1.Resection of mediastinal tumor combined with persistent left superior vena cava: A case report
Zongjun XIANG ; Fan ZHANG ; Lei LI ; Yongguo LU ; Xiaoming LI ; Haide MU ; Xiaowei ZHOU ; Linqi YANG ; Zhiyu WAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):1044-1046
Persistent left superior vena cava is a rare venous variant that is often combined with cardiovascular malformations. In thoracic surgery, especially mediastinal tumor resection, neglect of this variant may make the surgery difficult and risky, and careful preoperative imaging interpretation and adequate preoperative evaluation play an important role in the perioperative safety of the patient. In this paper, we reported a case of a 17-year-old female patient with a persistent left superior vena cava combined with mediastinal tumors. She was successfully discharged 5 days after thoracoscopic surgery, and after 3 years of postoperative follow-up, no tumor recurrence was observed.
2.Diagnosis and treatment of colorectal liver metastases: Chinese expert consensus-based multidisciplinary team (2024 edition).
Wen ZHANG ; Xinyu BI ; Yongkun SUN ; Yuan TANG ; Haizhen LU ; Jun JIANG ; Haitao ZHOU ; Yue HAN ; Min YANG ; Xiao CHEN ; Zhen HUANG ; Weihua LI ; Zhiyu LI ; Yufei LU ; Kun WANG ; Xiaobo YANG ; Jianguo ZHOU ; Wenyu ZHANG ; Muxing LI ; Yefan ZHANG ; Jianjun ZHAO ; Aiping ZHOU ; Jianqiang CAI
Chinese Medical Journal 2025;138(15):1765-1768
3.Research and clinical application progress of foot lengthening surgery.
Zhiyu WANG ; Baozhou ZHANG ; Xuewen WANG ; Ban LU ; Zeyu ZHANG ; Yingdong ZHANG ; Sihe QIN ; Yong WU ; Hui DU
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(8):937-941
OBJECTIVE:
To summarize the research and clinical application progress of foot lengthening surgery.
METHODS:
Relevant research literature on foot lengthening surgery in recent years at home and abroad was reviewed, and a summary was made from aspects such as the types of lengthening surgery, the types of foot diseases treated by clinical application, effectiveness, and complications.
RESULTS:
Bone defects and shortening deformities of the foot are relatively common clinically. As an innovative treatment method, foot lengthening surgery has gradually attracted attention, mainly including the Ilizarov technique and one-stage bone grafting lengthening surgery. The former promotes bone regeneration based on the tension-stress principle and is widely used in the treatment of calcaneal defects and congenital metatarsal brachymetatarsia, achieving good curative effects. However, there are also complications such as pin-tract infection, joint stiffness and contracture, non-union and delayed union of bone, re-fracture, and alignment deviation. The latter has a short treatment cycle, but the lengthening length is limited. Bone graft resorption and soft tissue complications are its main complications.
CONCLUSION
Foot lengthening surgery will develop towards the direction of personalization, intelligence, and precision. With the help of multi-center research, biological materials, and intelligent technologies, the effectiveness and safety will be further improved to better restore the function and appearance of the foot.
