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.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.
3.Clinical experience of extraperitoneal laparoscopic radical cystectomy in 340 cases
Ke WANG ; Zhaofeng LI ; Zongliang ZHANG ; Kai ZHAO ; Xinbao YIN ; Guanqun ZHU ; Zhenlin WANG ; Han YANG ; Xueyu LI ; Xuechuan YAN ; Qinglei WANG ; Zaiqing JIANG
Journal of Modern Urology 2024;29(9):762-765
Radical cystectomy combined with pelvic lymph node dissection is the standard procedure for the treatment of muscle invasive bladder cancer and complex non-muscle invasive bladder cancer.Our department has routinely carried out laparoscopic radical cystectomy(ELRC)through the extraperitoneal approach in 340 cases.This article summarizes the establishment of the peritoneal space,the expansion of the peritoneal space,the operation steps of bladder resection and lymph node dissection through the peritoneal channel,and how to shorten the operation time and reduce the difficulty of the operation.During the surgery,the bladder is removed periperitoneally without destroying the peritoneum to preserve the functions of peritoneum support,secretion,protection and lubrication,which has little impact on the abdominal organs,reduces the incidence of complications,and provides favorable conditions for subsequent treatment.
4.Research progress in the protective efficacy of human papillomavirus vaccines in males
Yahui WANG-JIANG ; Zhaofeng BI ; Shoujie HUANG ; Ting WU ; Yingying SU
Chinese Journal of Microbiology and Immunology 2023;43(6):485-492
Human papillomavirus (HPV) is one of the most common sexually transmitted pathogens. It can cause a variety of diseases such as condyloma acuminatum, anal cancer, penile cancer and oropharyngeal cancer in men, resulting in a high disease burden. With the development of society, the application of HPV vaccines in males has attracted more attention. Currently, there are many clinical trials and real-world research results of HPV vaccines applied to boys and men worldwide, and many countries have introduced HPV vaccination for underage boys into their national immunization programs. This article intended to review the research progress in the efficacy of HPV vaccines in male population.
5.Oblique supine one-piece posterior laparoscopic total nephroureterectomy plus cystic sleeve resection in the treatment of 24 cases of upper urinary tract uroepithelial carcinoma
Xuechuan YAN ; Kai ZHAO ; Zongliang ZHANG ; Xinbao YIN ; Zhenlin WANG ; Guanqun ZHU ; Yulian ZHANG ; Xueyu LI ; Han YANG ; Zhaofeng LI ; Qinglei WANG ; Zaiqing JIANG ; Ke WANG
Journal of Modern Urology 2023;28(11):976-979
【Objective】 To explore the safety and efficacy of a modified one-piece posterior laparoscopic total nephroureterectomy with cystic sleeve resection in the treatment of upper urinary tract uroepithelial carcinoma (UTUC). 【Methods】 A total of 24 patients treated during Jan. and Jun. 2022 were involved, including 16 males and 8 females, aged 62 to 90 (average 73) years. The UTUC was in the left side in 15 cases, and in the right side in 9 cases. There were 10 cases of renal pelvis tumor, 6 cases of upper ureteral tumor and 8 cases of lower ureteral tumor. 【Results】 All operations were successful without conversion to open surgery. The operation time ranged from 60 to 100 minutes, average (71.25±9.80) minutes. The intraoperative bleeding volume was 20 to 200 mL, average (30.03±8.13) mL. No significant intraoperative or postoperative complications occurred. The postoperative hospital stay was 4 to 7 days, average (5.83±1.44) days. Bladder perfusion chemotherapy was performed after surgery. 【Conclusion】 The modified one-piece posterior laparoscopic total nephroureterectomy plus cystic sleeve resection for UTUC is an effective and feasible procedure with satisfactory tumor control, which is worth further promotion in clinical practice.
6.Single position transabdominal and extraperitoneal laparoscopic radical nephroureterectomy in the treatment of upper tract urothelial carcinoma
Xueyu LI ; Kai ZHAO ; Zongliang ZHANG ; Xinbao YIN ; Zhenlin WANG ; Guanqun ZHU ; Yulian ZHANG ; Han YANG ; Zhaofeng LI ; Qinglei WANG ; Zaiqing JIANG ; Ke WANG
Journal of Modern Urology 2023;28(5):429-432
【Objective】 To investigate the efficacy and safety of single position transabdominal and extraperitoneal laparoscopic radical nephroureterectomy in the treatment of upper tract urothelial carcinoma (UTUC). 【Methods】 Clinical data of 31 UTUC cases treated in our hospital during Nov.2018 and Jun.2022 were retrospectively analyzed, including 11 tumors in the right side, and 20 in left side. There were 14 cases of renal pelvic carcinoma, 16 cases of ureter carcinoma, and 1 case of renal pelvic carcinoma plus ureter carcinoma. 【Results】 All surgeries were successfully performed without conversion to open surgery. The mean operation time was (81.45±19.80) min, and the estimated blood loss was (69.03±24.13) mL. No serious perioperative complications were observed. The average postoperative hospital stay was (6.13±2.44) d, and the median follow-up was 28 (3.0-49.0) months. At the last follow-up, 2 patients died, 3 had recurrence, but no contralateral recurrence was observed. 【Conclusion】 Single position transabdominal and extraperitoneal laparoscopic radical nephroureterectomy is safe, effective and feasible in the treatment of UTUC. It is worth clinical popularization.
