1.Content Determination of2Components in Xiaozhiyin by HPLC Simultaneonsly
China Pharmacy 2005;0(24):-
OBJECTIVE:To establish a HPLC method for content determination of salvianolic acid B and chrysophenine glycoside in Xiaozhiyin.METHODS:The compounds were base-isolated on the column of Kromesile C 18 at30℃and gradient elution was performed in mobile phase of acetonitrile-0.15%phosphoric acid solution,the wavelength was320nm,and the flow rate was1ml/min.RESULTS:The linearity was obtained between sample size and peak area score over the range of0.8336?g~ 8.336?g(r=1.0000)for salvianolic acid B,and0.352?g~3.52?g(r=1.0000)for chrysophenine glycoside.The average re?covery rate was99.5%(RSD=0.40%)for salvianolic acid B and100.2%(RSD=0.70%)for chrysophenine glycoside.CON?CLUSION:The method is accurate,simple,and highly reproducible,and it can be used for the quality control of Xiaozhiyin.
2.Association of TCF7L2 gene rs290487 polymorphism and polycystic ovarian syndrome in Hans in Anhui Province
Guoxi JIN ; Yaxin BI ; Lei YU ; Youmin WANG
Chinese Journal of Endocrinology and Metabolism 2010;26(10):868-870
One-hundred and sixty-nine women with polycystic ovarian syndrome (PCOS)and 95 healthy women were enrolled. All subjects were genotyped for rs290487 ( transcription factor 7-like 2 gene) by TaqManMGB probe hybridization assay. The results showed that polymorphism rs290487 had association with PCOS in Han people in Anhui area. The allele C was associated with the risk of PCOS. Genotype CC seems to be the risk factor of insulin resistance in PCOS patients.
3.The Changes of Serum Osteocalcin, Interleukin-18 in Patients With Different Glucose Tolerance and Their Relationship to Carotid Atherosclerosis in Type 2 Diabetes
Xiaoyan PEI ; Guoxi JIN ; Yaxin BI ; Li WANG ; Lei YU ; Shirong ZHANG
Chinese Circulation Journal 2017;32(7):684-688
To compare the changes of serum osteocalcin (OC), interleukin-18 (IL-18) in patients with different glucose tolerance and to explore their relationship to carotid atherosclerosis in type 2 diabetes mellitus (T2DM). Methods: According to the result of oral glucose tolerance test (OGTT), 140 research subjects were divided into 3 groups: Normal control group, n=50, Pre-diabetes group, n=30 and T2DM group, n=60 which included in 2 subgroups:Normal carotid intima-media thickness (IMT) subgroup, n=26 and Carotid IMT thickening subgroup, n=34. Carotid IMT, serum OC, IL-18 and glycosylated hemoglobin (HbA1c), fasting glucose, OGTT 2-hour blood glucose (2hPG), TC, TG, LDL-C, HDL-C, body mass index (BMI), insulin resistance index (HOMA-IR) and insulin cell function index (HOMA-β) were measured in all subjects. Pearson correlation and multi liner regression model were conducted to analyze the relevant parameters. Results: From Normal control to Pre-diabetes to T2DM groups, serum OC was decreased and IL-18 was increased gradually, all P<0.05. OC was negatively related to HbA1c (r=-0.426), fasting glucose (r=-0.582), 2hPG (r=-0.489), HOMA-IR (r=-0.456), TC (r=-0.451) and carotid IMT (r=-0.559), all P<0.05; while positively related to HOMA-β (r=0.439), P<0.05. IL-18 was positively related to BMI (r=0.395), HbA1c (r=0.693), fasting glucose (r=0.880), 2hPG (r=0.715), HOMA-IR (r=0.667), TC (r=0.734), TG (r=0.326), LDL-C (r=0.471) and carotid IMT (r=0.857), all P<0.05; while negatively related to HOMA-β (r=-0.678), P<0.05. In T2DM group, carotid IMT was positively related to IL-18 (r=0.817), fasting glucose (r=0.415), HOMA-IR (r=0.356), TC (r=0.396) and TG (r=0.362), all P<0.05; while negatively related to OC (r=-0.588), P<0.05. Multi liner regression analysis indicated that IL-18, OC, TC and fasting glucose were the independent impact factors for carotid IMT (regression coefficients were 0.013, -0.011, 0.044 and 0.044 respectively), P<0.05. Conclusion: Serum OC and IL-18 had been involved in glucolipid metabolism and closely related to the occurrence and development of carotid atherosclerosis in T2DM patients.
4.Results of different interventions applied to 118 cases with impaired fasting glucose for 3 years
Yaxin BI ; Guoxi JIN ; Lei YU ; Jing ZHOU ; Shirong ZHANG ; Fengxiu JIANG ; Zhiyi SONG ; Jianhua SHI
Chinese Journal of Endocrinology and Metabolism 2010;26(7):586-587
The results of different interventions administered in 118 cases with impaired fasting glucose (IFG) for 3 years were investigated. The rates of transformation of IFG to diabetes mellitus in metformin treatment groups and rosiglitazone treatment groups were significantly lower than that in life style intervention group. This study suggested that metformin or rosiglitazone treatment could effectively reduce transformation of IFG to diabetes as compared with life style intervention.
5.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