1.Investigation of Component Difference of Astragali Radix Before and After Rice Stir-frying by UPLC-Q-TOF-MS/MS Combined with Chemometrics
Miaoshi YAO ; Yimeng ZHAO ; Zekun WANG ; Minglu LI ; Chenxi LIU ; Chen CHEN ; Yajun CHEN ; Yachun SHU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):189-197
ObjectiveA qualitative analysis method was established for the composition of Astragali Radix(AR) before and after rice stir-frying. On the basis of systematic characterization of the chemical compositions in AR and stir-fried AR with rice(ARR), the structures of their major compounds were deduced and identified, and the differential compositions between them were analyzed. MethodsUltra performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS/MS) was used to detect the samples of AR and ARR in positive and negative ion modes, respectively. The compounds were analyzed and identified through self-constructed databases, literature, and reference standards, etc. And the data were analyzed by chemometrics, in order to screen for the differential components between AR and ARR. ResultsA total of 123 compounds were identified in AR and ARR, including 41 flavonoids, 19 terpenoids, 26 organic acids, 8 amino acids, 5 nucleotides, 5 carbohydrates and 19 other compounds. Among them, there were 95 common components in both, 18 unique components in AR, and 10 unique components in ARR. Principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) results both showed that there were significant differences in the chemical constituents of AR before and after rice stir-frying, and a total of 26 constituents with differences in the content were screened out, including L-canavanine, L-pyroglutamic acid, L-phenylalanine, cis-caffeic acid, and malonylastragaloside Ⅰ. Among them, 19 constituents of ARR were down-regulated and 7 constituents were up-regulated by comparing with AR. ConclusionThis study clarifies that the chemical composition of AR and ARR is mainly composed of flavonoids, terpenoids, and organic acids, and analyzes the components with significant differences in content between the two in combination with chemometrics, and the differential components are dominated by amino acids, organic acids and terpenoids, which can provide reference for the subsequent quality control and material basis research.
2.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
3.Anti-inflammatory and osteogenic effects of chitosan/sodium glycerophosphate/sodium alginate/leonurine hydrogel
Zengbo ZHAO ; Chenxi LI ; Chenlei DOU ; Na MA ; Guanjun ZHOU
Chinese Journal of Tissue Engineering Research 2025;29(4):678-685
BACKGROUND:Leonurine has many biological activities such as improving microcirculation,anti-oxidation,anti-apoptosis,scavenging free radicals,anti-inflammation,and anti-fibrosis,and can promote osteogenic differentiation of bone marrow mesenchymal stem cells,which has the potential to be applied in the treatment of periodontitis. OBJECTIVE:To explore the anti-inflammatory and osteogenic effects of leonurine loading into chitosan/sodium glycerophosphate/sodium alginate hydrogel. METHODS:(1)Chitosan/sodium glycerophosphate/sodium alginate hydrogel(blank hydrogel)and chitosan/sodium glycerophosphate/sodium alginate/leonurus alkali hydrogel were prepared respectively.RAW 264.7 and MC3T3-E1 cells were inoculated with the two kinds of hydrogel.The cytotoxicity of hydrogels was detected by CCK-8 assay and live/dead cell staining.(2)RAW 264.7 cells were cultured in five groups.The blank group was cultured for 24 hours routinely.The lipopolysaccharide group was treated with lipopolysaccharide.The simple hydrogel group was treated with lipopolysaccharide and blank hydrogel.The drug-loaded hydrogel group was treated with lipopolysaccharide and drug-loaded hydrogel.The inhibitor group was treated with lippolysaccharide,drug-loaded hydrogel,and PI3K inhibitor LY294002.24 hours later,mRNA expression of inflammation-related factors was detected by qRT-PCR.Western blot assay was utilized to detect the protein expression of inflammation-related factors and PI3K/AKT signaling pathway.