1.Analysis of risk factors for neurological complications in patients with Stanford type A aortic dissection
Chuanwen LI ; Qingyan SUN ; Yanqing GAN ; Xianqing LI ; Teng CAI ; Hongsheng LIU ; Liangchun NI ; Zhonghua FEI
Chinese Journal of Postgraduates of Medicine 2025;48(7):635-642
Objective:To explore how one-sided/two-sided brain blood flow affects the occurrence of neurological complications in patients with Stanford type A aortic dissection, as well as to assess the factors that contribute to the development of neurological complications.Methods:A total of 162 patients diagnosed with Stanford type A aortic dissection who had undergone ascending aorta and total aortic arch replacement at Affiliated Hospital of Jining Medical College from August 2020 to December 2023 were retrospectively reviewed. These patients were categorized into two groups based on the presence of postoperative neurological complications: a group with neurological complications comprising 77 cases and a group without neurological complications comprising 85 cases. A comparative analysis was carried out on general clinical data, surgical and brain perfusion characteristics, as well as preoperative test indicators between these two groups in order to investigate the factors influencing the occurrence of postoperative neurological complications in patients with Stanford type A aortic dissection. The data was analyzed using Logistic regression to identify the risk factors associated with postoperative neurological complications and to develop a predictive nomogram model. Calibration curves, receiver operating characteristic (ROC) curves and decision curve (DCA) were generated to assess the accuracy and predictive capability of the nomogram model.Results:In the group of patients who experienced neurological complications, there was a higher prevalence of a history of hypertension, longer operation time, extended periods of cardiopulmonary bypass, cross-clamping, brain perfusion, cooling, and rewarming, as well as increased postoperative drainage volume. Additionally, the levels of preoperative blood urea nitrogen (BUN), creatinine (Cr) and lactic acid (Lac) were elevated compared to those in the non-neurological complications group: 77.9% (60/77) vs. 52.9% (45/85), (409.99 ± 104.26) min vs. (348.29 ± 63.12) min, (223.36 ± 66.86) min vs. (179.25 ± 38.59) min, 112 (94, 133) min vs. 96 (84, 113) min, (35.23 ± 9.89) min vs. (32.14 ± 6.81) min, (82.19 ± 28.69) min vs. (68.76 ± 29.06) min, (79.30 ± 22.60) min vs. (69.54 ± 16.42) min, 806 (529, 1 127) ml vs. 663 (449, 925) ml, 6.78 (5.38, 8.84) mmol/L vs. 6.08 (4.66, 7.76) mmol/L, 86.3 (64.0, 131.9) μmol/L vs. 71.0 (55.6, 84.9) μmol/L, 2.1(1.2, 4.0) mmol/L vs. 1.5 (0.9, 2.3) mmol/L. On the other hand, the percentage of patients who underwent bilateral brain perfusion was lower, and they experienced lower lowest temperature, preoperative platelet count, and ejection fraction levels than those in the non-neurological complications group: 57.1% (44/77) vs. 75.3% (64/85), (25.69 ± 1.04) ℃ vs. (26.04 ± 0.82) ℃, (175.79 ± 58.14) ×10 9/L vs. (213.87 ± 77.29) ×10 9/L, (54.18 ± 3.84)% vs. (55.34 ± 3.56)% ( P<0.05). Multivariate Logistic regression analysis revealed that a prior history of high blood pressure, prolonged cardiopulmonary bypass duration were identified as autonomous risk factors for the development of postoperative neurological issues in individuals with Stanford type A aortic dissection, while simultaneous brain perfusion emerged as an independent protective element ( P<0.05). Subsequently, a predictive nomogram was constructed incorporating these three pivotal factors to assess the likelihood of postoperative neurological complications in patients with Stanford type A aortic dissection. The calibration curve exhibited a noteworthy level of accuracy for the nomogram predictive model ( χ2 = 9.01, P = 0.342). Additionally, the ROC curve analysis displayed an area under the curve of 0.84 (95% CI 0.78 to 0.90) for the nomogram model in predicting postoperative neurological complications in patients with Stanford type A aortic dissection, indicating a high predictive accuracy. Moreover, DCA analysis indicated that the nomogram model provided a net benefit above 0 across the spectrum of 0 to 90%. Conclusions:Postoperative neurological complications in patients with Stanford type A aortic dissection is linked to factors such as a previous history of hypertension, unilateral brain perfusion, an extended cardiopulmonary bypass duration. By developing a nomogram model that incorporates these factors, it becomes feasible to accurately forecast the likelihood of postoperative neurological complications in this patient population. This predictive tool holds significant value in facilitating proactive clinical risk evaluation and preventive measures.