Humans
;
Bone Transplantation/methods*
;
Bone Lengthening/methods*
;
Ilizarov Technique
;
Osteogenesis, Distraction/methods*
;
Foot Deformities/surgery*
;
Postoperative Complications
;
Treatment Outcome
;
Foot/surgery*
4.Research on the management of the Glissonean pedicle in laparoscopic anatomical hemihepatectomy and the in-fluence of indocyanine green dose on the fluorescence staining effect
Zhiyu LU ; Ji SUN ; Jialu DU ; Xuan MENG ; Man LUO ; Yue LIU ; Hongguang WANG
Journal of Surgery Concepts & Practice 2024;29(2):138-142
Objective To investigate the technique and dosage selection of indocyanine green(ICG)fluorescence staining in laparoscopic anatomical hemihepatectomy.Methods A retrospective cross-sectional study was conducted.The clinical date of the patients who underwent laparoscopic anatomical hemihepatectomy in the Cancer Hospital of the Chinese Academy of Medical Sciences from October 2020 to October 2023 was collected and analyzed,and the management of the Glissonean pedicle,the method and effect of ICG fluorescence staining during the operation,the dose of ICG injection,and the postoperative recovery were analyzed.Results A total of 91 laparoscopic anatomical hemihepatectomies were enrolled in this study,including 28 right hemihepatectomies and 63 left hemihepatectomies.The Glissonean pedicle was dissected intra-sheath in 9 cases and extra-sheath in 82 cases.ICG fluorescence staining was all performed using the negative staining method,of which 69 cases(75.8%)were successfully stained.The success rate of staining in the extra-sheath dissection and low-dose ICG group was higher than that in the intra-sheath dissection and high-dose ICG group.The average operation time was(168.5±32.2)minutes,the intraoperative bleeding volume was(152.4±56.3)ml,and the intraoperative blood transfusion rate was 6.6%(6/91),the average postoperative hospital stay was(8.5±2.6)days.One case was converted to laparotomy due to exophytic growth of the tumor compressing the Glissonean pedicle.Four cases had Clavien-Dindo Ⅰ-Ⅱ complications,all of which improved after treatment.There were 3 cases of grade Ⅲa complications,all of which were caused by bile leakage and abdominal cavity infection.They were cured by puncture and drainage.And there were no serious complications above grade Ⅲb.Conclusions In laparoscopic anatomical hemihepatectomy,the ICG fluorescence staining method was recommended to use the negative staining method of the extra-sheath dissection of the Glissonean pedicle,and a lower dose of ICG could help to increase the success rate of fluorescence staining.
5.Research progress of risk factors affecting prognosis of hypertrophic cardiomyopathy in children
Zhiyu TIAN ; Zhen ZHEN ; Lu GAO ; Yue YUAN
Chinese Pediatric Emergency Medicine 2024;31(11):861-866
Hypertrophic cardiomyopathy (HCM) in children is one of the most common hereditary cardiomyopathies caused by gene mutations encoding cardiac carcomeric proteins. It is mainly characterized by ventricular hypertrophy and non-enlarged cardiac chambers, with a potential risk of sudden cardiac death. Usually, the assessment is based on the general condition, clinical symptoms, imaging examination results, family history, and genetic testing of the patients, thereby providing a basis for judging the risk of sudden cardiac death, and then identifying the risk factors for sudden cardiac death in hypertrophic cardiomyopathy. Based on the relevant domestic and foreign literature in recent years and the accumulated work experience in the department of cardiology of Beijing Children's Hospital, these risk factors are divided into major and minor risk factors. A comprehensive understanding of these risk factors can guide the clinical early warning of high-risk children with possible sudden death, which is helpful for more accurate assessment of the prognosis of hypertrophic cardiomyopathy in children and the implementation of targeted intervention. This article reviewed the research progress of related risk factors for the prognosis of hypertrophic cardiomyopathy in children.
