1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Regression analysis of serum microRNAs in predicting early neurological deterioration in patients with branch atheromatous disease
Li NIE ; Xiangliang QIAO ; Wei CHENG ; Suhua HU ; Huanhuan HU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(8):1047-1050
Objective To perform a regression analysis on the predictive value of serum micro-RNAs(miR)for early neurological deterioration(END)in patients with branch atheromatous dis-ease(BAD).Methods A total of 134 BAD patients admitted in our department from February 2020 to February 2023 were enrolled,and according to the END status,they were divided into de-terioration group(28 cases)and non-deterioration group(106 cases).Serum levels of miR-130a,miR-210,miR-141-3p and miR-29a-3p were measured at admission.NIHSS score was used to eval-uate the END status at admission and at 7 d after admission.Binary logistic regression analysis was adopted to construct a model of above four miRs in predicting END in BAD patients.ROC curve was plotted to assess the predictive value of the four miRs alone or combined together for END.Results The serum levels of miR-130a and miR-210 were significantly higher,while those of miR-141-3p and miR-29a-3p were obviously lower in the deterioration group than the non-deterioration group(P<0.01).Logistic regression analysis indicated that serum miR-130a,miR-210,miR-141-3p and miR-29a-3p were independent predictors of END in BAD patients(P<0.05,P<0.01).ROC curve analysis showed that the AUC value of the four miRs combined together in predicting END in BAD patients was 0.977(95%CI:0.936-0.995),with a sensitivity of 96.43%and a specificity of 90.57%,and the combined detection exhibited better predictive effi-ciency than each indicator alone(P<0.01).Conclusion Serum miR-130a,miR-210,miR-141-3p and miR-29a-3p have certain value in predicting END in BAD patients,and their combined detec-tion can enhance its predictive efficiency.
3.Principles, technical specifications, and clinical application of lung watershed topography map 2.0: A thoracic surgery expert consensus (2024 version)
Wenzhao ZHONG ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Wei JIANG ; Deping ZHAO ; Hecheng LI ; Xiaolong YAN ; Lijie TAN ; Junqiang FAN ; Guibin QIAO ; Qiang NIE ; Mingqiang KANG ; Weibing WU ; Hao ZHANG ; Zhigang LI ; Zihao CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):141-152
With the widespread adoption of low-dose CT screening and the extensive application of high-resolution CT, the detection rate of sub-centimeter lung nodules has significantly increased. How to scientifically manage these nodules while avoiding overtreatment and diagnostic delays has become an important clinical issue. Among them, lung nodules with a consolidation tumor ratio less than 0.25, dominated by ground-glass shadows, are particularly worthy of attention. The therapeutic challenge for this group is how to achieve precise and complete resection of nodules during surgery while maximizing the preservation of the patient's lung function. The "watershed topography map" is a new technology based on big data and artificial intelligence algorithms. This method uses Dicom data from conventional dose CT scans, combined with microscopic (22-24 levels) capillary network anatomical watershed features, to generate high-precision simulated natural segmentation planes of lung sub-segments through specific textures and forms. This technology forms fluorescent watershed boundaries on the lung surface, which highly fit the actual lung anatomical structure. By analyzing the adjacent relationship between the nodule and the watershed boundary, real-time, visually accurate positioning of the nodule can be achieved. This innovative technology provides a new solution for the intraoperative positioning and resection of lung nodules. This consensus was led by four major domestic societies, jointly with expert teams in related fields, oriented to clinical practical needs, referring to domestic and foreign guidelines and consensus, and finally formed after multiple rounds of consultation, discussion, and voting. The main content covers the theoretical basis of the "watershed topography map" technology, indications, operation procedures, surgical planning details, and postoperative evaluation standards, aiming to provide scientific guidance and exploration directions for clinical peers who are currently or plan to carry out lung nodule resection using the fluorescent microscope watershed analysis method.
