1.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
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
2.Value of cardiac magnetic resonance in the diagnosis of myocardial contusion
Qingsong MIAO ; Degang CONG ; Keyuan LIU ; Jianping DING ; Fuyan WANG
Chinese Journal of Trauma 2022;38(1):54-60
Objective:To evaluate the diagnostic value of cardiac magnetic resonance (CMR) in myocardial contusion.Methods:A case-control study was performed on 42 patients with blunt chest injury treated in Affiliated Hospital of Hangzhou Normal University from September 2018 to January 2021. There were 24 males and 18 females, with the age range of 23-66 years [(44.2±10.9)years]. The patients were divided into myocardial contusion group ( n=20) and non-myocardial contusion group ( n=22) according to the clinical diagnostic criteria of myocardial contusion (cardiac troponin I>0.06 ng/ml). All the patients underwent CMR examination within 7 days after hospitalization, and eletrocardiography (ECG) as well as transthoracic echocardiography (TTE) examinations with 24 hours. Abnormal findings on CMR, ECG and TTE were compared between the two groups. The receiver operating characteristic (ROC) curve was used for the comparison of the diagnostic efficacy of CMR, ECG and TTE for myocardial contusion. The area under the curve (AUC), sensitivity, specificity, positive predictive value and Youden index of CMR, ECG and TTE were calculated, respectively. Results:There were 15 patients (75%) presenting CMR abnormalities in myocardial contusion group compared to 2 patients (9%) in non-myocardial contusion group ( P<0.01). CMR abnormalities mainly included myocardial oedema, ischemia or hemorrhage, which were located in the left ventricle of 12 patients (71%), right ventricle of 3 (18%) and ventricular septal of 3 (12%). There were 12 patients (60%) showing ECG abnormalities in myocardial contusion group compared to 7 patients (32%) in non-myocardial contusion group ( P>0.05). Abnormal ECG changes included 8 patients (42%) with sinus tachycardia or bradycardia, 5 (26%) with ST-T changes, 3 (16%) with atrial premature beat, 2 (11%) with bundle branch block and 1 (5%) with frequent premature ventricular contractions. There were 10 patients (50%) showing TTE abnormalities in myocardial contusion group compared to 9 patients (41%) in non-myocardial contusion group ( P>0.05). TTE abnormalities manifested as left ventricular diastolic dysfunction in 12 patients (63%) and wall motion abnormalities in 7 (37%). The AUC of CMR, ECG and TTE for diagnosing myocardial contusion was 0.83 (95% CI 0.70-0.96), 0.64 (95% CI 0.47-0.81) and 0.55 (95% CI 0.70-0.72), respectively. For CMR, ECG and TTE, the diagnostic sensitivity was 75.0%, 60.0% and 50.0%, with the specificity of 91.0%, 68.2% and 59.1%, the positive predictive value was 88.2%, 63.2% and 52.6%, and the Youden index of 66.0, 28.2 and 9.1, respectively. Conclusion:CMR can accurately detect myocardial contusion, with better diagnostic performance than ECG and TTE as well as relatively higher sensitivity and specificity, indicating that CMR has great value for clinical diagnosis of myocardial contusion.
3.Risk perception and behavior status of college students extracurricular jogging exercise
HU Degang, LIU Jihua, ZHANG Wulong
Chinese Journal of School Health 2022;43(4):522-525
Objective:
To explore the relationship among jogging risk perception, jogging risk behavior and the incidence of jogging risk, so as to provide a feasible way to reduce the risk of college students extracurricular jogging exercise.
Methods:
The method of convenience sampling was used to conduct a follow up survey among 470 college students at a university in Beijing participating in extracurricular jogging exercise and the sports world campus app was used to record and monitor jogging exercise. During the tracking period, the jogging related information was counted once a month, a total of 6 times. At the same time, three questionnaires were distributed in three stages to collect relevant information. SPSS 26.0 was used for the descriptive analysis, and AMOS 22.0 was used for correlational analysis.
Results:
The risk rate of extracurricular jogging exercise of college students during the past academic year was 71.06 %, score of knowledge on jogging risk was(3.68±0.59), was (3.25±0.91)for jogging injury, and was( 3.23± 0.96)for jogging related disease. Significant negative correlation between college students jogging risk perception and jogging risk behavior ( r =-0.34), negative correlation between jogging risk perception and the incidence of jogging injuries ( r =-0.27), and positive correlation between jogging risk behavior and the incidence of jogging injuries ( r =0.28) were observed( P <0.01). PE(physical education) class was the main way of obtaining the knowledge about jogging risks among college students(43.40%).
