Objective To explore the role of Cyclin B1 and Cyclin D1 on Barrett esophagus,Barrett's esophagus mixed with atypical dysplasia and esophageal adenocarcinoma.Methods Cyclin B1 and Cyclin D1 were examined with immunohistochemistry.76 esophageal tissues of patients werB collected,including severe reflux esophagitis(RE,25 cases),Barrett esophagus(BE,35 cases),Barrett esophagus mixed with atypical dysplasia(DY,8 cases),esophageal carcinoma(CA,8 cases).Ten cases with normal esophageal mucosa were examined as the control. Results Cyclin B1 and Cyclin D1 were high expression in the specimens of the BE,DY and CA groups and very low expression in the control and RE group.Statistieal difference Was showed(P<0.01).Expression of Cyclin D1 was increasing gradually from the tissues of intestinal metaplasia,atypical dysplasia to adenocarcinoma(50.04 vs 67.94 vs 74.31).There Was significant difference among these three groups(P<0.01).Conclusion Cyclin B1 and Cyclin D1 as markers of tumour development could evaluate the risk from Barrett esophagus to adenocarcinoma.Perhaps it is the earlv event in the development of esophageal carcinoma.

Objective To evaluate the influence of successful revascularization by percutaneous coronary intervention(PCI)on heart function of patients with heart dysfunction combined with chronic total occlusion(CTO).Methods The clinical data of 272 patients with heart dysfunction combined with CTO were analyzed.The patients were divided into PCI success group(246 cases)and PCI failure group(26 cases)respectively according to the results of PCI.Six months after PCI,the patients underwent cardiac ultrasound examination to compare the heart function between the two groups.Results Cardiac ultrasound examination was successfully performed in 229 patients in PCI success group and 24 patients in PCI failure group at 6 months after PCI.The left ventricular ejection fraction(LVEF)and left ventricular end-diastolic volume index(LVEDVI)showed no significant difference in PCI failure group at 6 months after PCI compared with that before PCI(P＞0.05).In PCI success group,LVEF and LVEDVI were significantly increased at 6 months after PCI compared with that before PCI and compared with that in PCI failure group at 6 months after PCI[(51±5)％ vs.(43±6)％ and(45±2)％,(77±13)ml/m2 vs.(86±12)ml/m2 and(86±10)ml/m2,P＜0.05].The cardiac functional grading in PCI failure group had no significant difference compared with that before PCI(P＞0.05),but in PCI success group it had significant difference compared with that before PCI and compared with that in PCI failure group at 6 months after PCI(P＜0.05).Conclusion Successful revascularization by PCI can improve heart function in patients with heart dysfunction combined with CTO.

