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 efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis(IM)and its impact on the immune function of diseased children.Methods Totally 120 diseased children with IM accepted by our hospital from February 2022 to August 2024 were stochastically assigned into a treatment group and a monotherapy group.The monotherapy group received treatment with ganciclovir,while the treatment group received treatment with spleen aminopeptide in addition to the monotherapy group.The efficacy,symptom improvement time,serum inflammatory factors,immune indicators,and biochemical indicators before and after treatment were compared between the two groups.Results The efficacy of the treatment group was better than that of the monotherapy group,and the symptom relief time was shorter than that of the monotherapy group(P＜0.05).After treatment,the serum amyloid A,TNF-α,IL-6,procalcitonin,CD3+T,CD8+T,lactate dehydrogenase,alanine aminotransferase,EBV-DNA,creatine kinase,and white blood cell count in both groups decreased,while CD4+T and CD4+T/CD8+T increased.The amplitude of the treatment group was greater than that of the monotherapy group(P＜0.05).Conclusion The combination of ganciclovir and spleen aminopeptide in treating IM is beneficial for enhancing the immune function of T lymphocytes of diseased children,alleviating inflammatory reactions,improving biochemical indicators,and enhancing efficacy.

Objective To investigate the efficacy of ganciclovir combined with spleen aminopeptide in treating infectious mononucleosis(IM)and its impact on the immune function of diseased children.Methods Totally 120 diseased children with IM accepted by our hospital from February 2022 to August 2024 were stochastically assigned into a treatment group and a monotherapy group.The monotherapy group received treatment with ganciclovir,while the treatment group received treatment with spleen aminopeptide in addition to the monotherapy group.The efficacy,symptom improvement time,serum inflammatory factors,immune indicators,and biochemical indicators before and after treatment were compared between the two groups.Results The efficacy of the treatment group was better than that of the monotherapy group,and the symptom relief time was shorter than that of the monotherapy group(P＜0.05).After treatment,the serum amyloid A,TNF-α,IL-6,procalcitonin,CD3+T,CD8+T,lactate dehydrogenase,alanine aminotransferase,EBV-DNA,creatine kinase,and white blood cell count in both groups decreased,while CD4+T and CD4+T/CD8+T increased.The amplitude of the treatment group was greater than that of the monotherapy group(P＜0.05).Conclusion The combination of ganciclovir and spleen aminopeptide in treating IM is beneficial for enhancing the immune function of T lymphocytes of diseased children,alleviating inflammatory reactions,improving biochemical indicators,and enhancing efficacy.

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 develop the Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with Inflammatory Bowel Disease (IBD), and test its reliability and validity.Methods:Guided by the theory of knowledge, attitude, and practice, a preliminary draft of the scale was formed through literature review, Delphi expert consultation, and pre-survey. From May to August 2022, convenience sampling was used to select 200 IBD patients who visited the Gastroenterology Clinic of three ClassⅢ Grade A comprehensive hospitals in Jiangsu Province as the research subject for a questionnaire survey. The critical ratio method, correlation analysis method, internal consistency method, commonality and factor loadings were used for item analysis of the scale. Exploratory factor analysis, content validity index, and internal consistency reliability were applied to test the reliability and validity of the scale.Results:A total of 200 questionnaires were distributed, and 181 valid questionnaires were collected, with an effective response rate of 90.50% (181/200). The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD included three dimensions of knowledge, attitude and practice, with a total of 21 items. The content validity index at the scale level was 0.917, and the content validity index at the item level ranged from 0.833 to 1.000. Exploratory factor analysis extracted three common factors, with a cumulative variance contribution rate of 74.197%. The Cronbach's α coefficient of the total scale was 0.951, and the coefficients of each dimension were 0.914 to 0.942. The test-retest reliability coefficient of the total scale was 0.918, and the test-retest reliability coefficients of each dimension ranged from 0.737 to 0.833.Conclusions:The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD has good reliability and validity, which can help medical and nursing staff evaluate patients' understanding and acceptance of microbial transplantation, so as to provide a basis for personalized communication in shared decision making between doctors and patients.

