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.Analysis of the Correlation between Intrahepatic Cholestasis of Pregnancy and Adverse Pregnancy Outcomes
Huili ZHANG ; Yuan JIANG ; Peili DU ; Yuee CHEN ; Jingyu LIU ; Chuyi CHEN ; Xiuhua ZHOU ; Lin YU ; Dunjin CHEN ; Guangyi MA
Journal of Practical Obstetrics and Gynecology 2025;41(11):922-927
Objective:To explore the correlation between intrahepatic cholestasis of pregnancy(ICP)and ad-verse pregnancy outcomes.Methods:A total of 511 singleton pregnant women with ICP treated at The Third Affili-ated Hospital of Guangzhou Medical University from August 2017 to January 2024 were selected as the study sub-jects.Among them,patients were divided into the adverse pregnancy outcome group(n=49)and the control group without adverse pregnancy outcomes(n=462).The general and clinical data of the two groups were com-pared and analyzed.Results:①General situation:The number of pregnancies and deliveries,ICU transfer rate,total hospital stay,and total hospitalization costs were significantly higher in the adverse pregnancy outcome group compared to the control group(P<0.05).The number of prenatal check-ups,diagnostic gestational weeks,and gestational weeks at delivery were significantly lower compared to the control group(P<0.05).②Clinical symp-toms:The incidence of itching in the adverse pregnancy outcome group was lower compared to the control group(10.2%vs.26.6%,P<0.05),while other symptoms such as rash,fatigue,jaundice,and gastrointestinal symp-toms showed no significant difference between the two groups(P>0.05).③Laboratory examinations:Compared with the control group,patients in the adverse pregnancy outcome group had significantly the increased levels of alanine aminotransferase,aspartate aminotransferase,uric acid,urea nitrogen,and triglycerides,and significantly the decreased levels of alkaline phosphatase and fasting blood glucose,with statistical significance(P<0.05).Other biochemical indicators showed no significant difference between the two groups(P>0.05).④ICP grading and complications:The proportion of early-onset ICP,severe and very severe ICP in the adverse pregnancy out-come group was significantly higher compared to the control group(P<0.001);the proportion of adverse preg-nancy outcome group with pregnancy-induced hypertension was significantly higher compared to the control group;the incidence of preterm birth,fetal growth restriction,meconium-stained amniotic fluid,and fetal distress in the adverse pregnancy outcome group was significantly higher compared to the control group(P<0.001).⑤Neo-natal outcomes:The neonatal Apgar scores(1 min,5 min,10 min)and neonatal weight in the adverse pregnancy outcome group were lower compared to the control group(P<0.001),and the incidence of mild neonatal asphyx-ia was significantly higher,with a statistically significant difference(P<0.001).Conclusions:The severity of ICP is closely related to the occurrence of adverse pregnancy outcomes.Therefore,it is clinically necessary to pay at-tention to the grading of ICP,closely monitor the levels of total bile acids and liver enzymes,and try to avoid ad-verse pregnancy outcomes,especially intrauterine fetal death.
3.Analysis of the Correlation between Intrahepatic Cholestasis of Pregnancy and Adverse Pregnancy Outcomes
Huili ZHANG ; Yuan JIANG ; Peili DU ; Yuee CHEN ; Jingyu LIU ; Chuyi CHEN ; Xiuhua ZHOU ; Lin YU ; Dunjin CHEN ; Guangyi MA
Journal of Practical Obstetrics and Gynecology 2025;41(11):922-927
Objective:To explore the correlation between intrahepatic cholestasis of pregnancy(ICP)and ad-verse pregnancy outcomes.Methods:A total of 511 singleton pregnant women with ICP treated at The Third Affili-ated Hospital of Guangzhou Medical University from August 2017 to January 2024 were selected as the study sub-jects.Among them,patients were divided into the adverse pregnancy outcome group(n=49)and the control group without adverse pregnancy outcomes(n=462).The general and clinical data of the two groups were com-pared and analyzed.Results:①General situation:The number of pregnancies and deliveries,ICU transfer rate,total hospital stay,and total hospitalization costs were significantly higher in the adverse pregnancy outcome group compared to the control group(P<0.05).The number of prenatal check-ups,diagnostic gestational weeks,and gestational weeks at delivery were significantly lower compared to the control group(P<0.05).②Clinical symp-toms:The incidence of itching in the adverse pregnancy outcome group was lower compared to the control group(10.2%vs.26.6%,P<0.05),while other symptoms such as rash,fatigue,jaundice,and gastrointestinal symp-toms showed no significant difference between the two groups(P>0.05).