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.Diagnosis and treatment of a case of acute severe Stanford type A aortic dissection
Guochang ZHAO ; Penghong LIU ; Bing WEN ; Wenzeng ZHAO
Chinese Critical Care Medicine 2019;31(2):238-240
Patients?with?acute?myocardial?infarction?(AMI)?complicated?with?acute?Stanford?type?A?aortic?dissection?after?percutaneous?coronary?intervention?(PCI)?are?critically?ill,?with?a?very?high?fatality?rate,?and?few?cases?are?successfully?treated?clinically.?A?case?with?AMI?admitted?to?the?First?Affiliated?Hospital?of?Zhengzhou?University?complicated?with?acute?left?cardiac?insufficiency?after?PCI,?Stanford?type?A?aortic?dissection,?pericardial?and?pleural?infection,?recurrent?AMI?was?reviewed.?In?the?condition?of?coexistence?of?many?diseases,?through?timely?adjustment?of?treatment?strategy?and?exploratory?application?of?drugs?to?improve?cardiac?function,?the?patient?successfully?received?operation?and?discharged?from?the?hospital.?By?presenting?the?successful?treatment?experience?of?this?case,?the?author?aims?to?improve?the?overall?treatment?of?AMI?patients?with?acute?Stanford?type?A?aortic?dissection?after?PCI.
3.A modified method for common carotid artery puncture in the establishment of a rat model of middle cerebral artery occlusion
Hua LIU ; Yuemei LIU ; Rui GUAN ; Zhao XU ; Wenzeng ZHU
Acta Laboratorium Animalis Scientia Sinica 2016;24(4):399-402
Objective To compare the timeliness, success and mortality rates between the modified carotid artery puncture method ( MCAPM) and standard suture method ( SSM) in the establishment of rat model of a middle cerebral ar?tery occlusion ( MCAO) . Methods Thirty?two male rats were randomly and equally assigned into MCAPM group and SSM group. The MCAO models were established by inserting a thread into the common carotid artery ( CCA) . 24 h after modeling, the rats of the two groups were evaluated with Bederson neurological scores, and the modeling success rate and mortality rate were analyzed. Results The suture insertion times, success rates and mortality rates of the MCAPM vs. SSM groups were (82?3 ±17?4) s versus (164?6 ± 22?0) s (P<0?01), 87?5% versus 68?75% (P>0?05), and 6?25% versus 18?75% (P>0?05). Conclusions MCAPM can be used to establish the rat model of MCAO due to its simplicity, mild wound and feasibility.
4.Ventricular septal plication for post infarction anterior and anterior-septal aneurysm of the left ventricle.
Huashan XU ; Wenzeng ZHAO ; Jing XU ; Chenhui QIAO ; Chao LIU ; Khan MOHAMMED FIROJ
Journal of Central South University(Medical Sciences) 2013;38(3):279-282
OBJECTIVE:
To determine the use of septal plication with Dor or Cooley procedure for post infarction anterior and anterior-septal aneurysm of the left ventricle.
METHODS:
A total of 23 patients with post infarction anterior and anterior-septal aneurysm of the left ventricle underwent septal plication and Dor or Cooley procedure along with coronary artery bypass grafting concomitantly. Data of NYHA grading, left ventricular end diastolic volume index (LVEDVI), left ventricular end systolic volume index (LVESVI) and left ventricular ejection fraction (LVEF) were recorded before the surgery, before discharge and 3 months after the surgery.
RESULTS:
Compared with the preoperative data, the NYHA grading before the discharge and 3 months after the surgery improved from 3.21 ± 0.62 to 1.72 ± 0.31 and 1.57 ± 0.23(P<0.05); LVEDVI decreased from (102.31 ± 18.71) mL/m² to (62.11 ± 6.21) mL/m² and (54.63 ± 4.54) mL/m² (P<0.05); LVESVI decreased from (69.32 ± 17.48) mL/m² to (30.23 ± 3.25)mL/m² and (28.34 ± 3.12) mL/m²; while LVEF increased from (32.92 ± 8.12)% to (48.78 ± 4.51)% and (50.52 ± 4.68)% (P<0.05), respectively.
CONCLUSION
Ventricular septal plication combined with Dor or Cooley procedure can remarkably improve the left heart function in patients with post infarction ventricular aneurysm.
