1.Prospects for the application of nonfasting lipids
Chinese Journal of Laboratory Medicine 2016;39(9):720-725
The article reviewed the value of blood lipids in cardiovascular event risk assessment, especially the selectionof the nonfasting blood samples.The article introduced the latest foreign issued guidelines and expert consensus about the application of nonfasting lipids.There were several clinical trials which compared nonfasting lipidswith fasting lipids in sample collection, their predictive value of CVD and the effects of diet on blood lipids.The existing problems of nonfasting lipids in the clinical application were also demonstrated.The interpretation of the results and the influences of the measurment for nonfasting lipids would be recognized.
2.Serum small dense low-density lipoprotein cholesterol and performance evaluation of commercial detection kits and its relationship with the severity of coronary heart disease
Lan ZHANG ; Wenqi SHAO ; Ailun ZHANG ; Qian DAI ; Jiong WU ; Beili WANG ; Wei GUO ; Baishen PAN
Chinese Journal of Laboratory Medicine 2017;40(6):425-430
Objective To evaluate the performance of serum small dense low-density lipoprotein cholesterol(sdLDL-C)kit using enzymic method and evaluate the relationship with the severity of coronary heart disease.Methods Performance verification methodology. The analytical performance consisted of accuracy, precision and linearity of serum sdLDL-C kit using enzymic method was assessed. One hundred and twenty healthy persons were recruited to establish serum sdLDL-C reference interval. Two hundred and twelve patients underwent coronary angiography were enrolled in the study.Among them 110 cases were positive for coronary angiography, where as 102 cases were negative. We examined serum levels of sdLDL-C in 110 patients with positive angiography, 102 patients with negative angiography and 120 healthy volunteers. Positive group was classfied into severe group(Gensini score>30) and mild group (Gensini score≤30).Results The accuracy and precision of sdLDL-C examination were in compliance with manufacturer′s statement and there was a good linear correlation(Y=0.9937X-0.1063,R2=0.99) in range of 0.06-2.45 mmol/L. The reference interval of sdLDL-C was 0.15-0.97 mmol/L and without gender and age specificity. The level of sdLDL-C was higher in positive angiography group than in negative angiography group and healthy control group(P<0.01). The level of sdLDL-C was higher in severe group than in mild group(P<0.05). Binary stepwise regression analysis demonstrated that sdLDL-C was independently associated with the severity of coronary heart disease(OR=3.101,P<0.05).ConclusionsExperiment data demonstrated that serum sdLDL-C kit using enzymic method has good performance in the accuracy, precision and linearity. SdLDL-C that plays an important role in the occurrence and progression of coronary heart disease, is an independent important risk of the severity of coronary heart disease.
3.The analytical performance assessment of high-sensitivity cardiac troponin T reference intervals investigation
Lingyan SONG ; Jiong WU ; Binbin SONG ; Wenqi SHAO ; Chunyan ZHANG ; Beili WANG ; Wei GUO ; Baishen PAN
Chinese Journal of Laboratory Medicine 2010;33(9):814-818
Objective To assess the analytical performance of hs-cTnT and biological variations in healthy population as well as establish hs-cTnT reference intervals. Methods The serum samples from 100 acute myocardial infraction patients and 474 apparently healthy subjects were collected. The functional sensitivity,within- and between-run imprecision were determined. The hs-cTnT assay and con-cTnT assay were evaluated. The serum hs-cTnT levels were detected in apparently healthy subjects to establish reference intervals. Moreover,the long-term and short-term biological variations for hs-cTnT in healthy volunteers were assessed. Results The functional sensitivity of hs-cTnT was 0. 005 μg/L. The within- and between-run precision for lower level control(0. 014 μg/L) and higher level control(2. 500 μg/L) was 2. 97% vs 3. 64%and 0. 66% vs 1.01% ,respectively. The correlation between hs-cTnT assay and con-cTnT assay was good ( R2 =0. 972 ,P <0. 01 ). The 99th percentile in apparently healthy subjects was 0. 003 μg/L for women less than60 years, 0.008 μg/L for men less than 60 years, 0.015 μg/L for women above 60 years and 0. 021 μg/L for men above 60 years. The CVa, CVi, CVg and CVt of short-term biological variations in detecting hs-cTnT from 22 apparently healthy subjects were 3.8%, 4. 8%, 49.9% and 58.5%,respectively. The CVa,CVi ,CVg and CVt of long-term biological variations were 5. 3% ,6. 4% ,56. 6% and 68. 3% respectively. Conclusions The analytical performance of the hs-cTnT is better than con-cTnT assay,achieving acceptable level according to guideline. Our experimental result could provide the basis for the new high sensitivity cTnT assay in the diagnosis of acute myocardial infarction.
