1.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
2.Construction and application of the "Huaxi Hongyi" large medical model
Rui SHI ; Bing ZHENG ; Xun YAO ; Hao YANG ; Xuchen YANG ; Siyuan ZHANG ; Zhenwu WANG ; Dongfeng LIU ; Jing DONG ; Jiaxi XIE ; Hu MA ; Zhiyang HE ; Cheng JIANG ; Feng QIAO ; Fengming LUO ; Jin HUANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(05):587-593
Objective To construct large medical model named by "Huaxi HongYi"and explore its application effectiveness in assisting medical record generation. Methods By the way of a full-chain medical large model construction paradigm of "data annotation - model training - scenario incubation", through strategies such as multimodal data fusion, domain adaptation training, and localization of hardware adaptation, "Huaxi HongYi" with 72 billion parameters was constructed. Combined with technologies such as speech recognition, knowledge graphs, and reinforcement learning, an application system for assisting in the generation of medical records was developed. Results Taking the assisted generation of discharge records as an example, in the pilot department, after using the application system, the average completion times of writing a medical records shortened (21 min vs. 5 min) with efficiency increased by 3.2 time, the accuracy rate of the model output reached 92.4%. Conclusion It is feasible for medical institutions to build independently controllable medical large models and incubate various applications based on these models, providing a reference pathway for artificial intelligence development in similar institutions.
3.Relationship between serum CHI3L1,SDC1 levels and bone metabolism in elderly patients with type 2 diabetes mellitus and their predictive efficacy on osteoporosis
Jiamin ZHOU ; Chao LUO ; Lijun AN ; Ning YANG ; Jing ZHANG ; Yuan ZHANG ; Jialin XUN ; Qian WANG
International Journal of Laboratory Medicine 2025;46(1):70-74
Objective To explore the relationship between serum chitosinase 3-like protein 1(CHI3L1)and Syndecan-1(SDC1)levels and bone metabolism in elderly patients with type 2 diabetes mellitus and their predictive efficacy on osteoporosis.Methods A total of 412 elderly patients with type 2 diabetes admitted to this hospital from May 2019 to May 2023 were included in this study,and were divided into normal bone mass group(n=151),reduced bone mass group(n=138)and osteoporosis group(n=123)according to the iffer-ences in bone mineral density.Serum CHI3L1 and SDC1 levels were detected by enzyme-linked immunosor-bent assay,and serum levels of type 1 collagen cross-linked carboxyl terminal peptide(CTX),25-hydroxyvita-min D[25-(OH)D],osteocalcin(OC),and type 1 procollagen N-terminal propeptide(P1NP)were deter-mined by automatic chemiluminescence immunoassay.Pearson correlation analysis was used to investigate the relationship between serum CHI3L1,SDC1 and bone metabolism in elderly patients with type 2 diabetes.Re-ceiver operating characteristic(ROC)curve was drawn to evaluate the predictive value of serum CHI3L1 and SDC1 on osteoporosis in elderly patients with type 2 diabetes.Multivariate Logistic regression analysis was used to investigate the influencing factors of osteoporosis in elderly patients with type 2 diabetes.Results There were significant differences in diabetes course,fasting blood glucose,HbA1c and HDL-C a-mong normal bone mass group,decreased bone mass group and osteoporosis group(P<0.05).The levels of serum CHI3L1,25-(OH)D,P1NP and osteocalcin in osteoporosis group were lower than those in osteopenia group,and those in osteopenia group were lower than those in normal bone mass group,the differences were statistically significant(P<0.05).Serum SDC1 and CTX levels in osteoporosis group were higher than those in osteopenia group,and those in osteopenia group were higher than those in normal bone mass group,the differences were statistically significant(P<0.05).Serum CHI3L1 was positively correlated with 25-(OH)D,P1NP and OC(P<0.05),and negatively correlated with CTX(P<0.05).Serum SDC1 was negatively correlated with 25-(OH)D,P1NP,OC(P<0.05),and positively correlated with CTX(P<0.05).The area under the curve(AUC)of serum CHI3L1,SDC1 and their combination predicted osteoporosis in elderly pa-tients with type 2 diabetes were 0.851,0.772 and 0.904,respectively.Multivariate Logistic regression analysis showed that long duration of diabetes,increased HbA1c,high expression of OC,CHI3L1>4.16 ng/mL,SDC1≥50.94 ng/mL were all influential factors for osteoporosis in elderly patients with type 2 diabetes(P<0.05).Conclusion Low expression of CHI3L1 and high expression of SDC1 in serum are associated with ab-normal bone metabolism in elderly patients with type 2 diabetes.These two indexes are expected to be used as biological markers to predict osteoporosis in elderly patients with type 2 diabetes.
