1.Influence of perceived stress on anxiety among college students:a moderated mediation model
Qiong CHEN ; Guohua JIANG ; Yajun TIAN ; Lin HE ; Qingjun GUO ; Shan HU ; Xiuyang ZHU ; Wei ZHENG ; Yulin XU ; Tao XU
Academic Journal of Naval Medical University 2025;46(5):637-643
Objective To explore the mediating role of intolerance of uncertainty(IU)and moderating role of the negative emotion differentiation in the influence of perceived stress on anxiety among college students from a cognitive perspective.Methods A total of 271 participants were surveyed using the perceived stress scale,intolerance of uncertainty scale,depression anxiety and stress scale(Chinese version),and the test on negative emotional differentiation.SPSS 22.0 was used to perform descriptive statistics and correlation analyses and to test the moderated mediation model.Results Perceived stress affected anxiety and IU played a mediating role-perceived stress could affect anxiety through influencing IU.At the same time,the influence of IU on anxiety could be adjusted through the negative emotion differentiation.The higher the degree of negative emotion differentiation,the lower the degree of anxiety increase(β=0.17,t=5.70,P<0.01).Conclusion It may be effective to develop training programs to reduce anxiety by regulating perceived stress,increasing acceptance of uncertainty,and improving the negative emotion differentiation,which can help individuals reduce anxiety by perceiving and adjusting anxiety-related emotional or cognitive factors in a timely manner.
2.Overview of the studies on influencing factors of morphological characteristics and chemical composition of Angelicae Sinensis Radix
Tao LI ; Shaojing CHEN ; Peng CUI ; Chengjin YANG ; Guohua ZHOU ; Xuefang LI
International Journal of Traditional Chinese Medicine 2025;47(5):725-728,F3
The literature on the characteristics, commodity grade specifications and chemical composition of Angelicae Sinensis Radix was reviewed. It was found that the main factors affecting the changes of traits and chemical composition of Angelicae Sinensis Radix included origin, altitude, climate, soil, cultivation methods, processing and processing methods and storage methods. Among them, the volatile oil types and ferulic acid content of Angelicae Sinensis Radix produced in Minxian County of Gansu Province were better than those in some non-authentic producing areas, but some component differences remained to be verified; direct seeding and film mulching cultivation could improve the yield, volatile oil and polysaccharide content of Angelicae Sinensis Radix; continuous cropping may lead to rhizosphere soil problems of Angelicae Sinensis Radix, and rotation or intercropping could be considered; drying in the shade and smoking drying could retain the oil and aroma of Angelicae Sinensis Radix; wine stir-frying method could increase the content of Z-ligustilide, but stir-frying carbon may reduce the content of ferulic acid; high temperature and high humidity storage may affect the content of ligustilide. In the future, the quality evaluation system of Angelicae Sinensis Radix should be strengthened and improved, genuine research should be strengthened, and scientific field management methods and appropriate harvesting and processing methods should be established, so as to ensure the good clinical efficacy and stable and controllable quality of Angelicae Sinensis Radix.
3.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.
4.Epidemiological investigation of a brucellosis outbreak transmitted through a lamb slaughtering site
ZHANG Hongfang ; WANG Guohua ; LIU Jian ; QIAN Hua ; TANG Tao
Journal of Preventive Medicine 2024;36(10):887-888,892
Abstract
On August 11, 2022, Tongxiang Center for Disease Control detected a case of brucellosis, and the case was not engaged in related work. Case finding and risk factor investigation were immediately conducted to trace the source of infection. It was revealed that the case sold aquatic products at a farmer's market and frequently picked up goods at a seafood warehouse adjacent to a lamb slaughtering site. There was a potential risk of infection due to indirect contact with slaughtered lambs or contaminants. Serological tests were conducted on 9 employees of the slaughtering site and 48 residents nearby, and the brucellosis cases diagnosed in hospitals in the same area were searched. A total of 11 brucellosis cases were identified, including 9 confirmed cases and 2 asymptomatic infections. There were 2 cases of slaughtering workers and 9 cases of non-occupational individuals from the surrounding area of the slaughtering site. Brucella melitensis biovar 3 were isolated from a slaughtering worker and a non-occupational individual. The slaughtered lambs primarily came from northern regions such as Inner Mongolia and Heilongjiang. It was concluded that it was a cluster caused by Brucella melitensis biovar 3 and spread through direct or indirect contact with imported infected lambs or contaminated environments from a lamb slaughtering site. It is suggested to strengthen the quarantine of imported sheep, legally shut down non-compliant lamb slaughtering sites, implement designated slaughtering and enhance occupational protection.
