1.Comparison of the efficacy, safety, and cost-effectiveness of trastuzumab biosimilar HLX02 and the originator combined with pertuzumab and chemotherapy in the neoadjuvant treatment of patients with HER-2-positive breast cancer
Zixuan LEI ; Die SANG ; Bo LAN ; Ying FAN ; Ruigang CAI ; Yang LUO ; Qiao LI ; Jiayu WANG ; Longmei ZHAO ; Peng YUAN
Chinese Journal of Oncology 2025;47(6):517-524
Objective:To compare the efficacy, safety, and cost-effectiveness of the trastuzumab originator (HST) versus its biosimilar (HLX02) combined with pertuzumab and chemotherapy as neoadjuvant treatment in patients with HER-2-positive breast cancer.Methods:This retrospective cohort study included 175 patients with HER-2-positive breast cancer who received neoadjuvant therapy followed by curative surgery at the Cancer Hospital Chinese Academy of Medical Sciences between October 2020 and January 2024. Patients were divided into two groups based on the trastuzumab formulation used: the HST group ( n=89) and the HLX02 group ( n=86).The efficacy, safety, and trastuzumab-related treatment costs were compared between the two groups. Moreover, using Logistic regression model to identify the factors influencing total pathological complete response (tpCR) rates. Results:There were statistically significant differences in clinical T stage and surgical approach between the HST and HLX02 groups ( P<0.05). Other clinicopathological characteristics, such as age and histological grade, showed no statistically significant differences ( P>0.05), with most baseline characteristics remaining balanced between the two groups. There were no significant differences in tpCR rates ( P=0.957) or Miller-Payne (MP) grading rates ( P=0.991) between the HST and HLX02 groups. The tpCR rates for the two groups were 55.1% (49/89) and 54.7% (47/86), respectively. The rates of achieving grade 5 (G5) in the postoperative MP pathological grading system were 55.1% (49/89) and 55.8% (48/86), respectively, with no statistically significant difference ( P=0.991). Univariate and multivariate Logistic regression analyses showed that hormone receptor status is an independent risk factor affecting tpCR ( OR=0.31, 95% CI; 0.16-0.61, P<0.001). The incidence of adverse event during neoadjuvant therapy was similar between the groups, with no occurrences of trastuzumab-related cardiac toxicity. The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P<0.05]. Conclusions:In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.
2.Design and application of a special bra for vest-type breast dressing
Dan LIU ; Lu ZHENG ; Shuhua YE ; Die TANG ; Li LUO ; Milin LAI ; Jingyan ZHANG
Chinese Journal of Practical Nursing 2025;41(13):987-992
Objective:To design a vest-type breast dressing bra and explore its application effect in the external application of traditional Chinese medicine therapy for patients with granulomatous lobular mastitis(GLM).Methods:A randomized controlled study was conducted, utilizing convenience sampling to select female patients with 122 GLM who underwent their first topical medication treatment in the Breast Department of Guangdong Provincial Hospital of Traditional Chinese Medicine between January and May 2023. The patients were divided into a control group and an observation group, with 61 patients in each, using a random number table. Following medication application, patients in the control group used a regular sports bra to secure the medication, while patients in the observation group used a custom-designed vest-style breast medication bra for the same purpose. Three hours after the intervention, comparisons were made between the two groups in terms of the incidence of medication detachment, medication displacement, clothing contamination, patient satisfaction, and safety.Results:Both groups of patients completed the study. The age of the observation group was (32.18 ± 5.50) years old, while the age of the control group was (33.66 ± 5.20) years old. Three hours after the intervention, the incidence of medication detachment, medication displacement, clothing contamination in the observation group were 3.28% (2/61), 6.56% (4/61), and 8.20% (5/61), which were lower than those in the control group with 18.03% (11/61), 26.23% (16/61), and 67.21% (41/61), respectively. The differences were statistically significant ( χ2=6.97, 8.61, 45.23; all P<0.05). The satisfaction level of patients towards the bra in the observation group was (4.43 ± 0.85) points, higher than that of the control group (3.85 ± 1.08) points, with a statistically significant difference ( t=3.30, P<0.05). The incidence rates of skin allergic reactions were 3.28%(2/61) and 4.92%(3/61) in the observation group and the control group, respectively, with no statistically significant difference ( P>0.05). Conclusions:The vest-type breast dressing bra designed in this study can properly secure the medicinal paste, reduce the rate of medication detachment, medication displacement, clothing contamination, and enhance patient satisfaction. It facilitates the external application of traditional Chinese medicine for patients with GLM and is worthy of clinical promotion.
