1.Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI
Hyun Jin AHN ; Francesco BRUNO ; Jeehoon KANG ; Doyeon HWANG ; Han-Mo YANG ; Jung-Kyu HAN ; Leonardo De LUCA ; Ovidio de FILIPPO ; Alessio MATTESINI ; Kyung Woo PARK ; Alessandra TRUFFA ; Wojciech WANHA ; Young Bin SONG ; Sebastiano GILI ; Woo Jung CHUN ; Gerard HELFT ; Seung-Ho HUR ; Bernardo CORTESE ; Seung Hwan HAN ; Javier ESCANED ; Alaide CHIEFFO ; Ki Hong CHOI ; Guglielmo GALLONE ; Joon-Hyung DOH ; Gaetano De FERRARI ; Soon-Jun HONG ; Giorgio QUADRI ; Chang-Wook NAM ; Hyeon-Cheol GWON ; Hyo-Soo KIM ; Fabrizio D’ASCENZO ; Bon-Kwon KOO
Korean Circulation Journal 2025;55(1):5-16
Background and Objectives:
The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men.
Methods:
COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents.We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Results:
Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups.
Conclusions
In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.
2.Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI
Hyun Jin AHN ; Francesco BRUNO ; Jeehoon KANG ; Doyeon HWANG ; Han-Mo YANG ; Jung-Kyu HAN ; Leonardo De LUCA ; Ovidio de FILIPPO ; Alessio MATTESINI ; Kyung Woo PARK ; Alessandra TRUFFA ; Wojciech WANHA ; Young Bin SONG ; Sebastiano GILI ; Woo Jung CHUN ; Gerard HELFT ; Seung-Ho HUR ; Bernardo CORTESE ; Seung Hwan HAN ; Javier ESCANED ; Alaide CHIEFFO ; Ki Hong CHOI ; Guglielmo GALLONE ; Joon-Hyung DOH ; Gaetano De FERRARI ; Soon-Jun HONG ; Giorgio QUADRI ; Chang-Wook NAM ; Hyeon-Cheol GWON ; Hyo-Soo KIM ; Fabrizio D’ASCENZO ; Bon-Kwon KOO
Korean Circulation Journal 2025;55(1):5-16
Background and Objectives:
The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men.
Methods:
COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents.We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Results:
Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups.
Conclusions
In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.
3.Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI
Hyun Jin AHN ; Francesco BRUNO ; Jeehoon KANG ; Doyeon HWANG ; Han-Mo YANG ; Jung-Kyu HAN ; Leonardo De LUCA ; Ovidio de FILIPPO ; Alessio MATTESINI ; Kyung Woo PARK ; Alessandra TRUFFA ; Wojciech WANHA ; Young Bin SONG ; Sebastiano GILI ; Woo Jung CHUN ; Gerard HELFT ; Seung-Ho HUR ; Bernardo CORTESE ; Seung Hwan HAN ; Javier ESCANED ; Alaide CHIEFFO ; Ki Hong CHOI ; Guglielmo GALLONE ; Joon-Hyung DOH ; Gaetano De FERRARI ; Soon-Jun HONG ; Giorgio QUADRI ; Chang-Wook NAM ; Hyeon-Cheol GWON ; Hyo-Soo KIM ; Fabrizio D’ASCENZO ; Bon-Kwon KOO
Korean Circulation Journal 2025;55(1):5-16
Background and Objectives:
The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men.
Methods:
COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents.We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Results:
Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups.
Conclusions
In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.
4.Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI
Hyun Jin AHN ; Francesco BRUNO ; Jeehoon KANG ; Doyeon HWANG ; Han-Mo YANG ; Jung-Kyu HAN ; Leonardo De LUCA ; Ovidio de FILIPPO ; Alessio MATTESINI ; Kyung Woo PARK ; Alessandra TRUFFA ; Wojciech WANHA ; Young Bin SONG ; Sebastiano GILI ; Woo Jung CHUN ; Gerard HELFT ; Seung-Ho HUR ; Bernardo CORTESE ; Seung Hwan HAN ; Javier ESCANED ; Alaide CHIEFFO ; Ki Hong CHOI ; Guglielmo GALLONE ; Joon-Hyung DOH ; Gaetano De FERRARI ; Soon-Jun HONG ; Giorgio QUADRI ; Chang-Wook NAM ; Hyeon-Cheol GWON ; Hyo-Soo KIM ; Fabrizio D’ASCENZO ; Bon-Kwon KOO
Korean Circulation Journal 2025;55(1):5-16
Background and Objectives:
The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men.
Methods:
COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents.We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization.
Results:
Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups.
Conclusions
In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.
