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.Comparison of the efficacy of continuous VA chemotherapy and I/HDAC consolidation in postremission therapy for acute myeloid leukemia fit for standard chemotherapy
Li SUN ; Pengpeng ZHANG ; Simei REN ; Nan ZHOU ; Liyuan LI ; Zhenzhen WANG ; Weiguang CUI ; Fan YANG ; Jianmin LUO ; Lin YANG
Chinese Journal of Hematology 2025;46(4):343-348
Objective:To compare the efficacy and safety of continuous venetoclax combined azacitidine (VA) chemotherapy and intermedium/high-dose cytarabine (I/HDAC) consolidation in patients with acute myeloid leukemia (AML) fit for standard chemotherapy (transform from UNFIT) .Methods:Clinical data of patients who were fit for standard chemotherapy were collected among those with AML who underwent VA induction in the Department of Hematology, the Second Hospital of Hebei Medical University. The overall survival (OS), relapse-free survival (RFS), event-free survival (EFS), and incidence of adverse events were analyzed retrospectively.Results:This study enrolled 69 patients, consisting of 46 cases in the VA group and 23 cases in the I/HDAC group. We revealed the following. ① The median OS, RFS, EFS were 26.18, 24.69, 20.34 months in the VA group, and 34.14, 30.99, 28.42 months in the I/HDAC group, respectively, with no statistically significant difference (all P>0.05). Median OS of patients who underwent I/HDAC consolidation with European Leukemia Net (ELN) favorable-risk, positive measurable residual disease (MRD), wild type FLT3, or IDH1/2 mutation was significantly longer than those who received VA ( P<0.05). ②Adverse events rate of grade 3 - 4 neutropenia, grade 3 - 4 thrombocytopenia, and bacteremia were significantly lower in the VA group than in the I/HDAC group ( P<0.05) . Conclusions:I/HDAC consolidation was more likely to help get survival benefits for patients with ELN favorable-risk, positive MRD, wild type FLT3, or IDH1/2 mutation. Continuous VA chemotherapy exhibited superior safety than I/HDAC consolidation.
3.Comparison of the efficacy of continuous VA chemotherapy and I/HDAC consolidation in postremission therapy for acute myeloid leukemia fit for standard chemotherapy
Li SUN ; Pengpeng ZHANG ; Simei REN ; Nan ZHOU ; Liyuan LI ; Zhenzhen WANG ; Weiguang CUI ; Fan YANG ; Jianmin LUO ; Lin YANG
Chinese Journal of Hematology 2025;46(4):343-348
Objective:To compare the efficacy and safety of continuous venetoclax combined azacitidine (VA) chemotherapy and intermedium/high-dose cytarabine (I/HDAC) consolidation in patients with acute myeloid leukemia (AML) fit for standard chemotherapy (transform from UNFIT) .Methods:Clinical data of patients who were fit for standard chemotherapy were collected among those with AML who underwent VA induction in the Department of Hematology, the Second Hospital of Hebei Medical University. The overall survival (OS), relapse-free survival (RFS), event-free survival (EFS), and incidence of adverse events were analyzed retrospectively.Results:This study enrolled 69 patients, consisting of 46 cases in the VA group and 23 cases in the I/HDAC group. We revealed the following. ① The median OS, RFS, EFS were 26.18, 24.69, 20.34 months in the VA group, and 34.14, 30.99, 28.42 months in the I/HDAC group, respectively, with no statistically significant difference (all P>0.05). Median OS of patients who underwent I/HDAC consolidation with European Leukemia Net (ELN) favorable-risk, positive measurable residual disease (MRD), wild type FLT3, or IDH1/2 mutation was significantly longer than those who received VA ( P<0.05). ②Adverse events rate of grade 3 - 4 neutropenia, grade 3 - 4 thrombocytopenia, and bacteremia were significantly lower in the VA group than in the I/HDAC group ( P<0.05) . Conclusions:I/HDAC consolidation was more likely to help get survival benefits for patients with ELN favorable-risk, positive MRD, wild type FLT3, or IDH1/2 mutation. Continuous VA chemotherapy exhibited superior safety than I/HDAC consolidation.
4.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.
