1.Experience of Using Charcoal-Processed Traditional Chinese Medicine in the Treatment of Gynecological Hemorrhagic Disorders
Xiaolan WU ; Zhaoling YOU ; Guiyun WANG ; Kailing WANG ; Xiaojuan YE ; Lingyu LIAO ; Yueheng LI ; Huiping LIU
Journal of Traditional Chinese Medicine 2025;66(3):308-311
Charcoal-processed traditional Chinese herbal medicine has various therapeutic effects, including astringing, hemostasis, anti-diarrhea, clearing heat, tonifying, and warming the interior. This paper summarizes the clinical application features, compatible experiences, dosages, and precautions for over 20 types of charcoal-processed herbal medicine in the treatment of gynecological bleeding disorders caused by dysfunctions such as dysfunctional uterine bleeding, endometriosis, uterine incision pseudocavity, and vaginal bleeding resulting from threatened miscarriage. The charcoal-processed herbal medicine include Huangqin (Scutellaria Baicalensis) Charcoal, Dahuang (Rheum Palmatum) Charcoal, Cebai (Platycladus Orientalis) Charcoal, Diyu (Sanguisorba Officinalis) Charcoal, Daji (Cirsium Setosum) Charcoal, Xiaoji (Cirsium Japonicum) Charcoal, Shengdi (Rehmannia Glutinosa) Charcoal, Aiye (Artemisia Argyi) Charcoal, Paojiang (Zingiber Officinale) Charcoal, Xuduan (Dipsacus Asper) Charcoal, Duzhong (Eucommia Ulmoides) Charcoal, Qiancao (Rubia Cordifolia) Charcoal, Puhuang (Typha Angustifolia) Charcoal, Shanzha (Crataegus Pinnatifida) Charcoal, Jingjie (Schizonepeta Tenuifolia) Charcoal, Xueyu (Carthamus Tinctorius) Charcoal, Zonglyu (Areca Catechu) Charcoal, Wumei (Prunus Mume) Charcoal, Shudahuang (Rheum Officinale) Charcoal, Lianfang (Nymphaea Alba) Charcoal, Mianmaguanzhong (Clematis Armandii) Charcoal, and Oujie (Nelumbo Nucifera) Charcoal.
2.Quality evaluation of Abri Mollis Herba
Xingmei LIN ; Huiping LI ; Ting WANG ; Chengzhong ZHANG ; Baokang HUANG
Journal of Pharmaceutical Practice and Service 2025;43(5):251-258
Objective To establish a quality evaluation method for Abri Mollis Herba based on its morphological characteristics, microscopic features, and the determination of principal component contents. Methods The morphological characteristics of Abri Mollis Herba were identified by morphological authentication methods. Microscopic techniques were employed to observe the microscopic features of both the powdered form and cross-sectional tissue of Abri Mollis Herba. Additionally, a high-performance liquid chromatography (HPLC) method was developed to establish the quantify the main components, abrine and soyasaponin Bb, in Abri Mollis Herba. Results The morphological characteristics of Abri Mollis Herba were defined by numerous long pubescence on both the upper and lower surfaces of the leaflets, with indistinct veins and vein islands. The microscopic features mainly included non-glandular hairs, prismatic crystals, and crystal-sheathed fibers in the powdered form. In the root cross-section, xylem bundles, rays, vessels, and stone cells were visible. The stem cross-section displayed rays, vessels, and a hollow pith, while the leaf cross-section revealed collateral vascular bundles, vessels, and prismatic crystals. Conclusion The quality of Abri Mollis Herba could be effectively evaluated by the combination of morphological identification, microscopic authentication, and the quantification of main components abrine and soyasaponin Bb .
