1.Efficacy Analysis of RCT of Arsenic-containing TCM Compound in Treatment of Myelodysplastic Syndrome Based on MMRM and Win Ratio
Daxiang SUN ; Peizhen JIANG ; Haixia DI ; Bing WU ; Qifeng LIU ; Jian LIU ; Jiahe LIANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):251-259
ObjectiveThis paper aims to conduct a secondary analysis of a randomized controlled trial on the treatment of myelodysplastic syndrome (MDS) with deficiency of both the spleen and kidney and blockage of toxin and blood stasis with an arsenic-containing traditional Chinese medicine compound, by applying the mixed model for repeated measure (MMRM) and the method of stratified composite outcome with win ratio. The analysis includes the assessment of hematological efficacy and the composite outcome evaluation of adverse reactions, so as to more comprehensively assess the therapy of this regimen. MethodsThe MMRM and win ratio methods were used to evaluate the efficacy of a prospective,multi-center,double-blind,randomized controlled study. The blood routine (hemoglobin concentration,neutrophil count, and platelet count) and biochemical indexes (aspartate aminotransferase,alanine aminotransferase,serum creatinine,and serum ferritin) of the patients were detected at the time of enrollment and at the end of each course of treatment in the laboratory department of Xiyuan Hospital. The patients' syndromes at the time of enrollment and after treatment were recorded and scored according to the therapy standard of traditional Chinese medicine for diseases and syndromes. MMRM was used to analyze the blood routine indexes of the experimental group and the control group. This method has the advantages of high data reliability and dynamic efficacy under intervention and time. The win ratio method was used to evaluate the composite outcome of traditional Chinese medicine syndrome scores and biochemical indexes according to the priority and to verify the clinical safety of arsenic-containing traditional Chinese medicine compound. ResultsThe results of MMRM analysis showed that the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly compared with that before treatment in the group,while that in the placebo group decreased significantly (P<0.01). When compared with that after treatment in the placebo group,the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly,and the mean difference of least squares (LS) was statistically significant (P<0.01). When compared with those before treatment in the group,there were no statistically significant differences in the neutrophil count and platelet count in both groups. After treatment,there were no statistically significant differences in the neutrophil count, platelet count, and the mean difference of LS between the two groups. The analysis results of win ratio showed that the group with arsenic-containing traditional Chinese medicine compound had a significant advantage in the comparison of composite outcomes,with a win ratio (95% CI) of 2.01 (1.24-3.27) (P<0.01),and that the possibility of "winning" in terms of safety was 2.01 times that of the placebo group. The safety advantage of the group with arsenic-containing traditional Chinese medicine compound mainly came from the traditional Chinese medicine syndrome scores,renal function indexes, and iron reserve capacity indexes,and the number of winning times was less than that of losing times in the comparison of liver function outcomes. ConclusionThe MMRM analysis proves that the arsenic-containing traditional Chinese medicine compound can significantly improve the hemoglobin concentration of patients with myelodysplastic syndrome with refractory cytopenia and multilineage dysplasia (MDS-RCMD) of the type of deficiency of both the spleen and kidney and blockage of toxin and blood stasis. This conclusion is not interfered with by time trends and individual relationships and methodologically improves the credibility of the therapy of the arsenic-containing traditional Chinese medicine compound in treating MDS. Four outcomes are evaluated by the win ratio method,namely traditional Chinese medicine syndromes,liver function,renal function, and iron reserve capacity,proving that the arsenic-containing traditional Chinese medicine compound has the comprehensive advantages of improving the survival quality of the patients and reducing adverse reactions. The win ratio outcome provides clear comparative indexes for the evaluation of adverse reactions,making it easier for regulatory authorities,medical staff, and patients to understand the safety of the arsenic-containing traditional Chinese medicine compound in clinical application.