3.Design and application of a special bra for vest-type breast dressing
Dan LIU ; Lu ZHENG ; Shuhua YE ; Die TANG ; Li LUO ; Milin LAI ; Jingyan ZHANG
Chinese Journal of Practical Nursing 2025;41(13):987-992
Objective:To design a vest-type breast dressing bra and explore its application effect in the external application of traditional Chinese medicine therapy for patients with granulomatous lobular mastitis(GLM).Methods:A randomized controlled study was conducted, utilizing convenience sampling to select female patients with 122 GLM who underwent their first topical medication treatment in the Breast Department of Guangdong Provincial Hospital of Traditional Chinese Medicine between January and May 2023. The patients were divided into a control group and an observation group, with 61 patients in each, using a random number table. Following medication application, patients in the control group used a regular sports bra to secure the medication, while patients in the observation group used a custom-designed vest-style breast medication bra for the same purpose. Three hours after the intervention, comparisons were made between the two groups in terms of the incidence of medication detachment, medication displacement, clothing contamination, patient satisfaction, and safety.Results:Both groups of patients completed the study. The age of the observation group was (32.18 ± 5.50) years old, while the age of the control group was (33.66 ± 5.20) years old. Three hours after the intervention, the incidence of medication detachment, medication displacement, clothing contamination in the observation group were 3.28% (2/61), 6.56% (4/61), and 8.20% (5/61), which were lower than those in the control group with 18.03% (11/61), 26.23% (16/61), and 67.21% (41/61), respectively. The differences were statistically significant ( χ2=6.97, 8.61, 45.23; all P<0.05). The satisfaction level of patients towards the bra in the observation group was (4.43 ± 0.85) points, higher than that of the control group (3.85 ± 1.08) points, with a statistically significant difference ( t=3.30, P<0.05). The incidence rates of skin allergic reactions were 3.28%(2/61) and 4.92%(3/61) in the observation group and the control group, respectively, with no statistically significant difference ( P>0.05). Conclusions:The vest-type breast dressing bra designed in this study can properly secure the medicinal paste, reduce the rate of medication detachment, medication displacement, clothing contamination, and enhance patient satisfaction. It facilitates the external application of traditional Chinese medicine for patients with GLM and is worthy of clinical promotion.
4.Comparison of the efficacy, safety, and cost-effectiveness of trastuzumab biosimilar HLX02 and the originator combined with pertuzumab and chemotherapy in the neoadjuvant treatment of patients with HER-2-positive breast cancer
Zixuan LEI ; Die SANG ; Bo LAN ; Ying FAN ; Ruigang CAI ; Yang LUO ; Qiao LI ; Jiayu WANG ; Longmei ZHAO ; Peng YUAN
Chinese Journal of Oncology 2025;47(6):517-524
Objective:To compare the efficacy, safety, and cost-effectiveness of the trastuzumab originator (HST) versus its biosimilar (HLX02) combined with pertuzumab and chemotherapy as neoadjuvant treatment in patients with HER-2-positive breast cancer.Methods:This retrospective cohort study included 175 patients with HER-2-positive breast cancer who received neoadjuvant therapy followed by curative surgery at the Cancer Hospital Chinese Academy of Medical Sciences between October 2020 and January 2024. Patients were divided into two groups based on the trastuzumab formulation used: the HST group ( n=89) and the HLX02 group ( n=86).The efficacy, safety, and trastuzumab-related treatment costs were compared between the two groups. Moreover, using Logistic regression model to identify the factors influencing total pathological complete response (tpCR) rates. Results:There were statistically significant differences in clinical T stage and surgical approach between the HST and HLX02 groups ( P<0.05). Other clinicopathological characteristics, such as age and histological grade, showed no statistically significant differences ( P>0.05), with most baseline characteristics remaining balanced between the two groups. There were no significant differences in tpCR rates ( P=0.957) or Miller-Payne (MP) grading rates ( P=0.991) between the HST and HLX02 groups. The tpCR rates for the two groups were 55.1% (49/89) and 54.7% (47/86), respectively. The rates of achieving grade 5 (G5) in the postoperative MP pathological grading system were 55.1% (49/89) and 55.8% (48/86), respectively, with no statistically significant difference ( P=0.991). Univariate and multivariate Logistic regression analyses showed that hormone receptor status is an independent risk factor affecting tpCR ( OR=0.31, 95% CI; 0.16-0.61, P<0.001). The incidence of adverse event during neoadjuvant therapy was similar between the groups, with no occurrences of trastuzumab-related cardiac toxicity. The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P<0.05]. Conclusions:In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage.
