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.

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.

Objective To investigate the effect of standardized hand-washing spectrum for the improvement of the hand-wash-ing hygiene rate for hepatobiliary surgery medical staff.Methods The standardized surgical hand-washing spectrum was developed in accordance with the requirements of pre-surgical hand-washing procedures,hand-washing of operation table distribution and hand-wash-ing after removing surgical gloves,as specified in《the Technical Standards for Disinfection》(the Ministry of Health of the People′s Re-public of China)and 《the Technical Standards for Nosocomial Infection Management》(the General Logistics Department of PLA).Four hundred surgical personnel involved in surgeries were enrolled for the study and were randomized into the experimental group and the control group,each consisting of 200 people.The surgical personnel in the experimental group washed their hands as required by the standardized hand-washing spectrum,and those in the control group washed their hands with conventional methods or by experience. Results The qualification rates of hand-washing procedures and hand hygiene in the medical personnel of the experimental group were all significantly higher than those of the control group.The positive rate of bacteriological detection and the incidence of nosocomial in-fection in the surgical patients of the experimental group were lower than those of the control group,and statistical significance could be seen,when comparisons were made between the 2 groups (P <0.01).Conclusion The standardized hand-washing spectrum,which was simple and practical for use,could increase the qualification rate of hand hygiene in the medical staff.

Objective To investigate the effect of standardized hand-washing spectrum for the improvement of the hand-wash-ing hygiene rate for hepatobiliary surgery medical staff.Methods The standardized surgical hand-washing spectrum was developed in accordance with the requirements of pre-surgical hand-washing procedures,hand-washing of operation table distribution and hand-wash-ing after removing surgical gloves,as specified in《the Technical Standards for Disinfection》(the Ministry of Health of the People′s Re-public of China)and 《the Technical Standards for Nosocomial Infection Management》(the General Logistics Department of PLA).Four hundred surgical personnel involved in surgeries were enrolled for the study and were randomized into the experimental group and the control group,each consisting of 200 people.The surgical personnel in the experimental group washed their hands as required by the standardized hand-washing spectrum,and those in the control group washed their hands with conventional methods or by experience. Results The qualification rates of hand-washing procedures and hand hygiene in the medical personnel of the experimental group were all significantly higher than those of the control group.The positive rate of bacteriological detection and the incidence of nosocomial in-fection in the surgical patients of the experimental group were lower than those of the control group,and statistical significance could be seen,when comparisons were made between the 2 groups (P <0.01).Conclusion The standardized hand-washing spectrum,which was simple and practical for use,could increase the qualification rate of hand hygiene in the medical staff.