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.PD-1/PD-L signaling pathway in chronic hepatitis B
Journal of Clinical Hepatology 2016;32(12):2373-2379
Hepatitis B is one of the major diseases that affect the health of Chinese people, and chronic hepatitis B virus (HBV) infection can lead to disease progression. Programmed death-1 (PD-1) discovered in recent years is an important coordinated stimulus molecule which belongs to the B7/CD28 family. After its binding with programmed death ligand (PD-L), it can regulate the activation, differentiation, and proliferation of T lymphocytes. PD-1 and its ligand are differently expressed in different stages of chronic HBV infection. The interaction between PD-1 and its ligand in different immune cells induces immune tolerance in human body and finally leads to the chronicity of HBV infection. Blocking the PD-1/PD-L signaling pathway through different ways can improve T cell exhaustion, suggesting that this might be one of the directions of antiviral therapy in future.
4.Research advances in immunotherapy for chronic hepatitis B
Journal of Clinical Hepatology 2016;32(10):1984-1988
At present, nucleos(t)ide analogues and interferon-α still have limited effects in patients with chronic hepatitis B (CHB), and therefore, it is of vital importance to develop more effective therapeutic strategies to improve the treatment outcome of CHB patients. This article introduces the immunotherapy for CHB, including therapeutic vaccines (protein vaccines, DNA vaccines, and dendritic cell vaccines) and cell regulation therapy, and points out that immunotherapy is considered a promising treatment regimen for HBV infection. With further studies on the clinical outcome after HBV infection, significant advances have been achieved in immunotherapy for CHB.
5.Using anterior tibial artery periosteal perforator flap repairs soft tissue defects of shank
Lilin SHEN ; Cuixia LIN ; Xuesheng SUN ; Tao ZHU ; Qiang LI ; Xinxia LI
Chinese Journal of Microsurgery 2013;36(6):545-547
Objective To explore the effect of repairing soft tissure defects of shank by anterior tibial artery periosteal perforator flap.Methods Eleven patients received the operation using anterior tibial artery periosteal perforator flap after reversing 180° repairs soft tissue defects of the same shank.The defect after the flap transfer was closed by skin-grafting.Results All the flaps of these 11 cases were successful.The fellow-up time was 3 months to 2 years.All fractures healed,and the appearance and the skin's color were satisfied.Conclusion The operation using anterior tibial artery periosteal perforator flap repairs soft tissue defects of shank has lots of merits:it is handled easily and causes small trauma and retains anterior tibial artery.It has a good success rate.The flap is thin that has a good appearance.
6.Operative therapeutic effect comparative analysis in femoral intertrochanteric fracture of the aged
Qiang LI ; Junqiang XU ; Xuesheng SUN ; Tao ZHU ; Songke KANG ; Lilin SHEN ; Chaoliang WANG
Chinese Journal of Postgraduates of Medicine 2013;36(35):1-4
Objective To analyze the operative therapeutic effect of proximal femoral nail antirotation blade (PFNA),dynamic hip screw (DHS) and femoral proximal locking compression plate (LCP)internal fixation in treatment with femoral intertrochanteric fracture of the aged.Methods Seventy-three aged patients with femoral intertrochanteric fracture were divided into 3 groups according to different internal fixation method:PFNA group (30 cases) was treated with PFNA internal fixation,DHS group (22 cases) was treated with DHS internal Fxation,LCP group (21 cases) was treated with LCP internal fixation.The operative time,intraoperative bleeding volume,fracture healing time,bad limb load time and hip joint function score were compared among the 3 groups.Results The operative time in PFNA group,DHS group and LCP group was (73.9 ± 8.5),(82.3 ± 10.6),(79.5 ± 11.2) min,there was statistical difference between PFNA group and DHS group (P < 0.05),but there was no statistical difference between PFNA group and LCP group (P> 0.05).The intraoperative bleeding volume in PFNA group was significantly lower than that in DHS group and LCP group [(160.2 ± 15.6) ml vs.(208.4 ± 20.2) and (216.6 ml ± 24.9) ml],there was statistical difference (P <0.05).The fracture healing time and bad limb load time in PFNA group were significantly shorter than those in DHS group and LCP group [(97.4 ± 5.8) d vs.(101.2 ± 4.2),(110.0 ±8.3) d and (78.0 ±5.4) d vs.(85.9 ±7.6),(90.8±6.0) d],furtbermore DHS group were significantly shorter than those in LCP group,there were statistical differences among the 3 groups (P < 0.05).There were no statistical differences in excellent and good rate of hip joint function score among the 3 groups (P > 0.05).Conclusions PFNA is the ideal therapeutic method for femoral intertrochanteric fracture of the aged.It has better curative effect compared to the DHS and LCP,and has less surgical trauma and can shorten the recovery time.

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