1.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
2.Epidemiological investigation on a cluster epidemic of COVID-19 in Taizhou, Zhejiang Province
Chao KONG ; Jia-yu HE ; Wen-sheng WANG ; Chang-you HE ; Yan LI ; Hong-biao LIANG ; Ya-fei HU ; Hai-jiang LIN ; Chun-ping LIN
Shanghai Journal of Preventive Medicine 2021;33(6):471-476
Objective:To analyze the epidemiological characteristics of a family and workplace clustering of COVID-19, identify the source of infection and the transmission chain, and provide evidence for prevention and control of COVID-19 pandemic. Method:Field epidemiological method was used to conduct the investigation of confirmed cases and close contacts in this cluster. Data were analyzed with descriptive method. Real-time fluorescent quantitative PCR (RT-PCR) was used to detect the novel coronavirus nucleic acid in the collected respiratory tract samples. Results:A total of 18 epidemiological related cases were collected including 16 confirmed cases and 2 cases of asymptomatic infections. The involved places included 1 beauty clinic workplace and 3 families. Seven cases were males and 11 cases were females, with the minimum, maximum and median age of 3, 65 and 32 years old, respectively. Among them, the employees attack rate was 9.80% (10/102), the family attack rate was 7.70% (5/78), and the customer attack rate was 0.58% (1/173). Positive nucleic acid test result in the respiratory tract sample of asymptomatic infection lasted for more than 2 months. Conclusions:The cause of this clustered COVID-19 epidemic is that the workplace environment is relatively closed with clustering crowds, and the source of imported infection is not discovered in time, which lead to a point-source outbreak and spread through family close contacts and clustering.
3.COVID-ONE-hi:The One-stop Database for COVID-19-specific Humoral Immunity and Clinical Parameters
Xu ZHAOWEI ; Li YANG ; Lei QING ; Huang LIKUN ; Lai DAN-YUN ; Guo SHU-JUAN ; Jiang HE-WEI ; Hou HONGYAN ; Zheng YUN-XIAO ; Wang XUE-NING ; Wu JIAOXIANG ; Ma MING-LIANG ; Zhang BO ; Chen HONG ; Yu CAIZHENG ; Xue JUN-BIAO ; Zhang HAI-NAN ; Qi HUAN ; Yu SIQI ; Lin MINGXI ; Zhang YANDI ; Lin XIAOSONG ; Yao ZONGJIE ; Sheng HUIMING ; Sun ZIYONG ; Wang FENG ; Fan XIONGLIN ; Tao SHENG-CE
Genomics, Proteomics & Bioinformatics 2021;19(5):669-678
Coronavirus disease 2019(COVID-19),which is caused by SARS-CoV-2,varies with regard to symptoms and mortality rates among populations.Humoral immunity plays critical roles in SARS-CoV-2 infection and recovery from COVID-19.However,differences in immune responses and clinical features among COVID-19 patients remain largely unknown.Here,we report a database for COVID-19-specific IgG/IgM immune responses and clinical parameters(named COVID-ONE-hi).COVID-ONE-hi is based on the data that contain the IgG/IgM responses to 24 full-length/truncated proteins corresponding to 20 of 28 known SARS-CoV-2 proteins and 199 spike protein peptides against 2360 serum samples collected from 783 COVID-19 patients.In addition,96 clinical parameters for the 2360 serum samples and basic information for the 783 patients are integrated into the database.Furthermore,COVID-ONE-hi provides a dashboard for defining samples and a one-click analysis pipeline for a single group or paired groups.A set of samples of interest is easily defined by adjusting the scale bars of a variety of parameters.After the"START"button is clicked,one can readily obtain a comprehensive analysis report for further interpretation.COVID-ONE-hi is freely available at www.COVID-ONE.cn.
4.Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study.
Bin SU ; Cheng YAO ; Qing-Xia ZHAO ; Wei-Ping CAI ; Min WANG ; Hong-Zhou LU ; Yuan-Yuan CHEN ; Li LIU ; Hui WANG ; Yun HE ; Yu-Huang ZHENG ; Ling-Hua LI ; Jin-Feng CHEN ; Jian-Hua YU ; Biao ZHU ; Min ZHAO ; Yong-Tao SUN ; Wen-Hui LUN ; Wei XIA ; Li-Jun SUN ; Li-Li DAI ; Tai-Yi JIANG ; Mei-Xia WANG ; Qing-Shan ZHENG ; Hai-Yan PENG ; Yao WANG ; Rong-Jian LU ; Jian-Hua HU ; Hui XING ; Yi-Ming SHAO ; Dong XIE ; Tong ZHANG ; Fu-Jie ZHANG ; Hao WU
Chinese Medical Journal 2020;133(24):2919-2927
BACKGROUND:
Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.
METHODS:
We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.
RESULTS:
At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.
CONCLUSIONS:
The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.