(3)MC3T3-E1 cells were inoculated in four groups.The blank group was cultured without any material.The simple hydrogel group was treated with blank hydrogel.The drug-loaded hydrogel group was treated with drug-loaded hydrogel.The inhibitor group was treated with drug-loaded hydrogel and PI3K inhibitor LY294002 for 7 days.Alkaline phosphatase staining was performed.mRNA expression levels of osteogenic factors were detected by qRT-PCR.The protein expression levels of the PI3K/AKT signaling pathway were detected by western blot assay. RESULTS AND CONCLUSION:(1)The results of CCK-8 assay and live/dead cell staining showed that the two kinds of hydrogels had no cytotoxic effect and had good cytocompatibility.(2)Compared with the blank group,the mRNA and protein expression levels of interleukin 6,tumor necrosis factor α,and interleukin 1β were significantly increased(P<0.05),and the protein expression levels of p-AKT,p-PI3K,p-p65,and p-IκBα were significantly increased in the lipopolysaccharide group(P<0.05).Compared with lipopolysaccharide group,mRNA and protein expression levels of the above indexes were decreased in drug-loaded hydrogel group(P<0.05).Compared with the drug-loaded hydrogel group,the mRNA and protein expression levels of the above indexes were decreased in the inhibitor group(P<0.05).(3)The activity of alkaline phosphatase in drug-loaded hydrogel group was higher than that in the blank group,simple hydrogel group,and inhibitor group(P<0.05).Compared with blank group,the mRNA expression levels of alkaline phosphatase,Runx2,osteocalcin,and type I collagen were increased(P<0.05),and the protein expression levels of p-AKT and p-PI3K were increased in the simple hydrogel group(P<0.05).Compared with the simple hydrogel group,the mRNA and protein expression levels of the above indexes were increased in the drug-loaded hydrogel group(P<0.05).Compared with the drug-loaded hydrogel group,the mRNA and protein expression levels of the above indexes were decreased in the inhibitor group(P<0.05).(4)These findings conclude that chitosan/sodium glycerophosphate/sodium alginate/leonurine hydrogel has anti-inflammatory and osteogenic effects,which may be related to the regulation of PI3K/AKT signaling pathway.
4.Advances in the Application of Zebrafish in the Research of Inflammatory Bowel Disease Mechanisms and Drug Development
Xin ZHAO ; Chenxi WANG ; Wenqing SHI ; Yuefen LOU
Laboratory Animal and Comparative Medicine 2025;45(4):422-431
Inflammatory bowel disease (IBD) is a chronic, relapsing intestinal disorder driven by multiple factors including genetics, immunity, and environment, and is clinically classified into ulcerative colitis and Crohn's disease. Currently, mice and zebrafish are the primary experimental animals used in IBD research, among which zebrafish have emerged as an ideal model due to their unique advantages. Compared with rodent models, zebrafish serve as an effective and convenient model, offering advantages such as a short life cycle, robust reproductive capacity, small size, and transparent embryos. These characteristics make zebrafish highly suitable for dynamic tracking of continuous pathological progression and high-throughput drug screening. Zebrafish share over 70% genetic homology with humans, and their intestinal cellular composition and ontogeny closely resemble those of humans. Moreover, the structure and characteristics of their gut microbiota are similar to the human intestinal microbiome, providing a solid foundation for studying the relationship between gut microbiota and IBD. With advances in biotechnology, zebrafish IBD models generated by chemical induction or genetic engineering can accurately simulate the core pathological features of human IBD, such as intestinal wall thickening, inflammatory cell infiltration, and elevated expression of pro-inflammatory factors. These models have played a significant role in revealing the pathogenesis of IBD as well as the development of targeted therapeutic drugs. This article first outlines the intestinal characteristics of zebrafish and features of zebrafish IBD models, then provides an in-depth analysis of their application in IBD pathogenesis research from multiple aspects, including genetics, immunity, environment and diet, and infection. It also reviews research progress on the application of zebrafish in the development of anti-inflammatory drugs, probiotics, and traditional Chinese medicine therapies, aiming to provide researchers with references for the rational use of zebrafish models at all stages of preclinical research, to advance fundamental IBD research and accelerate breakthroughs in this field.