4.Effect of performance of pneumatic logistics transmission system on quality of laboratory medicine
Hailong WANG ; Jing WU ; Xiaoya ZHENG ; Yaping WANG ; Lili CHEN ; Zhenbao SONG ; Xun CHEN
International Journal of Laboratory Medicine 2025;46(12):1498-1502
Objective To evaluate the effect of pneumatic logistics transport system(PTS)on the trans-portation efficiency of the transferred samples and the accuracy of the results.Methods The transportation speed,temperature and humidity change of PTS were analyzed by temperature and humidity transmitter.Anti-coagulant samples containing disodium ethylenediaminetetraacetate(EDTA-K2),sodium citrate,lithium hepa-rin and samples containing inert separation gel coagulant were selected.and used respectively for complete blood cell analysis,prothrombin time(PT),activated partial prothrombin time(APTT),troponin T(TnT)and other myocardial markers,as well as the detection of items such as glucose(Glu)and lactate dehydrogen-ase(LDH).According to the transfer mode,they were divided into the manual transfer group and the PTS transfer group,and according to the number of PTS transfers,they were divided into the one-time transfer group,the three-time transfer group and before transfer(control).The differences among each group were statistically analyzed,and 1/3 allowable total error(1/3TEa)was adopted as the criterion for determining the clinical application value.Results There was no statistically significant difference in the changes of tempera-ture and humidity during the transportation process of PTS compared with manual transportation(P>0.05),but it was significantly faster than manual transportation in terms of transportation time(P<0.05).Com-pared with before transfer,the differences between the PT,APTT,Glu and LDH items in the one-time trans-fer group and the three-time transfer group were statistically significant(P<0.01),and their deviations were all much greater than 1/3TEa.However,in the plasma samples,compared with before transport,there were statistically significant differences in Glu and LDH between the one-time transfer group and the three-time transfer group(P<0.05),but the deviations were all less than 1/3TEa.For the items of TnT,red blood cell count and hematocrit,compared with before transfer,there were statistically significant differences between some groups of the one-time transfer group and the three-time transfer group(P<0.05),but the deviations were all less than 1/3TEa.Conclusion PTS can significantly improve the transportation efficiency of sam-ples,but it significantly affects the detection of Glu and LDH in plasma samples,which can be improved by u-sing serum sample transportation instead.In addition,PTS also affects the detection of PT and APTT,and it is not recommended to use PTS to transport coagulation specimen.
