1.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
2.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
3.False-positive HIV-1 nucleic acid testing results in patients with severe thalassemia after receiving cell and gene therapy
Yifan ZHONG ; Jifei NIU ; Yue LI ; Jing LIU ; Xiaohui WANG ; Hao LI ; Yongxia GAN ; Guilian LI ; Chenli ZHENG ; Chenglong LI ; Yifan CAI ; Zijie YANG ; Wei TAN ; Xiaozhen CHEN ; Tiejian FENG ; Cong JIN ; Jin ZHAO
Chinese Journal of Laboratory Medicine 2024;47(4):451-454
A 11-year old female patient with severe thalassemia, receipt a lentivirus-based cell and gene therapy (CGT) therapy in Shenzhen Children′s Hosptial on July 27th, 2021. At the two follow-up visits after discharge, patient were continuously tested positive for HIV screening through HIV Ag/Ab Combo assay (chemiluminescence Immunoassay), and the viral load results of HIV-1 nucleic acid testing (NAT) were both>5 000 copies/ml. The patient can be diagnosed with HIV infection according to the National Guideline for Detection of HIV/AIDS(2020 Revised Edition). The thorough investigation findings and supplementary experiment results indicated that the false-positive HIV-1 NAT results was caused by cross-reactivity between the target sites detected by conventional HIV-1 NAT reagents and the lentiviral vectors fragments integrated into the genome of patient′s hematopoietic stem/progenitor cells. In conclusion, it is important for laboratories to select appropriate HIV-1 NAT testing platforms which won′t cause cross-reactivity for the testing of samples from patients who have been treated with HIV-derived vectors. It is also recommended to design and develop NAT testing platforms with multiple target regions labeled by different fluorescents for HIV NAT supplementation experiment to reduce the risk of false-positive diagnoses of HIV infection.
4.Application of Eurorad database in the teaching of radiology in standardized residency training: A case study of teaching film-reading
Jingyu ZHONG ; Qinhua MIN ; Caisong ZHU ; Zhenmin JIANG ; Yifan WANG ; Huan ZHANG ; Weiwu YAO
Chinese Journal of Medical Education Research 2024;23(1):134-139
The teaching of radiology in standardized residency training needs a large number of case data to strengthen the subjective understanding and awareness of residents. The database built by residency training bases can meet the needs of teaching to a certain extent, but the conditions of training bases vary across regions, which makes it difficult to achieve homogeneity in the teaching of radiology. This article discusses the application of Eurorad database in the teaching of radiology in standardized residency training. This database is free of charge, reliable, and comprehensive and provides a large number of free reliable cases and images for teaching, covering both common and rare diseases. Moreover, it can also be used to cultivate the English ability and comprehensive quality of residents and help to establish a hierarchical training system for radiology and non-radiology residents, thereby promoting the improvement in the quality of standardized residency training. This article shows the potential value of Eurorad database in the teaching of radiology in standardized residency training, and comparative studies are needed in the future to further prove its effectiveness.
