1.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
2.Research on the preventive and reparative mechanisms of platelet-rich plasma-biodegradable quick setting spray for solar dermatitis
Zhanhong ZHU ; Shaowen LI ; Li CHEN ; Yubing XU ; Mou ZHOU
Chinese Journal of Blood Transfusion 2026;39(2):188-195
Objective: To investigate the preventive and reparative mechanisms of platelet-rich plasma-biodegradable quick setting spray (PRP-BQSS) on solar dermatitis, thereby providing a safe and effective novel therapeutic approach for clinical application. Methods: PRP-BQSS was prepared. A ultraviolet B (UVB)-induced solar dermatitismodel was established in SPF-grade male SD rats. The rats were divided into the prevention experiment (treated with PRP-BQSS, L' Oréal SPF 50+sunscreen, Nature's Hall SPF 50+sunscreen, or saline) and the treatment experiment (treated with PRP-BQSS, Jingwanhong ointment, Green ointment, or saline). The effects were evaluated by measuring epidermal thickness (HE staining) and quantifying the integrated optical density (IOD) of inflammatory cells (CD11b staining). One-way ANOVA and Tukey's HSD test were performed using GraphPad Prism 9.4.0. Results: The PRP-BQSS exhibited significant efficacy in both prevention and repair. In the prevention experiment, the PRP-BQSS prevention group (Group A) showed only mild pale red erythema on the dorsal skin of rats, without significant swelling or desquamation. Histological analysis revealed that epidermal thickness in Group A (36.55±6.58 μm) was comparable to Groups B (L' Oréal, 34.84±6.59 μm) and C (Natural Hall, 34.59±8.20 μm)(P>0.05), but significantly lower than that in Group D (control group, 47.82±11.69 μm). Skin sections from Group A demonstrated intact epidermal structure with clear stratification and no significant inflammatory cell infiltration. The CD11b-positive cell count (24.30±7.43) was significantly lower than that in Group D (33.65±8.47, P<0.05). In the treatment experiment, HE staining of Group A (PRP-BQSS treatment group) showed intact epidermal structure with orderly arrangement of the basal layer, spinous layer, and granular layer, thin and uniform stratum corneum, and regular collagen fiber arrangement. The epidermal thickness of Group A (37.10±6.41 μm) showed no significant difference from Groups B (Jingwanhong ointment group, 38.66±9.07 μm) or C (Green ointment group, 35.72±4.98 μm)(P>0.05), but was significantly lower than that in Group D (control group, 48.35±8.99 μm)(P<0.05). The integral optical density value of CD11b-positive cells in Group A (32.82±11.01) was significantly lower than that in Group D (47.25±13.52, P>0.05). Moreover, the degree of inflammatory infiltration in Group A was relatively lower compared to Group B (37.14±9.20) and Group C (34.32±16.87), suggesting a superior repair capacity. However, the intergroup differences were not statistically significant (P>0.05). Conclusion: PRP-BQSS hydrogel dressing possesses dual preventive and reparative functions. It exerts its effects by reducing CD11b-positive cell infiltration (inflammation suppression) and promoting the orderly arrangement of the basal layer-epidermal layer-granular layer (epidermal reconstruction). This material holds promise as a novel and effective therapeutic approach for the prevention and treatment of solar dermatitis, particularly suitable for high-risk populations such as children, individuals with sensitive skin, and those engaged in outdoor activities.
