BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective:To explore the effect of cloud follow-up system in post-hospital follow-up management of hyperuricemia gout patients.Methods:Using the convenient sampling method, a total of 120 gout patients who were discharged after treatment in Taizhou Central Hospital in June 2021 were selected as the research objects and they were randomly divided into the control group and the experimental group according to the random number table method, with 60 cases in each group. The control group carried out routine follow-up, while the experimental group carried out follow-up based on cloud follow-up system. The serum uric acid level and self-management ability of gout patients were compared between the two groups before and after 6 months of follow-up.Results:After 6 months of follow-up, the serum uric acid levels of the control group and the experimental group were lower than those before follow-up and that of the experimental group was lower than the control group, and the differences were statistically significant ( P<0.05) . After 6 months of follow-up, the self-management ability score of the experimental group was higher than that before follow-up and higher than that after follow-up of the control group, and the differences were statistically significant ( P<0.05) . Conclusions:The new follow-up model based on cloud follow-up system is helpful to improve the self-management ability of gout patients and reduce the blood uric acid level of gout patients.

Objective:To evaluate direct bilirubin /total bilirubin(D/T), B-mode ultrasound(BUS), multislice spiral computed tomography (MSCT), magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) in the diagnosis of choledocholithiasis abdominal pain (CAP).Methods:We retrospectively analyzed the materials of patients who were diagnosed with choledocholithiasis abdominal pain by above imagines in the emergency department of Beijing Friendship Hospital during March 2016 to December 2018. The stones were taken out by endoscopic retrograde cholangiopancreatography or surgical operation as the golden standard.Results:Among 256 patients, 195 cases, 138 cases, 107 cases and 26 cases were diagnosed by EUS, MRCP, CT and BUS, respectively. The sensitivity were 0.86, 0.62, 0.45, 0.13, respectively. The specificity were 0.86, 0.81, 0.75, 0.87. The positive predictive value were 0.97, 0.96, 0.91, 0.83.The negative predictive value were 0.55, 0.19, 0.21, 0.16. The accuracy rate were 0.88, 0.64, 0.48, 0.30, respectively. The sensitivity of D/T and D/T combined with EUS in the diagnosis of CAP were 0.57 and 0.67, and the accuracy were 0.16 and 0.56, respectively.Conclusions:EUS has a high diagnostic value for CAP. MRCP is superior to CT in the value of diagnosis of CAP. BUS in imaging diagnosis of CAP value is relatively low, but D/T combined with BUS can improve the sensitivity and accuracy of diagnosis for CAP.

Apoptosis ; Cardiopulmonary Resuscitation ; Humans ; Out-of-Hospital Cardiac Arrest ; Programmed Cell Death 1 Receptor/biosynthesis* ; Return of Spontaneous Circulation ; Th1 Cells ; Th2 Cells

Objective To explore the relationship between those myocardial markers serum cardiac troponin T (cTNT),serum cardiac troponin I (cTNI),N-terminal pro-brain natriuretic peptide (NT-proBNP),echocardiography and myocardial injury in the oldest-old septic patients,as well as to evaluate prognosis in the oldest-old septic patients.Methods 140 oldest-old septic patients hospitalized in Beijing Friendship Hospital from January 1 st,2015 to Jun 31st,2017 were collected and analyzed retrospectively.They were divided into survival group (90 cases) death group (50 cases)according to their survival time.Serum cTNT,cTNI and NT-proBNP level at 1,3 and 7d post-diagnosis were collected and echocardiography left ventricular diastolic diameter (EDD),left ventricular systolic diameter (ESD),right ventricular diameter (RV),left ventricular ejection fraction (EF) was performed.Results 140 oldest-old septic patients were enrolled in the analysis.There were 90 cases in survival group and 50 cases in death group.Mean values of cTNT,cTNI,NT-proBNP,EDD,ESD in survival group were obviously higher than those in death group (P ＜ 0.05),left ventricular ejection fraction (LVEF) in survival group was lower than that in death group (P ＜ 0.01).But there were no difference in E/A and RV between survival group and death group (P ＞ 0.05).There were positive correlation between cTNT,cTNI,NT-proBNP and EDD,ESD (P ＜ 0.05),negative correlation between cTNT,cTNI,NT-proBNP and LVEF (P ＜ 0.05),and no correlation between cTNT,cTNI,NT-proBNP and E/A,RV (P ＞0.05).There were obviously correlation between cTNT,cTNI,NT-proBNP,EDD,ESD and mortality rate (OR ＞ 1,P ＜ 0.05).It was shown the prognosis value of cTNT,cTNI,NT-proBNP,EDD,ESD to mortality rate in oldest-old septic patient.The prognosis value was cTNT ＞ NT-proBNP ＞ cTNI ＞ EDD ＞ ESD.Conclusions There were obviously correlation between cT NT,cTNI,NT-proBNP,EDD,ESD and myocardium restrain,heart dysfunction as well as mortality rate.cTNT was the best prognosis indicator in sensitivity,and NT-proBNP was the best prognosis indicator in specificity.The combination of cTNT and NT-proBNP can better forecast the prognosis of the oldest-old septic patient.