4. Review of Shanghai glycohemoglobin harmonization program
Beili WANG ; Yiwen ZHOU ; Jiong WU ; Wenqi SHAO ; Wen XU ; Wei GUO ; Baishen PAN
Chinese Journal of Laboratory Medicine 2020;43(1):36-43
Objective:
To review the results of inter-laboratory comparisons in Shanghai glycohemoglobin harmonization program from 2010 to 2018, and to analyze the evolution of quality levels of HbA1c determination, so as to provide the reference for improving the HbA1c determination quality in China.
Methods:
Retrospective analysis. The comparison data of Shanghai Glycohemoglobin Harmonization Program from 2010 to 2018 was collected. And the change trend was analyzed about hospital and determination method distribution. The judgment criteria, quarterly and annual pass rate, bias and coefficient of variation of the results of the inter-laboratory comparison were analyzed retrospectively, and the results were compared with the results of External Quality Assessment Programme carried out by the National Center for Clinical Laboratories, Shanghai Center for Clinical Laboratories and College of American Pathologists (CAP). The data in the first quarter of 2019 was collected and the imprecision, bias and sigma were calculated, which were drew in the evaluation model of sigma combined with biomedical variation parameters.
Results:
The number of participating laboratories increased from 9 in Shanghai to 192 in the whole country, with an average annual growth rate of 76.6%. The quarterly comparison criteria improved from ±8% to ±6% and the passing rate of participating laboratories increased from 39.1% to nearly 90%. The maximum CV of each instrument among laboratories decreased from 14.3% to 4.8%. In the first quarter of 2019, nearly 60% of the laboratories met 6σcriteria and more than 95% of the laboratories met the "standard criteria" in the model of biological variation parameters.
Conclusion
Shanghai Glycohemoglobin harmonization program has improved the harmonization of HbA1c test results among the participating laboratories.
5.Research progress on the relationship between adverse childhood experiences and cardiovascular diseases
LEI Wenqi,SUN Wenjie,SUN Jingyuan,WANG Yiru,SUN Xianghui,SHAO Jinang,Ma Yanan
Chinese Journal of School Health 2025;46(1):148-152
Abstract
To understand the relationship between cardiovascular disease (CVD) and adverse childhood experiences (ACEs), the present review aims to describe the burden and influencing factors of CVD, epidemiological characteristics and burden of ACEs, current research on the relationship between ACEs and CVD, and the mechanism of ACEs leading to CVD. It is proposed that further assessment of the relationship is warranted through identifying blood biomarkers, conducting prospective cohort studies and intervention studies. Such efforts would provide valuable scientific insights for primary prevention strategies for cardiovascular disease.
6.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
7.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
8.A Single-Arm Phase II Clinical Trial of Fulvestrant Combined with Neoadjuvant Chemotherapy of ER+/HER2– Locally Advanced Breast Cancer: Integrated Analysis of 18F-FES PET-CT and Metabolites with Treatment Response
Qing SHAO ; Ningning ZHANG ; Xianjun PAN ; Wenqi ZHOU ; Yali WANG ; Xiaoliang CHEN ; Jing WU ; Xiaohua ZENG
Cancer Research and Treatment 2025;57(1):126-139
Purpose:
This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy.