5.A case of extracorporeal membrane oxygenation intubation assisted percutaneous coronary intervention through axillary artery approach
Zheng-Le YANG ; Cheng-Yi XU ; Dong YI ; Xiao-Die XU ; Dan SONG ; Ting LUO ; Hua YAN
Chinese Journal of Interventional Cardiology 2024;32(6):357-360
Veno-arterial extracorporeal membrane oxygenation is an effective method to reduce perioperative adverse events such as cardiogenic shock in patients undergoing complex high-risk indicated percutaneous coronary intervention.Femoral artery and femoral vein are the main routes for conventional veno-arterial extracorporeal membrane oxygenation in China,while the cases of extracorporeal membrane oxygenation insertion via axillary artery are relatively rare.However,the axillary artery intubation veno-arterial extracorporeal membrane oxygenation assisted mode has been regarded as one of the routine clinical paths for the treatment of critically ill patients in foreign countries.This paper reports a case of an elderly male patient who underwent high risk and complex percutaneous coronary interventional therapy by right axillary artery implantation with extracorporeal membrane oxygenation assisted circulation due to the difficulty of femoral artery approach.In order to provide reference for the selection of clinical extracorporeal membrane oxygenation technique route.
6.PKD3 promotes metastasis and growth of oral squamous cell carcinoma through positive feedback regulation with PD-L1 and activation of ERK-STAT1/3-EMT signalling.
Bomiao CUI ; Jiao CHEN ; Min LUO ; Yiying LIU ; Hongli CHEN ; Die LÜ ; Liwei WANG ; Yingzhu KANG ; Yun FENG ; Libin HUANG ; Ping ZHANG
International Journal of Oral Science 2021;13(1):8-8
Oral squamous cell carcinoma (OSCC) has a high incidence of metastasis. Tumour immunotherapy targeting PD-L1 or PD-1 has been revolutionary; however, only a few patients with OSCC respond to this treatment. Therefore, it is essential to gain insights into the molecular mechanisms underlying the growth and metastasis of OSCC. In this study, we analysed the expression levels of protein kinase D3 (PKD3) and PD-L1 and their correlation with the expression of mesenchymal and epithelial markers. We found that the expression of PKD3 and PD-L1 in OSCC cells and tissues was significantly increased, which correlated positively with that of mesenchymal markers but negatively with that of epithelial markers. Silencing PKD3 significantly inhibited the growth, metastasis and invasion of OSCC cells, while its overexpression promoted these processes. Our further analyses revealed that there was positive feedback regulation between PKD3 and PD-L1, which could drive EMT of OSCC cells via the ERK/STAT1/3 pathway, thereby promoting tumour growth and metastasis. Furthermore, silencing PKD3 significantly inhibited the expression of PD-L1, and lymph node metastasis of OSCC was investigated with a mouse footpad xenograft model. Thus, our findings provide a theoretical basis for targeting PKD3 as an alternative method to block EMT for regulating PD-L1 expression and inhibiting OSCC growth and metastasis.
