1.Study on the screening value of platelet parameters for MYH9-related disorders
Xiaojuan LUO ; Ke CAO ; Tao HUANG ; Xiaoning MAO ; Yan ZHANG ; Shiyang CHEN ; Meizhu LUO ; Changgang LI ; Xiaoying FU ; Yunsheng CHEN
Chinese Journal of Laboratory Medicine 2025;48(8):1028-1033
Objective:To explore the screening value of platelet parameters from blood cell analysis for MYH9-related disorders(MYH9-RD).Methods:A cross-sectional study was conducted with 38 patients diagnosed with MYH9-RD at Shenzhen Children's Hospital from May 1, 2016, to August 31, 2024, including 24 males and 14 females; the median age was 11.5 (3.8, 35) years; categorized by gene mutation location into "head region" ( n=8 ) and "tail region" ( n=30); and by clinical manifestations into " isolated hematological manifestations" ( n=16) and "hematological manifestations with extra-hematological involvement"( n=22). The control groups included 39 cases of immune thrombocytopenia (ITP), 38 cases of acute lymphoblastic leukemia (ALL), and 40 healthy individuals. Platelet-related parameters were detected by hematology analyzer, and platelet counts and sizes were confirmed by manually counting and microscopic observation. Kruskal-Wallis test was used to compare platelet parameters between MYH9-RD and control groups. Receiver operating characteristic (ROC) curves were used to assess the diagnostic efficacy of platelet parameters for MYH9-RD. Results:In MYH9-RD patients the median value of mean platelet volume (MPV) was 13.4 (11.2, 14.7) fl, immature platelet fraction (IPF) was 52.7% (43.5%, 58.0%), platelet large cell ratio(PLCR) was 57.6 %(45.0%, 62.9%), and microscopic large platelet ratio (PLCR-M) was 30.0% (25.0%, 30.0%).And those values weresignificantly higher than in ITP, ALL, and healthy controls (all P<0.05). Patients with MYH9 gene "head region" mutations had a lower platelet count [24.5 (15.0, 47.5)×10 9/L]than those with "tail region" mutations [69.0 (49.5, 86.3) ×10 9/L]( Z=-3.493, P<0.001), but a higher IPF ( t=2.024, P=0.044).Patients with "extra-hematological involvement had a lower platelet count than those with "isolated hematological manifestations" ( t=-2.015, P=0.043). The optimal cutoff value for diagnosing MYH9-RD with IPF was 26.7%, with a sensitivity of 100% and specificity of 98.7%; the area under the curve was 0.999 (95% CI 0.995-1.000), which was superior toMPV, PLCR and PLCR-M parameters. Conclusion:IPF is superior to other platelet parameters sush as MPV,showing high diagnostic efficacy in distinguishing MYH9-RD from ITP and ALL. It can be used as a simple and effective indicator for early screening of MYH9-RD.
2.A preliminary study on the application of one-stage clotting assay in Emicizumab laboratory testing
Dong PENG ; Ying WANG ; Liping LUO ; Meizhu LUO ; Qiuyue DUAN ; Guichi ZHOU ; Xiaoying FU
Chinese Journal of Laboratory Medicine 2025;48(11):1432-1438
Objective:To establish a modified one-stage clotting assay (mOSA) based on the STA-R Evolution coagulation analyzer for quantifying emicizumab (EMI) concentration and to preliminarily evaluate its analytical performance; meanwhile to explore the clinical utility of the standard one-stage clotting assay (sOSA) in indirectly predicting EMI levels through surrogate factor Ⅷ (FⅧ) activity.Methods:A total of 30 pediatric patients with hemophilia A (HA) treated with EMI in the Hemophilia Treatment Center of Shenzhen Children′s Hospital from January 2023 to March 2025 were enrolled, and 48 post-treatment plasma samples were collected. EMI standards (2.5~100 μg/ml) were prepared using FⅧ-deficient plasma to establish the mOSA detection system. The linearity, accuracy, and precision of the method were evaluated. Surrogate FⅧ activity was measured by sOSA to estimate EMI concentrations, and its correlation with mOSA-derived EMI concentrations was analyzed using Spearman correlation analysis. The equivalent FⅧ activity in patient plasma samples was measured using a human chromogenic substrate assay-based FⅧ activity detection reagent, and Spearman correlation analysis was employed to evaluate its correlations with both the EMI concentrations