1.Preliminary clinical practice of radical prostatectomy without preoperative biopsy.
Ranlu LIU ; Lu YIN ; Shenfei MA ; Feiya YANG ; Zhenpeng LIAN ; Mingshuai WANG ; Ye LEI ; Xiying DONG ; Chen LIU ; Dong CHEN ; Sujun HAN ; Yong XU ; Nianzeng XING
Chinese Medical Journal 2025;138(6):721-728
BACKGROUND:
At present, biopsy is essential for the diagnosis of prostate cancer (PCa) before radical prostatectomy (RP). However, with the development of prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and multiparametric magnetic resonance imaging (mpMRI), it might be feasible to avoid biopsy before RP. Herein, we aimed to explore the feasibility of avoiding biopsy before RP in patients highly suspected of having PCa after assessment of PSMA PET/CT and mpMRI.
METHODS:
Between December 2017 and April 2022, 56 patients with maximum standardized uptake value (SUVmax) of ≥4 and Prostate Imaging Reporting and Data System (PI-RADS) ≥4 lesions who received RP without preoperative biopsy were enrolled from two tertiary hospitals. The consistency between clinical and pathological diagnoses was evaluated. Preoperative characteristics were compared among patients with different pathological types, T stages, International Society of Urological Pathology (ISUP) grades, and European Association of Urology (EAU) risk groups.
RESULTS:
Fifty-five (98%) patients were confirmed with PCa by pathology, including 49 (89%) with clinically significant prostate cancer (csPCa, defined as ISUP grade ≥2 malignancy). One patient was diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN). CsPCa patients, compared with clinically insignificant prostate cancer (cisPCa) and HGPIN patients, were associated with a higher level of prostate-specific antigen (22.9 ng/mL vs . 10.0 ng/mL, P = 0.032), a lower median prostate volume (32.2 mL vs . 65.0 mL, P = 0.001), and a higher median SUVmax (13.3 vs . 5.6, P <0.001).
CONCLUSIONS
It might be feasible to avoid biopsy before RP for patients with a high probability of PCa based on PSMA PET/CT and mpMRI. However, the diagnostic efficacy of csPCa with PI-RADS ≥4 and SUVmax of ≥4 is inadequate for performing a procedure such as RP. Further prospective multicenter studies with larger sample sizes are necessary to confirm our perspectives and establish predictive models with PSMA PET/CT and mpMRI.
Humans
;
Male
;
Prostatectomy/methods*
;
Prostatic Neoplasms/diagnosis*
;
Middle Aged
;
Aged
;
Positron Emission Tomography Computed Tomography/methods*
;
Biopsy
;
Multiparametric Magnetic Resonance Imaging
;
Prostate-Specific Antigen/metabolism*
2.Development goals and strategies of ecological agriculture of Chinese materia medica.
Chuan-Zhi KANG ; Si-Qi LIU ; Bang-Xing HAN ; Tao ZHOU ; Xiao WANG ; Da-Hui LIU ; Ye YANG ; Lan-Ping GUO
China Journal of Chinese Materia Medica 2025;50(1):42-47
This paper aims to contribute to guaranteeing the stable development and enhancing the understanding of ecological agriculture of Chinese materia medica so that the national strategy and industrial demand can be better served. It first introduces current traditional Chinese medicine(TCM)policy and industrial development status from five aspects, including policy guarantee, theoretical support, technological innovation, standardization system, and brand influence. Then, the paper analyzes the development dilemma of TCM agriculture in production and quality increase and ecological environment protection. It also proposes the development goals of ecological agriculture of Chinese materia medica that meet the current industrial development demand, which are reducing chemical fertilizers, pesticides, and carbon emissions, improving quality, increasing efficiency, and protecting ecological environment. In addition, the new development goals are interpreted through case studies. Finally, this paper proposes four development strategies for ecological agriculture of Chinese materia medica: conducting research on the pattern and spatial and temporal variations of nationwide TCM production areas; studying the internal and external ecological memories of medicinal plant growth from the perspectives of genetic variations and environmental adaptation variations and elucidating their contributions to the formation of quality; carrying out selection and breeding of stress-resistant varieties for ecological agriculture of Chinese materia medica, the optimization of key technologies for soil improvement and restoration and green prevention and control against diseases and pests, and the improvement of quality; carrying out research on the quality assurance and value realization of ecological products made from TCM. This research can provide guidance for policy formulation, theoretical development of the discipline, and the enhancement of industrial technology for ecological agriculture of Chinese materia medica.
