1.Performance validation and clinical application evaluation of fluorescent magnetic particle chemiluminescence method for the determination of sIgE
Wenqi SHAO ; Mi ZHOU ; Jing ZHU ; Baishen PAN ; Beili WANG ; Wei GUO
Chinese Journal of Preventive Medicine 2025;59(9):1427-1433
To evaluate the analytical performance of a specific IgE (sIgE) quantitative detection system and explore the clinical application effect of dust mite extract and component detection. The fluorescent magnetic particle chemiluminescence method was used to verify the analytical performance of sIgE for house dust mite (D1), dust mite (D2) extracts, and their components (Der p 1, Der p 2, Der p 10, and Der p 23), including precision, limit of blank (LoB), limit of detection (LoD), linear range, and interfering factors. This is a retrospective cohort study. A total of 50 patients with allergic rhinitis and 50 patients with allergic asthma diagnosed at Zhongshan Hospital Affiliated to Fudan University from January 2022 to August 2023 were selected, along with 70 apparently healthy individuals who underwent physical examinations in the hospital as the healthy control group. The positive rates of each sIgE component in the three groups were compared, and the receiver operating characteristic (ROC) curve for diagnosing dust mite allergy was plotted. The results showed that the fluorescent magnetic particle chemiluminescence method for detecting sIgE demonstrated good repeatability and intermediate precision within the range of 0.1-100 kU/L. The LoB, LoD, and linear range all met the specified requirements. Except for Der p 10, which was interfered by the presence of conjugated bilirubin and free bilirubin (exceeding 40 mg/dl), the detection of other allergens was not significantly affected by common endogenous substances. In healthy individuals, 10% had positive sIgE for dustmite extract; in asthmatic and allergic rhinitis patients, the positive rates were 70% and 82%, respectively. The double positive rate of D1 and D2 in the healthy group was 8.6%, while in asthmatic and allergic rhinitis patients, it was 66% and 70%, respectively. When 0.35 kU/L was used as the threshold, the sensitivity of sIgE for dust mite extract to predict component positivity was 100%, specificity was 61.5%, positive predictive value (PPV) was 80.2%, and negative predictive value (NPV) was 100%. When the threshold was optimized to 0.78 kU/L, the sensitivity was 96.8%, specificity was 92.1%, PPV was 95.2%, and NPV was 94.6%. In conclusion, the repeatability, intermediate precision, LoB, LoD, linear range, and anti-interference ability of the fluorescent magnetic particle chemiluminescence method for detecting sIgE meet the requirements of laboratory quality management. This ensures detection quality, meets clinical needs, and can be used for the auxiliary diagnosis of allergic diseases.
2.Investigation of use of disposable and reuseable supplies for prevention and control of infections in Shanghai
Meixia WANG ; Jiabing LIN ; Wei SUN ; Qingfeng SHI ; Hongfei MI ; Bijie HU ; Jue PAN ; Xiaodong GAO
Chinese Journal of Nosocomiology 2025;35(17):2681-2684
OBJECTIVE To investigate the use of common disposable and reusable supplies for prevention and con-trol of infections in Shanghai.METHODS A survey was conducted for the use and reuse of disposable high-value consumables,disposable bronchoscopes and environmental cleaning and disinfection tools in Shanghai by using structured questionnaire.RESULTS Totally 81 medical institutions were involved in the survey,44(54.32%)of which were tertiary hospitals,and the median number of beds was 500.The orthopedic implants(70.37%),ul-trasound knife(69.14%)and endoscopic puncture instrument(66.67%)were the high-value consumables rank-ing the top 3 utilization rates.There was reuse of 18 types of high-value consumables in total among the 12 medi-cal institutions.The major causes of reuse of high-value consumables included fee less tan cost of consumables(58.33%)or being unable to included in charge items(33.33%).27.78%of the recycle high-value consumables were not treated with a dedicated disinfection and sterilization system and procedures for the disposable high-value consumables,and 33.33%did not have the report systems for related adverse reactions.49.09%of the medi-cal institutions reported to use the disposable bronchoscopes,4 of which reused them.The majority of the medi-cal institutions could carry out centralized cleaning and disinfection for the recycled floor cloths(60.81%)and cloth towels(56.76%),and 32.43%of the medical institutions reused the cloth towels by manual cleaning.The utilization rate of antiseptic wipes was 75.41%in adult intensive care unit,62.50%in neonatal intensive care unit.CONCLUSION The study reveals that there are some problems in the use of disposal and reusable supplies for prevention and control of infections,which may provide baseline data for management of the related supplies and the surveillance of disinfection of the recycled supplies so as to enhance the quality of management of hospital-asso-ciated infections.
