1.Clinical Study on the Treatment of Thin Endometrium of Kidney Deficiency and Blood Stasis Syndrome by Herb-Partitioned Moxibustion and Estradiol Valerate on the Navel and Estrogen
Hao SUN ; Qingchang XIA ; Zhibin DONG ; Jiaze WANG ; Yuxia MA
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(2):539-544
Objective To observe the clinical efficacy of the combination of umbilical moxibustion and estradiol valerat in patients with thin endometrium.Methods A random number table was used to randomly divide 60 patients with thin endometrium of kidney deficiency and blood stasis type who met the inclusion criteria into an observation group of 30 cases and a control group of 30 cases.The control group took oral estradiol valerate tablets(DELPHARMLille S.A.S.,specification:1 mg/tablet),2 mg/day(bid),continuously for 21 days starting from the 5th day of the menstrual cycle;On the basis of the control group,the observation group was treated with herbal moxibustion on the navel,starting from the 7th day of the menstrual cycle,once a week,with an interval of 5-7 days.No treatment was given during the menstrual cycle,and both groups were treated continuously for three menstrual cycles.Observe the changes in endometrial thickness,Gonen classification of endometrium,uterine artery pulsatility index,resistance index,and traditional Chinese medicine clinical symptom score before and after treatment in two groups of patients.Results After treatment,the endometrial thickness of the two groups of patients increased(P<0.01),while the uterine artery pulsatility index and resistance index decreased compared to before(P<0.01).The total score of traditional Chinese medicine clinical symptoms decreased compared to before treatment(P<0.01).The above indicators were better in the observation group than in the control group(P<0.05).But the endometrial classification between the two groups of patients was no significant difference(P>0.05).Conclusion The combination of umbilical moxibustion and estradiol valerate can effectively promote uterine artery blood flow perfusion in patients with kidney deficiency and blood stasis type thin endometrium,reduce uterine artery pulsatility index and resistance index,increase the thickness of endometrium,and improve the clinical symptom score of traditional Chinese medicine.
2.Efficacy of flipped classroom combined with 3D body anatomy software in teaching of ultrasound-guided transversus thoracic muscle plane block
Hongdang XU ; Hongxiao ZHI ; Jie WANG ; Hao TANG ; Haoran ZHANG ; Zhibin LANG ; Zhaoyun CHENG ; Hongqi LIN
Chinese Journal of Anesthesiology 2025;45(11):1470-1473
Objective:To evaluate the efficacy of the flipped classroom combined with 3D body anatomy software in the teaching of ultrasound-guided transversus thoracic muscle plane block.Methods:In this randomized controlled trial, 100 second-year resident physicians from the Department of Anesthesiology and Perioperative Medicine at our hospital, male or female, aged 22-26 yr, who rotated during January 2023 to January 2025, were selected and divided into 2 groups ( n=50 each) using a table of random numbers: experimental group and control group. Experimental group employed the teaching model of flipped classroom combined with 3D body anatomy software, while control group used the traditional teaching model. The scores of theoretical assessment, accuracy rate of ultrasound image identification, scores of procedural skills, success rates of clinical procedure, teaching satisfaction, and success rates of clinical translation after 1 month follow-up were compared between two groups. Results:Compared with control group, the scores of theoretical assessment, accuracy rate of ultrasound image identification, scores of procedural skills, success rates of clinical procedure, teaching satisfaction, and success rates of clinical translation after 1 month follow-up were significantly increased in experimental group ( P<0.05). Conclusions:The combination of flipped classroom and 3D body anatomy software is more effective than the traditional teaching methods when used for teaching of ultrasound-guided transversus thoracic muscle plane block.
