1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
3.Prenatal diagnosis and genetic analysis of a fetus with der(X)t(X;Y)(p22.3;q11.2).
Jian LI ; Yanling DONG ; Junnan LI ; Jianyun LUO ; Chunlei LI ; Hongbo QI
Chinese Journal of Medical Genetics 2020;37(11):1287-1290
OBJECTIVE:
To explore the pathogenesis and genetic characteristics of a fetus with a der(X)t(X;Y)(p22.3;q11.2) karyotype.
METHODS:
G-banding karyotyping analysis, BoBs (BACs-on-Beads) assay, and single nucleotide polymorphism array (SNP-array) were used to delineate the structural chromosomal aberration of the fetus. The parents of the fetus were also subjected to karyotyping analysis.
RESULTS:
The fetus and its mother were both found to have a karyotype of 46,X,add(X)(p22), while the father was normal. BoBs assay indicated that there was a lack of Xp22 but a gain of Yq11 signal. SNP-array confirmed that the fetus and its mother both had a 7.13 Mb deletion at Xp22.33p22.31 (608 021-7 736 547) and gain of a 12.52 Mb fragment at Yq11.221q11.23 (16 271 151-28 788 643).
CONCLUSION
The fetus was determined to have a karyotype of 46,X,der(X)t(X;Y)(p22.3;q11.2)mat. The combined use of various methods has facilitated delineation of the fetal chromosomal aberration and prediction of the risk prediction for subsequent pregnancy.
Chromosome Banding
;
Chromosome Deletion
;
Chromosomes, Human, X/genetics*
;
Chromosomes, Human, Y/genetics*
;
Female
;
Fetus
;
Humans
;
Karyotyping
;
Male
;
Pregnancy
;
Prenatal Diagnosis
;
Translocation, Genetic
4.Great variety and unique growth history of HCV in China
Wangxia TONG ; Jianyun ZHU ; Ziying LEI ; Qihuan XU ; Ning LUO ; Xiaoliang HUANG
Chinese Journal of Experimental and Clinical Virology 2014;28(5):336-338
Objective To determine the constantlychanging HCV genotype distribution patterns in China and investigate the HCV epidemic history and evolutionary dynamics.Methods HCV RNA from 423 HCV patients was extracted using Qiagen Viral RNA extraction kit,cDNA was transcripted using RevertAid First Strand cDNA Synthesis kit,and both E1 and NS5B sequences were amplified using RT-PCR followed by fluorescent sequencing.The sequences were analyzed using phylogenetic trees.The evolutionary analyses were performed using the Bayesian MCMC (Markov Chain Monte Carlo) algorithm implemented in the BEAST software and the BSP was reconstructed to form a retrospective picture of the epidemic history of HCV.Results Six HCV genotypes and 12 subtypes were identified (1b:65.9%,6a:17.1%,2a:7.4%,3a:3.6%,3b:3.3%,6e:0.76%,1a,1c,2b,2f,4d 5a:0.25%),in addition to two novel HCV-6 variants.A period from 1993 to 2000 was highlighted by the five BSPs,during which rapid HCV growth appeared followed by an abrupt slowing.Conclusions A great diversity in HCV was detected,which reflected a constantly changing pattern of HCV genotypes in China over time.They concurrently highlighted fast HCV growth in 1993-2000.This is a period during which HCV infection become explosive in China because of an officially encouraged plasma campaign in the1990s.
5.Study of relationship of an androgen receptor CAG repeat polymorphism with postmenopausal osteoporosis
Li GENG ; Zhenwei YAO ; Aiwen LE ; Jianyun LUO ; Lili HAN ; Qi LU
Chinese Journal of Geriatrics 2008;27(5):337-341
Objective To study the relationship between a CAG repeat polymorphism of the androgen receptor (AR) gene and postmenopausal osteoporosis (PMO). Methods Genotypes for the AR polymorphisrn were determined by gene scan and DNA sequence methods in a case-control study,including 78 cases of PMO at femoral neck and 73 cases as controls, and 108 cases of PMO at lumbar spine (L2-4) and 60 cases as controls. Bone mineral density for the proximal femur and L2-4 was measured by NORLAND XR-46 dual-energy X-ray absorptiometry. The relationship between the CAG repeat polymorphism and PMO was investigated. Results Eleven different allelic variants,containing 18, 20, 21, 23, 24, 25, 26, 27, 28, 29, and 30 CAG repeats were detected, 16 genotypes were present in the subjects. There were no significant differences in the genotype and allele distributions of (CAG) n polymorphism between PMO group (SS : 25.6 %, SL : 39.7%, LL : 34.6 % ;S:45.5%,L:54.5%) and control group (SS: 23.3%,SL=45.2% ,LL:31.5%;S:45.9%,L:54.1%) at the femoral neck site (all P>0.05). The risk of PMO at femoral neck in females with the genotypes of SL (0R:0.798,95%CI:0.335~1.797), the LL (0R:0.998,95%CI:0.425~2.341), and the combined SL and LL (OR:0.880, 95% CI: 0.419~1.852) were not significantly increased in comparison with those of females with the SS genotype (all P>0.05). There were no significant differences in the genotype and allele distributions of (CAG)n polymorphism between PMO group(SS: 18.5%, SL: 49.1%, LL: 32.4%;S:43.1%, L: 56.9%) and control group (SS: 21.7%, SL:45.0% ,LL:33.3% ;S:44.2% ,L:55.8%) at the L2-4 site (P>0. 05). The risk of PMO at L2-4 in females with the genotypes of SL (OR:1. 276,95%CI:0. 552~2. 950), the LL (OR:1. 137,95%CI:0.468~2.766), and the combined SL and LL (OR: 1. 217,95% CI: 0. 556 ~2. 663 ) were not significantly increased in comparison with those of females with the SS genotype (all P>0.05). After adjustments for age, postmenopausal period, menopausal age, and body mass index, the logistic regression analyses revealed the (CAG)n polymorphism was not significantly associated with PMO at the femoral neck and L2-4 site (all P>0.05). Conclusions The CAG repeat polymorphism in the AR gene may not be associated with PMO at the femoral neck and L2-4 site.
