1.Research on the Standardization System of Mineral Medicines
Chunmei LIU ; Yuan SUN ; Min ZHANG ; Shaowu SHEN ; Guohua ZHENG ; Bisheng HUANG ; Juan LI
Herald of Medicine 2025;44(10):1709-1716
Objective On the basis of systematically summarizing and organizing the existing standards of mineral drugs in traditional Chinese medicine,this study aims to construct the top-level framework of the mineral drug standard system and promote the standardization process of the mineral drug industry.Methods A comprehensive search and analysis of the standards for 87 kinds of mineral drugs were conducted on authoritative platforms such as the National Standard Information Public Service Platform,China Standard Service Network,and Traditional Chinese Medicine Standard and Guideline Information Service.By delving into the theoretical foundation and scientific methods,combined with practical research,this study uses analogy reference,systematic decomposition,and process analysis to design the top-level framework of the mineral drug standard system.Results Through comprehensive analysis and scientific design,this study summarizes the construction process and methods of the mineral drug standard system,clarifies the hierarchical structure and classification principles of the system,proposes the compilation path,and forms a standard system covering the entire industry chain of mineral drugs,including raw minerals,product categories,and circulation categories.Conclusion This study constructs a full industry chain process framework for the standard system of mineral drugs,providing a clear perspective for the research of mineral drugs.It can more comprehensively display the current state of development of mineral drug standards in our country,laying a foundation for the research on the standardization of mineral drugs.
2.Prospects for the Application of An Advanced Mineral Identification and Characterization System in the Study of Mineral-Based Traditional Chinese Medicines
Chengcheng WANG ; Min LU ; Jingxu CHEN ; Guohua ZHENG ; Bisheng HUANG ; Juan LI ; Yan CAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(11):3196-3204
With the deepening of the modernization of traditional Chinese medicine(TCM),the analysis of mineralogical features of mineralogical TCM,as an important part of TCM,has received more and more attention.At present,the research of mineral-based traditional Chinese medicine is faced with problems such as confusion of medicinal resources,unclear material basis,and low exclusivity of quality standards,while common analytical techniques have certain limitations in quantitative analysis,sensitivity and comprehensive characterization,which restrict the modernization research of mineral-based medicines and its clinical applications.The advanced mineral identification and characterization system integrates energy spectrum and spectral analysis techniques,combined with efficient data processing algorithms,which can rapidly and accurately analyze mineral components qualitatively and quantitatively,but its application in mineral medicine research is still in its infancy.This article reviews the common analytical techniques for mineral medicine and the potential application of advanced mineral identification and characterization system in the identification of mineral Chinese medicine matrix and quality control.The advanced mineral identification and characterization system can not only accurately distinguish the mineralogical characteristics of mineral medicines,such as the mineral composition,elemental state and embedded characteristics,and provide data support for the research of mineral medicine resources,but also provide scientific basis for the establishment of systematic quality standards,the analysis of the preparation mechanism,the revelation of its potential medicinal effect of the material basis and the control of the risk of heavy metals.
3.Dual-modal Magnetic Resonance Imaging Contrast Agents Based on Polymetallic Nanoclusters for Targeted Diagnosis of Prostate Cancer
Qing-Dong LI ; Peng WANG ; Jian-Min XIAO ; Wen-Juan GAO ; Zhen-Hong XIA ; Gui-Long ZHANG ; Zheng-Yan WU
Chinese Journal of Analytical Chemistry 2025;53(4):602-611
Fe/Mn/Gd polymetallic nanooxide(FMGN)were prepared by one-step solvent thermal reaction by using Fe(acac)3,Mn(acac)2 and Gd(acac)3 as reaction precursors.Next,hyaluronic acid(HA)was used to modify FMGN to fabricate tumor-targeting T 1-T 2 dual-mode magnetic resonance imaging(MRI)contrast agent(HA-FMGN)for accurate diagnosis of prostate cancer.The structure and morphology of FMGN were observed by transmission electron microscope(TEM).It was found that FMGN exhibited a uniform nanocluster spherical structure when the feeding ratio of iron acetylacetonate,manganese acetylacetonate,and gadolinium acetylacetonate was 3:2:1.X-ray diffraction(XRD)analysis showed that FMGN had a typical inverse spinel structure of Mn doped Fe 3O 4,with Gd existing in the form of amorphous gadolinium oxide.The longitudinal relaxivity(r 1)and transverse relaxivity(r 2)of FMGN were 13.395 and 428.535 L/(mmol·s),respectively,measured by 0.5 T MRI analyzer,which proved that FMGN had excellent T 1-T 2 dual-mode MRI contrast capability.The cytotoxicity and hemolysis test found that HA-FMGN didn't damage red cells and induce toxicity for normal cells,indicating that HA-FMGN had excellent cell biocompatibility.The internalization efficacy of HA-FMGN was observed by CLSM,and the results showed that HA-FMGN possessed excellent prostate tumor-targeting ability.In vivo MRI experiment showed that HA-FMGN significantly enhanced T 1 and T 2 weighted MRI signal to noise ratio(SNR)of prostate tumor,which promoted the accurate diagnosis of orthotopic prostate cancer.
