1.Quality analysis of Pinghuo tea standard decoction
Xinmei ZHAO ; Hongyang SANG ; Chunjing YANG ; Jingwei LEI ; Haiyan GONG ; Caixia XIE ; Chunya ZHANG ; Haohan DUAN ; Hao YU
China Pharmacy 2025;36(1):71-78
OBJECTIVE To establish the fingerprint of Pinghuo tea standard decoction and a method for determination of multi-component to clarify the transfer relationship of quantities and quality from pieces and standard decoction. METHODS Fifteen batches of Pinghuo tea standard decoction were prepared and the extract rate was determined; the fingerprint of the preparation was established by using high-performance liquid chromatography(HPLC); the similarity evaluation and the determination of common peaks were performed, and chemometric analysis was performed; the same method was used to determine the content of indicator components and the transfer rate was calculated. The chromatographic column was Venusil C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (gradient elution); the column temperature was 30 ℃, and the detection wavelengths were 238 nm (0-37 min, 85-102 min) and 330 nm (37-85 min) at a flow rate of 1.0 mL/min with an injection volume of 10 μL. RESULTS The similarity of HPLC fingerprints for 15 batches of Pinghuo tea standard decoction was not lower than 0.968. A total of 24 common peaks were calibrated and 9 peaks were recognized, which were as follows neochlorogenic acid (peak 3), chlorogenic acid (peak 6), geniposide (peak 9), glycyrrhizin (peak 10), galuteolin (peak 11), isochlorogenic acid A (peak 14), luteolin (peak 21), kaempferol (peak 23) and glycyrrhizic acid (peak 24). Cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis showed consistent results, all of which could classify the 15 batches of samples into three categories. The linear range of indicator components in 15 batches of Pinghuo tea standard decoction, such as geniposide, luteolin, isochlorogenic acid A, glycyrrhizin, and glycyrrhizic acid, were 0.020 580-0.411 600, 0.001 617-0.080 850, 0.006 076-0.607 600, 0.005 125-0.071 740, and 0.017 288-0.432 200 mg/mL, respectively; RSDs of precision, repeatability, stability and recovery rate tests were all not higher than 4% (n=6). The mass fractions ranged 3.227 9-10.002 2, 0.297 4-0.554 6, 3.350 1-6.159 6, 0.720 6-1.073 3, 2.003 1-3.030 1 mg/g; transfer rates from the pieces and standard decoction were 19.762 8%-35.840 5%, 12.123 3%-21.254 0%, 46.097 2%-82.869 4%, 58.708 8%-91.629 6%, 39.114 3%-63.710 6%. The transfer rates of the extract from 15 batches of Pinghuo tea standard decoction ranged from 61.15%-84.68%. CONCLUSIONS Established HPLC fingerprint and content determination methods in this study are simple and accurate, which can provide reference for the quantitative value transfer study, quality control, clinical application and the development of subsequent formulations of Pinghuo tea standard decoction.
2.Discussion on the Application of Warm-Yang Method in Polycystic Ovary Syndrome Infertility
Pengxuan YAN ; Haiyan ZHANG ; Yukun ZHAO ; Yabei GAO ; Kun LI ; Jingchun ZHANG ; Yuping ZHAO ; Zixiao WEI
Journal of Traditional Chinese Medicine 2025;66(3):312-316
It is believed that there is a pathogenesis of yang deficiency in polycystic ovary syndrome (PCOS) infertility, and it is concluded that warm-yang method has a better effect in improving endometrial abnormality, enhancing the quality of follicles, correcting endocrine disorders, and resolving or alleviating clinical symptoms in PCOS infertility. Based on Yanghe Decoction (阳和汤), a representative traditional Chinese medicine decoction for warming yang, Yanghe Xiaonang Decoction (阳和消囊汤) was formulated, combining with warm medicinals according to symptoms, and aerobic exercise was also advocated to help generate and develop yang qi, in order to provide ideas for clinical treatments.