Adult
;
Anti-HIV Agents/adverse effects*
;
Antiretroviral Therapy, Highly Active
;
China
;
Drug Therapy, Combination
;
HIV Infections/drug therapy*
;
HIV-1
;
Humans
;
Maleimides
;
Peptides
;
Ritonavir/therapeutic use*
;
Treatment Outcome
;
Viral Load
5.Current status, progress and suggestions regarding prevention and control of brucellosis in China
Chinese Journal of Epidemiology 2020;41(9):1424-1427
Brucellosis is a neglected zoonosis, which not only endangers health of the people but also affects the development of animal husbandry, tourism and international trade as well as food safety. In the past two decades, great progress has been achieved in the prevention and control of both human and animal brucellosis, however, tremendous challenges still exists in the control and eradication of brucellosis, especially in the developing countries. In recent years, along with the increase of livestock breeding and animal or related product trade, human contacts with livestock has increased, resulting in the expansion of brucellosis endemic areas. In China, the brucellosis endemic areas are mainly distributed in Inner Mongolia and adjacent provinces, which might be explained by a lot of reasons, such as the development of animal husbandry, emerging and re-emerging of brucellosis endemic area and the movement of infection sources and degree of paid-attention. This paper summarizes the current status and progress in brucellosis prevention/control and surveillance in China and puts forward suggestions for the future improvement.
6.Tea Consumption is Associated with Increased Risk of Kidney Stones in Northern Chinese: A Cross-sectional Study.
Zhong Biao WU ; Tian JIANG ; Guo Bing LIN ; You Xin WANG ; Yong ZHOU ; Zhen Qian CHEN ; Yong Ming XU ; Hai Bo YE ; Bo Jun CHEN ; Xiao Zhao BAO ; Cun Ming ZHANG
Biomedical and Environmental Sciences 2017;30(12):922-926
Kidney stones are a common urinary system condition that can progress to kidney disease. Previous studies on the association between tea consumption and kidney stones are inconsistent. A cross-sectional study to investigate the association between tea consumption and kidney stones was conducted from 2013 to 2014 and recruited 9,078 northern Chinese adults. A total of 8,807 participants were included in the final analysis. Participants' prevalence of kidney stones was 1.07%, 1.73%, and 2.25% based on their tea consumption frequency of never, occasionally, and often groups, respectively. Compared with the 'never' group, the odds ratios (95% confidence intervals) for the occurrence of kidney stones were 1.57 (1.00-2.46) and 1.65 (1.06-2.57) in the 'occasionally' and 'often' groups, respectively. After adjusting for sex, age, and other potential confounding factors, tea consumption still significantly increased the risk of kidney stones. Tea consumption is independently associated with an increased risk of kidney stones in the investigated population, suggesting that a decrease in the consumption of tea may be a preventive strategy for kidney stones.
7.Complications associated with stent-assisted coil embolization of wide-neck intracranial aneurysms
long Yu ZHAO ; feng Hai ZHANG ; shu Yu DONG ; Wei JIANG ; zhi Guang HAO ; biao Guo LIANG ; Xu GAO
Chinese Journal of Tissue Engineering Research 2017;21(34):5506-5512
BACKGROUND: Stent-assisted coil embolization has become an important technique for the treatment of intracranial complex aneurysms. However, there is no systematic analysis of complications and prevention strategies related to this technique. OBJECTIVE: To systematically analyze the complications related to stent-assisted coil embolization of intracranial aneurysms during perioperative and follow-up periods and to assess the safety of this method. METHODS: A retrospective study of 232 consecutive patients with 239 wide-necked aneurysms who underwent stent-assisted coil embolization at the Department of Neurosurgery, General Hospital of Shenyang Military Command from July 2003 to December 2009 was performed. Angiographic results and clinical outcomes were evaluated. A variety of complications were analyzed. The technical feasibility of the procedure, procedure-related complications, angiographic results, clinical outcomes and follow-up angiography were evaluated. RESULTS AND CONCLUSION: Stenting was successful in the 236 of 239 aneurysms. Procedure-related complications included thomboembolism (n=13), intraprocedural rupture (n=8), coil protrusions (n=5), new mass effect (n=3), vessel injury (n=3), and stent dislodgement (n=2). Procedure-related morbidity and mortality was 4.3% (10/232) and 1.3% (3/232), respectively. Nonprocedural complications attributable to subarachnoid hemorrhage in 129 patients with acute ruptured aneurysms were symptomatic vasospasm (18.6%, 24/129) and shunt-dependent hydrocephalus (7.0%, 9/129). Favorable clinical outcomes (mRS 0-2) were observed in 88.3% (205/232) of the patients, and no rehemorrhage of treated aneurysms occurred. Follow-up angiography was obtained in 155 patients (159 treated aneurysms). The overall recanalization rate was 14.5% (23/159). No stenting or coiling displacement occurred during the follow-up. Delayed complications included in-stent stenosis (n=2) and penetrating artery occlusion (n=2). In conclusion, our study indicates that stent-assisted coil embolization of intracranial aneurysm is a safe technique with low morbidity and mortality rates. Thromboembolism is the main cause of procedure-related disability and death. Nevertheless, further long-term follow-up is necessary to determine the durability of these promising results.