6.Nursing about percutaneous biliary tract stent implantation to cure malignant obstructive jaundice
Xiuying LIU ; Xiaoli LIANG ; Kaibin LI ; Jianyun LUO ; Zhaoyun HUANG ; Ruizhen LIAO ; Lishan ZHANG
Chinese Journal of Practical Nursing 2006;0(27):-
Objective To study the nursing method about percutaneous biliary tract stent implantation to cure malignant obstructive jaundice.Methods Careful perioperative nursing cares and finished post-hospital direction were applied among 21 patients with malignant obstructive jaundice when by percutaneous biliary tract stent implantation.Results There were 20 patients obtained successful operation,the successful rate was 95%.The postoperative of glutamic pyruvic transaminase were(96.60?89.36) U/L,the total bilirubin was(137.96?103.95) ?mmol/L,the directed bilirubin was((85.67)?62.95) ?mmol/L and the indirected bilirubin was(56.76?37.37) ?mmol/L.All the indexes which have mentioned above were significant lower than those of before operative,P
7.Relationship between depressive degree and myocardial ischemia in elderly patients with coronary artery disease
Jinglan WU ; Yousu SU ; Jianyun FU ; Xiaoyan WANG ; Hongcheng FANG ; Guoqing LUO ; Guotai SHENG
Chinese Journal of Rehabilitation Theory and Practice 2005;11(1):51-52
Objective To research the relationship between the myocardiac ischemic activity and degree of depression in elderly patients.MethodsThe Center For Epidemiological Studies-Depressive Scale(CES-D) was administered to evaluate depressive degree for 121 patients who were defined as coronary artery diseased by coronary angiography (CAG); group A (n=64) for no depressive symptoms,group B (n=34) for minor depression, group C (n=23) for major depression were studied to observing the myocardial ischemia using Holter's recording and exercise testing.ResultsCAG showed that single vessel disease was more frequently in group A;single,double and three-vessel disease showed approximative proportion in group B,three-vessel disease was more frequently in group C.The times of ST-depress were (4.2±1.3),lasting time of ST-depress was (35.8±9.2) min,and index of ST-depress was (3.28±0.9) min/h,which were higher than those of group A [(1.8±0.3),(16.6±4.2) min,(1.76±0.4) min/h] and group C [(2.1±0.7),(17.8±5.8) min,(1.69±0.5)min/ h](P<0.05);There was significantly frequent myocardial ischemia in group B than in group A during exercise testing (χ2=3.274,P<0.05). patients in group C tended to have approximative incidence of ischemia compared with group A during daily living,but more incidence of ischemia than group B during exercise testing(χ2=5.473,P<0.05).ConclusionThe depressive degree was associated with severity of coronary artery disease,mild to moderate symptoms of depression are associated with an increased likelihood of myocardial ischemia during daily living and exercise,but patients with severity depression absence symptoms of myocardial ischemia during daily living,and exhibit markedly myocardial ischemia during exercise.
8.Changes of soluble fas and soluble fas ligand in serum and peritoneal fluid of infertile patients with endometriosis.
Hua LINGHU ; Xiaorong XU ; Jianyun LUO ; Lin ZHUANG
Chinese Medical Sciences Journal 2004;19(1):56-59
OBJECTIVETo evaluate the relationship between levels of soluble Fas (sFas) and soluble Fas ligand (sFasL) in serum and peritoneal fluid of endometriosis-associated infertility.