3.Clinical Study on the Treatment of 70 Cases Chronic Atrophic Gastritis with Intestinal Metaplasia Using Xianglian Huazhuo Granules (香连化浊颗粒):A Randomized,Double-Blind,Placebo-Controlled Trial
Ziyu LI ; Maopeng ZHANG ; Wen ZHAO ; Wei LI ; Shiyun SHENG ; Haiyan BAI ; Qian YANG
Journal of Traditional Chinese Medicine 2025;66(5):473-479
ObjectiveTo observe the clinical efficacy and possible mechanisms of Xianglian Huazhuo Granules (香连化浊颗粒, XHG) in the treatment of chronic atrophic gastritis with intestinal metaplasia. MethodsA total of 140 patients with chronic atrophic gastritis and intestinal metaplasia were randomly divided into a treatment group and a control group, with 70 cases in each group. The treatment group received 12.5 g of XHG orally, twice daily. The control group received 12.5 g of placebo orally, twice daily. Both groups were treated for 6 months. The traditional Chinese medicine (TCM) symptom scores, pathological types, serum tumor markers of the digestive system, and serum bile acids (TBA), interleukin-23 (IL-23), and Dickkopf-related protein 1 (DKK-1) levels were observed before and after treatment. Safety indicators and adverse events were recorded. After treatment, TCM syndrome efficacy and pathological types were evaluated, and patients were followed up for 18 months with gastric endoscopy and pathological results, which were compared with the results after treatment finished. ResultsTwo patients dropped out in the control group, and a total of 168 cases were included in the final analysis, 70 in the treatment group and 68 in the control group. The treatment group showed a significant reduction in TCM symptom scores, serum TBA, IL-23, and DKK-1 levels, and a significant increase in alpha-fetoprotein (AFP), carbohydrate antigen 125 (CA125), carbohydrate antigen 199 (CA199) levels; in the control group, carcinoembryonic antigen (CEA), CA125, CA199 levels significantly increased (P<0.05 or P<0.01); and carbohydrate antigen 242 (CA242) level in both the treatment group and the control group decreased significantly (P<0.01). The treatment group had lower TCM symptom scores and lower levels of serum TBA, IL-23, and DKK-1 compared to the control group (P<0.05). The effective rate for TCM syndrome efficacy in the treatment group was 80.00% (56/70), significantly higher than the 20.59% (14/68) in the control group (P < 0.05). The effective rate for pathological classification in the treatment group was 72.73% (8/11) for mixed intestinal metaplasia, significantly better than 46.15% (6/13) in the control group (P<0.05). No adverse events were reported in either group. Among 40 patients who had a follow-up endoscopy after one year, 21 were from the treatment group, of whom 11 showed reduced intestinal metaplasia, 9 showed no significant changes, and 1 had worsened; while 19 patients in the control group had 4 with reduced intestinal metaplasia, 13 with no significant changes, and 2 with worsened conditions. No cancer was detected in either group. The treatment group showed significantly better improvement in intestinal metaplasia on follow-up gastric endoscopy pathology than the control group (P<0.05). ConclusionXHG can significantly improve the clinical symptoms in patients with chronic atrophic gastritis and intestinal metaplasia and reduce the degree of mixed intestinal metaplasia. The mechanism may involve lowering serum TBA, DKK-1, and IL-23 levles, thus delaying the progression from inflammation to cancer.
4.Research progress on the influencing factors of psychological distress in patients with coronary heart disease
Xiaotian DUAN ; Hongshi CAO ; Taiyu BI ; Haiyan WANG ; Songyu WANG ; Quantong ZHAO ; Ran WANG ; Chunjing WU
Sichuan Mental Health 2025;38(1):89-96
Coronary heart disease is a chronic and lifelong disease, which places a dual burden on the physiological and psychological well-being of patients, and can easily lead to psychological distress and affect their prognosis and quality of life. This article provides a systematic review, in which the current status, evaluation tools, influencing factors and intervention methods of psychological distress in patients with coronary heart disease are explored, aiming to provide key information beneficial for identifying and preventing psychological distress, and to improve the overall management and treatment effectiveness of coronary heart disease patients. In this paper, 18 articles were included, and the demographic, physiological, psychological and social factors affecting the psychological distress of patients with coronary heart disease were systematically analyzed, thus to provide a deeper understanding of psychological distress and offering references for formulating targeted intervention strategies.