3.Construction of a gene-phenotypic association network of cell adhesion molecule-1-mediated sleep deprivation-induced anxiety-like behaviors with systems genetics
Shuijing PAN ; Zhaoxi GU ; Pengcheng YI ; Haofan WANG ; Chunhua YANG ; Jia MI
Chinese Journal of Pharmacology and Toxicology 2025;39(1):14-24
OBJECTIVE To explore the possible molecular mechanism through which amygdala cell adhesion molecule-1(CADM1)is involved in acute sleep deprivation-induced anxiety.METHODS Sixteen 8-week-old C57BL/6J mice were randomly divided into the control group and para-chlorophe-nylalanine(PCPA)-induced acute sleep deprivation experimental group.The PCPA mice were intraperi-toneally injected with PCPA suspension(at a dose of 300 mg?kg-1)between 8∶00 and 9∶00 am for 2 consecutive days while the control mice were injected with the same dose of normal saline.The sleep latency and sleep duration of mice were detected via the righting reflex test.Anxiety-like behaviors were detected by the open field test and elevated plus maze test.The expression level of CADM1 in the mouse amygdala was detected by Western Blot and Immunofluorescence staining.The GeneNet-work database was used to analyze the association between Cadm1 genes and other genes in the mouse amygdala.The key candidate regulatory genes were screened,and the Cadm1-anxiety behavior phenotype network was constructed.The mRNA expression levels of the key candidate regulatory genes were analyzed via qPCR analysis.RESULTS Compared with the control mice,the sleep latency of PCPA mice was significantly prolonged(P<0.01)while the sleep duration was significantly shortened(P<0.01).The activity time and distance of PCPA mice in the open field center were significantly shorter than those of the control group(P<0.05).The elevated plus maze experiment showed that the percentage of the number of times PCPA mice entered the open arm and the percentage of residence time in the open arm were significantly lower than those of the control group(P<0.05).Western Blot and immuno-fluorescence staining showed that the expression of CADM1 protein in the amygdala from PCPA mice was down-regulated compared with the control mice(P<0.05).Based on gene-behavioral association network analysis,Cadm1 was significantly associated with 25 anxiety-like behavior-related genes.The enrichment analysis of Cadm1 co-expression genes showed that Cadm1 was associated with γ-amino-butyric acid GABAergic synaptic pathway(P=4.31e-09),and that the key genes were huntingtin associ-ated protein 1(Hap1)(r=0.705,P=1.09e-08)、inositol 1,4,5-triphosphate receptor type 1(Itpr1)(r=-0.751,P=3.34e-10)、gamma-aminobutyric acid type A receptor subunit delta(Gabrd)(r=-0.836,P=3.93e-14)、γ-aminobutyric acid A receptor β1 subunit gene(Gabrb1)(r=0.732,P=1.50e-09)and adrenoceptor alpha 2A(Adra2a)(r=0.759,P=1.73e-10).The results of qPCR analysis showed that the mRNA levels of Hap1(P<0.05)、Gabrb1 and Adra2a were significantly up-regulated(P<0.01)while those of Itpr1 and Gabrd were significantly down-regulated(P<0.01).CONCLUSION Acute sleep deprivation leads to down-regulation of Cadm1 expression in the amygdala,and induces anxiety-like behaviors by affecting the expression of GABAergic synaptic signaling pathways Hap1,Gabrb1,Adra2a,Itpr1 and Gabrd.