3.Effect of Bushen Huoxue Prescription in Regulating PINK1/Parkin Pathway in Rat Model of Premature Ovarian Failure
Kailing WANG ; Yichen JING ; Guiyun WANG ; Yueheng LI ; Huiping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):150-158
ObjectiveTo investigate the mechanism of action of Bushen Huoxue prescription (BSHXP) in regulating premature ovarian failure in rats through the PTEN-induced kinase 1 (PINK1)/Parkinson's protein (Parkin) signaling pathway-mediated mitophagy. MethodsA total of 48 rats were randomly divided into a blank group consisting of eight rats, while the remaining 40 rats underwent modeling. The modeling group was intraperitoneally injected with 4 mg·kg-1 cisplatin solution, followed by a second injection one week later, for a total of two injections. The estrous cycle was observed through vaginal smears for 14 consecutive days to determine whether the modeling was successful. The successfully modeled rats were randomly divided into a model group, groups receiving low, medium, and high doses of BSHXP at 9.72, 19.44, and 38.88 g·kg-1·d-1 (BSHXP-L, BSHXP-M, and BSHXP-H groups), and a positive control group treated with estradiol valerate (0.09 mg·kg-1·d-1), for 21 consecutive days. The body weight of the rats was measured weekly. After the final administration, rats were anesthetized, and their blood and ovaries were collected. The ovarian weight was measured. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2). Assay kits were used to measure the levels of superoxide dismutase (SOD) and malondialdehyde (MDA) in the rat serum. Hematoxylin-eosin (HE) staining was used to observe the morphological changes in the ovaries. Immunohistochemistry (IHC) was performed to detect microtubule autophagy-related protein 1 light chain 3B(LC3B) protein expression in ovarian tissue, and electron microscopy was employed to examine the mitochondrial and autophagosome changes in the rat ovaries. Western blot was used to detect the protein expression of PINK1, Parkin, LC3B, and p62. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of PINK1, Parkin, LC3B, and p62 in ovarian tissue. ResultsCompared with the blank group, the model group showed significant reductions in body weight, weight gain, and ovarian weight (P<0.01), along with decreased serum AMH and E2 levels (P<0.01), while FSH and LH levels were increased (P<0.01). Serum MDA levels were significantly increased (P<0.01), and SOD levels were significantly reduced (P<0.01). The ovarian tissue structure was disordered, and the zona pellucida was wrinkled into an irregular acidophilic annular object, accompanied by an increased number of closed follicles. Electron microscopy showed mitochondrial swelling, unclear structure, and no obvious autophagosomes and autolysosome structures. The proteins and mRNA expression levels of PINK1, Parkin, LC3B, and p62 in the ovarian tissue were significantly reduced (P<0.01). Compared with the model group, all treatment groups showed varying degrees of increases in body weight and ovarian weight (P<0.05, P<0.01). Except for the BSHXP-L group, all treatment groups showed increased body weight gain (P<0.01). All treatment groups showed significantly increased serum AMH and decreased FSH levels (P<0.01). Except for the BSHXP group, all treatment groups showed varying degrees of increase and decrease in serum E2 and LH levels (P<0.05, P<0.01). All treatment groups showed reduced serum MDA levels (P<0.01), while the BSHXP-M, BSHXP-H, and the positive control groups demonstrated improved serum SOD levels (P<0.05, P<0.01). All treatment groups showed an increased number of follicles at all stages, visible mature follicles, and a decreased number of closed follicles. Electron microscopy showed relieved mitochondrial swelling, morphology close to normal, clear structure, and visible formation of autolysosomes in all treatment groups. Additionally, the protein and mRNA expression levels of PINK1, Parkin, LC3B, and p62 in ovarian tissue were significantly increased (P<0.05, P<0.01). ConclusionBSHXP may improve ovarian function in rats with premature ovarian failure by regulating the PINK1/Parkin signaling pathway, activating mitochondrial autophagy, and reducing oxidative damage.
4.Effect of Bushen Huoxue Prescription in Regulating PINK1/Parkin Pathway in Rat Model of Premature Ovarian Failure
Kailing WANG ; Yichen JING ; Guiyun WANG ; Yueheng LI ; Huiping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):150-158
ObjectiveTo investigate the mechanism of action of Bushen Huoxue prescription (BSHXP) in regulating premature ovarian failure in rats through the PTEN-induced kinase 1 (PINK1)/Parkinson's protein (Parkin) signaling pathway-mediated mitophagy. MethodsA total of 48 rats were randomly divided into a blank group consisting of eight rats, while the remaining 40 rats underwent modeling. The modeling group was intraperitoneally injected with 4 mg·kg-1 cisplatin solution, followed by a second injection one week later, for a total of two injections. The estrous cycle was observed through vaginal smears for 14 consecutive days to determine whether the modeling was successful. The successfully modeled rats were randomly divided into a model group, groups receiving low, medium, and high doses of BSHXP at 9.72, 19.44, and 38.88 g·kg-1·d-1 (BSHXP-L, BSHXP-M, and BSHXP-H groups), and a positive control group treated with estradiol valerate (0.09 mg·kg-1·d-1), for 21 consecutive days. The body weight of the rats was measured weekly. After the final administration, rats were anesthetized, and their blood and ovaries were collected. The ovarian weight was measured. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2). Assay kits were used to measure the levels of superoxide dismutase (SOD) and malondialdehyde (MDA) in the rat serum. Hematoxylin-eosin (HE) staining was used to observe the morphological changes in the ovaries. Immunohistochemistry (IHC) was performed to detect microtubule autophagy-related protein 1 light chain 3B(LC3B) protein expression in ovarian tissue, and electron microscopy was employed to examine the mitochondrial and autophagosome changes in the rat ovaries. Western blot was used to detect the protein expression of PINK1, Parkin, LC3B, and p62. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of PINK1, Parkin, LC3B, and p62 in ovarian tissue. ResultsCompared with the blank group, the model group showed significant reductions in body weight, weight gain, and ovarian weight (P<0.01), along with decreased serum AMH and E2 levels (P<0.01), while FSH and LH levels were increased (P<0.01). Serum MDA levels were significantly increased (P<0.01), and SOD levels were significantly reduced (P<0.01). The ovarian tissue structure was disordered, and the zona pellucida was wrinkled into an irregular acidophilic annular object, accompanied by an increased number of closed follicles. Electron microscopy showed mitochondrial swelling, unclear structure, and no obvious autophagosomes and autolysosome structures. The proteins and mRNA expression levels of PINK1, Parkin, LC3B, and p62 in the ovarian tissue were significantly reduced (P<0.01). Compared with the model group, all treatment groups showed varying degrees of increases in body weight and ovarian weight (P<0.05, P<0.01). Except for the BSHXP-L group, all treatment groups showed increased body weight gain (P<0.01). All treatment groups showed significantly increased serum AMH and decreased FSH levels (P<0.01). Except for the BSHXP group, all treatment groups showed varying degrees of increase and decrease in serum E2 and LH levels (P<0.05, P<0.01). All treatment groups showed reduced serum MDA levels (P<0.01), while the BSHXP-M, BSHXP-H, and the positive control groups demonstrated improved serum SOD levels (P<0.05, P<0.01). All treatment groups showed an increased number of follicles at all stages, visible mature follicles, and a decreased number of closed follicles. Electron microscopy showed relieved mitochondrial swelling, morphology close to normal, clear structure, and visible formation of autolysosomes in all treatment groups. Additionally, the protein and mRNA expression levels of PINK1, Parkin, LC3B, and p62 in ovarian tissue were significantly increased (P<0.05, P<0.01). ConclusionBSHXP may improve ovarian function in rats with premature ovarian failure by regulating the PINK1/Parkin signaling pathway, activating mitochondrial autophagy, and reducing oxidative damage.
5.Construction and Preliminary Application of Animal Disease Model Digital Atlas Database Platform
Huiping LI ; Hongbin GAO ; Jinyin WEN ; Jinchun YANG
Laboratory Animal and Comparative Medicine 2025;45(3):300-308
Objective Domestic research institutions and researchers have established a wide variety of animal disease models and accumulated a wealth of specialized, distinctive, and targeted atlas data during the model development process. These atlas data are of great value for development and application. Therefore, it is necessary to develop a professional and complete digital atlas database platform for animal models, which can achieve the open sharing of animal model atlas data and the integration and optimization of atlas resources related to disease animal models held by relevant domestic institutions. Methods Based on the B/S architecture, the authors' institution built a digital atlas database of animal models, using Java as the main development language and Oracle database system along with related auxiliary tools. The database platform ran in a Linux environment and could be accessed by users through a web browser. At present, the data on this platform mainly came from the atlas resources submitted by animal model resource units within Guangdong Province. Results In August 2024, a digital atlas database platform for animal models was constructed based on the classification structure of three dimensions: systemic diseases, animal species, and resource units. This platform provided functions such as collection, management, retrieval, and viewing of atlas data. As of January 2025, four resource units had submitted 61 atlas data entries of animal models to the platform, totalling 610 data items. Conclusion The animal model digital atlas database platform has been constructed and put into preliminary use. Although the amount of data on the platform is still limited, it is capable of integrating and openly sharing animal model atlas data. It is believed that with the continuous enrichment of atlas data in the future, this platform is expected to provide important data support for the development of laboratory animal science and comparative medicine research, thereby promoting the efficient utilization of scientific research resources.
