1.Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items
Jiali LIU ; Wei WANG ; Bingquan CHEN ; Zhiguo WANG
Journal of Modern Laboratory Medicine 2025;40(5):194-199
Objective To develop a statistical quality control(SQC)program design software to help laboratories design comprehensive SQC programs based on patient risk.Methods Based on the power function diagram,operation process specification diagram,risk-based multi-level internal quality control(IQC)scheme,and online calculator for IQC frequency,corresponding software modules were integrated and designed,and applied the data of potassium project to the software.Results For the power function diagram,operation process specification,and online calculator for IQC frequency,13s/22s/R4s/41s[Number of quality control measurement values(N)=2]was the best choice for potassium for IQC.In the risk-based multi-level IQC scheme,13s/22s/R4s/41s(N=2)could be selected as the startup quality control event,while different subsequent bracketing quality control events could be obtained based on different expected reporting intervals and maximum workloads to achieve the expected quality requirements.Conclusion The development of statistical quality control program design soft is proves beneficial for clinical laboratories to assess the current quality level and select appropriate quality control approaches,and assists the laboratories in enhancing quality.
2.Analysis of results for the covered rate and acceptable performance of EQA items in nationwide medical laboratories from 2019 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2025;43(2):126-129
Objective To understand the status of medical laboratories participating in external quality assessment(EQA)program in China.Methods The test covered by an EQA control rate and acceptable performance rate of theinformation collection and data analy-sis systems in the EQA program developed by National Center for Clinical Laboratories in medical laboratories of nationwide various re-gions were evaluated descriptively and analyzed statistically.Forty analytes in various disciplines were selected to analyze statistically the implementation of the testing items and participation retes of EQA program.Results The number of medical laboratories participat-ing in EQA program increased yearly from 592 in 2019 to 1 169 in 2023.The nationwide median test covered by an EQA control rate and acceptable performance rate of EQA program reached over 91%and 98%,respectively.In 2023,the median test covered by an EQA control rate of EQA program in the medical laboratories of nationwide regions showed that the median test covered by an EQA con-trol rate reached 100%in Gansu and Hainan regions,and the medians of acceptable performance rate reached 100%in Beijing,Guangdong,Hubei,Jiangsu,Shandong,Shanxi,Shanghai,Tianjin,Xinjiang,and Zhejiang regions.Among the 40 analytes,the test covered by an EQA control rate of only 6 EQA items were greater than 80%in nationwide medical laboratories,i.e.,rheumatoid factor,neonatal deafness gene detection,high throughput sequencing of peripheral fetal chromosome aneuploidy(T21,T18 and T13)by high throughput sequencing,thalassemia gene typing,hepatitis C virus RNA quantification,and EGFR gene mutation,and the acceptable performance rates of only 3 EQA items were 100%,i.e.,HbA2,urine microalbumin,and non-invasive prenatal testing(NIPT).Thir-ty-six analytes exhibited acceptable performance rate above of 80%,while that of troponin I was below 80%.Conclusion The medical laboratories in China should further increase their test covered by an EQA control rate and acceptable performance rate of EQA pro-gram,and consistantly improve testing quality by utilizing EQA programs adequately.
