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.Clinical study on the adjuvant treatment of varicocele infertility with self-prescribed Huoxue Shengjing Prescription based on semen quality and IVF-ET/ICSI outcomes
Jiatao ZHENG ; Hongyi FU ; Dongdong SU ; Peizhi JIN ; Jincheng ZHANG ; Boyang ZHANG ; Hua KANG ; Xuchu WANG
International Journal of Traditional Chinese Medicine 2025;47(10):1370-1377
Objective:To investigate the efficacy of self-prescribed Huoxue Shengjing Prescription as adjuvant therapy for varicocele-induced infertility and its impact on the outcomes of in vitro fertilization-embryo transfer/intracytoplasmic sperm injection (IVF-ET/ICSI).Methods:A randomized controlled trial was conducted. A total of 99 patients with varicocele-induced infertility in our hospital from January 2022 to July 2023 were selected as observation subjects and divided into three groups using a random number table method, with 33 patients in each group. The low ligation group received low ligation of varicocele under a microscope, the low ligation + conventional Western medicine treatment group received low ligation + conventional Western medicine therapy, and the combined group received low ligation + conventional Western medicine therapy + a self-prescribed Huoxue Shengjing Prescription. Among them, the low ligation of varicocele under a microscope was followed by IVF-ET/ICSI assisted reproductive technology 3 months after surgery; the conventional Western medicine therapy involved continuous administration of L-carnitine oral solution for 3 months; the self-prescribed Huoxue Shengjing Prescription was started on the first day after surgery and continued for 3 months. TCM syndrome scores were assessed before and after treatment, and semen routine analysis was performed using an automated semen quality analyzer. Mitochondrial activity of granulosa cells was measured using the Hrudka extraction method, and sperm nuclear DNA integrity was assessed using a modified alkaline single-cell gel electrophoresis method. Follow-up was conducted for 1 year to observe and record the outcomes of IVF-ET/ICSI and evaluate the clinical efficacy.Results:The total effective rate was 93.9% (31/33) in the combined group, 69.7% (23/33) in the low ligation group, and 75.8% (25/33) in the low ligation + conventional Western medicine treatment group, with statistical significance ( χ 2=6.52, P=0.039). After treatment, the scores for mild abdominal pain, testicular heavy pain, impotence, mental fatigue, and the total score in the combined group were lower than those in the low ligation + conventional Western medicine treatment group and the low ligation group ( F values were 89.29, 97.51, 136.36, 155.06, and 311.13, respectively, P<0.001). The sperm survival rate, sperm concentration, normal morphology rate, and progressive motility rate in the combined group were higher than those in the low ligation + conventional Western medicine treatment group and the low ligation group ( F values were 19.23, 11.85, 35.97, and 52.21, respectively, P<0.001). Mitochondrial grade I cell activity of granulosa cells was higher than that of the low ligation + conventional treatment group and low ligation group ( F=23.23, P<0.001), and grade Ⅲ cell activity was lower than that of the low ligation + conventional treatment group and low ligation group ( F=20.28, P<0.001). After treatment, the detection of grade Ⅰ and Ⅱ sperm nuclear DNA integrity in the combined group were higher than those in the low ligation + conventional Western medicine treatment group and the low ligation group ( F values were 17.73 and 18.39, respectively, P<0.001), while grades Ⅲ and Ⅳ were lower than those in the low ligation + conventional Western medicine treatment group and the low ligation group ( F values were 29.07 and 10.36, respectively, P<0.001). During follow-up, the excellent embryo rate and the spouse's clinical pregnancy rate in the combined group were higher than those in the low ligation + conventional Western medicine treatment group and the low ligation group ( χ2 values were 14.92 and 8.38, respectively; P values were 0.001 and 0.015, respectively). Conclusion:The adjuvant treatment with a self-prescribed Huoxue Shengjing Prescription can enhance sperm quality in patients with varicocele-related infertility, maintain DNA integrity, regulate seminal plasma mitochondrial function, increase the rate of high-quality embryos, and improve the spouse's pregnancy outcomes.
3.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.Association between inflammation, body mass index, and long-term outcomes in patients after percutaneous coronary intervention: A large cohort study.