Agriculture/methods*
;
China
;
Drugs, Chinese Herbal
;
Plants, Medicinal/chemistry*
;
Ecosystem
;
Materia Medica
;
Medicine, Chinese Traditional
3.Biomarkers Screening and Mechanisms Analysis of the Restraint Stress-Induced Myocardial Injury in Hyperlipidemia ApoE-/-Mice
Shang-Heng CHEN ; Sheng-Zhong DONG ; Zhi-Min WANG ; Guang-Hui HONG ; Xing YE ; Zi-Jie LIN ; Jun-Yi LIN ; Jie-Qing JIANG ; Shou-Yu WANG ; Han-Cheng LIN ; Yi-Wen SHEN
Journal of Forensic Medicine 2024;40(2):172-178
Objective To explore the biomarkers and potential mechanisms of chronic restraint stress-induced myocardial injury in hyperlipidemia ApoE-/-mice.Methods The hyperlipidemia combined with the chronic stress model was established by restraining the ApoE-/-mice.Proteomics and bioinformatics techniques were used to describe the characteristic molecular changes and related regulatory mechanisms of chronic stress-induced myocardial injury in hyperlipidemia mice and to explore potential diagnostic biomarkers.Results Proteomic analysis showed that there were 43 significantly up-regulated and 58 sig-nificantly down-regulated differentially expressed proteins in hyperlipidemia combined with the restraint stress group compared with the hyperlipidemia group.Among them,GBP2,TAOK3,TFR1 and UCP1 were biomarkers with great diagnostic potential.KEGG pathway enrichment analysis indicated that fer-roptosis was a significant pathway that accelerated the myocardial injury in hyperlipidemia combined with restraint stress-induced model.The mmu_circ_0001567/miR-7a/Tfr-1 and mmu_circ_0001042/miR-7a/Tfr-1 might be important circRNA-miRNA-mRNA regulatory networks related to ferroptosis in this model.Conclusion Chronic restraint stress may aggravate myocardial injury in hyperlipidemia mice via ferrop-tosis.Four potential biomarkers are selected for myocardial injury diagnosis,providing a new direction for sudden cardiac death(SCD)caused by hyperlipidemia combined with the restraint stress.
4.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.
5.Comparison of safety and effectiveness of active migration technique and in situ lithotripsy technique in the treatment of 1-2 cm upper ureteral calculi by flexible ure-teroscopy.
Lei WANG ; Tian Dong HAN ; Wei Xing JIANG ; Jun LI ; Dao Xin ZHANG ; Ye TIAN
Journal of Peking University(Health Sciences) 2023;55(3):553-557
OBJECTIVE:
To compare the safety and effectiveness of active migration technique and in situ lithotripsy technique in the treatment of 1-2 cm upper ureteral calculi by retrograde flexible ureteroscopy.
METHODS:
A total of 90 patients with 1-2 cm upper ureteral calculi treated in the urology department of Beijing Friendship Hospital from August 2018 to August 2020 were selected as the subjects. The patients were divided into two groups using random number table: 45 patients in group A were treated with in situ lithotripsy and 45 patients in group B were treated with active migration technique. The active migration technique was to reposition the stones in the renal calyces convenient for lithotripsy with the help of body position change, water flow scouring, laser impact or basket displacement, and then conduct laser lithotripsy and stone extraction. The data of the patients before and after operation were collected and statistically analyzed.