5.Establishment and stress analysis of a finite element model for adolescent cervical disc herniation
Yuxin ZHAO ; Liang LIANG ; Feng JIN ; Yangyang XU ; Zhijie KANG ; Yuan FANG ; Yujie HE ; Xing WANG ; Haiyan WANG ; Xiaohe LI
Chinese Journal of Tissue Engineering Research 2025;29(3):448-454
BACKGROUND:Cervical disc herniation can cause pain in the neck and shoulder area,as well as radiating pain in the upper limbs.The incidence rate is increasing year by year and tends to affect younger individuals.Fully understanding the biomechanical characteristics of the cervical spine in adolescents is of great significance for preventing and delaying the onset of cervical disc herniation in this age group. OBJECTIVE:To reconstruct cervical spine models for both healthy adolescents and adolescent patients with cervical disc herniation utilizing finite element analysis techniques,to analyze the motion range of the C1-T1 cervical vertebrae as well as the biomechanical characteristics of the annulus fibrosus,nucleus pulposus,endplates,and the cartilage of the small joints. METHODS:A normal adolescent's cervical spine and an adolescent patient with cervical disc herniation were selected in this study.The continuous scan cervical spine CT raw image data were imported into Mimics 21.0 in DICOM format.The C1-T1 vertebrae were reconstructed separately.Subsequently,the established models were imported into the 3-Matic software for disc reconstruction.The perfected models were then imported into Hypermesh software for meshing of the vertebrae,nucleus pulposus,annulus fibrosus,and ligaments,creating valid geometric models.After assigning material properties,the final models were imported into ABAQUS software to observe the joint motion range of the C1-C7 cervical vertebrae segments under different conditions,and to analyze the biomechanical characteristics of the annulus fibrosus,nucleus pulposus,endplates,and small joint cartilage of each cervical spine segment. RESULTS AND CONCLUSION:(1)In six different conditions,the joint motion range of the C1 vertebra in the cervical spine models of both normal adolescent and adolescent patient with cervical disc herniation was higher than that of the other vertebrae.Additionally,the joint motion range of each cervical spine segment in normal adolescent was greater than that in adolescent patient with cervical disc herniation.(2)In the cervical spine model of normal adolescent,the maximum stress values in the annulus fibrosus and nucleus pulposus were found on the left side during C2-3 flexion conditions(0.43 MPa and 0.17 MPa,respectively).In the cervical spine model of adolescent patient with cervical disc herniation,the maximum stress values were found on the left side during C7-T1 flexion conditions(0.54 MPa and 0.18 MPa,respectively).(3)In the cervical spine model of normal adolescent,the maximum stress value on the endplate was found on the left side of the upper endplate of C3 during flexion conditions(1.46 MPa).In the model of adolescent patient with cervical disc herniation,the maximum stress value on the endplate was found on the left side of the lower endplate of C7 during flexion conditions(1.32 MPa).(4)In the cervical spine model of normal adolescent,the maximum stress value in the small joint cartilage was found in the C2-3 left rotation conditions(0.98 MPa).In adolescent patient with cervical disc herniation,the stress in the small joint cartilage significantly increased under different conditions,especially in C1-2,with the maximum stress found during left flexion(3.50 MPa).(5)It is concluded that compared to normal adolescent,adolescent patient with cervical disc herniation exhibits altered cervical curvature and a decrease in overall joint motion range in the cervical spine.In adolescent with cervical disc herniation,there is a significant increase in stress on the annulus fibrosus,nucleus pulposus,and endplates in the C7-T1 segment.The stress on the left articular cartilage of the C1-2 is notable.Abnormal cervical curvature may be the primary factor causing these stress changes.
6.Association of habitual reading and writing postures with common diseases and comorbidities among children and adolescents in Ningxia
WEI Rong, LUO Haiyan, MA Ning, ZHAO Yu, YANG Yi, CHEN Yaogeng
Chinese Journal of School Health 2025;46(5):723-727
Objective:
To investigate the association between habitual reading/writing postures and the co-occurrence of common health conditions (overweight/obesity, visual impairment, hypertension, and scoliosis) and comorbidities among children and adolescents, in order to provide data support for the joint prevention of common diseases and comorbidities among children and adolescents.
Methods:
From September 2021 to June 2022, a multi-stage cluster random sampling method was used to select a total of 4 577 children and adolescents from 16 primary and secondary schools in Ningxia: Jinfeng District of Yinchuan City, Shapotou District of Zhongwei City, Yanchi County of Wuzhong City, and Pingluo County of Shizuishan City. A weighted complex sampling design was used to investigate the association of habitual reading and writing postures with common comorbidities in children and adolescents.
Results:
The prevalence rates of common diseases among children and adolescents in Ningxia were as follows: overweight/obesity was 22.87%, visual impairment was 62.52%, scoliosis was 2.30%, and hypertension was 1.30%. The prevalence of multimorbidity (co-occurrence of ≥2 conditions) among Ningxia children and adolescents was 15.95%. Multivariate unconditional Logistic regression analysis showed that frequent/always collapsing waist and sitting forward with head lowered increased the risk of common comorbidities in children and adolescents ( OR =1.90, P <0.05). Compared with the corresponding reference group, male children and adolescents aged 9 to 12 years and boys had relatively lower risks of overweight/obesity ( OR =0.71, 0.70); the risk of poor vision among children and adolescents aged 9 to 12 years, male, and urban was relatively low ( OR =0.59, 0.60, 0.73)( P < 0.05 ). Children and adolescents who often/always sat leaning to the left or right were at higher risk of poor vision ( OR =1.78); urban children and adolescents had a higher risk of developing scoliosis ( OR =3.71); children and adolescents aged 9 to 12 had a relatively low risk of developing hypertension ( OR =0.09), and children and adolescents who often/always bent their backs and sat forward on their knees had a higher risk of hypertension ( OR =5.03)( P <0.05).