METHODSThe soluble Fas ligand and soluble Fas levels in serum and peritoneal fluid of 20 infertile patients with endometriosis were assessed with enzyme-linked immunosorbent assay, and were compared with 14 infertile patients due to chronic pelvic infectious disease and 16 fertile controls.
RESULTSThe sFasL levels were significantly higher in infertile patients with endometriosis (175.09 +/- 80.55 pg/mL in serum and 284.50 +/- 152.38 pg/mL in peritoneal fluid) than those of infertile controls (88.47 +/- 43.55 pg/mL in serum and 17.30 +/- 9.62 pg/mL in peritoneal fluid) and fertile controls (16.13 +/- 11.75 pg/mL in serum and 8.84 +/- 2.31 pg/mL in peritoneal fluid). In contrast, as for the sFas levels, infertile patients with endometriosis (828.60 +/- 429.65 pg/mL in serum and 349.61 +/- 288.89 pg/mL in peritoneal fluid) did not show any significant difference compared with those in infertile patients resulting from pelvic infectious disease (868.75 +/- 570.48 pg/mL in serum and 181.76 +/- 157.78 pg/mL in peritoneal fluid) and fertile control (822.26 +/- 129.12 pg/mL in serum and 318.42 +/- 145.16 pg/mL in peritoneal fluid).
CONCLUSIONSBased upon these results, high level of sFasL in serum and peritoneal fluid and thus apoptosis mediated by it may be implicated in the mechanism involved in endometriosis-related infertility.
Ascitic Fluid ; chemistry ; Endometriosis ; complications ; metabolism ; Fas Ligand Protein ; Female ; Humans ; Infertility, Female ; etiology ; metabolism ; Ligands ; Membrane Glycoproteins ; blood ; metabolism ; Pelvic Infection ; complications ; metabolism ; Solubility ; fas Receptor ; blood ; metabolism
9.Application of metallic stent implantation or percutaneous gastrostomy for high level cervical esophageal strictures:Report of 20 cases
Kaibin LI ; Zhaoyun HUANG ; Jianyun LUO
Chinese Journal of Minimally Invasive Surgery 2001;0(01):-
Objective To evaluate the feasibility and safety of interventional microinvasive techniques in the management of high level cervical esophageal strictures.Methods Among 20 cases of high level cervical esophageal strictures,13 cases of strictures at the level of C_7~T_3 were given an oral placement of nitinol metal stents woven by single thread under fluoroscopic guidance,while 7 cases of strictures at the level of C_7 and above were given a percutaneous gastrostomy(PG) under endoscopic or fluoroscopic guidance.Results All the operations were successfully accomplished without complications.Out of 13 cases of intraesophageal stent implatation,the improvement of dysphagia was classified as grade 0 in 10 cases and as grade Ⅰ in 3 cases.Esophago-tracheal fistula was completed occluded in 5 cases.Slight downward stent shift was found in 2 cases and no further management was carried out.Follow-up in 11 cases for 1~30 months(mean,18 months) revealed 3 cases of recurrence of esophageal stricture and 8 fatal cases.No stentinduced esophago-tracheal fistula occurred.Of 7 cases of percutaneous gastrostomy,liquid diet was given 2 days after operation.Infection with redness and swelling in the area of fistula wound was noted in 1 case at 1 week postoperatively and the fistula tube was found loosened in 1 case at 5 months postoperatively.No intraabdominal infection,peritonitis,or internal fistula occurred.Follow-up in 7 cases for 1~18 months showed 5 fatal cases.Conclusions Stent implantation should not be contraindicated in patients with high level cervical stricture of esophagus.Radiologically guided percutaneous gastrostomy is safe and feasible,which is preferred as the first choice of treatment.
10.MDM2 gene expression in nasopharyngeal carcinoma and its relationship with p53 protein expression and EB virus latent infection
Junli LUO ; Jianyun XIAO ; Yongquan TIAN ; Suping ZHAO ; Jiwei LIU ; Zhengde TAO
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2000;(11):507-509
Objective:To define the expression levels of MDM2 gene in nasopharyngeal carcinoma (NPC)and its relationship with p53 protein expression and EB virus latent infection. Method :MDM2 gene expression atmRNA and protein levels,p53 protein and EB virus DNA were detected by nonradioactive in situ hybridization(ISH) ,immunohistochemistry(IHC) and polymerase chain reaction (PCR) separately in 46 cases of NPC tissuesand 12 cases of chronic inflammation of nasopharyngeal epithelium (CINE). Result: Fourteen cases of NPCshowed MDM2 mRNA and protein overexpression, 38 cases were p53 protein positive,and 43 cases were EBV-DNA positive. Neither MDM2 nor p53 protein was expressed in any case of CINE. MDM2 expression was signifi-cantly related to p53 protein expression ( P <0. 05), but not to EB virus latent infection in NPC. Conclusion:MDM2 gene may play an important role in the pathogenesis of NPC through interacting with p53 protein.


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