7.Research progress in the regulation of exosomes on cell Ferroptosis
Sheng ZHAO ; Guodong WANG ; Jiawen JIANG ; Zhaofeng SUN ; Chuanxing ZHAI ; Yuanmin ZHANG
Journal of Chinese Physician 2023;25(7):1105-1109
Ferroptosis is an iron-dependent, apoptotic cell death caused by massive lipid peroxidation-mediated cell membrane damage. Recent evidence suggests that exosomes, as a 30-100 nm diameter follicular body, contain a variety of active ingredients such as proteins, various RNAs and lipids that can have a great impact on the diagnosis and treatment of related diseases by regulating cellular iron death. To this end, this paper elaborates the research significance of exosomes in the regulation of cell ferroptosis, analyzes their role in disease treatment, and reviews the relevant reports and studies on exosomes regulating cell ferroptosis in recent years.
8. Regulation mechanism of post-translational modification of farnesoid X receptor
Zhaofeng LIU ; Ling LI ; Shufang NA ; Qifa YE ; Jiang YUE ; Qifa YE
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(11):1292-1298
Farnesoid X receptor (FXR) is a nuclear receptor activated by bile acid that is involved in regulating gene expression related to bile acid, fat, glucose, and amino acid metabolism. The activity of FXR is regulated by a variety of post-translational modifications. Common post-translational modifications of FXR include O-GlcNAcylation, phosphorylation, acetylation, sumoylation, methylation, etc. These post-translational modifications may affect FXR binding of DNA and ligand, heterodimerization, and subcellular localization, and may specifically regulate downstream gene transcription and expression. Different post-translational modifications can lead to changes in FXR stability and biological function, which are closely related to the occurrence of diseases. This paper aims to review the post-translational modification of FXR in the past five years and the mechanisms involved in disease regulation, to explore the effects of post-translational modification on the physiological function of FXR and to provide a theoretical basis for mechanism research targeting FXR.
9.Clinical observation of nanoparticle albumin-bound paclitaxel monotherapy in the three-line treatment of elderly patients with advanced non-small cell lung cancer
Jianjun XIAO ; Wenjing DONG ; Jiewen PENG ; Xiaomei JIANG ; Zhaofeng YIN ; Huifen LI
Cancer Research and Clinic 2018;30(1):57-59
Objective To evaluate the clinical efficacy and safety of nanoparticle albumin-bound paclitaxel (Nab-P) in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Fifty-six over 65 years old patients with advanced NSCLC treated with Nab-P monotherapy in department of chemotherapy of the People's Hospital of Zhongshan City from January 2014 to January 2017 were analyzed retrospectively. The chemotherapy regimen was Nab-P 260 mg/m2, on d1 or d1 + d8, every 21 day for a cycle, imaging examination was made for efficacy evaluation after every 2 cycles. Results All 56 patients had been evaluated for efficacy, and received a total of 186 cycles of chemotherapy. All patients had been completed 2 cycles or more than 2 cycles of chemotherapy, and the median number of chemotherapy cycles was 3. The treatment response rate (RR) was 25.0 % and the disease control rate (DCR) was 76.8 %. The median progression free survival (PFS) time was 4.7 months. The main adverse reactions were neutropenia, nausea and vomiting, fatigue and peripheral nerve toxicity. However, the vast majorities of adverse reactions were grade 1-2, and can be improved after treatment. Conclusions Nab-P is effective in the treatment of advanced NSCLC in elderly patients. The adverse reactions are mild and tolerant, and it is worthy to be popularized.
10.The Clinical Study of Wenxin Keli in the Treatment of Atrial Fibrillation: a Systematic Review
Min LI ; Ruijin QIU ; Yang SUN ; Xiaoyu ZHANG ; Rui ZHENG ; Jiayuan HU ; Chengyu LI ; Shiqi CHEN ; Yin JIANG ; Xinyu YANG ; Zhaofeng SHI ; Songjie HAN ; Tianmai HE ; Ya HUANG ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1761-1771
Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli (WXKL) in the treatment of atrial fibrillation (AF) . Methods: Seven databases (PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials (RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate (MD=-7.14, 95%CI:-8.42——5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time (MD=-3.04, 95%CI:-3.47——2.61), increase the sinus rhythm conversion rate (RR=1.19, 95% CI: 1.09~1.29) and decrease recurrence rate of AF (RR=0.28, 95% CI: 0.13-0.59) . Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction (LVEF) (MD=3.44, 95% CI: 0.87-6.01), left ventricular end diastolic diameter (LVEDD) (MD=-2.47, 95% CI:-2.86——2.08), left atrialdiameter (LAd) (MD=-0.91, 95%CI:-1.58——0.25) and P wave dispersion (Pd) (MD=-4.04, 95%CI:-4.15——3.93) .WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave (Pmax) (MD=-8.25, 95% CI:-10.33——6.17), and WXKL combined with conventional-doseamiodarone is more effective (MD=-13.10, 95%CI:-13.65——12.55) . Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.

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