Objective: To explore a predictive nomogram for the result of prostate biopsy based on Prostate Imaging Reporting and Data System version 2(PI-RADS v2)combined with prostate specific antigen (PSA) and its related parameters, and to assess its ability to diagnose prostate cancer by internal validation. Methods: We retrospectively analyzed the clinical data of 509 patients who underwent transrectal prostate biopsy guided by ultrasound during the period from January 2014 to December 2018 in the Department of Urology, First Affiliated Hospital of Xiamen University. In 509 cases, the mean age was (68.1±7.2) years. The mean prostate volume(PV) was (55.8±30.7) ml. The mean tPSA value was (19.86±18.94) ng/ml. The mean value of fPSA was (2.63±3.60) ng/ml and the mean f/tPSA was 0.14±0.08. The mean PSAD was (0.46±0.52) ng/ml2. Based on the PI-RADS v2, score 1 point have 37 cases, score 2 point have 131 cases, score 3 point have 152 cases, score 4 point have 102 cases, score 5 point have 87 cases. Of these patients, we randomly selected 80% (407 cases) as development group, and the other 20% (102 cases) as validation group. Univariate and multivariate logistic regression analysis of the development group was performed to identify the independent influence factors that can predict prostate cancer (PCa), thereby establishing a predictive model for the result of prostate biopsy. In the development group, validation group and tPSA was between 4.1-20.0 ng/ml, the model was evaluated by analyzing the receiver operating characteristic (ROC) curve, calibration curve and decision curve, and compared to PSA, fPSA, f/tPSA, PSAD, PI-RADS v2. Results: Among the 509 patients enrolled in the study, the detection rate of PCa was 43.0% (219/509). In the development group, the logistic regression analysis demonstrated that patient age (OR=1.113), f/tPSA (OR=0.004), PV (OR=0.986), PSAD (OR=11.023), digital rectal examination (DRE) texture (OR=2.295), transabdominal ultrasound (TAUS) with or without hypoechoic (OR=2.089), and PI-RADS v2 (OR=1.920) were independent factors for PCa (P<0.05). The nomogram based on all variables was established. In the development group, the area under the curve (AUC) of the model (0.883) was greater than those of tPSA (0.686), fPSA (0.593), f/tPSA (0.626), PSAD (0.777), PI-RADS v2 (0.761). In the validation group, the area under the curve of the model (0.839) was greater than those of tPSA (0.758), fPSA (0.666), f/tPSA (0.648), PSAD (0.832), PI-RADS v2 (0.803). In patients whose tPSA was between 4.1-20.0 ng/ml, the area under the curve of the model (0.801) was greater than those of tPSA (0.570), fPSA (0.426), f/tPSA (0.657), PSAD (0.707), PI-RADS v2 (0.701). The calibration curve of the nomogram indicated that the prediction curve was basically fitted to the standard curve, and the Hosmer-Lemeshow showed thatχ²=5.434, P=0.710, both suggested that the prediction model had better calibration ability. The decision curve showed that the model based on PI-RADS v2 had high clinical application value. Conclusions The nomogram based on PI-RADS v2 had a high predictive value for prostate cancer and could significantly improve the diagnostic performance. It had better diagnostic value than PSA and its related parameters. It also provided important guidance for the prostate cancer on clinical treatment of patients to some extent.

Objective Less surveys on the economic burden of hepatitis B (HB)-related diseases have been conducted in China,so the socioeconomic harm caused by the diseases is not clear and the key parameters for economic evaluation of hepatitis B prevention and treatment are lacking.This study aimed to analyze the direct,indirect and intangible expenditures of hospitalized patients with HB-related diseases during hospitalization and during a year in different areas of China.Methods The hospitals for infectious diseases and the large general hospitals in 12 areas in China were selected in the study.All the inpatients with HB-related diseases were surveyed by cluster sampling of consecutive cases.The direct expenditure included direct medical cost and direct non-medical cost.The indirect expenditure,including work loss of patients and caregivers,were calculated by using human capital method for urban and rural populations in 12 areas.The intangible expenditure were reflected by willing to pay and stochastic tournament.The influencing factors of direct and indirect costs were identified by stepwise linear multi-variation regression analysis.Results A total of 27 hospitals in 12 areas were included in the survey.A total of 4 718 cases were surveyed,the overall response rate was 77.7％.The average hospital stay was 29.2 days (27-34) and the hospitalization expenditure was averagely 16 832.80 yuan (RMB) per case,in which the highest proportion (61.2％)was medicine fees [10 365.10 yuan (RMB)].The average direct expenditure and indirect expenditure were consistent with the severity of illness,which were 18 336.10 yuan (RMB) and 4 759.60 yuan (RMB) respectively,with the ratio of 3.85:1.The direct medical expenditure [17 434.70 yuan (RMB)] were substantially higher than the direct non-medical expenditure [901.40 yuan (RMB)].It was found that the hospitalization expenses was highest in direct medical expenditure and the transportation expenses was highest in direct non-medical expenditures.Among the average indirect expenditure,the loss of income for the patients [3 832.50 yuan (RMB)] was higher than that for the caregivers [927.20 yuan (RMB)],The total direct and indirect expenditure was highest for liver transplantation,followed by severe hepatitis,hepatocellular carcinoma and decompensated cirrhosis,acute hepatitis B,compensated cirrhosis and chronic hepatitis B.The influencing factors for both direct and indirect expenditure were high hospital level,severity of hepatitis B,living in urban area,antiviral therapy,long hospitalization and monthly income of family.For average 3.74 outpatient visits and 1.51 hospitalization,the average annual direct,indirect and intangible expenditure for HB-related diseases were 30 135.30,6 253.80 and 44 729.90 yuan (RMB) [totally 81 119.00 yuan (RMB)],accounting for 37.3％,7.7％ and 55.0％,respectively.Of the annual direct medical expenditure [28 402.80 yuan (RMB)],which were much higher than non-medical expenditure [1 732.50 yuan (RMB)],hospitalization expenditure [26 074.20 yuan (RMB)] was higher than outpatient visit expenditure [4 061.10 yuan (RMB)].The annual indirect expenditures for outpatient visit and hospitalization were 763.60 and 5 490.10 yuan (RMB),respectively.Of the annual intangible expenditure,the highest was that for/primary hepatocellular carcinoma,followed by cirrhosis,chronic hepatitis B,severe hepatitis B,liver transplantation and acute hepatitis B.Conclusions A heavy economic burden has been caused by HB-related diseases in China,and patients are more likely to rely on medical service rather than non-medical service.It is necessary to take effective treatment measures to prevent the adverse outcome of HB related diseases and achieve significant economic benefits.The influence of HB related diseases on mental health of the people can be reflected by an economics term,intangible expenditure.

