1.Pharmacoeconomic evaluation of finerenone combined with standard treatment regimen in the treatment of diabetic nephropathy
Hai LIANG ; Runan XIA ; Panpan DI ; Mengmeng ZHAO ; Pengcheng ZHANG ; Yashen HOU ; Hong ZHANG ; Wei WU ; Miao YANG
China Pharmacy 2025;36(1):86-90
OBJECTIVE To evaluate the cost-effectiveness of finerenone combined with standard treatment regimen in the treatment of diabetic nephropathy (DN). METHODS From the perspective of healthcare service providers, a Markov model was established to simulate the dynamic changes of each stage in DN patients who received finerenone combined with the standard treatment regimen or the standard treatment regimen alone based on the phase Ⅲ clinical trial study of finerenone for DN. Markov model was used to perform the cost-effectiveness of long-term effects and the costs of the two therapies with a simulation cycle of 4 months, a simulation period of 15 years and an annual discount rate of 5%. At the same time, one-way sensitivity analysis and probability sensitivity analysis were performed, and the stability of the results was validated. RESULTS Accumulative cost of the standard treatment regimen was 579 329.54 yuan, and the accumulative utility was 8.052 4 quality-adjusted life year (QALYs); the accumulative cost of finerenone combined with the standard treatment regimen was 332 520.61 yuan, and the accumulative utility was 8.187 4 QALYs. Finerenone combined with the standard treatment regimen was more cost-effective. The results of one-way sensitivity analysis showed that dialysis status utility value, DN stage 3 utility value and DN stage 4 utility value had a great influence on the incremental cost-effectiveness ratio, but did not affect the robustness of the model. The results of probability sensitivity analysis showed that finerenone combined with the standard treatment regimen was more cost-effective with 100% probability. CONCLUSIONS For DN patients, finerenone combined with the standard treatment regimen is more cost-effective as an absolute advantage option.
2.Pharmacoeconomic evaluation of finerenone combined with standard regimen in the treatment of heart failure with preserved or mildly reduced ejection fraction
Runan XIA ; Xu WANG ; Huijuan CHEN ; Mengyu JIANG ; Panpan DI ; Mengmeng ZHAO ; Li LIU ; Hai LIANG
China Pharmacy 2025;36(14):1770-1774
OBJECTIVE To evaluate the cost-effectiveness of finerenone combined with standard of care (SoC) in the treatment of heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF). METHODS Based on a phase Ⅲ clinical trial, a Markov model was constructed from the perspective of China’s healthcare system to compare the treatment outcomes of finerenone combined with SoC regimen versus SoC regimen alone in the treatment of different cardiac functional statuses of HFmrEF/HFpEF. Using quality-adjusted life year (QALY) as the health output index, 3 times China’s per capita GDP in 2023 as the willingness-to-pay (WTP) threshold, a simulation was conducted with a 3-month cycle length and a 10- year time horizon, incorporating an annual discount rate of 5%. The dynamic changes across various stages of HFmrEF/HFpEF treated with finerenone combined with SoC versus SoC alone were simulated to evaluate the long-term effectiveness and costs of the two treatment strategies. Additionally, one-way sensitivity analysis and probabilistic sensitivity analysis were performed, to test the robustness of the results. RESULTS The incremental cost-effectiveness ratio (ICER) of the finerenone combined with SoC regimen versus SoC regimen alone was 179 504.75 yuan/QALY, which was below the WTP threshold set in this study, indicating that the finerenone combined with SoC regimen possessed certain economic advantages. The results of one-way sensitivity analysis showed that the utility value of NYHA Ⅱ status, the drug price of finerenone, the discount rate, and the probability of hospital transfer for both groups had a great influence on ICER, but did not affect the robustness of the model. The probabilistic sensitivity analysis also confirmed the robustness of the model. CONCLUSIONS Under the WTP threshold set in this study, finerenone combined with SoC is cost-effective in the treatment of HFmrEF/HFpEF, compared with the SoC regimen.
3.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
4.Mechanism and research progress of S100A8/A9 in the microenvironment before high-risk tumor metastasis
Hai-Xia MING ; Zhao-Hua LIU ; Yan-Jun WANG ; Ming SHEN ; Yan-Wen CHEN ; Yang LI ; Ling-Ling YANG ; Qian-Kun LIANG
The Chinese Journal of Clinical Pharmacology 2024;40(13):1991-1995
S100 calc-binding protein A8/A9(S100A8/A9)can induce the migration of primary tumor cells to distant target organs by binding multiple channel proteins,promote the formation of tumor metastasis microenvironment,and play an important role in the immune and inflammatory response of the body.It provides a new target and idea for the prevention and treatment of tumor metastasis and invasion.This paper mainly reviewed the expression and mechanism of S100A8/A9 on related channel proteins in a variety of high incidence tumors,in order to provide a new strategy for tumor prevention,diagnosis and treatment.
