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.Double-Flower Moisturizing Ointment with Occlusive Dressing Therapy Managing Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitors Induced Hand-Foot Skin Reaction
Journal of Zhejiang Chinese Medical University 2025;49(10):1316-1320
[Objective]To investigate the efficacy and safety of Double-Flower Moisturizing Ointment occlusive dressing therapy in treating vascular endothelial growth factor receptor-tyrosine kinase inhibitors(VEGFR-TKIs)induced hand-foot skin reactions(HFSR).[Methods]A total of 58 cancer patients with HFSR induced by VEGFR-TKIs,who were treated at The First Affiliated Hospital of Zhejiang Chinese Medical University from October 8,2021 to December 31,2024,were enrolled in this study.Using a randomized single-blind design,they were assigned to either an observation group(29 cases)or a control group(29 cases).The observation group received oral vitamin B6 combined with Double-Flower Moisturizing Ointment occlusive dressing therapy,while the control group received oral vitamin B6 combined with base ointment occlusive therapy.Both groups were treated for 14 consecutive days.The total effective rate of HFSR management,pain relief rate,quality of life improvement,differences in efficacy between syndrome types and the incidence of adverse reactions were compared between the two groups.[Results]The total effective rate was significantly higher in observation group(89.7%)than in control group(58.6%).The observation group demonstrated a markedly superior overall pain relief rate of 76.9%,which was significantly higher than the 38.5%achieved in control group.Similarly,the quality of life improvement rate in observation group(44.8%)was markedly higher than that in control group(13.8%),with all differences being statistically significant(P<0.05).In the two main syndrome types of damp-heat stagnation and heat-toxicity accumulation on the skin,the observation group exhibited a significantly greater total effective rate compared to control group(P<0.05).No cutaneous adverse reactions or abnormal liver and kidney function were observed in either group.[Conclusion]Double-Flower Moisturizing Ointment occlusive therapy is effective in managing VEGFR-TKIs-induced HFSR.It demonstrates superior outcomes over base ointment occlusive dressing therapy in terms of the overall response rate,pain relief and quality of life improvement,particularly among patients presenting with damp-heat stagnation or heat-toxicity accumulation on the skin.Furthermore,this treatment modality exhibits a favorable safety profile,indicating high clinical application value.
3.Application of Lycii Fructus and Its Compound Formulas in Central Nervous System Diseases: A Review
Ruyang CHENG ; Weining SONG ; Xin JIANG ; Yehao WANG ; Chi ZHANG ; Zhendong ZHANG ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):273-281
The pathogenesis of central nervous system (CNS) diseases is complex, seriously affecting patients' physical and mental health and imposing a heavy economic burden on society. Western medicine shows limited efficacy in treating CNS diseases and is often associated with numerous adverse reactions and contraindications. Chinese medicine Lycii Fructus exhibits multiple pharmacological effects, including immune regulation, enhancement of hematopoietic function, liver protection, anti-tumor, hypoglycemic, antipyretic, anti-aging, and anti-radiation activities, and has gradually been applied in clinical treatment. In recent years, the active components of Lycii Fructus have attracted considerable attention for their potential therapeutic effects on CNS diseases. Studies indicate that these active components may exert neuroprotective effects through anti-inflammatory and antioxidant actions, inhibition of neuronal apoptosis, and repair of neuronal damage, involving multiple targets and pathways. This review summarizes the therapeutic effects of Lycii Fructus active components in CNS diseases over the past decade by searching PubMed, CNKI, Wanfang Data, and other electronic databases, aiming to provide new treatment strategies and insights for future research on Lycii Fructus in CNS disorders.
