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.Application of reduced-positioning restrictions nursing program in postoperative rehabilitation of total hip arthroplasty
Wenjuan MA ; Hongying YU ; Xiaofan DOU ; Qiao HE ; Li LI ; Qianyun FANG ; Wenfang SHI ; Binsong QIU
Chinese Journal of Practical Nursing 2025;41(22):1694-1701
Objective:To evaluate the effects of a reduced-positioning restrictions nursing program on postoperative recovery, sleep quality, self-care ability, and hip joint function in patients undergoing total hip arthroplasty (THA), providing a reference for postoperative positioning management.Methods:A randomized controlled trial was conducted, and 140 THA patients admitted to Zhejiang Provincial People′s Hospital from January 2022 to June 2023 were selected using convenience sampling. They were divided into a control group (70 cases) and an observation group (70 cases) using a random number table. The control group received conventional rehabilitation care, while the observation group received a reduced-positioning restrictions nursing program in addition to the conventional care. The incidence of dislocation at 3 months postoperatively, the activities of daily living, the hip joint function recovery at 1 month and 3 months postoperatively, the sleep quality at 1 month postoperatively were compared between the two groups.Results:Finally 63 cases in the control group and 64 cases in the observation group completed the study. The control group included 25 males and 38 females, with an average age of (65.44 ± 10.97) years, while the observation group included 28 males and 36 females, with an average age of (65.13 ± 12.18) years. At 3 months postoperatively, there was no significant difference in the dislocation rate between the control group and the observation group ( P>0.05). At 1 month and 3 months postoperatively, the scores of activities of daily living in the observation group were (77.89 ± 6.71) and (93.52 ± 6.59) points respectively, which were higher than those in the control group [(69.68 ± 5.53) and (87.38 ± 7.72) points], the differences were statistically significant ( t=5.38, 6.96, both P<0.05), the time, interaction and inter-group effects were all statistically significant ( F=33.93, 10.81, 876.91, all P<0.05). At 1 month postoperatively, the excellent and good rate of hip joint function score grade in the observation group was 73.44% (47/64), which was higher than 41.27% (26/63) in the control group, the difference was statistically significant ( Z=-3.67, P<0.05), there was no statistically significant difference between the two groups at 3 months postoperatively ( P>0.05). At 1 month after the operation, the excellent and good rate of sleep quality score grades in the observation group was 81.25% (52/64), which was higher than 57.14% (36/63) in the control group, and the difference was statistically significant ( Z=-3.00, P<0.05). Conclusions:Incorporating a reduced-positioning restrictions nursing program into the perioperative management of THA does not increase the risk of prosthesis dislocation. This approach enhances patient comfort, improves sleep quality, increases self-care ability, and supports the recovery of hip joint function.
3.Application of reduced-positioning restrictions nursing program in postoperative rehabilitation of total hip arthroplasty
Wenjuan MA ; Hongying YU ; Xiaofan DOU ; Qiao HE ; Li LI ; Qianyun FANG ; Wenfang SHI ; Binsong QIU
Chinese Journal of Practical Nursing 2025;41(22):1694-1701
Objective:To evaluate the effects of a reduced-positioning restrictions nursing program on postoperative recovery, sleep quality, self-care ability, and hip joint function in patients undergoing total hip arthroplasty (THA), providing a reference for postoperative positioning management.Methods:A randomized controlled trial was conducted, and 140 THA patients admitted to Zhejiang Provincial People′s Hospital from January 2022 to June 2023 were selected using convenience sampling. They were divided into a control group (70 cases) and an observation group (70 cases) using a random number table. The control group received conventional rehabilitation care, while the observation group received a reduced-positioning restrictions nursing program in addition to the conventional care. The incidence of dislocation at 3 months postoperatively, the activities of daily living, the hip joint function recovery at 1 month and 3 months postoperatively, the sleep quality at 1 month postoperatively were compared between the two groups.Results:Finally 63 cases in the control group and 