1.Expert consensus on the application of nasal cavity filling substances in nasal surgery patients(2025, Shanghai).
Keqing ZHAO ; Shaoqing YU ; Hongquan WEI ; Chenjie YU ; Guangke WANG ; Shijie QIU ; Yanjun WANG ; Hongtao ZHEN ; Yucheng YANG ; Yurong GU ; Tao GUO ; Feng LIU ; Meiping LU ; Bin SUN ; Yanli YANG ; Yuzhu WAN ; Cuida MENG ; Yanan SUN ; Yi ZHAO ; Qun LI ; An LI ; Luo BA ; Linli TIAN ; Guodong YU ; Xin FENG ; Wen LIU ; Yongtuan LI ; Jian WU ; De HUAI ; Dongsheng GU ; Hanqiang LU ; Xinyi SHI ; Huiping YE ; Yan JIANG ; Weitian ZHANG ; Yu XU ; Zhenxiao HUANG ; Huabin LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):285-291
This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans
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Nasal Cavity/surgery*
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Nasal Surgical Procedures
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China
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Consensus
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Sinusitis/surgery*
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Dermal Fillers
2.Analysis of the intervention effects of skill training for parents with autism child on toddlers with autism spectrum disorder
Qinyi YE ; Bingrui ZHOU ; Ying ZHANG ; Chunchun HU ; Yingzhi GU ; Xueyan LI ; Huiping LI ; Qiong XU ; Feiyong JIA ; Lan ZHANG ; Xiu XU
Chinese Journal of Pediatrics 2025;63(5):491-497
Objective:To explore the intervention effects of the skill training for parents with autism child (STPAC) on toddlers with autism spectrum disorder (ASD).Methods:A multicenter non-randomized concurrent controlled study design was conducted. Thirty children with ASD aged 15-30 months, first diagnosed at the Children′s Hospital of Fudan University, the First Hospital of Jilin University, and Chengdu Women′s and Children′s Central Hospital from 2019 to 2020, were enrolled in the STPAC group. Thirty children with ASD who visited the same hospitals during the same period but refused the STPAC intervention were selected as the control group. The STPAC group received an 8-week intervention (3 h/week) followed by quarterly follow-ups for 1 year, while the control group voluntarily chose community-based routine interventions. The Griffiths development scales-Chinese (GDS-C) was used to assess the developmental levels, and the communication and symbolic behavior scales developmental profile infant-toddler checklist (CSBS-DP-ITC) was completed by the primary caregivers to evaluate social, language and symbolic behavior. The independent samples t-tests or Mann-Whitney U tests, etc.was used for inter-group comparison. The paired t-tests or Wilcoxon signed-rank tests, etc. was used for inter-group pre-post intervention comparison. Results:The STPAC group included 30 children (22 males and 8 females, aged (23.9±2.2) months), and the control group included 30 children (20 males and 10 females, aged (24.2±2.6) months). Before the intervention, there were no statistically differences in GDS-C development quotient (DQ) and CSBS-DP-ITC scores between groups (all P>0.05). After 1-year intervention, GDS-C DQ in personal-social, hearing-language, hand-eye coordination, performance domains of STPAC group and GDS-C DQ in personal-social, hearing-language domains of control group were all increased (all P<0.01). After 1-year intervention, CSBS-DP-ITC scores of both groups were all improved in socia, language, symbolic behavior, and total scores (all P<0.001). GDS-C DQ changes before and after 1 year of intervention in hearing-language, hand-eye coordination, performance domains of the STPAC group were all higher the those of control group (34(15, 48 vs. 10(-4, 39), 11±20 vs. -1±19, 23±25 vs. 8±22, all P<0.05). CSBS-DP-ITC scores changes before and after 1 year of intervention in social and total scores of the STPAC group were both higher the those of control group (10(5, 30) vs. 3(1, 7), 26±17 vs. 11±8, both P<0.001). Conclusion:Compared with the community routine interventions, the STPAC better improves the language, hand-eye coordination, visual-spatial, social communication, and play skills in ASD toddlers.
3.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.
