1.Interpretation for the General Chapter 0237 the preparation and establishment of national biological reference standards in Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
WANG Yiping ; MAO Qunying ; WANG Xiaojuan ; LIANG Zhenglun
Drug Standards of China 2025;26(1):099-104
The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.
2.Effect of PACS-2 on the development of Alzheimer's disease
Yanyun WANG ; Qunying YE ; Jun QIAN ; Zhipeng LIU ; Hongbo LUO ; Yun LI
China Modern Doctor 2024;62(5):11-15
Objective To investigate the involvement of phosphofurin acidic cluster sorting protein-2(PACS-2)in mitochondrial function and apoptosis in N2a/APP695swe cells and further explore the role and significance of PACS-2 in the development of Alzheimer's disease(AD).Methods The CCK8 method was used to analyze the cell survival rate of N2a/APP695swe cells treated with different concentrations of tetrahydroxy stilbene glycoside(TSG)for 48h and to select the appropriate concentration of TSG for subsequent experiments.N2a/WT cells and N2a/APP695swe cells were routinely cultured in vitro,and the experimental cells were divided into 3 groups:blank control group(WT group):N2a/WT cells;model group(APP group):N2a/APP695swe cells;treatment group(TSG group):N2a/APP695swe cells with appropriate concentrations of TSG intervention.TUNEL method to observe apoptosis by fluorescence microscopy;JC-1 method for flow detection of cellular mitochondrial membrane potential;WB to detect protein expression of PACS-2;RT-qPCR to detect PACS-2 mRNA expression.Results CCK8 method was used to analyze the cell survival rate of different concentrations of TSG acting on cells after 48h:the protective effect of 100 μmol/L TSG was the most significant and the difference was statistically significant(P<0.01).The TUNEL method of fluorescence microscopy observed the apoptosis:compared with the WT group,the apoptosis rate of APP group was increased,compared with the APP group,the apoptosis rate of TSG group was decreased,and the differences were statistically significant(P<0.05).The JC-1 method was used to detect the mitochondrial membrane potential of cells:compared with the WT group,the membrane potential of APP group was decreased,compared with the APP group,the membrane potential of TSG group was increased,and the differences were statistically significant(P<0.05);Western blot(WB)detection of PACS-2 protein expression:compared with the WT group,PACS-2 expression was significantly higher in the APP group,and compared with the APP group,PACS-2 expression was significantly lower in the TSG group,with statistically significant differences(P<0.05);The RT-qPCR detected the mRNA expression of PACS-2:the expression of PACS-2 was elevated in the APP group compared with the WT group and decreased in the TSG group compared with the APP group,with statistically significant differences(P<0.05).Conclusion PACS-2 has an important role in the development of AD,and its upregulation may promote the development of AD.The cerebroprotective drug TSG may exert cytoprotective effects by downregulating PACS-2 to inhibit apoptosis and improve mitochondrial function in AD model cells.