3.Clinical application of pelvic floor en bloc resection in combined pelvic organ resection for locally advanced or locally recurrent rectal cancer
Guoliang CHEN ; Yao LU ; Ruoxin ZHANG ; Ning SU ; Zhiguo WANG ; Guoyi SHAO ; Jian ZHANG
Chinese Journal of Gastrointestinal Surgery 2025;28(7):743-750
Objective:To explore the feasibility, safety, and short-term efficacy of a total pelvic floor resection procedure as a component of combined resection of pelvic organs for locally advanced or locally recurrent rectal cancer.Methods:This was a descriptive case series. Relevant clinical data of patients with locally advanced or locally recurrent rectal cancer without extrapelvic metastasis or with only oligometastasis who had undergone combined pelvic organ resection with resection of the entire pelvic floor in the Department of Anorectal Surgery of the Second Affiliated Hospital of Naval Medical University from 1 January 2023 to 30 June 2024 were collected from a Chinese database of combined pelvic organ resection for rectal cancer. The study cohort comprised 143 patients, 74 of whom were male (51.7%) and 69 were female (48.3%); their ages averaged 54 (range: 31–75) years; 57 of the patients (39.9%) had locally advanced rectal cancer and 86 (60.1%) locally recurrent rectal cancer. In our institution, the pelvic floor is categorized into two anatomical layers: the levator ani/presacral anterior tissue, and the bone/ligament/pelvic floor soft tissue. The entire pelvic floor was resected en bloc after making incisions on both sides of the pelvic floor, followed by presacral sacral dissection, and abdominoperineal dissection of the anterior side of the pelvic floor. The main factors studied were related to the following: (1) surgical conditions, comprising the scope of surgical resection, operation time, intraoperative blood loss, tissue reconstruction; (2) postoperative recovery, comprising time to recovery of intestinal function, time to removal of drainage tubes, and time to healing of the empty pelvic cavity; and (3) postoperative complications, classified according to the international Clavien-Dindo classification. Results:Combined pelvic organ resection with entire pelvic floor resection was successfully completed in all patients. The operation time was 480 (390 to 1,020) minutes, intraoperative blood loss 800 (50 to 3,500) mL, and volume of blood transfused intraoperatively 1, 000 (400 to 7, 400). R0 resection was achieved in 116 cases (81.1%) and R1 resection in 27 (18.9%). The first layer of the pelvic floor wall (levator ani/sacral anterior tissue) was resected in 79 cases (55.2%) and the second layer of the pelvic floor wall (bone/ligament/pelvic floor soft tissue) in 64 (44.8%). The procedure was completed in the lithotomy position in 114 cases (79.7%) were and in the lithotomy + prone jackknife position in 29 (20.3%). The pelvic floor was reconstructed with mesh in 140 cases (97.7%) and with mesh plus pedicled omental flaps in 92 cases (64.3%). The urinary tract was reconstructed in 92 cases (64.3%). The time to recovery of intestinal function was 3.6 (2.0 to 7.0) days, to removal of drainage tubes 29.4 (24.0 to 54.0) days, and to healing of the empty pelvic cavity 36.2 (27.0 to 56.0) days. Twenty-three patients (16.1%) had Grade I - II complications and 36 (25.2%) Grade IIIa - IV complications. The median duration of follow-up was 15.5 (0.5 to 30.0) months. Six of the patients (4.2%) died, including two (1.4%) who died within 30 days after surgery.Conclusions:Pelvic floor en bloc resection has a high R0 resection rate and is a safe and feasible procedure for pelvic organ resection surgeries in patients with locally advanced or locally recurrent rectal cancer.
4.Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items
Jiali LIU ; Wei WANG ; Bingquan CHEN ; Zhiguo WANG
Journal of Modern Laboratory Medicine 2025;40(5):194-199
Objective To develop a statistical quality control(SQC)program design software to help laboratories design comprehensive SQC programs based on patient risk.Methods Based on the power function diagram,operation process specification diagram,risk-based multi-level internal quality control(IQC)scheme,and online calculator for IQC frequency,corresponding software modules were integrated and designed,and applied the data of potassium project to the software.Results For the power function diagram,operation process specification,and online calculator for IQC frequency,13s/22s/R4s/41s[Number of quality control measurement values(N)=2]was the best choice for potassium for IQC.In the risk-based multi-level IQC scheme,13s/22s/R4s/41s(N=2)could be selected as the startup quality control event,while different subsequent bracketing quality control events could be obtained based on different expected reporting intervals and maximum workloads to achieve the expected quality requirements.Conclusion The development of statistical quality control program design soft is proves beneficial for clinical laboratories to assess the current quality level and select appropriate quality control approaches,and assists the laboratories in enhancing quality.
