1.International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025).
Sheng-Sheng ZHANG ; Lu-Qing ZHAO ; Xiao-Hua HOU ; Zhao-Xiang BIAN ; Jian-Hua ZHENG ; Hai-He TIAN ; Guan-Hu YANG ; Won-Sook HONG ; Yu-Ying HE ; Li LIU ; Hong SHEN ; Yan-Ping LI ; Sheng XIE ; Jin SHU ; Bin-Fang ZENG ; Jun-Xiang LI ; Zhen LIU ; Zheng-Hua XIAO ; Jing-Dong XIAO ; Pei-Yong ZHENG ; Shao-Gang HUANG ; Sheng-Liang CHEN ; Gui-Jun FEI
Journal of Integrative Medicine 2025;23(5):502-518
Functional dyspepsia (FD), characterized by persistent or recurrent dyspeptic symptoms without identifiable organic, systemic or metabolic causes, is an increasingly recognized global health issue. The objective of this guideline is to equip clinicians and nursing professionals with evidence-based strategies for the management and treatment of adult patients with FD using traditional Chinese medicine (TCM). The Guideline Development Group consulted existing TCM consensus documents on FD and convened a panel of 35 clinicians to generate initial clinical queries. To address these queries, a systematic literature search was conducted across PubMed, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, China Biology Medicine (SinoMed) Database, Wanfang Database, Traditional Medicine Research Data Expanded (TMRDE), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS). The evidence from the literature was critically appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The strength of the recommendations was ascertained through a consensus-building process involving TCM and allopathic medicine experts, methodologists, pharmacologists, nursing specialists, and health economists, leveraging their collective expertise and empirical knowledge. The guideline comprises a total of 43 evidence-informed recommendations that span a range of clinical aspects, including the pathogenesis according to TCM, diagnostic approaches, therapeutic interventions, efficacy assessments, and prognostic considerations. Please cite this article as: Zhang SS, Zhao LQ, Hou XH, Bian ZX, Zheng JH, Tian HH, Yang GH, Hong WS, He YY, Liu L, Shen H, Li YP, Xie S, Shu J, Zeng BF, Li JX, Liu Z, Xiao ZH, Xiao JD, Zheng PY, Huang SG, Chen SL, Fei GJ. International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025). J Integr Med. 2025; 23(5):502-518.
Dyspepsia/drug therapy*
;
Humans
;
Medicine, Chinese Traditional/methods*
;
Practice Guidelines as Topic
;
Drugs, Chinese Herbal/therapeutic use*
2.Effects of Yiqi Juanbi Formula on chondrocyte pyroptosis in collagen-induced arthritic rats via NF-κB/NLRP3/Caspase-1 signaling pathway
Xin-yu CUI ; Hao-lin LI ; Wei-qing LI ; Hui-qin KANG ; Wei-gang CHENG ; Pei-xin HE ; Cai-hong YANG ; Ping CHEN ; Hai-dong WANG
Chinese Traditional Patent Medicine 2025;47(9):2880-2887
AIM To investigate the effects of Yiqi Juanbi Formula on chondrocyte pyroptosis in rat models of collagen-induced arthritis(CIA).METHODS Fifty rats were subcutaneously injected at the tail base with an emulsion containing equal volumes of bovine type Ⅱ collagen and incomplete Freund's adjuvant(IFA)to establish the CIA models.These rats were then randomly assigned to the model group,the methotrexate group(0.35 mg/kg),and the low-dose,medium-dose,and high-dose Yiqi Juanbi Formula groups(9.4,18.7,37.4 g/kg),in contrast to the ten intact rats serving in the normal control group.Following four weeks of intragastric administration,the rats had their general conditions observed;their joint swelling and arthritis indices measured;their ankle joint pathology assessed by HE staining;their serum levels of IL-1β,IL-18 and TNF-ɑ detected by ELISA;their mRNA expressions of NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ in ankle cartilage quantified by RT-qPCR;their protein expressions of NF-κB,NLRP3 and Caspase-1 in ankle cartilage analyzed by Western blot;and their NLRP3 and GSDMD positive expressions in ankle cartilage examined by immunohistochemistry.RESULTS Compared to the control group,the model group showed significantly increased joint swelling and arthritis indices(P<0.01);elevated serum levels of IL-1 β,IL-18 and TNF-ɑ(P<0.01);pathological changes including cartilage surface defects,reduced cell count,altered cellular morphology,irregular cell arrangement,and significant inflammatory cell infiltration in synovial tissue;upregulated mRNA expressions of NF-κB,NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ(P<0.01)and increased protein expressions of NF-κB,NLRP3 and Caspase-1(P<0.01)in ankle cartilage;enhanced positive expressions of NLRP3 and GSDMD in ankle cartilage(P<0.01).Compared to the model group,the groups intervened with methotrexate or medium-or high-dose Yiqi Juanbi Formula exhibited reduced joint swelling and arthritis indices(P<0.01);alleviated pathological damage in ankle joints;decreased serum levels of IL-1β,IL-18 and TNF-ɑ(P<0.01);downregulated mRNA expressions of NF-κB,NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ(P<0.05,P<0.01),and reduced protein expressions of NF-κB,NLRP3 and Caspase-1(P<0.05,P<0.01)in ankle cartilage;and diminished positive expressions of NLRP3 and GSDMD in ankle cartilage(P<0.01).CONCLUSION Yiqi Juanbi Formula alleviates inflammation in CIA rats,potentially by inhibiting the activation of the NF-κB/NLRP3/Caspase-1 signaling pathway,thereby suppressing chondrocyte pyroptosis.