5.Quercetin Alleviates Lipopolysaccharide-Induced Cardiac Inflammation via Inhibiting Autophagy and Programmed Cell Death
Hai Jin YU ; Liang Guo HU ; Quan Xiao GUO ; Bin Hua CAO ; Fei Zhao XIA ; Buhe AMIN
Biomedical and Environmental Sciences 2024;37(1):54-70
Objective The aim of this study is to explore the potential modulatory role of quercetin against Endotoxin or lipopolysaccharide (LPS) induced septic cardiac dysfunction.Methods Specific pathogen-free chicken embryos (n = 120) were allocated untreated control, phosphate buffer solution (PBS) vehicle, PBS with ethanol vehicle, LPS (500 ng/egg), LPS with quercetin treatment (10, 20, or 40 nmol/egg, respectively), Quercetin groups (10, 20, or 40 nmol/egg). Fifteen-day-old embryonated eggs were inoculated with abovementioned solutions via the allantoic cavity. At embryonic day 19, the hearts of the embryos were collected for histopathological examination, RNA extraction, real-time polymerase chain reaction, immunohistochemical investigations, and Western blotting.Results They demonstrated that the heart presented inflammatory responses after LPS induction. The LPS-induced higher mRNA expressions of inflammation-related factors (TLR4, TNFα, MYD88, NF-κB1, IFNγ, IL-1β, IL-8, IL-6, IL-10, p38, MMP3, and MMP9) were blocked by quercetin with three dosages. Quercetin significantly decreased immunopositivity to TLR4 and MMP9 in the treatment group when compared with the LPS group. Quercetin significantly decreased protein expressions of TLR4, IFNγ, MMP3, and MMP9 when compared with the LPS group. Quercetin treatment prevented LPS-induced increase in the mRNA expression of Claudin 1 and ZO-1, and significantly decreased protein expression of claudin 1 when compared with the LPS group. Quercetin significantly downregulated autophagy-related gene expressions (PPARα, SGLT1, APOA4, AMPKα1, AMPKα2, ATG5, ATG7, Beclin-1, and LC3B) and programmed cell death (Fas, Bcl-2, CASP1, CASP12, CASP3, and RIPK1) after LPS induction. Quercetin significantly decreased immunopositivity to APOA4, AMPKα2, and LC3-II/LC3-I in the treatment group when compared with the LPS group. Quercetin significantly decreased protein expressions of AMPKα1, LC3-I, and LC3-II. Quercetin significantly decreased the protein expression to CASP1 and CASP3 by immunohistochemical investigation or Western blotting in treatment group when compared with LPS group.Conclusion Quercetin alleviates cardiac inflammation induced by LPS through modulating autophagy, programmed cell death, and myocardiocytes permeability.
6.Monitoring indexes of healthcare-associated infection in 50 secondary or higher grade hospitals in a city for consecutive 6 years
Hai-Xia SUN ; Liang MA ; Yang ZHANG ; Miao-Miao ZHANG ; Liu-Fang FENG
Chinese Journal of Infection Control 2024;23(1):66-71
Objective To understand the changing trend of healthcare-associated infection(HAI)monitoring inde-xes in 50 secondary and higher grade hospitals in a city for 6 consecutive years from 2017 to 2022.Methods Infec-tion monitoring indexes from 50 secondary or higher grade hospitals in the city for 6 consecutive years were collec-ted,and changing trend of HAI monitoring indexes were compared.Results The number of full-time HAI manage-ment professionals increased from 91 in 2017 to 165 in 2022.The utilization rate of HAI information system in-creased from 17.00%in 2017 to 54.00%in 2022.In 6 consecutive years from 2017 to 2022,the incidence of HAI(0.91%vs 0.59%),prevalence rate of HAI(2.36%vs 1.08%),infection rate of class I incision surgical site in-fection(0.33%vs 0.16%)in 50 secondary or higher grade hospitals all showed downward trends,while health care workers'hand hygiene compliance rate showed an upward trend(61.03%vs 85.04%).Incidences of vascular cathe-ter-related bloodstream infection,ventilator-associated pneumonia,and catheter-associated urinary tract infection all showed downward trends.Incidence of HAI,prevalence rate of HAI,health care workers'hand hygiene compli-ance rate,and incidence of ventilator-associated pneumonia in tertiary hospitals were all higher than those in secon-dary hospitals,while surgical site infection rate of class Ⅰ incision in secondary hospitals was higher than that in tertiary hospitals,with statistically significant differences(all P<0.001).Conclusion Standardizing the monitoring of HAI,as well as improving the prevention and control system and measures of HAI according to the monitoring results can reduce the incidence of HAI.