4.The short-term effect of multielement intergration sound on tinnitus and its influence on HbO con-centration in frontal polar cortex
Qingchun PAN ; Bei LI ; Xueqin MI ; Xiaoying SONG ; Xiaoming TANG ; Yuanling WANG ; Jing ZHANG
Journal of Audiology and Speech Pathology 2025;33(4):348-352
Objective To identify the hemodynamic characteristics of frontal polar cortex(FPC)in patients with chronic subjective tinnitus,and to study the short-term efficacy of multielement integration sound(MIS)treatment,and its effects on FPC oxyhemoglobin(HbO).Methods Fifty patients with chronic subjective tinnitus(tinnitus group)and 50 subjects without tinnitus matching their age,sex and education level(control group)were collected from June 2023 to Oc-tober 2023.The tinnitus group and control group received MIS treatment for 15 minutes,respectively.Tinnitus handicap inventory(THI)and visual analogue scale(VAS)scores were collected before and after treatment in tinnitus group.Func-tional near infrared spectroscopy(fNIRS)was used to measure the 8-minute average HbO concentration in the frontal cortex of both groups before and after treatment.The changes of HbO concentration before and after treatment were compared be-tween the two groups.The correlation between clinical features and HbO was analyzed.Results The VAS score of the tin-nitus group decreased after short-term MIS treatment.The HbO concentration of FPC in tinnitus group was higher than that in control group before treatment.The HbO concentration of FPC in tinnitus group was decreased by MIS short-term treatment.The difference of HbO concentration before and after treatment(ΔHbO)was positively correlated with the difference of VAS score before and after treatment(ΔVAS)in the tinnitus group.Conclusion The hemodynamics of the frontal polar cortex in chronic subjective tinnitus patients is different from that of in non-tinnitus control group.MIS can change the hemodynamics of the frontal polar cortex in chronic subjective tinnitus patients.The frontal polar cortex may be the site of MIS.
5.Efficacy and safety of programmed death receptor 1 inhibitor combined with anlotinib in treatment of non-small cell lung cancer
Jing ZHOU ; Yuzhen WANG ; Lina LI ; Yahuan GUO ; Lian DUAN ; Mi JIAO ; Pan XI
Cancer Research and Clinic 2025;37(6):401-406
Objective:To investigate the efficacy and safety of a combination of programmed death receptor 1 (PD-1) inhibitor and multi-target tyrosine kinase inhibitor anlotinib in second-line treatment of non-small cell lung cancer (NSCLC).Methods:A prospective randomized controlled study was conducted. Using the random number table method, 118 NSCLC patients who were admitted to Shaanxi Provincial Cancer Hospital from June 2021 to June 2023 were randomly divided into the control group and the observation group, with 59 patients in each group. The observation group was treated with PD-1 inhibitor combined with anlotinib, while the control group was treated with PD-1 inhibitor. There were 36 males and 23 females in the observation group, with an age of (56±5) years; there were 34 males and 25 females in the control group, with an age of (56±5) years. There was no statistically significant difference in general clinicopathological data between the two groups (all P > 0.05). The short-term clinical efficacy [objective response rate (ORR) and disease control rate (DCR)], tumor-related factor levels [vascular endothelial growth factor (VEGF), matrix metalloproteinase 2 (MMP-2), tissue inhibitor of matrix metalloproteinase (TIMP), and tumor necrosis factor β1 (TNF-β1)], inflammatory status [plasma fibrinogen-to-albumin ratio (FAR)], lung function [forced vital capacity (FVC) and peak expiratory flow (PEF)] before and after treatment, the European Organization for Research and Treatment on Cancer (EORTC) core questionnaire for quality of life assessment (QLQ-C30) score, and occurrence of adverse reactions were compared between two groups of patients. Results:The ORR and DCR of the observation group were 33.90% (20/59) and 69.49% (41/59), respectively; the ORR and DCR of the control group were 10.17% (6/59) and 44.07% (26/59), respectively; the comparison of ORR and DCR between the two groups showed statistically significant differences ( χ2 values were 9.67 and 7.77, both P < 0.05). There was no statistically significant difference in the levels of tumor-related factors between the observation group and the control group before treatment (all P > 0.05); after 4 cycles of treatment, the levels of VEGF and MMP-2 in the observation group were lower than those in the control group, while the levels of TIMP and TNF-β1 were higher than those