4.The nomogram prediction model for the risk of dropout in sublingual immunotherapy of patients with allergic rhinitis
Cong PENG ; Zhuguang YI ; Huiping YE ; Dan LIU ; Min WU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):330-337
Objective:To develop and externally validate a nomogram prediction model for assessing the risk of treatment dropout in allergic rhinitis (AR) patients undergoing sublingual immunotherapy (SLIT).Methods:Between February 2016 and December 2019, data from 358 and 259 AR patients undergoing SLIT were collected from Guizhou Provincial People′s Hospital and Huangshi Central Hospital, respectively. The data included general patient information, dust mite sIgE levels, allergen types, and 22 other clinical variables. Data from Guizhou Provincial People′s Hospital were used as the training set, while data from Huangshi Central Hospital were served as the external validation set. A multivariable Cox regression model was used to identify independent factors associated with SLIT dropout and to develop a nomogram prediction model.Results:Multivariate Cox regression analysis identified several significant factors influencing SLIT dropout, including dust mite sIgE levels (Grade Ⅱ-Ⅳ; HR=1.48, 95% CI: 1.16-1.88), presence of other allergic diseases ( HR=0.47, 95% CI: 0.37-0.61), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score ( HR=0.98, 95% CI: 0.97-1.00), WeChat management ( HR=0.77, 95% CI: 0.60-0.98), treatment efficacy ( HR=0.72, 95% CI: 0.56-0.92), age (5-17 years, HR=0.50, 95% CI: 0.36-0.71;≥60 years, HR=1.42, 95% CI: 1.08-1.87), household income (<5 000 CNY, HR=1.44, 95% CI: 1.09-1.90;>20 000 CNY, HR=0.66, 95% CI: 0.44-0.99), allergen types (single dust mite, HR=0.70, 95% CI: 0.49-0.93; and combined pollen or mold, HR=1.45, 95% CI: 1.02-2.04), and time to efficacy <3 months ( HR=0.73, 95% CI: 0.56-0.94), all P<0.05. At the third-year follow-up, the area under curve (AUC) for the nomogram model was 0.913 (95% CI: 0.881-0.943) in the training group and 0.886 (95% CI: 0.838-0.933) in the validation group. Calibration and decision curve analyses demonstrated the model′s consistency with actual dropout rates and clinical benefit in both groups. Additionally, a Brier score of 0.29 further confirmed the model′s predictive accuracy. Conclusion:We successfully develop a nomogram-based prediction model for SLIT dropout in AR patients, which could assist healthcare professionals in effectively identifying high-risk patients and facilitate the development of more personalized and timely treatment plans aimed at enhancing patient compliance.
5.The Effects of Prone Position Ventilation in Patients Receiving Extracorporeal Membrane Oxygenation:a Meta-analysis
Lili LI ; Jing WU ; Junhui WANG ; Hangyan YE ; Chaonan WO ; Miaojie YU ; Fei LI ; Huiping YAO
Chinese Circulation Journal 2025;40(10):999-1005
Objectives:To analyze the effects of prone position ventilation in patients receiving extracorporeal membrane oxygenation(ECMO).Methods:A systematic search was conducted in databases including CNKI,Wanfang Data,China Biomedical Literature Database,PubMed,Embase,Cochrane Library,and Web of Science,from the inception of each database to October 2024,to identify studies on prone position ventilation for ECMO patients.Two researchers independently screened the literature,extracted data,and assessed the quality of the studies.Meta-analysis was performed using RevMan 5.4 software.Results:A total of 10 studies were included in this analysis,comprising 2 randomized controlled trials and 8 cohort studies.A total of 1 513 patients were included,674 were in the prone position ventilation group and 839 were in the supine position ventilation group.Analysis results of 6 studies showed that compared with supine position ventilation,prone position ventilation could increase the successful weaning rate of ECMO(OR=1.47,95%CI:1.07-2.01,P=0.02).Analysis results of 8 studies showed that compared with supine position ventilation,prone position ventilation could prolong the duration of ECMO treatment(mean difference[MD]=4.86 days,95%CI:0.95-8.77,P=0.01).Analysis results of 6 studies showed that the length of stay in the intensive care unit in the prone position ventilation group was significantly longer than that in the supine position ventilation group(MD=5.16 days,95%CI:1.08-9.25,P=0.01).Analysis results of 5 studies showed that the total length of hospital stay in the prone position ventilation group was significantly longer than that in the supine position ventilation group(MD=7.72 days,95%CI:2.10-13.34,P<0.01).Analysis results of 6 studies showed that compared with supine position ventilation,prone position ventilation could prolong the duration of mechanical ventilation(MD=6.06 days,95%CI:0.63-11.49,P=0.03).Prone position ventilation had no obvious advantage in improving patient survival rate.Conclusions:Prone position ventilation can improve the successful weaning rate from ECMO and prolong the duration of ECMO treatment as well as the duration of mechanical ventilation,but it has no significant impact on patient survival rate.Due to the generally small sample size in the studies,further research with larger sample sizes is needed to confirm the effective impact of prone position ventilation in patients receiving ECMO treatment.