3.Retrospective Study on Tongue Image Characteristics of Patients with Glucolipid Metabolism Disorders with Different Traditional Chinese Medicine Syndromes
Shi LIU ; Yang GAO ; Tao JIANG ; Zhanhong CHEN ; Jialin DENG ; Jiatuo XU
Journal of Traditional Chinese Medicine 2025;66(8):826-833
ObjectiveTo explore the distribution pattern of tongue image characteristics in patients with glucolipid metabolic disorders and its main syndromes. MethodsA total of 841 patients with glucolipid metabolic disorders (disease group), and 380 healthy subjects (control group) were included. The disease group was classified into three syndrome types: 283 cases of liver depression and spleen deficiency syndrome, 311 cases of phlegm-dampness obstruction syndrome, and 247 cases of qi stagnation and blood stasis syndrome. Tongue image data were collected using the TFDA-1 Tongue Diagnosis Instrument, and the TDAS V3.0 software was used to analyze the color, texture, and morphological features of the tongue body (TB) and tongue coating (TC) in patents with different syndromes of disease group (including lightness (L), red-green axis (a), yellow-blue axis (b), luminance (Y), difference between red signal and brightness (Cr), difference between blue signal and brightness (Cb), contrast (CON), angular second moment (ASM), entropy (ENT), mean value (MEAN), tongue coating area/tongue surface area (perAll), and tongue coating area/non-coated area (perPart)). Logistic regression analysis was conducted to identify influencing factors for different syndrome types of glucolipid metabolic disorders. ResultsThe tongue body indicators TB-L, TB-Y, and TB-Cb in the disease group were significantly higher than those in the control group, while TB-a, TB-b, and TB-Cr were significantly lower. The tongue coating indicators TC-L, TC-Y, TC-Cb, perAll, and perPart in the disease group were significantly higher than those in the control group, while TC-a, TC-b, and TC-Cr were significantly lower (P<0.05). Comparing with the different syndromes in disease group, the TB-L and TB-Y of the liver depression and spleen deficiency syndrome, and the phlegm-damp obstruction syndrome were higher than those of the qi stagnation and blood stasis syndrome; the TB-a and TB-Cr of the phlegm-damp obstruction syndrome were lower than those of the qi stagnation and blood stasis syndrome; the perAll of the phlegm-damp obstruction syndrome was higher than that of the qi stagnation and blood stasis syndrome (P<0.05). In the analysis of the morphological characteristics of tongue signs, more spotted tongue in disease group compared with control group, more teeth-marked tongue in liver depression and spleen deficiency syndrome than the other two syndromes, more greasy coating in phlegm-damp obstruction syndrome, and more stasis spots of tongue in qi stagnation and blood stasis syndrome (P<0.05). Logistic regression analysis identified that greasy coating, spotted tongue, stasis spots of tongue, tooth-marked tongue, perAll, and TB-Cb are the influencing factors of liver depression and spleen deficiency syndrome; greasy coating, tooth-marked tongue, TC-Cb, and TC-Cr are the influencing factors of phlegm-damp obstruction syndrome; cracked tongue, stasis spots of tongue, tooth-marked tongue, and TB-Y are the influencing factors of qi stagnation and blood stasis syndrome (P<0.05). ConclusionCompared to healthy individuals, patients with glycolipid metabolic disorder have darker tongue color and thicker, greasy tongue coating. Glycolipid metabolic disorder patients of liver depression and spleen deficiency syndrome exhibit a reddish tongue with finer textures and more tooth marks; patients of phlegm-damp obstruction syndrome have lighter tongue coating with a coarser texture and a higher prevalence of greasy coating; patients of qi stagnation and blood stasis syndrome display lower tongue brightness with a higher prevalence of blood stasis spots.
4.Association between dietary behavior and type 2 diabetes in the older adults aged 65 years and over in 18 longevity areas of China
Xuehua HU ; Yue CHEN ; Zenghang ZHANG ; Chen CHEN ; Yingli QU ; Xi MENG ; Jun WANG ; Zinan XU ; Zheng LI ; Sixin LIU ; Wenhui SHI ; Zhanhong XUE ; Fanye LONG ; Xiaoming SHI ; Yuebin LYU
Chinese Journal of Preventive Medicine 2025;59(5):588-596
Objective:To explore the impact of plant and animal dietary behaviors on type 2 diabetes mellitus (T2DM) in older adults aged ≥65 in 18 longevity areas of China.Methods:The subjects were 5 223 older adults over 65 years old from the Healthy Ageing and Biomarkers Cohort Study (HABCS) in 18 longevity areas in China. Through a questionnaire survey and physical examination, information about their demographic characteristics, lifestyles, daily activities, self-health status, current diseases, and fasting venous blood were collected. Food Frequency and Questionnaire (FFQ) was used to collect data on food intake frequency. Based on the prior method, the plant-based diet index (PDI) and animal-based diet index (ADI) of 5 223 older adults were calculated. Subjects were divided into three groups (low-level group: PDI<39 or ADI<31, middle-level group: 39≤PDI≤42 or 31≤ADI≤34, high-level group: PDI>42 or ADI>34) by tertiles of PDI and ADI. Multivariate logistic regression was used to analyze the association between PDI and ADI and the risk of T2DM.Results:The average age of 5 223 subjects was (84.8±11.5) years, with the median ( Q1, Q3) of PDI about 41(38, 43) and the median ( Q1, Q3) of ADI about 33 (30, 35). The prevalence rate of T2DM was 16.41% (857/5 223). After adjusting for covariates, multivariate logistic regression showed that PDI was negatively associated with T2DM. Compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 0.83 (0.69-0.99). ADI was positively associated with T2DM, and compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 1.28 (1.06-1.55). For every one-point increase in PDI and ADI, the risk of T2DM decreased by 2% and increased by 3%, respectively, with the OR (95% CI) of 0.98 (0.96-1.00) and 1.03 (1.01-1.06), respectively. Conclusion:In Chinese older adults ≥65 years in 18 longevity areas, higher adherence to the plant-based behavior may be negatively associated with the risk of T2DM, while higher adherence to the animal-based behavior may be positively associated with the risk of T2DM.