5.Long-term outcome of patients with rectal cancer who achieve complete or near complete clinical responses after neoadjuvant therapy: a multicenter registry study of data from the Chinese Watch and Wait Database
Yiming ZHAO ; Weihu WANG ; Wei ZHANG ; Lin WANG ; Shuai LI ; Jingwen WANG ; Leen LIAO ; Guanyu YU ; Zhen SUN ; Yanli QU ; Yang GONG ; Yun LU ; Tao WU ; Yunfeng LI ; Quan WANG ; Guohua ZHAO ; Yi XIAO ; Peirong DING ; Zhen ZHANG ; Aiwen WU
Chinese Journal of Gastrointestinal Surgery 2024;27(4):372-382
Objective:To report the long-term outcomes of Chinese rectal cancer patients after adopting a Watch and Wait (W&W) strategy following neoadjuvant therapy (NAT).Methods:This multicenter, cross-sectional study was based on real-world data. The study cohort comprised rectal cancer patients who had achieved complete or near complete clinical responses (cCRs, near-cCRs) after NAT and were thereafter managed by a W&W approach, as well as a few patients who had achieved good responses after NAT and had then undergone local excision for confirmation of pathological complete response. All participants had been followed up for ≥2 years. Patients with distant metastases at baseline or who opted for observation while living with the tumor were excluded. Data of eligible patients were retrospectively collected from the Chinese Wait-and-Watch Data Collaboration Group database. These included baseline characteristics, type of NAT, pre-treatment imaging results, evaluation of post-NAT efficacy, salvage measures, and treatment outcomes. We herein report the long-term outcomes of Chinese rectal cancer patients after NAT and W&W and the differences between the cCR and near-cCR groups.Results:Clinical data of 318 rectal cancer patients who had undergone W&W for over 2 years and been followed up were collected from eight medical centers (Peking University Cancer Hospital, Fudan University Shanghai Cancer Center, Sun Yat-sen University Cancer Center, Shanghai Changhai Hospital, Peking Union Medical College Hospital, Liaoning Cancer Hospital, the First Hospital of Jilin University, and Yunnan Cancer Hospital.) The participants comprised 221 men (69.4%) and 107 women (30.6%) of median age 60 (26-86) years. The median distance between tumor and anal verge was 3.4 (0-10.4) cm. Of these patients, 291 and 27 had achieved cCR or near-cCR, respectively, after NAT. The median duration of follow-up was 48.4 (10.2-110.3) months. The 5-year cumulative overall survival rate was 92.4% (95%CI: 86.8%-95.7%), 5-year cumulative disease-specific survival (CSS) rate 96.6% (95%CI: 92.2%-98.5%), 5-year cumulative organ-preserving disease-free survival rate 86.6% (95%CI: 81.0%-90.7%), and 5-year organ preservation rate 85.3% (95%CI: 80.3%-89.1%). The overall 5-year local recurrence and distant metastasis rates were 18.5% (95%CI: 14.9%-20.8%) and 8.2% (95%CI: 5.4%-12.5%), respectively. Most local recurrences (82.1%, 46/56) occurred within 2 years, and 91.0% (51/56) occurred within 3 years, the median time to recurrence being 11.7 (2.5-66.6) months. Most (91.1%, 51/56) local recurrences occurred within the intestinal lumen. Distant metastases developed in 23 patients; 60.9% (14/23) occurred within 2 years and 73.9% (17/23) within 3 years, the median time to distant metastasis being 21.9 (2.6-90.3) months. Common sites included lung (15/23, 65.2%), liver (6/23, 26.1%), and bone (7/23, 30.4%) The metastases involved single organs in 17 patients and multiple organs in six. There were no significant differences in overall, cumulative disease-specific, or organ-preserving disease-free survival or rate of metastases between the two groups (all P>0.05). The 5-year local recurrence rate was higher in the near-cCR than in the cCR group (41.6% vs. 16.4%, P<0.01), with a lower organ preservation rate (69.2% vs. 88.0%, P<0.001). The success rates of salvage after local recurrence and distant metastasis were 82.1% (46/56) and 13.0% (3/23), respectively. Conclusion:Rectal cancer patients who achieve cCR or near-cCR after NAT and undergo W&W have favorable oncological outcomes and a high rate of organ preservation. Local recurrence and distant metastasis during W&W follow certain patterns, with a relatively high salvage rate for local recurrence. Our findings highlight the importance of close follow-up and timely intervention during the W&W process.