3.Study on the Distribution and Clinical Characteristics of TCM Syndromes in Infertility Patients with Autoimmune Thyroiditis
Xiaoru FANG ; Limin WU ; Qunying FANG ; Mengli WANG ; Shiyu ZHAO ; Zonghui QIAO ; Hongbing LUAN ; Zhaohui FANG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(1):164-170
Objective To investigate the distribution and clinical characteristics of TCM syndromes in infertility patients with autoimmune thyroiditis(AIT).Methods By referring to the relevant literature on the distribution of TCM syndromes of AIT and infertility in women of childbearing age,the TCM Syndromes Survey of Infertility Patients with Autoimmune Thyroiditis was formulated.256 cases of infertility patients with AIT who underwent in vitro fertilization-embryo transfer(IVF-ET)at the Reproductive Center of The First Affiliated Hospital of University of Science and Technology of China from June 2019 to December 2020 were retrospectively analyzed.The data of basic information,TCM syndromes,basic thyroid-stimulating hormone(TSH),thyroid peroxidase antibody(TPO-Ab)and thyroglobulin antibody(TG-Ab)were collected.By means of frequency analysis and systematic cluster analysis,the distribution regularity of TCM syndromes in infertility patients with AIT were concluded.Results After analysis,the following 5 common syndrome elements were obtained,namely,qi deficiency,liver depression,spleen deficiency,kidney deficiency and blood stasis.In addition,it was concluded that this disease was more common in complex syndromes.Through systematic clustering analysis,main TCM syndromes of this disease were obtained,which were qi deficiency and liver depression syndrome(69 cases,26.9%),spleen and kidney deficiency syndrome(45 cases,17.6%),spleen qi deficiency syndrome(38 cases,14.8%),qi deficiency and blood stasis syndrome(36 cases,14.1%),kidney deficiency and liver depression syndrome(32 cases,12.5%)and other syndrome types(36 cases,14.1%).The basic TSH level was higher in patients with qi deficiency and liver depression syndrome,spleen qi deficiency syndrome,qi deficiency and blood stasis syndrome than other syndrome types,with statistical significance(P<0.05).There was no significant difference in TPO-Ab and TG-Ab titers among different syndromes(P>0.05).Conclusion TCM syndromes of infertility patients with AIT can be clustered into qi deficiency and liver depression syndrome,spleen and kidney deficiency syndrome,spleen qi deficiency syndrome,qi deficiency and blood stasis syndrome,kidney deficiency and liver depression syndrome and other syndrome.The main element of syndrome is qi deficiency,and the pathological sites involved spleen,kidney and liver.Stasis blood is a main pathological product.It is required to pay close attention to the thyroid function in AIT patients with qi deficiency.
4.The occurrence and influencing factors of vascular calcification in non-dialysis chronic kidney disease patients of stage 3-5
Miaorong XUE ; Wenjiao ZHU ; Zhiman LAI ; Shaozhen FENG ; Yan WANG ; Jianbo LI ; Jianwen YU ; Xi XIA ; Qiong WEN ; Xin WANG ; Xiao YANG ; Haiping MAO ; Xionghui CHEN ; Zhijian LI ; Fengxian HUANG ; Wei CHEN ; Shurong LI ; Qunying GUO
Chinese Journal of Nephrology 2024;40(6):431-441
Objective:To explore the prevalence and independent associated factors of vascular calcification (VC) in non-dialysis chronic kidney disease (CKD) patients of stage 3-5.Methods:It was a single-center cross-sectional observational study. Non-dialysis stage 3-5 CKD patients ≥18 years old who were admitted to the Department of Nephrology, the First Affiliated Hospital of Sun Yat-sen University from May 1, 2022 to December 31, 2022 with VC evaluation were enrolled. The patients' general information, laboratory examination and imaging data were collected. Coronary artery calcification (CAC), thoracic aorta calcification (TAC), abdominal aorta calcification (AAC), carotid artery calcification and aortic valve calcification (AVC) were evaluated by cardiac-gated electron-beam CT (EBCT) scans, lateral lumbar x-ray, cervical macrovascular ultrasound and echocardiography, respectively. The differences in clinical data and the prevalence of VC at different sites of patients with different CKD stages were compared, and the prevalence of VC at different sites of patients in different age groups [youth group (18-44 years old), middle-aged group (45-64 years old) and elderly group (≥65 years old)] and patients with or without diabetes were compared. Multivariate logistic regression analysis was used to analyse the independent associated factors of