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.Relationship between the Expressions of Serum miR-133a-3p and miR-324-3p in Patients with Persistent Atrial Fibrillation and the Recurrence of Atrial Fibrillation after Radiofrequency Ablation
Yuesheng WANG ; Xiaochen LIU ; Enxiang LIU ; Jingjing LI
Journal of Modern Laboratory Medicine 2024;39(6):108-112,118
Objective To investigate the expression of serum miR-133a-3p and miR-324-3p in patients with persistent atrial fibrillation and their relationship with recurrence of atrial fibrillation after radiofrequency ablation.Methods A total of 180 patients with persistent atrial fibrillation(persistent atrial fibrillation group)who were hospitalized in Cangzhou City People's Hospital from July 2019 to July 2022 and received radiofrequency ablation were collected as research objects.According to whether atrial fibrillation recurred,they were assigned into a non recurrence group(n=116)and a recurrence group(n=64).Meanwhile,another 180 healthy individuals who underwent physical examination at the hospital were regarded as the control group.The expression levels of serum miR-133a-3p and miR-324-3p of each group were compared.Multivariate Logistic regression was applied to analyze the factors influencing the recurrence of persistent atrial fibrillation after radiofrequency ablation,and ROC curve analysis was applied to analyze the predictive value of serum miR-133a-3p and miR-324-3p levels for the recurrence of atrial fibrillation in patients with persistent atrial fibrillation after radiofrequency ablation.Results Compared with the control group,the levels of serum miR-133a-3p(0.76±0.25)and miR-324-3p(0.68±0.21)in the persistent atrial fibrillation group were lower than the control group(1.03±0.32,1.05±0.30),and the differences were statistically significant(t=8.921,13.556,all P<0.05).The serum levels of miR-133a-3p(0.58±0.19)and miR-324-3p(0.50±0.16)in the recurrent group were obviously lower than those in the non recurrent group(0.86±0.27,0.78±0.25),and the differences were statistically significant(t=7.349,8.087,all P<0.05).Multivariate Logistic regression analysis showed that serum miR-133a-3p[OR(95%CI):0.673(0.534~0.848)]and miR-324-3p[OR(95%CI):0.756(0.629~0.909)]were protective factors for atrial fibrillation recurrence after radiofrequency ablation in patients with persistent atrial fibrillation,while heart rate[OR(95%CI):2.143(1.265~3.631)]and LAD[OR(95%CI):1.756(1.159~2.661)]were independent risk factors for atrial fibrillation recurrence after radiofrequency ablation in patients with persistent atrial fibrillation(all P<0.05).The AUC of the combination of miR-133a-3p and miR-324-3p in predicting atrial fibrillation recurrence after radiofrequency ablation in patients with persistent atrial fibrillation was 0.901,with the sensitivity and specificity were 82.81%and 86.21%,respectively,which was better than those of their respective prediction alone(Z=4.210,2.804,all P<0.05).Conclusion The expressions of serum miR-133a-3p and miR-324-3p in patients with persistent atrial fibrillation are reduced,and the combination of the two has a good reference value in predicting the recurrence of atrial fibrillation in patients with persistent atrial fibrillation after radiofrequency ablation.
4.Preparation of collagen-polysaccharide composite hydrogels and research progress in biomedical applications.
Meihong XU ; Enxiang JIAO ; Ziru SUN ; Kunshan YUAN ; Xiangyi FENG ; Yuanbiao LIU ; Kai GUO ; Kun LI ; Haijun ZHANG ; Xuehai ZHANG
Journal of Biomedical Engineering 2024;41(6):1286-1292
Collagen contains abundant cell binding motifs, which are conducive to adhesion, migration, and differentiation, maintain cell vitality and promote cell proliferation. However, pure collagen hydrogel has some shortcomings such as poor mechanical properties, poor thermal stability and fast degradation. Numerous studies have shown that the properties of collagen can be improved by combining it with natural polysaccharides such as alginate, chitosan, hyaluronic acid and cellulose. In this paper, the research status and biological application fields of four kinds of composite hydrogels, including collagen-alginate composite hydrogels, collagen-chitosan hydrogels, collagen-hyaluronic acid hydrogels and collagen-cellulose hydrogels, were summarized. The common preparation methods of four kinds of composite hydrogels were introduced, and the future development direction of collagen-based composite hydrogels was prospected.
