1.Effect and significance of fibroblast growth factor on recurrence after seg-mental mastectomy in patients with plasma cell mastitis
Hai-ming WU ; Yun ZHAO ; Zhi-hai GU ; Lu-lu YAN ; Yan-ru LIU ; Rui-yun LU
Chinese Journal of Current Advances in General Surgery 2025;28(4):259-265
Objective:To investigate the impact of fibroblast growth factor(FGF)on recurrence following segmen-tal mastectomy in patients with plasma cell mastitis.Methods:A total of 162 female patients diagnosed with plasma cell mastitis(PCM)were selected from our hospital from October 2021 to May 2023.All patients underwent segmental mastectomy.They were divided into recurrence group(n=28)and non-recurrence group(n=134)according to the follow-up survey on recurrence.Conduct a univariate analysis on the factors influencing recurrence in patients with PCM who undergo segmental mastectomy.After correcting for confounding factors,conduct a multiple linear regression analysis.Using a multivariate logistic regression model to explore the independent risk factors for recurrence in patients undergo-ing segmental mastectomy for PCM.Utilizing logistic regression analysis to explore the independent,multiplicative,or additive interaction between FGF and angiogenic factor in the management of recurrence in PCM patients undergoing segmental mastectomy.The Local Weighted Regression Scatter Method(LOWESS)is used to analyze the two-dimensional curve relationship of continuous variables.Evaluate the predictive efficacy of FGF for PCM recurrence fol-lowing segmental mastectomy using Receiver Operating Characteristic(ROC)curves.Results:The results of univariate analysis showed that the body mass index(BMI),estradiol,prolactin levels,nipple depression,and sinus phase propor-tion of patients in the recurrent group were significantly higher than those in the non recurrent group,and the differ-ences were statistically significant(P<0.05).Before surgery and 1 and 3 months after surgery,the levels of FGF,vascu-lar endothelial growth factor(VEGF),endostatin(ES),and VEGF/ES in the recurrent group were higher than those in the non recurrent group,with statistically significant differences between the groups(P<0.05).The intra group comparison results showed that compared with before surgery,all indicators in both groups of patients were significantly reduced at 1 month after surgery(P<0.05),while in the recurrent group,all indicators were significantly increased at 3 months after surgery(P<0.001).Logistic regression analysis showed that patients with elevated FGF had a higher risk of recurrence in PCM(P<0.05).LOWESS analysis found that there is a certain non-linear relationship between PCM recurrence rate and FGF.FGF has good predictive performance for PCM recurrence.After further adjusting for various confounding fac-tors such as BMI,it was found that the angiogenic factor is related to FGF.The interaction results show that there is an additive or multiplicative interaction between FGF and VEGF/ES.Conclusion:FGF elevation increases the risk of re-currence after segmental mastectomy for PCM.FGF and VEGF/ES exhibit additive or multiplicative interactions.FGF has good predictive performance for PCM recurrence.
2.Effect and significance of fibroblast growth factor on recurrence after seg-mental mastectomy in patients with plasma cell mastitis
Hai-ming WU ; Yun ZHAO ; Zhi-hai GU ; Lu-lu YAN ; Yan-ru LIU ; Rui-yun LU
Chinese Journal of Current Advances in General Surgery 2025;28(4):259-265
Objective:To investigate the impact of fibroblast growth factor(FGF)on recurrence following segmen-tal mastectomy in patients with plasma cell mastitis.Methods:A total of 162 female patients diagnosed with plasma cell mastitis(PCM)were selected from our hospital from October 2021 to May 2023.All patients underwent segmental mastectomy.They were divided into recurrence group(n=28)and non-recurrence group(n=134)according to the follow-up survey on recurrence.Conduct a univariate analysis on the factors influencing recurrence in patients with PCM who undergo segmental mastectomy.After correcting for confounding factors,conduct a multiple linear regression analysis.Using a multivariate logistic regression model to explore the independent risk factors for recurrence in patients undergo-ing segmental mastectomy for PCM.Utilizing logistic regression analysis to explore the independent,multiplicative,or additive interaction between FGF and angiogenic factor in the management of recurrence in PCM patients undergoing segmental mastectomy.The Local Weighted Regression Scatter Method(LOWESS)is used to analyze the two-dimensional curve relationship of continuous variables.Evaluate the predictive efficacy of FGF for PCM recurrence fol-lowing segmental mastectomy using Receiver Operating Characteristic(ROC)curves.Results:The results of univariate analysis showed that the body mass index(BMI),estradiol,prolactin levels,nipple depression,and sinus phase propor-tion of patients in the recurrent group were significantly higher than those in the non recurrent group,and the differ-ences were statistically significant(P<0.05).Before surgery and 1 and 3 months after surgery,the levels of FGF,vascu-lar endothelial growth factor(VEGF),endostatin(ES),and VEGF/ES in the recurrent group were higher than those in the non recurrent group,with statistically significant differences between the groups(P<0.05).The intra group comparison results showed that compared with before surgery,all indicators in both groups of patients were significantly reduced at 1 month after surgery(P<0.05),while in the recurrent group,all indicators were significantly increased at 3 months after surgery(P<0.001).Logistic regression analysis showed that patients with elevated FGF had a higher risk of recurrence in PCM(P<0.05).LOWESS analysis found that there is a certain non-linear relationship between PCM recurrence rate and FGF.FGF has good predictive performance for PCM recurrence.After further adjusting for various confounding fac-tors such as BMI,it was found that the angiogenic factor is related to FGF.The interaction results show that there is an additive or multiplicative interaction between FGF and VEGF/ES.Conclusion:FGF elevation increases the risk of re-currence after segmental mastectomy for PCM.FGF and VEGF/ES exhibit additive or multiplicative interactions.FGF has good predictive performance for PCM recurrence.