2.Analysis of recurrent cervical abscess: a case report.
Junxin WANG ; Hui WANG ; Maogang SUN ; Endong ZHANG ; Zhonghua ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(6):574-577
This report presents a case of esophageal fistula with recurrent cervical abscess as the initial symptom. The patient underwent anterior cervical fracture reduction and internal fixation in 2021 due to trauma. In 2023, the patient received radiofrequency ablation for bilateral thyroid lobe lesions, after which recurrent cervical abscesses occurred over an 8-month period. Fiberoptic laryngoscopy with the biopsy channel insufflation method revealed a large esophageal fistula at the esophageal inlet. After removing the internal fixation plate, the patient received daily wound care, and serial fiberoptic laryngoscopy revealed spontaneous healing of the esophageal fistula. During the 1-year follow-up, no recurrence of cervical abscess was observed, and the esophageal fistula healed well.
Humans
;
Abscess
;
Recurrence
;
Neck
;
Female
;
Adult
;
Fracture Fixation, Internal
3.Current situation investigation and analysis of influencing factors on the long-term quality of life of cured and discharged patients with severe acute pancreatitis.
Wenjun ZHOU ; Pinjie ZHANG ; Weili YU ; Zhonghua LU ; Mingjuan LI ; Lijun CAO ; Lu FU ; Shaokang WANG ; Yun SUN
Chinese Critical Care Medicine 2025;37(2):146-152
OBJECTIVE:
To investigate the current status of long-term quality of life in patients with severe acute pancreatitis (SAP) who have been cured and discharged, and to analyze the influencing factors affecting long-term quality of life in SAP cured patients after discharge.
METHODS:
A retrospective collection was conducted. Patients who were received standardized treatment before being cured and discharged from the hospital admitted to the first department of critical care medcine of the Second Affiliated Hospital of Anhui Medical University from January 2017 to December 2023 were enrolled. According to the 36-item short form health survey scale (SF-36) score, patients were divided into high score group (high quality of life, the top 50% of patients with total SF-36 score) and low score group (low quality of life, the bottom 50% of patients with total SF-36 score). The gender, age, history of hypertension and diabetes, etiology of pancreatitis, acute physiology and chronic health evaluation II (APACHE II), sequential organ failure assessment (SOFA), CT severity index (CTSI), laboratory indicators such as C-reactive protein (CRP), procalcitonin (PCT), blood glucose, and triglycerides upon admission, use of vasoactive drugs, non-invasive/high-flow ventilation, invasive ventilation, retroperitoneal puncture and drainage, open pancreatic surgery treatment and secondary infection during hospitalization were collected, as well as the retention of abdominal drainage tubes at discharge from hospital. Distribute follow-up questionnaires or telephone follow-up surveys through WeChat and Question Star programs to investigate the pancreatic secretion function, chronic abdominal pain, and recurrence of pancreatitis of patients after discharge. Multivariable Logistic regression was used to analyze the relevant factors affecting the long-term quality of life of cured patients with SAP.