5.Adjustment and preliminary application of a data-driven palliative care outcomes collaboration model
Yongyi CHEN ; Junchen GUO ; Jinfeng DING ; Boyong SHEN ; Ying WANG ; Zhiguo ZHOU ; Qinghui ZHANG ; Liqun LI ; Feng LIANG ; HOLLOWAY DAVID ; JOHNSON CLAIRE ; Yunyun DAI
Chinese Journal of Nursing 2025;60(18):2185-2191
Objective This study aimed to adapt the data-driven Palliative Care Outcomes Collaboration(PCOC)model to the local context and evaluate its feasibility and preliminary effectiveness in a palliative care unit in China,with the goal of informing its broader integration into national palliative care practice.Methods Based on international experience,a localized implementation protocol for the PCOC model was developed through expert con-sultations and a pilot study.The protocol incorporated key elements including organizational and managerial sup-port,team training and capacity building,information system integration,supervision and feedback mechanisms,pro-cess optimization,and data-driven decision-making.From June to December 2023,the protocol was piloted in the palliative care unit of a tertiary cancer hospital in Changsha,China.Implementation outcomes were assessed by comparing patients' urgent care response rates,symptom stability rates,and symptom improvement rates between the first 1~3 months and 4~6 months after implementation.Results During the study period,a total of 355 inpatients were enrolled,with the PCOC assessment achieving full coverage(100%)and a completion rate of 97.78%.There was no statistically significant difference in the urgent needs response rate between the first 1~3 months and the 4~6 months after the implementation of the PCOC model(P=0.533).However,compared to the first 1~3 months af-ter implementation,patients in the 4~6 months period showed significantly higher symptom stability rates for pain,psychological/spiritual issues,and family/caregiver problems,as well as a higher improvement rate for pain(P<0.05).Conclusion The localized PCOC implementation protocol facilitates standardized assessment and symptom manage-ment,and its application can enhance the quality of palliative care.
6.Exploring Multi-target Effect of Erzhiwan on Improving Myocardial Injury in Ovariectomized Mice Based on Non-targeted Metabolomics
Ying YANG ; Jing HU ; Pei LI ; Ruyuan ZHU ; Zhiguo ZHANG ; Haixia LIU ; Yanjing CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):74-84
ObjectiveTo explore the target of Erzhiwan in reducing myocardial injury in ovariectomized mice through non-targeted myocardial metabolomics combined with experimental verification. MethodsOvariectomized mouse model was selected, 40 female C57BL/6 mice were randomly divided into sham operation group, model group, estrogen group(estradiol valerate, 1.3×10-4 g·kg-1), Erzhiwan low and high dose groups(3.12, 9.36 g·kg-1), with 8 mice in each group. Each administration group was given the corresponding dose of Erzhiwan by gavage, and the sham operation group and model group were given equal volume of distilled water by gavage for 12 weeks. Echocardiography was used to detect cardiac function, hematoxylin-eosin(HE) staining was used to observe myocardial morphological changes, and enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of estrogen, N-terminal pro-brain natriuretic peptide(NT-proBNP), hypersensitive troponin T(hs-TnT), total cholesterol(TC), triglyceride(TG), low density lipoprotein cholesterol(LDL-C), high density lipoprotein cholesterol(HDL-C), interleukin(IL)-1β, IL-18 and tumor necrosis factor-α(TNF-α). The non-targeted metabolomics of mouse myocardium were analyzed by ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Exactive Orbitrap MS), and the differential metabolites and corresponding metabolic pathways were obtained. The mRNA expression levels of phosphatidylinositol 3-kinase(PI3K) and protein kinase B(Akt) in mouse myocardial tissues were detected by real-time fluorescence quantitative polymerase chain reaction(Real-time PCR), and the protein expression levels of PI3K, Akt, phosphorylated(p)-Akt were detected by Western blot. ResultsCompared with the sham operation