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.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.
4.Teaching experience on experiment course of the human dermatoglyphics
Zhendong YUAN ; Yuee JIN ; Lijun ZHANG ; Haiguo ZHANG
Chinese Journal of Medical Education Research 2006;0(09):-
Human Dermatoglyphics is elective in the Shanghai Jiaotong University, which is popular among the students. The 284 anonymous questionaires were received and the result was analyzed. Based on the teaching practice of human dermatoglyphic the opinions about the teaching reform and curriculum construction have been made in this paper.
5.Analysis of malaria prevalence in national malaria surveillance sites of Jiangsu Province
Weiming WANG ; Xiaolin JIN ; Huayun ZHOU ; Julin LI ; Guizhi SHE ; Yuee TANG
Chinese Journal of Schistosomiasis Control 1989;0(03):-
Objective To understand the current status of malaria prevalence,its impacts and malaria transmission trends in Jiangsu Province.MethodsThe malaria incidence,and its symptoms,mosquito preventive measures,Anopheles density,mosquito biting rates and related factors were investigated in malaria epidemic villages as surveillance sites such as Guanshan Town of Suining County,Tangzhang Town of Tongshan County,Tianganghu town of Sihong County,Qiuji Town of Xuyi County and Zhangzhu Twon of Yixing City.ResultsIn 2006,the bednet coverage was 20.29% and bednet-using rate was 34.32% in 27903 residents of 7921 households of 15 administrative villages.In 2005,750 Anopheles sinensi were captured from 50 bednets in the early morning,the human biting ratio was 0.17/person per night,and in 2006,1927 Anopheles sinensi were captured from 50 bednets in the early morning,human biting ratio was 0.38/person per night.The average blood smear checking rate was 2.72%(6089 people)and the average positive rate was 0.48%(29 plasmodium positive individuals).ConclusionThe lower blood smear microscopy testing,few positive rates of febrile patients and increased Anopheles sinensis density were the main factors of malaria relapses in the area of the North Huaihe River in Jiangsu Province.

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