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.

Ado-trastuzumab emtansine (T-DM1) is a conjugate of trastuzumab and emtansine, which is one of the options for adjuvant therapy of residual invasive lesions after neoadjuvant therapy and rescue treatment of advanced breast cancer in patients with human epidermal growth factor receprot 2(HER2) mutation. Thrombocytopenia is one of the common adverse reactions of T-DM1. The incidence of all grade of thrombocytopenia was 3.6%-38.2%, and the incidence of grade 3 and above of thrombocytopenia was 0.4%-14.3% during treatment. The risk of thrombocytopenia is higher in Asian populations, patients with prior therapy of platinum, and those with a baseline platelet count of ≤200×10 9/L. The mechanism of thrombocytopenia caused by T-DM1 is not clear. Attention should be paid to monitoring platelet count during treatment, and patients with thrombocytopenia should be treated according to the severity.

Ado-trastuzumab emtansine (T-DM1) is a conjugate of trastuzumab and emtansine, which is one of the options for adjuvant therapy of residual invasive lesions after neoadjuvant therapy and rescue treatment of advanced breast cancer in patients with human epidermal growth factor receprot 2(HER2) mutation. Thrombocytopenia is one of the common adverse reactions of T-DM1. The incidence of all grade of thrombocytopenia was 3.6%-38.2%, and the incidence of grade 3 and above of thrombocytopenia was 0.4%-14.3% during treatment. The risk of thrombocytopenia is higher in Asian populations, patients with prior therapy of platinum, and those with a baseline platelet count of ≤200×10 9/L. The mechanism of thrombocytopenia caused by T-DM1 is not clear. Attention should be paid to monitoring platelet count during treatment, and patients with thrombocytopenia should be treated according to the severity.

Triple negative breast cancer is a subtype of breast cancer with poor prognosis and lack of effective treatment. Cyclin dependent kinase (CDK) 4/6 inhibitors promote antitumor immunity by influencing the triple negative breast cancer immune microenvironment, such as increasing the tumor cell surface pragrammed death-ligand 1 protein expression, enhancing T cell activation and antigen presentation, changing the proportion of T cell subgroup and inducing lymphocyte infiltration. The change of immune microenvironment is related to tumor progression, but its mechanism is extremely complex. Exploring the mechanism of CDK4/6 inhibitor affecting immune microenvironment and its biomarkers can provide a new direction for the diagnosis and treatment of triple negative breast cancer.

Objective:To explore the effects of FOCUS-PDCA management on the improvement of disinfection quality of flexible endoscopes.Methods:From January 2018 to February 2020, a total of 124 flexible endoscopes and 23 nurses in Endoscopy Center of The First People's Hospital of Shangqiu were selected as the research objects by the convenient sampling method. From January 2018 to January 2019, the flexible endoscopes that were disinfected by conventional methods were set as the control group ( n=62) . From February 2019 to February 2020, the flexible endoscopes treated with Focus-PDCA disinfection were set as the observation group ( n=62) . The implementation status of the cleaning and disinfection specifications, the incidence of validity management defects and the quality of disinfection management of flexible endoscopes were compared between the two groups. Results:The observation group's flexible endoscope cleaning, disinfection specifications, and management evaluation scores were higher than those of the control group, and the differences were statistically significant ( P<0.01) . The disinfection and management defects of the flexible endoscope in the observation group were lower than those in the control group, the completeness rate of cleaning and disinfection records, the standard rate of cleaning operations, the qualification rate of biological test results, and the implementation rate of disinfection protection measures in the observation group were all higher than those of the control group, the differences were statistically significant. ( P<0.05) . Conclusions:The FOCUS-PDCA management model can effectively improve the cleanliness and disinfection quality of flexible endoscopes, which is worthy of clinical promotion.

Objective:To explore the effects of post level management and secondary performance distribution in the Central Supply Service Department.Methods:From January 2019, the job categories, job labor intensity, technical risk level, division of professional staff, specialist training, job description revision, job capability and other aspects of all staff ( n=67) of Central Supply Service Department of the First People's Hospital of Shangqiu, Henan were set up, and the competitive employment mechanism was applied. Based on the total amount of performance issued by the Nursing Department according to the total number of people in the disinfection supply center, the scientific design and implementation of post performance secondary assessment distribution and post promotion were carried out according to post workload, work quality, technical research, service satisfaction and so on. Results:The difference in the results of comprehensive skills assessment of nurses before and after the performance of secondary assessment and distribution management was statistically significant ( P<0.05) . The difference of job satisfaction of disinfection and supply center among different departments was statistically significant ( P<0.05) . There was statistical significance in the comparison of quality control defects in quality control examination of department ( P<0.05) . In the democratic evaluation of staff, 43 were very satisfied with the performance distribution, 3 were dissatisfied. The content of dissatisfaction was the coefficient in lactation has no difference from other posts. Conclusions:The implementation of the post level management and secondary performance assessment in the Central Supply Service Department has stimulated the potential of nurses at all levels, aroused their enthusiasm for work, and set up goals for everybody. All staff participating in the management improved the work efficiency and quality, guaranteed the nursing safety and the work operation, achieving the satisfactory effect.

ObjectiveTo explore the influence of centralized management mode on disinfection and sterilization of flexible endoscopes in Central Sterile Supply Department(CSSD). MethodsBy cluster sampling,the endoscopes processed in the First People＇s Hospital of Shangqiu in He＇nan province from 2015 to 2016 were selected for investigation. The endoscopes processed from 2015 to 2018 were put into the control group (n=47 250)and those processed from 2017 to 2018 were in the experimental group(n=55 319). The cleaning and sterilization room was set up to manage the flexible endoscopes in the control group while the CSSD centralized management mode was adopted in the experimental group. The quality of sterilization and disinfection in the two groups were compared. ResultsThere were statistically significant differences between the two groups of endoscopes in the sterilization and disinfection quality monitoring results(P＜0.05). ConclusionsThe cleaning, disinfection and sterilization of flexible endoscopes under the CSSD centralized management mode ensures the quality of disinfection and sterilization of flexible endoscopes and the safety of doctors, nurses and patients by reasonably equipping facilities and personnel and strict quality control.

It has been shown that the PIK3CA mutation in HER2 positive breast cancer is up to 25%, and thus activates PI3K-Akt signaling pathway,promotes HER2 mediated tumor cell epithelial transformation, alters the intrinsic phenotype of HER2 overexpression breast cancer,and finally leads to resistance to anti HER2 targeted therapy.Some studies have shown that the PIK3CA gene mutation is associated with the efficacy of anti-HER2 targeted therapy.Therefore,real-time monitoring of PIK3CA gene mutation will promote indivi-dualized anti-HER2 targeted therapy.

A 32-year-old woman with breast cancer received a postoperative adjuvant chemotherapy with epirubicin plus cyclophosphamide followed by paclitaxel.The drug regimen of paclitaxel was intravenous infusion 120 mg once a week.On the day 6 after the first cycle of paclitaxel treatment, the patient developed bilateral big toenail hollowness, the aperture was about 2 mm.She was given the second cycle of paclitaxel according to the original plan.Six days later, the hollow toenail was worsened with slight pain.Paclitaxel was stopped.Mecobalamin, erythromycin ointment and keeping warm of feet were applied.Four days later,the pain was reduced, and the toenail hollowness did not continue to enlarge.