5.The outcome of down-regulation+hormone replacement cycle endometrial preparation regimen in frozen-thawed embryo transfer in advanced age women
Xiaoyan WANG ; Chenxi YANG ; Yan ZHAO ; Yanni A
Chongqing Medicine 2024;53(2):251-256
Objective To analyze the effects of down-regulation+hormone replacement therapy(HRT)endometrial preparation regimen on the pregnancy outcomes of advanced age women(≥35 years old)undergoing frozen-thawed embryo transfer.Methods The clinical data of 329 patients with frozen-thawed em-bryo transfer in this hospital from June 2020 to June 2022 were analyzed retrospectively.Among them,149 pa-tients receiving gonadotropin-releasing hormone analogue(GnRHa)down-regulation+HRT endometrial preparation were included in the group A,and the other 180 patients with HRT endometrial preparation were included in the group B.The basic situation,endometrial transformation day situation and clinical outcome were compared between the two groups.The group A and group B were further divided into the two sub-groups according to age:group A1(35-<40 years old,n=101),group A2(≥40 years old,n=48),group B1(35-<40 years old,n=99)and group B2(≥40 years old,n=81).The effects of two endometrial prepara-tion regimens were compared among the different age groups.Results There were no significant differences in the age,infertility years,BMI,anti-Mullerian hormone level,as well as basal hormones levels such as estra-diol,progesterone,follicle-stimulating hormone,luteinizing hormone(LH),prolactin and testosterone between the two groups(P>0.05).The levels of estradiol and LH on the endometrial transformation day in the group A were significantly lower than those in the group B(P<0.05),the endometrial thickness,proportion of the patients with endometrial thickness ≥8 mm and proportion of the patients with type Ⅲ blood intima in the group A were significantly higher than those in the group B(P<0.05).There was no significant difference in the number of transplanted embryos and the number of transplanted excellent embryos between the two groups(P>0.05).The clinical pregnancy rate and embryo implantation rate in the group A were significantly higher than those in the group B(46.31%vs.35.56%;33.33%vs.25.18%,P<0.05),and there was no significant difference in the early miscarriage rate between the two groups(P>0.05).The further subgroup analysis showed that the clinical pregnancy rate and embryoimplantation rate in the group A2 were significant-ly higher than those in the group B2(35.42%vs.18.52%;21.43%vs.12.40%,P<0.05),while there was no significant difference between the group A1 and group B1(P>0.05).Conclusion The advanced age pa-tients undergoing frozen-thawed embryo transfer could select GnRHa down-regulation+HRT regimen to a-chieve better pregnancy outcomes,especially for those age ≥40 years old.
6.Exploring Scientific Connotation of "Fried Charcoal Survivability" of Lonicerae Japonicae Flos Based on Color-composition Correlation
Ting ZOU ; Jing WANG ; Xu WU ; Kai YANG ; Ming DANG ; Xiuchu GUO ; Lin WANG ; Chenxi LUO ; Juan PEI ; Chongbo ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):175-182
ObjectiveTo explore the scientific connotation of fried charcoal survivability of Lonicerae Japonicae Flos(LJF) by analyzing the correlation between the color change and the intrinsic components during the processing of LJF Carbonisata(LJFC), and taking pH, charcoal adsorption and microscopic characteristics as indexes. MethodLJFC samples with different degrees of processing were prepared according to the stir-frying time of 0.0, 1.5, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 min(numbered S1-S8), and the contents of gallic acid, chlorogenic acid, cryptochlorogenic acid, rutin, luteoloside, isochlorogenic acid A and isochlorogenic acid C were determined by high performance liquid chromatography(HPLC), and the L*(brightness), a*(red-greenness) and b*(yellow-blueness) of LJFC samples with different degrees of processing were determined by spectrophotometer, and the correlation analysis and principal component analysis(PCA) between the contents of seven representative components and the color of the samples were carried out by SPSS 26. 