6.Unveiling the oral-gut connection:chronic apical periodontitis accelerates atherosclerosis via gut microbiota dysbiosis and altered metabolites in apoE-/-Mice on a high-fat diet
Gan GUOWU ; Lin SHIHAN ; Luo YUFANG ; Zeng YU ; Lu BEIBEI ; Zhang REN ; Chen SHUAI ; Lei HUAXIANG ; Cai ZHIYU ; Huang XIAOJING
International Journal of Oral Science 2024;16(3):515-527
The aim of this study was to explore the impact of chronic apical periodontitis(CAP)on atherosclerosis in apoE-/-mice fed high-fat diet(HFD).This investigation focused on the gut microbiota,metabolites,and intestinal barrier function to uncover potential links between oral health and cardiovascular disease(CVD).In this study,CAP was shown to exacerbate atherosclerosis in HFD-fed apoE-/-mice,as evidenced by the increase in plaque size and volume in the aortic walls observed via Oil Red O staining.16S rRNA sequencing revealed significant alterations in the gut microbiota,with harmful bacterial species thriving while beneficial species declining.Metabolomic profiling indicated disruptions in lipid metabolism and primary bile acid synthesis,leading to elevated levels of taurochenodeoxycholic acid(TCDCA),taurocholic acid(TCA),and tauroursodeoxycholic acid(TDCA).These metabolic shifts may contribute to atherosclerosis development.Furthermore,impaired intestinal barrier function,characterized by reduced mucin expression and disrupted tight junction proteins,was observed.The increased intestinal permeability observed was positively correlated with the severity of atherosclerotic lesions,highlighting the importance of the intestinal barrier in cardiovascular health.In conclusion,this research underscores the intricate interplay among oral health,gut microbiota composition,metabolite profiles,and CVD incidence.These findings emphasize the importance of maintaining good oral hygiene as a potential preventive measure against cardiovascular issues,as well as the need for further investigations into the intricate mechanisms linking oral health,gut microbiota,and metabolic pathways in CVD development.
7.Incidence of venous thromboembolism in esophageal cancer: a real-world study of 8 458 cases
Kunyi DU ; Xin NIE ; Kexun LI ; Changding LI ; Kun LIU ; Zhiyu LI ; Kunzhi LI ; Simiao LU ; Kunhan NI ; Wenwu HE ; Chenghao WANG ; Jialong LI ; Haojun LI ; Qiang ZHOU ; Kangning WANG ; Guangyuan LIU ; Wenguang XIAO ; Qiang FANG ; Qiuling SHI ; Yongtao HAN ; Lin PENG ; Xuefeng LENG
Chinese Journal of Digestive Surgery 2024;23(1):109-113
Objective:To investigate the incidence of venous thromboembolism (VTE) in patients with esophageal cancer (EC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 8 458 EC patients who were admitted to Sichuan Cancer Hospital from January 2017 to December 2021 were collected. There were 6 923 males and 1 535 females, aged (64±9)years. There were 3 187 patients undergoing surgical treatment, and 5 271 cases undergoing non-surgical treatment. Observation indicators: (1) incidence of VTE in EC patients; (2) treatment and outcomes of patients with VTE. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was analyzed using the nonparameter rank sum test. Count data were expressed as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Comparison of ordinal data was analyzed using the nonparameter rank sum test. Results:(1) Incidence of VTE in EC patients. Of 8 458 EC patients, 175 cases developed VTE, with an incidence rate of 2.069%(175/8 458). Among 175 VTE patients, there were 164 cases of deep venous thrombosis (DVT), 4 cases of pulmonary embolism (PE), 7 cases of DVT and PE. There were 59 surgical patients and 116 non-surgical patients. There was no significant difference in thrombus type between surgical and non-surgical EC patients with VTE ( χ2=1.95, P>0.05). Of 3 187 surgical patients, the incidence of VTE was 1.851%(59/3 187), including an incidence of 0.157%(5/3 187) of PE. PE accounted for 8.475%(5/59) of surgical patients with VTE. Of 5 271 non-surgical patients, the incidence of VTE was 2.201%(116/5 271), including an incidence of 0.114%(6/5 271) of PE. PE accounted for 5.172%(6/116) of non-surgical patients with VTE. There was no significant difference in the incidence of VTE or PE between surgical patients and non-surgical patients ( χ2=1.20, 0.05, P>0.05). (2) Treatment and outcomes of patients with VTE. Among 175 EC patients with VTE, 163 cases underwent drug treatment, and 12 cases did not receive treatment. Among 163 cases with drug therapy, 158 cases underwent anticoagulant therapy, 5 cases were treated with thrombolysis. All the 163 patients were improved and discharged from hospital. Conclusions:The incidence of VTE in patients with EC is relatively low, as 2.069%. There is no significant difference in the incidence of VTE or thrombus type between surgical EC patients and non-surgical EC patients.