6.Long-term outcome of patients with rectal cancer who achieve complete or near complete clinical responses after neoadjuvant therapy: a multicenter registry study of data from the Chinese Watch and Wait Database
Yiming ZHAO ; Weihu WANG ; Wei ZHANG ; Lin WANG ; Shuai LI ; Jingwen WANG ; Leen LIAO ; Guanyu YU ; Zhen SUN ; Yanli QU ; Yang GONG ; Yun LU ; Tao WU ; Yunfeng LI ; Quan WANG ; Guohua ZHAO ; Yi XIAO ; Peirong DING ; Zhen ZHANG ; Aiwen WU
Chinese Journal of Gastrointestinal Surgery 2024;27(4):372-382
Objective:To report the long-term outcomes of Chinese rectal cancer patients after adopting a Watch and Wait (W&W) strategy following neoadjuvant therapy (NAT).Methods:This multicenter, cross-sectional study was based on real-world data. The study cohort comprised rectal cancer patients who had achieved complete or near complete clinical responses (cCRs, near-cCRs) after NAT and were thereafter managed by a W&W approach, as well as a few patients who had achieved good responses after NAT and had then undergone local excision for confirmation of pathological complete response. All participants had been followed up for ≥2 years. Patients with distant metastases at baseline or who opted for observation while living with the tumor were excluded. Data of eligible patients were retrospectively collected from the Chinese Wait-and-Watch Data Collaboration Group database. These included baseline characteristics, type of NAT, pre-treatment imaging results, evaluation of post-NAT efficacy, salvage measures, and treatment outcomes. We herein report the long-term outcomes of Chinese rectal cancer patients after NAT and W&W and the differences between the cCR and near-cCR groups.Results:Clinical data of 318 rectal cancer patients who had undergone W&W for over 2 years and been followed up were collected from eight medical centers (Peking University Cancer Hospital, Fudan University Shanghai Cancer Center, Sun Yat-sen University Cancer Center, Shanghai Changhai Hospital, Peking Union Medical College Hospital, Liaoning Cancer Hospital, the First Hospital of Jilin University, and Yunnan Cancer Hospital.) The participants comprised 221 men (69.4%) and 107 women (30.6%) of median age 60 (26-86) years. The median distance between tumor and anal verge was 3.4 (0-10.4) cm. Of these patients, 291 and 27 had achieved cCR or near-cCR, respectively, after NAT. The median duration of follow-up was 48.4 (10.2-110.3) months. The 5-year cumulative overall survival rate was 92.4% (95%CI: 86.8%-95.7%), 5-year cumulative disease-specific survival (CSS) rate 96.6% (95%CI: 92.2%-98.5%), 5-year cumulative organ-preserving disease-free survival rate 86.6% (95%CI: 81.0%-90.7%), and 5-year organ preservation rate 85.3% (95%CI: 80.3%-89.1%). The overall 5-year local recurrence and distant metastasis rates were 18.5% (95%CI: 14.9%-20.8%) and 8.2% (95%CI: 5.4%-12.5%), respectively. Most local recurrences (82.1%, 46/56) occurred within 2 years, and 91.0% (51/56) occurred within 3 years, the median time to recurrence being 11.7 (2.5-66.6) months. Most (91.1%, 51/56) local recurrences occurred within the intestinal lumen. Distant metastases developed in 23 patients; 60.9% (14/23) occurred within 2 years and 73.9% (17/23) within 3 years, the median time to distant metastasis being 21.9 (2.6-90.3) months. Common sites included lung (15/23, 65.2%), liver (6/23, 26.1%), and bone (7/23, 30.4%) The metastases involved single organs in 17 patients and multiple organs in six. There were no significant differences in overall, cumulative disease-specific, or organ-preserving disease-free survival or rate of metastases between the two groups (all P>0.05). The 5-year local recurrence rate was higher in the near-cCR than in the cCR group (41.6% vs. 16.4%, P<0.01), with a lower organ preservation rate (69.2% vs. 88.0%, P<0.001). The success rates of salvage after local recurrence and distant metastasis were 82.1% (46/56) and 13.0% (3/23), respectively. Conclusion:Rectal cancer patients who achieve cCR or near-cCR after NAT and undergo W&W have favorable oncological outcomes and a high rate of organ preservation. Local recurrence and distant metastasis during W&W follow certain patterns, with a relatively high salvage rate for local recurrence. Our findings highlight the importance of close follow-up and timely intervention during the W&W process.