0 and SIMCA-P 14.1. Then pH, adsorption force and characteristic structure of different samples of LJFC were detected and the processing pattern of LJFC was analyzed. ResultThe results of quantitative analysis revealed that the contents of luteoloside, rutin, chlorogenic acid and isochlorogenic acid A gradually decreased, and the contents of cryptochlorogenic acid, isochlorogenic acid C and gallic acid firstly increased and then decreased. The L* and b* of the sample powders decreased, and a* showed a trend of increasing and then decreasing. The L* and b* were positively correlated with the contents of chlorogenic acid, rutin, luteoloside, isochlorogenic acid A, b* was positively correlated with the content of gallic acid, and a* was positively correlated with the contents of cryptochlorogenic acid and isochlorogenic acid C. PCA revealed that samples could be clearly divided into 3 groups, S1-S2 as one group, S3-S5 as one group, and S6-S8 as one group, with S3 having the highest score. The results of regression analysis showed that only isochlorogenic acid C could be used to predict the contents of components by colorimetric values combined with regression equations. Physicochemical analysis showed that pH of LJFC increased with the increase of degree of charcoal stir-frying, while adsorption force showed a tendency of increasing and then decreasing, with the highest adsorption force in the S5 sample, and the non-glandular hairs, calcium oxalate clusters and pollen grains had a varying degree of decreasing with the deepening of processing degree, and the microstructures of S6-S8 samples were obviously charred with pollen grains almost invisible. ConclusionThe changes in chemical composition and color characteristics of LJFC during the processing have certain correlations, combined with the changes in physicochemical properties, S5 sample is found to be the optimal processed products, which can provide a reference for the processing standardization and quality evaluation of LJFC, and enrich the scientific connotation of fried charcoal survivability of LJF.
7.TCM practitioners’ attitudes and perceptions regarding the use of Ephedra sinica Stapf: An observational study
Aiwen Chang ; Xiaopeng Zhao ; Lin Zhang ; Sijia Zhao ; Zhongyi Pan ; Chenxi Song ; Yanling Fu
Journal of Traditional Chinese Medical Sciences 2024;11(4):435-442
Objective:
To understand the attitudes and perceptions of traditional Chinese medicine (TCM) practitioners in Beijing TCM hospitals regarding the use of Ephedra sinica Stapf (E. sinica, Ma Huang).
Methods:
A two-stage cross-sectional study was conducted using a questionnaire survey of TCM practitioners in Beijing TCM hospitals between April 2023 and March 2024. The questionnaire included demographic information, the clinical background of TCM practitioners, and the clinical application of E. sinica. Logistic regression analysis was used to analyze the relevant influencing factors when using E. sinica.
Results:
Of the 465 questionnaires collected, 441 were valid. Among these, 84.81% (374/441) reported having used E. sinica in clinical practice at least once. The commonly used doses of E. sinica—excluding the pediatric department—were 10 g for high doses, 6 g for medium, and 3 g for low. The three most frequently used formulas for E. sinica included Maxing Shigan decoction, Mahuang decoction, and Xiao Qing Long decoction. The most common TCM patterns treated with a high dose of E. sinica were wind-cold exterior pattern, wind-cold invading the lung, and wind and water combat with meridians congealed by cold. The top three Western medical diagnoses when using E. sinica for treatment were common cold, pneumonia, and upper respiratory tract infections. Nearly half of the respondents reported experiencing adverse reactions from the oral administration of E. sinica, with the most common being palpitations, insomnia, and restlessness. Starting with a low dose and gradually increasing it as appropriate was identified as an effective approach.
Conclusion
This study investigated the attitudes and perceptions of TCM practitioners in Beijing TCM hospitals regarding the dose–efficacy–adverse reaction relationship of E. sinica, providing a reference for the safe and effective clinical use of E. sinica.