group, the model group showed abnormal cardiac function, increased myocardial fiber space, cardiomyocyte atrophy, sarcoplasmic aggregation, and occasional dissolution or rupture of muscle fiber, the level of estrogen in the serum was decreased, the levels of NT-proBNP, hs-TnT, IL-1β, IL-18, TNF-α, TG, TC and LDL-C were increased, and the level of HDL-C was decreased(P<0.01). Compared with the model group, Erzhiwan could increase the level of estrogen, improve the abnormal cardiac function, reduce the pathological injury of myocardial tissue, decrease the levels of myocardial injury markers(NT-proBNP, hs-TnT) and inflammatory factors(IL-1β, IL-18, TNF-α), decrease the levels of TG, TC, LDL-C, and increased the level of HDL-C(P<0.01). The results of non-targeted myocardial metabolomics showed that 31 of the 162 differential metabolites between the model group and sham operation group were significantly adjusted after administration of Erzhiwan, which were mainly glycerol phospholipid metabolites. Pathway enrichment results showed that Erzhiwan mainly affected glycerophospholipid metabolic pathway, PI3K-Akt pathway, cyclic guanosine monophosphate(cGMP)-protein kinase G(PKG) pathway and other metabolic pathways. Compared with the sham operation group, the levels of phosphatidylcholine(PC, 11 types) and phosphatidylethanolamine(PE, 5 types) in mouse myocardial tissue of the model group were increased(P<0.05, P<0.01), and the mRNA and protein expressions of PI3K and p-Akt were decreased(P<0.05, P<0.01). Compared with the model group, the levels of PC(11 types) and PE(5 types) were decreased(P<0.05, P<0.01) in myocardial tissue of Erzhiwan group, the mRNA and protein expressions of PI3K and p-Akt were elevated(P<0.01). ConclusionErzhiwan can alleviate the pathological injury of myocardium in ovariectomized mice, improve the abnormal cardiac function, improve lipid metabolism disorder, and reduce the levels of myocardial injury markers and inflammatory factors, which involves a number of signaling and metabolic pathways in the heart, among which glycerophospholipid metabolism pathway and PI3K/Akt pathway may have key roles.
7.Clinical application of pelvic floor en bloc resection in combined pelvic organ resection for locally advanced or locally recurrent rectal cancer
Guoliang CHEN ; Yao LU ; Ruoxin ZHANG ; Ning SU ; Zhiguo WANG ; Guoyi SHAO ; Jian ZHANG
Chinese Journal of Gastrointestinal Surgery 2025;28(7):743-750
Objective:To explore the feasibility, safety, and short-term efficacy of a total pelvic floor resection procedure as a component of combined resection of pelvic organs for locally advanced or locally recurrent rectal cancer.Methods:This was a descriptive case series. Relevant clinical data of patients with locally advanced or locally recurrent rectal cancer without extrapelvic metastasis or with only oligometastasis who had undergone combined pelvic organ resection with resection of the entire pelvic floor in the Department of Anorectal Surgery of the Second Affiliated Hospital of Naval Medical University from 1 January 2023 to 30 June 2024 were collected from a Chinese database of combined pelvic organ resection for rectal cancer. The study cohort comprised 143 patients, 74 of whom were male (51.7%) and 69 were female (48.3%); their ages averaged 54 (range: 31–75) years; 57 of the patients (39.9%) had locally advanced rectal cancer and 86 (60.1%) locally recurrent rectal cancer. In our institution, the pelvic floor is categorized into two anatomical layers: the levator ani/presacral anterior tissue, and the bone/ligament/pelvic floor soft tissue. The entire pelvic floor was resected en bloc after making incisions on both sides of the pelvic floor, followed by presacral sacral dissection, and abdominoperineal dissection of the anterior side of the pelvic floor. The main factors studied were related to the following: (1) surgical conditions, comprising the scope of surgical resection, operation time, intraoperative blood loss, tissue reconstruction; (2) postoperative recovery, comprising time to recovery of intestinal function, time to removal of drainage tubes, and time to