measured by the mOSA method and estimated by the sOSA method respectively.Results:The established mOSA method for EMI detection showed excellent linearity in the range of 2.5?100 μg/ml ( Y=1.047 X?1.033, R 2=0.995, P<0.001). Average spike recovery rates at 25, 50, and 75 μg/ml were 101.55%(25.39/25.00), 105.31%(52.66/50.00), and 98.20%(73.65/75.00), respectively. Coefficients of variations of within-and inter-batch were 3.47%?4.80% and 6.30%?8.96%, respectively. A prediction model for EMI concentration was established as follows: estimated EMI concentration (μg/ml)=0.095×[alternative FⅧ activity (%) measured by sOSA]+2.652 ( R2=0.999, P<0.001). Validation demonstrated a strong correlation between the EMI concentration measured by the mOSA method and the EMI concentration estimated by the sOSA method ( r=0.989, P<0.001), with good consistency ( Y=1.014 X+0.684, R2=0.972, P<0.001). Both the EMI concentration measured by the mOSA method and the EMI concentration estimated by the sOSA method showed extremely strong correlations with the equivalent FⅧ activity ( r=0.986 and 0.987, respectively; P<0.001 for both). Conclusions:The mOSA system established on the STA-R Evolution analyzer demonstrates robust linearity, accuracy, and reproducibility, fulfilling clinical requirements for therapeutic drug monitoring of EMI. The sOSA method provides reliable indirect estimation of EMI concentrations through surrogate FⅧ activity, offering critical support for emergency decision-making.
3.Study on the screening value of platelet parameters for MYH9-related disorders
Xiaojuan LUO ; Ke CAO ; Tao HUANG ; Xiaoning MAO ; Yan ZHANG ; Shiyang CHEN ; Meizhu LUO ; Changgang LI ; Xiaoying FU ; Yunsheng CHEN
Chinese Journal of Laboratory Medicine 2025;48(8):1028-1033
Objective:To explore the screening value of platelet parameters from blood cell analysis for MYH9-related disorders(MYH9-RD).Methods:A cross-sectional study was conducted with 38 patients diagnosed with MYH9-RD at Shenzhen Children's Hospital from May 1, 2016, to August 31, 2024, including 24 males and 14 females; the median age was 11.5 (3.8, 35) years; categorized by gene mutation location into "head region" ( n=8 ) and "tail region" ( n=30); and by clinical manifestations into " isolated hematological manifestations" ( n=16) and "hematological manifestations with extra-hematological involvement"( n=22). The control groups included 39 cases of immune thrombocytopenia (ITP), 38 cases of acute lymphoblastic leukemia (ALL), and 40 healthy individuals. Platelet-related parameters were detected by hematology analyzer, and platelet counts and sizes were confirmed by manually counting and microscopic observation. Kruskal-Wallis test was used to compare platelet parameters between MYH9-RD and control groups. Receiver operating characteristic (ROC) curves were used to assess the diagnostic efficacy of platelet parameters for MYH9-RD. Results:In MYH9-RD patients the median value of mean platelet volume (MPV) was 13.4 (11.2, 14.7) fl, immature platelet fraction (IPF) was 52.7% (43.5%, 58.0%), platelet large cell ratio(PLCR) was 57.6 %(45.0%, 62.9%), and microscopic large platelet ratio (PLCR-M) was 30.0% (25.0%, 30.0%).And those values weresignificantly higher than in ITP, ALL, and healthy controls (all P<0.05). Patients with MYH9 gene "head region" mutations had a lower platelet count [24.5 (15.0, 47.5)×10 9/L]than those with "tail region" mutations [69.0 (49.5, 86.3) ×10 9/L]( Z=-3.493, P<0.001), but a higher IPF ( t=2.024, P=0.044).Patients with "extra-hematological involvement had a lower platelet count than those with "isolated hematological manifestations" ( t=-2.015, P=0.043). The optimal cutoff value for diagnosing MYH9-RD with IPF was 26.7%, with a sensitivity of 100% and specificity of 98.7%; the area under the curve was 0.999 (95% CI 0.995-1.000), which was superior toMPV, PLCR and PLCR-M parameters. Conclusion:IPF is superior to other platelet parameters sush as MPV,showing high diagnostic efficacy in distinguishing MYH9-RD from ITP and ALL. It can be used as a simple and effective indicator for early screening of MYH9-RD.