RESULTS:
A total of 86 patients were ultimately enrolled. There were 43 patients in both the high and low score groups. Among 86 patients, 20 experienced acute pancreatitis recurrence, with a recurrence rate of 23.26%. Twenty-two (25.58%) experienced chronic abdominal pain after discharge, and 5 patients (5.81%) needed medication to relieve pain. Thirty-three patients (38.37%) had pancreatic exocrine dysfunction after discharge, characterized by abdominal distension, constipation or diarrhea. Twenty-two patients (25.58%) suffered from pancreatic endocrine dysfunction, and were diagnosed with diabetes. Univariate analysis showed that compared with the high score group, the low score group had more patients with hypertension, initial renal dysfunction, initial severe metabolic acidosis, initial serum calcium < 2.0 mmol/L, blood glucose > 11.1 mmol/L and cultured Gram positive bacteria (from blood/body fluid/pancreatic necrotic tissue) during treatment (48.84% vs. 16.28%, 60.47% vs. 32.56%, 18.60% vs. 4.65%, 88.37% vs. 62.79%, 55.81% vs. 30.23%, 34.88% vs. 13.95%), had higher CTSI score (6.60±1.61 vs. 5.77±1.32), lower hemoglobin level at discharge (g/L: 102.30±18.78 vs. 110.72±16.68), and a lower proportion of etiological interventions after discharge (34.88% vs. 67.44%), the differences were statistically significant (all P < 0.05). Multivariate Logistic regression analysis showed that hypertension [odds ratio (OR) = 4.814, 95% confidence interval (95%CI) was 1.196-19.378], initial serum calcium < 2.0 mmol/L (OR = 6.688, 95%CI was 1.321-33.873) and initial blood glucose > 11.1 mmol/L (OR = 6.473, 95%CI was 1.399-29.950) were risk factors for long-term quality of life in cured SAP patients (all P < 0.05), while post discharge prophylactic intervention was a protective factor for long-term quality of life (OR = 0.092, 95%CI was 0.020-0.425, P < 0.01).
CONCLUSIONS
Cured SAP patients have varying degrees of impaired secretion function and the possibility of recurrence of acute pancreatitis. Hypertension, initial serum calcium < 2.0 mmol/L and blood glucose > 11.1 mmol/L are independent influencing factors for low long-term quality of life in cured SAP patients. Prevention and intervention targeting the etiology of pancreatitis after discharge can improve the long-term quality of life of cured SAP patients.
Humans
;
Quality of Life
;
Retrospective Studies
;
Pancreatitis/therapy*
;
Patient Discharge
;
Male
;
Female
;
Middle Aged
;
APACHE
;
Adult
;
Acute Disease
;
Aged
4.Analysis of risk factors for neurological complications in patients with Stanford type A aortic dissection
Chuanwen LI ; Qingyan SUN ; Yanqing GAN ; Xianqing LI ; Teng CAI ; Hongsheng LIU ; Liangchun NI ; Zhonghua FEI
Chinese Journal of Postgraduates of Medicine 2025;48(7):635-642
Objective:To explore how one-sided/two-sided brain blood flow affects the occurrence of neurological complications in patients with Stanford type A aortic dissection, as well as to assess the factors that contribute to the development of neurological complications.Methods:A total of 162 patients diagnosed with Stanford type A aortic dissection who had undergone ascending aorta and total aortic arch replacement at Affiliated Hospital of Jining Medical College from August 2020 to December 2023 were retrospectively reviewed. These patients were categorized into two groups based on the presence of postoperative neurological complications: a group with neurological complications comprising 77 cases and a group without neurological complications comprising 85 cases. A comparative analysis was carried out on general clinical data, surgical and brain perfusion characteristics, as well as preoperative test indicators between these two groups in order to investigate the factors influencing the occurrence of postoperative neurological complications in patients with Stanford type A aortic dissection. The data was analyzed using Logistic regression to identify the risk factors associated with postoperative neurological complications and to develop a predictive nomogram model. Calibration