healing of the empty pelvic cavity; and (3) postoperative complications, classified according to the international Clavien-Dindo classification. Results:Combined pelvic organ resection with entire pelvic floor resection was successfully completed in all patients. The operation time was 480 (390 to 1,020) minutes, intraoperative blood loss 800 (50 to 3,500) mL, and volume of blood transfused intraoperatively 1, 000 (400 to 7, 400). R0 resection was achieved in 116 cases (81.1%) and R1 resection in 27 (18.9%). The first layer of the pelvic floor wall (levator ani/sacral anterior tissue) was resected in 79 cases (55.2%) and the second layer of the pelvic floor wall (bone/ligament/pelvic floor soft tissue) in 64 (44.8%). The procedure was completed in the lithotomy position in 114 cases (79.7%) were and in the lithotomy + prone jackknife position in 29 (20.3%). The pelvic floor was reconstructed with mesh in 140 cases (97.7%) and with mesh plus pedicled omental flaps in 92 cases (64.3%). The urinary tract was reconstructed in 92 cases (64.3%). The time to recovery of intestinal function was 3.6 (2.0 to 7.0) days, to removal of drainage tubes 29.4 (24.0 to 54.0) days, and to healing of the empty pelvic cavity 36.2 (27.0 to 56.0) days. Twenty-three patients (16.1%) had Grade I - II complications and 36 (25.2%) Grade IIIa - IV complications. The median duration of follow-up was 15.5 (0.5 to 30.0) months. Six of the patients (4.2%) died, including two (1.4%) who died within 30 days after surgery.Conclusions:Pelvic floor en bloc resection has a high R0 resection rate and is a safe and feasible procedure for pelvic organ resection surgeries in patients with locally advanced or locally recurrent rectal cancer.
8.Analysis of results for the covered rate and acceptable performance of EQA items in nationwide medical laboratories from 2019 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2025;43(2):126-129
Objective To understand the status of medical laboratories participating in external quality assessment(EQA)program in China.Methods The test covered by an EQA control rate and acceptable performance rate of theinformation collection and data analy-sis systems in the EQA program developed by National Center for Clinical Laboratories in medical laboratories of nationwide various re-gions were evaluated descriptively and analyzed statistically.Forty analytes in various disciplines were selected to analyze statistically the implementation of the testing items and participation retes of EQA program.Results The number of medical laboratories participat-ing in EQA program increased yearly from 592 in 2019 to 1 169 in 2023.The nationwide median test covered by an EQA control rate and acceptable performance rate of EQA program reached over 91%and 98%,respectively.In 2023,the median test covered by an EQA control rate of EQA program in the medical laboratories of nationwide regions showed that the median test covered by an EQA con-trol rate reached 100%in Gansu and Hainan regions,and the medians of acceptable performance rate reached 100%in Beijing,Guangdong,Hubei,Jiangsu,Shandong,Shanxi,Shanghai,Tianjin,Xinjiang,and Zhejiang regions.Among the 40 analytes,the test covered by an EQA control rate of only 6 EQA items were greater than 80%in nationwide medical laboratories,i.e.,rheumatoid factor,neonatal deafness gene detection,high throughput sequencing of peripheral fetal chromosome aneuploidy(T21,T18 and T13)by high throughput sequencing,thalassemia gene typing,hepatitis C virus RNA quantification,and EGFR gene mutation,and the acceptable performance rates of only 3 EQA items were 100%,i.e.,HbA2,urine microalbumin,and non-invasive prenatal testing(NIPT).Thir-ty-six analytes exhibited acceptable performance rate above of 80%,while that of troponin I was below 80%.Conclusion The medical laboratories in China should further increase their test covered by an EQA control rate and acceptable performance rate of EQA pro-gram,and consistantly improve testing quality by utilizing EQA programs adequately.
9.Peptide-based immuno-PET/CT monitoring of dynamic PD-L1 expression during glioblastoma radiotherapy.