64 cases in the observation group completed the study. The control group included 25 males and 38 females, with an average age of (65.44 ± 10.97) years, while the observation group included 28 males and 36 females, with an average age of (65.13 ± 12.18) years. At 3 months postoperatively, there was no significant difference in the dislocation rate between the control group and the observation group ( P>0.05). At 1 month and 3 months postoperatively, the scores of activities of daily living in the observation group were (77.89 ± 6.71) and (93.52 ± 6.59) points respectively, which were higher than those in the control group [(69.68 ± 5.53) and (87.38 ± 7.72) points], the differences were statistically significant ( t=5.38, 6.96, both P<0.05), the time, interaction and inter-group effects were all statistically significant ( F=33.93, 10.81, 876.91, all P<0.05). At 1 month postoperatively, the excellent and good rate of hip joint function score grade in the observation group was 73.44% (47/64), which was higher than 41.27% (26/63) in the control group, the difference was statistically significant ( Z=-3.67, P<0.05), there was no statistically significant difference between the two groups at 3 months postoperatively ( P>0.05). At 1 month after the operation, the excellent and good rate of sleep quality score grades in the observation group was 81.25% (52/64), which was higher than 57.14% (36/63) in the control group, and the difference was statistically significant ( Z=-3.00, P<0.05). Conclusions:Incorporating a reduced-positioning restrictions nursing program into the perioperative management of THA does not increase the risk of prosthesis dislocation. This approach enhances patient comfort, improves sleep quality, increases self-care ability, and supports the recovery of hip joint function.
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.Summary of evidence for postoperative exercise in patients with rotator cuff injury
Qiao HE ; Xiaofan DOU ; Hongying YU ; Xueliang SONG ; Qianyun FANG ; Yin ZHANG
Chinese Journal of Modern Nursing 2023;29(27):3716-3723
Objective:To evaluate and summarize the evidence on postoperative exercise in patients with rotator cuff injury, so as to provide a basis for guiding the postoperative exercise in patients with rotator cuff injury.Methods:We searched the Joanna Briggs Institute (JBI) Evidence-Based Health Care Center Database, British Medical Journal (BMJ) Best Practice, UpToData, China Biomedical Literature Database, WanFang Data, China National Knowledge Infrastructure, and other databases on postoperative exercise in patients with rotator cuff injury, including guidelines, evidence summaries, systematic reviews, best practice information books, clinical decision-making, recommended practices, and expert consensus. The retrieval period was from the establishment of the database to June 4, 2022.Results:A total of 30 articles were included, including one guideline, one evidence summary, one clinical decision-making, two expert consensuses, and 25 systematic reviews. 22 pieces of evidence from 12 aspects were summarized, including applicable population, exercise benefit, exercise risk, exercise assessment, exercise program, exercise method, exercise time, exercise intensity, exercise monitoring, formulation principles, management mode, and health education were summarized.Conclusions:The evidence summary process is scientific, rigorous, and comprehensive in content. In the process of evidence transformation, medical and nursing staff should select the best evidence according to specific situations and individual patient factors, so as to guide patients with rotator cuff injury to exercise safely and effectively after surgery to improve clinical outcomes.
6.Research progress on patient-reported outcome measures in hip replacement
Qiao HE ; Xiaofan DOU ; Xiaomin CHEN ; Qianyun FANG ; Xueliang SONG ; Hongying YU
Chinese Journal of Modern Nursing 2022;28(8):997-1001
With the transition from quantity-centric healthcare to value-centric healthcare, patient-reported outcome plays an important role in healthcare. Patient-reported outcome is an effective method for evaluating the outcome of hip replacement patients. It can be used not only in science research, but also in clinical practice and medical care quality assessment. This article reviews the patient-reported outcome measures in hip replacement, so as to provide references for clinical practice and research of clinical medical and nursing staff to accurately select appropriate patient-reported outcome measures in hip replacement.