5.A clinical study on the application of different feeding formulas in early postnatal feeding of premature infants
LuYan HAN ; Miao LI ; YaNan GU ; LiFeng CUI ; LiYuan ZHANG ; XiaoJing XU
Chinese Journal of Clinical Nutrition 2024;32(3):160-166
Objective:To investigate the effects of different feeding formulas on the feeding and growth and metabolism of premature infants in the early postnatal period.Methods:Eligible premature infants with the gestational age of ≤ 34 weeks hospitalized from March 2023 to March 2024 were selected as per inclusion criteria, excluding those with congenital metabolic diseases, severe congenital heart disease and developmental malformations of digestive tract. According to the feeding formulas within 2 weeks after birth, premature infants were divided into three groups, namely donor human milk (DHM) group, preterm formula (PF) group and extensively hydrolyzed formula (eHF) group. The characteristics of premature infants, perinatal condition, feeding formulas, milk intake on the 7th and 14th day, the time to the daily milk intake of 120ml/kg and 150ml/kg respectively, the time on parenteral nutrition, the length of hospitalization, feeding intolerance, cholestasis, extrauterine growth retardation and biochemical metabolic indexes at 7 days, 14 days and discharge were collected. The differences of feeding and biochemical metabolic parameters were compared across the three groups.Results:A total of 108 cases were enrolled ,of whom 39 were in DHM group, 37 in PF group and 32 in eHF group. There was no significant difference in gestational age, birth weight, head circumference and maternal complications across the three groups. The milk intake in the DHM group was (50.7±29.1) ml/(kg·d) on the 7th day, compared with (34.2±27.3) ml/(kg·d) in PF group ( P=0.031), and (103.1±36.7) ml/(kg·d) on the 14th day, compared with (73.9±39.2) ml/(kg·d) in the PF group. Compared with the PF group, the DHM group reached the daily milk intake of 120 ml/(kg·d) earlier [(18.5±10.4) days vs. (24.1±10.3) days, P=0.020], had shorter duration of parenteral nutrition [(17.9±10.9) days vs. (23.2±11.2) days, P=0.042], and lower incidence of feeding intolerance (28.2% vs. 48.6%). The length of hospitalization in DHM group was shorter than that in PF group [(33.8±15.5) days vs. (37.8±17.6) days], but there was no significant difference ( P>0.05). There was no significant difference between the DHM group and the eHF group in terms of the milk intake on the 7th and 14th day, the time to the daily milk intake of 120 ml/(kg·d), the time on parenteral nutrition, the length of hospitalization and feeding intolerance. At 1 and 2 weeks after birth, alkaline phosphatase in DHM group was higher than that in PF group and eHF group ( P<0.05), but there was no significant difference in biochemical nutritional metabolism parameters (hemoglobin, urea nitrogen, albumin, prealbumin, alkaline phosphatase and total bile acid) across the three groups at discharge( P>0.05). Conclusion:Early use of DHM in premature infants is better tolerated than PF and can help achieve complete enteral nutrition earlier and shorten the use of parenteral nutrition, while not affecting the growth and development of premature infants.
6.Exploration of the Application of Blockchain Technology in the Future Medical Service System
Huan WANG ; Tao LIU ; Jing WANG ; Yanan GAO ; Xin LI ; Liyuan HU ; Zihang FENG ; Zhiyong ZHAO ; Qingyang HUANG ; Quanyu MENG ; Xiaojuan ZHANG ; Hexuan CUI ; Tianming CHEN
Journal of Medical Informatics 2024;45(11):91-94,103
Purpose/Significance To explore the feasibility of applying blockchain technology to the current healthcare system of hos-pitals,and to achieve the purpose of protecting patients'privacy to the greatest extent possible at a lower cost.Method/Process 505 questionnaires are randomly distributed and collected from people of different age groups in Beijing,Tianjin,Shanghai and Shenzhen who have a certain degree of understanding of blockchain technology,and the results are analyzed.Result/Conclusion Different age groups are highly concerned about personal privacy and privacy protection,and are willing to accept blockchain as an emerging technology.There is a greater demand and acceptance for the application of blockchain technology in the primary health care systems.
7.Application of A Tiered Progressive Training Model in the Standardized Residency Training on Laboratory Medicine
Guiyu SONG ; Zhenrong LIU ; Yongming ZHANG ; Liyuan ZHANG ; Wenqi TAI ; Yan JIAO ; Wei CUI
Journal of Modern Laboratory Medicine 2024;39(2):181-183,191
Objective To cultivate the ability of laboratory resident physicians in multiple aspects and enhance their post-competence for laboratory medicine.Methods The residents recruited into the Cancer Hospital of China Academy of Medical Sciences Laboratory Base were divided into junior residents and senior residents.According to the different training contents and objectives,the exploration of the hierarchically progressive training model was carried out,which mainly included three aspects:training plan,process training and process assessment.Results After the implementation of the hierarchical progressive training model,the average theoretical score and the average score in the skill operation examination of the residents increased to over 90 and 95,respectively.Meanwhile,the comprehensive clinical ability was also improved.Breakthroughs of teaching,scientific research and honor were achieved from"nothing"before the implementation to"something"after the implementation,and it actively promoted the improvement of the post-competency of the residents in laboratory medicine.Conclusion The application of the hierarchically progressive training mode in standardized training of residents in laboratory medicine could play a good role in promoting the training of post-competence for residents.