5.Analysis of risk factors for bleeding as a complication of ultrasound-guided percutaneous liver biopsy examination
Miaoyang CHEN ; Yifan HU ; Qingfang XIONG ; Yandan ZHONG ; Duxian LIU ; Yongfeng YANG
Chinese Journal of Hepatology 2024;32(10):923-928
Objective:To explore the independent risk factors for bleeding in patients following percutaneous liver biopsy examination.Methods:The clinicopathological data of patients who underwent percutaneous liver biopsy examination at Nanjing Second Hospital from January 2012 to December 2021 were retrospectively collected. Univariate and multivariate logistic regression analysis were used to investigate the effect of age, gender, lesion type (diffuse liver parenchymal lesions, focal liver lesions), number of biopsies, tissue length, presence or absence of cirrhosis, presence or absence of portosystemic shunt, erythrocytes, white blood cells, hemoglobin, platelets, prothrombin time, fibrinogen, international normalized ratio, and liver biochemical indicators on bleeding following liver biopsy, as well as to screen independent risk factors.Results:A total of 3 331 patients were examined by percutaneous liver biopsy, and 3 060 cases were actually included by excluding 271 cases who took consultation from other hospitals. The overall postoperative hemorrhagic rate was 1.6% (49/3 060). Of which, forty-four cases (1.4%) had overt bleeding (hemodynamic changes or hemoglobin decreased by more than 20 g/L), five cases (0.2%) had minor bleeding, three cases had subcapsular hepatic hemaotma, and two cases had local bleeding from liver biopsy. Among the overt bleeding cases, two cases were in the off-label group (platelet<50×10 9/L or international normalized ratio>1.5), and the rest were in the non-off-label group. The results of univariate analysis showed that factors such as focal liver lesions, portosystemic shunt, prolonged prothrombin time, increased international normalized ratio, bilirubin, and alkaline phosphatase were associated with bleeding after liver biopsy in the non-off-label group. The multivariate collinearity diagnosis revealed statistically significant differences for the indicators. Multivariate logistic regression analysis finally included factors such as lesion type, portosystemic shunt, international normalized ratio, total bilirubin, and alkaline phosphatase. The results showed that patients with focal liver lesions were more prone to bleed after surgery than patients with diffuse liver parenchymal lesions ( OR=3.396, P=0.002, 95% CI: 1.596-7.228). Patients with portosystemic shunt were more prone to bleed than those without portosystemic shunt ( OR=3.301, P=0.018, 95% CI: 1.232-8.845). Patients were more likely to experience bleeding following liver biopsy when their total bilirubin levels were elevated ( OR=1.006, P<0.001, 95% CI:1.003-1.008). Conclusion:Focal liver lesions, portosystemic shunts, and elevated total bilirubin are independent risk factors for bleeding after percutaneous liver biopsy.
6.Predictive Analysis of Quality Markers of Anticoagulant Activity of Kunning Granules Based on UHPLC-Q-TOF-MS/MS and Spectral Efficacy
Linjiang ZHONG ; Fang YANG ; Jianxiong WU ; Zhiwei XIE ; Yanli LEI ; Peiling TIAN ; Lijun JIA ; Tao LIU
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(7):168-176
ObjectiveTo perform a predictive analysis of the quality marker(Q-Marker) for the anticoagulant activity of Kunning granules. MethodThe chemical components of Kunning granules were analyzed by ultra high performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry(UHPLC-Q-TOF-MS/MS) on a Waters ACQUITY UPLC HSS T3 column(2.1 mm×100 mm, 1.8 μm) with the mobile phase of acetonitrile(A)-25 mmol∙L-1 ammonium acetate aqueous solution(B) for gradient elution (0-5 min, 5%-22%A; 5-10 min, 22%-30%A; 10-15 min, 30%-95%A; 15-20 min, 95%-5%A; 20-30 min, 5%A), flow rate of 0.2 mL∙min-1, column temperature at 30 ℃, injection volume of 1 μL, electrospray ionization(ESI), positive and negative ion detection modes. Interaction analysis between the targets of chemical components and the targets of abnormal uterine bleeding(AUB) was performed by network pharmacology, and the key components were screened through network topology analysis. The fingerprints of 10 batches of Kunning granules were established by high performance liquid chromatography(HPLC), the anticoagulant activity of the granules was determined by blood coagulation method and fibrinogen plate method, and the spectrum-effective relationship was established. The components co-occurring in the topological analysis and spectrum-effective relationship were selected as Q-Markers, and their anticoagulant activities were verified and confirmed. ResultA total of 475 chemical components were identified from Kunning Granule, of which 22 key components such as salvianolic acid B, paeoniflorin, naringin and neohesperidin, were the potential material basis for the treatment of AUB. The spectrum-effective analysis showed that peaks 7(paeoniflorin), 9(naringin), 10(neohesperidin) and 11(salvianolic acid B) were the optimal principal components, and in vitro activity test showed that these four components could better characterize their anticoagulant activity. ConclusionSalvianolic acid B, paeoniflorin, neohesperidin and naringin may be Q-Markers for the anticoagulant activity of Kunning granules.