Objective: To observe the impact of cardiac resynchronization therapy (CRT) on ventricular remodeling in patients with III°atrio-ventricular block (AVB) combining systolic dysfunction.
Methods: A total of 49 III °AVB patients received CRT in our hospital from 2009-01 to 2014-10 were studied. Echocardiography was conducted at pre-operation and 6, 12 months post-operation to measure left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV), left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD) and mitral regurgitation (MR) grade in order to observe the changes of cardiac structure and function in relevant patients.
Results: Compared with pre-operative condition, at 6 months post-operation, LVEF was increased (4.92±5.24)%and at 12 months post-operation, it was further increased (5.02±6.52)%, both P<0.05;at 6 months post-operation, LVESV reduced (25.02±17.95) ml and at 12 months post-operation, it was further reduced (24.79±22.49) ml, both P<0.05. Compared with pre-operative condition, at 6 months post-operation, LVEDV dropped (25.61±24.24) ml, LVEDD dropped (3.22±2.91) mm, LVESD dropped (4.43±2.86) mm and MR grade dropped 0.49±0.76, all P<0.05. Compared with 6 months post-operation, at 12 months post-operation, LVEDV declined (28.18±22.36) ml, LVEDD declined (4.17±3.14) mm, both P<0.05, LVESD declined (4.92±4.40) mm, P<0.01 and MR grade declined (0.22±0.55), P<0.05.
Conclusion:CRT may reverse ventricular remodeling and improve cardiac function in patients with III°AVB combining systolic dysfunction.

Objective: To analyze the predictors of left ventricular reverse remodeling in patients with III? atrio-ventricular block (AVB) combining left ventricular systolic dysfunction after cardiac re-synchronization therapy (CRT). Methods: A total of 65 III? AVB patients received CRT in our hospital from 2009-01 to 2015-05 were enrolled. Clinical information before and after the operation were recorded. Left ventricular reverse remodeling was deifned by left ventricular end systolic volume (LVESV) decreased 15% or left ventricular ejection fraction (LVEF) increased≥5% at 12 months after CRT. The patients were divided into 2 groups: Reversal group,n=36 and No reversal group,n=29. Clinical condition was compared between 2 groups, predictors for CRT reversing left ventricular remodeling were evaluated by two classiifcation Logistic regression analysis. Results: The patients' average age was (62±14) years and 36/65 (55.4%) with reverse remodeling. In Reversal group, the ratios of female (P=0.011), baseline QRS width>120ms (P=0.001), inter-ventricular mechanical delay (IVMD)≥40 ms (P=0.027) and standard deviation of time-to-minimum systolic volume of 16 segments [Tmsv16-SD (%R-R)≥8.3%, (P=0.001)] were higher than those in No reversal group. Two classiifcation Logisitic regression analysis indicated that female (OR=6.228, 95%CI 1.561-24.842, P=0.01), QRS duration>120 ms (OR=7.778, 95% CI 1.996-30.769,P=0.003) and Tmsv16-SD (%R-R)≥8.3% (OR=8.134, 95% CI 2.064-32.057,P=0.003) were the independent predictors for ventricular reverse remodeling . Conclusion: Female, QRS>120ms and Tmsv16-SD (%R-R)≥8.3% could be used as the predictors for CRT reversing left ventricular remodeling in III? AVB patients combining left ventricular systolic dysfunction.