6.Construction and Preliminary Application of Animal Disease Model Digital Atlas Database Platform
Huiping LI ; Hongbin GAO ; Jinyin WEN ; Jinchun YANG
Laboratory Animal and Comparative Medicine 2025;45(3):300-308
Objective Domestic research institutions and researchers have established a wide variety of animal disease models and accumulated a wealth of specialized, distinctive, and targeted atlas data during the model development process. These atlas data are of great value for development and application. Therefore, it is necessary to develop a professional and complete digital atlas database platform for animal models, which can achieve the open sharing of animal model atlas data and the integration and optimization of atlas resources related to disease animal models held by relevant domestic institutions. Methods Based on the B/S architecture, the authors' institution built a digital atlas database of animal models, using Java as the main development language and Oracle database system along with related auxiliary tools. The database platform ran in a Linux environment and could be accessed by users through a web browser. At present, the data on this platform mainly came from the atlas resources submitted by animal model resource units within Guangdong Province. Results In August 2024, a digital atlas database platform for animal models was constructed based on the classification structure of three dimensions: systemic diseases, animal species, and resource units. This platform provided functions such as collection, management, retrieval, and viewing of atlas data. As of January 2025, four resource units had submitted 61 atlas data entries of animal models to the platform, totalling 610 data items. Conclusion The animal model digital atlas database platform has been constructed and put into preliminary use. Although the amount of data on the platform is still limited, it is capable of integrating and openly sharing animal model atlas data. It is believed that with the continuous enrichment of atlas data in the future, this platform is expected to provide important data support for the development of laboratory animal science and comparative medicine research, thereby promoting the efficient utilization of scientific research resources.
7.Characteristics of unintentional injury among college students and its association with sexual orientation and gender identity
LI Ruyu, ZHOU Xiaoding, GAO Qi, CHENG Peixia, ZHU Huiping
Chinese Journal of School Health 2025;46(9):1272-1276
Objective:
To analyze the occurrence of unintentional injuries among college students and their association with sexual orientation and gender identity, so as to provide a targeted scientific basis for injury prevention measures and intervention strategies.
Methods:
From October 24 to November 18, 2023, a sample of 1 629 college students from two general universities in Beijing was selected using convenience sampling method. A questionnaire survey was conducted to collect information on the gender identity, sexual orientation and occurrence of unintentional injuries among college students in the past year. The Symptom Checklist-90 (SCL-90), Pittsburgh Sleep Quality Index (PSQI), Childhood Trauma Questionnaire (CTQ), and Delaware Bullying Victimization Scale-Student (DBVS-S) were used to assess mental health, sleep quality, childhood trauma, and dysfunctional impulsivity status. Analyses of sexual orientation and gender identity were conducted. The t-test and Chi square test were used for intergroup comparison,and multivariate Logistic regression analysis was used to examine risk factors for unintentional injuries among college students of different gender identities.
Results:
The incidence rate of unintentional injuries among college students was 16.94%, with boys (17.08%) being higher than girls (16.90%). Compared with those who did not experience unintentional injuries (5.28± 3.60 , 118.68±41.38), college students who experienced unintentional injuries had poorer sleep quality and mental health status ( 6.38 ±3.93, 135.59±50.96)( t =-3.92, -4.26); the differences in the incidence of unintentional injury among college students with non suicidal self injury, interpersonal violence, childhood trauma, and different sexual orientations and gender identities were all statistically significant ( χ 2=28.75, 75.18, 9.83, 16.20, 4.13) (all P <0.05). Multivariate Logistic regression analysis showed that after adjusting for age, gender and body mass index, non heterosexual orientation increased the risk of unintentional injuries ( OR=1.61, 95%CI =1.09-2.38), whereas existing non suicidal self injury behaviors ( OR=2.10, 95%CI =1.02-4.37) and poorer mental health status ( OR=1.54, 95%CI =1.05-2.27) increased the risk of unintentional injuries among non heterosexual college students (all P <0.05).
Conclusions
The incidence rate of unintentional injuries among college students is relatively high, with non heterosexual groups having increased risk of unintentional injuries. Mental health status and non suicidal self injury behaviors are important factors related to unintentional injuries among non heterosexual college students.
8.Mediating effects of metabolic related indicators on the association between childhood overweight/obesity and left ventricular hypertrophy
LI Huiping, YANG Lili, ZHAO Min, XI Bo
Chinese Journal of School Health 2024;45(1):41-45
Objective:
To examine the mediating effects of blood pressure, glucose, lipids, and serum uric acid on the association between childhood overweight/obesity and left ventricular hypertrophy (LVH), and to provide scientific evidence for the prevention and control of cardiovascular diseases during childhood.