7.Health risk and spatial distribution characteristics of heavy metal exposure in typical abandoned mining area in Liuzhou, Guangxi
Tufeng HE ; Qingmiao WEI ; Jingze LI ; Sanjin WEI ; Yifan ZHANG ; Qiu’an ZHONG
Journal of Environmental and Occupational Medicine 2023;40(2):190-195
Background Exposure to heavy metals has potential adverse impacts on human health, and the concentration of heavy metals in abandoned mining areas may still be higher than that in general areas, so the health risk assessment in such areas cannot be ignored. Objective To explore the health risk of heavy metal exposure and the spatial distribution characteristics of associated main metals in a typical abandoned mining area. Methods Environmental samples of irrigated soil, rice, and drinking water were collected from 13 natural villages under the jurisdiction of a township in Liuzhou, Guangxi from November to December 2019, where a typical abandoned mining was located. Finally, 13 irrigation soil samples, 11 rice samples, and 13 drinking water samples were collected. The concentrations of six metals and metalloid elements in each environmental sample were detected by inductively coupled-plasma mass spectrometry (ICP-MS), including cadmium (Cd), arsenic (As), lead (Pb), chromium (Cr), copper (Cu), and zinc (Zn). At the same time, 251 local residents were recruited for health risk assessment. Model parameters such as body weight, rice intake, and drinking water intake of local residents were obtained through field survey, and the median metal concentration of each environmental sample was taken as the risk assessment parameter of the region. The health risk of heavy metal exposure of local residents was assessed by using oral health risk assessment model of U.S. Environmental Protection Agency. The spatial distribution characteristics of health risks associated with heavy metals were evaluated by empirical Bayes interpolation method using Geographic Information System (GIS) technology. Results The positive rates of Cd, As, Pb, Cr, Cu, and Zn in the irrigated soil samples were 100.00%. The positive rate of Pb was 63.64% in the rice samples, while the rates of other metals were 100.00%. The positive rates of Cd, As, Pb, Cr, Cu, and Zn in the drinking water samples were 53.85%, 76.92%, 92.31%, 15.38%, 84.62%, and 100.00%, respectively. The results of non-carcinogenic risk assessment of oral exposure to heavy metals suggested that the contribution of heavy metals causing non-carcinogenic risk from high to low was As (70.52%) > Cd (18.03%) > Zn (6.63%) > Cu (4.12%) > Pb (0.64%) > Cr (0.06%), and the corresponding estimated non-carcinogenic risk values were 3.54 × 100, 9.05 × 10−1, 3.33 × 10−1, 2.07 × 10−1, 3.23 × 10−2, and 5.42 × 10−4, respectively. The results of carcinogenic risk assessment of oral exposure to heavy metals suggested that the contribution of studied metals from high to low was Cd (87.00%) > As (10.24%) > Cr (2.60%) > Pb (0.16%), and the estimated carcinogenic risks were 4.35× 10−3, 5.12 × 10−4, 1.30 × 10−4, and 3.08 × 10−7, respectively. Rice was the leading media associated with non-carcinogenic risk and carcinogenic risk (99.4% and 99.8% respectively). The spatial distribution characteristics of GIS showed no obvious regularity in the distribution of As in irrigated soil, rice, and drinking water. In rice and irrigated soil, the content of Cd in the villages adjacent to the mining area was obviously higher than that in the other villages, while in drinking water, the content in the villages far away from the mining area was higher. Conclusion As and Cd are the main heavy metals that increase the health risk of local residents in a typical abandoned mining area, and the distribution characteristics of the two heavy metals in different environmental media are not completely consistent.