Hydrogels/chemical synthesis*
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Collagen/chemistry*
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Polysaccharides/chemistry*
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Alginates/chemistry*
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Hyaluronic Acid/chemistry*
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Chitosan/chemistry*
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Biocompatible Materials/chemistry*
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Humans
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Tissue Engineering/methods*
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Cellulose/chemistry*
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Tissue Scaffolds
5.Clinical characteristics of a family with myotonic dystrophy type 1
Shiwen CHEN ; Enxiang TAO ; Dongying LIU ; Chaoying LI ; Huanzhang HUANG ; Kaixiong TANG
Chinese Journal of Neuromedicine 2014;13(10):1039-1042
Objective To explore the clinical features of a family with myotonic dystrophy type 1 (DM1) in order to improve the knowledge of this disease.Methods Clinical data of members from the family were collected.Electrocardiogram (ECG),electromyogram (EMG) and blood biochemistry were performed in some members of the family.Characteristics of pathology and gene of the propositi were detected.Results Anticipation was found in the family which was verified as DM1.In the all 19 patients,17 had myasthenia gravis,14 had muscle atrophy,16 had myotonia,5 had complicated with cataract,and 7 had complicated with hypophrenia.The 5 patients accepted ECG all had abnormal results,3 of them had myotonic discharge and metabolic abnormalities.Pathological analysis showed the main fibers atrophy was type Ⅰ,and the protein dystrophin expression was completely in the propositi.Conclusions The clinical manifestations of patients are various.DM1 affects eye (the lens),heart (mainly the conduction system),reproductive system besides skeletal muscle.Necessary auxiliary examinations and regular follow-up should be performed to evaluate and deal with multisystemic involvement in DM1 patients.EMG and pathological results are helpful in the diagnosis.Gene analysis can verify the disease and identify subclinical patients.
6.Study on the efficacy of breviscapine in the treatment of vascular cognitive impairment
Limin WANG ; Lijuan WANG ; Zhonglin LIU ; Enxiang TAO
Chinese Journal of Primary Medicine and Pharmacy 2010;17(2):148-149
Objective To investigate the efficacy of breviscapine in the treatment of vascular cognitive impairment.Methods A self-controlled trial was carried out in 36 patients with vascular cognitive impairment.36 cases were treated with breviscapine injection 50mg intravenous infusion daily for 3 weeks.At the same time,all cases were also given citicoline 0.75g/d and enteric-coated aspirin 100mg/d as routine treatment.The means of the evaluation on therapeutic effect included MMSE and ADL,and the adverse reactions were also observed.Results After the treatment,the MMSE scales increased from(18.75 ± 3.25)to(21.62 ± 3.58)(t=2.52,P<0.05),Meanwhile,ADL scales declined from(45.65 ±3.36)to(42.33 ±4.18)(t=3.71,P<0.05).There was significant difference on the MMSE and ADL between the pre and post therapy.No obvious side effects were found.Conclusion The results indicated that the breviscapine injection is an effective medicine in the treatment of vascular cognitive impairment,while the adverse reactions were few.
7.Clinical and electrophysiological analysis of limb-girdle muscular dystrophy:A geneological report
Yuegui CHEN ; Tiebin YAN ; Woliang YUAN ; Jingfeng WANG ; Ruqiong NIE ; Enxiang TAO ; Yingmei LIU ; Yu MIN ; Hailian YAN
Chinese Journal of Physical Medicine and Rehabilitation 2008;30(8):543-545
Objective To analyze the clinical and electrophysiological features of one geneology with limbgirdle muscular dystrophy(LGMD). Methods Twenty-seven members of one family with limb-girdle muscular dystrophy(LGMD)were investigated.Fourteen of them were examined with electromyography(EMG)and their motor conduction velocities(MCV)and sensory conduction velocities(SCV)were measured.Among them,10 had no clinical manifestations,while 4 demonstrated symptoms and signs of LGMD. Results Three of the 4 patients had suffered from LGMD when young.They demonstrated the typical clinical features,including the progressive muscle weakness in the upper and lower extremities,positive Gower signs,duck gait,muscle atrophy distributed tO the proximal extremity,and no gastrocnemius hypertrophy.One subject presented atypical characteristics.The MCVs and SCVs of the 4 patients were normal,but neuropathic manifestations were found in the EMGS of 3 of them.and mixed neuropathic and myopathic manifestations were found in the EMG of the other.Conclusion LGMD patients in the same family can vary in their clinical characteristics.The longer the duration,the more severe the clinical features.Electrophysiological examination can reveal normal MCV and SCV but abnormal elctromyography.
