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.

convalescents, and to screen for broad-spectrum neutralizing antibodies against the SARS-CoV-2 RBD. Methods Using biotinylated RBD as a molecular probe, flow cytometry was employed to perform single-cell sorting of B cells from peripheral blood mononuclear cells (PBMCs) of convalescents. The obtained B cells were lysed and subjected to reverse transcription, followed by nested PCR amplification of the heavy and light chains of antibodies was conducted using random primers. The amplified products were cloned into corresponding expression vectors, and the respective matched heavy-light chain plasmids were co-transfected into 293F cells for expression. Monoclonal antibodies were then purified using Protein A column chromatography. Neutralization experiments were conducted with the wild-type (WT) pseudovirus, and antibodies with IC50<0.1 μg/mL were selected for further testing of neutralizing breadth and potency against the wild-type (WT), Beta variant (B.1.351), Delta variant (B.1.617.2), and currently prevalent pseudovirus strains (XBB, BA.5, BF.7). Results A total of 21 RBD-specific monoclonal B cells were obtained from two recovered patients, resulting in the isolation of 13 pairs of antibody light/heavy chains. Nine antibodies were successfully expressed, with P1-A1, P1-B6, and P1-B9 exhibiting IC50 values below 0.1 μg/mL against the pseudovirus of the wild-type strain (WT). Specifically, P1-B6 effectively neutralized the wild-type strain (WT), Beta variant (B.1.351), and Delta variant (B.1.617.2), with IC50 values reaching 0.01 μg/mL. P1-B9 demonstrated effective neutralization against the wild-type strain (WT), Beta variant (B.1.351), Delta variant (B.1.617.2), and Gamma variant (P.1) pseudoviruses, with IC50 values of 0.42 μg/mL, 0.63 μg/mL, 0.28 μg/mL, and 2.50 μg/mL, respectively. Additionally, P1-B6 exhibited good neutralization against BA.5 and BF.7 pseudoviruses, with IC50 values of 0.06 μg/mL and 0.09 μg/mL, respectively. Conclusions Infection with the SARS-CoV-2 WT strain can induce the generation of neutralizing antibodies with broad-spectrum activity. Generating these broadly neutralizing antibodies does not require an excessively high somatic hypermutation. The obtained antibodies can be used as candidates for SARS-CoV-2 diagnosis and prevention.

Objective:To explore the application effect of multimodal quantitative rehabilitation exercise in patients with ankylosing spondylitis and to provide reference for patients′ rehabilitation exercise.Methods:The quasi-experimental study method was used to select 78 patients with ankylosing spondylitis admitted to Rheumatology and Immunology Department of First Affiliated Hospital of Xinjiang Medical University from February 2021 to February 2022 as the research objects. The 39 patients admitted from February 2021 to August 2021 as the control group, and 39 patients admitted from September 2021 to February 2022 as the experimental group. The control group adopted conventional rehabilitation exercise program, and the experimental group adopted multimodal quantitative rehabilitation exercise program. The Bath ankylosing spondylitis disease activity index, Bath ankylosing spondylitis function index, inflammatory factors after 6 months of intervention were compared between the two groups.Results:The Bath ankylosing spondylitis disease activity index in the experimental group after 6 months of intervention was (2.35 ± 0.81) points, and that in the control group was (3.47 ± 1.04) points, with a statistically significant difference ( t = 4.02, P<0.05). The Bath ankylosing spondylitis disease activity index in the two groups were analyzed by repeated measurement variance. The differences of time effect, inter group effect and interaction effect were statistically significant ( Fgroup = 11.27, Ftime = 62.05, Finteraction = 5.47, all P<0.05). The Bath ankylosing spondylitis function index in the experimental group after 6 months of intervention was (2.11 ± 0.32) points, and that in the control group was (3.07 ± 0.58) points, with a statistically significant difference ( t = 4.03, P<0.05). The Bath ankylosing spondylitis function index in the two groups were analyzed by repeated measurement variance. The differences in time effect, inter group effect and interaction effect were statistically significant ( Fgroup = 21.44, Ftime = 42.25, Finteraction = 16.67, all P<0.05). After 6 months of intervention, C-reactive protein, interleukin-6, transforming growth factor β, tumor necrosis factor-α were (43.15 ± 2.21) mg/L, (3.28 ± 0.85) mg/L, (41.67 ± 9.04) ng/L, (176.63 ± 20.15) ng/L respectively in the experimental group, and (50.12 ± 1.67) mg/L, (5.27 ± 0.68) mg/L, (48.65 ± 8.96) ng/L, (194.56 ± 19.45) ng/L respectively in the control group. There was a statistically significant difference in the content of inflammatory factors between the two groups ( t values were 2.05-4.45, all P<0.05). Conclusions:Multimodal quantitative rehabilitation exercise can improve the physiological function of ankylosing spondylitis patients′spine, reduce the disease activity of patients, and promote the rehabilitation of patients.