3. Mechanism of Ruanmai decoction in treating atherosclerosis based on YWHAZ/p38MAPK/CASP3 signaling pathway
Xue ZHAO ; Yun GU ; Lu ZHANG ; Wen-Ting DU
Chinese Pharmacological Bulletin 2024;40(3):573-581
Aim To explore the mechanism of action of Ruanmai decoction in treating atherosclerosis through network pharmacology. Methods The chemical components and targets of Ruanmai decoction were queried using TCMSP. Relevant targets for atherosclerosis were retrieved from DrugBank, GeneCards, OMIM, and TTD databases. The " Drug-Active Ingredient-Target" PPI network was constructed using Cyto-scape software. GO and KEGG enrichment analysis were performed using the David database. Molecular docking verification of key components with core targets was conducted using the Seesar software. Atherosclerosis mouse models were established by feeding ApoE mice with a high-fat diet, and Ruanmai decoction granules were administered orally. Aortic pathological sections were stained, blood lipids were measured, and immunofluorescence was used to detect Mac2 and YWHAZ protein expression. Western blot was used to detect p-p38MAPK and C-CASP3 protein expression. Results Ruanmai decoction screened a total of 72 active drug components corresponding to 168 target genes for the treatment of atherosclerosis. The targets were primarily enriched in biological processes related to lip-id metabolism, inflammation and immunity, oxidative stress, vascular endothelial function, cell proliferation and apoptosis, glycolysis, and ubiquitination. Signaling pathways such as МАРК, TNF, PDK-Akt, and IL-17 were also involved. Animal experiments verified that RMJ could regulate the p38MAPK signaling pathway by down-regulating key targets YWHAZ, p-p38MAPK, and C-CASP3, thereby reducing AS inflammation and inflammation-induced apoptosis. Conclusions Ruanmai decoction can inhibit the expression of YWHAZ and activate the p38MAPK signaling pathway, potentially improving vascular inflammation, lipid metabolism, oxidative stress, and other pathological processes by regulating the МАРК, TNF, PDK-Akt, and IL-17 signaling pathways, thus preventing and treating atherosclerosis.
5.Japan’s stable supply system for pharmaceuticals:its inspiration for enhancing the supply assurance capability of drugs in shortage in China
Linning WANG ; Lingna GU ; Jie YU ; Yun LU
China Pharmacy 2024;35(10):1157-1162
OBJECTIVE To provide insights for enhancing the supply assurance capability of drugs in shortage in China. METHODS By sorting out top-level design ideas for Japan’s stable supply system for pharmaceuticals, this study elaborates on its current policies for stabilizing drug supply. Policy suggestions were proposed for existing challenges in the supply of drugs in shortage in China. RESULTS & CONCLUSIONS To stabilize drug supply, Japan formulated a systematic 3-tier policy framework that ran through pre-prevention, early risk monitoring, and response mechanisms for supply problems. Pre-prevention measures included establishing a graded classification system for stable supply lists, strengthening government control over the drug production process, and implementing a continuous supply system and cessation reporting system for post-market drugs. Early risk monitoring included self-assessing risks in enterprises, disclosing information concerning supply assurance of enterprises, and providing enterprises with price protection and incentives measures. Response mechanisms for supply problems included establishing the mechanism of increasing production and coordinated supply in enterprises, opening fast-track review and approval channels for changes in raw materials, and establishing emergency systems of transferring drugs to supply. To balance supply assurance and strong regulation of drugs in shortage through refining the incentive and regulatory policies for them, it is recommended to refine the criteria for selecting drugs in shortage, strengthen the circulation of information, optimize price management methods, and clarify problem feedback and solving.