Aged
;
Coronary Artery Bypass
;
methods
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Female
;
Heart Aneurysm
;
etiology
;
surgery
;
Heart Ventricles
;
pathology
;
surgery
;
Humans
;
Male
;
Middle Aged
;
Myocardial Infarction
;
complications
;
Ventricular Function, Left
;
physiology
;
Ventricular Septum
;
surgery
5.Expression of MRP1 and CD34 in colorectal carcinoma tissue and its clinical significance
Wenzeng ZHAO ; Ronghong LIU ; Jianbing WANG ; Rong QI ; Hongmei XIE ; Lixian ZHANG ; Shunmao MA ; Bin CAO
Chinese Journal of Primary Medicine and Pharmacy 2012;19(20):3041-3043
ObjectiveTo explore the expression of MRP1 and CD34 in colorectal carcinoma tissue and the relationship with clinicopathological factors.MethodsImmunohistochemical streptavidin-perosidase method was used to examine the expression of MRP1 and CD34 in 53 cases with colorectal carcinoma and normal colorectal tissue.The correlation between the levels of MRP1and CD34 expression and clinicopathological factors were analyzed.ResultsThe positive expression rates of MRP1 in the carcinoma group and normal colorectal tissue group were 49.1% and 15.1% respectively,and there was a significant difference of the positive expression between the two groups( x2 =14.029,P < 0.01 ).The expression of MRP1 had no correlation with the degree of differentiation,the depth of invasion,the metastasis of lymph node and all the other clinicopathological factors ( P > 0.05 ).CD34 value in the carcinoma group and normal colorectal tissue group were ( 35.63 ± 12.23 ) MVD/HP and ( 6.12 ± 0.97) MVD/HP,respectively,and there was a significant difference between the two groups (t =17.565,P < 0.01 ).CD34 was not correlated with age,sex,tumor size,localization of the primary tumor ( P > 0.05 ),but correlated with Dukes staging,lymph node metastasis,differentiation of the tumor,depth of invasion( all P < 0.05).ConclusionThe overexpression of MRP1 and CD34 protein may involve in colorectal carcinogenesis;MRP1 may involve in the primary multidrug resistance in colorectal carcinoma.; CD34 may involve in the colorectal carcinoma invasion and metastasis.Investigating the expression of MRP1 and CD34 in colorectal carcinoma simultaneously can provide new referential indexes for the treatment and prognosis of colorectal carcinoma.
6.Mid- and long-term results of tricuspid valve repair with an annuloplasty ring
Zhenwei GE ; Wenzeng ZHAO ; Gang SU ; Chao LIU ; Jingchao ZHANG
Clinical Medicine of China 2010;26(9):963-966
Objective To compare the mid- and long-term results of tricuspid valve (TV) repair with or without an annuloplasty ring. Methods Two hundred seventy-seven patients underwent TV repair at our division (Sep. 2001 to Sep. 2008) ,of which 203 had, predominantly, a De Vega or Kay procedure (non-ring group) and 74had an annuloplasty with an artificial ring (ring group). TV pathology mainly was functional (secondary) and several with rheumatic leaflets involvement. Concomitant procedures consisted of mitral valve surgery in all patients,aortic valve surgery in 81 ,and coronary bypass in 19. Clinical and echocardiographic data followed for 1.5 to 3.5years were obtained. Results Postoperationally,the mid-term(1.5 years) follow-up was 100% completed and the long-term follow-up for 3. 5 years was 89. 9%. The recurrence of TV regurgitation (TR) of moderate and lower degree was not significantly different(χ2 = 1.3128, P= 0.26) in the 1.5 years follow-up between the two group,whereas the recurrence of TR of moderate to severity degree was significantly less in the ring group (χ2 =5. 8159,P =0.023).In the long term follow up,the TR in the ring group (25%) was significantly lower than that of 15% in the non-ring group (χ2 = 4. 9328, P = 0.036) . There are higher proportion of patients developing to moderate TR in the non ring group(34%) than in the ring group (10%) (χ2 =7. 9120,P =0.005). The TR developed fast in the ring group,increasing from 18% at 1.5 years follow up to 10% at 3.5 years follow up (χ2 = 2. 1327, P = 0.016),whereas it was relatively stable in the non-ring group,with 7% at 1.5 year follow up and 10% at 3.5 year follow up. Conclusions Placement of an annuloplasty ring in patients undergoing TV repair could remarkably improved the mid and long terum outcome. In clinic practice, we should be more positive to the functional TR and prefer to the procedure with annuloplasty ring.
7.Effect of inhaled low density nitric oxyde in pig' s pulmonary thromboembolism
Sugang GONG ; Jinming LIU ; Tong ZHOU ; Bo SUN ; Peilan GAO ; Wenzeng LIU ; Xia LI ; Tao GUI
Chinese Journal of Emergency Medicine 2009;18(8):846-850
Objective To investigate the mechanism and significance of low concentration nitric oxide (NO) inhalation in the treatment of pulmonary thromboembelism in swine. Method The pulmonary thromboem-bolism(PTE) model was made in 15 healthy infantile swines which were subsequently assigned to either control group (n = 8) or NO group (n = 7). Swines of the control group were not treated with any medicine, while 10 ppm of NO was administered by continuous inhalation for 2 hours to swines of NO group. Volume of physiological dead space (VDphy), volume of alveolar dead space (VDalv), intrapulmonary shunt (Qs/Qt), mean pulmonary arterial pressure (PAP), systolic blood pressure (SBP), heart rate (HR), cardiac output (CO), arterial blood pH (pH), arterial partial pressure of carbon dioxide (PaCO2) and arterial partial pressure of oxygen (PaO2) were measured 30 min before and 0 min, 30 min, 60 min, 120 min and 180 min after establishment of VIE. Results The post-FIE VDphy, VDalv, Qs/Qt and PAP in both groups increased markedly after PTE compared with the cor-responding pre-PTE measurements (P < 0.01). Post-FIE PaO2 of both groups decreased significandy (P <0.05 and P <0.01), while significance difference was found between pre- and post-PTE HR, SBP, CO, pH or PaCO2 in neither groups (P > 0.05). Both post-PTE PAP and VDalv in NO group were markedly lower(P <0.05 and P <0.01) and beth PaCO2 and PaO2 were much higher than those of the control group (P <0.05). No signi-fieant difference were found in other measurements between two groups. Conclusions Pulmonary arterial pressure may be lowered, alveoli dead space may be reduced and PaCO2 increased by low concentration NO inhalation for the treatment of PIE without decline in haemodynamic status.