③Laboratory examinations:Compared with the control group,patients in the adverse pregnancy outcome group had significantly the increased levels of alanine aminotransferase,aspartate aminotransferase,uric acid,urea nitrogen,and triglycerides,and significantly the decreased levels of alkaline phosphatase and fasting blood glucose,with statistical significance(P<0.05).Other biochemical indicators showed no significant difference between the two groups(P>0.05).④ICP grading and complications:The proportion of early-onset ICP,severe and very severe ICP in the adverse pregnancy out-come group was significantly higher compared to the control group(P<0.001);the proportion of adverse preg-nancy outcome group with pregnancy-induced hypertension was significantly higher compared to the control group;the incidence of preterm birth,fetal growth restriction,meconium-stained amniotic fluid,and fetal distress in the adverse pregnancy outcome group was significantly higher compared to the control group(P<0.001).⑤Neo-natal outcomes:The neonatal Apgar scores(1 min,5 min,10 min)and neonatal weight in the adverse pregnancy outcome group were lower compared to the control group(P<0.001),and the incidence of mild neonatal asphyx-ia was significantly higher,with a statistically significant difference(P<0.001).Conclusions:The severity of ICP is closely related to the occurrence of adverse pregnancy outcomes.Therefore,it is clinically necessary to pay at-tention to the grading of ICP,closely monitor the levels of total bile acids and liver enzymes,and try to avoid ad-verse pregnancy outcomes,especially intrauterine fetal death.
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.Application of biological maternal sounds stimulation in mechanically ventilated children with severe pneumonia
Dan LUO ; Muhua CHEN ; Xiaoming PENG ; Rong ZHANG ; Yuee XIONG ; Lihui ZHU
Chinese Journal of Practical Nursing 2023;39(21):1601-1607
Objective:To investigate the effect of biological maternal sounds on blood gas analysis index, mechanical ventilation time, oxygen therapy time and hospital stay in mechanically ventilated children with severe pneumonia.Methods:This study was a randomized controlled trial. From June 2020 to November 2020, 128 mechanically ventilated children with severe pneumonia in Hunan Children′s Hospital were selected by convenient sampling method and divided into four groups with 32 cases in each group by random number table method. Group A was given routine nursing care, group B was given mother sounds, group C was given mother cardiotone, group D was given biological maternal sounds. Data of blood gas analysis index, mechanical ventilation duration, oxygen therapy duration, hospital stays were collected for comparative analysis.Results:Finally, group A, B, C, and D included 28, 30, 28 and 28 cases, respectively. There was no statistically significant difference in PaO 2 among the four groups on the 1st to 2nd day after intervention ( P>0.05), but PaO 2 on the 3rd to 7th day after intervention were (75.57 ± 12.88), (77.71 ± 15.81), (78.21 ± 14.51), (78.64 ± 17.71), (79.04 ± 11.57) mmHg (1 mmHg=0.133 kPa), (81.71 ± 17.89), (82.93 ± 18.36), (82.68 ± 15.47), (83.25 ± 14.24), (83.77 ± 13.90) mmHg, (80.89 ± 18.78) (82.11 ± 13.34), (82.96 ± 14.20), (83.43 ± 14.37), (83.68 ± 12.64) mmHg, (84.54 ± 18.77), (86.29 ± 10.94), (86.96 ± 10.53), (87.46 ± 12.64), (89.08 ± 12.21) mmHg, with statistically significant differences ( F values were 41.17 - 332.68, all P<0.01). Further pairwise comparison revealed that PaO 2 in group B and group C were higher than those in group A on the 3rd to 7th day after intervention, while those in group D were higher on the 3rd to 7th day after intervention than those in group A, B, and C, with statistically significant differences( t values were 3.35- 4.75, all P<0.01). There was no statistically significant difference in PaCO 2 among the four groups on the 1st to 4th day after intervention ( P>0.05), but PaCO 2 on the 5th to 7th day after intervention was (47.31 ± 2.89), (46.18 ± 2.06), (41.94 ± 2.09) mmHg, (44.73 ± 1.76), (41.38 ± 1.30), (38.33 ± 1.16) mmHg, (44.81 ± 1.24), (41.23 ± 1.89), (38.73 ± 2.55) mmHg, (40.83 ± 1.78), (37.87 ± 1.43), (34.78 ± 2.05) mmHg, with statistically significant differences ( F=29.48, 36.12, 34.52, all P<0.05). Further pairwise comparison revealed that PaCO 2 in group B and group C were lower than those in group A on the 5th to 7th day after intervention, while PaCO 2 in group D were lower than those in groups A, B, and C, with