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 examine the effect of anemia on the prognosis of elderly patients with acute coronary syndrome.Methods:We searched PubMed, Scopus, OVID, the Cochrane Library, Web of Science, Embase, China National Knowledge Infrastructure, China Biology Medicine Disc, the WanFang and Weipu databases for studies on the association between anemia and the prognosis of acute coronary syndrome in elderly patients.The date range included the period from the establishment of the database to December 10, 2022.Two reviewers independently completed the literature screening and data extraction according to the inclusion and exclusion criteria for the literature.Stata 16.0 software was used to analyze the data.Results:Of 1 399 references retrieved from the initial search, 13 met the inclusion criteria, including a total of 9540 patients with a mean age of 70.3 years.2872 of these patients had concurrent anemia and 6 668 patients had no anemia.In elderly patients with acute coronary syndrome, those with anemia showed significantly increased risk of death, compared with those with no anemia( RR=2.28, 95% CI: 1.74-3.00). Anemia also increased the incidence of ischemia( RR=1.36, 95% CI: 1.13-1.64)and bleeding events( RR=2.18, 95% CI: 1.59-3.01)( P<0.05 for all). Conclusions:Anemia significantly increases the risk of death and is associated with poor prognosis in elderly patients with acute coronary syndrome.

Organoid models are used to study kidney physiology, such as the assessment of nephrotoxicity and underlying disease processes. Personalized human pluripotent stem cell-derived kidney organoids are ideal models for compound toxicity studies, but there is a need to accelerate basic and translational research in the field. Here, we developed an automated continuous imaging setup with the "read-on-ski" law of control to maximize temporal resolution with minimum culture plate vibration. High-accuracy performance was achieved: organoid screening and imaging were performed at a spatial resolution of 1.1 μm for the entire multi-well plate under 3 min. We used the in-house developed multi-well spinning device and cisplatin-induced nephrotoxicity model to evaluate the toxicity in kidney organoids using this system. The acquired images were processed via machine learning-based classification and segmentation algorithms, and the toxicity in kidney organoids was determined with 95% accuracy. The results obtained by the automated "read-on-ski" imaging device, combined with label-free and non-invasive algorithms for detection, were verified using conventional biological procedures. Taking advantage of the close-to-in vivo-kidney organoid model, this new development opens the door for further application of scaled-up screening using organoids in basic research and drug discovery.
Humans ; Kidney ; Organoids ; Pluripotent Stem Cells

Objective:To investigate the relationship between caspase activation and recruitment domain 8 ( CARD8) gene rs2043211 polymorphism and the age of onset for large artery atherosclerosis (LAA) stroke in Chinese Han population. Methods:Based on Nanjing Stroke Registry Program, patients with LAA stroke from January 2010 to December 2014 were included retrospectively and genotyped. Grouping according to different genetic models, the age distribution among different genotypes were compared, and Kaplan-Meier curve was used to compare the age-related cumulative non-onset frequency of the patients with different genotypes.Results:A total of 738 patients were admitted and 717 (97.15%) were successfully genotyped and included in the study. There were no significant differences in age, sex, body mass index, hypertension, diabetes, hyperlipidemia, smoking and drinking history among the genotype groups. Patients with T allele had earlier onset under codominant model (AA genotype: 61.68 years, 95% confidence interval [ CI] 59.92-63.45 years; AT genotype: 60.51 years, 95% CI 59.41-61.60 years; TT genotype: 60.44 years, 95% CI 58.96-61.92 years). Kaplan-Meier curve analysis showed that there was a significant difference in the age-related cumulative non-onset frequency between patients with different genotypes (log-rank test, P=0.041). Similar results in the female was observed in the stratified analysis (log-rank test, P=0.001). Conclusions:T allele of CARD8 rs2043211 is associated with the early age of onset of large artery atherosclerosis stroke in Chinese Han population, especially in female patients.