6.The Effects of Prone Position Ventilation in Patients Receiving Extracorporeal Membrane Oxygenation:a Meta-analysis
Lili LI ; Jing WU ; Junhui WANG ; Hangyan YE ; Chaonan WO ; Miaojie YU ; Fei LI ; Huiping YAO
Chinese Circulation Journal 2025;40(10):999-1005
Objectives:To analyze the effects of prone position ventilation in patients receiving extracorporeal membrane oxygenation(ECMO).Methods:A systematic search was conducted in databases including CNKI,Wanfang Data,China Biomedical Literature Database,PubMed,Embase,Cochrane Library,and Web of Science,from the inception of each database to October 2024,to identify studies on prone position ventilation for ECMO patients.Two researchers independently screened the literature,extracted data,and assessed the quality of the studies.Meta-analysis was performed using RevMan 5.4 software.Results:A total of 10 studies were included in this analysis,comprising 2 randomized controlled trials and 8 cohort studies.A total of 1 513 patients were included,674 were in the prone position ventilation group and 839 were in the supine position ventilation group.Analysis results of 6 studies showed that compared with supine position ventilation,prone position ventilation could increase the successful weaning rate of ECMO(OR=1.47,95%CI:1.07-2.01,P=0.02).Analysis results of 8 studies showed that compared with supine position ventilation,prone position ventilation could prolong the duration of ECMO treatment(mean difference[MD]=4.86 days,95%CI:0.95-8.77,P=0.01).Analysis results of 6 studies showed that the length of stay in the intensive care unit in the prone position ventilation group was significantly longer than that in the supine position ventilation group(MD=5.16 days,95%CI:1.08-9.25,P=0.01).Analysis results of 5 studies showed that the total length of hospital stay in the prone position ventilation group was significantly longer than that in the supine position ventilation group(MD=7.72 days,95%CI:2.10-13.34,P<0.01).Analysis results of 6 studies showed that compared with supine position ventilation,prone position ventilation could prolong the duration of mechanical ventilation(MD=6.06 days,95%CI:0.63-11.49,P=0.03).Prone position ventilation had no obvious advantage in improving patient survival rate.Conclusions:Prone position ventilation can improve the successful weaning rate from ECMO and prolong the duration of ECMO treatment as well as the duration of mechanical ventilation,but it has no significant impact on patient survival rate.Due to the generally small sample size in the studies,further research with larger sample sizes is needed to confirm the effective impact of prone position ventilation in patients receiving ECMO treatment.
7.Analysis of the intervention effects of skill training for parents with autism child on toddlers with autism spectrum disorder
Qinyi YE ; Bingrui ZHOU ; Ying ZHANG ; Chunchun HU ; Yingzhi GU ; Xueyan LI ; Huiping LI ; Qiong XU ; Feiyong JIA ; Lan ZHANG ; Xiu XU
Chinese Journal of Pediatrics 2025;63(5):491-497
Objective:To explore the intervention effects of the skill training for parents with autism child (STPAC) on toddlers with autism spectrum disorder (ASD).Methods:A multicenter non-randomized concurrent controlled study design was conducted. Thirty children with ASD aged 15-30 months, first diagnosed at the Children′s Hospital of Fudan University, the First Hospital of Jilin University, and Chengdu Women′s and Children′s Central Hospital from 2019 to 2020, were enrolled in the STPAC group. Thirty children with ASD who visited the same hospitals during the same period but refused the STPAC intervention were selected as the control group. The STPAC group received an 8-week intervention (3 h/week) followed by quarterly follow-ups for 1 year, while the control group voluntarily chose community-based routine interventions. The Griffiths development scales-Chinese (GDS-C) was used to assess the developmental levels, and the communication and symbolic behavior scales developmental profile infant-toddler checklist (CSBS-DP-ITC) was completed by the primary caregivers to evaluate social, language and symbolic behavior. The independent samples t-tests or Mann-Whitney U tests, etc.was used for inter-group comparison. The paired t-tests or Wilcoxon signed-rank tests, etc. was used for inter-group pre-post intervention comparison. Results:The STPAC group included 30 children (22 males and 8 females, aged (23.9±2.2) months), and the control group included 30 children (20 males and 10 females, aged (24.2±2.6) months). Before the intervention, there were no statistically differences in GDS-C development quotient (DQ) and CSBS-DP-ITC scores between groups (all P>0.05). After 1-year intervention, GDS-C DQ in personal-social, hearing-language, hand-eye coordination, performance domains of STPAC group and GDS-C DQ in personal-social, hearing-language domains of control group were all increased (all P<0.01). After 1-year intervention, CSBS-DP-ITC scores of both groups were all improved in socia, language, symbolic behavior, and total scores (all P<0.001). GDS-C DQ changes before and after 1 year of intervention in hearing-language, hand-eye coordination, performance domains of the STPAC group were all higher the those of control group (34(15, 48 vs. 10(-4, 39), 11±20 vs. -1±19, 23±25 vs. 8±22, all P<0.05). CSBS-DP-ITC scores changes before and after 1 year of intervention in social and total scores of the STPAC group were both higher the those of control group (10(5, 30) vs. 3(1, 7), 26±17 vs. 11±8, both P<0.001). Conclusion:Compared with the community routine interventions, the STPAC better improves the language, hand-eye coordination, visual-spatial, social communication, and play skills in ASD toddlers.