3.Associations of Genetic Risk and Physical Activity with Incident Chronic Obstructive Pulmonary Disease: A Large Prospective Cohort Study.
Jin YANG ; Xiao Lin WANG ; Wen Fang ZHONG ; Jian GAO ; Huan CHEN ; Pei Liang CHEN ; Qing Mei HUANG ; Yi Xin ZHANG ; Fang Fei YOU ; Chuan LI ; Wei Qi SONG ; Dong SHEN ; Jiao Jiao REN ; Dan LIU ; Zhi Hao LI ; Chen MAO
Biomedical and Environmental Sciences 2025;38(10):1194-1204
OBJECTIVE:
To investigate the relationship between physical activity and genetic risk and their combined effects on the risk of developing chronic obstructive pulmonary disease.
METHODS:
This prospective cohort study included 318,085 biobank participants from the UK. Physical activity was assessed using the short form of the International Physical Activity Questionnaire. The participants were stratified into low-, intermediate-, and high-genetic-risk groups based on their polygenic risk scores. Multivariate Cox regression models and multiplicative interaction analyses were used.
RESULTS:
During a median follow-up period of 13 years, 9,209 participants were diagnosed with chronic obstructive pulmonary disease. For low genetic risk, compared to low physical activity, the hazard ratios ( HRs) for moderate and high physical activity were 0.853 (95% confidence interval [ CI]: 0.748-0.972) and 0.831 (95% CI: 0.727-0.950), respectively. For intermediate genetic risk, the HRs were 0.829 (95% CI: 0.758-0.905) and 0.835 (95% CI: 0.764-0.914), respectively. For participants with high genetic risk, the HRs were 0.809 (95% CI: 0.746-0.877) and 0.818 (95% CI: 0.754-0.888), respectively. A significant interaction was observed between genetic risk and physical activity.
CONCLUSION
Moderate or high levels of physical activity were associated with a lower risk of developing chronic obstructive pulmonary disease across all genetic risk groups, highlighting the need to tailor activity interventions for genetically susceptible individuals.
Humans
;
Pulmonary Disease, Chronic Obstructive/epidemiology*
;
Exercise
;
Male
;
Female
;
Middle Aged
;
Prospective Studies
;
Aged
;
Genetic Predisposition to Disease
;
Risk Factors
;
United Kingdom/epidemiology*
;
Incidence
;
Adult
4.Analysis on the current status of outpatient benefit policies for patients with hypertension and diabetes in urban and rural residents
Pei-lin WU ; Jing LIANG ; Yan-qing MIAO ; Dong-hua TIAN
Chinese Journal of Health Policy 2025;18(2):24-29
Objective:To analyze the current policy design of outpatient benefit policies for patients with hypertension and diabetes(H&D)in urban and rural residents in China,and to provide references for optimizing the outpatient benefit mechanism for patients with H&D.Methods:A questionnaire survey was conducted to collect data on the basic features of General Outpatient Benefit(GOB),Outpatient Medication Guarantee Mechanisms for Hypertension and Diabetes(OMGM-H&D)and Outpatient Benefit for Patient with Chronic and Special Diseases(OB-C&S),focusing on deductibles,policy reimbursement ratios,and maximum payment limits.Descriptive statistical analysis was performed on the data.Results:A total of 334 regions were surveyed,of which 253 regions(75.34%)had implemented all three policies.Regional analysis revealed significant differences(P<0.001)in reimbursement ratios for GOB and the OMGM-H&D between the eastern,central,and western regions,with the western region having notably higher ratios than the eastern and central regions.However,no significant difference (P>0.05) was observed in the reimbursement ratios for OB-C&S across regions. Regarding deductibles,no significant regional difference (P>0.05) was found for GOB,but significant differences (P<0.05) existed for the OMGM-H&D and OB-C&S. Additionally,the annual maximum payment limits for all three policies showed significant regional variations (P<0.001). Conclusions:The outpatient benefits policy for patients with H&D have achieved full coverage nationwide among urban and rural residents in China,but regional equity in benefit levels requires improvement. It is recommended to strengthen data feedback mechanisms and promote provincial-level pooling of medical insurance.