4.Risk factors for recurrence of autoimmune pancreatitis
Mengruo JIANG ; Liqi SUN ; Lisi PENG ; Zhendong JIN ; Zhaoshen LI ; Haojie HUANG
Academic Journal of Naval Medical University 2025;46(4):474-480
Objective To explore the risk factors for the recurrence of autoimmune pancreatitis(AIP),so as to provide a new reference for its clinical treatment.Methods The clinical data of 198 AIP patients admitted to The First Affiliated Hospital of Naval Medical University from 2014 to 2021 were collected,including 164 patients with type 1 AIP and 34 patients with type 2 AIP.Based on the recurrence status of AIP,the patients were categorized into recurrence group(38 cases)and non-recurrence group(160 cases),and differences between the 2 groups were analyzed.Patients with definite duration of glucocorticoid maintenance therapy were further screened,and logistic regression model and Spearman rank correlation analysis were used to analyze the risk factors of AIP recurrence.Results During the follow-up period,19.19%(38/198)of AIP patients experienced a relapse.The 1-,3-,and 5-year cumulative recurrence rates were 6.57%,9.09%,and 12.63%,respectively,with type 1 AIP demonstrating a significantly higher recurrence rate than type 2 AIP(21.95%[36/164]vs 5.88%[2/34],P=0.030).Univariate logistic regression analysis showed that serum low density lipoprotein-cholesterol level(odds ratio[OR]=0.544,95%confidence interval[CI]0.321-0.924,P=0.024)and the duration of glucocorticoid maintenance therapy(OR=0.797,95%CI 0.704-0.902,P<0.001)were the potential factors of AIP recurrence in 112 patients with definite data on the duration of glucocorticoid maintenance therapy.Multivariate logistic regression analysis showed that the duration of glucocorticoid maintenance therapy was independently associated with AIP recurrence(OR=0.813,95%CI 0.713-0.926,P=0.002).Spearman rank correlation analysis further demonstrated a negative correlation between the duration of glucocorticoid maintenance therapy and AIP recurrence(r=-0.545,P<0.001).Additionally,receiver operating characteristic curve analysis indicated that the duration of glucocorticoid maintenance therapy had good predictive effect on AIP recurrence,with an area under curve value of 0.873(95%CI 0.800-0.945,P<0.001).Conclusion Long-term regular glucocorticoid therapy is an independent protective factor against AIP recurrence,and it can significantly reduce the recurrence of AIP.
5.A randomized controlled trial comparing mini-open TLIF via midline approach with MIS-TLIF for degenerative lumbar diseases
Xiang WANG ; Liangzhi XU ; Fengxian JIANG ; Kelyu SHEN ; Yuhang MA ; Zhendong HUANG ; Zhengfeng LU
Chinese Journal of Orthopaedics 2025;45(12):767-776
Objective:To compare the clinical efficacy and analyze the surgical approach differences using CT parameters between mini-open transforaminal lumbar interbody fusion (MO-TLIF) and minimally invasive surgery of transforaminal lumbar interbody fusion (MIS-TLIF) in the treatment of degenerative lumbar diseases.Methods:A total of 68 consecutive patients with degenerative lumbar diseases undergoing surgery at the Second Affiliated Hospital of Soochow University from January 2022 to January 2023 were randomized into the MO-TLIF group (34 cases, percutaneous screw-assisted posterior midline MO-TLIF) and the MIS-TLIF group (34 cases, Wiltse approach MIS-TLIF using the Quadrant channel). Perioperative indicators (operative time, incision length, intraoperative blood loss, fluoroscopy frequency, postoperative bedrest duration, and hospital stay) and complications were compared. Visual analogue scale (VAS) and Oswestry disability index (ODI) were assessed preoperatively and at 3 days, 3 months, and 1 year postoperatively. Effective cross-sectional area (eCSA) of paraspinal muscles was evaluated on MRI preoperatively and 1 year postoperatively. CT parameters of surgical approaches, including spinous process-midline distance (SM), Wiltse-midline distance (WM), surgical approach angle, depth, and multifidus muscle displacement were compared. Pearson correlation and multivariate linear regression analyses were performed to explore associations between CT parameters, operative time, blood loss, and eCSA atrophy.Results:Baseline characteristics showed no significant differences between groups ( P>0.05). The MO-TLIF group exhibited shorter operative time (109.85±7.82 min vs. 133.82±20.22 min), reduced blood loss (77.21±21.83 ml vs. 141.18±31.44 ml), smaller incision length (6.09±0.22 cm vs. 7.00±0.43 cm), shorter bedrest duration (1.59±0.49 d vs. 2.38±0.50 d), and shorter hospital stay (8.93±1.44 d vs. 10.35±1.45 d), but higher fluoroscopy frequency (19.53±1.92 times vs. 16.29±1.78 times) compared to the MIS-TLIF group ( P<0.05). Complications included fat liquefaction (5 cases) and dural tears (2 cases). Both groups showed improved VAS and ODI postoperatively ( P<0.05). At 3 d postoperatively, the MO-TLIF group had lower VAS (2.74±0.47 points vs. 3.35±0.48 points) and ODI (27.46%±2.16% vs. 30.42%±2.52%) than the MIS-TLIF group ( P<0.05). Postoperative eCSA decreased significantly in the MIS-TLIF group ( P<0.05) but remained stable in the MO-TLIF group ( P>0.05). The MO-TLIF group demonstrated smaller SM (8.43±1.81 mm vs. 31.15±6.53 mm), approach angle, depth, and muscle displacement ( P<0.05). CT parameters in the MO-TLIF group showed no correlation with operative time, blood loss, or eCSA atrophy ( r<0.3, P>0.05), whereas parameters in the MIS-TLIF group correlated positively with these outcomes (0.3< r<0.6, P<0.05). Multivariate regression revealed a significant association between CT parameters and eCSA atrophy in the MIS-TLIF group ( R 2=0.474, P<0.05). Conclusion:Compared to MIS-TLIF, MO-TLIF reduces intraoperative blood loss, accelerates recovery, and minimizes paraspinal muscle trauma.