Objective:To evaluate the effect of the timing of peripancreatic drainage on the survival outcome of patients with severe acute pancreatitis (SAP).Methods:This retrospective study included 271 patients with SAP admitted to two tertiary hospitals from January 2015 to December 2019. The Acute Physiology and Chronic Health EvaluationⅡ score (APACHEⅡ), Sequential Organ Failure Assessment score (SOFA), computed tomography (CT) grade, peripancreatic drainage situations, and survival outcome of patients were recorded. Patients were divided into the early and non-early peripancreatic catheter drainage groups (EPCD and non-EPCD). The data were analyzed using the Cox proportional hazard model for propensity score matching (PSM) and stratification.Results:After PSM, the 30-day and 90-day risk of death between the EPCD and non-EPCD groups were significantly different (0.134, 95% CI: 0.029-0.576, P=0.007; 0.166, 95% CI: 0.044-0.631, P=0.008, respectively). Furthermore, stratified analysis revealed significant differences in 30-day and 90-day risk of death between the EPCD and non-EPCD groups when the SOFA score was≥4 or the APACHEⅡ score was ≥8. Conclusions:For patients with SAP with SOFA score ≥4 or APACHEⅡ score≥8, early peripancreatic drainage can reduce the risk of death, but CT grading is not helpful for the decision-making of drainage timing in patients with SAP.

Objective:To investigate the imaging and clinical characteristics of posttransplantation lymphoproliferative disorders (PTLD) after liver transplantation in children.Methods:From February 2017 to November 2020, the imaging and clinical data of 17 children with PTLD after liver transplantation confirmed by pathology or clinical diagnosis were retrospectively analyzed in Shanghai Children′s Medical Center, School of Medicine, Shanghai Jiao Tong University. The site, range, density/signal/echo of the lesions were observed.Results:The mean age at transplantation was 8 (7, 11) months, and 14 patients were younger than 1 year old. The interval between liver transplantation and PTLD diagnosis was 22 (10, 34) months, ranging from 3 to 54 months. The interval was less than 1 year in 6 patients (early onset) and equal or greater than 1 year in 11 patients (late onset). Fifteen patients had Epstein-Barr virus infection. Among the 12 pathologically confirmed PTLD cases, 8 cases were diffuse large B-cell lymphoma, 3 cases were Burkitt lymphoma, and 1 case was reactive plasma cell hyperplasia. Among the 17 children with PTLD, 8 cases demonstrated involvement of lymph nodes and 16 cases had extranodal involvement. The latter included 15 cases of abdominal involvement. Abdominal sites involved included small intestine in 14 cases, colon in 7 cases, mesentery in 4 cases, kidney in 3 cases, liver in 2 cases, abdominal lymph nodes in 2 cases, peritoneum in 1 case, and stomach in 1 case. The sites of extra-abdominal involvement included lymph nodes in 7 cases, lung in 3 cases, skull in 1 case, brain in 1 case, pleura in 1 case, chest wall in 1 case, and nasopharynx in 1 case. The most common abdominal imaging abnormalities were thickening of the intestinal wall, eccentric mass and dilation of the lumen. Both small intestines and colons could be involved, and the former more commonly. Multiple masses were found in patients with liver and kidney involvement. The most common imaging manifestation of PTLD outside the abdomen was lymph node enlargement, which was found in 7 cases, and the most common was in the neck. The manifestation was shorter diameter of lymph nodes>10 mm, uniform density and signal, with mild enhancement.Conclusions:PTLD can occur months to years after liver transplantation in children, which can affect many parts of the whole body. Extranodal lesions are more than intranodal lesions. Abdominal involvement is most common in PTLD, and the infection rate of EB virus is high. Combined with medical history, EB virus infection status and imaging examination are helpful for early diagnosis.

Objective: To investigate the radiographic manifestations and clinical relevance to central nervous system complications of leukemia (CNSCL)in children. Methods: The CT and magnetic resonance imaging(MRI) fin-dings and clinical features of 49 pediatric patients with CNCSL in Shanghai Children′s Medical Center Affiliated to Shanghai Jiaotong University School of Medicine from May 2010 to June 2018 were retrospectively analyzed. Results: (1) Cerebrovascular abnormalities in 23 cases included hemorrhage(20 cases), infarction(2 cases) and sinus thrombosis(1 case). One case of epidural hematoma and 19 cases of intracerebral multiple bleeding were seen in the hemorrhage group, which demonstrated high-density on CT and different signal on MRI as time went by.Microhe-morrhage displayed as low signal on susceptibility weighted imaging.(2) Among 23 cases of leukemic infiltration, the dura and/or skull were involved in 18 cases, which presented as fusiform or mass, with high density on CT, low signal on T1WI, intermediate signal on T2WI and strong enhancement; 6 leptomeningeal infiltration demonstrated as meningeal thickening and enhancement; 2 parenchymal involvement manifested with high-density mass; 2 oculomotor nerve and 1 optic nerve infiltration demonstrated thickening and enhancement.(3)White matter disease was seen in 2 cases, with hyper-intensity on T2WI.(4) One case of secondary tumor was glial tumor in the brainstem. Conclusions The radiographic manifestations of CNCSL in children are various.CT and MRI are of important diagnostic values.Choosing the best imaging examination method and sequence according to clinical symptoms and test results can provide more valuable information for clinical diagnosis and treatment.