5.Effects of Yiqi Juanbi Formula on chondrocyte pyroptosis in collagen-induced arthritic rats via NF-κB/NLRP3/Caspase-1 signaling pathway
Xin-yu CUI ; Hao-lin LI ; Wei-qing LI ; Hui-qin KANG ; Wei-gang CHENG ; Pei-xin HE ; Cai-hong YANG ; Ping CHEN ; Hai-dong WANG
Chinese Traditional Patent Medicine 2025;47(9):2880-2887
AIM To investigate the effects of Yiqi Juanbi Formula on chondrocyte pyroptosis in rat models of collagen-induced arthritis(CIA).METHODS Fifty rats were subcutaneously injected at the tail base with an emulsion containing equal volumes of bovine type Ⅱ collagen and incomplete Freund's adjuvant(IFA)to establish the CIA models.These rats were then randomly assigned to the model group,the methotrexate group(0.35 mg/kg),and the low-dose,medium-dose,and high-dose Yiqi Juanbi Formula groups(9.4,18.7,37.4 g/kg),in contrast to the ten intact rats serving in the normal control group.Following four weeks of intragastric administration,the rats had their general conditions observed;their joint swelling and arthritis indices measured;their ankle joint pathology assessed by HE staining;their serum levels of IL-1β,IL-18 and TNF-ɑ detected by ELISA;their mRNA expressions of NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ in ankle cartilage quantified by RT-qPCR;their protein expressions of NF-κB,NLRP3 and Caspase-1 in ankle cartilage analyzed by Western blot;and their NLRP3 and GSDMD positive expressions in ankle cartilage examined by immunohistochemistry.RESULTS Compared to the control group,the model group showed significantly increased joint swelling and arthritis indices(P<0.01);elevated serum levels of IL-1 β,IL-18 and TNF-ɑ(P<0.01);pathological changes including cartilage surface defects,reduced cell count,altered cellular morphology,irregular cell arrangement,and significant inflammatory cell infiltration in synovial tissue;upregulated mRNA expressions of NF-κB,NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ(P<0.01)and increased protein expressions of NF-κB,NLRP3 and Caspase-1(P<0.01)in ankle cartilage;enhanced positive expressions of NLRP3 and GSDMD in ankle cartilage(P<0.01).Compared to the model group,the groups intervened with methotrexate or medium-or high-dose Yiqi Juanbi Formula exhibited reduced joint swelling and arthritis indices(P<0.01);alleviated pathological damage in ankle joints;decreased serum levels of IL-1β,IL-18 and TNF-ɑ(P<0.01);downregulated mRNA expressions of NF-κB,NLRP3,Caspase-1,GSDMD,IL-1β,IL-18 and TNF-ɑ(P<0.05,P<0.01),and reduced protein expressions of NF-κB,NLRP3 and Caspase-1(P<0.05,P<0.01)in ankle cartilage;and diminished positive expressions of NLRP3 and GSDMD in ankle cartilage(P<0.01).CONCLUSION Yiqi Juanbi Formula alleviates inflammation in CIA rats,potentially by inhibiting the activation of the NF-κB/NLRP3/Caspase-1 signaling pathway,thereby suppressing chondrocyte pyroptosis.