4.Animal experimental study of transoral transgastric endoscopic surgery cholecystectomy
Hong-liang ZHENG ; Huan YANG ; Xu-biao NIE ; Xue PENG ; Qiu-jian QIAO ; Jian-ying BAI
Journal of Regional Anatomy and Operative Surgery 2025;34(7):584-588
Objective To investigate the feasibility and safety of transoral transgastric natural orifice transluminal endoscopic surgery(TG-NOTES)cholecystectomy in miniature pigs.Methods A total of 11 miniature pigs were selected as the experimental subjects and underwent TG-NOTES cholecystectomy.These pigs were divided into the Group A and Group B according to the surgical procedures.Among them,7 miniature pigs in the Group A underwent endoscopic cholecystectomy without dissecting the gallbladder triangle,while 4 miniature pigs in the Group B underwent endoscopic cholecystectomy after dissecting the gallbladder triangle.The success rate of surgery,the time of each stage of surgery,the incidence of complications,the success rate of cholecystectomy and the survival rate of miniature pigs in the two groups were counted.One miniature pig in the Group A and 4 miniature pigs in the Group B were selected for survival experiments.After surviving for 1 week,they were killed and dissected to observe the healing of incision and incidence of complications.Results The surgical survival rate of experimental animals was 100%,and the success rate of cholecystectomy was 100%.There was no significant difference in the surgical time,time of cut the stomach into the abdomen,time of gallbladder exploration or time of gallbladder removal of miniature pigs between the two groups(P>0.05).The time of ligating gallbladder artery of miniature pigs in the Group B was longer than that in the Group A,and the time of isdating gallbladder was shorter than that in the Group A,with statistically significant differences(P<0.05).There was no significant difference in the average number of complications of miniature pigs between the two groups(P>0.05).The dissection of animals after survival experiments revealed that the incisions healed well without serious complications.Conclusion This study successfully establishes the surgical model of TG-NOTES cholecystectomy,and confirms the safety and feasibility of TG-NOTES cholecystectomy.
5.Relationship between serum ANGPTL8 and Sema 3A levels and postoperative cerebral vasospasm in patients with intracranial aneurysm rupture
Li NIE ; Xiangliang QIAO ; Wei CHENG ; Suhua HU ; Huanhuan HU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(9):1238-1241
Objective To analyze the relationship between serum angiopoietin-like protein 8(ANGPTL8)and semaphorin 3A(Sema 3A)levels and postoperative cerebral vasospasm(CVS)in patients with intracranial aneurysm(IA)rupture.Methods A total of 188 patients with IA rupture receiving surgical treatment in our hospital were prospectively selected during October 2021 and October 2023,and according to whether CVS occurred after surgery,they were classified into a spasm group(75 cases)and a non-spasm group(113 cases).Serum ANGPTL8 and Sema 3A levels were measured after admission.Spearman correlation analysis was performed to assess the correlation of the levels with CVS occurrence.Binary logistic regression analysis was applied to construct a prediction model with serum ANGPTL8 and Sema 3A as variables.ROC curve was plotted to evaluate the predictive value of the levels for postoperative CVS.Results The serum ANGPTL8 level was significantly higher while that of Sema 3A was obviously lower in the spasm group then the non-spasm group(P<0.01).Binary logistic regression analysis showed that the levels of serum ANGPTL8 and Sema 3A were independent predictors of postoperative CVS in patients with ruptured IA(OR=1.021,95%CI:1.013-1.029,P=0.000;OR=0.980,95%CI:0.967-0.993,P=0.003).ROC curve analysis indicated that the AUC value,sensitivity and speci-ficity of the two indicators combined together in predicting postoperative CVS was 0.939(95%CI:0.894-0.969),89.33%and 89.38%,respectively,with better predictive efficiency than each indicator alone(P<0.01).Conclusion Serum ANGPTL8 and Sema 3A levels are closely associat-ed with postoperative CVS in patients with IA rupture,and they can be used as effective indicators for early prediction of postoperative CVS.