Guyu ZENG ; Deshan YUAN ; Sida JIA ; Peizhi WANG ; Liu RU ; Tianyu LI ; Ce ZHANG ; Xueyan ZHAO ; Song LEI ; Lijian GAO ; Jue CHEN ; Yuejin YANG ; Shubin QIAO ; Runlin GAO ; Xu BO ; Jinqing YUAN
Chinese Medical Journal 2023;136(14):1738-1740
6.A modified mouse model of orthotopic left lung transplantation based on "pendulum" anastomosis of the reverse-view plane (with video demonstration)
Caihan LI ; Heng HUANG ; Junjie WANG ; Hongtao TANG ; Ye WU ; Senlin HOU ; Peizhi LIU ; Wan YANG ; Tingting CHEN ; Shengxuan ZHANG ; Siyi FU ; Yujie ZUO ; Junjie YANG ; Haoji YAN ; Dong TIAN
Organ Transplantation 2022;13(5):634-
Objective To modify the mouse model of orthotopic left lung transplantation from different perspectives, aiming to establish a simpler, faster and stabler mouse model of lung transplantation. Methods Based on preliminary modified rat model of orthotopic left lung transplantation established by our team, varying extent of modifications were made regarding the tracheal intubation, cannula preparation and anastomosis procedures of orthotopic left lung transplantation in the recipient mice. Orthotopic left lung transplantation in 40 mice were performed by an operator with microsurgical experience. The dissection of the recipient's hilar structure was carried out at the plane of the hilar clamp model within the reverse-view, and the three branches (left main bronchus, pulmonary artery and pulmonary vein) of the pulmonary hilum were anastomosed in turn by the "pendulum" anastomosis method. The operation time of each procedure was recorded. The recipient mice were sacrificed at postoperative 2 weeks, and the incidence of postoperative complications was recorded. Results Lung transplantation was successfully completed in 40 mice, with no bronchial and vascular tearing or twisting, and no bleeding at the anastomosis site. The overall cardiopulmonary procurement time was (10.7±1.5) min, cannula preparation time was (16.2±1.5) min, cold ischemia time was (25.1±2.4) min, warm ischemia time was (19.4±1.6) min, and the total operation time was (57.2±2.9) min, respectively. During the follow-up from 6 to 14 days after surgery, one recipient mouse died of pleural effusion, probably caused by infection. No pneumothorax, thrombosis or atelectasis was found in the remaining recipient mice during postoperative follow-up. Conclusions The modified mouse model of orthotopic left lung transplantation based on "pendulum" anastomosis of the reverse-view plane possesses multiple advantages of short operation time, high success rate and few complications, which is expected to become an alternative model of studying pathological changes after lung transplantation and worthy of further application.
7.Prenatal diagnosis of isolated tricuspid valve dysplasia by echocardiography
Peizhi YANG ; Bin GENG ; Wenxiu LI ; Liling SHI ; Yan WANG ; Rui ZHANG
Chinese Journal of Ultrasonography 2021;30(8):685-690
Objective:To improve the prenatal recognition and diagnostic accuracy of isolated tricuspid valve dysplasia (TVD) by analyzing fetal echocardiographic features.Methods:The fetal echocardiographic features of 7 cases with prenatal diagnosis of TVD were analyzed retrospectively in Pediatric Cardiovascular Center, Beijing Anzhen Hospital, Capital Medical University and Children′s Hospital of Shanxi from June 2012 to December 2020. The fetal echocardiographic characteristics of TVD were summarized.Results:Among the 7 fetuses with TVD, 6 cases showed functional pulmonary atresia with intact ventricular septum and different degrees of pulmonary valve regurgitation, and 1 case showed slightly narrowed pulmonary artery. Characteristic sonographical findings included: ①The axis of heart was exaggerated left-axis deviation and the ratio of cardiothoracic was obviously increased. The right heart was enlarged, in which the right atrium was significantly dilated (an important feature of TVD). ②The position of tricuspid valve ring was normal, the attachment point of each leaf was normal, some tricuspid valves were thickened and insufficiency. ③It was common to be complicated with functional pulmonary valve atresia with intact ventricular septum or severe pulmonary valve stenosis. ④Color Doppler imaging showed severe tricuspid regurgitation and the regurgitation velocity was less than 350 cm/s (an important feature of TVD). ⑤In fetus with functional pulmonary valve atresia with intact ventricular septum, color Doppler imaging showed retrograded ductal flow across the pulmonary artery and the different degrees regurgitation of pulmonary valve.Conclusions:Fetal TVD has typical echocardiographic features, mainly including large tricuspid regurgitation and significant enlargement of the right atrium. The prognosis of fetus with functional pulmonary atresia is poor. Early diagnosis plays a crucial role in prenatal consultation and prognosis evaluation.
8.Dietary intake of persons with depressive and psychotic disorders in Singapore.
Ying Ying LEE ; Jue Hua LAU ; Vanessa SEET ; Clare WHITTON ; P V ASHARANI ; Fiona Devi SIVA KUMAR ; Peizhi WANG ; Kumarasan ROYSTONN ; Laxman CETTY ; Wen Lin THE ; Swapna VERMA ; Yee Ming MOK ; Mythily SUBRAMANIAM
Annals of the Academy of Medicine, Singapore 2021;50(5):379-389
INTRODUCTION:
Nutritional psychiatry is an emerging field of study that investigates the role of diet and nutrition in mental health. Studies conducted in the general population have linked depressive symptoms with poor dietary patterns. The aim of this study was to characterise the dietary intake and analyse the dietary pattern using the Dietary Approach to Stop Hypertension (DASH) in a sample of psychiatric patients in a multiethnic Asian nation.