4.A preliminary study on the application of one-stage clotting assay in Emicizumab laboratory testing
Dong PENG ; Ying WANG ; Liping LUO ; Meizhu LUO ; Qiuyue DUAN ; Guichi ZHOU ; Xiaoying FU
Chinese Journal of Laboratory Medicine 2025;48(11):1432-1438
Objective:To establish a modified one-stage clotting assay (mOSA) based on the STA-R Evolution coagulation analyzer for quantifying emicizumab (EMI) concentration and to preliminarily evaluate its analytical performance; meanwhile to explore the clinical utility of the standard one-stage clotting assay (sOSA) in indirectly predicting EMI levels through surrogate factor Ⅷ (FⅧ) activity.Methods:A total of 30 pediatric patients with hemophilia A (HA) treated with EMI in the Hemophilia Treatment Center of Shenzhen Children′s Hospital from January 2023 to March 2025 were enrolled, and 48 post-treatment plasma samples were collected. EMI standards (2.5~100 μg/ml) were prepared using FⅧ-deficient plasma to establish the mOSA detection system. The linearity, accuracy, and precision of the method were evaluated. Surrogate FⅧ activity was measured by sOSA to estimate EMI concentrations, and its correlation with mOSA-derived EMI concentrations was analyzed using Spearman correlation analysis. The equivalent FⅧ activity in patient plasma samples was measured using a human chromogenic substrate assay-based FⅧ activity detection reagent, and Spearman correlation analysis was employed to evaluate its correlations with both the EMI concentrations measured by the mOSA method and estimated by the sOSA method respectively.Results:The established mOSA method for EMI detection showed excellent linearity in the range of 2.5?100 μg/ml ( Y=1.047 X?1.033, R 2=0.995, P<0.001). Average spike recovery rates at 25, 50, and 75 μg/ml were 101.55%(25.39/25.00), 105.31%(52.66/50.00), and 98.20%(73.65/75.00), respectively. Coefficients of variations of within-and inter-batch were 3.47%?4.80% and 6.30%?8.96%, respectively. A prediction model for EMI concentration was established as follows: estimated EMI concentration (μg/ml)=0.095×[alternative FⅧ activity (%) measured by sOSA]+2.652 ( R2=0.999, P<0.001). Validation demonstrated a strong correlation between the EMI concentration measured by the mOSA method and the EMI concentration estimated by the sOSA method ( r=0.989, P<0.001), with good consistency ( Y=1.014 X+0.684, R2=0.972, P<0.001). Both the EMI concentration measured by the mOSA method and the EMI concentration estimated by the sOSA method showed extremely strong correlations with the equivalent FⅧ activity ( r=0.986 and 0.987, respectively; P<0.001 for both). Conclusions:The mOSA system established on the STA-R Evolution analyzer demonstrates robust linearity, accuracy, and reproducibility, fulfilling clinical requirements for therapeutic drug monitoring of EMI. The sOSA method provides reliable indirect estimation of EMI concentrations through surrogate FⅧ activity, offering critical support for emergency decision-making.