7.IL-6 promotes pluripotency of mouse embryonic stem cells and regulates cardiac differentiation in a development-dependent manner.
Si-Qi JI ; Ya-Nan ZHAO ; Jian-Xia ZHOU ; Zong-Hai CHEN ; Hua-Min LIANG
Acta Physiologica Sinica 2023;75(1):49-58
Interleukin 6 (IL-6), an important component of cardiac microenvironment, favors cardiac repair by improving cardiomyocyte regeneration in different models. This study aimed to investigate the effects of IL-6 on stemness maintenances and cardiac differentiation of mouse embryonic stem cells (mESCs). The mESCs were treated with IL-6 for two days, and then subjected to CCK-8 essay for proliferation analysis and quantitative real-time PCR (qPCR) to evaluate the mRNA expression of genes related to stemness and germinal layers differentiation. Phosphorylation levels of stem cell-related signal pathways were detected by Western blot. siRNA was used to interfere the function of STAT3 phosphorylation. Cardiac differentiation was investigated by the percentage of beating embryoid bodies (EBs) and qPCR analysis of cardiac progenitor markers and cardiac ion channels. IL-6 neutralization antibody was applied to block the endogenous IL-6 effects since the onset of cardiac differentiation (embryonic day of 0, EB0). The EBs were collected on EB7, EB10 and EB15 to investigate the cardiac differentiation by qPCR. On EB15, Western blot was applied to investigate the phosphorylation of several signaling pathways, and immunochemistry staining was adopted to trace the cardiomyocytes. IL-6 antibody was administered for two days (short term) on EB4, EB7, EB10 or EB15, and percentages of beating EBs at late developmental stage were recorded. The results showed that exogenous IL-6 promoted mESCs proliferation and favored maintenances of pluripotency, evidenced by up-regulated mRNA expression of oncogenes (c-fos, c-jun) and stemness markers (oct4, nanog), down-regulated mRNA expression of germ layer genes (branchyury, FLK-1, pecam, ncam, sox17), and increased phosphorylation of ERK1/2 and STAT3. siRNA targeting JAK/STAT3 partially attenuated the effects of IL-6 on cell proliferation and mRNA expression of c-fos and c-jun. During differentiation, long term IL-6 neutralization antibody application decreased the percentage of beating EBs, down-regulated mRNA expression of ISL1, GATA4, α-MHC, cTnT, kir2.1, cav1.2, and declined the fluorescence intensity of cardiac α actinin in EBs and single cell. Long term IL-6 antibody treatment decreased the phosphorylation of STAT3. In addition, short term (2 d) IL-6 antibody treatment starting from EB4 significantly reduced the percentage of beating EBs in late development stage, while short term IL-6 antibody treatment starting from EB10 significantly increased the percentage of beating EBs on EB16. These results suggest that exogenous IL-6 promotes mESCs proliferation and favors stemness maintenance. Endogenous IL-6 regulates mESC cardiac differentiation in a development-dependent manner. These findings provide important basis for the study of microenvironment on cell replacement therapy, as well as a new perspective for understanding the pathophysiology of heart diseases.
Animals
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Mice
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Interleukin-6
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Mouse Embryonic Stem Cells
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Cell Differentiation
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Proto-Oncogene Proteins c-fos
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RNA, Messenger
8.A prospective study on the expansion rule of the directional skin and soft tissue expander in abdominal scar reconstruction.
