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 Tuina Gongfa prescription in treating pulmonary diseases guided by the concept of"preventing a disease before it arises"
Ji MA ; Yu ZHANG ; Yumin LIU ; Yazhou LI ; Chao ZHOU ; Yuanshuai NING ; Dengjun JI ; Yan ZHANG ; Fei GU
Journal of Acupuncture and Tuina Science 2025;23(5):431-436
Gongfa is an essential approach to prevent and treat diseases in traditional Chinese medicine(TCM),often used to prevent a disease before it arises.Guided by TCM and modern scientific theories,the Tuina(Chinese therapeutic massage)Gongfa prescription theory implements the principle,method,prescription,and form in clinical pattern-identified treatment to prescribe the corresponding Tuina Gongfa prescription,i.e.,to prescribe a basic Tuina Gongfa prescription,specifically for a systemic disease,and modify Gongfa forms based on the basic prescription according to different patterns.The Gongfa prescription for pulmonary diseases designs corresponding Gongfa forms from six perspectives:lifting Yang,securing the exterior,opening the orifices,soothing the chest,harmonizing the stomach,and regulating Qi to prevent and treat diseases.The application of the pulmonary Gongfa prescription indicates the potential to apply the Tuina Gongfa prescription theory for the clinical prevention,treatment,and rehabilitation of disorders of other systems,thereby fully realizing the unique role of TCM Gongfa.
3.Current situation and influencing factors of nasal injury in newborns with nasal continuous positive pressure ventilation
Yumin LIU ; Yuxia ZHANG ; Min ZHOU ; Yahui CHENG
Modern Clinical Nursing 2025;24(3):1-6
Objective To investigate current status in nasal injury caused by nasal continuous positive airway pressure(nCPAP)in neonates in the neonatal intensive care unit(NICU)and its influencing factors so as to provide a basis for clinical nursing.Methods Data between October 2022 and March 2024 were collected from 268 neonates who underwent nCPAP in NICU of our hospital.The number of newborn nasal injury was recorded and multivariate logistic regression analysis was used to explore the risk factors associated with nasal injury caused by nCPAP in NICU neonates.Results The incidence of nasal injury in the 268 neonates with nCPAP was 19.40%(52/268).Risk factors that associated with nasal injury included gestational age≤32 weeks,birth weight<1500g,frequency of sedative use within 24 hours≥2 times,forced body position,incubator humidity>65%,lethargy/coma,history of invasive ventilation,neonatal skin risk assessment scale score≥13 points before nCPAP,and with nCPAP≥8 days(all P<0.05).Conclusion The incidence of nasal injury in NICU neonates with nCPAP is high with many influencing factors.Preventive measures should be taken according to the identified risk factors in order to reduce the incidence of nasal injury in neonates with nCPAP.
4.Application of Tuina Gongfa prescription in treating pulmonary diseases guided by the concept of"preventing a disease before it arises"
Ji MA ; Yu ZHANG ; Yumin LIU ; Yazhou LI ; Chao ZHOU ; Yuanshuai NING ; Dengjun JI ; Yan ZHANG ; Fei GU
Journal of Acupuncture and Tuina Science 2025;23(5):431-436
Gongfa is an essential approach to prevent and treat diseases in traditional Chinese medicine(TCM),often used to prevent a disease before it arises.Guided by TCM and modern scientific theories,the Tuina(Chinese therapeutic massage)Gongfa prescription theory implements the principle,method,prescription,and form in clinical pattern-identified treatment to prescribe the corresponding Tuina Gongfa prescription,i.e.,to prescribe a basic Tuina Gongfa prescription,specifically for a systemic disease,and modify Gongfa forms based on the basic prescription according to different patterns.The Gongfa prescription for pulmonary diseases designs corresponding Gongfa forms from six perspectives:lifting Yang,securing the exterior,opening the orifices,soothing the chest,harmonizing the stomach,and regulating Qi to prevent and treat diseases.The application of the pulmonary Gongfa prescription indicates the potential to apply the Tuina Gongfa prescription theory for the clinical prevention,treatment,and rehabilitation of disorders of other systems,thereby fully realizing the unique role of TCM Gongfa.
5.Current situation and influencing factors of nasal injury in newborns with nasal continuous positive pressure ventilation
Yumin LIU ; Yuxia ZHANG ; Min ZHOU ; Yahui CHENG
Modern Clinical Nursing 2025;24(3):1-6
Objective To investigate current status in nasal injury caused by nasal continuous positive airway pressure(nCPAP)in neonates in the neonatal intensive care unit(NICU)and its influencing factors so as to provide a basis for clinical nursing.Methods Data between October 2022 and March 2024 were collected from 268 neonates who underwent nCPAP in NICU of our hospital.The number of newborn nasal injury was recorded and multivariate logistic regression analysis was used to explore the risk factors associated with nasal injury caused by nCPAP in NICU neonates.Results The incidence of nasal injury in the 268 neonates with nCPAP was 19.40%(52/268).Risk factors that associated with nasal injury included gestational age≤32 weeks,birth weight<1500g,frequency of sedative use within 24 hours≥2 times,forced body position,incubator humidity>65%,lethargy/coma,history of invasive ventilation,neonatal skin risk assessment scale score≥13 points before nCPAP,and with nCPAP≥8 days(all P<0.05).Conclusion The incidence of nasal injury in NICU neonates with nCPAP is high with many influencing factors.Preventive measures should be taken according to the identified risk factors in order to reduce the incidence of nasal injury in neonates with nCPAP.