5.Construction of an"Internet+Traditional Chinese Medicine nursing"service capability evaluation index system based on the three-dimensional quality structure model
Yanjiao HU ; Yan LI ; Shimiao LUO ; Tao ZOU ; Meizhu DING
Chinese Journal of Nursing 2024;59(15):1818-1823
Objective To construct an evaluation index system of"Internet+Traditional Chinese Medicine nursing"service capability,in order to provide references for the standardized and effective evaluation of"Internet+Traditional Chinese Medicine nursing"service capability.Methods Literature analysis and semi-structured interview method were adopted,and three-dimensional quality structure model was used as the theoretical framework to initially construct the"Internet+Traditional Chinese Medicine nursing"service capability evaluation index item pool.From July to 0ctober 2022,the Delphi method was used to conduct 2 rounds of consultation with 16 experts from Guangdong Province,to evaluate the enthusiasm,authority,degree of opinion concentration and degree of opinion coordination of the experts in the correspondence consultation,and the weight of the index system was determined with the combination of chromatography analysis.Results 2 rounds of expert letter consultation were conducted.The questionnaire recovery rates were 100%,and the authority coefficients were 0.844 and 0.834,respectively.Kendall coordination coefficients were 0.161 and 0.110,respectively(P<0.001).The first level indexes of the index system are structure evaluation,process evaluation and outcome evaluation.There were 3 first-level evaluation indicators,14 second-level evaluation indicators and 57 third-level evaluation indicators.Conclusion The evaluation index is scientific and practical,and it is carried out around the Internet+Traditional Chinese Medicine nursing capability,which provides a certain reference for the effective evaluation of the service capability of"Internet+Traditional Chinese Medicine nursing".
6.Action research on optimizing nurse training of "Internet+ TCM nursing" based on CIPP and Kirkpatrick Model
Guixing LIANG ; Meizhu DING ; Lina LUO ; Juan LIU ; Tao ZOU ; Jing ZHU ; Chujun HUANG
Chinese Journal of Medical Education Research 2021;20(8):971-976
Objective:To explore whether the action research on the pre-service training evaluation system of "Internet + TCM Nursing" guided by CIPP (context, input, process and product) and Kirkpatrick Model can improve the training effect of nursing staff under the background of internet and TCM nursing service.Methods:Taking 211 nurses of "Internet + TCM Nursing" in Guangdong Provincial Hospital of TCM from 2019 to 2020 as the research objects, action teams were made, and the data were collected and analyzed by various methods. According to the collected data, the action teams constructed the training scheme of "Internet + TCM Nursing", the compilation requirements of "internet + TCM Nursing", the case optimization scheme of "internet + TCM Nursing" process, and the evaluation model of "internet + TCM Nursing". After the training, the nurses' knowledge, skills and related attitudes, the general reaction and feelings to the training programs, and the evaluation of nurses' work performance by the competent leaders, medical staff and clients were compared by comparing their scores and issuing self-made questionnaires. SPSS 20.0 software was used for statistical analysis.Results:The results showed that the theoretical scores of nurses after training were (85.16±6.22) points, and the case assessment scores after training [(81.22±7.03) points] were higher than the previous theoretical scores [(61.23±12.90) points] and the case assessment scores [(59.54±14.41) points], with statistical significance ( P<0.001). The results of self-made questionnaire showed that there were significant differences in theoretical knowledge, skills and related attitudes among nurses after training ( P<0.001). In the process of training, there were statistically significant differences in training content, teacher training, training implementation and training guarantee at the end of training ( P<0.001). After training, there were significant differences in the evaluation of nurses' job performance by leaders in charge, medical staff and clients improved in knowledge and skills, professional ethics, working process and learning ability, and the improvement rate ( P<0.001). Conclusion:Action research is an effective research method to continuously improve nursing training. The optimization scheme of "internet + TCM Nursing" nurses based on CIPP and Kirkpatrick Model through action research can effectively improve the training effect.