5.Short-term clinical efficacy observation of lesion removal,bone graft fusion,and external brace treatment for late-stage wrist tuberculosis
Yi-Bin HU ; Jun FEI ; De-Xin HU ; Gen-Jun CHEN ; Jin-Ping HU
China Journal of Orthopaedics and Traumatology 2024;37(1):51-56
Objective To observe the clinical efficacy of lesion removal,bone grafting,fusion,and external fixation in the treatment of late-stage wrist tuberculosis.Methods From October 2015 to May 2019,25 patients with late-stage wrist tubercu-losis were treated using lesion removal,bone grafting,fusion,and external fixation.Among these patients,there were 14 males and 11 females,aged from 40 to 74 years old,with an average age of(60.72±8.45)years old.The duration of the disease ranged from 5 to 24 months,with an average of(11.52±7.61)months.There were 11 cases of left wrist tuberculosis and 14 cases of right wrist tuberculosis,with 5 cases accompanied by sinus formation.Postoperative regular anti-tuberculosis treatment was continued.Visual analogue score(VAS),inflammatory indicators,Gartland-Werley wrist function score,and upper limb function score were observed before and after treatment.Results All 25 patients were followed up for ranging from 12 to 36 months with an average of(19.7±6.3)months.At the latest follow-up,all wounds were healed satisfactorily,and there was no recurrence of tuberculosis or infection.VAS at one week before operation and three months after operation were(5.16±1.14)score and(1.68±0.80)score respectively.One week before operation and three months after operation,erythrocyte sedimenta-tion rate(ESR)was(44.20±20.56)mm·h-1 and(14.44±1.14)mm·h-1,and C-reactive protein(CRP)was(12.37±7.95)mg· L-1and(4.3±3.37)mg·L-1.The differences in all three data sets were statistically significant(P<0.01).According to Gartland-Werley wrist function scoring,the scores at one week before operation and one year after operation were(21.32±3.44)and(14.96±1.37)respectively,showed a statistically significant difference(P<0.01).According to the upper limb function score(disabilities of the arm,shoulder,and hand,DASH),the score was(70.52±7.95)at one week before operation and(28.84± 2.30)at one year after operation.The difference was statistically significant(P<0.01).At the latest follow-up,no patient had a recurrence of tuberculosis.Conclusion The short-term clinical efficacy of treating wrist tuberculosis with lesion removal,bone grafting,fusion,and external fixation is satisfactory.
6.Efficacy of Wuda Granule on Recovery of Gastrointestinal Function after Laparoscopic Bowel Resection: A Randomized Double-Blind Controlled Trial.
Hai-Ping ZENG ; Li-Xing CAO ; De-Chang DIAO ; Ze-Huai WEN ; Wen-Wei OUYANG ; Ai-Hua OU ; Jin WAN ; Zhi-Jun PENG ; Wei WANG ; Zhi-Qiang CHEN
Chinese journal of integrative medicine 2024;30(12):1059-1067
OBJECTIVE:
To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care.
METHODS:
A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded.
RESULTS:
A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events.
CONCLUSION
The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).
Humans
;
Laparoscopy/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Double-Blind Method
;
Recovery of Function
;
Drugs, Chinese Herbal/adverse effects*
;
Treatment Outcome
;
Gastrointestinal Tract/physiopathology*
;
Defecation
;
Aged
;
Intestines/physiopathology*
7.Epidemiological Survey of Hemoglobinopathies Based on Next-Generation Sequencing Platform in Hunan Province, China.
Hui XI ; Qin LIU ; Dong Hua XIE ; Xu ZHOU ; Wang Lan TANG ; De Guo TANG ; Chun Yan ZENG ; Qiong WANG ; Xing Hui NIE ; Jin Ping PENG ; Xiao Ya GAO ; Hong Liang WU ; Hao Qing ZHANG ; Li QIU ; Zong Hui FENG ; Shu Yuan WANG ; Shu Xiang ZHOU ; Jun HE ; Shi Hao ZHOU ; Fa Qun ZHOU ; Jun Qing ZHENG ; Shun Yao WANG ; Shi Ping CHEN ; Zhi Fen ZHENG ; Xiao Yuan MA ; Jun Qun FANG ; Chang Biao LIANG ; Hua WANG
Biomedical and Environmental Sciences 2023;36(2):127-134
OBJECTIVE:
This study was aimed at investigating the carrier rate of, and molecular variation in, α- and β-globin gene mutations in Hunan Province.
METHODS:
We recruited 25,946 individuals attending premarital screening from 42 districts and counties in all 14 cities of Hunan Province. Hematological screening was performed, and molecular parameters were assessed.
RESULTS:
The overall carrier rate of thalassemia was 7.1%, including 4.83% for α-thalassemia, 2.15% for β-thalassemia, and 0.12% for both α- and β-thalassemia. The highest carrier rate of thalassemia was in Yongzhou (14.57%). The most abundant genotype of α-thalassemia and β-thalassemia was -α 3.7/αα (50.23%) and β IVS-II-654/β N (28.23%), respectively. Four α-globin mutations [CD108 (ACC>AAC), CAP +29 (G>C), Hb Agrinio and Hb Cervantes] and six β-globin mutations [CAP +8 (C>T), IVS-II-848 (C>T), -56 (G>C), beta nt-77 (G>C), codon 20/21 (-TGGA) and Hb Knossos] had not previously been identified in China. Furthermore, this study provides the first report of the carrier rates of abnormal hemoglobin variants and α-globin triplication in Hunan Province, which were 0.49% and 1.99%, respectively.