6.Progress of research and clinical applications of TERT promoter mutationsins in adult-type diffuse gliomas
Zhendong JIANG ; Bingkun WANG ; Wenjun LUO ; Cuiyun SUN ; Shizhu YU
Chinese Journal of Clinical and Experimental Pathology 2025;41(9):1206-1210
Telomerase reverse transcriptase(TERT)promoter mutation(TPM)in the TERT gene is one of the most frequent genetic alterations in adult-type diffuse gliomas,particularly in IDH-wildtype glioblastoma and IDH-mu-tant oligodendroglioma with 1p/19q co-deletion.Consequently,the WHO(2021)classification of tumors of the central nervous system incorporates TPM as a key molecular criterion for molecular subtyping and grading,differential diagno-sis,prognosis assessment,and treatment-planning in these gliomas.This article briefly reviews the physiological roles of TERT,the relationship between TPM and gliomagenesis.In order to provide reference for clinical practice.
7.Progress of research and clinical applications of TERT promoter mutationsins in adult-type diffuse gliomas
Zhendong JIANG ; Bingkun WANG ; Wenjun LUO ; Cuiyun SUN ; Shizhu YU
Chinese Journal of Clinical and Experimental Pathology 2025;41(9):1206-1210
Telomerase reverse transcriptase(TERT)promoter mutation(TPM)in the TERT gene is one of the most frequent genetic alterations in adult-type diffuse gliomas,particularly in IDH-wildtype glioblastoma and IDH-mu-tant oligodendroglioma with 1p/19q co-deletion.Consequently,the WHO(2021)classification of tumors of the central nervous system incorporates TPM as a key molecular criterion for molecular subtyping and grading,differential diagno-sis,prognosis assessment,and treatment-planning in these gliomas.This article briefly reviews the physiological roles of TERT,the relationship between TPM and gliomagenesis.In order to provide reference for clinical practice.
8.A randomized controlled trial comparing mini-open TLIF via midline approach with MIS-TLIF for degenerative lumbar diseases
Xiang WANG ; Liangzhi XU ; Fengxian JIANG ; Kelyu SHEN ; Yuhang MA ; Zhendong HUANG ; Zhengfeng LU
Chinese Journal of Orthopaedics 2025;45(12):767-776
Objective:To compare the clinical efficacy and analyze the surgical approach differences using CT parameters between mini-open transforaminal lumbar interbody fusion (MO-TLIF) and minimally invasive surgery of transforaminal lumbar interbody fusion (MIS-TLIF) in the treatment of degenerative lumbar diseases.Methods:A total of 68 consecutive patients with degenerative lumbar diseases undergoing surgery at the Second Affiliated Hospital of Soochow University from January 2022 to January 2023 were randomized into the MO-TLIF group (34 cases, percutaneous screw-assisted posterior midline MO-TLIF) and the MIS-TLIF group (34 cases, Wiltse approach MIS-TLIF using the Quadrant channel). Perioperative indicators (operative time, incision length, intraoperative blood loss, fluoroscopy frequency, postoperative bedrest duration, and hospital stay) and complications were compared. Visual analogue scale (VAS) and Oswestry disability index (ODI) were assessed preoperatively and at 3 days, 3 months, and 1 year postoperatively. Effective cross-sectional area (eCSA) of paraspinal muscles was evaluated on MRI preoperatively and 1 year postoperatively. CT parameters of surgical approaches, including spinous process-midline distance (SM), Wiltse-midline distance (WM), surgical approach angle, depth, and multifidus muscle displacement were compared. Pearson correlation and multivariate linear regression analyses were performed to explore associations between CT parameters, operative time, blood loss, and eCSA atrophy.Results:Baseline characteristics showed no significant differences between groups ( P>0.05). The MO-TLIF group exhibited shorter operative time (109.85±7.82 min vs. 133.82±20.22 min), reduced blood loss (77.21±21.83 ml vs. 141.18±31.44 ml), smaller incision length (6.09±0.22 cm vs. 7.00±0.43 cm), shorter bedrest duration (1.59±0.49 d vs. 