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 biological maternal sounds on blood gas analysis index, mechanical ventilation time, oxygen therapy time and hospital stay in mechanically ventilated children with severe pneumonia.Methods:This study was a randomized controlled trial. From June 2020 to November 2020, 128 mechanically ventilated children with severe pneumonia in Hunan Children′s Hospital were selected by convenient sampling method and divided into four groups with 32 cases in each group by random number table method. Group A was given routine nursing care, group B was given mother sounds, group C was given mother cardiotone, group D was given biological maternal sounds. Data of blood gas analysis index, mechanical ventilation duration, oxygen therapy duration, hospital stays were collected for comparative analysis.Results:Finally, group A, B, C, and D included 28, 30, 28 and 28 cases, respectively. There was no statistically significant difference in PaO 2 among the four groups on the 1st to 2nd day after intervention ( P>0.05), but PaO 2 on the 3rd to 7th day after intervention were (75.57 ± 12.88), (77.71 ± 15.81), (78.21 ± 14.51), (78.64 ± 17.71), (79.04 ± 11.57) mmHg (1 mmHg=0.133 kPa), (81.71 ± 17.89), (82.93 ± 18.36), (82.68 ± 15.47), (83.25 ± 14.24), (83.77 ± 13.90) mmHg, (80.89 ± 18.78) (82.11 ± 13.34), (82.96 ± 14.20), (83.43 ± 14.37), (83.68 ± 12.64) mmHg, (84.54 ± 18.77), (86.29 ± 10.94), (86.96 ± 10.53), (87.46 ± 12.64), (89.08 ± 12.21) mmHg, with statistically significant differences ( F values were 41.17 - 332.68, all P<0.01). Further pairwise comparison revealed that PaO 2 in group B and group C were higher than those in group A on the 3rd to 7th day after intervention, while those in group D were higher on the 3rd to 7th day after intervention than those in group A, B, and C, with statistically significant differences( t values were 3.35- 4.75, all P<0.01). There was no statistically significant difference in PaCO 2 among the four groups on the 1st to 4th day after intervention ( P>0.05), but PaCO 2 on the 5th to 7th day after intervention was (47.31 ± 2.89), (46.18 ± 2.06), (41.94 ± 2.09) mmHg, (44.73 ± 1.76), (41.38 ± 1.30), (38.33 ± 1.16) mmHg, (44.81 ± 1.24), (41.23 ± 1.89), (38.73 ± 2.55) mmHg, (40.83 ± 1.78), (37.87 ± 1.43), (34.78 ± 2.05) mmHg, with statistically significant differences ( F=29.48, 36.12, 34.52, all P<0.05). Further pairwise comparison revealed that PaCO 2 in group B and group C were lower than those in group A on the 5th to 7th day after intervention, while PaCO 2 in group D were lower than those in groups A, B, and C, with statistically significant differences ( t values were 3.37-4.85, all P<0.01). During the analysis of PaO 2 and PaCO 2 in the four groups at different time points, the interaction effects were not statistically significant ( P>0.05). There was no significant difference in invasive mechanical ventilation duration, non-invasive mechanical ventilation duration and hospital stay among the four groups after intervention ( P>0.05). The oxygen therapy time of the four groups were (8.61 ± 6.40), (6.17 ± 4.80), (6.23 ± 2.75), and (3.75 ± 2.10) days, with statistically significant differences ( F=17.27, P<0.01). Further pairwise comparison revealed that the oxygen therapy time in group B and group C was shorter than that in group A, while group D was significantly shorter than that in groups A, B, and C, with statistically significant differences ( t values were 4.02-4.74, all P<0.01). Conclusions:Biological maternal sounds is superior to maternal sound and mother cardiotone in improve the blood gas analysis index, shorten the oxygen treatment time, which is worthy of clinical promotion in neonatal unaccompanied ward.