8.The nomogram prediction model for the risk of dropout in sublingual immunotherapy of patients with allergic rhinitis
Cong PENG ; Zhuguang YI ; Huiping YE ; Dan LIU ; Min WU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):330-337
Objective:To develop and externally validate a nomogram prediction model for assessing the risk of treatment dropout in allergic rhinitis (AR) patients undergoing sublingual immunotherapy (SLIT).Methods:Between February 2016 and December 2019, data from 358 and 259 AR patients undergoing SLIT were collected from Guizhou Provincial People′s Hospital and Huangshi Central Hospital, respectively. The data included general patient information, dust mite sIgE levels, allergen types, and 22 other clinical variables. Data from Guizhou Provincial People′s Hospital were used as the training set, while data from Huangshi Central Hospital were served as the external validation set. A multivariable Cox regression model was used to identify independent factors associated with SLIT dropout and to develop a nomogram prediction model.Results:Multivariate Cox regression analysis identified several significant factors influencing SLIT dropout, including dust mite sIgE levels (Grade Ⅱ-Ⅳ; HR=1.48, 95% CI: 1.16-1.88), presence of other allergic diseases ( HR=0.47, 95% CI: 0.37-0.61), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score ( HR=0.98, 95% CI: 0.97-1.00), WeChat management ( HR=0.77, 95% CI: 0.60-0.98), treatment efficacy ( HR=0.72, 95% CI: 0.56-0.92), age (5-17 years, HR=0.50, 95% CI: 0.36-0.71;≥60 years, HR=1.42, 95% CI: 1.08-1.87), household income (<5 000 CNY, HR=1.44, 95% CI: 1.09-1.90;>20 000 CNY, HR=0.66, 95% CI: 0.44-0.99), allergen types (single dust mite, HR=0.70, 95% CI: 0.49-0.93; and combined pollen or mold, HR=1.45, 95% CI: 1.02-2.04), and time to efficacy <3 months ( HR=0.73, 95% CI: 0.56-0.94), all P<0.05. At the third-year follow-up, the area under curve (AUC) for the nomogram model was 0.913 (95% CI: 0.881-0.943) in the training group and 0.886 (95% CI: 0.838-0.933) in the validation group. Calibration and decision curve analyses demonstrated the model′s consistency with actual dropout rates and clinical benefit in both groups. Additionally, a Brier score of 0.29 further confirmed the model′s predictive accuracy. Conclusion:We successfully develop a nomogram-based prediction model for SLIT dropout in AR patients, which could assist healthcare professionals in effectively identifying high-risk patients and facilitate the development of more personalized and timely treatment plans aimed at enhancing patient compliance.
9.Stepwise intensive rehabilitation can effectively improve the pulmonary and diaphragmatic functioning of persons with serious chronic obstructive pulmonary disease
Yanping FU ; Jinzhu WANG ; Shuyan LI ; Juanhong CHEN ; Lingzhi JIANG ; Huiping YAO ; Xiangming YE
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(11):1004-1010
Objective:To document the impact of information-based, stepwise, intensive rehabilitation therapy on patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).Methods:Eighty such patients in an intensive care unit (ICU) were randomly divided into a control group and an observation group, each of 40. The control group received routine ICU rehabilitation, while the observation group underwent information-based, step-wise ICU rehabilitation. Upon admission to and discharge from the ICU, the forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, and diaphragm functioning were compared between the two groups. The duration of mechanical ventilation, the incidence of ventilator-associated pneumonia (VAP), length of stay in the ICU, incidence of delirium, and the incidence of deep vein thrombosis (DVT) were also recorded. The number of patients readmitted to the ICU after discharge, and the 28-day hospital mortality rate were recorded as well.Results:Significant improvement was observed in both groups in terms of their lung and diaphragm functioning, as well as in the rehabilitation- and hospital-related indicators. At discharge, significantly greater improvements were observed in the observation group compared with the control group in terms of their average FEV1, FVC, FEV1/FVC, inspiratory and expiratory diaphragm thickness, and diaphragm thickening rate. The average duration of mechanical ventilation and of rehabilitation interruptions was significantly less in the observation group. And incidents of accidental extubation, VAP, delirium and DVT were significantly fewer in the observation group as well. Their ICU stays tended to be significantly shorter without any significant difference between the two groups in the 28-day hospital mortality rate. The control group spent significantly less time in their daily rehabilitation sessions, with the result that significantly fewer of them achieved a grading of 2 or better on the mMRC respiratory questionnaire.Conclusion:Information-based stepwise intensive rehabilitation treatment can effectively improve the pulmonary and diaphragmatic function of AECOPD patients admitted to an ICU, shorten their mechanical ventilation time and the length of their ICU stay, and lower their incidence of VAP and DVT during hospitalization.
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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