Ji Dong XUE ; Yan LIANG ; Pei Peng XING ; Hai Ping DI ; Jian ZHANG ; Gao Yuan YANG ; Cheng De XIA
Chinese Journal of Burns 2023;39(2):150-157
Objective: To observe the expansion rule of directional skin and soft tissue expander (hereinafter referred to as expander) in abdominal scar reconstruction. Methods: A prospective self-controlled study was conducted. Twenty patients with abdominal scar who met the inclusion criteria and admitted to Zhengzhou First People's Hospital from January 2018 to December 2020 were selected by random number table method, including 5 males and 15 females, aged 12-51 (31±12) years, with 12 patients of type Ⅰ scar and 8 patients of type Ⅱ scar. In the first stage, two or three expanders with rated capacity of 300-600 mL were placed on both sides of the scar, of which at least one expander had rated capacity of 500 mL (as the follow-up observation object). After the sutures were removed, water injection treatment was started, with the expansion time of 4 to 6 months. After the water injection volume reached 2.0 times of the rated capacity of expander, abdominal scar excision+expander removal+local expanded flap transfer repair was performed in the second stage. The skin surface area at the expansion site was measured respectively when the water injection volume reached 1.0, 1.2, 1.5, 1.8, and 2.0 times of the rated capacity of expander, and the skin expansion rate of the expansion site at corresponding multiples of expansion (1.0, 1.2, 1.5, 1.8, and 2.0 times) and adjacent multiple intervals (1.0-1.2, 1.2-1.5, 1.5-1.8, and 1.8-2.0 times) were calculated. The skin surface area of the repaired site at 0 (immediately), 1, 2, 3, 4, 5, and 6 months after operation, and the skin shrinkage rate of the repaired site at different time points (1, 2, 3, 4, 5, and 6 months after operation) and different time periods (0-1, 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation) were calculated. Data were statistically analyzed with analysis of variance for repeated measurement and least significant difference-t test. Results: Compared with the expansion of 1.0 time ((287.6±2.2) cm2 and (47.0±0.7)%), the skin surface area and expansion rate of the expansion site of patients ((315.8±2.1), (356.1±2.8), (384.9±1.6), and (386.2±1.5) cm2, (51.7±0.6)%, (57.2±0.6)%, (60.4±0.6)%, and (60.5±0.6)%) were significantly increased when the expansion reached 1.2, 1.5, 1.8, and 2.0 times (with t values of 46.04, 90.38, 150.14, 159.55, 45.11, 87.83, 135.82, and 118.48, respectively, P<0.05). Compared with the expansion of 1.2 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.5, 1.8, and 2.0 times (with t values of 49.82, 109.64, 122.14, 144.19, 49.51, and 105.85, respectively, P<0.05). Compared with the expansion of 1.5 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.8 times (with t values of 38.93 and 39.22, respectively, P<0.05) and 2.0 times (with t values of 38.37 and 38.78, respectively, P<0.05). Compared with the expansion of 1.8 times, the skin surface area and expansion rate of the expansion site of patients both had no statistically significant differences when the expansion reached 2.0 times (with t values of 4.71 and 4.72, respectively, P>0.05). Compared with the expansion of 1.0-1.2 times, the skin expansion rate of the expansion site of patient was significantly increased when the expansion reached 1.2-1.5 times (t=6.95, P<0.05), while the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 5.89 and 40.75, respectively, P<0.05). Compared with the expansion of 1.2-1.5 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 10.50 and 41.92, respectively, P<0.05). Compared with the expansion of 1.5-1.8 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.8-2.0 times (t=32.60, P<0.05). Compared with 0 month after operation, the skin surface area of the repaired site of patient at 1, 2, 3, 4, 5, and 6 months after operation was significantly decreased (with t values of 61.66, 82.70, 96.44, 102.81, 104.51, and 102.21, respectively, P<0.05). Compared with 1 month after operation, the skin surface area of the repaired site of patient was significantly decreased at 2, 3, 4, 5, and 6 months after operation (with t values of 37.37, 64.64, 69.40, 72.46, and 72.62, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 32.29, 50.00, 52.67, 54.76, and 54.62, respectively, P<0.05). Compared with 2 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 3, 4, 5, and 6 months after operation (with t values of 52.41, 60.41, 70.30, and 65.32, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 52.97, 59.29, 69.68, and 64.50, respectively, P<0.05). Compared with 3 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 4, 5, and 6 months after operation (with t values of 5.53, 38.00, and 38.52, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 25.36, 38.59, and 37.47, respectively, P<0.05). Compared with 4 months after operation, the skin surface area (with t values of 41.10 and 50.50, respectively, P>0.05) and skin shrinkage rate (with t values of 48.09 and 50.00, respectively, P>0.05) of the repaired site of patients at 5 and 6 months after operation showed no statistically significant differences. Compared with 5 months after operation, the skin surface area and skin shrinkage rate of the repaired site of patient at 6 months after operation showed no statistically significant differences (with t values of 9.40 and 9.59, respectively, P>0.05). Compared with 0-1 month after operation, the skin shrinkage rate of the repaired site of patient at 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 13.56, 40.00, 49.21, 53.97, and 57.68, respectively, P<0.05). Compared with 1-2 months after operation, the skin shrinkage rate of the repaired site of patients at 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 12.37, 27.72, 30.16, and 31.67, respectively, P<0.05). Compared with 2-3 months after operation, the skin shrinkage rate of the repaired site of patients at 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 33.73, 41.31, and 54.10, respectively, P<0.05). Compared with 3-4 months after operation, the skin shrinkage rate of the repaired site of patient at 4-5 and 5-6 months after operation showed no statistically significant differences (with t values of 10.90 and 23.60, respectively, P>0.05). Compared with 4-5 months after operation, the skin shrinkage rate of the repaired site of patient at 5-6 months after operation showed no statistically significant difference (t=20.90, P>0.05). Conclusions: The expander can effectively expand the abdominal skin, thus repairing the abdominal scar deformity. Maintained expansion for one month after the water injection expansion reaches 1.8 times of the rated capacity of the expander can be set as a phase Ⅱ operation node.