4.Prospects for the Application of An Advanced Mineral Identification and Characterization System in the Study of Mineral-Based Traditional Chinese Medicines
Chengcheng WANG ; Min LU ; Jingxu CHEN ; Guohua ZHENG ; Bisheng HUANG ; Juan LI ; Yan CAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(11):3196-3204
With the deepening of the modernization of traditional Chinese medicine(TCM),the analysis of mineralogical features of mineralogical TCM,as an important part of TCM,has received more and more attention.At present,the research of mineral-based traditional Chinese medicine is faced with problems such as confusion of medicinal resources,unclear material basis,and low exclusivity of quality standards,while common analytical techniques have certain limitations in quantitative analysis,sensitivity and comprehensive characterization,which restrict the modernization research of mineral-based medicines and its clinical applications.The advanced mineral identification and characterization system integrates energy spectrum and spectral analysis techniques,combined with efficient data processing algorithms,which can rapidly and accurately analyze mineral components qualitatively and quantitatively,but its application in mineral medicine research is still in its infancy.This article reviews the common analytical techniques for mineral medicine and the potential application of advanced mineral identification and characterization system in the identification of mineral Chinese medicine matrix and quality control.The advanced mineral identification and characterization system can not only accurately distinguish the mineralogical characteristics of mineral medicines,such as the mineral composition,elemental state and embedded characteristics,and provide data support for the research of mineral medicine resources,but also provide scientific basis for the establishment of systematic quality standards,the analysis of the preparation mechanism,the revelation of its potential medicinal effect of the material basis and the control of the risk of heavy metals.
5.Research on the Standardization System of Mineral Medicines
Chunmei LIU ; Yuan SUN ; Min ZHANG ; Shaowu SHEN ; Guohua ZHENG ; Bisheng HUANG ; Juan LI
Herald of Medicine 2025;44(10):1709-1716
Objective On the basis of systematically summarizing and organizing the existing standards of mineral drugs in traditional Chinese medicine,this study aims to construct the top-level framework of the mineral drug standard system and promote the standardization process of the mineral drug industry.Methods A comprehensive search and analysis of the standards for 87 kinds of mineral drugs were conducted on authoritative platforms such as the National Standard Information Public Service Platform,China Standard Service Network,and Traditional Chinese Medicine Standard and Guideline Information Service.By delving into the theoretical foundation and scientific methods,combined with practical research,this study uses analogy reference,systematic decomposition,and process analysis to design the top-level framework of the mineral drug standard system.Results Through comprehensive analysis and scientific design,this study summarizes the construction process and methods of the mineral drug standard system,clarifies the hierarchical structure and classification principles of the system,proposes the compilation path,and forms a standard system covering the entire industry chain of mineral drugs,including raw minerals,product categories,and circulation categories.Conclusion This study constructs a full industry chain process framework for the standard system of mineral drugs,providing a clear perspective for the research of mineral drugs.It can more comprehensively display the current state of development of mineral drug standards in our country,laying a foundation for the research on the standardization of mineral drugs.
6.Rodent monitoring and analysis in kitchens: the Bright Kitchen, Clear Stove approach
Xiao-ying ZHENG ; Fei LIU ; Shi-ji TAO ; Dun-jia WANG ; Jia-min SHEN ; Yi-zhou CAI ; Le JIANG ; Lin-juan DONG ; Min-hui ZHU ; Yi-bin ZHOU
Acta Parasitologica et Medica Entomologica Sinica 2025;32(4):247-251
Objective To assess the status of rodent infestation in commercial kitchens using data from the‘Bright Kitchen, Clean Stove' initiative. The potential use of artificial-intelligence(AI)-based surveillance systems to monitor rodent density was explored, thereby providing a scientific basis for rodent control strategies. Methods As a component of the ‘Bright Kitchen, Clean Stove' initiative, the Minhang District Market Supervision Administration in Shanghai has installed cameras in 297 kitchens. These systems incorporate an AIpowered rodent image recognition method that automatically captures and stores the first image captured in each kitchen each day when a rodent is detected. In 2023, the system collected and stored 736 screenshots of rodents. Following manual verification,720 of the images were confirmed to contain rodents. The images were analyzed by noting the time, location, and kitchen area, and the species were manually identified to assess the population density. Results Rodent activity was detected in 34 of the 297 monitored kitchens, with an overall infestation rate of 11.45%. Of the 720 confirmed images of rodents, Rattus norvegicus(brown rat)was the predominant species, present in 409(56.81 %)images. Rodents were primarily concentrated in hot food preparation spaces. The density fluctuation curve had a multimodal pattern peaking in spring and autumn. The peak of daily activity was between 22: 00 and 2: 00. There was a significant difference in the rodent detection frequency between weekends and weekdays during peak hours and during non-peak hours(χ2=7.18, P< 0.01). Conclusions The ‘Bright Kitchen, Clear Stove' smart monitoring system has been proven to be applicable to rodent density monitoring. To control rodents in commercial kitchens, greater efforts are required to address and identify the specific infesting conditions and the key points in the control process.