Conclusion
College students show high vulnerability for extracurricular jogging related risks, and low level of perception of jogging risks and jogging injuries. Relevant measures need to be taken to improve the cognitive level of running risk among college students, so as to reduce the incidence of running risk.
4.The expression of FOXO3 in pancreatic cancer and its effects on pancreatic cancer cells
Ming CHEN ; Jun LI ; Xuezhi DU ; Yaqing WEI ; Zhijia JIANG ; Yanxun LI ; Geng LIU ; Jinjin SUN ; Degang KONG
Chinese Journal of Hepatobiliary Surgery 2022;28(11):854-859
Objective:To investigate the expression of forkhead box protein O3(FOXO3) in pancreatic cancer and its effect on the motility and proliferation of pancreatic cancer cells.Methods:The FOXO3 expression in pancreatic cancer and adjacent tissues was retrieved from LinkedOmics database. Western blotting and real-time quantitative polymerase chain reaction were used to detect FOXO3 expression in pancreatic cancer cells and human pancreatic stellate cells. PANC-1 and MIAPaCa-2 pancreatic cancer cells with low FOXO3 expression were selected to transfect FOXO3 overexpression plasmid and negative control plasmid, respectively. The motility and proliferation ability of pancreatic cancer cells were detected by colony formation assay, cell scratch assay, Transwell assay and flow cytometry.Results:In the LinkedOmics database, the relative expression of FOXO3 protein in the cancer tissues of 64 patients with pancreatic cancer was significantly lower than that in the adjacent tissues ( t=8.36, P<0.001). The number of clones in PANC-1 cell line was (30.0±6.6) after overexpressed FOXO3, which was lower than that in negative control cells (92.7±6.7), and the difference was statistically significant ( t=11.54, P<0.001). After overexpressed FOXO3 in PANC-1 and MIAPaCa-2 cell lines, the scratch repair rate was significantly decreased compared with the control group. In Transwell experiment, the number of cells in FOXO3 overexpressed group in PANC-1 cell lines was (21.0±6.6), which was lower than that of negative control groups (55.7±8.5), and the difference was statistically significant ( t=5.59, P=0.005). The results of MIAPaCa-2 cell line were consistent with that of PANC-1 cell line. After overexpressing of FOXO3 in PANC-1 and MIAPaCa-2 cell lines, the proportion of cells in the G0/G1 phase decreased, while the proportion in the S phase increased. Conclusion:The expression of FOXO3 was decreased in pancreatic cancer. Overexpression of FOXO3 could significantly inhibit the proliferation, migration and invasion of pancreatic cancer cells and induce cell cycle arrest, which is a potential target for the treatment of pancreatic cancer.
5.Expression and function analysis of FaCO gene in Festuca arundinacea.
Xi CHEN ; Ying CHEN ; Xiaoxia LIU ; Jianhong SHU ; Xiaoli WANG ; Degang ZHAO
Chinese Journal of Biotechnology 2021;37(4):1324-1333
Photoperiod plays an important role in transformation from vegetative growth to reproductive growth in plants. CONSTANS (CO), as a unique gene in the photoperiod pathway, responds to changes of day length to initiate flowering in the plant. In this study, the expression level of FaCONSTANS (FaCO) gene under long-day, short-day, continuous light and continuous darkness conditions was analyzed by real-time quantitative PCR. We constructed the over-expression vector p1300-FaCO and infected into Arabidopsis thaliana by Agrobacterium-mediated method. We constructed the silencing vector p1300-FaCO-RNAi and infected into Festuca arundinacea by Agrobacterium-mediated method. The expression of FaCO gene was regulated by photoperiod. The over-expression of FaCO promoted flowering in wild type of Arabidopsis thaliana under long day condition and rescued the late flowering phenotype in co-2 mutant of Arabidopsis thaliana. Silencing FaCO gene in Festuca arundinacea by RNAi showed late-flowering phenotype or always kept in the vegetative growth stage. Our understanding the function of FaCO in flowering regulation will help further understand biological function of this gene in Festuca arundinacea.