VC for different areas.Results:A total of 206 patients aged (51±14) years were included, including 129 (62.6%) males. There were 44 patients with CKD stage 3 (21.4%), 51 patients with CKD stage 4 (24.8%), and 111 patients with CKD stage 5 (53.9%). CKD was caused by chronic glomerulonephritis [104 cases (50.5%)], diabetic kidney damage [35 cases (17.0%)], hypertensive kidney damage [29 cases (14.1%)] and others [38 cases (18.4%)]. Among 206 patients, 131 (63.6%) exhibited cardiovascular calcification, and the prevalence of CAC, TAC, AAC, carotid artery calcification, and AVC was 37.9%, 43.7%, 37.9%, 35.9% and 9.7%, respectively. The overall prevalence of VC in young, middle-aged and elderly patients was 24.6%, 73.6% and 97.4%, respectively. With the increase of age, the prevalence of VC in each site gradually increased, and the increasing trend was statistically significant (all P<0.001). The overall prevalence of VC in CKD patients with diabetes was 92.5% (62/67), and the prevalence of VC at each site in the patients with diabetes was significantly higher than that in the patients without diabetes (all P<0.001). Multivariate logistic regression analysis revealed that age (every 10 years increase, OR=2.51, 95% CI 1.77-3.56, P<0.001), hypertension ( OR=5.88, 95% CI 1.57-22.10, P=0.009), and diabetes ( OR=4.66, 95% CI 2.10-10.35, P<0.001) were independently correlated with CAC; Age (every 10 years increase, OR=6.43, 95% CI 3.64-11.36, P<0.001) and hypertension ( OR=6.09, 95% CI 1.33-27.84, P=0.020) were independently correlated with TAC; Female ( OR=0.23, 95% CI 0.07-0.72, P=0.011), age (every 10 years increase, OR=3.90, 95% CI 2.42-6.29, P<0.001), diabetes ( OR=5.37, 95% CI 2.19-13.19, P<0.001) and serum magnesium ( OR=0.01,95% CI 0-0.35, P=0.014) were independently correlated with AAC. Moreover, age and diabetes were independently correlated with carotid artery calcification, AVC and overall VC Conclusions:The prevalence of VC in non-dialysis CKD patients of stage 3-5 is 63.59%, of which CAC reaches 37.9%, TAC is the most common one (43.7%), while AVC is the least one (9.7%). Age and diabetes are the independent associated factors for VC of all sites except TAC, while hypertension is an independent associated factor for both CAC and TAC.
5.Summary of best evidence for fertility management in cervical cancer patients of childbearing age
Fei SHEN ; Weilian CONG ; Chunlan WANG ; Qunying FANG ; Dingding YAN
Chinese Journal of Modern Nursing 2024;30(4):446-452
Objective:To retrieve, evaluate, and summarize the evidence on fertility management for cervical cancer patients of childbearing age, providing a basis for clinical medical and nursing staff to carry out fertility management for cervical cancer patients.Methods:The evidence on fertility in cervical cancer patients included clinical decision-making, guidelines, summary of evidence, expert consensus, and systematic review, which were systematically searched on domestic and international evidence-based medicine databases, clinical decision-making systems, guideline websites, professional association websites, medical literature service websites, and databases such as UpToDate, Cochrane Library, British Medical Journal (BMJ) Best Practice, China Guidelines Network, China National Knowledge Infrastructure, WanFang Med Online, China Biology Medicine disc, and VIP. The search period was from database establishment to March 1, 2023. Two researchers who received evidence-based nursing knowledge training independently conducted literature screening and quality evaluation, and jointly discussed with clinical experts on the literature that met the requirements to complete evidence extraction and summary.Results:A total of 11 articles were included, including three clinical decision-making, four guidelines, three expert consensus, and one systematic review. A total of 30 pieces of best evidence were summarized from six aspects, including fertility assessment and safety, fertility preservation methods, fertility preservation surgery and anti-tumor treatment, fertility timing, pregnancy management and follow-up, and special treatment for pregnancy with cervical cancer.Conclusions:The evidence on fertility management for cervical cancer patients of childbearing age provides a basis for clinical medical and nursing staff to provide fertility guidance for cervical cancer patients. In clinical application, factors such as patient willingness and condition should be fully considered, and personalized treatment plans should be provided to maximize patient benefits.