7.Effects of reinfusion of the remaining blood filtered by leukocyte depletion filter on postoperative cellar immune function after cardiopulmonary bypass
Lin LUO ; Dan WANG ; Meizhu CHEN ; Meixia LI
Chinese Critical Care Medicine 2019;31(8):989-993
To evaluate effects of reinfusion of the remaining blood filtered by leukocyte depletion filter on postoperative cellular immune function after cardiopulmonary bypass (CPB). Methods Forty patients who underwent selective cardiac valve replacement surgery with CPB in department of anesthesiology of Haikou Municipal Hospital from January to June in 2018 were enrolled. All the patients were divided into the control group and experimental group according to the random number table method, with 20 patients in each group. In the experimental group, patients received residual pump blood transfusion which had been filtered by leukocyte depletion filter and stored in sterile blood collection bags. In the control group, patients received residual pump blood transfusion which was stored in sterile blood collection bags without being filtered. The remaining blood was reinfused after CPB in two groups. Blood samples were taken before CPB (T1), 2 hours following CPB (T2), and 1, 3, 5 days after reinfusion of the remaining blood (T3, T4, T5), the levels of T lymphocyte subsets CD3+, CD4+, CD8+ and natural killer cells (NK cells) were detected by flow cytometer, and CD4+/CD8+ ratio was calculated. The levels of plasma tumor necrosis factor-α (TNF-α), interleukins (IL-2, IL-6, IL-8) were measured by enzyme linked immunosorbent essay (ELISA). The duration of mechanical ventilation, the length of intensive care unit (ICU) stay, the length of hospital stay, and incidence of wound and pulmonary infection after surgery were compared between two groups. Results Among 40 patients, there were 22 males and 18 females; with an age of (47.88±12.29) years old; and with 25 cases of American Society of Anesthesiologists (ASA) physical status Ⅱ, and 15 cases of ASAⅢ. There was no statistical difference in the volume of the remaining blood between the two groups (mL: 959.00±116.84 vs. 971.50±115.68, P > 0.05). Compared with T1, the levels of T lymphocyte subsets CD3+, CD4+, CD8+, NK cells and plasma levels of IL-2 were significantly decreased from T2, the CD4+/CD8+ ratio was significantly decreased from T3 in two groups, but there was no statistical difference in CD3+, CD4+, CD8+, NK cells, CD4+/CD8+ ratio or plasma level of IL-2 at each time between the two groups. Compared with T1, the plasma levels of TNF-α, IL-6 and IL-8 were significantly increased at T2 in two groups and then decreased gradually. The plasma levels of TNF-α, IL-6 and IL-8 from T3 in experimental group were lower than those in control group [TNF-α (ng/L): 28.49±4.66 vs. 33.82±4.30, IL-6 (ng/L): 25.98±4.51 vs. 31.38±5.42, IL-8 (ng/L):38.98±4.67 vs. 45.76±5.33, all P < 0.05], they restored to the level of T1 at T5. In addition, compared with control group, the duration of mechanical ventilation, the length of ICU stay in experimental group were significantly decreased (hours: 8.07±1.30 vs. 9.16±1.52, 28.22±2.78 vs. 31.25±3.18, both P < 0.05), and there was no statistical difference in the length of hospital stay (days: 20.65±2.76 vs. 22.45±3.22), incidence of wound and pulmonary infection (25.0% vs. 15.0%, 5.0% vs. 15.0%) between the two groups (all P > 0.05). Conclusion Reinfusion of the remaining blood filtered by leukocyte depletion filtercan inhibit inflammatory responses and don't affect the function of cellular immunity, and don't increase the incidence of infection.
8.Lung protection of residual pump blood processed by microaggregate blood filter-reinfusion in patients undergoing cardiac surgery under cardiopulmonary bypass
Lin LUO ; Meizhu CHEN ; Dan WANG ; Meixia LI
Chinese Journal of Anesthesiology 2019;39(2):143-146
Objective To evaluate the lung protection of residual pump blood processed by microaggregate blood filter-reinfusion in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB).Methods A total of 40 patients,aged 28-55 yr,weighing 46-66 kg,of American Society of Anesthesiologists physical status Ⅱ or Ⅲ,with New York Heart Association of Ⅱ or Ⅲ,with left ventricular ejection fraction>50%,scheduled for elective cardiac valve replacement under general anesthesia,were divided into 2 groups (n =20 each) using a random number table method:residual pump blood reinfusion group (group C) and residual pump blood processed by microaggregate blood filter-reinfusion group (group M).Residual pump blood was collected immediately after the end of CPB.The residual pump blood was stored in sterile blood collection bags without being filtered in group C.The residual pump blood was stored in sterile blood collection bags after being processed by microaggregte blood filter in group M.Residual pump blood was intravenously reinfused after the CPB pipe was removed.At 10 min before CPB (T1),immediately after the end ofCPB (T2),immediately after processing (T3) and at 12 and 24 h after residual pump blood reinfusion (T4,5),blood samples were collected to measure blood components and serum tumor necrosis factor-alpha and intedeukin-6 concentrations (by enzyme-linked immunosorbent assay).Airway plateau pressure was recorded,arterial blood samples were collected for blood gas analysis,and static lung compliance,oxygenation index and respiratory index were calculated at T1.5.The postoperative mechanical ventilation time,duration of intensive care unit stay,length of hospital stay,and incidence of hypoxemia and pulmonary infection were recorded.Results Compared with group C,white blood cell count was significantly decreased at T3-5,and static lung compliance and oxygenation index were increased,respiratory index was decreased,serum tumor necrosis factor-alpha and interleukin-6 concentrations were decreased,postoperative mechanical ventilation time and duration of intensive care unit stay were shortened,and the incidence of hypoxemia was decreased at T4.5 in group M (P<0.05).Conclusion Residual pump blood proccessed by microaggregate blood filter-reinfusion can reduce systemic inflammatory responses and exerts lung protection to some extent in the patients undergoing cardiac surgery under CPB.