【Objective】 To explore the status and characteristics of voluntary blood donors in rural areas of Dali Bai Autonomous Prefecture (referred as Dali), and to provide basis for scientific and effective voluntary blood donation in rural population in regions inhabited by ethnic groups. 【Methods】 The data of rural blood donors who donated blood in Dali from 2010 to 2019 were collected, including demographic data as nationality, gender, age, educational background, as well as the blood donation frequency and blood infection screening (index) results. The above data of urban blood donors who donated blood in Dali during the same period were selected to investigate the increasing trend of blood donation rate. SPSS26.0 was used for statistical analysis of the collected data of rural and urban blood donation population. 【Results】 From 2010 to 2019,the number of blood donors in Dali increased from 13 949 to 19 479,with an increasing rate of 39.64%. The number of rural blood donors increased from 2 623 to 8 727,among which the number of ethnic minority groups increased from 1 779 to 5 059.The ratio of male to female blood donors was 70.30% (1 844/2 623) vs 29.70% (779/2 623) in 2010,56.37% (4 919/8 727) vs 43.63%(3 808/8 727) in 2019. Those with educational level of junior middle school or below were the most, accounted for 43.97%(38 443/85 836),with ethnic donors of 24.47%(23 583/85 836). The proportion of donors aged between 36 and 45 was the highest[40.73% (30 477/74 827) ], with ethnic donors of [28.56% (21 374/74 827), and the proportion of repeated blood donors was 54.87%(35 279/64 299),with ethnic donors of 49.89%(18 080/36 240) [the proportion of repeated blood donors in urban donors in the same period was 48.13% (55 677/115 675) ] (P<0.01). The unqualified rate of ALT was the highest [1.21%(1 272/105 489) ] [The unqualified rate in local donors was 1.99%(3 837/192 552) ] (P<0.01), and that of the ethnic donors was 1.51%(358/56 718). There was no significant difference in the unqualified rates of HB-sAg, anti-HCV, anti-HIV and anti-TP among urban and rural blood donors (P>0.05). 【Conclusion】 It is of great significance to explore the characteristics of blood donors in rural areas (especially regions inhabited by ethnic groups) and the reasons for disqualification, in order to scientifically carry out the recruitment of voluntary blood donors and further promote blood donation for rural residents

Objective:To explore the association between genetic polymorphism of APP gene and bipolar disorder(BD) in children and adolescents for seeking suitable single nucleotide loci(SNP), and provide reference for early diagnosis and intervention of children and adolescent BD.Methods:The genomic DNA of peripheral blood was extracted from 178 BD cases(case group) and 178 normal controls(control group) of Han children and adolescents.Four SNP loci of APP gene were selected and were analyzed by LDR-PCR SNP genotyping.Genotypes and allele differences were compared between the cases and control group by SPSS22.0 software.The software SHEsis was also used to make linkage disequilibrium and haplotype analysis.Results:The genotype frequency and allele frequency of the 4 SNP loci of APP gene were statistically significant different between the case group and the control group ( P<0.05). The association of s2040273, rs466433, rs463946, rs364048 with BD in the APP gene was statistically significant( P<0.05). The construction of 4 SNP haplotypes indicated that AACT, AGGC, and GACT accounted for more than 80% of the total.The percentage of haplotype AGGC in the case group(11.9%)was significantly higher than that in the control group(4.7%)( P<0.05), and the odds ratio of AGGC haploid was 2.727. Conclusion:Four SNP loci s2040273, rs466433, rs463946, rs364048 in the APP gene and haplotype AGGC are associated with BD in Han children and adolescents.These results confirmed that the APP gene is one of BD susceptible gene.