6.Characteristics of whole blood donors from 26 blood stations before and after the outbreak of COVID-19:a multicenter study
Peng LI ; Youhua SHEN ; Wei GAO ; Wei ZHANG ; Jianling ZHONG ; Hao LI ; Lin BAO ; Ying WANG ; Xuefang FENG ; Tao SUN ; Xiaoqin CHEN ; Li LI ; Hongzhi JIA ; Shouguang XU ; Xiaobo CAI ; Wen ZHANG ; Qunying LAI ; Zhiqiang YU ; Zhenxing WANG ; Yanjun ZHOU ; Peng WANG ; Yanhua ZHANG ; Guoqiang ZHANG ; Haiying NIU ; Hongli JING
Chinese Journal of Blood Transfusion 2023;36(10):907-912
【Objective】 To analyze the basic characteristics of whole blood donors from blood stations before and after the outbreak of COVID-19. 【Methods】 After excluding invalid data, data related to the basic characteristics of whole blood donors collected from 26 blood stations in China during 2018 to 2021 were statistically analyzed, including the trend of total whole blood donors, the number of repeated blood donors, the frequency of blood donation, the average age of donors and the recruitment of first-time blood donors. 【Results】 Affected by the epidemic, 8 out of 14 indicators were with large variations, accounting for 57%. The overall growth rate of total whole blood donors during the epidemic was higher than before the epidemic (P<0.05).The number of repeated blood donors has shown an increased trend, with a higher number during the epidemic than before (P<0.05). The frequency of blood donation was lower during the epidemic than before(P<0.05).Average ages of blood donors and female blood donors fluctuated widely during the epidemic, both higher than those before the epidemic(P<0.05).The donation rate of first-time blood donors <25 years old and ≥25 years old varied widely and irregularly during the epidemic (both P<0.05). The percentage of first-time blood donors fluctuated irregularly during the epidemic, with overall percentage lower than that before the epidemic(P<0.05). 【Conclusion】 Whole blood donors from 26 blood stations increased after the outbreak of COVID-19, and some indicators in certain areas showed significant fluctuations during the epidemic.
7.The role and mechanism of transforming growth factor β1 and matrix metalloproteinase-2 in pancreatic tissue repair and reconstruction in rats with acute pancreatitis
Wenzhu DONG ; Dong LI ; Qi ZHAO ; Zhen LI ; Haitao YU ; Qunying WANG
Chinese Journal of Pancreatology 2023;23(5):353-359
Objective:To investigate the role of transforming growth factor β1 (TGF-β1) and matrix metalloproteinase (MMP)-2 in pancreatic tissue repair and reconstruction in rats with acute pancreatitis and its potential mechanism.Methods:114 male SD rats were randomly divided into normal control group (CON group) and acute edematous pancreatitis model group (AEP group), acute necrotic pancreatitis model group (ANP group), ANP control group and ANP intervention group. The rat AEP model was constructed by subcutaneous injection of caerulein, and the rat ANP model was prepared by intraperitoneal injection of L-arginine. The ANP intervention group and ANP control group were prepared by intraperitoneal injection of TGF-β1 inhibitor SB431542 or DMSO 30 min before, 24 h and 48 h after pancreatitis induction, respectively. Hydroxyproline content in pancreatic tissue was determined by hydroxyproline kit. The expression of TGF-β1, phosphorylated Smad3 (p-Smad3), type Ⅲ collagen and MMP-2 in pancreatic tissue was detected by immunohistochemical method. The activity of MMP-2 was determined by gelatin enzyme spectrometry. The expression levels of MMP-2 and p-Smad3 proteins in pancreatic tissue were detected by Western blot.Results:The hydroxyproline content in CON group was (61.71±8.56)μg/mg protein. The hydroxyproline content in AEP group reached the peak (116.72±8.53)μg/mg