in the control group, and the differences were statistically significant (all P < 0.001). The FAR of the observation group and the control group before treatment were (0.15±0.06) g/L and (0.16±0.06) g/L, respectively, with no statistically significant difference ( t = 0.90, P = 0.367); after 4 cycles of treatment, the FAR were (0.07±0.01) g/L and (0.11±0.04) g/L, respectively, with statistically significant difference ( t = 7.45, P < 0.001). Before treatment, there was no statistically significant difference in FVC and PEF between the observation group and the control group (both P > 0.05); after 4 cycles of treatment, the FVC and PEF in the observation group were higher than those in the control group, and the differences were statistically significant (both P < 0.001). There were no statistically significant differences in the EORTC QLQ-C30 scores of functional dimension, symptom dimension and global health status/quality of life dimension between the observation group and the control group before treatment (all P > 0.05); after 4 cycles of treatment, the scores of functional dimension and global health status/quality of life dimension in the observation group were higher than those in the control group, while the symptom dimension score was lower than that in the control group, and the differences were statistically significant (all P < 0.001). The incidence of adverse reactions in the observation group was 6.78% (4/59), while in the control group it was 10.17% (6/59), and the difference was not statistically significant ( P = 0.741). Conclusions:The combination of PD-1 inhibitor and anlotinib in second-line treatment of NSCLC has good clinical efficacy, it can reduce the inflammatory response, improve the lung function and quality of life, and has good safety.
6.Performance validation and clinical application evaluation of fluorescent magnetic particle chemiluminescence method for the determination of sIgE
Wenqi SHAO ; Mi ZHOU ; Jing ZHU ; Baishen PAN ; Beili WANG ; Wei GUO
Chinese Journal of Preventive Medicine 2025;59(9):1427-1433
To evaluate the analytical performance of a specific IgE (sIgE) quantitative detection system and explore the clinical application effect of dust mite extract and component detection. The fluorescent magnetic particle chemiluminescence method was used to verify the analytical performance of sIgE for house dust mite (D1), dust mite (D2) extracts, and their components (Der p 1, Der p 2, Der p 10, and Der p 23), including precision, limit of blank (LoB), limit of detection (LoD), linear range, and interfering factors. This is a retrospective cohort study. A total of 50 patients with allergic rhinitis and 50 patients with allergic asthma diagnosed at Zhongshan Hospital Affiliated to Fudan University from January 2022 to August 2023 were selected, along with 70 apparently healthy individuals who underwent physical examinations in the hospital as the healthy control group. The positive rates of each sIgE component in the three groups were compared, and the receiver operating characteristic (ROC) curve for diagnosing dust mite allergy was plotted. The results showed that the fluorescent magnetic particle chemiluminescence method for detecting sIgE demonstrated good repeatability and intermediate precision within the range of 0.1-100 kU/L. The LoB, LoD, and linear range all met the specified requirements. Except for Der p 10, which was interfered by the presence of conjugated bilirubin and free bilirubin (exceeding 40 mg/dl), the detection of other allergens was not significantly affected by common endogenous substances. In healthy individuals, 10% had positive sIgE for dustmite extract; in asthmatic and allergic rhinitis patients, the positive rates were 70% and 82%, respectively. The double positive rate of D1 and D2 in the healthy group was 8.6%, while in asthmatic and allergic rhinitis patients, it was 66% and 70%, respectively. When 0.35 kU/L was used as the threshold, the sensitivity of sIgE for dust mite extract to predict component positivity was 100%, specificity was 61.5%, positive predictive value (PPV) was 80.2%, and negative predictive value (NPV) was 100%. When the threshold was optimized to 0.78 kU/L, the sensitivity was 96.8%, specificity was 92.1%, PPV was 95.2%, and NPV was 94.6%. In conclusion, the repeatability, intermediate precision, LoB, LoD, linear range, and anti-interference ability of the fluorescent magnetic particle chemiluminescence method for detecting sIgE meet the requirements of laboratory quality management. This ensures detection quality, meets clinical needs, and can be used for the auxiliary diagnosis of allergic diseases.