Female
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Male
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Humans
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Cicatrix/surgery*
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Prospective Studies
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Tissue Expansion Devices
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Skin
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Abdominal Wall
9.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
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Child
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Humans
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Female
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Glycated Hemoglobin
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Cohort Studies
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Diabetes Mellitus/diagnosis*
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Sensitivity and Specificity
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ROC Curve
10.Factors influencing bilirubin elevation and its correlation with UGT1A1 gene polymorphism in the early postoperative period of transjugular intrahepatic portosystemic shunt.
Bi Feng ZHANG ; Jian FANG ; Zhi Qiang ZHANG ; Xiu Lan AO ; Lei XIA ; Hai Cong WU ; Shi An ZHANG ; Zhi Xian WU ; Dong Liang LI
Chinese Journal of Hepatology 2023;31(5):524-531
Objective: To investigate the factors influencing total bilirubin elevation and its correlation with UGT1A1 gene polymorphism in the early postoperative period of transjugular intrahepatic portosystemic shunt (TIPS). Methods: 104 cases with portal hypertension and esophageal variceal hemorrhage (EVB) treated with elective TIPS treatment were selected as the study subjects and were divided into a bilirubin-elevated group and a normal bilirubin group according to the total bilirubin elevation level during the early postoperative period. Univariate analysis and logistic regression were used to analyze the factors influencing total bilirubin elevation in the early postoperative period. PCR amplification and first-generation sequencing technology were used to detect the polymorphic loci of the UGT1A1 gene promoter TATA box, enhancer c.-3279 T > G, c.211G > A, and c.686C > A. Logistic regression was used to analyze the correlation of four locus alleles and genotypes with elevated total bilirubin in the early postoperative period. Results: Among the 104 cases, 47 patients were in the bilirubin elevated group, including 35 males (74.5%) and 12 females (25.5%), aged (50.72 ± 12.56) years. There were 57 cases in the normal bilirubin group, including 42 males (73.7%) and 15 females (26.3%), aged (51.63 ± 11.10) years. There was no statistically significant difference in age (t = -0.391, P = 0.697) and gender (χ(2) = 0.008, P = 0.928) between the two groups of patients. Univariate analysis revealed that preoperative alanine transaminase (ALT) level (χ(2) = 5.954, P = 0.015), total bilirubin level (χ(2) = 16.638, P < 0.001), MELD score (χ(2) = 10.054, P = 0.018), Child-Pugh score (χ(2) = 6.844, P = 0.022), and postoperative portal vein branch development (χ(2) = 6.738, P = 0.034) were statistically significantly different between the two groups. Logistic regression analysis showed that preoperative ALT level, total bilirubin level, and portal vein branch development after TIPS were correlated with the elevated total bilirubin in the early postoperative period. The polymorphism of the c.211G > A locus of the UGT1A1 gene correlation had elevated total bilirubin in the early postoperative period of TIPS. The risk of elevated total bilirubin was increased in the population carrying allele A (P = 0.001, OR = 4.049) in the early postoperative period. Allelic polymorphisms in the TATA box promoter region and enhancer c.-3279 T > G and c.686C > A had no statistically significant difference between the bilirubin-elevated group and the normal bilirubin group. Conclusion: The preoperative ALT level, total bilirubin level, and portal vein branch development are correlated with the elevated total bilirubin in early postoperative patients. The polymorphisms of the UGT1A1 gene and enhancer c.211G > A are correlated with the occurrence of elevated total bilirubin in the early postoperative period of TIPS. Allele A carrier may have a higher risk of elevated total bilirubin in the early postoperative period.
Female
;
Humans
;
Male
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Bilirubin
;
Esophageal and Gastric Varices
;
Gastrointestinal Hemorrhage/surgery*
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Portasystemic Shunt, Transjugular Intrahepatic
;
Postoperative Period
;
Retrospective Studies
;
Treatment Outcome
;
Adult
;
Middle Aged
;
Glucuronosyltransferase/genetics*

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