Arabidopsis/metabolism*
;
Arabidopsis Proteins/genetics*
;
Festuca/metabolism*
;
Flowers/genetics*
;
Gene Expression Regulation, Plant
;
Photoperiod
6.Influencing factors of benign and malignant diagnosis in 317 cases of solitary pulmonary nodule treated with thoracoscopic resection
Hongyun LIU ; Sihai YU ; Degang WANG
Chinese Journal of Postgraduates of Medicine 2021;44(10):875-878
Objective:To retrospectively analyze the efficacy of video-assisted thoracoscopic surgery (VATS) in the treatment of solitary pulmonary nodule (SPN) and related factors affecting the diagnosis of benign and malignant SPN.Methods:The clinical data and surgical conditions of 317 patients with SPN who were resected by VATS and diagnosed by pathology in Chaoyang Central Hospital from January 2017 to December 2019 were retrospectively analyzed.The patient′s surgical efficacy and corresponding imaging features were explored.Results:Of the 317 patients, 124 (39.1%) cases underwent uniportal VATS and 193(60.9%) cases underwent multi-portal-portal VATS, 195(61.5%) cases had lobectomy, 16(5.1%) cases had anatomical segmentectomy, and 106(33.4%) cases had wedge resection. The operation time of the whole group was 50 - 210 (146.5 ± 34.7) min, intraoperative blood loss was 10 - 180 (69.3 ± 31.5) ml, thoracic drainage tube retention time was 2 - 7 (3.7 ± 1.4) d, postoperative hospital stay was 3 - 21 (6.4 ± 1.8) d, and the complication rate was 1.0%(3/317). No perioperative death occurred. Among all the nodules, 98(31.0%) cases were benign nodules and 219(69.1%) cases were malignant. Multivariate analysis showed that maximum nodule diameter, lobulated sign, burr sign, vascular bundle sign and pleural sag sign were independent related factors for the diagnosis of benign and malignant nodules ( P<0.05). Conclusions:VATS has less trauma and fewer complications, which has important clinical value for the diagnosis and treatment of benign and malignant SPN. Nodule maximum diameter, lobulated sign, burr sign, vascular bundle sign, pleural pit sign are independent related factors that affect the diagnosis of benign and malignant SPN.
7.Expression of IKBKE and NF-κB in pancreatic cancer and the effect of IKBKE on proliferation and migration of pancreatic cancer cells
Jun LI ; Dong YU ; Degang KONG ; Xin LOU ; Shuang FENG ; Zhijia JIANG ; Yaqing WEI ; Ming CHEN ; Geng LIU ; Jinjin SUN
Chinese Journal of Hepatobiliary Surgery 2020;26(4):274-280
Objective:To investigate the expression of IKBKE and NF-κB in pancreatic cancer, and to explore the effect of IKBKE on pancreatic cancer proliferation and migration.Methods:Immunohistochemistry staining was used to study the expression of IKBKE and NF-κB in tissues of 61 pancreatic cancer patients admitted to the Second Hospital of Tianjin Medical University from January 2012 to January 2017 and 13 normal pancreatic tissues. The correlations between those expression to clinicopathological features were analyzed. Lentivirus mediated RNAi was transfected into pancreatic cancer cells to block IKBKE. Western blot was performed to test the silencing effeciency; CCK-8 and plate clone and scratch assays were used to investigate the proliferation and migration of pancreatic cancer.Results:Immunohistochemical staining showed that 60 (98.4%) of IKBKE staining were weakly positive, positive, and strongly positive in pancreatic cancer tissues, which were significantly higher than normal pancreatic tissues(76.9% cases were weakly positive and the rest were negative), and the differences were statistically significant ( P<0.05). All cases of NF-κB exhibited weakly positive expression and above in pancreatic cancer tissues, which was markedly higher than normal tissues (30.8% cases were weak positive and the rest were negative staining), statistically significant ( P<0.05). Survival analysis showed that patients with high level of IKBKE showed a shorter overall survival ( P<0.05). CCK-8, plate cloning and scratch assays showed that the proliferation and migration of were significantly decreased in IKBKE knocking down group ( P<0.05). Conclusions:IKBKE and NF-κB are highly expressed in pancreatic cancer, and IKBKE is correlated with NF-κB in pancreatic cancer. Blocking of IKBKE could distinctly inhibit the proliferation and migration of pancreatic cancer.