7.Research on pilots′ hypoxic sensitive EEG index in cognitive conflict processing
Qiong CHEN ; Guohua JIANG ; Yulin XU ; Qingjun GUO ; Xiaojian CHEN ; Wei FENG ; Xinni XU ; Wei ZHENG ; Yin TAO ; Tao XU
Chinese Journal of Aerospace Medicine 2024;35(3):180-186
Objective:To investigate the brain activity and related hypoxic indicators in early cognitive processing stage (200-600 ms) and late cognitive processing stage (600-1 000 ms) by comparing their cognitive processing in pilots performed classical Stroop task under hypoxic state.Methods:Fifteen male Air Force pilots who were qualified in aeromedical assessment were selected. The behavioral indicators (accuracy, response time), event related potentials (ERP) component metrics (N2), and spectral metrics (Alpha band, Beta band) were monitored and analyzed when the pilots complete the cognitive conflict control task in the simulated 5 000 m hypoxic state and normal state.Results:The main effect of relationship type factors in response time indicators was significant ( F=4.10, P=0.027), and no difference found in accuracy indicators (all P>0.05). The reaction time under conflict conditions was (543.360±21.202) ms, which was higher than the reaction time under consistent conditions (509.078±14.420) ms, and the difference was significant ( F=3.28, P=0.039). The reaction time under unrelated conditions was (521.697±15.073) ms, and there was no significant difference between the reaction time under consistent and conflicting conditions (all P>0.05). Hypoxic status resulted in a significant increases in early stage indicator N2 amplitude ( F=5.34, P=0.037), and the power of Alpha, Low beta and Mid beta of late stage ( F=7.76, 5.34, 4.92, P=0.015, 0.037, 0.044). Conclusions:The amplitude of N2 can be used as the ERP indicator to investigate the pilots′ brain activities at the early stage of cognitive processing under hypoxia state; Alpha, Low beta and Mid beta bands of the spectrum can be used as the indicators to evaluate the brain activity of pilots in the late stage of cognitive processing under hypoxia state, which can be used in the training evaluation of pilots to provide more objective physiological data to improve the training effect of pilots.