5.Diagnostic value of 68Ga-PSMA-11 PET/CT combined with abnormal prothrombin in different tumors
Meng-Xia ZHAO ; Jing YANG ; Li-Sha WANG ; Yi-Bo LI ; Bo-Xun CHEN
Medical Journal of Chinese People's Liberation Army 2025;50(6):728-732
Objective To explore the diagnostic value of 68Ga-PSMA-11 PET/CT combined with abnormal prothrombin(PIVKA-Ⅱ)in the diagnosis of different tumors.Methods A total of 200 patients with suspected cancer who underwent examinations in the Affiliated Hospital of Southwest Medical University from September 2021 to December 2023 were retrospectively selected,including 51 suspected liver cancer,49 suspected pancreatic cancer,52 suspected rectal cancer and 48 suspected prostate cancer.All patients underwent both serum PIVKA-Ⅱ testing and 68Ga-PSMA-11 PET/CT imaging.Receiver operating characteristic(ROC)curve analysis was used to assess the diagnostic performance of 68Ga-PSMA-11 PET/CT and serum PIVKA-Ⅱ for liver cancer,pancreatic cancer,rectal cancer and prostate cancer.Results No significant differences were found in general data of 4 suspected tumor groups(P>0.05)except for age.Serum PIVKA-Ⅱ levels were significantly higher in patients with suspected liver cancer and rectal cancer compared with those with suspected pancreatic cancer and prostate cancer(P<0.05).No significant difference was observed in the serum PIVKA-Ⅱ levels between suspected pancreatic cancer group and suspected prostate cancer group(P>0.05).The positive rates of 68Ga-PSMA-11 PET/CT and serum PIVKA-Ⅱ for diagnosing liver,pancreatic,rectal,and prostate cancers were significantly lower than those of pathological examination(49.0%vs.47.1%vs.92.2%,57.1%vs.55.1%vs.87.8%,48.1%vs.44.2%vs.92.3%,64.6%vs.62.5%vs.89.6%,respectively,P<0.05).ROC curve analysis showed that serum PIVKA-Ⅱ had a sensitivity of 79.06%,specificity of 72.02%,area under ROC curve(AUC)of 0.822,and Youden index of 0.512.For 68Ga-PSMA-11 PET/CT,the sensitivity was 79.11%,specificity 72.07%,AUC 0.829,and Youden index 0.510.The combined use of 68Ga-PSMA-11 PET/CT and serum PIVKA-Ⅱ achieved higher diagnostic accuracy,with a sensitivity of 93.28%,specificity of 81.15%,AUC of 0.924 and Youden index of 0.744,all surpassing the single index.Conclusion Both 68Ga-PSMA-11 PET/CT and serum PIVKA-Ⅱ are effective diagnostic tools for liver,pancreatic,rectal,and prostate cancers,with the combined approach yielding superior diagnostic performance.
6.Investigation and analysis of adult skeletal fluorosis caused by drinking tea-type endemic fluorosis in Yushu Tibetan Autonomous Prefecture, Qinghai Province in 2021
Guanglan PU ; Mingjun WANG ; Yanan LI ; Xin ZHOU ; Peizhen YANG ; Ping CHEN ; Qing LU ; Xun CHEN ; Hongting SHEN ; Jing MA ; Jinmei ZHANG ; Cuiling LA ; Qiang ZHANG ; Xianya MENG
Chinese Journal of Endemiology 2024;43(3):207-211
Objective:To investigate the prevalence of adult skeletal fluorosis caused by drinking tea-type endemic fluorosis in Yushu Tibetan Autonomous Prefecture (hereinafter referred to as Yushu Prefecture), Qinghai Province, and provide scientific basis for prevention and control of the disease.Methods:In August 2021, one village was selected as a survey site in six counties (cities) in Yushu Prefecture, including Nangqian, Chindu, Yushu, Zadoi, Qumarlêb, and Zhiduo. Drinking water samples and 10 brick tea samples were collected from each village to determine the fluoride content in water and brick tea; at least 100 permanent residents aged ≥ 25, who had a habit of drinking brick tea and had lived in the local area for more than 5 years, were selected for X-ray imaging to examine the prevalence of adult skeletal fluorosis.Results:A total of 75 samples of residential drinking water were collected, with a fluoride content of (0.21 ± 