8.Effect of oxymatrine on Cryptosporidium parvum infection in mice based on the HMGB1-TLR2/TLR4-NF-κB pathway
Jie SHI ; Rui JI ; Zhiyu GUAN ; Xiaoning ZHANG ; Yilong LU
Chinese Journal of Schistosomiasis Control 2024;36(3):286-293
Objective To investigate the involvement of the high mobility group box protein B1 (HMGB1)-Toll-like receptor 2 (TLR2)/TLR4-nuclear factor κB (NF-κB) pathway in the intestinal mucosal injury induced by Cryptosporidium parvum infection, and to examine the effect of oxymatrine (OMT) on C. parvum infection in mice. Methods Forty SPF 4-week-old BALB/c mice were randomly divided into four groups, including the control group, infection group, glycyrrhizin (GA) group and OMT group. Each mouse was orally administered with 1 × 105 C. parvum oocysts one week in the infection, GA and OMT groups following dexamethasone-induced immunosuppression to model C. parvum intestinal infections in mice. Upon successful modeling, mice in the GA group were intraperitoneally injected with GA at a daily dose of 25.9 mL/kg for successive two weeks, and animals in the OMT group were orally administered OMT at a daily dose of 50 mg/kg for successive two weeks, while mice in the control group were given normal food and water. All mice were sacrificed two weeks post-treatment, and proximal jejunal tissues were sampled. The pathological changes of mouse intestinal mucosal specimens were observed using hematoxylin-eosin (HE) staining, and the mouse intestinal villous height, intestinal crypt depth and the ratio of intestinal villous height to intestinal crypt depth were measured. The occludin and zonula occludens protein 1 (ZO1) expression was determined in mouse intestinal epithelial cells using immunohistochemistry, and the relative expression of HMGB1, TLR2, TLR4, myeloid differentiation primary response gene 88 (MyD88) and NF-κB p65 mRNA was quantified in mouse jejunal tissues using quantitative real-time PCR (qPCR) assay. Results HE staining showed that the mouse intestinal villi were obviously atrophic, shortened, and detached, and the submucosal layer of the mouse intestine was edematous in the infection group as compared with the control group, while the mouse intestinal villi tended to be structurally intact and neatly arranged in the GA and OMT groups. There were significant differences among the four groups in terms of the mouse intestinal villous height (F = 6.207, P = 0.000 5), intestinal crypt depth (F = 6.903, P = 0.000 3) and the ratio of intestinal villous height to intestinal crypt depth (F = 37.190, P < 0.000 1). The mouse intestinal villous height was lower in the infection group than in the control group [(321.9 ± 41.1) μm vs. (399.5 ± 30.9) μm; t = 4.178, P < 0.01] and the GA group [(321.9 ± 41.1) μm vs. (383.7 ± 42.7) μm; t = 3.130, P < 0.01], and the mouse intestinal crypt depth was greater in the infection group [(185.0 ± 35.9) μm] than in the control group [(128.4 ± 23.6) μm] (t = 3.877, P < 0.01) and GA group [(143.3 ± 24.7) μm] (t = 2.710, P < 0.05). The mouse intestinal villous height was greater in the OMT group [(375.3 ± 22.9) μm] than in the infection group (t = 3.888, P < 0.01), and there was no significant difference in mouse intestinal villous height between the OMT group and the control group (t = 1.989, P > 0.05). The mouse intestinal crypt depth was significantly lower in the OMT group [(121.5 ± 27.3) μm] than in the infection group (t = 4.133, P < 0.01), and there was no significant difference in mouse intestinal crypt depth between the OMT group and the control group (t = 0.575, P > 0.05). The ratio of the mouse intestinal villous height to intestinal crypt depth was significantly lower in the infection group (1.8 ± 0.2) than in the control group (3.1 ± 0.3) (t = 10.540, P < 0.01) and the GA group (2.7 ± 0.3) (t = 7.370, P < 0.01), and the ratio of the mouse intestinal villous height to intestinal crypt depth was significantly higher in the OMT group (3.1 ± 0.2) than in the infection