Objective To explore the value of miniprobe sonography (MPS) in differentiating Crohn??s disease (CD) and ulcerative colitis (UC). Methods 46 patients with active inflammatory bowel disease (IBD) were included into the patient group (16 patients with CD and 30 cases with UC). 20 healthy cases ( underwent physical examination in outpatient department) were recruited as the control group. All cases underwent MPS and high sensitive C-reactive protein (Hs-CRP) test.The MPS measurement index include thetotalwallthickness(TWT), mucosal thickness (MT), submucosal thickness (SMT), muscularispropria thickness (MPT), and the number of enlarged colic and paracolic lymph nodes. Results TheTWT, M, SM, MP(mm)and Hs-CRP(mg/L)in CD, UC and control group are 5.84 ± 1.42, 1.48 ± 0.23, 1.88 ± 0.28, 2.31 ± 0.85, 40.58 ± 19.33, 4.74 ± 1.01, 1.79 ± 0.35, 1.41 ± 0.25, 1.32 ± 0.34, 22.41 ± 15.25,2.86 ± 0.23, 0.97 ± 0.13, 1.06 ± 0.11, 0.64 ± 0.0 and 1.70 ± 0.65. TWT, MT, SMT, MPT and Hs-CRP in UC group has significant different with those in controp group(P<0.05). The mean value of TWT, MT, SMT, MPT and Hs-CRP in CD group are higher than those in UC group. M in UC group is higher than that in CE group. The difference is significant(P<0.05). 5 cases in CD and 2 cases with UC had enlarged colic or paracolic lymph nodes. Conclusions The MPS can distinctly observe the changesof different colonic tissue layers and the surrounding tissue structures in IBD patients,which helps for distinguishing active CD from UC.

OBJECTIVETo introduce the Ages and Stages Questionnaires, Third Edition (ASQ-3), to China, created ASQ-Chinese (ASQ-C) and carried out studies of its national norm and the psychometrical properties in the children aged 1-66 months in the mainland of China in collaboration with the author of the ASQ System and under the authorizations from its publisher on translation, researches, publication and distribution of the ASQ-3.

METHODThe ASQ-3 questionnaires were translated and adapted into a Simplified Chinese version, the ASQ-C, with six steps such as translation, back-translation and adaptation and so on to ensure consistency with the core of the original document and to have the cultural relevance in China.A stratified cluster sampling method was utilized to recruit children aged 1-66 months with respect to demographic characteristics such as the proportion of population in each administrative region and in urban and rural areas and so on that are representative of 2010 China census data.A sample size of over 200 was collected for each ASQ-C age interval.Children were excluded from the normative sample who (1) are from communities or villages at an elevation of 2 000 m or above and(or) where simplified Chinese is not the official language, or (2) had been diagnosed as having a developmental delay by any authoritative organizations.The national normative sample for the ASQ-C had a total sample size of 4 452, sample size within each age interval ranged from 218 to 227, including 2 230 male cases and 2 222 female cases, 2 236 urban cases and 2 216 rural cases.A convenience sample was recruited from the normative sample to examine inter-rater reliability and test-retest reliability in all six administrative regions.Researchers completed the ASQ-C on the same child with their parents for 162 children for inter-rater reliability(the size of each ASQ-C age interval was 5-9); parents of 168 children completed another age-appropriate ASQ-C for test-retest reliability during 10-15 days after they completed the normative ASQ-C(The size of each ASQ-C age interval is 6-10). Another convenience sample was recruited from the follow-up of low birth weight infants for the concurrent validity of the ASQ-C in comparison with the Beijing Gesell.Parents of 198 children completed age-appropriate ASQ-C and professional administered to the children with the Beijing Gesell.In the ASQ-C norm and test-retest reliability, parents completed the age-appropriate ASQ-C, independently or with needed assistance. In inter-rater reliability, researchers completed the same ASQ-C after parents. In validity test, after parents completing age-appropriate ASQ-C, professional tested children with the Beijing Gesell.Data were analyzed using SPSS version 13.0 software.The mean and standard deviation of the national normative sample were calculated, reliability and validity of the ASQ-C was examined.