2.Quality assessment of blood components prepared by an automatic whole blood processing system
Liu HE ; Xin JI ; Yuwei HU ; Ling FANG ; Haixia XU
Chinese Journal of Blood Transfusion 2026;39(3):384-390
Objective: To compare the Reveos automated blood processing system with the current method, and to evaluate the feasibility and validity of using the Reveos system for blood component preparation. Methods: Forty units of 400 mL whole blood samples were divided into two groups: 2C group (for two-component preparation) and 3C group (for three-component preparation). Each group was further divided into a Reveos subgroup and a control subgroup. Blood components were prepared using the Reveos system and the current centrifugation method respectively. The 2C group yielded suspended red blood cells and plasma, while the 3C group yielded suspended red blood cells, plasma, and platelets. Key quality indicators for red blood cells, plasma, and platelets were measured before and after separation. Inter-group differences were analyzed using SPSS 25.0. Results: The trend of changes in the main performance indicators of red blood cells, plasma, and platelets before and after separation was generally consistent between the Reveos group and the control group, with no significant differences for most performance indicators. The Reveos system outperformed the current method in several aspects: in the 3C group, the hematocrit (Hct) was significantly higher in the Reveos group than in the control group [(62.82%±1.64%) vs (53.62%±3.04)%, P<0.001]; the white blood cell count in red blood cell suspensions was significantly lower than that in the control group [(3.37±1.42)×10
/L vs (8.42±2.30)×10
/L, P<0.001]; plasma yield was 27.5% higher than that in the control group [(183.90±17.37) mL vs (144.28±20.53) mL, P<0.001]; and the platelet activation rate was significantly lower than that in the control group [(21.97±14.25)% vs (34.73±11.92)%, P=0.044]. Conclusion: The Reveos system demonstrates good consistency with the current method in preparing blood components, and outperforms the current method in terms of leukocyte reduction and red blood cell concentration.
3.Clinical application of KASP-based RHCE genotyping in RhD-positive patients
Xiaoyu LIAN ; Mengdan LI ; Xiaoyu GUAN ; Li TIAN ; Chenying WANG ; Di WU ; Tianqiong LUO ; Xiaolin DU ; Xin JI ; Haixia XU ; Jue WANG ; Ling LI ; Zhong LIU
Chinese Journal of Blood Transfusion 2026;39(5):596-602
Objective: To develop a RHCE genotyping assay based on kompetitive allele-specific PCR (KASP) and assess its clinical accuracy for RhCE blood group determination. Methods: KASP primers were designed to interrogate three RHCE loci: the 109 bp insertion/deletion in intron 2, c. 307T>C, and c. 676C>G. A total of 1 194 RhD-positive inpatients from Chengdu were typed by both KASP genotyping and manual tube serology. Discordant samples (n=10) were retested by both methods and further resolved by Sanger sequencing. An additional 377 cases were tested for the c. 48C>G locus to evaluate the predictive accuracy of individual loci and combined locus testing for RhC antigen. Results: Genotyping concordance with serology was 100.0% for both the c. 676C>G locus (RhE/Rhe) and the c. 307T>C locus (Rhc). For RhC prediction using the 109 bp insertion, overall accuracy was 99.7% (1 191/1 194); the 3 discordant cases were confirmed by Sanger sequencing to be false negatives attributable to 109 bp deletion in intron 2. Testing the c. 48C>G allele for RhC prediction yielded 7 false positives, with an accuracy of 98.1% (370/377). RhC antigen status was determined by combining the 109 bp insertion and the c. 48C allele. After excluding 10 samples with inconsistent results between the two loci, the accuracy reached 100% in the remaining 367 samples. When both loci were applied in combination, accuracy reached 100% in the 367 cases with concordant results. Among the 1 194 patients, CCee (45.8%) and CcEe (31.7%) were the most common RhCE phenotypes. The e antigen had the highest positivity rate (92.2%), and the Ce haplotype was the most frequent (66.9%). Conclusion: The KASP-based RHCE genotyping method achieves high accuracy for clinical RhCE typing. Combining the 109 bp insertion/deletion with the c. 48C allele significantly improves RhC antigen prediction compared with either locus alone. This method was applied to RhCE genotyping of 1 194 RhD-positive inpatients in Chengdu, providing local RhCE phenotype and haplotype distribution data to support RhCE-matched transfusion practice.
4.Ginsenosides against non-small cell lung cancer:advances in mechanisms of action
Junsong GUO ; Ying LI ; Haixia LIU ; Yang LUO ; Yongzhong WANG
China Pharmacy 2026;37(20):2753-2758
Long-term outcomes in non-small cell lung cancer (NSCLC) are challenged by acquired resistance, recurrence and metastasis, as well as an immunosuppressive tumor microenvironment. In recent years, the antitumor effects of ginsenosides Rg 3 , Rh 2 , Rh 4 and Re, as well as their metabolite compound K (CK), in NSCLC have attracted increasing attention. This review summarizes the mechanisms of different ginsenosides with respect to the malignant phenotypes of NSCLC cells, the tumor microenvironment and immune responses, as well as their use in combination therapy. Available evidence indicates that ginsenoside Rg 3 inhibits cell proliferation, epithelial-mesenchymal transition and angiogenesis; reduces programmed death-ligand 1 glycosylation and thereby its stability; and enhances the antitumor effects of certain chemotherapeutic agents, epidermal growth factor receptor tyrosine kinase inhibitors and radiotherapy regimens. Ginsenoside Rh 2 mainly regulates apoptosis, glycolysis and cancer stemness, and modulates tumor-associated macrophages. Ginsenoside Rh 4 is involved in ferroptosis, ginsenoside Re in endoplasmic reticulum stress and M2 macrophage polarization, and CK in autophagy and hypoxic metabolism. At present, ginsenoside Rg 3 combined with chemotherapy has been clinically evaluated, whereas evidence for the other ginsenosides is still mainly preclinical. Future studies should standardize formulations, incorporate molecular features and resistance mechanisms into stratified studies, clarify the dose, sequence and safety of combination regimens, and confirm the long-term benefits of ginsenosides as an adjunctive intervention for NSCLC in well-designed prospective clinical trials.