8.Application value of carbon nanoparticle tracer in lymph node dissection for Siewert typeⅡ and Ⅲ adenocarcinoma of esophagogastric junction
Huaifu CHENG ; Shiyu HUANG ; Tao CUI ; Qi YAO ; Liyuan YANG ; Jiaobang XU
Chinese Journal of Digestive Surgery 2023;22(S1):13-18
Objective:To investigate the application value of carbon nanoparticle tracer in lymph node dissection for Siewert type Ⅱ and Ⅲ adenocarcinoma of esophagogastric junction (AEG).Methods:The retrospective cohort study was conducted. The clinicopathological data of 147 patients with Siewert type Ⅱ and Ⅲ AEG who were admitted to Shengli Petroleum Central Hospital from June 2015 to July 2020 were collected. There were 109 males and 38 females, aged (65±9)years. All the patients underwent laparoscopic-assisted radical resection of AEG via esophageal hiatus. Of 147 patients, 61 cases not injected with carbon nanoparticle tracer preoperatively were allocated into control group and 86 cases injected with carbon nanoparticle tracer preoperatively were allocated into experimental group. Observation indicators: (1) surgical and postoperative situations; (2) influencing factors analysis of No.10 lymph nodes metastasis. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Count data were represented as absolute numbers or percentages, and comparison between groups was analyzed by the chi-square test. Univariate analysis was conducted by statistic methods based on data type, and multivariate analysis was conducted by the Logistic step-wise regression model. Results:(1) Surgical and postoperative situations. Patients of the experimental group and control group completed laparoscopic-assisted radical resection of AEG via esophageal hiatus successfully. There was no significant difference in the operation time, volume of intraoperative blood loss, the total number of lymph node dissection, the number of the first station, the second station and positive lymph nodes between the two groups ( P>0.05). For the experimental group, the black staining rate of lymph nodes was 57.937%(1 365/2 356), the black staining rate of the first station and second station lymph nodes was 77.989%(1 024/1 313) and 43.691%(232/531), the black staining rate of Siewert type Ⅱ and Ⅲ AEG patients was 56.855%(423/744) and 58.437%(942/1 612), respectively. The lymph node metastasis rate was 19.091%(815/4 269) of 147 patients, 18.573%(242/1 303)of Siewert type Ⅱ AEG patients and 19.319%(573/2 966) of Siewert type Ⅲ AEG patients. For Siewert type Ⅱ AEG patients, the metastasis rate of No.1, 2, 3, 4sa, 4sb, 7, 8a, 11p lymph nodes was more than 10%, the metastasis rate of No.4d, 5, 6, 9, 10, 11d, 12a lymph nodes was lower than 10%. For Siewert type Ⅲ AEG patients, the metastasis rate of No.1, 2, 3, 4sa, 4sb, 7, 8a, 10, 11p and lower mediastinal lymph nodes was more than 10%, the metastasis rate of No.4d, 5, 6, 9 11d, 12a and lower mediastinal lymph nodes was lower than 10%. There was no significant difference in the Clavien Dindo classification of postoperative complications between the two groups ( P>0.05). (2) Influencing factors analysis of No.10 lymph nodes metastasis. Results of multivariate analysis showed that tumor T staging and degree of tumor differention was an independent influencing factor for No.10 lymph nodes metastasis ( P<0.05). Conclusions:For Siewert type Ⅱ and Ⅲ AEG patients, the application of carbon nano-partide tracer can not increase the number of lymph node dissection. The second station lymph node dissection should be paid attention for Siewert type Ⅱ AEG. Tumor T staging and degree of tumor differentiation are independent influencing factors for No.10 lymph nodes metastasis.
