1.Changes of central nervous system leucine-enkephaline in experimental hypo- and hyperthyroid rats
Chinese Journal of Pathophysiology 1986;0(03):-
In presnt experiment, animal models for hyperthyroidism and hypothyroidism were made, and using radioimmunoassay, the immunoeactive leucine-enkephalin (Ir-LEK) levels of such discrete brain areas as hypothalamus, striatum, cerebral cortex(frontal lobe) and whole pituitary were determined in different groups. The results obtained indicated that both hyperthyroidism and hypothyroidism induced significant changes of concentration in CNS Ir-LEK. It was found in hypothyroid group that concentration of Ir-LEK in hypothalamus, cerebral cortex and pituitary increased significantly against the control (P
2.Risk factors of postoperative morbidity after hepatectomy for intrahepatic stones
Shunjun FU ; Shaoqiang LI ; Lijian LIANG ; Baogang PENG ; Wenjie HU ; Jie LIN
Chinese Journal of Hepatobiliary Surgery 2010;16(5):325-327
Objective To study the risk factors of complications after hepatectomy for intrahepatic stone.Method Clinical data of 363 patients with hepatolithiasis receiving elected hepatic resection in past 4 years in our hospital were analyzed retrospectively.Postoperative complications were recorded.Possible risk factors pertaining to the development of complications were identified using univariate and multivariate analysis.Results the surgical mortality was 0.6%(2/363).Postoperative complications occurred in 110 of 363 patients(30.3%).The morbidity included wound infection/liquafication in 42 cases(11.6%),pleural effusion in 41(11.3%),subphrenic collection in 36 (9.9%),bile leakage in 21(5.8%),intra-abdominal collection/infection in 13(3.6%),gastrointestinal bleeding in 3(0.8%),biliary hemorrhage in 2(0.6%),hepatic function insufficiency in 1 (0.3%).The multivariate logistic regression analysis identified that previous history of biliary surgery (P=0.042,odds ratio[OR]=0.617,95%confidence interval[CI]:0.388 to 0.982)and operative time(P=0.0001,odds ratio[OR]=0.994,95%confidence interval[CI]:0.991 to 0.997)were the independent risk factors for development of complications after hepatoectomy for hepatolithiasis.Conclusion Previous history of biliary duct surgery and operative time are the independent risk factors for development of complications after hepatoectomy for intrahepatic stone.For patients with previous biliary surgery,adequate preoperative preparation,improving operative skills and shortening operative time are critical important to prevent occurrence of complications.
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