5.Severe Anti-HER2 Drug-induced Interstitial Lung Disease: A Report of Two Cases and Clinical Implications
Zhu SHEN ; Dandan FAN ; Lei CHEN ; Guangqiang CHEN ; Yanan WANG ; Zhanhong HU ; Jie PAN ; Zhou GENG
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1419-1424
Human epidermal growth factor receptor 2 (HER2) is a key therapeutic target for breast cancer. With the wide application of anti-HER2 and HER2 antibody-drug conjugates such as trastuzumab, pertuzumab, trastuzumab emtansine, and trastuzumab deruxtecan, the survival of patients with advanced HER2-positive breast cancers have been significantly improved. However, the subsequent drug-induced interstitial lung disease (DILD) has gradually become an important complication affecting the therapeutic effect and safety. However, the clinical understanding of interstitial lung disease (ILD) caused by this type of drugs is still insufficient, the management lacks unified standards, and the molecular mechanism has not been fully clarified. This study, through two clinical cases of severe DILD, explores the pathogenesis, treatment strategies, risk factors and follow-up monitoring requirements of ILD caused by HER2-targeted drugs, providing a scientific basis for optimizing the clinical diagnosis and treatment plan.
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.Reflections on the Management of Patients' Self-provided Infusion Drugs in Secondary and above General Hospitals in China
Guotao LI ; Xi CHEN ; Yuqi FU ; Zhanhong HU ; Yujin GUO ; Yingbo ZHAO
Herald of Medicine 2025;44(8):1352-1358
Objective To understand the current situation of the management of patients'self-provided infusion drugs in secondary and above general hospitals in China,and to provide a theoretical and practical basis for improving the management system.Methods The annual pharmacy professional quality control work survey conducted by the National Pharmaceutical Management Professional Quality Control Center was used to obtain information on the management of patients'self-provided infusion drugs in secondary and above general hospitals in 31 provinces(autonomous regions and municipalities directly under the central government)and the Xinjiang Production and Construction Corps of Chinese mainland from 2020 to 2022,and was summarized and calculated using data-processing software.Results The total number of secondary and above general hospitals included in the analysis from 2020 to 2022 is 4 786,5 063 and 6 041,respectively.In 2022,compared with 2020,the percentage of hospitals allowing patients to use self-provided infused drugs decreased from 55.08%to 48.54%,the percentage of hospitals that have established a system for managing patients' self-provided drugs increased from 81.54%to 98.09%,and the percentage of hospitalized patients' use of self-provided drugs that are all documented in their medical orders increased from 79.76%to 90.72%.The types of drugs that hospitals allow patients to use for self-provided infusion are mainly antitumor drugs,the places where self-provided infusion drugs are dispensed are mainly clinical departments(wards),and the main source of self-provided infusion drugs is self-pickup by patients.Conclusion Hospitals should establish a management system for patients'self-provided drugs,strengthen the information management of self-provided infusion drugs,and ensure drug supply and medication safety for patients.