3.Clinical Study on the Treatment of Thin Endometrium of Kidney Deficiency and Blood Stasis Syndrome by Herb-Partitioned Moxibustion and Estradiol Valerate on the Navel and Estrogen
Hao SUN ; Qingchang XIA ; Zhibin DONG ; Jiaze WANG ; Yuxia MA
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(2):539-544
Objective To observe the clinical efficacy of the combination of umbilical moxibustion and estradiol valerat in patients with thin endometrium.Methods A random number table was used to randomly divide 60 patients with thin endometrium of kidney deficiency and blood stasis type who met the inclusion criteria into an observation group of 30 cases and a control group of 30 cases.The control group took oral estradiol valerate tablets(DELPHARMLille S.A.S.,specification:1 mg/tablet),2 mg/day(bid),continuously for 21 days starting from the 5th day of the menstrual cycle;On the basis of the control group,the observation group was treated with herbal moxibustion on the navel,starting from the 7th day of the menstrual cycle,once a week,with an interval of 5-7 days.No treatment was given during the menstrual cycle,and both groups were treated continuously for three menstrual cycles.Observe the changes in endometrial thickness,Gonen classification of endometrium,uterine artery pulsatility index,resistance index,and traditional Chinese medicine clinical symptom score before and after treatment in two groups of patients.Results After treatment,the endometrial thickness of the two groups of patients increased(P<0.01),while the uterine artery pulsatility index and resistance index decreased compared to before(P<0.01).The total score of traditional Chinese medicine clinical symptoms decreased compared to before treatment(P<0.01).The above indicators were better in the observation group than in the control group(P<0.05).But the endometrial classification between the two groups of patients was no significant difference(P>0.05).Conclusion The combination of umbilical moxibustion and estradiol valerate can effectively promote uterine artery blood flow perfusion in patients with kidney deficiency and blood stasis type thin endometrium,reduce uterine artery pulsatility index and resistance index,increase the thickness of endometrium,and improve the clinical symptom score of traditional Chinese medicine.
4.Efficacy of flipped classroom combined with 3D body anatomy software in teaching of ultrasound-guided transversus thoracic muscle plane block
Hongdang XU ; Hongxiao ZHI ; Jie WANG ; Hao TANG ; Haoran ZHANG ; Zhibin LANG ; Zhaoyun CHENG ; Hongqi LIN
Chinese Journal of Anesthesiology 2025;45(11):1470-1473
Objective:To evaluate the efficacy of the flipped classroom combined with 3D body anatomy software in the teaching of ultrasound-guided transversus thoracic muscle plane block.Methods:In this randomized controlled trial, 100 second-year resident physicians from the Department of Anesthesiology and Perioperative Medicine at our hospital, male or female, aged 22-26 yr, who rotated during January 2023 to January 2025, were selected and divided into 2 groups ( n=50 each) using a table of random numbers: experimental group and control group. Experimental group employed the teaching model of flipped classroom combined with 3D body anatomy software, while control group used the traditional teaching model. The scores of theoretical assessment, accuracy rate of ultrasound image identification, scores of procedural skills, success rates of clinical procedure, teaching satisfaction, and success rates of clinical translation after 1 month follow-up were compared between two groups. Results:Compared with control group, the scores of theoretical assessment, accuracy rate of ultrasound image identification, scores of procedural skills, success rates of clinical procedure, teaching satisfaction, and success rates of clinical translation after 1 month follow-up were significantly increased in experimental group ( P<0.05). Conclusions:The combination of flipped classroom and 3D body anatomy software is more effective than the traditional teaching methods when used for teaching of ultrasound-guided transversus thoracic muscle plane block.
5.Clinical and genetic characteristics of X-linked intellectual disability associated with HUWE1 gene variants
Xiao LI ; Huan GONG ; Zheng CHEN ; Xianhe JIANG ; Zhibin LI ; Xiaoli ZHANG ; Lin LI ; Hao CHEN ; Jing GUAN ; Lina KONG ; Kaixian DU
Chinese Journal of Pediatrics 2025;63(12):1360-1365
Objective:To explore the clinical and genetic characteristics of X-linked intellectual disability associated with HUWE1 gene variants.Methods:A cases series study retrospectively analyzed the clinical data of 6 children with HUWE1 gene variants. The children were identified from the Third Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Henan University of Chinese Medicine, and Guangzhou Women and Children′s Medical Center of Guangzhou Medical University between April 2021 and July 2023.The data included sex, age, dysmorphic features, intellectual and motor development, seizure history, neuroimaging findings, family history, and genetic results was analyzed.Results:A total of 6 children, including 5 boys and 1 girl. The age of onset ranged from 1 day to 3 years. All children presented with varying degrees of intellectual disability, with or without motor developmental delay. Dysmorphic features were observed in 4 children, including microcephaly in 3 children. Short stature were observed in 3 children. One child was diagnosed with autism spectrum disorders and 1 child had seizures. Two boys had relevant maternal family histories of febrile seizures and mild intellectual disability, respectively. Abnormal neuroimaging findings were presented in 4 children, including cerebral dysplasia (1 child), prominent supratentorial ventricles (1 child), and mild white matter demyelination (2 children). Whole-exome sequencing identified 5 missense variants and 1 in-frame deletion variant. Five variants were novel and previously unreported (c.12290C>T, c.12701T>C, c.9875C>T, c.9641A>T and c.10313_10315del). The variants in 4 boys were maternally inherited, while the remaining 2 children had de novo variants. The child with the in-frame deletion variant (c.10313_10315del) presented with the most severe phenotype, exhibiting symptoms from 1 day of age, absent cognitive development, feeding difficulties, and congenital laryngeal chondrodysplasia. He was lost to follow-up at 3 months of age after treatment was withdrawn. The age at the last follow-up for the remaining 5 children ranged from 2 years and 10 months to 17 years. A boy with seizures died at 2 years and 10 months of age. The remaining 4 children were able to walk independently at the last follow-up, although their developmental progress was slow. Conclusions:HUWE1 gene related X-linked intellectual disability is characterized by varying degrees of developmental delay and intellectual disability, frequently accompanied by microcephaly, short stature, and occasionally by seizures and autism spectrum disorders. Missense variants are more common and the in-frame deletion variant appears to be associated with a particularly severe phenotypic presentation.