6.Management and practice of antiplatelet therapy after percutaneous coronary intervention in patient with chronic kidney disease undergoing hemodialysis
Hao TANG ; Yan QIAO ; Yan YAN ; Shaoping NIE
Adverse Drug Reactions Journal 2025;27(2):115-119
With the increasing prevalence of chronic kidney disease (CKD) and the progress of renal replacement therapy, there were more and more patients with long-term hemodialysis (hemodialysis). Cardiovascular diseases were the leading cause of death among hemodialysis patients, and a lot of these patients needed to be treated with percutaneous coronary intervention (PCI). However, hemodialysis patients had higher risks of both bleeding and thrombotic events, which made it difficulty to select drugs and their dosages for post-PCI dual antiplatelet therapy in clinical practice, and the impacts of hemodialysis on dual antiplatelet therapy were still unclear. We reported a 65-year-old male patient with CKD, who was on long-term hemodialysis treatment and underwent PCI for acute non-ST segment elevation myocardial infarction. The patient was given dual antiplatelet therapy with aspirin and clopidogrel after the procedure, and on the fourth day after PCI (14 hours after restarting hemodialysis), he developed subacute stent thrombosis due to clopidogrel resistance, which was resolved after revascularization. Based on the treatment experience in this patient and review of relevant literature, we proposed recommendations on management of dual antiplatelet therapy in long-term hemodialysis patients from 3 aspects: drug selection, clopidogrel dose adjustment, and hemodialysis management after PCI.
7.Animal experimental study of transoral transgastric endoscopic surgery cholecystectomy
Hong-liang ZHENG ; Huan YANG ; Xu-biao NIE ; Xue PENG ; Qiu-jian QIAO ; Jian-ying BAI
Journal of Regional Anatomy and Operative Surgery 2025;34(7):584-588
Objective To investigate the feasibility and safety of transoral transgastric natural orifice transluminal endoscopic surgery(TG-NOTES)cholecystectomy in miniature pigs.Methods A total of 11 miniature pigs were selected as the experimental subjects and underwent TG-NOTES cholecystectomy.These pigs were divided into the Group A and Group B according to the surgical procedures.Among them,7 miniature pigs in the Group A underwent endoscopic cholecystectomy without dissecting the gallbladder triangle,while 4 miniature pigs in the Group B underwent endoscopic cholecystectomy after dissecting the gallbladder triangle.The success rate of surgery,the time of each stage of surgery,the incidence of complications,the success rate of cholecystectomy and the survival rate of miniature pigs in the two groups were counted.One miniature pig in the Group A and 4 miniature pigs in the Group B were selected for survival experiments.After surviving for 1 week,they were killed and dissected to observe the healing of incision and incidence of complications.Results The surgical survival rate of experimental animals was 100%,and the success rate of cholecystectomy was 100%.There was no significant difference in the surgical time,time of cut the stomach into the abdomen,time of gallbladder exploration or time of gallbladder removal of miniature pigs between the two groups(P>0.05).The time of ligating gallbladder artery of miniature pigs in the Group B was longer than that in the Group A,and the time of isdating gallbladder was shorter than that in the Group A,with statistically significant differences(P<0.05).There was no significant difference in the average number of complications of miniature pigs between the two groups(P>0.05).The dissection of animals after survival experiments revealed that the incisions healed well without serious complications.Conclusion This study successfully establishes the surgical model of TG-NOTES cholecystectomy,and confirms the safety and feasibility of TG-NOTES cholecystectomy.
8.Management and practice of antiplatelet therapy after percutaneous coronary intervention in patient with chronic kidney disease undergoing hemodialysis
Hao TANG ; Yan QIAO ; Yan YAN ; Shaoping NIE
Adverse Drug Reactions Journal 2025;27(2):115-119
With the increasing prevalence of chronic kidney disease (CKD) and the progress of renal replacement therapy, there were more and more patients with long-term hemodialysis (hemodialysis). Cardiovascular diseases were the leading cause of death among hemodialysis patients, and a lot of these patients needed to be treated with percutaneous coronary intervention (PCI). However, hemodialysis patients had higher risks of both bleeding and thrombotic events, which made it difficulty to select drugs and their dosages for post-PCI dual antiplatelet therapy in clinical practice, and the impacts of hemodialysis on dual antiplatelet therapy were still unclear. We reported a 65-year-old male patient with CKD, who was on long-term hemodialysis treatment and underwent PCI for acute non-ST segment elevation myocardial infarction. The patient was given dual antiplatelet therapy with aspirin and clopidogrel after the procedure, and on the fourth day after PCI (14 hours after restarting hemodialysis), he developed subacute stent thrombosis due to clopidogrel resistance, which was resolved after revascularization. Based on the treatment experience in this patient and review of relevant literature, we proposed recommendations on management of dual antiplatelet therapy in long-term hemodialysis patients from 3 aspects: drug selection, clopidogrel dose adjustment, and hemodialysis management after PCI.