statistically significant differences ( t values were 3.37-4.85, all P<0.01). During the analysis of PaO 2 and PaCO 2 in the four groups at different time points, the interaction effects were not statistically significant ( P>0.05). There was no significant difference in invasive mechanical ventilation duration, non-invasive mechanical ventilation duration and hospital stay among the four groups after intervention ( P>0.05). The oxygen therapy time of the four groups were (8.61 ± 6.40), (6.17 ± 4.80), (6.23 ± 2.75), and (3.75 ± 2.10) days, with statistically significant differences ( F=17.27, P<0.01). Further pairwise comparison revealed that the oxygen therapy time in group B and group C was shorter than that in group A, while group D was significantly shorter than that in groups A, B, and C, with statistically significant differences ( t values were 4.02-4.74, all P<0.01). Conclusions:Biological maternal sounds is superior to maternal sound and mother cardiotone in improve the blood gas analysis index, shorten the oxygen treatment time, which is worthy of clinical promotion in neonatal unaccompanied ward.
6.Research progress on regenerative endodontic procedures
DAI Xingzhu ; CHEN Lijuan ; LIANG Yuee ; ZHAO Wanghong
Journal of Prevention and Treatment for Stomatological Diseases 2023;31(1):73-76
Regenerative endodontic procedures, based on dental pulp biology, use the basic principles of tissue engineering to promote the functional regeneration of dental pulp-dentin complexes. Good results have been achieved in the treatment of young permanent teeth with pulp necrosis or apical periodontitis. There have also been preliminary clinical explorations of the treatment of mature permanent teeth in recent years. The key to successful treatment is controlling infection as well as promoting tissue repair and regeneration. Moderate root canal mechanical preparation is allowed in the therapy of mature permanent teeth, while it is not recommended in the treatment of young permanent teeth. The choice of root canal irrigation and intracanal antisepsis requires a comprehensive consideration of the antibacterial effects, biological safety, and possible complications, such as crown discoloration and root canal calcification. The development of bioceramic materials provides more options for crown sealing materials, but further clinical evaluation is needed. In addition to traditional blood clot scaffolds, new types of tissue scaffolds represented by platelet-rich plasma, platelet-rich fibrin, concentrated growth factors and other platelet concentrates have been developed. Long-term and large-scale studies are needed to evaluate the actual clinical efficacy of these new scaffolds and the efficacy of their combined application with blood clots.
7.A qualitative research on the real emotional experience and needs of parents of dying newborns
Na ZHANG ; Rong ZHANG ; Yuqiong XIANG ; Tingwei LUO ; Yuee XIONG ; Muhua CHEN ; Dan LUO ; Lihui ZHU
Chinese Journal of Modern Nursing 2022;28(20):2708-2713
Objective:To deeply understand the real emotional experience and needs of the parents of dying newborns, so as to provide a reference for future neonatal palliative care.Methods:From February to October 2021, purposeful sampling was used to select 15 parents of dying newborns in the Department of Neonatology of Hunan Children's Hospital as the research object. A qualitative research design was conducted, and the semi-structured interview method was used to conduct in-depth interviews with the research subjects, and NVivo 10.0 software was used for data analysis.Results:A total of 3 themes were extracted, namely, the ambivalence when giving up treatment, negative life effects after giving up, needs and expectations.Conclusions:Parents of dying newborns generally have ambivalence when they give up treatment. After giving up, they will show emotions such as sadness and helplessness, self-blame and regret, and depression. Understanding the real emotions and inner needs of the parents of dying newborns helps medical and nursing staff to pay attention to parents' negative psychology and understand their needs, and provide parents with targeted psychological support and other care, so as to help the parents of dying newborns and their families through a special period.
8. Ketorolac tromethamine combiend with sufentanil on median effective dose of analgesia after cesarean delivery
Yuee LIU ; Jun'er GUO ; Tao CHEN
Chinese Journal of Primary Medicine and Pharmacy 2018;25(11):1383-1386
Objective:
To study the median effective dose of ketorolac tromethamine combined with different doses of sufentanil.