METHODS:
Participants were recruited from an outpatient clinic and an inpatient unit at the Institute of Mental Health in Singapore. Self-reported dietary habits of a sample of psychiatric patients (N=380) were analysed using DASH. To examine the variables associated with DASH scores, a linear regression was conducted with the full sample and sociodemographic variables.
RESULTS:
Persons with depressive disorders had a mean DASH score of 21.3 (±4.2), while persons with psychotic disorders had a mean DASH score of 21.2 (±4.9). Respondents who were older (B=1.94, 95% confidence interval [CI] 0.91-2.96,
CONCLUSION
Dietary patterns of persons with mental disorders were characterised. A host of sociodemographic factors, and not diagnosis of mental disorders, influenced the dietary quality of people with depressive and psychotic disorders. Clinicians treating psychiatric patients need to be aware of the nuanced reasons behind poor dietary choices and provide targeted psychoeducation to specific subgroups within the patient population.
9.Epidemiological survey of in-patients with femoral supracondylar fracture in The Third Hospital of Hebei Medical University from 2009 to 2018
Hongzhi LYU ; Juan WANG ; Wei CHEN ; Peizhi YUWEN ; Dongzheng LI ; Yingze ZHANG
Chinese Journal of Orthopaedic Trauma 2019;21(5):392-397
Objective To investigate the epidemiological characteristics of the in-patients with femoral supracondylar fracture in the Third Hospital of Hebei Medical University from 2009 through 2018.Methods The medical imaging computer archiving and transmission system and the medical record inquiry system were used to collect the data of all the in-patients with femoral supracondylar fracture who had been treated from January 2009 through December 2018 in The Third Hospital of Hebei Medical University.Their gender and age distribution,basic sociological data and cause of injury were characterized.The in-patients from January 2009 to December 2013 were assigned into group A while those from January 2004 to December 2018 into group B.The 2 groups were compared to find out the epidemiological characteristics and trends of the in-patients with femoral supracondylar fracture in the 10 years.Results Of the 508 in-patients with femoral supracondylar fracture,279 (54.9%) were male and 229 (45.1%) female.Their age ranged from 1 to 94 years,averaging 44.3 years.The age group from 41 to 50 years accounted for the largest proportion (104 cases,23.9%).In males,the age group from 41 to 50 years accounted for the largest proportion (33.3%,80/279);in females,the age group from 51 to 60 years the largest proportion (30.3 %,59/229).The proportion of females in the in-patients under 50 years of age (37.1%) was significantly lower than that (62.9%) in the in-patients over 50 years of age (P < 0.05).According to the AO classification,there were 193 cases (38%) of type 33-A1,117 ones (23%) of type 33-A2 and 198 ones (39%) of type 33-A3.There were 270 farmers (53.1%),164 workers (32.4%) and 74 students (14.5%).Most injuries were caused by high energy (56.5%).The age of in-patients with low-energy injury (50.5 ±20.7 years) was significantly higher than that of in-patients with high-energy injury (39.5 ± 19.6 years) (P <0.05).The proportions of urban residents (30.0%),patients with low energy injury (37.9%) and type 33-A1 fractures (23.9%) in group A were significantly lower than in group B (43.3%,46.9% and 32.3%,respectively) (P < 0.05);the age of group A (41.9 ± 21.8 years) was significantly younger than that of group B (45.9 ± 19.9 years) (P <0.05);type 33-A3 fractures in group A (46.5%) were significantly more than in group B (36.3%) (P <0.05).Conclusions Femoral supracondylar fractures were more common in farmers.Most of the fractures were type 33-A3.The fractures were common in males from 41 to 50 years old and in females from 51 to 60 years old.There were more males than females in the junior patients but more females than males in senior patients.There were more young patients in complex fractures but there were more old patients in simple fractures and there were more very old patients in low-energy injuries.In the past 10 years,the patients with femoral supracondylar fracture increased year by year.Compared with the first 5 years,the late 5 years witnessed significant increases in age of patients and proportions of low-energy injury and simple fracture.
10.Authors' reply.
Saleha SHAFIE ; Siau Pheng LEE ; Samantha Bee Cheng ONG ; Peizhi WANG ; Esmond SEOW ; Hui Lin ONG ; Siow Ann CHONG ; Mythily SUBRAMANIAM
Singapore medical journal 2019;60(2):104-104

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