Animals
;
B7-H1 Antigen/metabolism*
;
Carcinoma, Squamous Cell
;
Cell Line, Tumor
;
Feedback
;
Head and Neck Neoplasms
;
Humans
;
Mice
;
Mouth Neoplasms
;
Protein Kinase C
;
STAT1 Transcription Factor
;
Squamous Cell Carcinoma of Head and Neck
7.Application of an autoregressive integrated moving average model in prediction of cardiovascular disease mortality
Liang GUO ; Jia-wei LAI ; Xiao-jun ZHOU ; Die LUO ; Jia-yan CHEN ; Jia-jun-ni LI
Shanghai Journal of Preventive Medicine 2021;33(9):807-812
Objective:To use autoregressive integrated moving average (ARIMA) model for predicting the mortality of cardiovascular diseases in residents in Yushui District, Jiangxi Province, and to provide basis for developing the prevention and control strategies as well as to promote the continuous optimization of chronic disease prevention and treatment demonstration area. Methods:Based on the cardiovascular death monitoring data of residents in Yushui District, Jiangxi Province from 2014 to 2018, Econometrics View 9.0 software was used to construct the ARIMA seasonal adjustment model to predict the monthly cardiovascular death in this area. Results:The monthly death rate of cardiovascular diseases in Yushui showed a long-term rising trend, with an apparent seasonal pattern (a peak of cardiovascular death from December to January each year). After the original sequence was subjected to first-order difference and first-order seasonal difference, the difference sequence showed good stationarity (
8.Effect of -induced changes in tumor tissue acoustic properties on efficacy of high-intensity focused ultrasound ablation.
Die XU ; Yong LUO ; Xuan GAO ; Jie XIONG ; Binglei JIANG ; Yaotai WANG ; Yu TANG ; Fujie JIANG ; Lu WANG ; Huanan LI ; Hai QIAO ; Jianzhong ZOU
Journal of Southern Medical University 2019;39(9):1009-1016
OBJECTIVE:
To investigate the effects of on the acoustic characteristics of tumor tissue and how such acoustic changes affect the efficacy of high-intensity focused ultrasound (HIFU) ablation in nude mice.
METHODS:
Forty mice bearing human breast cancer cell (MDA-MB-231) xenograft were randomized into experimental group (=20) and control group (=20) for intravenous injection of suspension (200 μL, 4 × 10 cfu/mL) and PBS (200 μL) for 3 consecutive days, respectively. Before and at 3 and 7 days after the first injection, shear wave elastography was used to evaluate the hardness of the tumor tissue. On day 7 after the first injection, 10 mice from each group were sacrificed and the sound velocity and sound attenuation of the tumor tissues were measured. The changes in the collagen fibers in the tumors were evaluated using Masson staining, and neovascularization in the tumor was assessed with immunohistochemistry for platelet endothelial cell adhesion molecule-1 (PECAM-1/CD31). The remaining 10 tumor-bearing mice in each group were subjected to HIFU ablation, and the ablation efficiency was evaluated by assessing the changes in irradiation gray values, coagulative necrosis volume, energy efficiency factor (EEF) and irradiation area and by pathological examination with HE staining.
RESULTS:
In the experimental group, the collagen fibers in the tumor tissues were strong and densely aligned, and the tumors contained fewer new blood vessels showing strip-or spot-like morphologies. In the control group, the collagen fibers in the tumors were thin and loosely arranged, and the tumors showed abundant elongated or round new blood vessels. colonized in the tumor 7 days after the injection, and the tumor hardness was significantly greater in the experimental group than in the control group (=0.01); the acoustic velocity (=0.001) and the acoustic attenuation (=0.000) of the tumor tissues were also greater in the experimental group. HIFU irradiation resulted in significantly greater changes in the gray scale of tumor (=0.0006) and larger coagulative necrosis volume (=0.0045) in the experimental group than in the control group, and the EEF was significantly smaller in the experimental group (=0.0134).
CONCLUSIONS
can cause changes in collagen fiber content, acoustic velocity and attenuation in the tumor tissue and reduce the EEF of HIFU irradiation, thereby improving the efficacy of HIFU irradiation.