8.Optimizing outdoor smoking points outside large exhibition halls based on real-time on-site PM2.5 and CO2 monitoring
Jin SUN ; Chenxi YAN ; Zhuohui ZHAO ; Chenchen XIE ; Zhengyang GONG ; Hao TANG ; Kunlei LE ; Yuzhi CHENG ; Zhuyan YIN ; Jingyi YUAN ; De CHEN ; Yunfei CAI
Journal of Environmental and Occupational Medicine 2024;41(6):673-680
Background Improper settings of outdoor smoking points in public places may increase the risk of secondhand smoke exposure among the population. Conducting research on air pollution in and around smoking spots and related influencing factors can provide valuable insights for optimizing the setting of outdoor smoking points. Objective To investigate the influence of the number of smokers at outdoor smoking points and the distance on the diffusion characteristics of surrounding air pollutants, in order to optimize the setting of outdoor smoking points. Methods Surrounding the exhibition halls in the China International Import Expo (CIIE), two outdoor smoking points were randomly selected, one on the first floor (ground level) and the other on the second floor (16 m above ground), respectively. At 0, 3, 6, and 9 m from the smoking points in the same direction, validated portable air pollutant monitors were used to measure the real-time fine particulate matter (PM2.5) and carbon dioxide (CO2) concentrations for consecutive 5 d during the exhibition, as well as the environmental meteorological factors at 0 m with weather meters including wind speed, wind direction, and air pressure. An open outdoor atmospheric background sampling point was selected on each of the two floors to carry out parallel sampling. Simultaneously, the number of smokers at each smoking point were double recorded per minute. The relationships between the number of smokers, distance from the smoking points, and ambient PM2.5 and CO2 concentrations were evaluated by generalized additive regression models for time-series data after adjustment of confounders such as temperature, relative humidity, and wind speed. Results The median numbers of smokers at smoking points on the first and second floors were 6 [interquartile range (IQR): 3, 9] and 9 (IQR: 6, 13), respectively. Windless (wind speed <0.6 m·s−1) occupied most of the time (85.9%) at both locations. The average concentration of ambient PM2.5 at the smoking points (0 m) [mean ± standard deviation, (106±114) μg·m−3] was 4.2 times higher than that of the atmospheric background [(25±7) μg·m−3], the PM2.5 concentration showed a gradient decline with the increase of distance from the smoking points, and the average PM2.5 concentration at 9 m points [(35±22) μg·m−3] was close to the background level (1.4 times higher). The maximum concentration of CO2 [(628±23) μmol·mol−1] was observed at 0 m, and its average value was 1.3 times higher than that of the atmospheric background [(481±40) μmol·mol−1], and there was no gradient decrease in CO2 concentration with increasing distance at 0, 3, 6, and 9 m points. The regression analyses showed that, taking smoking point as the reference, every 3 m increase in distance was associated with a decrease of ambient PM2.5 by 24.6 [95% confidence interval (95%CI): 23.5, 25.8] μg·m−3 (23.2%) and CO2 by 54.1 (95%CI: 53.1, 55.1) μmol·mol−1 (8.6%). Every one extra smoker at the smoking point was associated with an average increase of PM2.5 and CO2 by 2.0 (95%CI: 1.7, 2.8) μg·m−3 and 1.0 (95%CI: 0.7,1.2) μmol·mol−1, respectively. The sensitivity analysis indicated that, under windless conditions, the concentrations of PM2.5 and CO2 at the smoking points were even higher but the decreasing and dispersion characteristics remained consistent. Conclusion Outdoor smoking points could significantly increase the PM2.5 concentrations in the surrounding air and the risks of secondhand smoke exposure, despite of the noticeable decreasing trend with increasing distance. Considering the inevitable poor dispersion conditions such as windless and light wind, outdoor smoking points are recommended to be set at least 9 m or farther away from non-smoking areas.
9.Application of quality monitoring indicators of blood testing in blood banks of Shandong province
Xuemei LI ; Weiwei ZHAI ; Zhongsi YANG ; Shuhong ZHAO ; Yuqing WU ; Qun LIU ; Zhe SONG ; Zhiquan RONG ; Shuli SUN ; Xiaojuan FAN ; Wei ZHANG ; Jinyu HAN ; Lin ZHU ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):258-266
【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
10.Application of quality control indicator system in blood banks of Shandong
Qun LIU ; Yuqing WU ; Xuemei LI ; Zhongsi YANG ; Zhe SONG ; Zhiquan RONG ; Shuhong ZHAO ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xuejing LI ; Bo ZHOU ; Chenxi YANG ; Haiyan HUANG ; Guangcai LIU ; Kai CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):267-274
【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.


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