8.Relationship between hereditary susceptibility of Parkinson disease and polymorphism of NAD (P) H: quinone oxidoreductase gene
Ming SHAO ; Zhuolin LIU ; Enxiang TAO ; Biao CHEN
Chinese Journal of Tissue Engineering Research 2005;9(13):182-183
BACKGROUND: Causes of Parkinson disease have not been mentioned clearly up to now yet. Theory of hereditary susceptibility is the main theory to explain Parkinson disease now. But there is no definite conclusion on which hereditary factors have relationship with it.OBJECTIVE: To study the relationship between gene polymorphism caused by point mutation C to T on cDNA609 basic group of reduced NAD(P) H:quinone oxidoreductase(NQO1) gene and hereditary susceptibility of Parkinson disease.DESIGN: A non-randomized synchronized control research based on patient and healthy people.SETTING: Neurology departments in two university hospitals and a senile disease research institute in a university hospital.PARTICIPANTS: Totally 126 patients(Parkinson disease group) diagnosed as Parkinson disease in Neurology Clinic of First Hospital Affiliated to Sun Yat-sen University from September 1994 to September 1997, aged 46 to 73 years, in which 74 were males and 52 were females. Totally 136 healthy adults (control group), in which 66 were males and 70 were females, who came to the clinic to do health examination at the same time, aged 40 to 72 years.METHODS: Polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP) was used to analyze NQO1 gene polymorphism in Parkinson disease group and healthy adult control group.MAIN OUTCOME MEASURES: Mutation frequency and genotype of point mutation of basic group C to T on NQO1 gene cDNA609.RESULTS: T allele frequency in Parkinson disease group was 52% and that in control group was 43%. There was significant difference between two groups (P < 0. 005) . There was significant difference on distribution of genotype in Parkinson disease group and control group( P < 0.05). The risk incidence increased 3.8 times in individual with T allele.CONCLUSION: NQO1 gene cDNA609 mutation T allele may be a risk factor to Parkinson disease, which could be associated with the hereditary susceptibility of Parkinson disease.
9.Consensus for the management of severe acute respiratory syndrome.
Nanshang ZHONG ; Yanqing DING ; Yuanli MAO ; Qian WANG ; Guangfa WANG ; Dewen WANG ; Yulong CONG ; Qun LI ; Youning LIU ; Li RUAN ; Baoyuan CHEN ; Xiangke DU ; Yonghong YANG ; Zheng ZHANG ; Xuezhe ZHANG ; Jiangtao LIN ; Jie ZHENG ; Qingyu ZHU ; Daxin NI ; Xiuming XI ; Guang ZENG ; Daqing MA ; Chen WANG ; Wei WANG ; Beining WANG ; Jianwei WANG ; Dawei LIU ; Xingwang LI ; Xiaoqing LIU ; Jie CHEN ; Rongchang CHEN ; Fuyuan MIN ; Peiying YANG ; Yuanchun ZHANG ; Huiming LUO ; Zhenwei LANG ; Yonghua HU ; Anping NI ; Wuchun CAO ; Jie LEI ; Shuchen WANG ; Yuguang WANG ; Xioalin TONG ; Weisheng LIU ; Min ZHU ; Yunling ZHANG ; Zhongde ZHANG ; Xiaomei ZHANG ; Xuihui LI ; Wei CHEN ; Xuihua XHEN ; Lin LIN ; Yunjian LUO ; Jiaxi ZHONG ; Weilang WENG ; Shengquan PENG ; Zhiheng PAN ; Yongyan WANG ; Rongbing WANG ; Junling ZUO ; Baoyan LIU ; Ning ZHANG ; Junping ZHANG ; Binghou ZHANG ; Zengying ZHANG ; Weidong WANG ; Lixin CHEN ; Pingan ZHOU ; Yi LUO ; Liangduo JIANG ; Enxiang CHAO ; Liping GUO ; Xuechun TAN ; Junhui PAN ; null ; null
Chinese Medical Journal 2003;116(11):1603-1635
10.A new point mutation on exon 2 of parkin gene in Parkinson's disease.
Yanming XU ; Zhuolin LIU ; Yukai WANG ; Enxiang TAO ; Guojun CHEN ; Biao CHEN
Chinese Journal of Medical Genetics 2002;19(5):409-411
OBJECTIVETo detect the relationship between point mutations on exon 2 of parkin gene and sporadic early-onset Parkinson's disease.
METHODSThe point mutations on exon 2 of parkin gene were detected using polymerase chain reaction(PCR), agarose electrophoresis, single strand conformation polymorphism(SSCP), DNA sequencing and analysis of restrict enzyme in DNA of 60 Parkinson's disease patients with an onset age under 50 and 120 normal controls.
RESULTSOne homozygous mutation (G(237)-->C) on exon 2 was found by sequencing and verified by analysis of restrict enzyme, whereas no mutation was found in normal controls.
CONCLUSIONPoint mutations on exon 2 of parkin gene are likely to be related to sporadic early-onset Parkinson's disease.
Adult ; Aged ; Aged, 80 and over ; Exons ; Female ; Humans ; Ligases ; genetics ; Male ; Middle Aged ; Parkinson Disease ; genetics ; Point Mutation ; Polymorphism, Single-Stranded Conformational ; Sequence Analysis, DNA ; Ubiquitin-Protein Ligases

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