:In March 2020, a total of 500 interventional radiology workers (interventional group) and 200 non-interventional radiology workers (control group) who underwent an occupational health examination in Liaoning Center for Disease Control and Prevention from 2018 to 2019 were selected as the subjects. The general information, occupation related information, blood routine, fasting blood glucose and thyroid stimulating hormone test results of the subjects were collected. The differences in the levels and abnormal detection rates of blood indexes between the two groups were compared. And the influencing factors of blood indexes of the intervention riodiology workers were analyzed.Results:The lymphocyte count of interventional group[2.10 (1.70, 2.50) ×10 9/L] was lower than that of control group[2.20 (1.80, 2.60) ×10 9/L], the difference was statistically significant ( P<0.05) . The white blood cell count and lymphocyte count of interventional workers in the service age≤13 years were higher than those of service age≥28 years group, and fasting blood glucose was lower than those of service age ≥28 years group ( P<0.05) . The detection rate of abnormal fasting blood glucose of interventional radiology workers in the service age ≤13 years group was lower than that of the service age 14-27 years and service age ≥28 years ( P<0.05) . The lymphocyte count and platelet count of interventional radiology workers in annual effective dose<0.5 mSv group was higher than that of annual effective dose≥1 mSv group ( P<0.05) . The results of multi-factor linear regression analysis showed that service age, annual effective dose and female gender were the influencing factors of lymphocyte count of interventional radiology workers ( b=-0.008, -0.110, -0.167, P<0.05) . Conclusion:Long-term low-dose radiation exposure had certain influence on the lymphocyte count of interventional radiology workers. Service age, annual effective dose and gender are the influencing factors of lymphocyte count in interventional radiology workers. It should be reinforced to the radiological protection monitoring and risk assessment on interventional radiology workers.
5.Investigation on influencing factors of blood indexes of interventional radiology workers
Lidong WANG ; Xiangjie NA ; Jie ZHAO ; Sumei SUN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(12):924-928
Objective:To analyze the influencing factors of blood indicators indexes of interventional radiology workers, and provide a theoretical basis for radiological occupational health monitoring, radiation protection monitoring and risk assessment.Methods:In March 2020, a total of 500 interventional radiology workers (interventional group) and 200 non-interventional radiology workers (control group) who underwent an occupational health examination in Liaoning Center for Disease Control and Prevention from 2018 to 2019 were selected as the subjects. The general information, occupation related information, blood routine, fasting blood glucose and thyroid stimulating hormone test results of the subjects were collected. The differences in the levels and abnormal detection rates of blood indexes between the two groups were compared. And the influencing factors of blood indexes of the intervention riodiology workers were analyzed.Results:The lymphocyte count of interventional group[2.10 (1.70, 2.50) ×10 9/L] was lower than that of control group[2.20 (1.80, 2.60) ×10 9/L], the difference was statistically significant ( P<0.05) . The white blood cell count and lymphocyte count of interventional workers in the service age≤13 years were higher than those of service age≥28 years group, and fasting blood glucose was lower than those of service age ≥28 years group ( P<0.05) . The detection rate of abnormal fasting blood glucose of interventional radiology workers in the service age ≤13 years group was lower than that of the service age 14-27 years and service age ≥28 years ( P<0.05) . The lymphocyte count and platelet count of interventional radiology workers in annual effective dose<0.5 mSv group was higher than that of annual effective dose≥1 mSv group ( P<0.05) . The results of multi-factor linear regression analysis showed that service age, annual effective dose and female gender were the influencing factors of lymphocyte count of interventional radiology workers ( b=-0.008, -0.110, -0.167, P<0.05) . Conclusion:Long-term low-dose radiation exposure had certain influence on the lymphocyte count of interventional radiology workers. Service age, annual effective dose and gender are the influencing factors of lymphocyte count in interventional radiology workers. It should be reinforced to the radiological protection monitoring and risk assessment on interventional radiology workers.
6.Study on the relationship between promoter -579G>T of DNMT3B with genetic susceptibility to gastric cancer in Jiangsu Suqian region
Wei QIU ; Jianjiang ZHAO ; Sumei CHEN ; Dongsheng LIU
International Journal of Laboratory Medicine 2017;38(20):2842-2844
Objective To investigate the association between DNA methyltransferase 3B(DNM T3B) promoter single nucleotide polymorphism(SNP) with susceptibility to gastric cancer (GC) in Han population of Suqian region .Methods A total of 233 pa-tients with gastric cancer were recruited into the study group ,208 healthy persons were recruited in the control group .Genomic DNA was extracted from peripheral blood ,and the frequency distribution of -579G> T locus in DNMT3B promoter region was de-tected by polymerase chain reaction with restriction fragment length polymorphism (PCR-RFLP) .Results The distribution of TT genotypes compared with GT +GG in all the two groups were significantly different (χ2 =6 .517 ,P<0 .05) .When stratified by age , there was significant difference between TT and GT + GG genotypes at the age range ≥60 years(χ2 = 4 .728 ,P< 0 .05) .When stratified by gender ,there was no significant difference between different gender groups (χ2 = 3 .541 ,P> 0 .05 ;χ2 = 3 .676 ,P>0 .05) .Conclusion The DNMT3B -579G> T is associated with the genetic susceptibility of gastric cancer .It might be a risk fac-tor of gastric cancer .
