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.Misdiagnosis of adenoid cystic carcinoma of oropharynx: a case report.
Jiuzhou ZHAO ; Ke LI ; Xiaodong HAN ; Zhaohui SHI ; Xianhai ZENG ; Xiangmin ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(10):837-839
Adenoid cystic carcinoma usually occurs in the salivary glands of the head and neck. It is a malignant tumor with a high degree of malignancy, resistance to radiotherapy and chemotherapy and poor prognosis. The clinical course of adenoid cystic carcinoma is slow and easy to be misdiagnosed. The main diagnosis and treatment means are individualized and precise treatment under the multi-disciplinary consultation mode, that is, surgical treatment and radiotherapy and chemotherapy. Adenoid cystic carcinoma is prone to relapse and hematologic metastasis, and the traditional radiotherapy and chemotherapy based therapies have not achieved satisfactory efficacy in the past three decades. How to detect, diagnose and treat early is an urgent task faced by clinicians.
Humans
;
Carcinoma, Adenoid Cystic/pathology*
;
Neoplasm Recurrence, Local
;
Neck/pathology*
;
Oropharynx/pathology*
;
Diagnostic Errors
3.PFKL, a novel regulatory node for NOX2-dependent oxidative burst and NETosis.
Zhaohui CAO ; Di HUANG ; Cifei TANG ; Min ZENG ; Xiaobo HU
Journal of Zhejiang University. Science. B 2022;23(7):607-612
Neutrophils are predominant leukocytes in the circulation, which are essential for killing invading pathogens via the activation of effector responses and the production of reactive oxygen species (ROS), also named as "oxidative burst." When infected, activated neutrophils fight bacteria, fungi, and viruses through oxidative burst, phagocytosis, degranulation, and the production of neutrophil extracellular traps (NETs) in a neutrophil death process named as "NETosis" (Mutua and Gershwin, 2021). NETs, consisting of DNA fibers decorated with modified histones and numerous antimicrobial proteins from cytoplasmic granules and the nucleus, can either be beneficial or detrimental (Mutua and Gershwin, 2021). Several pathways can lead to this death process. In response to various stimuli, NETosis traps and clears pathogens, facilitating phagocytosis by other neutrophils and phagocytes. However, excessive NETosis often results in disease due to increasing the pro-inflammatory response and perpetuating the inflammatory condition (Hellebrekers et al., 2018; Hidalgo et al., 2019; Klopf et al., 2021). Accordingly, inhibiting aberrant NETosis may alleviate the severity of various autoimmune and inflammatory diseases.
DNA
;
Extracellular Traps/metabolism*
;
Neutrophils/metabolism*
;
Reactive Oxygen Species/metabolism*
;
Respiratory Burst
4.Analysis of the verification results of the laboratory ability to detect ammonia nitrogen in drinking water in the CDC in Hubei Province
Xinfu PENG ; Li CHEN ; Mingxing ZENG ; Dongmei SUN ; Zhaohui ZHENG
Journal of Public Health and Preventive Medicine 2020;31(5):61-63
Objective To understand the ability of the CDC to detect ammonia nitrogen in drinking water in Hubei Province. Methods The blind samples of two concentration levels were tested in the laboratories of the disease control institutions in the province, and the test results were evaluated by double-sample Z score. Results The satisfaction rate was 76.29% (74/97), the problem rate was 15.46% (15/97), and the dissatisfaction rate was 8.25% (8/97). Conclusion The detection ability of ammonia nitrogen in drinking water in laboratories of disease control institutions in Hubei Province is generally high,however,some laboratories need to be further improved.
5. Application of endoscopic retrograde cholangiopancreatology in pediatric chronic pancreatitis
Zhaohui DENG ; Jingqing ZENG ; Biao GONG ; Lirong JIANG
Chinese Journal of Applied Clinical Pediatrics 2019;34(19):1445-1447
Chronic pancreatitis is a focal or diffuse chronic inflammation and fibrosis of pancreatic tissue, which is progressive, persistent and irreversible.Chronic pancreatitis in children has its own characteristics of early onset and frequent occurrence, which greatly affects the nutritional status and quality of life of children.Recently, diagnosis and treatment of this severe inflammation gradually improved with a burgeoning technique: endoscopic retrograde cholangiopancreatography (ERCP), especially in the treatment of pediatric chronic pancreatitis.The detection rate of the disease has been increasing year by year.As an effective and safe procedure for the treatment of chronic pancreatitis in children, ERCP has replaced traditional surgery and become the first-line treatment method for pediatric chronic pancreatitis.