7.Investigation of use of disposable and reuseable supplies for prevention and control of infections in Shanghai
Meixia WANG ; Jiabing LIN ; Wei SUN ; Qingfeng SHI ; Hongfei MI ; Bijie HU ; Jue PAN ; Xiaodong GAO
Chinese Journal of Nosocomiology 2025;35(17):2681-2684
OBJECTIVE To investigate the use of common disposable and reusable supplies for prevention and con-trol of infections in Shanghai.METHODS A survey was conducted for the use and reuse of disposable high-value consumables,disposable bronchoscopes and environmental cleaning and disinfection tools in Shanghai by using structured questionnaire.RESULTS Totally 81 medical institutions were involved in the survey,44(54.32%)of which were tertiary hospitals,and the median number of beds was 500.The orthopedic implants(70.37%),ul-trasound knife(69.14%)and endoscopic puncture instrument(66.67%)were the high-value consumables rank-ing the top 3 utilization rates.There was reuse of 18 types of high-value consumables in total among the 12 medi-cal institutions.The major causes of reuse of high-value consumables included fee less tan cost of consumables(58.33%)or being unable to included in charge items(33.33%).27.78%of the recycle high-value consumables were not treated with a dedicated disinfection and sterilization system and procedures for the disposable high-value consumables,and 33.33%did not have the report systems for related adverse reactions.49.09%of the medi-cal institutions reported to use the disposable bronchoscopes,4 of which reused them.The majority of the medi-cal institutions could carry out centralized cleaning and disinfection for the recycled floor cloths(60.81%)and cloth towels(56.76%),and 32.43%of the medical institutions reused the cloth towels by manual cleaning.The utilization rate of antiseptic wipes was 75.41%in adult intensive care unit,62.50%in neonatal intensive care unit.CONCLUSION The study reveals that there are some problems in the use of disposal and reusable supplies for prevention and control of infections,which may provide baseline data for management of the related supplies and the surveillance of disinfection of the recycled supplies so as to enhance the quality of management of hospital-asso-ciated infections.
8.Construction of laboratory biosafety evaluation index system for emergency public health events in medical institutions from the perspective of integrating routine and emergency measures
Di ZHANG ; Fangchao LIU ; Fengling MI ; Zihui LI ; Hairong HUANG ; Liping PAN ; Guangli SHI ; Guanglu JIANG ; Junhua PAN
Chinese Journal of Medical Science Research Management 2025;38(3):182-190
Objective:To construct a biosafety evaluation index system for major emergency public health events in medical institutions.Methods:Based on previous laboratory biosafety evaluation work, relevant regulations and standards on biosafety in China were collected through literature research and expert consultations. Candidate indicators for constructing the biosafety evaluation system for major emergency public health events in medical institutions were selected, and a framework was established. Two rounds of expert questionnaires were conducted to determine the content of the index system based on experts′ evaluation, and each indicator′s relevance and importance were scored. Finally, two rounds of Delphi consultations were carried out, and the Analytic Hierarchy Process (AHP) was applied to calculate the weights of indicators.Results:The response rates for the total four rounds of questionnaire surveys were all 100%. The first two rounds focused on determining the framework, while the latter two focused on determining the weights for each indicator. The authority coefficients of the expert consultations for the two rounds of weights were 0.65 and 0.70, respectively, indicating the reliability of the research results. In the final round of survey, the Kendall′s coefficients of concordance at each level were all greater than 0.1. Through statistical testing, the P-values were all less than 0.05, indicating good coordination of expert opinions. Ultimately, we established an operational biosafety evaluation system for major emergency public health events in medical institutions, consisting of 4 primary indicators, 26 secondary indicators, and 119 tertiary indicators, with additional deduction items, bonus items, unacceptable items, and monitoring indicators.Conclusions:Based on scientific theory, a biosafety evaluation system for major emergency public health events in medical institutions was constructed, achieving the integration of routine and emergency measures. This system can be used for self-assessment of laboratory biosafety during emergency public health events, addressing the lack of unified standards in biosafety evaluation. Through regular self-assessment, it can enhance the level of biosafety management in medical institution laboratories, to realize the value of application and dissemination.