7.Therapeutic Observation of Electroacupuncture at Extensors plus Acupoints Based on Syndrome Differentiation for Wrist-ankle Activity in Post-stroke Hemiplegia
Ying Lü ; Xiangdong SHI ; Jie WANG ; Enzhuo CHEN ; Yan ZHANG ; Chunyan CHEN ; Sumei LU ; Jie ZHAO
Shanghai Journal of Acupuncture and Moxibustion 2017;36(7):776-780
Objective To observe the effect of electroacupuncture at extensors plus acupoints based on syndrome differentiation on the wrist-ankle activity in post-stroke hemiplegia. Method A total of 168 patients with post-stroke hemiplegia were randomly divided into a control group and a treatment group, 84 cases each. Both groups were prescribed with Western medication, based on which, the control group received electroacupuncture at acupoints based on syndrome differentiation, and the treatment group received electroacupuncture at extensors plus acupoints based on syndrome differentiation. The changes of electromyography (EMG) in the two groups after the intervention were observed, and the clinical efficacies were compared between the two groups.Results The total effective rate was 95.1% in the treatment group versus 91.0% in the control group, and the between-group difference was statistically significant (P<0.05). After the intervention, the EMG of extensor carpi radialis in the treatment group was significantly different from that in the control group (P<0.05); the between-group difference was statistically insignificant in comparing the EMG of tibialis anterior muscle (P>0.05), but the intra-group differences were statistically significant in both groups(P<0.05). The value of M-amp/H-amp was changed significantly in both groups after the treatment (P<0.01), but the between-group difference was statistically insignificant after the treatment (P>0.05).Conclusion Electroacupuncture at extensors plus acupoints based on syndrome differentiation can increase the motor unit of carpi radialis and decrease the spasm of gastrocnemius in post-stroke hemiplegia, and consequently produce a remarkable clinical efficacy.
8.Study on the Separation of Ketoprofen Enantiomer by Pre-column Derivation RP-HPLC
Xiaoyan LIN ; Jieyi JIANG ; Aili XU ; Zhao CHEN ; Sumei LI
China Pharmacist 2016;19(6):1045-1047
Objective:To establish a method for the separation and determination of ketoprofen enantiomer .Methods:A pre-col-umn derivation RP-HPLC method was used with L-alanine-β-naphthylamine ( L-Ala-β-NA) as the derivation reagent .The RP-HPLC conditions were as follows: a Hypersil ODS-2 column (250 mm ×4.6 mm,5 μm) was applied, the mobile phase was acetonitrile-0.025 mol· L-1 phosphate buffer solution (40∶60, v/v) and the flow rate was 1.0 ml· min-1 , the detection wavelength was set at 245 nm and the column temperature was 25℃.The injection volume was 10μl.Results:Base line separation was achieved for the sep-aration of enantiomer from ketoprofen , and the retention time for S-(+) -ketoprofen and the R-(-) -ketoprofen was 24.2 min and 26.0 min, respectively.Dexketoprofen within the range of 0.025-0.125 mg had a good linear relationship (r=0.998 1) and the aver-age recovery was 90.93%(RSD =4.10%, n=9 ).Conclusion:The method is simple, accurate and reliable, which can be applied in the separation and determination of ketoprofen .
9.Antibacterial Effect in vitro of Sanhuang Shaoshangling after Preparation Technology Change
Sumei LI ; Baiqing GAO ; Yuping ZHAO
China Pharmacist 2016;19(9):1686-1688
Objective: To study the antibacterial activity in vitro of Sanhuang Shaoshangling on several common bacteria after changing the preparation process. Methods:Using the new technology of ethanol reflux extraction and water extraction, Sanhuang Sha-oshangling was prepared. A micro-broth dilution method was used to determine the minimum inhibitory concentration ( MIC) of San-huang Shaoshangling for escherichia coli, pseudomonas aeruginosa, staphylococcus aureus and type B paratyphoid salmonella after chan-ging the preparation process. The antibacterial effect of Sanhuang Shaoshangling prepared by the new and the old technology was com-pared, and the inhibition zone was detected by a paper strip method. Results:The antibacterial effect of Sanhuang Shaoshangling pre-pared by the new technology on escherichia coli, pseudomonas aeruginosa, staphylococcus aureus and type B paratyphoid salmonella was better than that of the products prepared by the old technology with the minimum inhibitory concentration ( MIC) of 16 μg·ml-1 , 16μg·ml-1 , 8 μg·ml-1 and 16 μg·ml-1 , respectively, while that of the product prepared by the old technology was 32 μg·ml-1 , 64 μg·ml-1 , 16 μg·ml-1 and 64 μg·ml-1 , respectively. Conclusion: The antibacterial effect of Sanhuang Shaoshangling after changing the preparation process is more significant, which shows certain clinical significance.
10.Finger pressing and garlic-partition moxibustion for 12 cases of chronic appendicitis.
Chinese Acupuncture & Moxibustion 2015;35(6):566-566
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therapy
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Chronic Disease
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therapy
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Female
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Garlic
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chemistry
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Humans
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Male
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Middle Aged
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Moxibustion
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Young Adult

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