8.A new femoral distractor used in close reduction and internal fixation with antegrade intramedullary nail for femoral shaft fractures
Zhigang WANG ; Zhaolin WANG ; Dong LIU ; Degang ZHANG ; Long JIA ; Kai ZHANG ; Dechun ZHANG ; Mingliang MA ; Gangqiang DU
Chinese Journal of Orthopaedic Trauma 2017;19(2):164-168
Objective To introduce a novel femoral distractor which is applied in close reduction and internal fixation (CRIF) with antegrade intramedullary nail for femoral shaft fractures.Methods From September 2010 to March 2015,85 patients with femoral shaft fracture were treated by CRIF with antegrade intramedullary nail in which our self-designed novel distractor was used.They were 64 males and 21 females,with an average age of 36.6 years.By AO classification,we had 32 cases of type 32-A,40 cases of type 32-B,and 13 cases of type 32-C.The intervals between injury and surgery averaged 7.5 days (range,from 1 to 16 days).The fracture was located at the upper shaft in 26 cases,at the middle shaft in 57 cases,at the middle shaft and ipsilateral neck in one,and at the lower shaft and ipsilateral intertrochanteric site in one.Their operation time,intraoperative blood loss,intra-and post-operative complications,and fracture union time were recorded and analyzed.Results Successful close reduction was achieved in all the 85 patients with no iatrogenic injury to major vessels or nerves.Operation time averaged 105.5 minutes;time for X-ray exposure averaged 25.8 seconds;intraoperative blood loss averaged 209.2 mL.The 85 patients received follow-ups from 8 to 24 months (mean,16.3 months).Fracture union was achieved in 83 cases after an average duration of 7.8 weeks (range,from 4 to 12 weeks),but nonunion occurred in 2 cases.One-year follow-ups revealed recovery of normal function of the affected knee in all,with no limb shortening > 10 mm,rotational angulation > 15°,or lateral or anteroposterior angulation > 10°.No incision infection,deep vein thrombosis or pulmonary embolism happened during the entire follow-up.Conclusion Our self-designed novel distractor can facilitate CRIF with antegrade intramedullary nail for femoral shaft fractures,and avoid the complications and inconvenience associated with a traction table.
9.Expert Consensus on Evaluation, Treatment and Rehabilitation of Traumatic Spinal Cord Injury
Jianjun LI ; Mingliang YANG ; Degang YANG ; Feng GAO ; Liangjie DU ; Limin LIAO ; Bohua CHEN ; Fang ZHOU ; Xuesong ZHANG ; Tiansheng SUN ; Baozhong ZHANG ; Xiaopei XIANG ; Lixia CHEN ; Hongjun ZHOU ; Songhuai LIU ; Zhihan SUN ; Ying LIU ; Xuan LIU ; Chunying HU ; Qiuchen HUANG ; Juan WU ; Fubiao HUANG ; Xiaoying ZHANG ; Jun LI ; Liang CHEN ; Hongwei LIU ; Huiming GONG
Chinese Journal of Rehabilitation Theory and Practice 2017;23(3):274-287
Spinal cord injury is a catastrophic injury causing lifelong severe disabilities, and poses a great burden to the individuals, families and society. In order to promote the standardization in treatment of traumatic spinal cord injury, the consensus on the evaluation, treatment and rehabilitation of traumatic spinal cord injury was suggested by experts, who came from authoritative multicenter in China. The expert consensus, which formed a standardization process from the first aid clinical treatment to rehabilitation of spinal cord injury, shall give a better practical guide for clinic and rehabilitation physicians.
10.Application of Navien catheter in intracranial aneurysm embolization
Degang WU ; Zhenbao LI ; Xintong ZHAO ; Niansheng LAI ; Jiaqiang LIU ; Bin SHENG ; Jinlong YUAN ; Xinggen. FANG
Chinese Journal of Cerebrovascular Diseases 2017;14(3):133-138
Objective To investigate the application technology and effect of Navien catheter in intracranial aneurysms embolization.Methods The clinical data of 15 patients with intracranial aneurysm treated with Navien catheter in Department of Neurosurgery of Yijishan Hospital Affiliated to Wannan Medical College from March to December 2016 were analyzed retrospectively. The extracranial segments of internal carotid arteries were seriously tortuous in all patients. The coaxial system was used during procedure. Whether the Navien catheter could be smoothly placed into the target artery or not was observed,and the coils or stent-assisted coils were used to embolize the intracranial aneurysms in the corresponding positions. The immediate embolization results were assessed by the Raymond grading. The intraoperative and postoperative complications were observed and the patients were followed up by imaging.Results All 15 patients had abnormal tortuosity of extracranial segments of internal carotid arteries. The Navien catheter was able to smoothly pass through the tortuous vessels and reach the desired position. The stent-assisted coil embolization was used in 9 patients,and the coil embolization was used in 6 patients. The success rate of the coil and stent placement technology was 100%. The stents were all accurately put in place without shift. According to the Raymond grading,the immediate embolization rate of aneurysms showed that 15 patients achieved Raymond gradeⅠ. One case developed internal carotid spasm during the procedure. The patient was improved after giving papaverine. Others did not have intraoperative complications,such as cerebral vasospasm,vascular dissection,in-stent thrombosis,and intraoperative aneurysm rupture. Five patients were followed up for 3 to 6 months with digital subtraction angiography (DSA). There was no recurrence of aneurysm and no in-stent stenosis and shift,No rebleeding or cerebral ischemia was observed.Conclusion Forpatients with severely tortuous in extracranial segments of internal carotid artery,using the Navien catheter may overcome artery tortuosity and other unfavorable factors of the patients and successfully reach the target vessel position,enable the embolization of intracranial aneurysms to be completed successfully.


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