group (t = 15.020, P < 0.01); however, there was no significant difference in the ratio of the mouse intestinal villous height to intestinal crypt depth between the OMT group and the control group (t = 0.404, P > 0.05). Immunohistochemical staining showed significant differences among the four groups in terms of occludin (F = 28.031, P < 0.000 1) and ZO1 expression (F = 14.122, P < 0.000 1) in mouse intestinal epithelial cells. The proportion of positive occluding expression was significantly lower in mouse intestinal epithelial cells in the infection group than in the control group [(14.3 ± 4.5)% vs. (28.3 ± 0.5)%; t = 3.810, P < 0.01], and the proportions of positive occluding expression were significantly higher in mouse intestinal epithelial cells in the GA group [(30.3 ± 1.3)%] and OMT group [(25.8 ± 1.5)%] than in the infection group (t = 7.620 and 5.391, both P values < 0.01); however, there was no significant differences in the proportion of positive occluding expression in mouse intestinal epithelial cells between the GA or OMT groups and the control group (t = 1.791 and 2.033, both P values > 0.05). The proportion of positive ZO1 expression was significantly lower in mouse intestinal epithelial cells in the infection group than in the control group [(14.4 ± 1.8)% vs. (24.2 ± 2.8)%; t = 4.485, P < 0.01], and the proportions of positive ZO1 expression were significantly higher in mouse intestinal epithelial cells in the GA group [(24.1 ± 2.3)%] (t = 5.159, P < 0.01) and OMT group than in the infection group [(22.5 ± 1.9)%] (t = 4.441, P < 0.05); however, there were no significant differences in the proportion of positive ZO1 expression in mouse intestinal epithelial cells between the GA or OMT groups and the control group (t = 0.037 and 0.742, both P values > 0.05). qPCR assay showed significant differences among the four groups in terms of HMGB1 (F = 21.980, P < 0.000 1), TLR2 (F = 20.630, P < 0.000 1), TLR4 (F = 17.000, P = 0.000 6), MyD88 (F = 8.907, P = 0.000 5) and NF-κB p65 mRNA expression in mouse jejunal tissues (F = 8.889, P = 0.000 7). The relative expression of HMGB1 [(5.97 ± 1.07) vs. (1.05 ± 0.07); t = 6.482, P < 0.05] 、TLR2 [(5.92 ± 1.29) vs. (1.10 ± 0.14); t = 5.272, P < 0.05] 、TLR4 [(5.96 ± 1.50) vs. (1.02 ± 0.03); t = 4.644, P < 0.05] 、MyD88 [(3.00 ± 1.26) vs. (1.02 ± 0.05); t = 2.734, P < 0.05] and NF-κB p65 mRNA [(2.33 ± 0.72) vs. (1.04 ± 0.06); t = 2.665, P < 0.05] was all significantly higher in mouse jejunal tissues in the infection group than in the control group. A significant reduction was detected in the relative expression of HMGB1 (0.63 ± 0.01), TLR2 (0.42 ± 0.10), TLR4 (0.35 ± 0.07), MyD88 (0.70 ± 0.11) and NF-κB p65 mRNA (0.75 ± 0.01) in mouse jejunal tissues in the GA group relative to the control group (t = 8.629, 5.830, 11.500, 4.729 and 6.898, all P values < 0.05), and the relative expression of HMGB1, TLR2, TLR4, MyD88 and NF-κB p65 mRNA significantly reduced in mouse jejunal tissues in the GA group as compared to the infection group (t = 7.052, 6.035, 4.084, 3.165 and 3.274, all P values < 0.05). In addition, the relative expression of HMGB1 (1.14 ± 0.60), TLR2 (1.00 ± 0.24), TLR4 (1.14 ± 0.07), MyD88 (0.96 ± 0.25) and NF-κ B p65 mRNA (1.12 ± 0.17) was significantly lower in mouse jejunal tissues in the OMT group than in the infection group (t = 7.059, 5.320, 3.510, 3.466 and 3.273, all P values < 0.05); however, there were no significant differences between the OMT and control groups in terms of relative expression of HMGB1, TLR2, TLR4, MyD88 or NF-κB p65 mRNA in mouse jejunal tissues (t = 0.239, 0.518, 1.887, 0.427 and 0.641, all P values > 0.05). Conclusions C. parvum infection causes intestinal inflammatory responses and destruction of intestinal mucosal barrier through up-regulating of the HMGB1-TLR2/TLR4-NF-κB pathway. OMT may suppress the intestinal inflammation and repair the intestinal mucosal barrier through inhibiting the activity of the HMGB1-TLR2/TLR4-NF-κB pathway.