Materials and Methods:
Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety.
Results:
Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways.
Conclusion
This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.
9.Cost accounting for diagnosis items based on virtual standardized clinical chemistry laboratory
Wenqi SHAO ; Ying ZHAO ; Haiyin WANG ; Qian YU ; Beili WANG ; Wei GUO ; Baishen PAN
Chinese Journal of Hospital Administration 2021;37(9):788-792
Objective:Cost accounting for its diagnosis items based on virtual standardized clinical chemistry laboratory.Methods:Relevant data of clinical chemistry laboratories from January to June 2019 were extracted from the laboratory information systems of 10 hospitals in Shanghai, and three health economic experts and the directors of their laboratory departments were interviewed in this regard.On such basis, a virtual standardized clinical chemistry laboratory was constructed. The project cost of the virtual laboratory was calculated from the aspects of supplies exhaust, labor and others. The routine clinical chemistry diagnosis items were clustered according to the principle of laboratory methods, and the cost differences of items in the same cluster were compared using paired t test. Results:The cost of rate method and dry chemical method in testing alanine aminotransferase was 5.12 and 11.63 respectively, and that of immune turbidimetry and immune scattering turbidimetry method in testing immunoglobulin G was 20.00 and 22.26 respectively. Cluster analysis was conducted on 214 routine clinical biochemical diagnostic items, of which 202 items were classified into 42 clusters. The average of clinical chemistry items accounted for 91.7%(4 493/4 900)of the total per day. Based on enzymology, the calculation costs of alanine aminotransferase(rate method), aspartate aminotransferase(rate method), cholesterol(enzyme method)and uric acid(enzyme method)was 5.12, 5.10, 5.24 and 5.14 respectively, presenting no statistical difference( P>0.05). Conclusions:Research on the cost accounting method of clinical chemistry laboratory diagnosis items constructed includes labor cost, reflects the technical labor value of medical staff. Cost accounting based on project clustering can provide references for medical service pricing and financial management of hospitals.
10.Study on the application and effect of adjustable mirabilite external vest in severe acute pancreatitis
Lifeng JIANG ; Ping HAO ; Lei XU ; Yongping SHAO ; Wenqi SUN ; Lingfeng YAO ; Yan LIU
Chinese Journal of Practical Nursing 2023;39(26):2039-2043
Objective:To investigate the clinical effect of homemade adjustable mirabilite vest in patients with severe acute pancreatitis and supply reference for clinical nursing.Methods:This was a randomized controlled study. One hundred patients with acute severe pancreatitis admitted to Putuo Hospital, Shanghai University of Traditional Chinese Medicine from January 2021 to June 2022 were selected, and were divided into the pocket group and the vest group according to the order of admission with 50 cases in each group. The pocket group used traditional mirabilite bag for external application, the vest group used adjustable mirabilite vest for external application. The other treatment measures were the same for both two group. The comfort degree, itching severity and average length of hospital stay of these two groups were compared.Results:The basic data of the two groups were homogeneous. The difference were not statistically significant( P>0.05). After intervention, the comfort degree of the pocket group was (65.90 ± 7.95) points while the comfort degree of the vest group was (77.04 ± 5.96) points. The difference was statistically significant ( t = 7.93, P<0.01). The degree of pruritus was (12.72 ± 3.95) points in the pocket group and (8.00 ± 1.20) points in the vest group.The difference was statistically significant ( t = 8.08, P<0.05). The mean length of hospital stay in the pocket group was (15.86 ± 5.83) days and (11.02 ± 3.38) days in the vest group. The difference was statistically significant ( t = 5.08, P<0.01). Conclusions:When using topical mirabilite for patients with acute severe pancreatitis, the use of adjustable mirabilite vest can significantly improve patients′ comfort, reduce itching, and reduce the number of hospital days, which has the value of promotion and use.