6.Analysis on the current status of outpatient benefit policies for patients with hypertension and diabetes in urban and rural residents
Pei-lin WU ; Jing LIANG ; Yan-qing MIAO ; Dong-hua TIAN
Chinese Journal of Health Policy 2025;18(2):24-29
Objective:To analyze the current policy design of outpatient benefit policies for patients with hypertension and diabetes(H&D)in urban and rural residents in China,and to provide references for optimizing the outpatient benefit mechanism for patients with H&D.Methods:A questionnaire survey was conducted to collect data on the basic features of General Outpatient Benefit(GOB),Outpatient Medication Guarantee Mechanisms for Hypertension and Diabetes(OMGM-H&D)and Outpatient Benefit for Patient with Chronic and Special Diseases(OB-C&S),focusing on deductibles,policy reimbursement ratios,and maximum payment limits.Descriptive statistical analysis was performed on the data.Results:A total of 334 regions were surveyed,of which 253 regions(75.34%)had implemented all three policies.Regional analysis revealed significant differences(P<0.001)in reimbursement ratios for GOB and the OMGM-H&D between the eastern,central,and western regions,with the western region having notably higher ratios than the eastern and central regions.However,no significant difference (P>0.05) was observed in the reimbursement ratios for OB-C&S across regions. Regarding deductibles,no significant regional difference (P>0.05) was found for GOB,but significant differences (P<0.05) existed for the OMGM-H&D and OB-C&S. Additionally,the annual maximum payment limits for all three policies showed significant regional variations (P<0.001). Conclusions:The outpatient benefits policy for patients with H&D have achieved full coverage nationwide among urban and rural residents in China,but regional equity in benefit levels requires improvement. It is recommended to strengthen data feedback mechanisms and promote provincial-level pooling of medical insurance.
7.Data Mining of Medication Rules for the Treatment of Atopic Dermatitis the Children by Chinese Medical Master XUAN Guo-Wei
Jin-Dian DONG ; Cheng-Cheng GE ; Yue PEI ; Shu-Qing XIONG ; Jia-Fen LIANG ; Qin LIU ; Xiu-Mei MO ; Hong-Yi LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):752-758
Objective Data mining technology was used to mine the medication rules of the prescriptions used in the treatment of pediatric atopic dermatitis by Chinese medical master XUAN Guo-Wei.Methods The medical records of effective cases of pediatric atopic dermatitis treated by Professor XUAN Guo-Wei at outpatient clinic were collected,and then the medical data were statistically analyzed using frequency statistics,association rule analysis and cluster analysis.Results A total of 242 prescriptions were included,involving 101 Chinese medicinals.There were 23 commonly-used herbs,and the 16 high-frequency herbs(frequency>100 times)were Glycyrrhizae Radix et Rhizoma,Saposhnikoviae Radix,Glehniae Radix,Perillae Folium,Ophiopogonis Radix,Cynanchi Paniculati Radix et Rhizoma,Microctis Folium,Dictamni Cortex,Scrophulariae Radix,Coicis Semen,Cicadae Periostracum,Lilii Bulbus,Rehmanniae Radix,Kochiae Fructus,Sclerotium Poriae Pararadicis,and Euryales Semen.The analysis of the medicinal properties showed that most of the herbs were sweet and cold,and mainly had the meridian tropism of the spleen,stomach and liver meridians.The association rule analysis yielded 24 commonly-used drug combinations and 20 association rules.Cluster analysis yielded 2 core drug combinations.Conclusion For the treatment of pediatric atopic dermatitis,Professor XUAN Guo-Wei focuses on the clearing,supplementing and harmonizing therapies,and the medication principle of"supporting the healthy-qi to eliminate the pathogen,and balancing the yin and yang"is applied throughout the treatment.
8.Effect of transcutaneous auricular vagus nerve stimulation on functional connectivity in the related brain regions of patients with depression based on the resting-state fMRI.
Yue MA ; Chun-Lei GUO ; Ji-Fei SUN ; Shan-Shan GAO ; Yi LUO ; Qing-Yan CHEN ; Yang HONG ; Lei ZHANG ; Jiu-Dong CAO ; Xue XIAO ; Pei-Jing RONG ; Ji-Liang FANG
Chinese Acupuncture & Moxibustion 2023;43(4):367-373
OBJECTIVE:
To explore the brain effect mechanism and the correlation between brain functional imaging and cognitive function in treatment of depressive disorder (DD) with transcutaneous auricular vagus nerve stimulation (taVNS) based on the resting-state functional magenetic reasonance imaging (rs-fMRI).