Objective To explore the clinical manifestations and radiological features of cystic fibrosis (CF) in children.Methods The clinical and radiographic data of 5 CF patients were retrospectively analyzed.Results Among the 5 cases,there are 3 males and 2 females,aging from 2 to 13 years old (median age 6).Four of the five cases had complaints of repeated productive cough with or without fever and short breath.Pseudomonas aeruginosa was positive in sputum culture of three cases.Chest CT showed pneumonia and bronchiectasis with peribronchial thickening and mucus plugging.Paranasal CT showed frontal sinus agenesis and sinusitis with sticky secretion.The other one of the 5 cases had a complaint of abnormal hepatic function.The abdominal MRI showed liver cirrhosis and high signal intensity in the periportal area on T1-weighted imaging.Chest CT showed air trapping from small airways obstruction and bronchiectasis with sputum plugging.Five recurrent and two novel CFTR mutations were identified in all of the 5 cases.Conclusions The radiographic findings of CF are characteristic,and of great significance to the clinical diagnosis of CF.The gene mutations of CF in Chinese are different from those in Caucasians.

Objective To explore the dosimetry of simplified intensity modulated radiotherapy (sIMRT)in the spinal component of craniospinal irradiation(CSI)compared with conventional plan(3D-CRT).Methods Five previously treated patients were adopted to generate 3D-CRT,3-and 5-field slMRT plans.The prescribed dose was 36 Gy to the planning target volume(PTV)in 20 fractions.The dose distributions of target volume and normal tissues,and homogeneity index(HI)were ananlyzed using the dose volume histogram.The total monitor units(MUs)were also analyzed to compare the delivery time indirectly.Results For 3D-CRT plans,the region of the neighbouring fields only received 70％ of the prescribed dose,and the maximum dose delivered in the normal tissues was increased to approximately 140％ of the prescribed dose.The homogeneity index(HI)of 3-and 5-field sIMRT were 0.09 ± 0.01 and 0.08 ±0.01,respectively,superior to that of 3D-CRT(0.18 ± 0.02,t=7.80,7.65,P＜0.05).The values of V10 for the heart of 3-and 5-field sIMRT were(8.4 ± 1.9)％ and(8.4 ± 2.0)％,respectively,lower than that of 3D-CRT((36.0 ± 6.0)％(t=13.3,13.0,P＜0.05).V20 for the thyroid gland were (12.4±1.5)％ and(12.4±1.6)％,respectively,lower than(69.4±5.7)％ of 3D-CRT(t=26.3,26.4,P＜0.05).V20 for the larynx were(17.2 ± 1.2)％ and(17.9 ± 1.5)％,respectively,lower than that of 3D-CRT[(89.4±7.0)％(t=25.5,26.5,P＜0.05)].V30for the NTwas(4.4±1.4)％,(4.9± 1.9)％,lower than that of 3 D-CRT[(31.9 ± 6.1)％(t=8.5,10.1,P＜0.05)].The averaged values of total MUs for 3-and 5-field sIMRT were 1100 ± 177 and 1160 ±204,respectively,higher than that of 3D-CRT(640 ± 151).Conclusions Compared with the 3D-CRT CSI technique,3-and 5-field sIMRT have better dose distribution and can improve target dose uniformity and protect the organs at risk.

Objective To study the catalytic capability of glucosamirie-Cu( Ⅱ) complex for decomposition of H2O2 and its relative factors. Methods Glucosamine-Cu( Ⅱ ) complex was prepared by the reaction of D-glucosamine hydrochloride with Cu2+ in aqueous solution, then added it into H2O2 solution. The concentration of H2O2 was determined by titrimetric analysis in a regular interval of time, the rate of decomposition of H2O2 was obtained in various conditions. Results Strong catalytic capability of glucosamine-Cu( Ⅱ ) complex was obtained at 30℃ pH 6. 5, the rate of decomposition was over 90% after 12h, and was almost 100% after 24h. Conclusion The complex of glucosamine-Cu( Ⅱ ) showed good catalytic capability for decomposition of H2O2.