6.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.
7.Values of serum human epididymis protein 4, endothelial cell specific molecule-1 and epidermal growth factor receptor in the diagnosis of lung cancer
Yumin ZHANG ; Xiaonan ZHANG ; Xiujuan GAO ; Simin JU ; Yuzhu LI ; Qi ZHOU
Cancer Research and Clinic 2023;35(2):81-85
Objective:To investigate the diagnostic values of human epididymis protein 4 (HE4), endothelial cell specific molecule-1 (ESM-1) and epidermal growth factor receptor (EGFR) for lung cancer.Methods:The clinical data of 90 patients with lung cancer and 50 patients with benign lung diseases diagnosed by the pathological examination in Tangshan People's Hospital from December 2019 to January 2021 were retrospectively analyzed, and 40 healthy physical examiners in the same period were selected as the controls. The serum HE4 levels were detected by electrochemiluminescence method. The serum ESM-1 and EGFR levels were tested by enzyme-linked immunosorbent assay. The differences in serum HE4, ESM-1 and EGFR levels between the three groups were compared; logistic regression analysis was used to screen out the effective indicators for the diagnosis of lung cancer and to construct a prediction model for the diagnosis of lung cancer. Using pathological diagnosis result as the gold standard, the receiver operating characteristic (ROC) curve was drawn, and the diagnostic efficacy of indicators for lung cancer was evaluated.Results:The levels of serum HE4 in lung cancer group, benign lung diseases group and healthy control group were 119.55 pmol/L (82.06 pmol/L, 189.00 pmol/L), 58.84 pmol/L (45.62 pmol/L, 69.41 pmol/L) and 42.67 pmol/L (37.09 pmol/L, 51.84 pmol/L), the levels of ESM-1 were 33.00 ng/ml (25.85 ng/ml, 47.40 ng/ml), 20.14 ng/ml (11.93 ng/ml, 28.90 ng/ml) and 15.39 ng/ml (11.84 ng/ml, 20.19 ng/ml), and the levels of EGFR were 46.60 pg/ml (37.45 pg/ml, 58.98 pg/ml), 32.77 pg/ml (26.27 pg/ml, 40.86 pg/ml) and 30.43 pg/ml (27.54 pg/ml, 35.75 pg/ml), and the differences in each indicator among the three groups were statistically significant (all P < 0.001). The levels of serum HE4, ESM-1 and EGFR in lung cancer group were higher than those in benign lung diseases group and healthy control group. In patients with lung cancer, logistic regression analysis was performed with HE4 (X 1), ESM-1 (X 2) and EGFR (X 3) as the independent variables and pathological diagnosis as the dependent variable, and a lung cancer prediction regression model was established: P = 0.171X 1+0.351X 2+0.184X 3-24.660. The accuracy of this model in predicting lung cancer could reach 98.5%, and serum HE4, ESM-1 and EGFR were risk factors for the occurrence of lung cancer (all P < 0.05). The area under ROC curve from high to low was HE4 (0.960), ESM-1 (0.942) and EGFR (0.859). The diagnostic sensitivity of serum HE4 63.67 pmol/L for lung cancer was 86.7%, and the specificity was 97.5%. Both serum HE4 ( r = 0.304, P = 0.004) and ESM-1 ( r = 0.416, P < 0.001) were correlated with EGFR. Conclusions:Serum HE4, ESM-1 and EGFR can be used as effective indicators for the diagnosis of lung cancer, and the prediction model established based on the three serum tumor markers is of good value for the diagnosis and prediction of lung cancer.
8.Genetic Architecture and Functional Implications of the CSF-Contacting Nucleus.
Siyuan SONG ; Yumin YUAN ; Lingling XU ; Jun JIANG ; Ying LI ; Yao YAN ; Qing LI ; Fang ZHOU ; Junli CAO ; Licai ZHANG
Neuroscience Bulletin 2023;39(11):1638-1654
We previously identified a unique nucleus, the cerebrospinal fluid (CSF)-contacting nucleus. This study aims to understand its gene architecture and preliminarily suggest its functions. The results showed that there were about 19,666 genes in this nucleus, of which 913 were distinct from the dorsal raphe nucleus (non-CSF contacting). The top 40 highly-expressed genes are mainly related to energy metabolism, protein synthesis, transport, secretion, and hydrolysis. The main neurotransmitter is 5-HT. The receptors of 5-HT and GABA are abundant. The channels for Cl-, Na+, K+, and Ca2+ are routinely expressed. The signaling molecules associated with the CaMK, JAK, and MAPK pathways were identified accurately. In particular, the channels of transient receptor potential associated with nociceptors and the solute carrier superfamily members associated with cell membrane transport were significantly expressed. The relationship between the main genes of the nucleus and life activities is preliminarily verified.