curves, receiver operating characteristic (ROC) curves and decision curve (DCA) were generated to assess the accuracy and predictive capability of the nomogram model.Results:In the group of patients who experienced neurological complications, there was a higher prevalence of a history of hypertension, longer operation time, extended periods of cardiopulmonary bypass, cross-clamping, brain perfusion, cooling, and rewarming, as well as increased postoperative drainage volume. Additionally, the levels of preoperative blood urea nitrogen (BUN), creatinine (Cr) and lactic acid (Lac) were elevated compared to those in the non-neurological complications group: 77.9% (60/77) vs. 52.9% (45/85), (409.99 ± 104.26) min vs. (348.29 ± 63.12) min, (223.36 ± 66.86) min vs. (179.25 ± 38.59) min, 112 (94, 133) min vs. 96 (84, 113) min, (35.23 ± 9.89) min vs. (32.14 ± 6.81) min, (82.19 ± 28.69) min vs. (68.76 ± 29.06) min, (79.30 ± 22.60) min vs. (69.54 ± 16.42) min, 806 (529, 1 127) ml vs. 663 (449, 925) ml, 6.78 (5.38, 8.84) mmol/L vs. 6.08 (4.66, 7.76) mmol/L, 86.3 (64.0, 131.9) μmol/L vs. 71.0 (55.6, 84.9) μmol/L, 2.1(1.2, 4.0) mmol/L vs. 1.5 (0.9, 2.3) mmol/L. On the other hand, the percentage of patients who underwent bilateral brain perfusion was lower, and they experienced lower lowest temperature, preoperative platelet count, and ejection fraction levels than those in the non-neurological complications group: 57.1% (44/77) vs. 75.3% (64/85), (25.69 ± 1.04) ℃ vs. (26.04 ± 0.82) ℃, (175.79 ± 58.14) ×10 9/L vs. (213.87 ± 77.29) ×10 9/L, (54.18 ± 3.84)% vs. (55.34 ± 3.56)% ( P<0.05). Multivariate Logistic regression analysis revealed that a prior history of high blood pressure, prolonged cardiopulmonary bypass duration were identified as autonomous risk factors for the development of postoperative neurological issues in individuals with Stanford type A aortic dissection, while simultaneous brain perfusion emerged as an independent protective element ( P<0.05). Subsequently, a predictive nomogram was constructed incorporating these three pivotal factors to assess the likelihood of postoperative neurological complications in patients with Stanford type A aortic dissection. The calibration curve exhibited a noteworthy level of accuracy for the nomogram predictive model ( χ2 = 9.01, P = 0.342). Additionally, the ROC curve analysis displayed an area under the curve of 0.84 (95% CI 0.78 to 0.90) for the nomogram model in predicting postoperative neurological complications in patients with Stanford type A aortic dissection, indicating a high predictive accuracy. Moreover, DCA analysis indicated that the nomogram model provided a net benefit above 0 across the spectrum of 0 to 90%. Conclusions:Postoperative neurological complications in patients with Stanford type A aortic dissection is linked to factors such as a previous history of hypertension, unilateral brain perfusion, an extended cardiopulmonary bypass duration. By developing a nomogram model that incorporates these factors, it becomes feasible to accurately forecast the likelihood of postoperative neurological complications in this patient population. This predictive tool holds significant value in facilitating proactive clinical risk evaluation and preventive measures.
5.Chemical components in cultivated Cordyceps sinensis and their effects on fibrosis.
Chinese Herbal Medicines 2024;16(1):162-167
OBJECTIVE:
Cultivated Cordyceps sinensis powder has been used as clinical drug and healthy food to nourish the lung and kidney, which solves the problem of serious shortage of wild C. sinensis. This study aims to explore the chemical components and compared their anti-fibrotic effects in cultivated C. sinensis.
METHODS:
Nucleosides, sterols and polysaccharides were separated and purified from cultivated C. sinensis, and analyzed by high performance liquid chromatography, gas chromatography-mass spectrometry and chemical chromogenic methods, respectively. In high glucose-induced rat mesangial cell models, fibronectin and type 1 collagen were used as evaluation indicators.