METHODS:
Thirty-two DD patients were included in a depression group and 32 subjects of healthy condition were enrolled in a normal group. In the depression group, the taVNS was applied to bilateral Xin (CO15) and Shen (CO10), at disperse-dense wave, 4 Hz/20 Hz in frequency and current intensity ≤20 mA depending on patient's tolerance, 30 min each time, twice daily. The duration of treatment consisted of 8 weeks. The patients of two groups were undertaken rs-fMRI scanning. The scores of Hamilton depression scale (HAMD), Hamilton anxiety scale (HAMA) and Wisconsin card sorting test (WCST) were observed in the normal group at baseline and the depression group before and after treatment separately. The differential brain regions were observed before and after treatment in the two groups and the value of degree centrality (DC) of fMRI was obtained. Their correlation was analyzed in terms of HAMD, HAMA and WCST scores.
RESULTS:
The scores of HAMD and HAMA in the depression group were all higher than those in the normal group (P<0.05). After treatment, the scores of HAMD and HAMA were lower than those before treatment in the depression group; the scores of total responses, response errors and perseverative errors of WCST were all lower than those before treatment (P<0.05). The brain regions with significant differences included the left inferior temporal gyrus, the left cerebellar peduncles region 1, the left insula, the right putamen, the bilateral supplementary motor area and the right middle frontal gyrus. After treatment, the value of DC in left supplementary motor area was negatively correlated to HAMD and HAMA scores respectively (r=-0.324, P=0.012; r=-0.310, P=0.015); the value of DC in left cerebellar peduncles region 1 was negatively correlated to the total responses of WCST (r=-0.322, P=0.013), and the left insula was positively correlated to the total responses of WCST (r=0.271, P=0.036).
CONCLUSION
The taVNS can modulate the intensity of the functional activities of some brain regions so as to relieve depressive symptoms and improve cognitive function.
Humans
;
Depression/therapy*
;
Magnetic Resonance Imaging/methods*
;
Vagus Nerve Stimulation/methods*
;
Brain/diagnostic imaging*
;
Transcutaneous Electric Nerve Stimulation/methods*
;
Vagus Nerve
9.Correlation between Elbow Flexor Muscle Strength and Needle Electromyography Parameters after Musculocutaneous Nerve Injury.
Dong GAO ; Pei-Pei ZHUO ; Dong TIAN ; Dan RAN ; Qing XIA ; Wen-Tao XIA
Journal of Forensic Medicine 2023;39(2):137-143
OBJECTIVES:
To explore the changes of elbow flexor muscle strength after musculocutaneous nerve injury and its correlation with needle electromyography (nEMG) parameters.
METHODS:
Thirty cases of elbow flexor weakness caused by unilateral brachial plexus injury (involving musculocutaneous nerve) were collected. The elbow flexor muscle strength was evaluated by manual muscle test (MMT) based on Lovett Scale. All subjects were divided into Group A (grade 1 and grade 2, 16 cases) and Group B (grade 3 and grade 4, 14 cases) according to their elbow flexor muscle strength of injured side. The biceps brachii of the injured side and the healthy side were examined by nEMG. The latency and amplitude of the compound muscle action potential (CMAP) were recorded. The type of recruitment response, the mean number of turns and the mean amplitude of recruitment potential were recorded when the subjects performed maximal voluntary contraction. The quantitative elbow flexor muscle strength was measured by portable microFET 2 Manual Muscle Tester. The percentage of residual elbow flexor muscle strength (the ratio of quantitative muscle strength of the injured side to the healthy side) was calculated. The differences of nEMG parameters, quantitative muscle strength and residual elbow flexor muscle strength between the two groups and between the injured side and the healthy side were compared. The correlation between elbow flexor manual muscle strength classification, quantitative muscle strength and nEMG parameters was analyzed.
RESULTS:
After musculocutaneous nerve injury, the percentage of residual elbow flexor muscle strength in Group B was 23.43% and that in Group A was 4.13%. Elbow flexor manual muscle strength classification was significantly correlated with the type of recruitment response, and the correlation coefficient was 0.886 (P<0.05). The quantitative elbow flexor muscle strength was correlated with the latency and amplitude of CMAP, the mean number of turns and the mean amplitude of recruitment potential, and the correlation coefficients were -0.528, 0.588, 0.465 and 0.426 (P<0.05), respectively.
CONCLUSIONS
The percentage of residual elbow flexor muscle strength can be used as the basis of muscle strength classification, and the comprehensive application of nEMG parameters can be used to infer quantitative elbow flexor muscle strength.
Humans
;
Elbow
;
Electromyography
;
Musculocutaneous Nerve
;
Elbow Joint/physiology*
;
Muscle, Skeletal
;
Muscle Strength
;
Peripheral Nerve Injuries
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