Rats
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Animals
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Rats, Sprague-Dawley
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Serotonin/metabolism*
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Signal Transduction
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Cerebrospinal Fluid/metabolism*
9.A prediction model based on contrast-enhanced MRI radiomics and clinical features for early recurrence of hepatocellular carcinoma after radical resection
Yang GAO ; Chuanqiang LAN ; Weichuan YE ; Yumin HU ; Jianjian XING ; Yongjin ZHOU ; Jingle FEI ; Jiansong JI
Chinese Journal of Hepatobiliary Surgery 2022;28(11):817-821
Objective:To develop a prediction model based on imaging features by contrast-enhanced MRI radiomics combined with clinical features for early recurrence of hepatocellular carcinoma (HCC) after radical resection.Methods:A retrospective study was carried out on 109 HCC patients who underwent radical resection at the Fifth Affiliated Hospital of Wenzhou Medical University from January 2015 to December 2020. Of 109 patients enrolled in this study, there were 96 males and 13 females, aged (58.3±10.7) years. Based on whether there was recurrence within 12 months after operation, the patients were divided into the early recurrence group ( n=31) and the control group ( n=78). These 109 patients were then randomly divided into the validation set ( n=23) and the training set ( n=86) at a ratio of 1∶4. Based on preoperative multi-phase contrast-enhanced MRI scanning, the tumor lesions were delineated on the Radcloud platform, and 1 409 quantitative radiomic features were extracted. Dimension reduction and screening of these features were carried out using variance threshold, SelectKBest and LASSO. Combined with clinical features (alpha fetoprotein, tumor size), several prediction model were established through machine learning. The predictive efficiencies of these models were evaluated using the area under the receiver operating characteristic (ROC) curve, accuracy rate, recall rate and balanced F score. Results:The proportions of irregular tumor shape and unclear tumor boundary, as well as maximum tumor diameter in the early recurrence group were significantly higher than that in the control group, but the proportion of pseudocapsule was significantly lower than that in the control group (all P<0.05). A total of 465 features were screened from the 1 409 features using the variance threshold method, followed by 38 features were screened using the method of SelectKBest. Finally 7 optimal radiomic features were screened based on the LASSO method. When combined with clinical features, 5 prediction models were established through machine learning. These models were support vector machine, Gaussian naive bayes, logistic regression, Multinomial naive bayes and K-nearest neighbor (KNN), respectively. Among these 5 models, the prediction efficiency of the KNN model was relatively highest, with the area under the ROC curve, accuracy rate, recall rate and balanced F score being 0.90, 0.98, 0.74 and 0.84 in the training set, and 0.76, 0.92, 0.75 and 0.83 in the verification set, respectively. Thus, the KNN model was selected as the best prediction model in this study. Conclusion:The prediction model of KNN was developed for early recurrence of HCC after radical resection based on preoperative contrast-enhanced MRI radiomics combined with clinical features.
10.Safety of PICC dressing replacement frequency in premature infants: a randomized controlled study
Jinhua GAO ; Jiayin WU ; Sufen DENG ; Yumin LIN ; Yanmei ZHOU ; Xiaoyan ZHAO ; Tingting LI
Chinese Journal of Neonatology 2021;36(6):33-37
Objective:To study the safety of different peripherally inserted central catheter (PICC) dressing replacement frequencies in preterm infants.Method:From June 2017 to February 2020, preterm infants were enrolled in this prospective randomized controlled study. Preterm infants with PICC were randomly assigned into 7 d, 11 d and 14 d dressing replacement groups using online randomization software. Polyurethane transparent dressing and the same dressing replacement method were used in all three groups. The incidences of catheter-related bloodstream infection (CRBSI) and positive skin bacterial culture at dressing site were compared among the three groups.Result:A total of 296 cases were enrolled, including 96 cases in the 7 d group, 108 cases in the 11 d group and 92 cases in the 14 d group. The incidences of CRBSI in three groups were 2.5/1 000 catheter day in 7 d group, 1.1/1 000 catheter day in 11 d group and 0.8/1 000 catheter day in 14 d group. The incidences of catheter pathogen colonization were 1.0% in 7 d group, 0.9% in 11 d group and 0% in 14 d group. The positive rates of skin bacterial culture at dressing site were 1.0% in 7 d group, 2.8% in 11d group and 2.2% in 14 d group. The incidences of PICC exit site infection in three groups were 1.0% in 7 d group, 0.9% in 11d group and 1.1% in 14 d group and no significant differences existed among the groups ( P>0.05). Gram-positive cocci were the main bacteria [91.7% (11/12)] of CRBSI and skin bacterial culture at dressing site and gram negative bacilli accounted for 8.3% (1/12). No fungal infection were found. Conclusion:It is safe to replace the PICC dressing in premature infants as needed within 14 days if the dressing is intact without curling, bleeding and exudation.

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