OBJECTIVE: To investigate the evaluation value of preoperative peripheral blood lymphocyte-to-monocyte ratio (LMR) on the prognosis of patients with stage III colon cancer undergoing radical resection and postoperative adjuvant chemotherapy. METHODS: Electronic medical record were retrospectively retrived for stage III colon cancer patients who underwent radical surgery at Sun Yat-sen University Cancer Center from December 2007 to December 2013. Inclusion criteria were pathologically comfirmed colon adenocarcinoma, complete clinicopathological data, and postoperative XELOX (oxaliplatin + capecitabine) chemotherapy with follow-up of at least 3 months. Patients with neoadjuvant anti-tumor therapy, infectious disease, other malignant tumors and death of non-tumor causes within 3 months after operation were excluded. A total of 258 patients were included in this retrospective cohort study, including 146 males and 112 females with median age of 55 (22 to 85) years. Tumors of 100(38.8%) patients were located in the right hemicolon, and of 158 (61.2%) in the left hemicolon. Tumors of 194(75.2%) patients were highly and moderately differentiated, and of 64 (24.8%) were poorly differentiated. According to the TNM tumor pathological stage of AJCC 7th edition, 196 (76.0%) patients were stage IIIA to IIIB, and 62(24.0%) patients were stage IIIC. The median preoperative CEA was 3.8 (0.3 to 287.5) μg /L and the median cycle of the adjuvant chemotherapy was 6 (1 to 8). The cut-off value of preoperative LMR in prediction of 3-year overall survival (OS) outcome was determined by receiver operating characteristic (ROC) curve analysis. All patients were divided into low LMR group and high LMR group according to the critical value. Clinicopathological characteristics between the two groups were compared by using chi-square test or Fisher's exact test as appropriate. The 3-year disease-free survival and overall survival rate were estimated with the Kaplan-Meier method, and differences between two groups were assessed with the log-rank test. Univariate and multivariate analyses were performed through Cox regression model. RESULTS: ROC curve showed that the cut-off value of preoperative LMR in predicting 3-year overall survival was 4.29. Then 143 patients were divided into low LMR group (LMR<4.29) and 115 patients into high LMR group (LMR ≥ 4.29). Compared with high LMR group, the low LMR group presented higher proportions of male [62.2%(89/143) vs. 50.4%(58/115), χ²=4.167, P=0.041], right hemicolon cancer [44.8% (64/143) vs. 31.3% (36/115), χ²=4.858, P=0.028], and the largest tumor diameter>4 cm [60.1% (86/143) vs. 33.0% (38/115), χ²=18.748, P<0.001]. During a median follow-up of 46.0 (range, 3.0 to 74.0) months, 3-year disease-free survival rate was 83.8% in high LMR group and 78.9% in low LMR group, which was not significantly different (P=0.210). While 3-year overall survival rate in low LMR group was significant lower than that in high LMR group (86.6% vs. 97.2%, P=0.018). Univariate analysis revealed that preoperative low LMR (HR=2.841, 95%CI: 1.146 to 7.043, P=0.024), right hemicolon cancer (HR=2.865, 95%CI: 1.312 to 6.258, P=0.008) and postoperative adjuvant chemotherapy≥6 cycles (HR=0.420, 95%CI: 0.188 to 0.935, P=0.034) were the risk factors for poor overall survival. Multivariate analysis identified that preoperative low LMR (HR=2.550, 95%CI: 1.024 to 6.347, P=0.004) and right hemicolon cancer (HR=2.611, 95%CI: 1.191 to 5.723, P=0.017) were the independent risk factors for overall survival. CONCLUSIONS Preoperative peripheral blood LMR level represents an effective prognostic predictor for patients with stage III colon cancer receiving radical therapy. Low LMR indicates the poor prognosis and such patients require aggressive postoperative treatment strategy.
Adenocarcinoma ; blood ; drug therapy ; surgery ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Chemotherapy, Adjuvant ; Colonic Neoplasms ; blood ; drug therapy ; surgery ; therapy ; Female ; Humans ; Kaplan-Meier Estimate ; Leukocyte Count ; methods ; Lymphocytes ; Male ; Middle Aged ; Monocytes ; Preoperative Care ; Prognosis ; Retrospective Studies ; Young Adult