9.Preliminary study on three-dimensional measurement of upper lip-related indexes of normal young Han population in Chengdu area
Liyuan ZHANG ; Xiaobo YOU ; Zhen CAI ; Wei CUI
Chinese Journal of Plastic Surgery 2022;38(2):208-214
Objective:To conduct a preliminary investigation on the establishment of a three-dimensional measurement database of upper lip-related indicators in the normal young Han population in Chengdu, and to establish reference values.Methods:A simple random sampling method was used to recruit 150 volunteers who visited Sichuan Provincial People’s Hospital between September 2012 and December 2019. The facial multi-slice spiral CT (MSCT) data were collected, and the image data was obtained to generate a three-dimensional model, which was analyzed by applying 3-matic Medical 13.0 software. The linear and proportional indices of upper lip correlation were measured including the crista philtra, right side point-the crista philtra, left side point (CphR-CphL), the right cheilion point- the left cheilion point (ChR-ChL), the middle point of crista philtra, right side point-the middle point of crista philtra, left side point (MphR-MphL), the apex of philtral column, right side point-the apex of philtral column, left side point(SbalR-SbalL), the stomion point-the sublabiale point (Sto-Sl)], ratio index [Ls-Sto/Sto-Li, MphR-MphL/ChR-ChL, MphR-MphL/CphR-CphL, Ls-Sto/Sn-Sto, Sto -Li/Sto-Sl]. In addition, the angle of the nasolabial angle was measured, and the radian of the upper lip was measured by the lip bead-bilateral angle three-point fitting circle method. The t test was used to compare the differences of the above indicators in different genders and ages (18-24, 25-30 years old). For the ChR-Ls-ChL, the Mphr-the middle point of subnasale and labrale-mphl(MphR-A-MphL), the SbalR-Sn-SbalL different radian position indexes were compared by ANOVA and SNK- q method. Results:A total of 150 volunteers were included in this study, including 68 males (45.3%) and 82 females (54.7%), ranging in age from 18 to 30 years old, with an average age of 24 years. Between different genders: the differences in linear indicators Ls-Sto, Sto-Li, Sn-Sto, Sn-Ls, Ls-Li, CphR-CphL, ChR-ChL, SbalR-SbalL, Sto-Sl were statistically significant ( P<0.05), there was no significant difference in MphR-MphL ( P>0.05); there were significant differences in Ls-Sto/Sn-Sto, Sto-Li/Sto-Sl in the ratio indicators ( P<0.01), Ls -Sto/Sto-Li, MphR-MphL/ChR-ChL, MphR-MphL/CphR-CphL had no significant difference ( P>0.05). There was no significant difference in nasolabial angle ( P>0.05); the difference in radian index ChR-Ls-ChL was statistically significant( P<0.05), there was no significant difference in MphR-A-MphL, SbalR-Sn-SbalL in radian index ( P>0.05). Between different age groups: there was no significant difference in each linear index, proportional index, angle index and radian index. ( P>0.05) Between different radian positions: the radian values of 3 different radian positions were significantly different ( P<0.01). ChR-Ls-ChL was compared with MphR-A-MphL, SbalR-Sn-SbalR the difference in SbalL was statistically significant ( P<0.01), but there was no significant difference between MphR-PoinA-MphL and SbalR-Sn-Sbal ( P>0.05). Conclusions:Based on the MSCT image data, this paper completed the preliminary survey of the three-dimensional measurement database of the upper lip-related indexes of the normal young Han population in Chengdu area, and established the reference value. The obtained data set can provide an intuitive reference for clinical evaluation and design. In addition, evaluating the upper lip by measuring the curvature of the upper lip is a new measurement method that can effectively reflect the physiological curvature of the upper lip.
10.Diagnostic value of ultrasonography in Poland′s syndrome
Liyuan CUI ; Lishan ZHANG ; Hengtao QI ; Tiezheng WANG ; Lihua LIU ; Shougang BAO ; Xiaofei MU ; Jianbo TENG
Chinese Journal of Ultrasonography 2022;31(2):157-160
Objective:To investigate the diagnostic value of ultrasonography in Poland′s syndrome.Methods:From February 2016 to December 2020, the ultrasonographic images of 15 patients with Poland′s syndrome diagnosed by Provincial Hospital Affiliated to Shandong First Medical University were retrospectively analyzed, and the ultrasonographic features were summarized.Results:High-frequency ultrasound could clearly show the anatomical structures of each layer of the chest wall of the patients with Poland′s syndrome. The sonogram of Poland′s syndrome mainly showed the absence of all or part of the pectoralis major on the affected side, some of which were combined with the absence of pectoralis minor. The difference between the thickness of the affected chest wall and the healthy side was statistically significant ( P<0.01). Among the 15 cases of Poland′s syndrome, 11 cases had brachydactyly or syndactyly. Ultrasound showed that the bifurcation position of the common palmar digital artery of the middle finger was lower than that of the healthy side. Conclusions:The ultrasonography is an effective imaging method for diagnosis of Poland′s syndrome.

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