RESULTThe demographic characteristics of this Chinese sample match the 2010 China census data on gender, urban or rural location, and family income.All 20 intervals of the ASQ-C were standardized on 21 national normative samples.Cronbach's alpha coefficient for the whole measure was 0.8.The Pearson correlation coefficient between the ASQ-C total scores of the two raters was 0.8.The Pearson correlation coefficient between the ASQ-C total scores of the two times was 0.8 (all P<0.000 1). The sensitivity of ASQ-C was 87.50% and the specificity of ASQ-C was 84.48%.The percentage of the agreement between the ASQ-C and the Beijing Gesell was 84.74%.

CONCLUSIONThese findings indicate that the ASQ-C is a reliable and valid measure with a representative national sample aged 1-66 months.It can be used to screen and monitor the development of children in the mainland of China.

Beijing ; Child Development ; Child, Preschool ; China ; Female ; Humans ; Infant ; Infant, Low Birth Weight ; Language ; Male ; Parents ; Psychometrics ; Reproducibility of Results ; Sensitivity and Specificity ; Surveys and Questionnaires

Objective To investigate the effect of bone marrow stem cells (BMSCs) transplantation combined with body weight supported treadmill training on neural functional recovery of rats with spinal cord injury.Methods T11 complete spinal cord injury (SCI) was introduced into 40 Sprague-Dawley male rats using an improved simple device,imitating the Allen method.The rats were randomly divided into a stem cell transplantation group,a body weight support treadmill training group,a combined treatment group and a control group,each of 10 assigned according to a random number table.One week after the SCI operation,stem cell transplantation was performed on the rats in the stem cell transplantation group and the combined treatment group.One day before their transplantation,the third passage BMSCs were labeled with 5-ethynyl-2'-deoxyuridine (Edu).The rats in body weight support treadmill training group and combined treatment group were received body weight support treadmill training,while the other two groups were not given any training.At the 1 st,2nd,3rd,4th and 5th week after SCI modeling,Basso-Beattie-Bresnahan (BBB) movement function score was used to evaluate the motor function recovery of all rats.At the 5 th week after SCI,immunohistochemical staining and immunofluorescence staining was applied to detect neural specific markers including the neuron specific enolase (NSE),microtubule associated protein (MAP-1 β) and vimentin (VIM).The survival and differentiation of the transplanted cells,as well as the nerve fiber recovery in the lesion were also observed.Results The average BBB score of the combined treatment group was (6.60 ± 0.97) at the 2nd week after SCI operation,significantly higher than the other 3 groups,while that of the stem cell transplantation group and the body weight support treadmill training group was (5.00 ± 0.67) and (4.80 ± 0.63) respectively,both higher than that of the control group but without significant differences (P ＞ 0.05).In the third week after modeling,however,the value of the stem cell transplantation group rose to (8.00 ± 0.67),significantly higher than that of the body weight support treadmill training group (6.80 ± 0.79).The immuohistochemical staining showed that a variable degree of neural specific markers (NSE,MAP-1 β,VIM) positive cells were observed in the SCI tissues of all groups,with those in the combined treatment group significantly higher than the other 3 groups.The immunofluorescence also found significantly higher fluorescence expression of neural specific protein markers including NSE,MAP-1 βand VIM in the combined treatment group than the rest group,with obvious proliferation and differentiation of nerve fibers.Conclusions Stem cell transplantation combined with partial body weight supported treadmill training can effectively promote the recovery of neural function of rats with spinal cord injury,and the effect is better than solely stem cell transplantation or the weight loss training.