Objective To explore the application of 3D printing templates for titanium plate contouring (TrPC) in pelvic ring surgery.Methods From May 2016 to June 2018,12 patients with pelvic ring injury were treated by internal fixation with 24 titanium plates at Department of Orthopedics and Trauma,Sanshui People's Hospital.After solid digital models of the damaged pelves of the patients were reconstructed from their CT images via software,the hollowed ones were created with the wall thickness of 1.2 mm.After the models of damaged pelves were restored to be intact,the templates for titanium plate contouring were designed based on the area of fixation and manufactured via a stereo lithography apparatus.The total manufacturing time and material consumption of 3D printing TTPC were recorded and compared with those of 3D printing solid and hollow models.Before operation,the titanium plates were contoured according to the templates.The time for preoperative shaping the plate and the time for intraoperative preparing the plate before installation were recorded.After operation,all patients underwent CT scan again for reconstruction of 3D models of the postoperative pelves which were compared with their corresponding preoperative ones in the software.Matta criteria were used to evaluate the pelvic reduction and Majeed criteria to evaluate the functional recovery 6 months after operation.Results All patients were followed up for 6 to 28 months (average,16.3 months).The total manufacturing time and material consumption of 3D printing a TTPC were significantly less than those of 3D printing a solid or hollow model (P ＜ 0.05).The time for preoperative shaping the plate was 12.8 ± 4.1 minutes and the time for intraoperative preparing the plate was 1.4 ± 1.1 minutes.The average deviation between the preoperative 3D models and the postoperative ones was 1.4 ± 1.1 mm.According to the Matta criteria for pelvic reduction,6 cases were excellent,4 good and 2 satisfactory.According to the Majeed criteria,the pelvic functions were excellent in 7 cases,good in 4,and fair in one.Conclusion Application of 3D printing TTPC in the surgery for pelvic ring injury is advantageous in lowering the costs of 3D printing and reducing the intraoperative time for contouring the titanium plate,leading to satisfactory outcomes.

OBJECTIVETo explore the effects of acupuncture on the expression of protein kinase B (PKB/AKT) in lung tissues of asthma rats.

METHODSForty SPF male SD rats were randomly divided into a blank group, a model group, an acupuncture group and a blocker group, 10 rats in each one. The rat model of asthma was established by egg albumin stimulation in the model group, acupuncture group and blocker group. Since the establishment of rat model, the rats in the acupuncture group were treated with acupuncture at "Dazhui" (GV 14), "Feishu" (BL 13) and "Fengmen" (BL 12) before atomization; the rats in the blocker group were treated with intervention of blocker LY294002, once every two days, for 7 times. There was no treatment in the blank group and model group. HE staining was applied to observe the morphologic changes of lung tissues; the immunohistochemical method was applied to test the protein expression of AKT in lung tissue.

RESULTSHE staining indicated the infiltration and aggregation of a variety of inflammatory cells around airways, as well as bronchial smooth muscle spasm and confined lumen in the model group; in the acupuncture group and blocker group the inflammatory cells were less and confined lumen was relieved. Compared with the blank group, the protein expression of AKT was higher in the model group (<0.05); compared with the model group, the protein expression of AKT in the acupuncture group and blocker group was reduced (both<0.05); the differences between the acupuncture group and blank group, blocker group were not significant (both>0.05).

CONCLUSIONSAcupuncture could reduce the protein expression of AKT in lung tissue in asthma rats, leading to relieved inflammation reaction and airway remodeling.

Objective: To investigate the features of literature on hand-transmitted vibration in China, 1990-2016. Methods: In September 2017, the studies on hand-transmitted vibration in China, which were published in Chinese or English during 1990-2016, with "China" and "Taiwan" as the places where author affiliations were located, were retrieved. A bibliometric analysis was performed to investigate the type of articles, publication time, the journals in which articles were published, author affiliations, author regions, and funding. Results: A total of 205 articles on hand-transmitted vibration were retrieved. There were 7.59 articles on average published annually from 1990 to 2016. In the 205 articles, 114 (55.61%) were published in the journals indexed in one or two core journal databases. In the 64 journals, 22 (34.38%) were indexed in one or two core journal databases. The first authors were from 22 provincial regions (provinces, autonomous regions, or centrally administered municipalities) in China, with 152 articles (74.15%) by the authors in the top five regions. There were a total of 876 authors, and the co-authorship degree was 4.27 (876/205). Most of the first authors (136 articles, 66.34%) were affiliated with universities or institutes for prevention and control of occupational diseases. Among the 205 articles, 103 (50.24%) were original articles or investigations, and 72 (35.12%) were funded. Conclusion The studies on hand-transmitted vibration fluctuated and increased from 1990 to 2016, with a relatively concentrated distribution in terms of sources, regions, and institutions. Interregional and international academic exchange should be strengthened.

