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 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 estimate the social and economic burden of Downs syndrome for patients and their families residing in Changsha, China. METHODS: An 160-item self-administered questionnaire was designed and distributed to the primary caregivers of the patients in March 2020. A total of 81 eligible participants had completed the questionnaire, among which 20 were excluded for incomplete data. A patient perspective was taken to estimate the economic burden of the disease. The social impact of the disease on the patient's family was evaluated through questions adapted from the Stanford Psychological Wellbeing (PWB) Scale. RESULTS: The estimated life-course cost of a Downs syndrome patient in Changsha is 4 985 659 RMB, with the patient and caregiver's loss of income taking the greater proportion. In addition, as the majority of the patients' primary caregivers, female caregivers experienced not only considerable financial hardship caused by the care provision, but also a significant amount of psychological pressure and social discrimination. CONCLUSION Increased level of social welfare for the patients and social support for their female caregivers are essential for reducing economic burden and improving their quality of life in the area. In addition, prenatal screening and diagnosis for Downs syndrome are important for reducing both the social and economic burden of the disease by preventing its occurrence.
Caregivers ; China ; Down Syndrome ; Female ; Financial Stress ; Humans ; Quality of Life ; Social Discrimination ; Surveys and Questionnaires

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.

AIM: To investigate the effects of astragalus injection combined with puerarin injection on endo-plasmic reticulum stress through PERK pathway in diabetic nephropathy mice .METHODS: Male KKAy mice were ran-domly divided into model group ( injected with normal saline ) and treatment group ( injected with astragalus and puerarin ) . The male C57BL/6J mice served as normal group .The mice were sacrificed 4 weeks after treatments for observing morpho-logical changes under electron microscope .The renal tissues were collected to determine the expression of protein kinase R-like endoplasmic reticulum kinase ( PERK ) , eukaryotic initiation factor 2α( eIF2α) and glucose-regulated protein 78 (GRP78) at mRNA and protein levels by real-time PCR and Western blot.RESULTS: Under electron microscope, the renal tubular epithelial cells in model group and treatment group showed the swelling of the nucleus , endoplasmic reticulum and mitochondria .The results of real-time PCR and Western blot showed that the expression of PERK , eIF2αand GRP78 at mRNA and protein levels in model group was higher than that in normal group (P<0.05), while that in treatment group was lower than that in model group .CONCLUSION: Astragalus injection combined with puerarin injection reduces the mRNA and protein expression of PERK , eIF2αand GRP78, thus inhibiting the endoplasmic reticulum stress in type 2 dia-betic mice to protect the kidney function .

The present study aimed to study the effects of applying mixed probiotics in the feed on growth performance,antioxidant activity and immune function in yellow-feathered broilers.Three hundred sixty yellow-feathered broilers at 10-day-old were divided into 4 groups.Group A was fed with basal diets,group B with basal diets added 50 g/t mixed probiotics,group C with basal diets added 100 g/t mixed probiotics and group D with basal diets added 300 g/t mixed probiotics.Each group included 9 replicates(10 birds per replicates),and the experiment lasted 50 days.Results showed that group D got the highest average daily gain(ADG) of all groups,and compared with the control group A,ADG was increased by 4.11％ (P＜0.05).Group B got the lowest feed-gain ratio of all groups,and the feed-gain ratio was decreased by 4.58％(P＜0.05) compared with the control group A.Group D got significantly increased duodenal villous length,serum antioxidant index and antibody titer(P＜0.05) compared with the control group A.The effects of mixed probiotics on the growth performance,antioxidant activity and immune function were distinct in yellow-feathered broilers,and 100 g/t mixed probiotics was recommended.