8.Inhibitory effects of N-acetyl-L-cysteine on brain inflammation in mice with periodontitis and Alzheimer’s disease
Liangqiuyue ZHONG ; Di MIAO ; Yifan ZHANG ; Ziling CHEN ; Yue CHEN
Journal of Xi'an Jiaotong University(Medical Sciences) 2023;44(2):229-235
【Objective】 To explore the effects of periodontitis on the brains of Alzheimer’s disease (AD) mice and the effects of N-acetyl-L-cysteine (NAC) on the periodontium and the brain of AD mice with experimental chronic periodontitis (CP). 【Methods】 Ten wild-type C57 mice were in the blank control group (Group C57), and another 40 3-month-old APP/PS1 transgenic mice were randomly divided into four groups: AD+CP group, AD+CP+NAC group, AD+NAC group, and AD group. The periodontitis model was established in mice in AD+CP group and AD+CP+NAC group by silk ligation. At the same time, mice in AD+CP+NAC group and AD+NAC group were injected with NAC (200 mg/kg). The height of alveolar bone loss was detected after 3 weeks, and the cell morphology of the hippocampus was observed. We determined the expression levels of NLRP3 inflammasome and amyloid-β (Aβ) in the hippocampus as well as the expression levels of interleukin (IL)-1β and IL-18 in the hippocampus and gums by ELISA. 【Results】 Compared with AD group, the height of alveolar bone loss in AD+CP group was higher (P<0.05), and the expression levels of IL-18 in the gum and IL-1β and NLRP3 in the hippocampus were increased significantly (P<0.05). In addition, compared with AD+CP group, the height of alveolar bone loss in AD+CP+NAC group was reduced significantly (P<0.05), the expression levels of IL-1β and IL-18 in the gum were reduced significantly (P<0.05) as well as the expression levels of IL-1β and Aβ in the hippocampus were reduced significantly (P<0.05). Compared with C57 group, the neurons in the hippocampus of AD+CP group were more loose and disordered, and the activation of microglia was increased, while the disarrangement of cells in AD+CP+NAC group was less than that in AD+CP group. 【Conclusion】 Periodontitis can aggravate brain inflammation in AD mice. NAC can effectively reduce alveolar bone resorption in AD mice caused by periodontitis as well as reduce the levels of inflammatory factors in the gum and hippocampus. NAC can effectively reduce the alveolar bone absorption of AD mice caused by periodontitis, reduce the level of inflammatory factors in the gingiva and hippocampus, and reduce the damage of nerve cells in the hippocampus.
10.Incision scar recovery assessment of patients with transaxillary dual-plane breast augmentation assisted with endoscopy
Juan AN ; Huai'an LIN ; Yifan ZHANG ; Jiahua HU ; Yang YU ; Jiaming SUN ; Zhaohao ZHONG ; Danning ZHENG ; Li YU
Chinese Journal of Medical Aesthetics and Cosmetology 2023;29(3):167-170
Objective:To evaluate incision scars of transaxillary breast augmentation by different methods of scar assessment.Methods:A retrospective study was carried out on 30 patients (age range 20 to 50 years, with mean age of 32 years) who underwent endoscopic assisted transaxillary type Ⅰ dual plane breast implant augmentation by a same surgeon from August 2014 to November 2016. Scars were estimated by 3 methods which included Vancouver Scar Scale (VSS), Visual Assessment Scale (VAS) and patients' questionnaire.Results:VAS score for left side scars ranged from 0 to 8 and the median was 1. VAS score for right side scars ranged from 0 to 8.3 and the median was 1. A total of 48 scars were scored in the 0-2 point range, representing 80% of the 60 total. VSS score for left side scars ranged from 0 to 11.6 and the median was 0.8. VSS score for right side scars ranged from 0 to 11.3 and the median was 1.2. A total of 46 scars were scored in the 0-2 point range, representing 76.7% of the total 60 breats. The scores between VSS and VAS had significant statistical differences ( P<0.001). 80.0% of our patients regarded scars as unconspicuous or basically invisible in our questionnaire. Conclusions:The majority of transaxillary incision scars recover in favorable status with high patients satisfactory rate. VAS is a practical tool for evaluating transaxillary incision scars. The VSS score is not equivalent to the VAS score when grading scars only by photos.

Result Analysis
Print
Save
E-mail