7.Systematic review of bleeding risk prediction models for patients with venous thromboembolism
Qiao HE ; Xiaofan DOU ; Xiaomin CHEN ; Xueliang SONG ; Hongying YU
Chinese Journal of Modern Nursing 2022;28(18):2443-2448
Objective:To systematically analyze and evaluate the bleeding risk prediction model of patients with venous thromboembolism (VTE) , so as to provide a reference for nursing practice.Methods:PubMed, Web of Science, Embase, Cochrane Library, Wiley Online Library, CINAHL, Scopus, ProQuest, Clinicalkey, Wanfang, China National Knowledge Infrastructure, VIP databases were searched for bleeding risk prediction model of VTE patients. The retrieval time was from the establishment of the databases to August 19, 2021. Two researchers independently screened the literature according to the inclusion and exclusion criteria, then extracted the data and evaluated the quality of the literature.Results:Ten relevant literatures were included in this study, including 4 retrospective studies and 6 prospective studies. The area under the receiver operating characteristic curve of one model was greater than 0.7, and the C-index of four models were greater than 0.7. The prediction model contained many relevant factors, including bleeding history, age, anemia, tumor, antiplatelet therapy, gender, renal insufficiency, etc. In the evaluation of risk of bias and applicability, 10 studies had good applicability, but there were bias mainly due to insufficient number of events in the dependent variable, conversion of continuous variables into dichotomous variables and missing data were not reported. Conclusions:The research on the prediction model of bleeding risk in VTE patients is still in the development stage. In the future, risk prediction models with excellent performance in all aspects and low risk of bias can be developed and verified externally.
8.Analysis of surveillance results of human brucellosis in Anyang City, Henan Province in 2019
Hongying QIAO ; Junfeng HAN ; Qiaoling MENG
Chinese Journal of Endemiology 2021;40(5):390-393
Objective:To understand the distribution characteristics of human brucellosis in Anyang City, Henan Province, and to provide scientific basis for control of brucellosis.Methods:The epidemic data and population data of human brucellosis in 2019 in Anyang City were collected from the Chinese Disease Control and Prevention Information System, and the epidemiological and clinical data were collected by Anyang Center for Disease Control and Prevention. Descriptive epidemiological method was used to sort out and analyze the epidemiological and clinical characteristics of brucellosis.Results:In 2019, 128 cases of brucellosis were reported in Anyang City, with an incidence rate of 3.12/100 000 (128/4 096 193). Among them, 85 cases were male and 43 cases were female, the sex ratio of male to female was 1.98∶1.00; the youngest was 1 year old, and the oldest was 83 years old, there were 100 cases between 40 and 69 years old, accounting for 78.12% (100/128); the main occupation was farmer (119 cases), accounting for 92.97% (119/128); a total of 96 cases had contact history with sheep, accounting for 75.00% (96/128). The peak of incidence was from April to August (81 cases), accounting for 63.28% (81/128). Eight counties (cities and districts) in Anyang City were all affected, and the top three counties (districts) were Yindu District (15.39/100 000, 42/272 983), Longan District (5.16/100 000, 12/232 421) and Neihuang County (4.02/100 000, 27/672 396). The median time from onset to diagnosis was 32.18 d, ranging from 3 to 350 d, 72 cases were ≥ 31 d, accounting for 56.25% (72/128).Conclusions:In 2019, the main population of brucellosis in Anyang City is male middle-aged and elderly farmers, and the main infection route is contact transmission. It is suggested to strengthen the implementation of prevention and control measures of brucellosis.