9.Application of meticulous management in safety construction of intravenous infusion
Yanmei DENG ; Meizhu DING ; Qihua HUANG ; Lijuan LUO ; Jingyue FAN ; Dansi MO ; Caimei KUANG ; Qiuting ZHANG
Chinese Journal of Medical Education Research 2018;17(7):718-722
For the safety problems of internal medicine intravenous infusion,we carry out meticulous management,establish quality control system of intravenous infusion safety management,and formulate quality control plan.We collect and analyse the potential unsafety factors in the various departments of internal medicine.We have revised the intravenous infusion system and procedures,formulated standards for safety inspection of intravenous fluids,and standardized the admission system for nurses.We carry out training on intravenous infusion related knowledge for nursing staff,carry out meticulous management of venous transfusion links,and actively carry out learning and communication.All these measures have greatly enhanced the safety awareness of the nursing staff.The safety index of intravenous infusion for liver diseases was preliminarily summarized.The use rate of the safe indwelling needle was increased from 30.60% to 92.30%,the rate of appropriate rate of drop speed increased from 68.45% to 93.20%,the three sign standard rate rose from 75.20% to 95.10%,and the patient's satisfaction with infusion increased from 85.60% to 96.82%.Meticulous management can improve the safety of the internal medicine intravenous infusion as a whole.
10.Clinical application of Cystatin C-based eGFR equations in the estimation of glomerular filtration rate in elderly type 2 diabetic patients
Yajie ZHAO ; Yongju ZHAO ; Linhui SHEN ; Wei WANG ; Binyu LUO ; Jie MIAO ; Meizhu YAN ; Danying YANG
Chinese Journal of Geriatrics 2010;29(8):662-666
Objective To explore the most suitable equation in accessing renal function for the elderly type 2 diabetic patients, and its clinical utility in combination with hypersensitive C-reactive protein (hsCRP). Methods The new Cystatin C-based equations for estimated glomerular filtration rate (Cys-eGFR) and conventional predictive equations were compared with isotopic GFR (iGFR) by linear regression analysis, paired t-test, Bland and Altman procedures and non-parametric receiver operating characteristic (ROC) curves. The new Cys-eGFR equation and hsCRP were also incorporated for detecting renal disease in this population. Results The new Cys-eGFR equation had a better relativity with iGFR (r= 0.767, P<0.001), a less bias (bias: 0.0007, P>0.05), a higher conformance (2SD: 21.56), higher sensitivity (90.7%) and specificity (88.6%) for diagnosing moderate decrease in renal function. There was a negative relationship between the new Cys-eGFR and hsCRP (r=-0.655, P<0.01). When the new Cys-eGFR was 67.06 ml· min-1 ·1.73 m-2 and hsCRP was 5.65 mg/L, the combination of Cys-eGFR and hsCRP was better than the combination of serum creatinine and urine albumin/creatinine ratio in screening stage 3 chronic kidney disease (95%vs.46%). Conclusions The combination of new Cys-eGFR equation and hsCRP may screen an early decrease of moderate GFR.

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