8.Association between dietary behavior and type 2 diabetes in the older adults aged 65 years and over in 18 longevity areas of China
Xuehua HU ; Yue CHEN ; Zenghang ZHANG ; Chen CHEN ; Yingli QU ; Xi MENG ; Jun WANG ; Zinan XU ; Zheng LI ; Sixin LIU ; Wenhui SHI ; Zhanhong XUE ; Fanye LONG ; Xiaoming SHI ; Yuebin LYU
Chinese Journal of Preventive Medicine 2025;59(5):588-596
Objective:To explore the impact of plant and animal dietary behaviors on type 2 diabetes mellitus (T2DM) in older adults aged ≥65 in 18 longevity areas of China.Methods:The subjects were 5 223 older adults over 65 years old from the Healthy Ageing and Biomarkers Cohort Study (HABCS) in 18 longevity areas in China. Through a questionnaire survey and physical examination, information about their demographic characteristics, lifestyles, daily activities, self-health status, current diseases, and fasting venous blood were collected. Food Frequency and Questionnaire (FFQ) was used to collect data on food intake frequency. Based on the prior method, the plant-based diet index (PDI) and animal-based diet index (ADI) of 5 223 older adults were calculated. Subjects were divided into three groups (low-level group: PDI<39 or ADI<31, middle-level group: 39≤PDI≤42 or 31≤ADI≤34, high-level group: PDI>42 or ADI>34) by tertiles of PDI and ADI. Multivariate logistic regression was used to analyze the association between PDI and ADI and the risk of T2DM.Results:The average age of 5 223 subjects was (84.8±11.5) years, with the median ( Q1, Q3) of PDI about 41(38, 43) and the median ( Q1, Q3) of ADI about 33 (30, 35). The prevalence rate of T2DM was 16.41% (857/5 223). After adjusting for covariates, multivariate logistic regression showed that PDI was negatively associated with T2DM. Compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 0.83 (0.69-0.99). ADI was positively associated with T2DM, and compared with the low-level group, the OR (95% CI) for T2DM in the high-level group was 1.28 (1.06-1.55). For every one-point increase in PDI and ADI, the risk of T2DM decreased by 2% and increased by 3%, respectively, with the OR (95% CI) of 0.98 (0.96-1.00) and 1.03 (1.01-1.06), respectively. Conclusion:In Chinese older adults ≥65 years in 18 longevity areas, higher adherence to the plant-based behavior may be negatively associated with the risk of T2DM, while higher adherence to the animal-based behavior may be positively associated with the risk of T2DM.
9.Reflections on the Management of Patients' Self-provided Infusion Drugs in Secondary and above General Hospitals in China
Guotao LI ; Xi CHEN ; Yuqi FU ; Zhanhong HU ; Yujin GUO ; Yingbo ZHAO
Herald of Medicine 2025;44(8):1352-1358
Objective To understand the current situation of the management of patients'self-provided infusion drugs in secondary and above general hospitals in China,and to provide a theoretical and practical basis for improving the management system.Methods The annual pharmacy professional quality control work survey conducted by the National Pharmaceutical Management Professional Quality Control Center was used to obtain information on the management of patients'self-provided infusion drugs in secondary and above general hospitals in 31 provinces(autonomous regions and municipalities directly under the central government)and the Xinjiang Production and Construction Corps of Chinese mainland from 2020 to 2022,and was summarized and calculated using data-processing software.Results The total number of secondary and above general hospitals included in the analysis from 2020 to 2022 is 4 786,5 063 and 6 041,respectively.In 2022,compared with 2020,the percentage of hospitals allowing patients to use self-provided infused drugs decreased from 55.08%to 48.54%,the percentage of hospitals that have established a system for managing patients' self-provided drugs increased from 81.54%to 98.09%,and the percentage of hospitalized patients' use of self-provided drugs that are all documented in their medical orders increased from 79.76%to 90.72%.The types of drugs that hospitals allow patients to use for self-provided infusion are mainly antitumor drugs,the places where self-provided infusion drugs are dispensed are mainly clinical departments(wards),and the main source of self-provided infusion drugs is self-pickup by patients.Conclusion Hospitals should establish a management system for patients'self-provided drugs,strengthen the information management of self-provided infusion drugs,and ensure drug supply and medication safety for patients.
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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