2.38±0.50 d), and shorter hospital stay (8.93±1.44 d vs. 10.35±1.45 d), but higher fluoroscopy frequency (19.53±1.92 times vs. 16.29±1.78 times) compared to the MIS-TLIF group ( P<0.05). Complications included fat liquefaction (5 cases) and dural tears (2 cases). Both groups showed improved VAS and ODI postoperatively ( P<0.05). At 3 d postoperatively, the MO-TLIF group had lower VAS (2.74±0.47 points vs. 3.35±0.48 points) and ODI (27.46%±2.16% vs. 30.42%±2.52%) than the MIS-TLIF group ( P<0.05). Postoperative eCSA decreased significantly in the MIS-TLIF group ( P<0.05) but remained stable in the MO-TLIF group ( P>0.05). The MO-TLIF group demonstrated smaller SM (8.43±1.81 mm vs. 31.15±6.53 mm), approach angle, depth, and muscle displacement ( P<0.05). CT parameters in the MO-TLIF group showed no correlation with operative time, blood loss, or eCSA atrophy ( r<0.3, P>0.05), whereas parameters in the MIS-TLIF group correlated positively with these outcomes (0.3< r<0.6, P<0.05). Multivariate regression revealed a significant association between CT parameters and eCSA atrophy in the MIS-TLIF group ( R 2=0.474, P<0.05). Conclusion:Compared to MIS-TLIF, MO-TLIF reduces intraoperative blood loss, accelerates recovery, and minimizes paraspinal muscle trauma.
9.Double-Flower Moisturizing Ointment with Occlusive Dressing Therapy Managing Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitors Induced Hand-Foot Skin Reaction
Journal of Zhejiang Chinese Medical University 2025;49(10):1316-1320
[Objective]To investigate the efficacy and safety of Double-Flower Moisturizing Ointment occlusive dressing therapy in treating vascular endothelial growth factor receptor-tyrosine kinase inhibitors(VEGFR-TKIs)induced hand-foot skin reactions(HFSR).[Methods]A total of 58 cancer patients with HFSR induced by VEGFR-TKIs,who were treated at The First Affiliated Hospital of Zhejiang Chinese Medical University from October 8,2021 to December 31,2024,were enrolled in this study.Using a randomized single-blind design,they were assigned to either an observation group(29 cases)or a control group(29 cases).The observation group received oral vitamin B6 combined with Double-Flower Moisturizing Ointment occlusive dressing therapy,while the control group received oral vitamin B6 combined with base ointment occlusive therapy.Both groups were treated for 14 consecutive days.The total effective rate of HFSR management,pain relief rate,quality of life improvement,differences in efficacy between syndrome types and the incidence of adverse reactions were compared between the two groups.[Results]The total effective rate was significantly higher in observation group(89.7%)than in control group(58.6%).The observation group demonstrated a markedly superior overall pain relief rate of 76.9%,which was significantly higher than the 38.5%achieved in control group.Similarly,the quality of life improvement rate in observation group(44.8%)was markedly higher than that in control group(13.8%),with all differences being statistically significant(P<0.05).In the two main syndrome types of damp-heat stagnation and heat-toxicity accumulation on the skin,the observation group exhibited a significantly greater total effective rate compared to control group(P<0.05).No cutaneous adverse reactions or abnormal liver and kidney function were observed in either group.[Conclusion]Double-Flower Moisturizing Ointment occlusive therapy is effective in managing VEGFR-TKIs-induced HFSR.It demonstrates superior outcomes over base ointment occlusive dressing therapy in terms of the overall response rate,pain relief and quality of life improvement,particularly among patients presenting with damp-heat stagnation or heat-toxicity accumulation on the skin.Furthermore,this treatment modality exhibits a favorable safety profile,indicating high clinical application value.
10.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.

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