Conclusions
Ningxia has a high incidence of common diseases and multiple diseases among children and adolescents, frequent or always collapsing waist and sitting forward with head lowered is associated with common comorbidities in children and adolescents in Ningxia. Proper postural measures for reading and writing should be carried out as soon as possible to encourage children and adolescents to develop good reading and writing habits for effectively preventing and controlling the occurrence of common diseases.
7.Correlation between the serum levels of aminotransferases and liver inflammation activity in pediatric chronic hepatitis B patients: An analysis of 1 267 cases
Dan ZHAO ; Lina JIANG ; Shuhong LIU ; Haiyan WEI ; Chunmei BAO ; Jingmin ZHAO
Journal of Clinical Hepatology 2025;41(6):1062-1067
ObjectiveTo investigate the correlation of the serum levels of aminotransferases and their ratios with liver inflammation activity in pediatric chronic hepatitis B (pCHB) patients, and to provide a basis for selecting the dominant population for treatment. MethodsThis study was conducted among 1 267 pCHB patients who were admitted to The Fifth Medical Center of Chinese PLA General Hospital from January 2010 to August 2022 and these patients did not receive antiviral therapy. The patients were analyzed in terms of demographic features, blood routine, blood biochemistry, HBV serological markers, and liver biopsy data. According to liver inflammation activity based on liver biopsy, the patients were divided into no or mild inflammation activity (G0 — G1) group and significant inflammation activity (G2 — G4) group. The serum levels of aminotransferases and their ratios were compared between groups, and their correlation with liver inflammation activity in pCHB patients was analyzed. Additionally, the patients were stratified by the age, and the relationship between serum aminotransferase levels and liver inflammation activity was analyzed in each age group. For comparison of continuous data between two groups, the independent samples t-test was used when the data were normally distributed, while the Mann-Whitney U test was used when the data were not normally distributed; the chi-square test was employed for comparison of categorical data between two groups. A Spearman’s correlation analysis was performed for correlation assessment. ResultsAmong the 1 267 pCHB patients, there were 468 (36.9%) in the G0 — G1 group and 799 (63.1%) in the G2 — G4 group, and there were significant differences between the two groups in the levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), AST/ALT ratio, gamma-glutamyl transpeptidase (GGT), total bilirubin, direct bilirubin, HBeAg quantification, low-density lipoprotein, and platelet count (PLT) (all P<0.05). The correlation analysis showed that liver inflammation activity was negatively correlated with PLT and low-density lipoprotein (both P<0.05) and was positively correlated with GGT, total bilirubin, direct bilirubin, and HBeAg titer (all P<0.05), while it was not significantly correlated with ALT, AST, and AST/ALT ratio (all P>0.05). In the 0 — 12 years group, the 13 — 18 years male group, and the 13 — 18 years female group, liver inflammation activity aggravated with the increases in the serum levels of ALT and AST, and there were significant differences between groups (all P<0.05). In the 0 — 12 years group, there was a significant difference in significant liver inflammation activity between the AST/ALT ratio >1 group and the AST/ALT ratio ≤1 group (P<0.001). Among the 1 267 patients, 447 (35.28%) had an ALT level of <2×upper limit of normal (ULN), among whom 196 (43.85%) had G≥2 liver inflammation, accounting for 15.47% of all children enrolled. ConclusionLiver inflammation activity is not significantly correlated with ALT, AST, and AST/ALT ratio in pCHB patients, suggesting that the serum levels of aminotransferases cannot truly reflect liver inflammation activity in pCHB patients with an aminotransferase level of <2×ULN. In clinical practice, liver biopsy should be performed for children with an aminotransferase level of <2×ULN to clarify whether antiviral therapy should be performed.
8.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.
9.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.
10.Quality monitoring indicator system in blood banks of Shandong: applied in blood donation services, component preparation and blood supply process
Yuqing WU ; Hong ZHOU ; Zhijie ZHANG ; Zhiquan RONG ; Xuemei LI ; Zhe SONG ; Shuhong ZHAO ; Zhongsi YANG ; Qun LIU ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):275-282
【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of 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. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.


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