RESULTS:
There were 10 kinds of nucleosides and one sterol in cultivated C. sinensis. The contents of nucleosides, sterols and polysaccharides in the cultivated C. sinensis were close to 2%, 0.55% and 4.4%, respectively. Furthermore, nucleoside, sterol and polysaccharide components exhibited varying degrees of anti-fibrotic activity. The nucleoside components and sterol components inhibited the expression of extracellular matrix more effectively in the three main components.
CONCLUSION
Cultivated C. sinensis remains the similar compounds with the wild C. sinensis, and nucleosides and sterols may be the main active substances that contribute to its anti-fibrotic effects. The project of this study may provide valuable information on further optimization of more effective remedies with few side effects based on cultivated C. sinensis.
6.Characteristics of human papillomavirus prevalence and genotype distribution of 18 535 cases in Yuncheng
Wugang SUN ; Haitao XIE ; Xiali CHEN ; Zhonghua LUAN ; Mengxin LU
Journal of Public Health and Preventive Medicine 2024;35(5):113-116
Objective To investigate the characteristics of human papillomavirus (HPV) prevalence and genotype distribution of 18 535 cases in Yuncheng . Methods A sample of 18535 residents who underwent HPV testing in our hospital from August 2020 to September 2023 were enrolled, and HPV genotyping was done to all samples. Then the rate of HPV infection, age distribution, genotype distribution, and multiple infections were statistically analyzed. Results Of the 18,535 subjects included, a total of 4,639 tested positive for HPV, demonstrating a positive rate of 25.03%. The positive rate of HPV infection varied among different age groups (χ2=29.587, P<0.05), with higher rates found in <25 years old group (29.61%) and >60 years old group (25.89%). Overall, 23 genotypes, covering 5315 viruses, were detected. There were 5 low-risk genotypes with the highest percentage of HPV42 (9.29%), and there were 18 high-risk genotypes with HPV52, HPV58, HPV66 and HPV53, subtypes as the most frequent subtypes, accounting for 13.64%, 8.97%, 7.41% and 7.04%, respectively. The type of HPV infection was predominantly single infections, with an overall single infection rate of 21.62% (4008/18535), which accounted for 86.40% (4 008/4 639) of all positive cases, and a multiple genotype infections rate of 3.40% (631/18535). The 25-34 year old group accounted for the largest proportion of single infections (25.12%), while the <25 year old group accounted for the largest proportion of multiple genotype infections (30.74%). Conclusion The prevalence rate of HPV infection in Yuncheng is 25.03%, with a higher positive rate in the <25 years age group and the >60 years age group. A total of 23 HPV genotypes are detected, of which the main genotypes are HPV42, HPV58, HPV66 and HPV53, and the type of infection is dominated by single infections.
7.Pharmacometabolomics and mass spectrometry imaging approach to reveal the neurochemical mechanisms of Polygala tenuifolia
Li QIAN ; Bai JINPENG ; Ma YUXUE ; Sun YU ; Zhou WENBIN ; Wang ZHAOYING ; Zhou ZHI ; Wang ZHONGHUA ; Chen YANHUA ; Abliz ZEPER
Journal of Pharmaceutical Analysis 2024;14(7):1035-1046
Polygala tenuifolia,commonly known as Yuanzhi(YZ)in Chinese,has been shown to possess anti-insomnia properties.However,the material basis and the mechanism underlying its sedative-hypnotic effects remain unclear.Herein,we investigated the active components and neurochemical mechanism of YZ extracts using liquid chromatography tandem mass spectrometry(LC-MS/MS)-based pharmaco-metabolomics and mass spectrometry imaging(MSI)-based spatial resolved metabolomics.According to the results,17 prototypes out of 101 ingredients in the YZ extract were detected in both the plasma and brain,which might be the major components contributing to the sedative-hypnotic effects.Network pharmacology analysis revealed that these prototypes may exert their effects through neuroactive ligand-receptor interaction,serotonergic synapse,dopaminergic synapse,and dopaminergic synapse,among other pathways.LC-MS/MS-based targeted metabolomics and Western blot(WB)revealed that tryptophan-serotonin-melatonin(Trp-5-HT-Mel)and tyrosine-norepinephrine-adrenaline(Tyr-Ne-Ad)are the key regulated pathways.Dopa decarboxylase(DDC)upregulation and phenylethanolamine N-methyltransferase(PNMT)downregulation further confirmed these pathways.Furthermore,MSI-based spatially resolved metabolomics revealed notable alterations in 5-HT in the pineal gland(PG),and Ad in the brainstem,including the middle brain(MB),pons(PN),and hypothalamus(HY).In summary,this study illustrates the efficacy of an integrated multidimensional metabolomics approach in unraveling the sedative-hypnotic effects and neurochemical mechanisms of a Chinese herbal medicine,YZ.