8.Mechanism and correlated factors of SAM phenomenon after aortic valve replacement.
Jing, XU ; Jianguo, WEN ; Liliang, SHU ; Chao, LIU ; Jingchao, ZHANG ; Wenzeng, ZHAO
Journal of Huazhong University of Science and Technology (Medical Sciences) 2007;27(1):72-4
To investigate the mechanism and correlated factors of systolic anterior motion (SAM) phenomenon after aortic valve replacement, 48 patients with severe aortic valvular stenosis were studied. Tested by echo-Doppler one week after aortic valve replacement, the patients were divided into two groups: SAM group and non-SAM group. The data of the left ventricular end-diastolic diameters, the left ventricular end-systolic diameters, the left ventricular outflow diameters, the thickness of the interventricular septum, the posterior wall of left ventricle, the blood velocities of left ventricular outflow and intra-cavitary gradients were recorded and compared. The results showed that no patients died during or after the operation. The blood velocities of left ventricular outflow was increased significantly in 9 patients (>2.5 m/s), and 6 of them developed SAM phenomenon. There was significant difference in all indexes (P<0.05 or P<0.01) except the posterior wall of left ventricle (P>0.05) between two groups. These indicated that the present of SAM phenomenon after aortic valve replacement may be directly related to the increase of blood velocities of left ventricular outflow and intra-cavitary gradients. It is also suggested that smaller left ventricular diastolic diameters, left ventricular systolic diameters, left ventricular outflow diameters and hypertrophy of interventricular septum may be the anatomy basis of SAM phenomenon.
9.Mechanism and Correlated Factors of SAM Phenomenon after Aortic Valve Replacement
Jing XU ; Jianguo WEN ; Liliang SHU ; Chao LIU ; Jingchao ZHANG ; Wenzeng ZHAO
Journal of Huazhong University of Science and Technology (Medical Sciences) 2007;27(1):72-74
To investigate the mechanism and correlated factors of systolic anterior motion (SAM) phenomenon after aortic valve replacement, 48 patients with severe aortic valvular stenosis were studied. Tested by echo-Doppler one week after aortic valve replacement, the patients were divided into two groups: SAM group and non-SAM group. The data of the left ventricular end-diastolic diameters, the left ventricular end-systolic diameters, the left ventricular outflow diameters, the thickness of the interventricular septum, the posterior wall of left ventricle, the blood velocities of left ventricular outflow and intra-cavitary gradients were recorded and compared. The results showed that no patients died during or after the operation. The blood velocities of left ventricular outflow was increased significantly in 9 patients (>2.5 m/s), and 6 of them developed SAM phenomenon. There was significant difference in all indexes (P<0.05 or P<0.01) except the posterior wall of left ventricle (P>0.05) between two groups. These indicated that the present of SAM phenomenon after aortic valve replacement may be directly related to the increase of blood velocities of left ventricular outflow and intra-cavitary gradients. It is also suggested that smaller left ventricular diastolic diameters, left ventricular systolic diameters, left ventricular outflow diameters and hypertrophy of interventricular septum may be the anatomy basis of SAM phenomenon.
10.A Study on Teachers' Occupational Burnout and Mental Health
Chinese Journal of Clinical Psychology 2000;0(04):-
Objective:To investigate the relationship between primary and secondary school teachers' occupational burnout and mental health.Methods: Maslach questionaiers about occupational burnout and mental (MBI) and SCL-90 were administrated to 528 primary and secondary school teachers. Results: (1) Correlation analysis showed significantly positive correlation between primary and secondary school teachers' occupational burnout and mental health. Emotional Exhaustion related highest to somatization, compulsion, interpersonal relation, depression, anxiety, hostility, and paranoid. (2) Stepwise regression analysis revealed that the three dimensions of professional burnout predict significantly mental health, Emotional Exhaustion accounted most for the variance.Conclusion:Teachers occupational burnout is correlated with mental health. Different occupational burnout dimensions can all predict mental health.

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