8.Research on pilots′ hypoxic sensitive EEG index in cognitive conflict processing
Qiong CHEN ; Guohua JIANG ; Yulin XU ; Qingjun GUO ; Xiaojian CHEN ; Wei FENG ; Xinni XU ; Wei ZHENG ; Yin TAO ; Tao XU
Chinese Journal of Aerospace Medicine 2024;35(3):180-186
Objective:To investigate the brain activity and related hypoxic indicators in early cognitive processing stage (200-600 ms) and late cognitive processing stage (600-1 000 ms) by comparing their cognitive processing in pilots performed classical Stroop task under hypoxic state.Methods:Fifteen male Air Force pilots who were qualified in aeromedical assessment were selected. The behavioral indicators (accuracy, response time), event related potentials (ERP) component metrics (N2), and spectral metrics (Alpha band, Beta band) were monitored and analyzed when the pilots complete the cognitive conflict control task in the simulated 5 000 m hypoxic state and normal state.Results:The main effect of relationship type factors in response time indicators was significant ( F=4.10, P=0.027), and no difference found in accuracy indicators (all P>0.05). The reaction time under conflict conditions was (543.360±21.202) ms, which was higher than the reaction time under consistent conditions (509.078±14.420) ms, and the difference was significant ( F=3.28, P=0.039). The reaction time under unrelated conditions was (521.697±15.073) ms, and there was no significant difference between the reaction time under consistent and conflicting conditions (all P>0.05). Hypoxic status resulted in a significant increases in early stage indicator N2 amplitude ( F=5.34, P=0.037), and the power of Alpha, Low beta and Mid beta of late stage ( F=7.76, 5.34, 4.92, P=0.015, 0.037, 0.044). Conclusions:The amplitude of N2 can be used as the ERP indicator to investigate the pilots′ brain activities at the early stage of cognitive processing under hypoxia state; Alpha, Low beta and Mid beta bands of the spectrum can be used as the indicators to evaluate the brain activity of pilots in the late stage of cognitive processing under hypoxia state, which can be used in the training evaluation of pilots to provide more objective physiological data to improve the training effect of pilots.
9.Clinical application of adjustable traction skin stretchers in repair of wounds at the lower leg, foot and ankle
Wenchao SONG ; Xuejian WU ; Juyu TANG ; Jianli WANG ; Bo LIU ; Peng XIAO ; Chong MENG ; Jianzhong GUAN ; Tao SONG ; Guohua NI ; Dehong ZHANG ; Weihong ZHANG
Chinese Journal of Orthopaedic Trauma 2023;25(3):226-232
Objective:To evaluate the clinical effects of adjustable traction skin stretchers used in repair of wounds at the lower leg, foot and ankle.Methods:A retrospective study was performed to analyze the clinical data of 56 patients who had been treated for skin defects at the lower leg, foot and ankle from August 2016 to September 2022 at The First Affiliated Hospital of Zhengzhou University, Honghui Hospital, Affiliated to Xi'an Jiaotong University Medical College, The First Affiliated Hospital of Henan Polytechnic University, and Yunnan Zhongde Orthopedic Hospital. There were 35 males and 21 females, aged (39.9±18.7) years. There were 43 traumatic wounds, 3 burns, 6 inflammatory wounds, 3 relief incisions due to osteofascial compartment syndrome, and 1 scar. The areas of skin defect ranged from 2.5 cm × 2.0 cm to 20.0 cm × 10.0 cm. The duration of wounds was (8.6±7.8) d. All the wounds were repaired with adjustable traction skin stretchers. The row-hook type of skin stretchers was used in 28 cases, the single-rod type in 20 cases, the single-rod type combined with an external fixator in 5 cases, and a combination of the row-hook type and the single-rod type in 3 cases.The time for wound traction closure, color of wound skin margin, skin swelling around the wound, functional recovery of affected limb and complications were recorded.Results:The time from skin stretching to wound closure was (7.8±3.8) d in the 56 patients. The color of wound skin edge after stretching was normal in 16 cases, dark red in 38 cases, and dark in 2 cases; the skin swelling around the wound was degree 1 in 21 cases, degree 2 in 33 cases, and degree 3 in 2 cases. The 56 patients were followed up for (8.9±4.1) months. Primary wound closure was achieved in 48 patients, and secondary wound closure in 8 patients after repair with an autologous skin graft. Partial skin necrosis occurred due to tension blisters after skin stretching in 2 patients, one of whom was repaired with an autologous skin graft and the other of whom by dressing change. Deep bone infection recurred in 2 patients whose wounds healed after their bone defects were repaired using Ilizarov technique of bone transfer. In the 56 patients, the muscle strength of the lower extremity beyond the wound was recovered to normal, and the range of motion of the joints adjacent to the wound also recovered to normal.Conclusion:In repair of wounds at the lower leg, foot and ankle, adjustable traction skin stretchers can lead to fine clinical effects and limited complications, because the stretchers can control the tension of skin digitally and precisely.
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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