0.05) mg/L, ranging from 0.11 to 0.34 mg/L; 60 samples of brick tea, with a fluoride content of (626.70 ± 157.27) mg/kg, ranging from 324.00 to 2 102.00 mg/kg. A total of 1 136 adults were examined, and 318 cases of skeletal fluorosis were diagnosed, with a detection rate of 27.99%. Among them, the detection rates of mild, moderate, and severe skeletal fluorosis were 20.95% (238/1 136), 6.07% (69/1 136), and 0.97% (11/1 136), respectively, with mild symptoms being the main. The detection rates of skeletal fluorosis in males and females were 29.09% (121/416) and 27.36% (197/720), respectively, with no statistically significant difference between the gender (χ 2 = 0.39, P = 0.533). Comparison of the skeletal fluorosis in different gender, the differences were statistically significant (χ 2 = 22.31, P < 0.001). The detection rates of skeletal fluorosis in the age groups of 25 - 35, 36 - 45, 46 - 55, 56 - 65, 66 - 75, and ≥76 years old were 6.86% (7/102), 22.37% (51/228), 24.02% (92/383), 37.44% (73/195), 43.48% (70/161), and 37.31% (25/67), respectively. The differences between the groups were statistically significant (χ 2 = 59.84, P < 0.001). Moreover, there was a statistically significant difference in the composition of skeletal fluorosis among different age groups ( H = 37.66, P < 0.001). The Spearman correlation analysis results showed that the severity of adult skeletal fluorosis was positively correlated with age ( r = 0.34, P < 0.001). Conclusions:There is a certain degree of prevalence of adult skeletal fluorosis in Yushu Prefecture. And as age increases, the condition of skeletal fluorosis becomes more severe.
7.Clinical observation of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia
Ling ZHOU ; Qiuyuan PENG ; Pan ZHAO ; Jin WEI ; Xiaojing LIN ; Xingli ZOU ; Wenfeng LUO ; Jing WANG ; Kunying XIE ; Xianglong LI ; Yang LIU ; Xun NI
China Pharmacy 2024;35(14):1743-1747
OBJECTIVE To observe the short-term efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia (AML). METHODS The data of 40 newly diagnosed AML patients admitted to our hospital from October 2022 to November 2023 were retrospectively collected and divided into observation group and control group according to treatment plan, with 20 cases in each group. The patients in the control group were given Daunorubicin hydrochloride for injection+Cytarabine for injection, and the patients in the observation group were given Venetoclax tablets+ Homoharringtonine injection+Cytarabine for injection. The patients in both groups were given relevant medicine, with 28 days as one cycle. The short-term efficacy, negative rate of minimal residual disease (MRD), duration of granulocyte deficiency, duration of platelet (PLT) <20×109 L-1, transfusion volume of suspended red blood cells and platelet, and the occurrence of adverse drug reactions were evaluated in both groups after 1 cycle of induction chemotherapy. RESULTS The complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate in the observation group was significantly higher than control group (P<0.05), and the negative rate of MRD in the observation group was also significantly higher than control group (P<0.05). However, in low-, medium- and high-risk patients, there was no statistical significance in CR/CRi rates between the two groups (P>0.05). There were no significant differences in the duration of agranulocytosis, the duration of PLT <20×109 L-1, the amount of suspended red blood cell transfusion, the amount of platelet transfusion, the incidence of hematologic toxicity and the incidence of non-hematologic toxicity between 2 groups (P>0.05). CONCLUSIONS Venetoclax combined with homoharringtonine and cytarabine show good short-term efficacy and safety in the treatment of AML.