CONCLUSION
Our study demonstrates the high complexity and diversity of thalassemia gene mutations in the Hunan population. The results should facilitate genetic counselling and the prevention of severe thalassemia in this region.
Humans
;
beta-Thalassemia/genetics*
;
alpha-Thalassemia/genetics*
;
Hemoglobinopathies/genetics*
;
China/epidemiology*
;
High-Throughput Nucleotide Sequencing
8.Comparison of curative effect between Tianji robot assisted screw placement and traditional cannulated screw internal fixation for femoral neck fracture.
De-Xin NIE ; Wen-Gao SUN ; Xiao-Qiang WANG ; Ming-Jun WANG ; Jin-Bo SUN ; Chun CHEN
China Journal of Orthopaedics and Traumatology 2023;36(3):221-225
OBJECTIVE:
To investigate the clinical efficacy and advantages of Tianji orthopedic robot assisted cannulated screw internal fixation for femoral neck fracture.
METHODS:
The clinical data of 41 patients with femoral neck fracture who underwent internal fixation with cannulated screws from January 2019 to January 2022 were retrospectively analyzed. According to different surgical methods, they were divided into Tianji robot group and traditional cannulated screw fixation group (traditional operation group). Among them, there were 18 patients in Tianji robot group including 8 males and 10 females with age of (56.00±4.22) years old, Garden typeⅠ (4 cases), type Ⅱ (11 cases), type Ⅲ (2 cases), and type Ⅳ (1 case). There were 23 patients in the traditional operation group, including 10 males and 13 females, aged (54.87±4.81) years old;there were 5 cases of Garden typeⅠ, 14 cases of type Ⅱ, 3 cases of type Ⅲ and 1 case of type Ⅳ. The operation time, intraoperative blood loss, fluoroscopy times, guide needle placement times, operation costs and other indicators were observed and compared between two groups. Harris score was used to evaluate hip joint function 12 months after operation.
RESULTS:
The wounds of all patients healed in Grade A without complications. There were significant differences between two groups in terms of operation time, times of intraoperative fluoroscopy, times of guide needle placement, amount of intraoperative bleeding, and operation cost (P<0.05). All 41 patients were followed up for at least 12 months. The fractures of both groups were healed. There was no infection, screw loosening, fracture displacement and femoral head necrosis in Tianji robot group during follow-up;Screw loosening occurred in 2 patients in the traditional operation group during follow-up. At 12 months after operation, Harris hip joint function score of Tianji robot group was higher than that of traditional operation group in daily activity, lameness, joint activity score and total score (P<0.05).
CONCLUSION
Tianji robot assisted nail placement is a better method for the treatment of femoral neck fracture, which improves the surgical efficiency, is more accurate, has higher success rate of one-time nail placement, shorter operation time, less radiation, and has better hip joint function recovery after surgery.
Male
;
Female
;
Humans
;
Middle Aged
;
Robotics
;
Retrospective Studies
;
Femoral Neck Fractures/surgery*
;
Bone Screws
;
Fracture Fixation, Internal/methods*
;
Treatment Outcome
9.Efficacy and safefy of Polymyxin B treatment for neutropenic patients suffering from refractory Gram-negative bacterial bloodstream infection.
Meng ZHOU ; Hui Zhu KANG ; Cheng Yuan GU ; Yue Jun LIU ; Ying WANG ; Miao MIAO ; Jian Hong FU ; Xiao Wen TANG ; Hui Ying QIU ; Cheng Cheng FU ; Zheng Ming JIN ; Cai Xia LI ; Su Ning CHEN ; Ai Ning SUN ; De Pei WU ; Yue HAN
Chinese Journal of Hematology 2023;44(6):484-489
Objective: To assess the efficacy and safety of polymyxin B in neutropenic patients with hematologic disorders who had refractory gram-negative bacterial bloodstream infection. Methods: From August 2021 to July 2022, we retrospectively analyzed neutropenic patients with refractory gram-negative bacterial bloodstream infection who were treated with polymyxin B in the Department of Hematology of the First Affiliated Hospital of the Soochow University between August 2021 to July 2022. The cumulative response rate was then computed. Results: The study included 27 neutropenic patients with refractory gram-negative bacterial bloodstream infections. Polymyxin B therapy was effective in 22 of 27 patients. The median time between the onset of fever and the delivery of polymyxin B was 3 days [interquartile range (IQR) : 2-5]. The median duration of polymyxin B treatment was 7 days (IQR: 5-11). Polymyxin B therapy had a median antipyretic time of 37 h (IQR: 32-70). The incidence of acute renal dysfunction was 14.8% (four out of 27 cases), all classified as "injury" according to RIFLE criteria. The incidence of hyperpigmentation was 59.3%. Conclusion: Polymyxin B is a viable treatment option for granulocytopenia patients with refractory gram-negative bacterial bloodstream infections.
Humans
;
Polymyxin B/adverse effects*
;
Retrospective Studies
;
Gram-Negative Bacterial Infections/complications*
;
Fever/drug therapy*
;
Sepsis/drug therapy*
;
Anti-Bacterial Agents/therapeutic use*
;
Bacteremia/complications*
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
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