RESULTS:
The age of the patients in group A was (51.6±14.1) years, including 34 males and 11 females. The stone diameter was (1.48±0.24) cm, and the stone density was (897.8±175.9) Hu. The stones were located on the left in 26 cases and on the right in 19 cases. There were 8 cases with no hydronephrosis, 20 cases with grade Ⅰ hydronephrosis, 11 cases with grade Ⅱ hydronephrosis, and 6 cases with grade Ⅲ hydronephrosis. The age of the patients in group B was (51.8±13.7) years, including 30 males and 15 females. The stone diameter was (1.52±0.22) cm, and the stone density was (964.6±214.2) Hu. The stones were located on the left in 22 cases and on the right in 23 cases. There were 10 cases with no hydronephrosis, 23 cases with grade Ⅰ hydronephrosis, 8 cases with grade Ⅱ hydronephrosis, and 4 cases with grade Ⅲ hydronephrosis. There was no significant diffe-rence in general parameters and stone indexes between the two groups. The operation time of group A was (67.1±16.9) min and the lithotripsy time was (38.0±13.2) min. The operation time of group B was (72.2±14.8) min and the lithotripsy time was (40.6±12.6) min. There was no significant difference between the two groups. Four weeks after operation, the stone-free rate in group A was 86.7%, and in group B was 97.8%. There was no significant difference between the two groups. In terms of complications, 25 cases of hematuria, 16 cases of pain, 10 cases of bladder spasm and 4 cases of mild fever occurred in group A. There were 22 cases of hematuria, 13 cases of pain, 12 cases of bladder spasm and 2 cases of mild fever in group B. There was no significant difference between the two groups.
CONCLUSION
Active migration technique is safe and effective in the treatment of 1-2 cm upper ureteral calculi.
Male
;
Female
;
Humans
;
Adult
;
Middle Aged
;
Aged
;
Ureteral Calculi/surgery*
;
Hematuria/therapy*
;
Ureteroscopy/methods*
;
Lithotripsy/methods*
;
Lithotripsy, Laser/methods*
;
Hydronephrosis/complications*
;
Pain
;
Treatment Outcome
;
Retrospective Studies
6.Practical Value of Environment-friendly Sample Release Agent Combined with Ultrasound in the Preparation of Pathological Tissue Sections
Yan-xing WU ; Chao-hua MO ; Fu-lan HAN ; Min ZENG ; Zeng-wei CHEN ; Wen-xiong YANG ; Xin-ye ZHOU ; Rong-jun MAO
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(5):847-853
ObjectiveTo explore the practical value of environment-friendly sample release agent combined with ultrasound in the preparation of pathological tissue sections. MethodsFrom February 2013 to December 2022, 2 518 pathological specimens submitted by Foshan Municipal Hospital of Traditional Chinese Medicine were selected as the study objects. Two samples of the same specimen were randomly divided into two groups: the environment-friendly fast group, in which the pathological tissue sections were made by using the environment-friendly sample release agent combined with ultrasound; and the traditional group, in which formaldehyde, ethanol and xylene were used to make slices in the conventional way. The differences of hematoxylin (HE) staining effect, immunohistochemistry (IHC) staining effect and MDM2 gene detection result of atypical lipomatous tumor/highly differentiated liposarcoma (ALT/WDL) tissue sections between the two groups were compared. Results① The wax of the two groups' pathological tissues was dehydrated well and the tissue hardness was moderate. After HE staining, the sections of the two groups were intact, without cracks and tremor marks, and the contrast between nucleus and cytoplasm was appropriate, with good transparency, uniform staining, and no tissue loss. The excellent rate and score of HE staining in the environmental fast group were higher than those in the traditional group, but the difference was not statistically significant (χ2 = 3.125,P1 = 0.070;t = 0.965,P2 = 0.334). ②After IHC staining of the two groups of sections, the positive location of the cells was accurate, the staining was specific and uniform, the staining intensity was moderate, the staining sensitivity was good, and there was no tissue loss. The excellent rate of IHC staining and the positive rate of IHC staining in the environmental fast group were lower than those in the traditional group, but the difference was not statistically significant (χ12 = 2.769,P1 = 0.092;χ22 = 0.800,P2 = 0.375). ③The background and outline of the two groups of WDL tissue sections were clear, the staining was uniform, the cells were clear and visible, the nuclear boundary was clear, the hybridization signal was clear and bright under the background fluorescence, and there was no miscellaneous signal. The two groups of sections were hybridized successfully, and MDM2 showed positive amplification. The number of cells successfully hybridized in the environment-friendly fast group was lower than that in the traditional group, but the difference was not statistically significant (t = 1.414,P = 0.230). ConclusionsThe tissue treatment method of using environment-friendly sample release agent combined with ultrasound can ensure the detection effect of HE staining, IHC staining and MDM2 gene detection of pathological tissue sections, and is more efficient and environment-friendly, suitable for promotion and use in hospitals at all levels.