Methods:
One public school in Huantai County, Zibo City was selected to conduct the baseline survey from November 2017 to January 2018 using a convenient cluster sampling method. A total of 1 400 children aged 6 to 11 were included in the study. According to the classification criteria based on body mass index (BMI), participants were divided into the non overweight/obese group ( n =787) and the overweight/obese group ( n =613). The mediating effects of metabolic variables on the association between childhood overweight/obesity and left ventricular hypertrophy (LVH) were analyzed using the "mediation" package in R software.
Results:
Children who were overweight/obese had higher levels of BMI- Z score (2.0±0.8), systolic blood pressure (SBP) (109.1±8.9 mmHg), diastolic blood pressure (DBP) (65.4±6.8 mmHg), fasting plasma glucose (FPG) (4.8±0.5 mmol/L), insulin (INS) (11.3±7.6 μU/mL), apolipoprotein B (ApoB) (0.7±0.2 g/L), lowdensity lipoprotein cholesterol (LDL-C) (2.4±0.7 mmol/L), total cholesterol (TC) (4.2±0.9 mmol/L), triglycerides (TG) (0.9±0.4 mmol/L), and serum uric acid (SUA) (321.2±91.4 μmol/L) compared to those who were non-overweight/obese [the corresponding values were (-0.2±0.7),(104.3±8.8) mmHg, (62.2±6.2) mmHg, (4.7±0.6) mmol/L, (6.1±4.2) μU/mL, (0.6±0.2) g/L, (2.2±0.6) mmol/L, (4.1±0.7) mmol/L, (0.7±0.2) mmol/L, and (278.6±74.7) μmol/L, respectively], whereas the levels of high density lipoprotein cholesterol (HDL-C) were lower in overweight/obese children (1.5±0.3 mmol/L) than in non-overweight/obese children (1.7±0.4 mmol/L). All differences were statistically significant ( t =53.66, 9.88, 9.19, 3.60, 16.32, 7.36, 5.11, 2.55, 11.08, 9.58, -10.31, P <0.05). After adjusting for potential covariates, overweight/obese children had 8.72 times increased risk of developing LVH compared to the non-overweight/obese children ( OR=8.72, 95%CI =5.45-14.66, P <0.01). Mediation analysis showed that INS, HDL-C, LDL-C, TG, ApoB, and SUA partially mediated the association between childhood overweight/obesity and LVH, and among these, INS and TG had relatively strong mediating effects, accounting for 28.05% and 13.71% of the total effects, respectively.
Conclusions
INS, HDL-C, LDL-C, TG, ApoB, and SUA are intermediate risk factors on the association between childhood overweight/obesity and LVH. Keeping metabolic indicators (especially INS and TG) at healthy levels is particularly important for reducing the burden of cardiovascular diseases in overweight/obese children.
9.Short-term knee function after total knee arthroplasty and related factors
Zihao WANG ; Xinhua LI ; Huiping JIANG ; Sainan GUO ; Qiuman LIANG ; Tingqi SHI
Chinese Journal of Rehabilitation Theory and Practice 2024;30(1):111-118
ObjectiveTo investigate the short-term knee function recovery of patients undergoing total knee arthroplasty (TKA) after discharge and analyze its related factors. MethodsFrom December, 2022 to April, 2023, 140 adult patients who underwent TKA in Nanjing Drum Tower Hospital and being about to be discharged were selected as the survey subjects using convenient sampling. Potential influencing factors were selected based on a literature review. They were investigated with general information questionnaire, Rehabilitation Exercise Compliance Scale, Self-Efficacy Scale for Rehabilitation Exercise (SER), Visual Analog Scale for pain (VAS), and joint range of motion measurements before discharge, and were investigated with the Hospital for Special Surgery Knee Score (HSS) one month after discharge. ResultsA total of 130 patients finished follow-up. One month after discharge, the HSS score ranged from 40 to 82, with an average of (70.89±6.26). Multiple linear regression analysis revealed that Body Mass Index (B = -0.423, 95%CI -0.622 to -0.224, P < 0.001), pre-discharge VAS (B = -1.016, 95%CI -1.198 to -0.113, P = 0.028), rehabilitation exercise compliance (B = 0.267, 95%CI 0.121 to 0.413, P < 0.001), SER (B = 0.478, 95%CI 0.315 to 0.642, P < 0.001), and knee joint flexion contracture angle (B = -0.251, 95%CI -0.414 to -0.088, P = 0.003) could influence HSS score one month after discharge (R2 = 0.615, F =17.106, P < 0.001). ConclusionPatients after TKA have recovered well in short time after discharge, however, there is still significant room for improvement. Clinical healthcare providers should design and implement appropriate interventions based on related factors to improve the function.
10.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.


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