on the 3rd day. The peak value of hydroxyproline content in ANP group was (174.93±11.75)μg/mg on day 5. The peak value in ANP group was significantly higher than that in AEP group, and the peak value of hydroxyproline content in AEP group was significantly higher than that in CON group. The hydroxyproline content at day 3, 5 and 7 in the ANP intervention group was (108.07±10.48)μg/mg, (137.14±8.66)μg/mg and (112.35±13.16)μg/mg, respectively, and that at day 3, 5 and 7 in the ANP control group was (132.35±14.2)μg/mg, (175.43±13.75)μg/mg and (137.92±12.65)μg/mg, respectively. TGF-β1 immunohistochemical peak score in control group, AEP group and ANP group was (0.12±0.03), (1.96±0.21) and (3.00±0.28), respectively. p-Smad3 immunohistochemical peak score was (0.15±0.05), (2.05±0.20), and (3.05±0.24), while type Ⅲ collagen immunohistochemical peak score was (0.11±0.04), (1.56±0.15), and (3.10±0.17). MMP-2 immunohistochemical peak score was (0.05±0.03), (1.45±0.20), and (2.45±0.15), respectively. The immunohistochemical peak scores of TGF-β1, p-Smad3, type Ⅲ collagen and MMP-2 in ANP group were significantly higher than those in AEP group. The immunohistochemical peak scores of TGF-β1, p-Smad3, type Ⅲ collagen and MMP-2 in pancreatic tissue of ANP intervention group and ANP control group were (2.36±0.21), (2.25±0.22), (2.47±0.19), (2.00±0.10) and (3.02±0.21), (3.01±0.19), (3.05±0.24), (2.43±0.11), respectively, which in ANP intervention group was significantly lower than those in the ANP control group. The peak value of MMP-2 activity in pancreatic tissue of CON group, AEP group and ANP group was (10.85±1.73), (85.78±7.16) and (115.43±8.7), respectively, which in ANP group was significantly higher than that in AEP group, and in AEP group was significantly higher than that in CON group. In ANP intervention group and ANP control group 3 and 5 days after molding, the expression levels of MMP-2 protein in pancreas were 0.20±0.01, 1.19±0.02, 0.52±0.01, 1.54±0.05, respectively; p-Smad3 protein expression levels were 0.30±0.04, 0.66±0.11, 1.95±0.05, 1.30±0.01, respectively; and MMP-2 and p-Smad3 in ANP intervention group was significantly lower than those the ANP control group. All the differences among the groups above were statistically significant (all P value <0.001). Conclusions:TGF-β1 and MMP-2 play an important role in tissue remodeling and extracellular matrix deposition after acute pancreatitis inflammation.
8.Practice and exploration of monitoring index for the construction of national regional medical centers of Beijing Children′s Hospital
Qunying GUO ; Yameng NIU ; Xiaoyu WANG ; Yafang DENG ; Xin NI
Chinese Journal of Hospital Administration 2023;39(10):717-722
Under the leadership and high-level promotion of the central and local governments, the construction of national regional medical centers(NRMCs) in China has achieved initial results, and has received recognition and high attention from all sectors of society. The current focus of NRMCs construction has progressed from the project selection to the evaluation of construction effectiveness and the establishment of corresponding operating mechanisms. On the basis of analyzing the characteristics of NRMCs construction and reviewing the evaluation of NRMCs construction at the national level, this paper systematically introduced the monitoring index system and its application of NRMCs construction in Beijing Children′s Hospital, and put forward corresponding policy suggestions. The monitoring of the construction indexes of NRMCs could provide a basis and support for hospitals to identify problems in time, seek government support, and carry out target management, and has reference for promoting the effective construction of NRMCs.