Objective To explore the influence of vagus nerve stimulation (VNS) on inflammatory factors in serum and nucleus of the solitary tract,and hippocampal apoptosis in rats with depression induced by chronic unpredictable stress ( CUS). Methods Totally 32 male Sprague Dawley ( SD) rats aged 8-9 weeks were selected. Eight rats were chosen as control group,and the other 24 rats were treated as the de-pression model with CUS. The rats were randomly divided into CUS,fluoxetine and VNS group,with 8 rats in each group after successful modeling. The control group and CUS group were induced by normal saline. Flu-oxetine group and VNS group were implanted with VNS stimulation electrode. The VNS stimulation lasted for 28 d. On the time points of before experiment,after modeling and after treatment,the sucrose consumption test and open-field test (OFT) were performed to observe the behavioral changes of rats. Elisa was used to detect the levels of TNF-α,IL-6 and IL-1β in serum and nucleus of the solitary tract. Cell apoptosis was ob-served with TUNEL staining in hippocampal CA1 region. Results ( 1) Sucrose consumption experiment and OFT showed that,compared with the CUS group,the consumption of sucrose,percentage of sucrose con-sumption,scores of vertical and horizontal movement increased significantly in the VNS group ( consumption of sucrose: (11. 78±2. 67) ml,(8. 06±2. 85) ml; percentage of sucrose consumption: (72. 31±9. 98)%, (63. 67±8. 95)%; score of vertical movement: (16. 61±3. 98),(10. 31±3. 86); score of horizontal move-ment: (44. 25±9. 59),(36. 21±7. 21)) (t=4. 87,7. 98,5. 87,9. 12,all P<0. 05). There was no signifi-cant difference between VNS and fluoxetine groups (consumption of sucrose: (11. 32±2. 66) ml; percentage of sucrose consumption: (71. 31±9. 03)%; score of vertical movement: (15. 63±4. 11); score of horizontal movement: (45. 61±8. 54)) (t=-0. 32,-1. 83,0. 98,-1. 13,all P>0. 05). (2) Compared with the CUS group,levels of TNF-α,IL-6 and IL-1β in serum decreased in the VNS group ( serum TNF-α: ( 46. 72 ± 11. 63) pg/ml,(125. 47±15. 18) pg/ml; serum IL-6: (243. 65±38. 90) pg/ml,(441. 39±83. 31) pg/ml;serum IL-1β: (209. 31±32. 45) pg/ml,(339. 21±76. 37) pg/ml) (t=-70. 38,-196. 25,-131. 13,all P<0. 05). The results in the VNS group were lower than those in the fluoxetine group (serum TNF-α: (58. 76 ±12. 64) pg/ml; serum IL-6: (308. 83± 64. 31) pg /ml,serum IL-1β: ( 249. 18 ± 43. 6) pg/ml) ( t=-15. 38,-64. 25,-18. 83,both P<0. 05). The levels of TNF-α,IL-6 and IL-1β in nucleus of the solitary tract in the VNS group were lower than those in the CUS ( TNF-α: (53. 52± 12. 31) pg/ml,(135. 51± 20. 64)pg/ml; IL-6: (265. 31±45. 63) pg/ml,(465. 32±60. 21) pg/ml; IL-1β: (212. 66±43. 32)pg/ml, (365. 96±76. 32) pg/ml) (t=-79. 38,-189. 13,-127. 50,all P<0. 05) and fluoxetine groups (TNF-α:(63. 42±10. 64) pg/ml; IL-6: (315. 62±53. 21) pg/ml; IL-1β: (278. 32±65. 38) pg/ml ) (t=-10. 25,-39. 00,-83. 00,all P<0. 05). (3) The apoptotic rate of hippocampal CA1 region in VNS group ((21. 41± 5. 86)%) was lower than that in the CUS group ((32. 78±8. 32)%) (t=-10. 75,P<0. 05); and there was no difference between VNS group and fluoxetine group ((22. 54±6. 31)%) (t=-1. 75,P>0. 05). Conclu-sion VNS can improve the depression behavior in rats with depression induced by CUS and the mechanism maybe related to inhibiting the expression of TNF-α,IL-6 and IL-1β in serum and nucleus of the solitary tract and cell apoptosis in hippocampal CA1 region.