9.The short-term effect of multielement intergration sound on tinnitus and its influence on HbO con-centration in frontal polar cortex
Qingchun PAN ; Bei LI ; Xueqin MI ; Xiaoying SONG ; Xiaoming TANG ; Yuanling WANG ; Jing ZHANG
Journal of Audiology and Speech Pathology 2025;33(4):348-352
Objective To identify the hemodynamic characteristics of frontal polar cortex(FPC)in patients with chronic subjective tinnitus,and to study the short-term efficacy of multielement integration sound(MIS)treatment,and its effects on FPC oxyhemoglobin(HbO).Methods Fifty patients with chronic subjective tinnitus(tinnitus group)and 50 subjects without tinnitus matching their age,sex and education level(control group)were collected from June 2023 to Oc-tober 2023.The tinnitus group and control group received MIS treatment for 15 minutes,respectively.Tinnitus handicap inventory(THI)and visual analogue scale(VAS)scores were collected before and after treatment in tinnitus group.Func-tional near infrared spectroscopy(fNIRS)was used to measure the 8-minute average HbO concentration in the frontal cortex of both groups before and after treatment.The changes of HbO concentration before and after treatment were compared be-tween the two groups.The correlation between clinical features and HbO was analyzed.Results The VAS score of the tin-nitus group decreased after short-term MIS treatment.The HbO concentration of FPC in tinnitus group was higher than that in control group before treatment.The HbO concentration of FPC in tinnitus group was decreased by MIS short-term treatment.The difference of HbO concentration before and after treatment(ΔHbO)was positively correlated with the difference of VAS score before and after treatment(ΔVAS)in the tinnitus group.Conclusion The hemodynamics of the frontal polar cortex in chronic subjective tinnitus patients is different from that of in non-tinnitus control group.MIS can change the hemodynamics of the frontal polar cortex in chronic subjective tinnitus patients.The frontal polar cortex may be the site of MIS.
10.Relationship between minimal residual disease on the 19th day and prognosis of children with acute B-lymphoblastic leukemia
Cong XIN ; Xin MI ; Yusu PAN ; Lei GUO ; Yongchao WANG ; Jizhao GAO
International Journal of Laboratory Medicine 2025;46(1):38-43
Objective To explore the relationship between minimal residual disease(MRD)on the 19th day(D19)and prognosis of children with acute B-lymphoblastic leukemia(B-ALL),as well as the correlation with related biological changes.Methods A total of 88 children with B-ALL newly diagnosed in this hospital from April 2016 to April 2020 who met the enrollment conditions were analyzed for induction therapy D19 MRD,overall survival(OS)rate,event-free survival(EFS)rate,chromosome karyotype,fusion gene and mu-tation gene.MRD≥ 0.01%was considered positive,and they were divided into MRD positive group and MRD negative group.The characteristics of OS rate,EFS rate,immunophenotype and molecular biology/cytogenet-ics were compared between the two groups over a period of 3 years.Results The 3-year OS rate and EFS rate of 88 pediatric patients were 92.0%and 86.4%,respectively.The rates of OS rate and EFS rate in MRD posi-tive group were lower than those in MRD negative group,with statistical significance(P<0.05).The detec-tion rate of CD10 in MRD positive group was lower than that in MRD negative group,and the difference was statistically significant(P<0.05).Thirty-two patients(36.4%)detected 8 types of 35 fusion genes.The de-tection rates of BCR-ABL1 and E2A-PBX1 in MRD positive group were higher than those in MRD negative group,and the differences were statistically significant(P<0.05).Among 48 cases(54.5%)of pediatric pa-tients,41 types of 91 mutated genes were detected,and the remaining mutated genes were less than 5 cases.Abnormal karyotype was detected in 18 cases(20.5%),and no mitotic phase was detected in 17 cases.There was no difference in MRD between normal and abnormal karyotype.Binary Logistic regression analysis showed that BCR-ABL1 and E2A-PBX1 were prognostic factors of children with B-ALL.Conclusion The positive D19 MRD is the influential factor of adverse OS and EFS in children with B-ALL.Both E2A-PBX1 and BCR-ABL1 have adverse effects on the prognosis of children with B-ALL.

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