6. Pilot study of the relationship between clinical classification of gallbladder cancer and prognosis: a retrospective multicenter clinical study
Dong ZHANG ; Zhimin GENG ; Chen CHEN ; Yongjie ZHANG ; Yinghe QIU ; Ning YANG ; Desheng WANG ; Xuezhi WANG ; Tianqiang SONG ; Jianying LOU ; Jiangtao LI ; Xianhai MAO ; Wenbin DUAN ; Shengping LI ; Xiangming LAO ; Xiangqian ZHAO ; Yajin CHEN ; Lei ZHANG ; Yudong QIU ; Jiansheng LIU ; Yongyi ZENG ; Wei GONG ; Zhaohui TANG ; Qingguang LIU ; Zhiwei QUAN
Chinese Journal of Surgery 2019;57(4):258-264
Objectives:
To propose a novel clinical classification system of gallbladder cancer, and to investigate the differences of clinicopathological characteristics and prognosis based on patients who underwent radical resection with different types of gallbladder cancer.
Methods:
The clinical data of 1 059 patients with gallbladder cancer underwent radical resection in 12 institutions in China from January 2013 to December 2017 were retrospectively collected and analyzed.There were 389 males and 670 females, aged (62.0±10.5)years(range:22-88 years).According to the location of tumor and the mode of invasion,the tumors were divided into peritoneal type, hepatic type, hepatic hilum type and mixed type, the surgical procedures were divided into regional radical resection and extended radical resection.The correlation between different types and T stage, N stage, vascular invasion, neural invasion, median survival time and surgical procedures were analyzed.Rates were compared by χ2 test, survival analysis was carried by Kaplan-Meier and Log-rank test.
Results:
Regional radical resection was performed in 940 cases,including 81 cases in T1 stage,859 cases in T2-T4 stage,119 cases underwent extended radical resection;R0 resection was achieved in 990 cases(93.5%).The overall median survival time was 28 months.There were 81 patients in Tis-T1 stage and 978 patients in T2-T4 stage.The classification of gallbladder cancer in patients with T2-T4 stage: 345 cases(35.3%)of peritoneal type, 331 cases(33.8%) of hepatic type, 122 cases(12.5%) of hepatic hilum type and 180 cases(18.4%) of mixed type.T stage(χ2=288.60,
7.The value of contrast-enhanced ultrasound and contrast-enhanced CT in the differential diagnosis of benign and malignant gallbladder diseases
Chunlin TANG ; Yanli GUO ; Ping CHEN ; Kaixuan CHEN ; Ying TAN ; Zhaohui CHEN ; Yan WANG ; Qiangwei LIU ; Ye ZOU ; Hongyue ZENG
Chinese Journal of Medical Ultrasound (Electronic Edition) 2018;15(4):251-257
Objective To comparatively analyze the image characteristic of contrast-enhanced ultrasound(CEUS)and contrast-enhanced computed tomography(CECT),and explore the diagnostic value of the two methods in benign and malignant lesions of gallbladder.Methods comparative analysis the image characteristic of CEUS and CECT,the preoperative diagnostic results of 86 cases of gallbladder diseases were confirmed by pathology.Results The enhancement patterns of CEUS and CECT in benign and malignant lesions of gallbladder are similar.The sensitivity,specificity and accuracy of CEUS were 77.9%(53/68),77.8%(14/18),77.9%(67/86),respectively.The sensitivity,specificity and accuracy of CECT were 75%(51/68),55.6%(10/18),70.9%(61/86),respectively.The sensitivity,specificity and accuracy of the combination of CEUS and CECT were 83.8%(57/68),55.6%(10/18),77.9%(67/86),respectively.The accuracy of the combination of CEUS and CECT was higher than that of CECT in the diagnosis of malignant gallbladder lesions [(53.9±10.00)s vs(35.50±6.72)s],the differences were statistically significant(t=6.729,P<0.001).Conclusions The enhancement patterns of CEUS and CECT in benign and malignant gallbladder lesions are similar.The combination of CEUS and CECT is helpful for improving the diagnostic accuracy of malignant gallbladder lesions.CEUS and CECT could corroborate and complement each other,and provide more valuable information for the differential diagnosis of benign and malignant gallbladder lesions.