7.Establishment and application of the ten-fold rehydration formula for emergency resuscitation of pediatric patients after extensive burns.
Zhuan An SHEN ; Xin Zhu LIU ; Xiao Ye XIE ; Bo Han ZHANG ; Da Wei LI ; Zhao Xing LIU ; Hua Geng YUAN
Chinese Journal of Burns 2023;39(1):59-64
Objective: To investigate the scientificity and feasibility of the ten-fold rehydration formula for emergency resuscitation of pediatric patients after extensive burns. Methods: A retrospective observational study was conducted. The total burn area of 30%-100% total body surface area (TBSA) and body weight of 6-50 kg in 433 pediatric patients (250 males and 183 females, aged 3 months to 14 years) with extensive burns who met the inclusion criteria and admitted to the burn departments of 72 Class A tertiary hospitals were collected. The 6 319 pairs of simulated data were constructed after pairing each body weight of 6-50 kg (programmed in steps of 0.5 kg) and each total burn area of 30%-100% TBSA (programmed in steps of 1%TBSA). They were put into three accepted pediatric rehydration formulae, namely the commonly used domestic pediatric rehydration formula for burn patients (hereinafter referred to as the domestic rehydration formula), the Galveston formula, and the Cincinnati formula, and the two rehydration formulae for pediatric emergency, namely the simplified resuscitation formula for emergency care of patients with extensive burns proposed by the World Health Organization's Technical Working Group on Burns (TWGB, hereinafter referred to as the TWGB formula) and the pediatric ten-fold rehydration formula proposed by the author of this article--rehydration rate (mL/h)=body weight (kg) × 10 (mL·kg-1·h-1) to calculate the rehydration rate within 8 h post injury (hereinafter referred to as the rehydration rate). The range of the results of the 3 accepted pediatric rehydration formulae ±20% were regarded as the reasonable rehydration rate, and the accuracy rates of rehydration rate calculated using the two pediatric emergency rehydration formulae were compared. Using the maximum burn areas (55% and 85% TBSA) corresponding to the reasonable rehydration rate calculated by the pediatric ten-fold rehydration formula at the body weight of 6 and 50 kg respectively, the total burn area of 30% to 100% TBSA was divided into 3 segments and the accuracy rates of the rehydration rate calculated using the 2 pediatric emergency rehydration formulae in each segment were compared. When neither of the rehydration rates calculated by the 2 pediatric emergency rehydration formulae was reasonable, the differences between the two rehydration rates were compared. The distribution of 433 pediatric patients in the 3 previous total burn area segments was counted and the accuracy rates of the rehydration rate calculated using the 2 pediatric emergency rehydration formulae were calculated and compared. Data were statistically analyzed with McNemar test. Results: Substitution of 6 319 pairs of simulated data showed that the accuracy rates of the rehydration rates calculated by the pediatric ten-fold rehydration formula was 73.92% (4 671/6 319), which was significantly higher than 4.02% (254/6 319) of the TWGB formula (χ2=6 490.88,P<0.05). When the total burn area was 30%-55% and 56%-85% TBSA, the accuracy rates of the rehydration rates calculated by the pediatric ten-fold rehydration formula were 100% (2 314/2 314) and 88.28% (2 357/2 670), respectively, which were significantly higher than 10.98% (254/2 314) and 0 (0/2 670) of the TWGB formula (with χ2 values of 3 712.49 and 4 227.97, respectively, P<0.05); when the total burn area was 86%-100% TBSA, the accuracy rates of the rehydration