Acoustics
;
Animals
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Bifidobacterium
;
pathogenicity
;
Breast Neoplasms
;
pathology
;
Collagen
;
Elasticity Imaging Techniques
;
High-Intensity Focused Ultrasound Ablation
;
Humans
;
Mice
;
Mice, Nude
;
Neoplasm Transplantation
;
Random Allocation
9.Study on influence of Chinese patent medicine for cold on anticoagulation effect in postoperative patients with mechanical valve replacement
Chengcheng QIN ; Huogang JIANG ; Xixi LI ; Chen WANG ; Qian LUO ; Die HAN ; Li ZHANG
Chongqing Medicine 2016;45(20):2792-2794
Objective To evaluate the influence of Chinese patent medicine Banlangen Granules and Ganmao Qingre Granules on war‐farin anticogulation effect during the process for treating acute upper respiratory tract infection in the postoperative patients with mechanical valve replacement in order to provide the theoretical reference for clinical medication .Methods The patient receiving mitral valve replace‐ment ,aortic valve replacement or double‐valve replacement and long term postoperative oral warfarin anticoagulation treatment were select‐ed ,moreover the symptoms of complicating acute upper respiratory tract infection occurred .The patients were divided into 2 groups ,30 cases in each group .The group A adopted oral Banlangen Granules ,while the group B was treated by oral Ganmao Qingre Granules .The treat‐ment course was 3 d .The International Normalized Ratio (INR) in the two groups was monitored before medication ,at 72 h after medication and at 72 h after drug withdrawal .Complicating bleeding or embolism reaction was observed .The INR values at various time points were compared between the two groups and the INR values in each group were compared among 3 time points .Results The INR values in the Banlangen Granules group had statistical differences between 72 h and other two time points ,and the INR values at the same time point had statistical difference compared with the Ganmao Qingre Granules group (P<0 .05);the INR value in the Banlangen Granules group had no statistical difference between before medication and at 72 h after medication(P>0 .05) .Thirty cases had no complication occurrence .The Ganmao Qingre Granules group had no statistical difference among various time points (P>0 .05) ,thirty cases had no complication occur‐rence .Conclusion The warfarin combined with Banlangen Granules causes the INR value increase ,while warfarin combined with Ganmao Qingre Granules has no impact on the INR value ,therefore which suggests that the combination use of warfarin and Banlangen Granules should be cautious in clinic .
10.Construction of a recombinant adenovirus co-expressing bone morphogenic proteins 9 and 6 and its effect on osteogenesis in C3H10 cells.
Xiaohong DIE ; Qing LUO ; Cong CHEN ; Guangjin LUO ; Quan KANG
Journal of Southern Medical University 2013;33(9):1273-1279
OBJECTIVETo construct a recombinant adenovirus co-expressing bone morphogenic protein (BMP) 9 and BMP6 and observe its effect on the osteogenesis in C3H10 cells.
METHODThe full-length sequences of BMP9 and BMP6 were amplified from AdEasy vector by PCR and cloned into the shuttle plasmid pASG2 vector to construct the co-expression shuttle plasmid pASG2-BMP9, 6 followed by homologous recombination with plasmid pAdeasy-1 in BJ5183. After confirmation by restriction endonuclease digestion, the recombinant vector was transfected into HEK293 cells, and high-titer recombinant adenovirus (Ad-BMP9, 6) was collected after amplification. Ad-BMP9, 6 was then transduced into C3H10 cells in vitro, and the mRNA expression of BMP9 and BMP6 was detected by RT-PCR. The osteogenic capability of the transfected cells was observed by alkaline phosphatase staining and calcium-alizarin red staining.
RESULTSAdBMP9,6 was constructed successfully and effectively infected in C3H10 cells, in which high expressions of BMP6 and BMP9 were detected. C3H10 cells infected with Ad-BMP9,6 showed stronger alkaline phosphatase and calcium-alizarin red staining than the cells transfected by either BMP9 or BMP6 alone.
CONCLUSIONThe recombinant adenovirus co-expressing BMP9 and BMP6 we constructed shows a more potent effect than the adenoviruses expressing either BMP9 or BMP6 alone in inducing the osteogenic differentiation of C3H10 cells into osteoblasts.
Adenoviridae ; genetics ; Bone Morphogenetic Protein 6 ; genetics ; Genetic Vectors ; Growth Differentiation Factors ; genetics ; HEK293 Cells ; Humans ; Osteoblasts ; cytology ; Osteogenesis ; Plasmids ; Recombinant Fusion Proteins ; genetics ; Transfection

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