8.Study on the changes of serum vitamin in different inflammatory states based on CRP levels
Jing-Jing WANG ; Ying WANG ; Xiao-Xiao TIAN ; Chen NIU ; Yu-Mei QI ; Guo-Xun LI
Parenteral & Enteral Nutrition 2024;31(5):262-267,274
Objective:To investigate the correlation between C-reactive protein(CRP)and vitamin levels,and to Elucidate that inflammation is a crucial cause of vitamin deficiency.Methods:The clinical data of 551 patients treated by the Department of Nutrition of Tianjin Third Central Hospital were retrospectively analyzed from September 2021 to July 2023.Based on CRP levels,the patients were categorized into three groups:the no/mild inflammation group(89 cases,CRP<10 mg/L),the moderate inflammation group(148 cases,10 mg/L≤CRP<50 mg/L),and the severe inflammation group(314 cases,CRP≥50 mg/L).Clinical characteristics and serum vitamin levels of the three groups were compared to further Investigate the effects of inflammation on serum vitamin concentrations.Results:A total of 551 patients were included in the analysis of nine water-soluble vitamins and four fat-soluble vitamins.CRP levels were negatively correlated with serum vitamin C,vitamin B3,vitamin B9,vitamin A,25-OH vitamin D3 and 25-OH vitamin D,and the correlation coefficients were as follows:-0.33,-0.11,-0.16,-0.33,-0.09,-0.12.Conversely,CRP was positively correlated with serum vitamin B6,and the correlation coefficient was 0.16.Analysis of the three inflammatory subgroups revealed that serum levels of vitamin C,vitamin B9,vitamin A,25-OH vitamin D3 and 25-OH vitamin D were progressively decreased with the severity of inflammation(P<0.001).With the exacerbation of inflammation,the serum vitamin B3 level decreased significantly only in the condition of severe inflammation(P<0.01).Serum levels of vitamin B2,vitamin B5 and vitamin B6 in moderate to severe inflammation group were higher than those in no/mild inflammation group(P<0.001).Levels of Vitamin B7,vitamin B12,vitamin E and vitamin K levels were not correlated with CRP,and no statistical significance was observed in the analysis of inflammation subgroups among the three groups(P>0.05).Conclusions:Certain vitamin levels are influenced by the body's inflammatory state.When clinically found abnormal increase in inflammatory indicators,the serum levels of vitamin C,B9,B3,A,and D should be further monitored to be vigilant against vitamin deficiency.
9.Research progress in mechanism of action of extracellular vesicle drug delivery system in the treatment of abdominal tumors
Huichao YANG ; Jing XUN ; Ximo WANG ; Hui ZHANG ; Dapeng ZHANG ; Qi ZHANG
International Journal of Biomedical Engineering 2024;47(2):200-204
Traditional drugs for the treatment of abdominal tumors often do not have the ability to target tumors and destroy normal cells while killing tumor cells. Therefore, new therapies are urgently needed to accurately target and kill tumor cells. As a drug carrier, extracellular vesicles have the advantages of naturalness, biotaxis, and low side effects, so they have attracted much attention in the research on the treatment of abdominal tumors. In this paper, the research progress in mechanism of action of extracellular vesicle drug delivery system in the treatment of abdominal tumors such as gastric, liver, pancreatic, bile duct, colorectal, and ovarian cancers with an extracellular vesicle drug delivery system was reviewed, including inhibiting the growth of abdominal tumor cells, reversing the drug resistance of the tumor stem cells, inhibiting the exocytosis of chemotherapeutic drugs from the tumor cells, and remodeling the tumor immune microenvironment.
10.Research on Construction of Test Environment for Assessment of RF-Induced Heating Effects of Implants
Yonghua LI ; Lingfeng LU ; Jing WANG ; Chengling LI ; Pengfei YANG ; Zhichao WANG ; Dajing WU ; Xun LIU ; Sheng HU
Chinese Journal of Medical Instrumentation 2024;48(3):281-284,297
In magnetic resonance examination,the interaction between implants and the radio frequency(RF)fields induces heating in human tissue and may cause tissue damage.To assess the RF-induced heating of implants,three steps should be executed,including electromagnetic model construction,electromagnetic model validation,and virtual human body simulations.The crucial step of assessing RF-induced heating involves the construction of a test environment for electromagnetic model validation.In this study,a hardware environment,comprised of a RF generation system,electromagnetic field measurement system,and a robotic arm positioning system,was established.Furthermore,an automated control software environment was developed using a Python-based software development platform to enable the creation of a high-precision automated integrated test environment.The results indicate that the electric field generated in this test environment aligns well with the simulated electric field,making it suitable for assessing the RF-induced heating effects of implants.

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