5.Epidemiological characteristics and spatio-temporal clustering analysis of pulmonary tuberculosis in Minqin County from 2014 to 2023
LIU Shigang ; FAN Haixia ; ZHOU Yingquan
Journal of Preventive Medicine 2026;38(3):242-245,250
Objective:
To analyze the epidemiological characteristics and spatio-temporal clustering characteristics of pulmonary tuberculosis (PTB) in Minqin County, Gansu Province from 2014 to 2023, so as to provide the evidence for formulating targeted PTB prevention and control strategies.
Methods:
Surveillance data on PTB cases in Minqin County from 2014 to 2023 were collected through the China Disease Prevention and Control Information System. Descriptive methods were used to analyze the population, temporal and regional distribution characteristics of PTB cases. Trend surface analysis and spatio-temporal scan analysis were used to analyze the spatio-temporal clustering characteristics of PTB.
Results:
A total of 1 856 PTB cases were reported in Minqin County from 2014 to 2023, with an average annual reported incidence of 86.50/105. The reported incidence of PTB decreased from 107.82/105 in 2014 to 83.56/105 in 2023, showing an average annual decline rate of 2.79%. There were 1 091 males, accounting for 58.78%, and 765 females, accounting for 41.22%. The average annual reported incidence of PTB was 99.05/105 in males, higher than 73.27/105 in females (P<0.05). The population aged 65-<70 years had the largest number of PTB cases, with 410 cases, accounting for 22.09%. Farmers were the predominant occupation, with 1 608 cases, accounting for 86.64%. A relatively large number of cases were reported in spring and winter, with 550 and 510 cases, accounting for 29.63% and 27.48%, respectively. Hongshaliang Town, Donghu Town and Shuangcike Town had higher average annual reported incidence of PTB, which were 167.82/105, 140.51/105 and 133.23/105, respectively. Trend surface analysis showed that the average annual reported incidence rates of PTB across various townships in Minqin County from 2014 to 2023 were unevenly distributed. In the east-west direction, the reported incidence of PTB was relatively higher in the eastern part. In the north-south direction, the reported incidence of PTB was relatively higher in the northern part. Spatio-temporal scan analysis showed that there was one Class Ⅰcluster of PTB in Minqin County from 2014 to 2023, covering 9 townships, with clustering period spanning from 2014 to 2017 (P<0.05). There was one Class Ⅱ cluster of PTB in Minqin County, covering 8 townships, with clustering period spanning from 2020 to 2021 (P<0.05).
Conclusions
From 2014 to 2023, the average annual reported incidence of PTB in Minqin County remained at a relatively high level, with a relatively slow decline rate. PTB was highly prevalent in winter and spring as well as in townships in the northeastern part. Special attention should be paid to high-risk groups such as males, the elderly, and farmers.