7.Distribution and antimicrobial resistance profiles of clinical isolates from blood samples:results from China Antimicrobial Surveillance Network (CHINET) from 2015 to 2021
Min ZHONG ; Xiangning HUANG ; Hua YU ; Yang YANG ; Fupin HU ; Demei ZHU ; Yi XIE ; Mei KANG ; Shanmei WANG ; Yafei CHU ; Wenen LIU ; Yanming LI ; Dawen GUO ; Jinying ZHAO ; Yuanhong XU ; Ying HUANG ; Yunzhuo CHU ; Sufei TIAN ; Ziyong SUN ; Zhongju CHEN ; Yunsong YU ; Jie LIN ; Jihong LI ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Fang DONG ; Zhiyong LÜ ; Han SHEN ; Wanqing ZHOU ; Sufang GUO ; Zhidong HU ; Jin LI ; Chuanqing WANG ; Pan FU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Bin SHAN ; Yan DU ; Lixia ZHANG ; Juan MA ; Yuxing NI ; Jingyong SUN ; Jinju DUAN ; Jianbang KANG ; Yan JIN ; Chunhong SHAO ; Wei JIA ; Gang LI ; Xuesong XU ; Chao YAN ; Yunjian HU ; Xiaoman AI ; Jinsong WU ; Yuemei LU ; Fangfang HU ; Lianhua WEI ; Fengmei ZOU ; Lei ZHU ; Jinhua MENG ; Shuping ZHOU ; Yan ZHOU ; Shifu WANG ; Xiaobo MA ; Yanping ZHENG ; Kaizhen WEN ; Yirong ZHANG ; Yunsheng CHEN ; Qing MENG ; Xuefei HU ; Ruizhong WANG ; Hua FANG ; Ruyi GUO ; Yan ZHU ; Jilu SHEN ; Wenhui HUANG ; Bixia YU ; Jiao FENG ; Yong ZHAO ; Ping GONG ; Shunhong XUE ; Hongqin GU ; Wen HE ; Jiangshan LIU ; Chunlei YUE ; Longfeng LIAO ; Lin JIANG
Chinese Journal of Infection and Chemotherapy 2024;24(6):664-677
Objective To investigate the distribution and antimicrobial resistance of bacterial isolates from blood samples in the hospitals participating in China Antimicrobial Surveillance Network (CHINET) from 2015 to 2021.Methods Bacterial strains isolated from blood samples were collected from 52 medical centers participating in CHINET from 2015 to 2021 for analysis of bacetrial distribution and antimicrobial resistance.Results A total of 153591 isolates were collected,48.8% of which were gram-positive bacteria and 51.2% were gram-negative bacteria.The top five bacterial strains were coagulase negative Staphylococcus (28.2%),Escherichia coli (20.7%),Klebsiella (13.7%),Enterococcus (7.2%),and Staphylococcus aureus (6.6%).Compard to female patients,male patients showed lower proportion of E.coli and higher proportions of other bacterial species in all the bacterial isolaets from blood samples.The proportions of Streptococcus pneumoniae and Salmonella in all the bacterial isolaets from blood samples were higher in children compared to adults.Enterobacterales species showed various resistance rates to antimicrobial agents.Overall,≥58.0%,≥36.8% and ≥56.8% of E.coli strains were resistant to cefotaxime,gentamicin and levofloxacin respectively over the 7-year period.However,less than 2.5% of the E.coli strains were resistant to carbapenems.K.pneumoniae showed higher resistance rates to imipenem and meropenem than other Enterobacterales species.During the 7-year period,the prevalence of imipenem-resistant and meropenem-resistant K.pneumoniae increased from 21.4% and 19.9% in 2015 to 25.7% and 26.6% in 2021,respectively.However,carbapenems still maintained good antibacterial activity against other Enterobacterales,associaetd with lower resistance rates.In the 7-year period,Acinetobacter baumannii showed a dwonward trend in the resistance rates to imipenem and meropenem,but remained 72.9% and 73.2% respectively in 2021.The prevalence of imipenem-resistant and meropenem-resistant P.aeruginosa decreased from 26.7% and 22.9% in 2015 to 18.5% and 14.7% in 2021,respectively.The prevalence of PRSP was 1.5% in the isolaets from adults and and 0.8% in the isolates from children.Less than 3.0% of the Enterococcus faecium and Enterococcus faecalis strains were resistant to vancomycin,teicolanin,or linezolid.The prevalence of methicillin-resistant S.aureus (MRSA) and coagulase negative Staphylococcus (MRCNS) was 32.1% and 81.0%,respectively.The prevalence of MRSA was relatively stable,28.5% in 2015 and 28.0% in 2021.Conclusions Coagulase negative Staphylococcus,E.coli and K.pneumoniae were the main bacterial species isolated from blood samples in the hospitals participaing in the CHINET from 2015 to 2021.Significant sex and age differences were found in the distribution of bcterial isolates from blood samples.The overall resistance rates of the top bacetrial strains from blood samples to antimicrobial agents showed a downward trend.Ongoing surveillance of antimicrobial resistance for the isolates from blood samples is still essential for prescribing rational antimicrobial therapies and curbing bacterial resistance.