rates calculated by the pediatric ten-fold rehydration formula and the TWGB formula were 0 (0/1 335). When the rehydration rates calculated by the 2 pediatric emergency rehydration formulae were unreasonable, the rehydration rates calculated by the pediatric ten-fold rehydration formula were all higher than those of the TWGB formula. There were 93.07% (403/433), 5.77% (25/433), and 1.15% (5/433) patients in the 433 pediatric patients had total burn area of 30%-55%, 56%-85%, and 86%-100% TBSA, respectively, and the accuracy rate of the rehydration rate calculated using the pediatric ten-fold rehydration formula was 97.69% (423/433), which was significantly higher than 0 (0/433) of the TWGB formula (χ2=826.90, P<0.05). Conclusions: The application of the pediatric ten-fold rehydration formula to estimate the rehydration rate of pediatric patients after extensive burns is more accurate and convenient, superior to the TWGB formula, suitable for application by front-line healthcare workers that are not specialized in burns in pre-admission rescue of pediatric patients with extensive burns, and is worthy of promotion.
Male
;
Female
;
Humans
;
Child
;
Burns/therapy*
;
Hospitalization
;
Resuscitation
;
Fluid Therapy/methods*
;
Body Surface Area
;
Retrospective Studies
8.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
9.A novel biological sources consistency evaluation method reveals high level of biodiversity within wild natural medicine: A case study of Amynthas earthworms as "Guang Dilong".
Zhimei XING ; Han GAO ; Dan WANG ; Ye SHANG ; Tenukeguli TULIEBIEKE ; Jibao JIANG ; Chunxiao LI ; Hong WANG ; Zhenguo LI ; Lifu JIA ; Yongsheng WU ; Dandan WANG ; Wenzhi YANG ; Yanxu CHANG ; Xiaoying ZHANG ; Liuwei XU ; Chao JIANG ; Luqi HUANG ; Xiaoxuan TIAN
Acta Pharmaceutica Sinica B 2023;13(4):1755-1770
For wild natural medicine, unanticipated biodiversity as species or varieties with similar morphological characteristics and sympatric distribution may co-exist in a single batch of medical materials, which affects the efficacy and safety of clinical medication. DNA barcoding as an effective species identification tool is limited by its low sample throughput nature. In this study, combining DNA mini-barcode, DNA metabarcoding and species delimitation method, a novel biological sources consistency evaluation strategy was proposed, and high level of interspecific and intraspecific variations were observed and validated among 5376 Amynthas samples from 19 sampling points regarded as "Guang Dilong" and 25 batches of proprietary Chinese medicines. Besides Amynthas aspergillum as the authentic source, 8 other Molecular Operational Taxonomic Units (MOTUs) were elucidated. Significantly, even the subgroups within A. aspergillum revealed here differ significantly on chemical compositions and biological activity. Fortunately, this biodiversity could be controlled when the collection was limited to designated areas, as proved by 2796 "decoction pieces" samples. This batch biological identification method should be introduced as a novel concept regarding natural medicine quality control, and to offer guidelines for in-situ conservation and breeding bases construction of wild natural medicine.
10.Discussion on
Chang-Zhen GONG ; Fan-Rong LIANG ; Can-Hui LI ; Wei-Xing PAN ; Yong-Ming LI ; San-Hua LENG ; Arthur Yin FAN ; Song-Ping HAN ; Jing LIU ; Shan WANG ; Zeng-Fu PENG ; Ye-Meng CHEN ; Guan-Hu YANG ; Xu-Ming GU ; Hong SU ; Shao-Bai WANG
Chinese Acupuncture & Moxibustion 2021;41(4):359-364
Professor
Acupuncture
;
Acupuncture Therapy
;
Angina, Stable
;
Combined Modality Therapy
;
Humans
;
Moxibustion

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