9.Prevention of vasovagal response by applied muscle tension at different time points during blood donation
Yuesheng LIAO ; Xiuhua ZHANG ; Shan WEN ; Yanting WANG ; Qunying LAI ; Yan ZHONG ; Jun XIE ; Xiaohua WANG
Chinese Journal of Blood Transfusion 2022;35(9):985-988
【Objective】 To explore the role and value of applied muscle tension (AMT) in preventing vasovagal nerve reaction (VVR) in blood donors. 【Methods】 A total of 2 992 people, susceptible to suffer VVR from May 2020 to may 2022, were randomly divided into control group (1406 cases) and observation group (1 586 cases). The control group was not given AMT intervention, while the observation group received AMT intervention at different periods during blood donation. The changes of systolic blood pressure, diastolic blood pressure, heart rate and psychological state of anxiety (self-rating anxiety scale, SAS) of blood donors were monitored in the two groups at each period to compare the occurrence of VVR. 【Results】 There were no statistically significant differences in blood pressure and heart rate between the two groups before blood donation (P>0.05). The parameters were relatively stable in observation group during and after donation, but significantly different from that of the controls(P>0.05). SAS score was similar in two groups before blood donation(P>0.05), while decreased in observation group during and after donation in comparison with the controls(P<0.05). The incidence of VVR in the observation group was 3.09%, which was significantly lower than that in the control group (7.97%)(P<0.05). The incidence of VVR was 2.18% after AMT exercise during blood donation. 【Conclusion】 AMT intervention in different periods of blood donation can significantly reduce the occurrence of VVR.
10.Epidemical characteristics of human brucellosis in Inner Mongolia Autonomous Region from 2018 to 2020
Litao SONG ; Mengguang FAN ; Na TA ; Wenqiang ZHANG ; Ruiping YU ; Qunying WANG ; Xiaoyan SI ; Guohui BAI
Chinese Journal of Endemiology 2022;41(1):62-65
Objective:To investigate the epidemic characteristics of human brucellosis in Inner Mongolia Autonomous Region from 2018 to 2020, and provide a reliable scientific basis for formulating brucellosis prevention and control strategies in Inner Mongolia Autonomous Region.Methods:A retrospective study was carried out to collect data of human brucellosis in Inner Mongolia Autonomous Region from 2018 to 2020 from the "China Disease Control and Prevention Information System", and the monitoring data and information of confirmed cases were collected from the annual summary data reported by the leagues (cities) of the Inner Mongolia Autonomous Region. Using descriptive epidemiological methods, the epidemic situation, three distributions (time, region and population distributions) of brucellosis, and the serological and pathogenic test results of active monitoring population were analyzed.Results:From 2018 to 2020, a total of 40 665 cases of brucellosis were reported in Inner Mongolia Autonomous Region, with an annual average incidence rate of 53.47/100 000. The number of annual incidence had increased from 10 111 in 2018 to 16 406 in 2020, and the annual incidence rate had increased from 39.99/100 000 in 2018 to 64.60/100 000 in 2020. The spring and summer was the peak incidence, mainly in March to August, accounting for 64.90% (26 390/40 665) . There were reports of brucellosis cases in 12 leagues (cities) of Inner Mongolia Autonomous Region, and the top 3 regions with the number of reported cases were Tongliao City (9 896 cases), Xing'an League (6 136 cases) and Chifeng City (4 934 cases). The age of onset of brucellosis cases was mainly 30 - < 65 years old(33 539 cases), and the sex ratio between men and women was 2.18 ∶ 1.00 (27 890 ∶ 12 775); the occupational distribution was mainly farmers, accounting for 79.23% (32 221/40 665). From 2018 to 2020, 704 085 people were actively monitored in the region, of which 391 941 were serologically tested, and the infection rate was 4.57% (17 920/391 941); and there were 9 539 new cases in the active monitoring population. In 3 years, 19 strains of Brucella sheep type 3 and 11 strains of Brucella sheep type 1 were isolated. Conclusions:From 2018 to 2020, the incidence rate of brucellosis in Inner Mongolia Autonomous Region is increasing year by year. There are many new cases in the active monitoring population, and more underreporting cases. It is recommended to expand the scope of monitoring, strengthen pathogen monitoring among humans and animals, and joint prevention and control of various departments to improve the self-protection awareness of the masses.

Result Analysis
Print
Save
E-mail