6.Clinical and genetic characteristics of X-linked intellectual disability associated with HUWE1 gene variants
Xiao LI ; Huan GONG ; Zheng CHEN ; Xianhe JIANG ; Zhibin LI ; Xiaoli ZHANG ; Lin LI ; Hao CHEN ; Jing GUAN ; Lina KONG ; Kaixian DU
Chinese Journal of Pediatrics 2025;63(12):1360-1365
Objective:To explore the clinical and genetic characteristics of X-linked intellectual disability associated with HUWE1 gene variants.Methods:A cases series study retrospectively analyzed the clinical data of 6 children with HUWE1 gene variants. The children were identified from the Third Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Henan University of Chinese Medicine, and Guangzhou Women and Children′s Medical Center of Guangzhou Medical University between April 2021 and July 2023.The data included sex, age, dysmorphic features, intellectual and motor development, seizure history, neuroimaging findings, family history, and genetic results was analyzed.Results:A total of 6 children, including 5 boys and 1 girl. The age of onset ranged from 1 day to 3 years. All children presented with varying degrees of intellectual disability, with or without motor developmental delay. Dysmorphic features were observed in 4 children, including microcephaly in 3 children. Short stature were observed in 3 children. One child was diagnosed with autism spectrum disorders and 1 child had seizures. Two boys had relevant maternal family histories of febrile seizures and mild intellectual disability, respectively. Abnormal neuroimaging findings were presented in 4 children, including cerebral dysplasia (1 child), prominent supratentorial ventricles (1 child), and mild white matter demyelination (2 children). Whole-exome sequencing identified 5 missense variants and 1 in-frame deletion variant. Five variants were novel and previously unreported (c.12290C>T, c.12701T>C, c.9875C>T, c.9641A>T and c.10313_10315del). The variants in 4 boys were maternally inherited, while the remaining 2 children had de novo variants. The child with the in-frame deletion variant (c.10313_10315del) presented with the most severe phenotype, exhibiting symptoms from 1 day of age, absent cognitive development, feeding difficulties, and congenital laryngeal chondrodysplasia. He was lost to follow-up at 3 months of age after treatment was withdrawn. The age at the last follow-up for the remaining 5 children ranged from 2 years and 10 months to 17 years. A boy with seizures died at 2 years and 10 months of age. The remaining 4 children were able to walk independently at the last follow-up, although their developmental progress was slow. Conclusions:HUWE1 gene related X-linked intellectual disability is characterized by varying degrees of developmental delay and intellectual disability, frequently accompanied by microcephaly, short stature, and occasionally by seizures and autism spectrum disorders. Missense variants are more common and the in-frame deletion variant appears to be associated with a particularly severe phenotypic presentation.