Objective:To deeply understand the real emotional experience and needs of the parents of dying newborns, so as to provide a reference for future neonatal palliative care.Methods:From February to October 2021, purposeful sampling was used to select 15 parents of dying newborns in the Department of Neonatology of Hunan Children's Hospital as the research object. A qualitative research design was conducted, and the semi-structured interview method was used to conduct in-depth interviews with the research subjects, and NVivo 10.0 software was used for data analysis.Results:A total of 3 themes were extracted, namely, the ambivalence when giving up treatment, negative life effects after giving up, needs and expectations.Conclusions:Parents of dying newborns generally have ambivalence when they give up treatment. After giving up, they will show emotions such as sadness and helplessness, self-blame and regret, and depression. Understanding the real emotions and inner needs of the parents of dying newborns helps medical and nursing staff to pay attention to parents' negative psychology and understand their needs, and provide parents with targeted psychological support and other care, so as to help the parents of dying newborns and their families through a special period.

Objective To investigate the pathogenesis in patients with uterine leiomyoma complicated by amyloidosis. Methods A total of 36 uterine leiomyoma patients were recruited in this study, and divided into two group by Congo red staining:amyloidosis group (n=6) and non-amyloidosis group (n=30). (1) Amyloidosis deposition was observed in amyloidosis group. (2) HE staining was used to compare changes of inflammatory cells in two groups. (3)PAS staining was used to observe polysaccharide difference in two groups. (4)Values of serum hemoglobin (HGB), white blood cell count (WBC), lymphocyte absolute value (LYM), neutrophil absolute value (NEU), total protein (TP), albumin (Alb) and prealbumin (PA) were com?pared between two groups. Results (1)Leiomyoma entity cells were negatively Congo red stained, while 5 out of 6 pseudo-capsule fiber deposition and 2 out of 6 blood vessel were positively Congo red stained. (2)Infiltrations of inflammatory cells were observed in two groups. (3) The PAS positive staining was found in amyloidosis deposition and non-amyloidosis deposi?tion groups. (4)There were no significant differences in HGB, WBC, NEU, LYM, TP, Alb and PA levels between two groups (P>0.05). Conclusion Metabolism changes resulted from cell function alterations in local micro-environment by uterine leiomyoma may be related to the formation of the amyloidosis.

Objective To investigate the prevalence of hypothyroidism during the second trimester and its relationship with thyroid peroxidase antibody (TPOAb). Methods Two thousand one hundred and forty one pregnant women whose gestational age between 14 to 28 weeks,accepted their prenatal care at the outpatient clinic of International Peace Maternity & Child Health Hospital from March 1,2010 to July 31,2010 were enrolled into this study. Serum TPOAb,thyroidstimulating hormone (TSH) and free thyroxine (FT4) of these women were detected. Logistic regression model was used to analyze the risk factors of subclinical hypothyroidism and positive TPOAb,while Spearman rank correlation was used to analyze the relationship between the levels of TSH,FT4 and TPOAb. Results (1) Subclinical hypothyroidism was detected in 13.36％ (286/2141) patients. Isolated maternal hypothyroxinemia occurs in 0.14％ (3/2141) of pregnant women.No overt hypothyroidism patient was detected and 6.26％ (134/2141) of all pregnant women exhibited positive TPOAb(≥50 U/ml).(2) Positive rate of TPOAb in subclinical hypothyroidism group,isolated maternal hypothyroxinemia group and normal thyroid function group was 13.64％ (39/286),0/3 and 5.06％ (86/1701) respectively,and there was difference among the three groups (x2 =30.82,P＜0.01).The positive rate of TPOAb did not relate to fetal gender,maternal age,gestational age,gravidity and parity.(3) TPOAb had positive relationship with TSH level (r=0.12,P＜0.01),while did not relate to FT4 level (r=-0.04,P=0.09). (4) Positive TPOAb (OR 3.18,95％ CI:2.10-4.83,P＜0.01) and gravidity (OR=1.21,95％ CI:1.02-1.43,P=0.030)were risk factors of subclinical hypothyroidism. Conclusions Hypothyroidism is common during the second trimester. It is necessary to screen TPOAb in pregnant women as TPOAb is an independent and important predictor of subclinical hypothyroidism.