8.Antimicrobial resistance profile of clinical isolates in hospitals across China:report from the CHINET Antimicrobial Resistance Surveillance Program,2023
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Hua FANG ; Penghui ZHANG ; Bixia YU ; Ping GONG ; Haixia SHI ; Kaizhen WEN ; Yirong ZHANG ; Xiuli YANG ; Yiqin ZHAO ; Longfeng LIAO ; Jinhua WU ; Hongqin GU ; Lin JIANG ; Meifang HU ; Wen HE ; Jiao FENG ; Lingling YOU ; Dongmei WANG ; Dong'e WANG ; Yanyan LIU ; Yong AN ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Jianping WANG ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Cunshan KOU ; Shunhong XUE ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Xiaoyan ZENG ; Wen LI ; Yan GENG ; Zeshi LIU
Chinese Journal of Infection and Chemotherapy 2024;24(6):627-637
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in healthcare facilities in major regions of China in 2023.Methods Clinical isolates collected from 73 hospitals across China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2023 Clinical & Laboratory Standards Institute (CLSI) breakpoints.Results A total of 445199 clinical isolates were collected in 2023,of which 29.0% were gram-positive and 71.0% were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species (excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi) (MRSA,MRSE and MRCNS) was 29.6%,81.9% and 78.5%,respectively.Methicillin-resistant strains showed significantly higher resistance rates to most antimicrobial agents than methicillin-susceptible strains (MSSA,MSSE and MSCNS).Overall,92.9% of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 91.4% of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis had significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 93.1% in the isolates from children and and 95.9% in the isolates from adults.The resistance rate to carbapenems was lower than 15.0% for most Enterobacterales species except for Klebsiella,22.5% and 23.6% of which were resistant to imipenem and meropenem,respectively .Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.6% to 10.0%.The resistance rate to imipenem and meropenem was 21.9% and 17.4% for Pseudomonas aeruginosa,respectively,and 67.5% and 68.1% for Acinetobacter baumannii,respectively.Conclusions Increasing resistance to the commonly used antimicrobial agents is still observed in clinical bacterial isolates.However,the prevalence of important crabapenem-resistant organisms such as crabapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a slightly decreasing trend.This finding suggests that strengthening bacterial resistance surveillance and multidisciplinary linkage are important for preventing the occurrence and development of bacterial resistance.
9.A real-world study of first-line albumin-bound paclitaxel in the treatment of advanced pancreatic cancer in China
Juan DU ; Xin QIU ; Jiayao NI ; Qiaoli WANG ; Fan TONG ; Huizi SHA ; Yahui ZHU ; Liang QI ; Wei CAI ; Chao GAO ; Xiaowei WEI ; Minbin CHEN ; Zhuyin QIAN ; Maohuai CAI ; Min TAO ; Cailian WANG ; Guocan ZHENG ; Hua JIANG ; Anwei DAI ; Jun WU ; Minghong ZHAO ; Xiaoqin LI ; Bin LU ; Chunbin WANG ; Baorui LIU
Chinese Journal of Oncology 2024;46(11):1038-1048
Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P<0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.
10.A real-world study of first-line albumin-bound paclitaxel in the treatment of advanced pancreatic cancer in China
Juan DU ; Xin QIU ; Jiayao NI ; Qiaoli WANG ; Fan TONG ; Huizi SHA ; Yahui ZHU ; Liang QI ; Wei CAI ; Chao GAO ; Xiaowei WEI ; Minbin CHEN ; Zhuyin QIAN ; Maohuai CAI ; Min TAO ; Cailian WANG ; Guocan ZHENG ; Hua JIANG ; Anwei DAI ; Jun WU ; Minghong ZHAO ; Xiaoqin LI ; Bin LU ; Chunbin WANG ; Baorui LIU
Chinese Journal of Oncology 2024;46(11):1038-1048
Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P<0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.


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