7.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
8.Expression and clinical value of miR-124 and miR-1976 in serum of patients with Parkinson's disease
Ting CHEN ; Hao CHEN ; Liang SHI ; Weihong YAN ; Zhibin DING ; Haoyu JI ; Meng ZHANG ; Xinyi LI
Chinese Journal of Geriatrics 2024;43(1):23-28
Objective:To investigate the expression and clinical significance of microRNA-124(miR-124)and microRNA-1976(miR-1976)in the serum of patients with Parkinson's disease(PD).Methods:A total of 58 patients with PD were selected from September 2020 to June 2022 and categorized as the PD group.The Unified Parkinson's Disease Rating Scale(UPDRS)score was used to divide the PD patients into two groups: those with a UPDRS score≤60(25 patients)and those with a UPDRS score >60(33 patients). The Hoehn-Yahr grading scale was used to grade the PD patients.Additionally, 30 healthy individuals who had undergone a physical examination during the same period were selected as the control group.After collecting the subjects' serum, we performed real-time fluorescent quantitative PCR(qRT-PCR)to detect the expressions of miR-124 and miR-1976 in the serum.Logistic regression analysis was employed to analyze the influencing factors, and the diagnostic significance of serum miR-124 and miR-1976 in PD patients was evaluated using the receiver operating characteristic(ROC)curve.To predict the target genes of miR-1976, we utilized several software including TargetScan and Mirtarbase.Results:Compared to the control group, the PD group showed a significant down-regulation of serum miR-124 expression[(1.49±0.36) vs.(1.02±0.32)]( t=8.85, P<0.001), while miR-1976 expression was sharply up-regulated[(0.98±0.30) vs.(1.33±0.37)]( t=6.92, P<0.001). The low expression of serum miR-124 and the overexpression of miR-1976 were identified as independent risk factors for PD( OR>1, P<0.05). The Hoehn-Yahr rating of PD patients with a UPDRS score above 60 was higher than that of patients with a UPDRS score below 60[(3.42 ± 0.73) vs.(2.16 ± 0.42)]( t=3.05, P<0.05). However, there was no significant difference in serum miR-124 and miR-1976 expression between groups with different UPDRS scores[miR-124: (1.09±0.26) vs.(0.98±0.38)( t=0.89, P>0.05); miR-1976: (1.42±0.43) vs.(1.23±0.68)( t=0.62, P>0.05)]. The ROC analysis results demonstrated that miR-124 and miR-1976 had area under the curve(AUC)values of 0.832 and 0.797, respectively, in diagnosing PD.The corresponding cutoff values were 1.205 and 1.196, respectively.The sensitivity for miR-124 was 74.1%, while for miR-1976 it was 51.8%.The specificity for miR-124 was 77.8%, and for miR-1976 it was 90.1%.When both miR-124 and miR-1976 were combined in the diagnosis of PD, the AUC was 0.912, with a sensitivity of 76.4% and a specificity of 93.2%.Furthermore, it was found that miR-1976 targeted the PINK1 gene, suggesting its potential as a target gene in PD. Conclusions:The expression of miR-124 was found to be decreased in PD patients, while the expression of miR-1976 was increased.Both miR-124 and miR-1976 showed some reference value in PD diagnosis, and their combined diagnostic value was higher.This suggests that further study on their significance is warranted.However, it should be noted that the expressions of miR-124 and miR-1976 were not found to be correlated with the UPDRS score of PD patients.
9.Visualization analysis of stem cell therapy for myocardial infarction based on Web of Science in recent ten years
Yukang SUN ; Lijuan SONG ; Chunli WEN ; Zhibin DING ; Hao TIAN ; Dong MA ; Cungen MA ; Xiaoyan ZHAI
Chinese Journal of Tissue Engineering Research 2024;28(7):1143-1148
BACKGROUND:Although traditional therapies,including drugs and surgery,cannot repair the damaged myocardial tissue,the mortality rate of myocardial infarction remains high.Stem cells provide the possibility to solve this problem due to their self-renewal and multi-directional differentiation potential. OBJECTIVE:To analyze the research progress of stem cell therapy for myocardial infarction in recent ten years by bibliometric analysis. METHODS:The related articles on stem cells and myocardial infarction published in SCI-E and SSCI from January 1,2012 to December 1,2022 in the Web of Science database were searched.EXCEL,CiteSpace and VOSviewer software were used to make statistical and visualization analyses of the data such as the number of publications,authors,institutions,journals,countries and keywords. RESULTS AND CONCLUSION:A total of 3 210 core articles were published,and the total number increased year by year.hausenloy,derek j.is the author with the largest number of publications,China is the country with the largest number of publications,and the Fourth Military Medical University is the institution with the largest number of publications.The research hotspots in this field are changing from cell experiments and animal experiments to clinical trials.In the past ten years,research in this field has been highly popular and still has great development prospects.It is necessary to promote international and inter-agency exchange and learning,and further explore the role of stem cells in the treatment of myocardial infarction.
10.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

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