1.Explorations in disciplines development at a research hospital
Jingbo WANG ; Yuan ZANG ; Xiaokang LI ; Dongguang WANG ; Zhanpeng YAO ; Ning LAO ; Bin FENG ; Lize XIONG
Chinese Journal of Hospital Administration 2016;(1):54-55
Aiming at building research disciplines,Xijing hospital has initially achieved a strategic transformation into a hospital with research disciplines,with such measures as scientific layout of disciplines,making of advantageous disciplines with overseas benchmarks,encouragement of potential disciplines with advantageous disciplines,promotion of medical innovation with innovative ideas,and upgrading clinical service quality with technical innovation.
2.Leptin expression in rats model with traumatic spinal cord injury and femoral fracture
Lei WANG ; Linjuan LIU ; Li XIAO ; Xiang YAO ; Hua DING ; Zhanpeng PAN
The Journal of Practical Medicine 2015;31(22):3688-3690
Objective To observe serum and callus leptin expression in rats model with fracture and traumatic spinal cord injury (SCI). Methods 72 male SD rats were randomized equally into 4 groups: control, SCI group, fracture group, and fracture/SCI group. Rats were sacrificed at 7, 14, 21 and 28 days after fracture/SCI. Serum leptin was detected by radioimmunoassayat 1, 7, 14, 21 and 28 days, and callus formation was measured radiologically at 14, 21 and 28 days. Callus leptin was analyzed with immunohistochemistry. Results Serum leptin in the fracture group, SCI group and combined fracture/SCI group were all higher than in control group at the 1, 7, 14 and 21 day time-point (P < 0.05). Serum leptin in the combined fracture/SCI group was significantly higher than the fracture group at 7, 14 and 21 days (P < 0.05), and higher than SCI groups at 14 and 21 days after operation (P < 0.05). The percentage of leptin-positive cells in the fracture/SCI callus, and callus volume was significantly higher than the fracture-only group (P < 0.001). Conclusions Leptin expression increases in the recovery process after SCI, and the recovery of fracture becomes sooner.
3.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