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.

Aim To investigate the risk factors of death after acute Stanford type A aortic dissection(ATAAD)complicated with malperfusion syndrome(MPS).Methods 244 patients with ATAAD complicated with MPS who ad-mitted to Nanchong Central Hospital from June 2020 to June 2023 were selected as the study objects.The postoperative survival of the patients was followed up and they were classified into survival group(156 cases)and death group(88 ca-ses).After propensity score matching(PSM)was applied in 1 ∶1 matching,there were 54 cases in both groups.Uni-variate and Logistic regression analysis was performed to analyze the risk factors of postoperative death in patients with ATA-AD complicated with MPS.Area under curve(AUC)of receiver operating characteristics(ROC)was used to analyze the prognosis of ATAAD complicated with MPS.The prediction model was established by using the regression equation y=1-1/(1+e-z)and the stability of the model was verified by cross-checking method.Results After matching,compared with the survival group(n=54),in the death group(n=54),the proportion of sex(male),the proportion of alcohol con-sumption,acute physiology and chronic health status Ⅱ(APACHE Ⅱ)score,sequential organ failure(SOFA)score,al-anine aminotransferase(ALT),aspartate aminotransferase(AST),total serum bilirubin(TSB),cholinesterase,serum creatinine(SCr),blood urea nitrogen(BUN),N-terminal pro-brain natriuretic peptide(NT-proBNP),D-dimer(D-D),white blood cell(WBC),neutrophile granulocyte(NEU),fibrinogen degradation product(FDP),platelet(PLT),fi-brinogen(FIB),C-reactive protein(CRP),hypersensitive troponin,operation time,ICU stay time,ventilator stay time,hospital stay,distal extremity hypoperfusion,renal hypoperfusion were significantly increased(P＜0.05).Logistic analy-sis displayed that gender(male),history of drinking,NT-proBNP ≥271.86 ng/L,D-D≥0.74 mg/L and NEU≥13.06× 109 L-1 were independent risk factors in ATAAD patients complicated with MPS for postoperative death(P＜0.05).The combination of NT-proBNP,D-D,gender(male),alcohol drinking history and NEU(referred to as"five factors")had the highest value in predicting ATAAD patients with MPS.The AUC of its ROC curve was 0.979(95％CI:0.937～0.984),the sensitivity was 94.3％,and the specificity was 91.8％,which was higher than the independent predictor.The best critical value predicted by the five factors was 5.02.The survival rate of the group＞5.02 was significantly high-er than that of the group ≤5.02.Log Rank test P＜0.01.A prediction model was established based on the important factors of postoperative death in ATAAD patients with MPS.The results showed that the model had good prediction accu-racy.Conclusion NT-proBNP≥271.86 ng/L,D-D≥0.74 mg/L,gender(male),history of alcohol consumption,and NEU≥×109 L-1 were independent risk factors for long-term prognosis in patients with ATAAD combined with MPS,and their combined application could effectively increase the accuracy of prognosis assessment.