8.Retroperitoneal fibrosis: a retrospective clinical data analysis of 30 patients in a 10-year period.
Hai-Jiang ZHOU ; Yong YAN ; Biao ZHOU ; Tian-Fei LAN ; Xue-Yan WANG ; Chun-Sheng LI
Chinese Medical Journal 2015;128(6):804-810
BACKGROUNDRetroperitoneal fibrosis (RPF) is an uncommon disease that is characterized by development of fibrosclerotic tissues involving retroperitoneal structures. This study aimed to investigate the clinical features of 30 patients with RPF in a single center in Beijing in a 10-year period.
METHODSWe retrospectively analyzed clinical data on demographic characteristics, clinical manifestations, laboratory findings, radiological findings, modalities of treatments, outcomes and prognosis of 30 patients with RPF. Patients were treated in Beijing Chao-Yang Hospital between January 2003 and December 2013.
RESULTSThe mean age of patients with RPF was 56.7 ± 14.4 years. Twenty-three patients were men and seven patients were women. Acute phase reactants were elevated in most patients. Rheumatic factor was positive in 4/25 (16.0%) patients, and antinuclear antibody was positive in 6/22 (27.3%) patients. Elevation of IgG4 was observed in 9/22 (40.9%) patients. The most common type was I + III (n = 13), followed by I + II + III (n = 12). Five patients undertook an 18 F-fluoro-deoxy-D-glucose positron emission tomography examination and increased uptake was detected in four patients. Eight patients received combination therapy with glucocorticoids and tamoxifen. Surgical intervention treatments included intraureteral double-J stent implantation (n = 26), percutaneous nephrostomy (n = 2), open ureterolysis and intraperitonealization of the ureters (n = 5) and laparoscopic ureterolysis and intraperitonealization of the ureters (n = 5). Three patients underwent hemodialysis because of renal failure.
CONCLUSIONSClinical characteristics of RPF patients in our study are similar to those previously reported. Steroids and immunosuppressive therapy combined with ureterolysis could be a viable choice of treatment for RPF. More prospective, multi-center studies with a longer follow-up are warranted.
Adult ; Aged ; Female ; Glucocorticoids ; therapeutic use ; Humans ; Immunoglobulin G ; blood ; Male ; Middle Aged ; Retroperitoneal Fibrosis ; blood ; diagnosis ; drug therapy ; surgery ; Retrospective Studies ; Tamoxifen ; therapeutic use ; Treatment Outcome
10.Evaluation of four candidate VNTR Loci for genotyping 225 Chinese clinical Mycobacterium tuberculosis complex strains.
Yi JIANG ; Hai Can LIU ; Hua Jun ZHENG ; Biao TANG ; Xiang Feng DOU ; Xiu Qin ZHAO ; Yong Qiang ZHU ; Bing LU ; Sheng Yue WANG ; Hai Yan DONG ; Guo Ping ZHAO ; Yuan Yuan ZHANG ; Biao KAN ; Kang Lin WAN
Biomedical and Environmental Sciences 2012;25(1):82-90
OBJECTIVETo evaluate four candidate variable number tandem repeat (VNTR) loci for genotyping Mycobacterium tuberculosis complex strains.
METHODSGenomic sequences for two M. tuberculosis strains (CCDC5079 and CCDC5180) were generated, and using published sequence data, four candidate VNTR loci were identified. The VNTRs were used to genotype 225 Chinese clinical M. tuberculosis complex strains. The discriminatory power of the VNTRs was evaluated using BioNumerics 5.0 software.
RESULTSThe Hunter-Gaston Index (HGI) for BJ1, BJ2, BJ3, and BJ4 loci was 0.634, 0.917, 0.697, and 0.910, respectively. Combining all four loci gave an HGI value of 0.995, thus confirming that the genotyping had good discriminatory power. The HGI values for BJ1, BJ2, BJ3, and BJ4, obtained from Beijing family strain genotyping, were 0.447, 0.878, 0.315, and 0.850, respectively. Combining all four loci produced an HGI value of 0.988 for genotyping the Beijing family strains. We observed unique patterns for M. bovis and M. africanum strains from the four loci.
CONCLUSIONWe have shown that the four VNTR loci can be successfully used for genotyping M. tuberculosis complex strains. Notably, these new loci may provide additional information about Chinese M. tuberculosis isolates than that currently afforded by established VNTR loci typing.
Cluster Analysis ; Genotyping Techniques ; Humans ; Minisatellite Repeats ; Mycobacterium bovis ; genetics ; Mycobacterium tuberculosis ; genetics

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