Yong WANG ; Kewen HE ; Yang ZHANG ; Yunhao CHEN ; Shijie WANG ; Kunlong ZHAO ; Zhiguo LIU ; Man HU
Journal of Pharmaceutical Analysis 2025;15(3):101082-101082
Real-time, noninvasive programmed death-ligand 1 (PD-L1) testing using molecular imaging has enhanced our understanding of the immune environments of neoplasms and has served as a guide for immunotherapy. However, the utilization of radiotracers in the imaging of human brain tumors using positron emission tomography/computed tomography (PET/CT) remains limited. This investigation involved the synthesis of [18F]AlF-NOTA-PCP2, which is a novel peptide-based radiolabeled tracer that targets PD-L1, and evaluated its imaging capabilities in orthotopic glioblastoma (GBM) models. Using this tracer, we could noninvasively monitor radiation-induced PD-L1 changes in GBM. [18F]AlF-NOTA-PCP2 exhibited high radiochemical purity (>95%) and stability up to 4 h after synthesis. It demonstrated specific, high-affinity binding to PD-L1 in vitro and in vivo, with a dissociation constant of 0.24 nM. PET/CT imaging, integrated with contrast-enhanced magnetic resonance imaging, revealed significant accumulation of [18F]AlF-NOTA-PCP2 in orthotopic tumors, correlating with blood-brain barrier disruption. After radiotherapy (15 Gy), [18F]AlF-NOTA-PCP2 uptake in tumors increased from 9.51% ± 0.73% to 12.04% ± 1.43%, indicating enhanced PD-L1 expression consistent with immunohistochemistry findings. Fractionated radiation (5 Gy × 3) further amplified PD-L1 upregulation (13.9% ± 1.54% ID/cc) compared with a single dose (11.48% ± 1.05% ID/cc). Taken together, [18F]AlF-NOTA-PCP2 may be a valuable tool for noninvasively monitoring PD-L1 expression in brain tumors after radiotherapy.
10.Research progress in online monitoring technologies for workplace dust concentration
Qiangzhi GUO ; Yuntao MU ; Jinning YU ; Chuntao GE ; Chen WANG ; Zhiguo ZHOU ; Xue JIANG ; Yazhen WANG ; Jinling LIU ; Di LIU ; Shibiao SU
China Occupational Medicine 2025;52(4):472-476
Occupational pneumoconiosis remains the most common occupational disease in China, with occupational mineral dust exposure being its primary causative factor. Although national standards for online monitoring and early warning systems of coal mine dust concentrations have been established, national occupational health standards for rapid and online monitoring of dust concentration and particle size distribution in other industries are still limited. Among dust concentration sensor technologies, the light scattering method is the preferred choice for online dust monitoring owing to its wide measurement range and low cost. The beta-ray absorption method is mature but highly sensitive to humidity. The electrostatic induction method offers high sensitivity, simple structure, and low maintenance costs but exhibits high errors in low-concentration dust monitoring. The tapered element oscillating microbalance method is highly sensitive but costly. Multi-sensor data fusion technology can improve monitoring reliability, however, mature domestic products are not yet available. For monitoring dust particle size distribution, sieving and sedimentation methods are cumbersome. The aerodynamic method shows broad prospects in the online monitoring of respirable dust but has obvious measurement errors for larger dust particles. The use of optical measurement method is limited by dust morphology and is not suitable for monitoring coal dust particle size distribution. The electrical mobility method is primarily applicable to submicron dust. Future research should focus on promoting the application of monitoring technology for respirable dust particle size distribution in online monitoring of industrial dust. By integrating Internet of Things, data mining, and artificial intelligence technologies, along with multi-sensor data fusion and numerical simulation, dust concentration prediction models can be established to achieve accurate dust concentration monitoring and early warning of exceedances. The advancements of technologies will provide scientific support for the assessment of industrial dust hazards and the prevention and control of occupational pneumoconiosis.

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