9.Effects of cyclamic acid on dynamic monitoring D-Dimer and thromboembolic prophylaxis during total hip arthroplasty
Anlie CAI ; Wei ZENG ; Zhaohui YUAN ; Jingling LIU ; Xuewen ZHENG ; Yin LIU ; Xiangcheng YANG
Clinical Medicine of China 2017;33(1):11-14
Objective To study the effects of use of cyclamic acid on monitoring D-Dimer and predicting deep venous thrombosis on lower limbs during total hip arthroplasty.Methods Ninety-three cases patients who received total hip arthroplasty operations at Joint Surgery Department of the Central Hospital of Zhuzhou city and Zhuzhou Hospital Affiliated to Xiangya Medical College of Central South University from December 2015 to May 2016 were selected as subjects and randomly assigned into study group with 50 cases and control group with 43 cases.During the operations,cyclamic acid was used intravenously and locally as a routine in the study group while saline was utilized instead in the control group.The D-Dimer was dynamically monitored before operation and 1,3,5,7,9 d after the operation,and venous color ultrasonography of both lower limbs were taken 3,6,9 d after the operation to check the conformation of thrombosis.Results The total blood loss after treatment in the study group was (350.5 ± 65.2) ml,intraoperative blood loss of (129.3 ± 43.1) ml,postoperative drainage volume of (80.9± 12.6) ml,occult blood loss of (141.9± 20.6) ml,corresponding to the control group were (560.8±60.6) ml,(208.9± 57.8) ml,(150.8 ± 18.9) ml,(202.9±23.9) ml.The above indicators were lower in the study group than in the control group,the differences between the two groups were statistically significant(t =16.02,7.59,21.24,13.22,P<0.05).There were significant differences in terms of D2-dimer level of 1,3,5 d after the operation between the study group and the control group (P<0.05),but at 7,9 d after the operation,the difference between the two groups were not statistically significant(P>0.05).The study group and the control group at 9 d after operation with color Doppler ultrasound examination showed that there were 1 cases of patients with calf vein thrombosis both in two groups,there was no significant difference between the two groups(2.00% vs.2.32%,x2 =0.012,P> 0.05).Conclusion The proper use of cyclamic acid can reduce blood loss and will not increase the risk of thrombosis.Monitoring dynamically on D-Dimer and deep venous color ultrasonography on lower limbs is helpful for early detection of thrombosis after total hip arthroplasty.However,the use of cyclamic acid during total hip arthroplasty will affect the monitoring on D-Dimer and therefore needs to be taken seriously.
10.Effect of Enteral Nutrition Liquid with Different Dietary Fiber Content on Serum Protein in Patients with Stress Hyperglycemia
Song ZHOU ; Yonggang LIU ; Guoxiang ZHANG ; Jing ZENG ; Zhaohui LIU ; Quanzhong LIU ; Fangjun LI
Herald of Medicine 2017;36(8):897-901
Objective To compare the effect of enteral nutrition liquid with different dietary fiber content on serum protein in patients with stress hyperglycemia.Methods A total of 90 patients with stress hyperglycemia were randomly divided into three groups:enteral nutritional suspension (SP) group (Peptisorb),enteral nutritional suspension (TPF-FOS) group (Jevety) and enteral nutritional suspension (TPF-D) group (Glucerna),each group consisting of 30 patients.In the three groups,prealbumi (PA),serum albumin (ALB),retinol binding protein (RBP),transfer-rin (TRF) and hemoglobin (Hb) were continuously measured on the 1st,2nd,3rd,4th,5th,6th and 7th day.Data were analyzed by SPSS 15.0.Variances on time and group were analyzed by repeated measures of general linear model.Results The PA,ALB,RBP,TRF and Hb were significantly different among Peptisorb group,Jevety group and Glucerna group (P< 0.05).The PA,ALB and Hb which were determined in different time,were not significantly impacted by Peptisorb,Jevety or Glucerna,and not significantly changed with time.The RBP and TRF which were determined at different time,were not impacted by Peptisorb,Jevety or Glucema,but time× group from RBP and TRF which were determined in different time,were significantly impacted in Peptisorb group,Jevety group and Glucerna group (P< 0.01).Conclusion The content from different dietary fiber significantly affects serum protein in patients with stress hyperglycemia,and TPF-D has the most significant effect on serum protein.


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