8.Research on the application of medical dialectics combined with textbook-based problem-oriented teaching in hematology internship teaching
Yuying LI ; Yehui TAN ; Jingnan SUN ; Zhonghua DU ; Sujun GAO
Chinese Journal of Medical Education Research 2024;23(6):804-808
Objective:To explore the application of medical dialectics combined with problem-oriented teaching based on textbooks in hematology internship teaching.Methods:A total of 100 undergraduate students who practiced in the Department of Hematology of the First Hospital of Jilin University from 2022 to 2023 were selected as the research subjects. Students were randomly assigned to a control group and an observation group, with 50 students in each group. The control group received traditional teaching, while the observation group received medical dialectics combined with textbook-based problem-oriented teaching. We assessed the theoretical and operational scores, classroom performance, comprehensive abilities, and teaching satisfaction of two groups of students using t-test and χ 2 test in SPSS 22.0. Results:The theoretical and operational scores of the observation group were (94.26±5.35) points and (92.68±4.72) points, respectively. The theoretical and operational scores of the control group were (86.16±5.42) points and (81.52±5.28) points, respectively. The differences between the two groups were statistically significant ( P<0.001). The recognition rates were significantly higher by students in the observation group than in the control group ( P<0.05) in terms of improving learning efficiency, self-learning ability, understanding and comprehensive analysis of diseases, problem-solving ability, language and organizational expression ability, integration of theory and practice, clinical thinking ability, and independent thinking ability. The satisfaction with teaching was higher in the observation group than in the control group ( P<0.05) in terms of teaching attitudes, teaching methods, teaching arrangements, practicality of teaching content, clear explanation of teaching theories, and outstanding teaching objectives. Conclusions:The medical dialectics combined with textbook-based problem-oriented teaching can improve the assessment scores of medical students, while helping to cultivate their comprehensive abilities and develop good clinical diagnosis and treatment thinking.
9.Exploration of the Path of Integrating Wu Liande’s Spirit into Professional Spirit Education for Medical Students
Fangjie CHEN ; Sijia LIU ; Yuhang SUN ; Meng WANG ; Zhonghua LI
Chinese Medical Ethics 2023;36(12):1389-1393
Wu Liande’s spirit was formed during the development of modern public health in China. It is a unity of the spirit of patriotism, humanitarianism, scientific exploration, and dedication, and a valuable resource and vivid textbook for medical students to carry out professional spirit education. Promoting Wu Liande’s spirit in the new era is not only conducive to inspiring the patriotism of medical students, bravely undertaking the mission of the times, and devoting themselves to the cause of human health, but also conducive to guiding medical students to refine benevolence and skill, and fulfill the sacred oath of medical students. To cultivate the professional spirit of medical students with Wu Liande’s spirit, it is necessary to achieve the "integration of specialized courses and ideological and political education" , promote the collaborative development of ideological and political courses and curriculum ideological and political education, innovate teaching methods and use modern information technology to empower Wu Liande’s spirit to be visualized and expressed, and take discipline practice as the starting point to expand the new path of professional spirit practice education for medical students.
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


Result Analysis
Print
Save
E-mail