Objective To study the expression of plasma oxidized low-density lipoprotein (oxLDL) in children with acute phase Kawasaki disease (KD), and investigate its value for early prediction of coronary artery lesions in KD. Methods Totally 80 children with KD were collected. Children were divided into four groups by the results of echocardiogram of coronary artery in different periods: CAL1 group (children with coronary artery lesions (CAL+) both in acute and sub-acute phase, 8 cases), CAL2 group (children with CAL+in acute phase but recovery normal (CAL-) in sub-acute phase, 10 cases), NCAL1 group (children with CAL-in acute phase but occur CAL+ in sub-acute phase, 10 cases) and NCAL2 group (children with CAL- both in acute and sub-acute phase, 52 cases). The serum samples (before the use of intravenous immunoglobulin) were collected in acute phase. Twenty healthy controls and twenty fever controls were enrolled into the study, and their serum samples were collected. OxLDL was measured by enzyme linked immunosorbent assay (ELISA). They were compared using ANOVA, pairwise comparison LSD-t test. And ROC curve analysis was used to determine the threshold. Results Compared with the control groups,plasma oxLDL levels were higher in children with KD, both CA+and CAL-[(15.0±3.3) mU/L, (12.3±3.5) mU/L vs (9.2±2.2) mU/L, (8.0±2.3) mU/L, F=20.435, P<0.05]. Plasma oxLDL levels were increased more significantly in children with CAL+ than children with CAL- in KD [(15.0 ±3.3) mU/L vs (12.3 ±3.5) mU/L, t=2.28, P=0.002]. There was significant difference in the concentration of oxLDL between the groups of Kawasaki disease (F=5.068, P=0.003). Plasma oxLDL levels were significantly higher in the NCAL1 group than those in the NCAL2 group [(14.5 ±3.8) mU/L vs (11.9±3.3) mU/L, t=2.29, P=0.02], but there were no statistically significant difference between the NCAL1 group and CAL1 or CAL2 group [(14.5±3.8) mU/L vs (15.9±3.9) mU/L, (14.5±3.8) mU/L vs (14.2±2.7) mU/L, t=0.73, 0.20;P=0.41, 0.84]. ROCs analysis indicated that oxLDL≥13.83 mU/L, could be the threshold for the prediction of coronary artery lesions with the sensitivity of 0.607 and a specificity of 0.75. Conclusion OxLDL plays an important role in coronary artery lesions in KD. The coronary endothelial dysfunction is earlier than coronary dilatation, and oxLDL is expected to become a reliable early predictor of coronary artery lesions in KD.

Objective To analysis the clinical outcome at discharge and its risk factors of extremely preterm infants.Method To retrospectively analysis the clinical outcome at discharge and it's risk factors of extremely preterm infants (less than 28 weeks gestation) admitted from September 2008 to August 2014 in our Hospital.Result A total of 179 cases were enrolled.Survival rate was 59.2％ (106/179).Unfavorable outcome rate was 74.3％ (133/179),among them 73 cases died.The top five causes of death were severe bronchopulmonary dysplasia (BPD) (28 cases),Ⅲ ～ Ⅳ o intraventricular hemorrhage (IVH) (19 cases),sepsis (16 cases) and necrotizing enterocolitis (NEC) (6 cases).Among the 60 survivals with unfavorable outcomes,35 cases had either severe neurologic or ophthalmological sequela,and 25 cases had severe pulmonary sequela.Univariate analysis showed that,comparing with improved group,unfavorable outcome group had higher rates of not receiving prenatal steroids,placental abruption,male,small for gestation age,resuscitation with chest compression,admission age older than 72 hour,severe respiratory distress syndrome (RDS),without pulmonary surfactant (PS) usage,mechanical ventilation beyond 2 weeks and sepsis (P ＜ 0.05).Logistic regression analysis showed that those without prenatal steroids (OR =9.402,P =0.002),small for gestational age (OR =8.271,P =0.018),resuscitation with chest compression (OR =6.325,P =0.023),admission age older than 72 hour (OR =4.174,P =0.028) were independent risk factors for unfavorable outcome of extremely premature at discharge.Conclusion Extremely preterm infants have a higher rate of unfavorable outcome at discharge.Avoid small for gestational age,transfer properly and in time both in utero and after birth,and conduct prenatal steroids could improve their clinical outcome at discharge.