9.Risk factors of death in patients undergoing extracorporeal cardiopulmonary resuscitation
Hongjie TONG ; Hongying NI ; Xiaoling ZHANG ; Kun CHEN ; Wei HU ; Qiao GU ; Erhui YU
Chinese Journal of Emergency Medicine 2021;30(2):221-225
Objectives:To analyze the clinical characteristics of patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR) and identify the risk factors for death.Methods:The clinical data of 60 patients undergoing ECPR admitted to our hospital and Hangzhou First People's Hospital from September 2014 to September 2019 were retrospectively analyzed. The patients were divided into the survival group and the death group. The clinical data of the two groups were compared to explore the risk factors related to death. COX regression analysis was used to identify the risk factors for death.Results:Sixty patients undergoing ECPR were included in our study, of them, 16 (26.7%) cases were out-of-hospital cardiac arrest (OHCA) and 44 (73.3%) cases were in-hospital cardiac arrest (IHCA). The mortality of OHCA patients was higher than that of IHCA patients (87.5% vs. 56.89%, P < 0.05), and the duration from CPR to ECMO installation in the death group was longer than that in the survival group [(105.4±105.1) min vs. (53.0±28.5) min, P < 0.05]. Compared with the survival group, patients in the death group had higher troponin and glutamic oxalacetic transaminase and lower PH and lactate ( P < 0.05). The median survival time of the 60 patients was 42 days. Out-of-hospital cardiac arrest, high SOFA score before ECMO, high-dose norepinephrine, pulmonary infection during ECMO support and long ECMO support time were independent predictors of patients’ death. Conclusions:Risk factors associated with patients’ death undergoing ECPR are out-of-hospital cardiac arrest, high SOFA score before ECMO, high-dose norepinephrine, long duration from CPR to ECMO installation, pulmonary infection during ECMO support and long ECMO support time.
10.Evidence-based nursing practice of perioperative nutritional risk screening for patients with primary liver cancer treated with Cyberknife
Liying LIU ; Luyu XIN ; Shaomei WANG ; Jingjing MA ; Baoying QIAO ; Qianhui YAO ; Hongying PI
Chinese Journal of Modern Nursing 2021;27(15):2061-2065
Objective:To introduce evidence-based concepts into clinical nursing, and carry out perioperative nutritional risk screening for patients with primary liver cancer treated with Cyberknife, so as to enhance the overall nutritional management awareness and the level of nutritional nursing intervention of the nursing staff, and at the same time provide a basis and support for pushing nursing staff to multidisciplinary cooperation and broadening their professional horizons.Methods:From August 2019 to July 2020, in accordance with the practice model of the Australian Joanna Briggs Institute Evidence-based Health Care Center, we searched the evidence on nutritional risk screening of patients with primary liver cancer treated with Cyberknife in the European Society for Parenteral and Enteral Nutrition website and the Chinese Parenteral and Enteral Nutrition Society website, PubMed, China National Knowledge Infrastructure (CNKI) and Wanfang Data. The evidence was evaluated by the team and applied to nurses and patients in the Liver Oncology Department of the Fifth Medical Center of the People's Liberation Army General Hospital. A total of 21 nurses were selected to conduct a survey with the Nutrition Knowledge Questionnaire of Primary Liver Cancer Patients undergoing Cyberknife Treatment designed by the research team before and after the application of evidence. A total of 41 patients treated with Cyberknife for primary liver cancer admitted from August to December 2019 (without the use of this evidence) were selected as the control group, and 39 patients treated with Cyberknife for primary liver cancer admitted from January to April 2020 (after the application of the evidence) were selected as the observation group. The nutrition-related indicators of the two groups of patients were collected and compared when the patients were admitted to the hospital and when they were discharged after the Cyberknife treatment was completed.Results:After the application of the evidence, 21 nurses' awareness rates of perioperative nutritional risk-related knowledge of patients treated with primary liver cancer Cyberknife, nutritional risk screening implementation rates, patients' nutritional screening knowledge awareness rates and nutritional screening implementation rates were higher than those before the application of the evidence, the differences were statistically significant ( P<0.05) . Conclusions:The evidence-based nursing practice based on the practice model of the Australian Joanna Briggs Institute Evidence-based Health Care Center is used to screen the nutritional risk of perioperative patients with primary liver cancer treated with Cyberknife treatment, which enriches the nurses' knowledge about nutrition risk screening, enhances the initiative of nurses in clinical work, and is also conducive to strengthening multidisciplinary cooperation, and improving the quality of perioperative nutritional nursing management for patients with primary liver cancer treated with Cyberknife.

Result Analysis
Print
Save
E-mail