6.Advances of Metal-Organic Framework Composites in Electrochemical Detection of Environmental Pollutants
Jian-Xia GU ; Hai-Xuan WANG ; Jing-Ting HE ; Jian BAI ; Lu-Yun MA
Chinese Journal of Analytical Chemistry 2024;52(8):1061-1071
With the continuous development of science and technology,environmental pollution has become increasingly severe,which makes environmental monitoring crucial.In recent years,electrochemical sensing strategy has attracted wide attention due to its advantages such as low cost,easy operation and fast detection speed.However,the detection performance still faces many challenges such as low sensitivity,high limit of detection and poor selectivity.Metal-organic frameworks(MOFs)is a kind of ordered network porous crystal formed by the coordination bond of organic ligands and metal ions/ion clusters,which can be used to prepare high-performance electrode materials for construction of electrochemical sensors because of their characteristics of large specific surface area,adjustable pore size and diverse structure.However,the poor conductivity and stability of MOFs result in poor electrochemical detection performance,which seriously limits their extensive applications in the field of electrochemistry.Combining MOFs with other functional materials can not only overcome the inherent defects of MOFs but also have the superior properties of both MOFs and functional materials,and the synergistic effect between MOFs and functional materials is conducive to improving the detection performance.Therefore,MOFs composites have been widely used in the electrochemical detection of environmental pollutants.This paper reviewed the applications progress of electrochemical sensors based on MOFs composites(MOFs combine with carbon materials,conductive polymers,metal nanoparticles or MOFs)in detection of environmental pollutants(Pesticides,heavy metal ions,phenolic compounds and nitrites)in the past five years.The prospects and challenges of electrochemical sensors based on MOFs composites for detection of environmental pollutants were also discussed.
7.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.
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.Clinicopathological Features of Primary Small Cell Neuroendocrine Carcinoma of the Bladder.
Yu-Mei GU ; Xiao-Long LIANG ; Yun-Gang ZHANG ; Hong-Ying ZHAO ; Mu-Lan JIN ; Xue LI ; Jun LU
Acta Academiae Medicinae Sinicae 2023;45(3):429-435
Objective To investigate the clinicopathological features,immunohistochemical features,diagnosis,and relationship with sporadic prostate cancer in primary small cell neuroendocrine carcinoma of the bladder. Methods We retrospectively analyzed the clinical characteristics of 12 patients with primary small cell neuroendocrine carcinoma of the bladder diagnosed at Beijing Chao-Yang Hospital affiliated to Capital Medical University from January 2013 to September 2022.The histological features of primary small cell neuroendocrine carcinoma of the bladder were re-evaluated by two pathologists according to the 2022 revision of the World Health Organization Classification of Tumors of the Urinary System and Male Genital Organs.Electronic medical records were retrieved,and telephone follow-up was conducted from the time of histopathological diagnosis to the death or the end of the last follow-up until January 31,2023. Results The 12 patients include 7 patients in pT3 stage and 1 patient in pT4 stage.Eight patients were complicated with other types of tumors,such as high-grade urothelial carcinoma of the bladder and squamous cell carcinoma.Five patients had sporadic prostate cancer.Immunohistochemical staining showed that 12 (100.0%),10 (83.3%),and 8 (66.7%) patients were tested positive for CD56,Syn,and CgA,respectively.The Ki67 proliferation index ranged from 80% to 90%.Five patients with urothelial carcinoma were tested positive for CK20,GATA3,and CK7.P504S was positive in all the 5 patients with prostate cancer,while P63 and 34βE12 were negative.The follow-up of the 12 patients lasted for 3-60 months.Eight of these patients died during follow-up,with the median survival of 15.5 months.Four patients survived. Conclusions Primary small cell neuroendocrine carcinoma of the bladder is a rare urological tumor with high aggressiveness and poor prognosis.In male patients with bladder prostatectomy,all prostate tissue should be sampled.If prostate cancer is detected,the prostate-specific antigen level should be monitored.
Humans
;
Male
;
Carcinoma, Transitional Cell/pathology*
;
Carcinoma, Neuroendocrine/pathology*
;
Urinary Bladder Neoplasms/pathology*
;
Urinary Bladder/pathology*
;
Retrospective Studies
;
Prostatic Neoplasms
;
Biomarkers, Tumor
10.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy
;
Child
;
Humans
;
Female
;
Glycated Hemoglobin
;
Cohort Studies
;
Diabetes Mellitus/diagnosis*
;
Sensitivity and Specificity
;
ROC Curve

Result Analysis
Print
Save
E-mail