9.Regression analysis of serum microRNAs in predicting early neurological deterioration in patients with branch atheromatous disease
Li NIE ; Xiangliang QIAO ; Wei CHENG ; Suhua HU ; Huanhuan HU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(8):1047-1050
Objective To perform a regression analysis on the predictive value of serum micro-RNAs(miR)for early neurological deterioration(END)in patients with branch atheromatous dis-ease(BAD).Methods A total of 134 BAD patients admitted in our department from February 2020 to February 2023 were enrolled,and according to the END status,they were divided into de-terioration group(28 cases)and non-deterioration group(106 cases).Serum levels of miR-130a,miR-210,miR-141-3p and miR-29a-3p were measured at admission.NIHSS score was used to eval-uate the END status at admission and at 7 d after admission.Binary logistic regression analysis was adopted to construct a model of above four miRs in predicting END in BAD patients.ROC curve was plotted to assess the predictive value of the four miRs alone or combined together for END.Results The serum levels of miR-130a and miR-210 were significantly higher,while those of miR-141-3p and miR-29a-3p were obviously lower in the deterioration group than the non-deterioration group(P<0.01).Logistic regression analysis indicated that serum miR-130a,miR-210,miR-141-3p and miR-29a-3p were independent predictors of END in BAD patients(P<0.05,P<0.01).ROC curve analysis showed that the AUC value of the four miRs combined together in predicting END in BAD patients was 0.977(95%CI:0.936-0.995),with a sensitivity of 96.43%and a specificity of 90.57%,and the combined detection exhibited better predictive effi-ciency than each indicator alone(P<0.01).Conclusion Serum miR-130a,miR-210,miR-141-3p and miR-29a-3p have certain value in predicting END in BAD patients,and their combined detec-tion can enhance its predictive efficiency.
10.Relationship between serum ANGPTL8 and Sema 3A levels and postoperative cerebral vasospasm in patients with intracranial aneurysm rupture
Li NIE ; Xiangliang QIAO ; Wei CHENG ; Suhua HU ; Huanhuan HU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(9):1238-1241
Objective To analyze the relationship between serum angiopoietin-like protein 8(ANGPTL8)and semaphorin 3A(Sema 3A)levels and postoperative cerebral vasospasm(CVS)in patients with intracranial aneurysm(IA)rupture.Methods A total of 188 patients with IA rupture receiving surgical treatment in our hospital were prospectively selected during October 2021 and October 2023,and according to whether CVS occurred after surgery,they were classified into a spasm group(75 cases)and a non-spasm group(113 cases).Serum ANGPTL8 and Sema 3A levels were measured after admission.Spearman correlation analysis was performed to assess the correlation of the levels with CVS occurrence.Binary logistic regression analysis was applied to construct a prediction model with serum ANGPTL8 and Sema 3A as variables.ROC curve was plotted to evaluate the predictive value of the levels for postoperative CVS.Results The serum ANGPTL8 level was significantly higher while that of Sema 3A was obviously lower in the spasm group then the non-spasm group(P<0.01).Binary logistic regression analysis showed that the levels of serum ANGPTL8 and Sema 3A were independent predictors of postoperative CVS in patients with ruptured IA(OR=1.021,95%CI:1.013-1.029,P=0.000;OR=0.980,95%CI:0.967-0.993,P=0.003).ROC curve analysis indicated that the AUC value,sensitivity and speci-ficity of the two indicators combined together in predicting postoperative CVS was 0.939(95%CI:0.894-0.969),89.33%and 89.38%,respectively,with better predictive efficiency than each indicator alone(P<0.01).Conclusion Serum ANGPTL8 and Sema 3A levels are closely associat-ed with postoperative CVS in patients with IA rupture,and they can be used as effective indicators for early prediction of postoperative CVS.

Result Analysis
Print
Save
E-mail