Methods:
From February 2016 to June 2017, 60 cases of cesarean section were selected.According to the random number table method, they were divided into two groups, with 30 cases in each group.Group I was treated with sufentanil 0.75μg/kg+ dexmedetomidine 200μg, while sufentanil 1μg/kg+ dexmedetomidine 200μg was used in group II.The first two groups were added to pump 150 mg ketorolac tromethamine, gradually increased or decreased in accordance with 30mg effect according to satisfaction or dissatisfaction.The median effective dose of ketorolac tromethamine in the two groups was analyzed.
Results:
After operation, the systolic blood pressure[(112.5±9.6)mmHg vs.(122.5±8.4)mmHg, (114.2±9.9)mmHg vs.(124.1±8.2)mmHg]and heart rate[(80.6±13.5)times/min vs.(90.5±16.5)times/min, (77.6±15.5)times/min vs.(88.2±18.8)times/min]in the two groups were significantly lower than those before operation (
9.Observations on the Efficacy of Multi-functional Fire Needling plus Auricular Plaster Therapy for Moderate to Severe Acne Vulgaris
Jihong LIU ; Yuee CHEN ; Shaoying SONG ; Shihui CHEN ; Tianhang XUAN ; Zhibin PAN
Shanghai Journal of Acupuncture and Moxibustion 2016;35(5):555-557
Objective To investigate the clinical efficacy of multi-functional fire needling plus auricular plaster therapy for moderate to severe acne vulgaris.Methods One hundred and fifty patients with moderate to severe acne vulgaris were randomly allocated to treatment and control groups, 75 cases each. Both groups were first given bloodletting at Ear apex and Helix 4. Then the treatment group received multi-functional fire needling plus auricular plaster therapy and the control group, auricular plaster therapy alone. The symptom and sign score was recorded in the two groups before and after treatment. The clinical therapeutic effects were compared between the two groups.Results There was a statistically significant pre-/post-treatment difference in the symptom and sign score in the two groups (P<0.01). There was a statistically significant post-treatment difference in the symptom and sign score between the two groups (P<0.05). The total efficacy rate and the cure and marked efficacy rate were 98.6% and 88.7%, respectively, in the treatment group and 93.2% and 60.8%, respectively, in the control group. There was a statistically significant difference in the cure and marked efficacy rate between the two groups (P<0.05).Conclusion Multi-functional fire needling plus auricular plaster therapy is an effective way to treat moderate to severe acne vulgaris.
10.Protective effect of Ulinastatin on intestinal barrier function of elderly patients with sepsis
Haiyan YIN ; Pei TAO ; Xiaoling YE ; Yuee CHEN
Chinese Journal of Emergency Medicine 2016;25(2):177-181
Objective To observe the effect of Ulinastatin (UTI) on intestinal barrier function of elderly patients with sepsis in order to explore an optimized program of early treatment for such patients instituting a guidelines for clinical practice.Methods All selected patients randomly (ramdom number) divided into conventional treatment group (n =34) and UTI treatment group (n =34).Peripheral venous blood samples of elderly patients with sepsis were routinely taken at days 0,2,3,7 (D0,D2,D3,D7) after admission for detecting the changes of ptasma values of Intestinal fatty acid binding protein (IFABP),Diamine oxidase (DAO),and D-lactate (D-Lac).While patients' APACHE Ⅱscores,length of ICU stay and 28 d mortality also were recorded at the same time.Results At admission,there were no significant differences in patients' APACHE Ⅱscores,plasma values of IFABP,DAO and D-Lac between two groups (P > 0.05).During the course of treatment,the patients' APACHE Ⅱscores,plasma values of IFABP,DAO and D-Lac were declining in both groups,while those declinations in UTI group showed significantly more prominent.Compared with conventional therapy group,IFABP level was significandy lower in UTI group (P < 0.05),and the plasma values of DAO and D-Lac were significantly lower at D2 and D3 in UTI group (P < 0.05),but not at D7 (P > 0.05).The plasma levels of IFABP,DAO and D-Lac were positively associated with APACHE Ⅱscores,but not with length of ICU-stay (P >0.05).After treatment,28d mortality did not differ significantly between the two groups (P >0.05).Conclusions UTI has a protective effect on intestinal barrier function in elderly patients with sepsis.UTI can improve the prognosis of elderly patients with sepsis and reduce ICU stay,while has no significant effect on reducing 28 d mortality.


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