Objective To evaluate the differences in efficacy,safety and economics of vancomycin hydrochloride for injection between two manufacturers based on real-world data.Methods A total of 6 757 cases of intravenous use of vancomycin hydrochloride for injection from different manufacturers between January 1,2013 and December 31,2019 in the Affiliated Drum Tower Hospital of Nanjing University Medical School were retrospectively analyzed,and 5308 cases were matched by 1∶1 propensity score method,including 2 654 cases in the group A(domestic drug group)and 2 654 cases in group B(the innovator drug group).The differences in efficacy and safety between the two groups were compared.Cost-effectiveness analysis was used to compare the drug economics of the two groups.Results There were no significant differences in clinical cure rate,bacterial clearance rate,and incidence of adverse events between the two groups(P>0.05).In terms of economics,the average cost of vancomycin per capita,average daily cost of vancomycin and average cost of antibiotics per capita were significantly different between the two groups(P<0.05),and the cost of group B was higher than that of group A.Conclusion The efficacy and safety of vancomycin hydrochloride for injection were consistent between the two manufacturers.

The Guangdong Province Laboratory Animals Ordinance (the GPLAO), officially enacted and implemented in October 2010, marked a new phase of legal management in the administration of laboratory animals in Guangdong Province. The GPLAO clearly authorizes the laboratory animal monitoring institutes in Guangdong Province to conduct laboratory animal quality monitoring and assume corresponding legal responsibilities. It also specifies the standards for the production and use of laboratory animals, while bringing attention to laboratory animal welfare and ethics. Through the formulation of supporting documents, the active promotion of the standardization and regulation of administrative law enforcement, and the implementation of measures to delegate power, streamline administration, and optimize government services, significant improvements have been made in the standardized management of laboratory animals in Guangdong Province and in supporting the innovative development of biomedicine. Moreover, notable achievements have been made in areas such as the construction of experimental animal technology platforms, standardization work, the preservation and development of unique resources, and talent pool development. However, with the advancements in science and technology, social economy, and legislative work, some aspects in the GPLAO have been identified for improvement. These include the need for clearer provisions on laboratory animal welfare, more specific guidelines for the management of genetically engineered animals, improved regulations on the safety and welfare of practitioners, further refined implementation of the "one-vote veto system", continued promotion of laboratory animal standardization, and the exploration of effective mechanisms for resource sharing. This paper reviews and summarizes the institutional characteristics, post-legislation implementation, and effectiveness of the GPLAO, as well as the issues and countermeasures identified during the implementation. It concludes the laboratory animals management practices in Guangdong Province during the past 10 years, aiming to provide a reference for laboratory animal legislation.

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