9.Study on the correlation between triglyceride glucose index and severe hypertriglyceridemic pancreatitis
Zhihua LU ; Yinshan WU ; Wei SU ; Ying YANG ; Zhiyu YING ; Feng GUO
Chinese Journal of Digestion 2023;43(5):315-320
Objective:To investigate the correlation between triglyceride glucose (TyG) index and severe hypertriglyceridemic pancreatitis (HTGP), and to provide assistance for early evaluation and clinical decision-making of HTGP.Methods:From January 2016 to December 2021, the clinical data of 770 patients diagnosed with HTGP at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine were retrospectively collected. According to severity of pancreatitis, the patients were divided into mild acute pancreatitis (MAP), moderate severe acute pancreatitis (MSAP) and severe acute pancreatitis (SAP) groups, and the differences in TyG index among the 3 groups was compared. According to the quartile range of the TyG index, the patients were divided into TyG Q1, Q2, Q3 and Q4 groups, and the distribution of severity of pancreatitis in each TyG index quartile group was calculated. Kruskal-Wallis H test was used for statistical analysis. Spearman correlation analysis was used to analyze the correlation between TyG index quartile range and the severity of pancreatitis. Linear trend chi-square test was used to analyze the trend of SAP incidence among groups. Binary logistic regression was used to analyze the relationship between TyG index quartile range and the risk of SAP, and the trend test was also conducted. Results:A total of 770 patients with HTGP were included, among them 330 (42.9%), 268 (34.8%) and 172 (22.3%) were MAP, MSAP and SAP, respectively. The TyG indices of MAP, MSAP and SAP group were 11.8(11.3, 12.4), 12.5(11.9, 13.2) and 12.7(12.1, 13.4), respectively, and the differences among the 3 groups were statistically significant ( H=121.77, P<0.001). The TyG index was 12.21 (11.57, 12.94) in the 770 patients. There were 192, 193, 193 and 192 patients enrolled in TyG Q1(TyG index <11.57)、 Q2(TyG index ranged from 11.57 to <12.21)、 Q3(TyG index ranged from 12.21 to <12.94) and Q4(TyG index≥12.94) group, respectively.The correlation test showed that the difference between TyG quartile range and the severity of pancreatitis was statistically significant ( ρ=0.372, P<0.001). The incidence of SAP in TyG Q1, Q2, Q3 and Q4 group was 10.9%(21/192), 14.5%(28/193), 27.5%(53/193) and 36.5%(70/192), respectively. The trend test of SAP incidence among the TyG gruops was statistically significant ( χ2 =44.33, P<0.001). After adjusting for confounding factors, taking the TyG Q1 group as a reference, the OR values of SAP risk (95% confidence interval) of the TyG Q2, Q3 and Q4 groups were 1.250 (0.619 to 2.524), 2.882 (1.506 to 5.514) and 6.660 (3.456 to 12.836), respectively, and the trend test of SAP risk showed a significant difference ( OR=2.508, 95%confidence interval 1.883 to 3.341, P<0.001). Conclusions:There is a correlation between TyG index and severity of pancreatitis in patients with HTGP. As the TyG index increases, the risk of SAP increases in HTGP patients. TyG index may be an early predictor of severe HTGP.
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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