Objective To investigate the conceptual feasibility and biomechanical advantages of our self-designed screw hole filler for a lateral bamboo-raft-type titanium locking plate in a digital model of proximal tibial fracture using linear statics finite element analysis.Methods A nut-type screw hole filler was designed.Four different idealized finite element models of proximal tibial fracture fixed by a lateral bamboo-raft-type anatomic locking plate were established on the basis of three-dimensional CT reconstruction and digital orthopedic techniques.The first one was assembled with the filler and stabilized fibula,the second with stabilized fibula but without the filler,the third with the filler and unstabilized fibula,and the fourth with unstabilized fibula but without the filler.Linear statics finite element analyses were conducted for the 4 models under the same 26 groups of loads.The 4 models were compared in terms of maximum relative displacement on fracture surface,average relative displacement on fracture surface,maximum Von Mises stress of internal fixation,maximum contact stress on fracture surface,maximum contact stress between plate and tibial surface,maximum contact pressure on fracture surface,and maximum contact pressure between plate and tibial surface.Outcomes of the analyses for the 4 models were harvested and treated with Wilcoxon Signed Ranks Test.Results There were significant differences between using filler and not using filler in maximum relative displacement on fracture surface,average relative displacement on fracture surface,maximum Von Mises stress of internal fixation and maximum contact pressure between plate and tibial surface (P ＜ 0.05),but no significant difference was found in maximum contact pressure on fracture surface (P ＞ 0.05).The model assembled with the filler and unstabilized fibula led to the greatest improvement in maximum Von Mises stress of internal fixation (P ＜ 0.05).Conclusions Since use of nut-type screw hole filler may increase the contact pressure between plate and bone surface,reduce the maximum Von Mises stress of internal fixation,the maximum displacement of the whole model,and the relative and average displacements on fracture surface,but has insignificant effect on the contact pressure on fracture surface,it improves the biomechanical performance of internal fixation.The filler deserves further study.

BACKGROUND:As a conventional internal fixation method, anatomic plate has some shortcomings. Recently locking plate has been widely used in treatment of Pilon fracture. How to effective reconstruct articular facet at the distal tibia and to reduce soft tissue damage have attracted increasing attentions. OBJECTIVE:To compare the curative effect of locking compression plate versus anatomic plate internal fixation in treatment of Pilon fracture. METHODS:A retrospective analysis was performed among 72 patients of Ruedi-Al gower II and III Pilon fracture, who were selected from Sanshui People’s Hospital of Foshan between January 2010 and August 2014. The involved patients were randomly divided into two groups:36 patients of observation group were treated with locking compression plate internal fixation, and 36 patients of control group were given anatomic plate internal fixation. The average operation time, postoperative recovery time, postoperative complications, curative effect and postoperative fracture situation were compared between the two groups. RESULTS AND CONCLUSION:The average operation time and the average postoperative recovery time of observation group were significantly better than that of control group (P<0.05). In terms of postoperative complications, there were less cases of delayed healing and non-union in the observation group than in the control group. 26 cases of observation group and 22 cases of control group recovered wel after internal fixation, observation group was better than control group. There was no significant difference in the radiological evaluation results of postoperative recovery between the two groups (P>0.05). Compared with the anatomic plate internal fixation, locking compression plate internal fixation can shorten the operation time and postoperative recovery time, reduce the incidence of delayed healing and nonunion after internal fixation, and improve clinical curative effect in treatment of Pilon fracture.