6.Analysis on Characteristics of Peripheral Blood Recovery in Treatment of Aplastic Anemia with Bushen Shengxue Method and Yiqi Yangxue Method Combined with Western Medicine
Yaoyin ZHANG ; Jiaqi HE ; Chaochang ZHANG ; Wenru WANG ; Yubin DING ; Jinhuan WANG ; Ruirong XU ; Haixia DI ; Jiangwei WAN ; Qifeng LIU ; Haixia WANG ; Antao SUN ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):151-157
Objective To investigate the characteristics of peripheral blood in the treatment of aplastic anemia(AA)with Bushen Shengxue Method and Yiqi Yangxue Method combined with Western medicine.Methods Totally 492 AA patients who were treated in 19 centers including Xiyuan Hospital China Academy of Chinese Medical Sciences from September 2018 to March 2021 were selected,and were randomized into three groups:161 cases in the Bushen Shengxue group,164 cases in the Yiqi Yangxue group,and 167 cases in the control group.All three groups were orally administered cyclosporine and androgens.Bushen Shengxue group was given Bushen Shengxue Granules,Yiqi Yangxue group was given Yiqi Yangxue Granules,and the control group was given placebo(half dosage of Bushen Shengxue granules).The general data,overall efficacy,and peripheral blood at the 1st month,the 4th month,and 6th month after treatment were analyzed.Results The total effective rate of Bushen Shengxue group was 98.8%(159/161),which was significantly higher than that of Yiqi Yangxue group(79.9%)and the control group(61.7%),with statistical significance(P<0.001);The total effective rate of Yiqi Yangxue group was significantly higher than that of the control group(P<0.001).Compared with before treatment,the hemoglobin(HGB)levels of all three groups of patients significantly increased after treatment(P<0.001,P<0.01),and the platelet levels of Bushen Shengxue group and the control group significantly increased after treatment(P<0.001);after treatment,the HGB levels in the three groups were ranked from high to low as the Bushen Shengxue group,Yiqi Yangxue group and the control group(P<0.01).25%of patients had HGB levels exceeding 20%of baseline values,Bushen Shengxue group took 1 month,while Yiqi Yangxue group and control group took 4 months;25%of patients had an increase in HGB levels exceeding 50%of the baseline value,Bushen Shengxue group took 6 months,while Yiqi Yangxue group and control group took more than 6 months.At 6 months,the number of patients with HGB elevation exceeding 20%and 50%of baseline values in Bushen Shengxue group was higher than that in Yiqi Yangxue group and the control group(P<0.05,P<0.001).25%of patients had white blood cell elevation exceeding 50%of the baseline value,Bushen Shengxue group took 4 months,Yiqi Yangxue group took 6 months,and the control group took more than 6 months.25%of patients showed an increase in platelet levels exceeding 100%of the baseline value,Bushen Shengxue group took 4 months,while Yiqi Yangxue group and control group took 6 months;at 6 months,the number of patients in Bushen Shengxue group and Yiqi Yangxue group with platelet elevation exceeding 20%of the baseline value was significantly higher than that in the control group(P<0.01,P<0.05).Conclusion Bushen Shengxue method combined with Western medicine intreating AA is better than the method of Yiqi Yangxue method combined with Western medicine.In terms of improving HGB,it is reflected in shortening the recovery time and increasing the number of beneficiaries,and the dosage can affect the recovery time and the number of beneficiaries at the same time;in terms of improving white blood cell and platelet,it is reflected in shortening the recovery time,and the dosage can affect the recovery time.
7.Ultrasensitive wash-free quantification of breast cancer-derived small extracellular vesicles via a self-locked DNAzyme nanoprobe
Xiaohui CHEN ; Haixia LIU ; Ningyu MA ; Qianqian WU ; Hengyi CHEN ; Yi CHEN ; Wei TU ; Jinghan CAO ; Yang LUO
Chinese Journal of Laboratory Medicine 2025;48(3):396-401
Objective:To develop a self-locked DNAzyme nanoprobe-based fluorescence amplification strategy for wash-free and ultrasensitive detection of breast cancer-derived small extracellular vesicles (sEV).Method:A DNAzyme self-locked probe was designed to recognize the epithelial cell adhesion molecule (EpCAM) specifically expressed on breast cancer-derived sEVs. Upon binding to EpCAM, the DNAzyme-lock structure was opened, restoring the DNAzyme cleavage activity. The activated DNAzyme then cyclically cleaved the RNA site on the substrate strand. Fluorescently labeled substrate strands were used to detect sEVs at varying concentrations, and the detection limit and linear range were determined.Results:The DNAzyme self-locked probe successfully identified breast cancer-derived sEVs and generated a fluorescent signal through cyclic cleavage. The proposed method achieved wash-free detection of sEVs, with the fluorescence intensity showing a strong linear correlation with sEV concentration ( R2=0.98). The linear detection range was 1.0×10 2-1.0×1.0 7 particles/μl, with a detection limit of 59 particles/μl. Conclusion:This study established a wash-free and highly sensitive strategy for quantifying breast cancer-derived sEVs, which provides a promising technical approach for the early diagnosis of cancer.
8.Building of an intelligent DRG grouping audit system in a hospital
Juan ZHANG ; Yang PU ; Wen LIU ; Yingpeng WANG ; Lianhua KONG ; Yaxin HUANG ; Bin WAN ; Haixia DING
Chinese Journal of Hospital Administration 2025;41(8):614-618
Diagnosis-related groups (DRG) payment is an important component of deepening the reform of medical insurance payment methods. In June 2023, a tertiary hospital launched an intelligent DRG grouping audit system to enhance grouping accuracy. By establishing a multi departmental collaborative organizational structure, building a standardized knowledge base and a rule base covering five categories (diagnosis, fees, testing, nursing, and pathology), and integrating electronic medical records, medical orders, testing, and imaging data throughout the entire diagnosis and treatment process, the intelligent DRG grouping audit system with data collection, identification, extraction, comparison, and output modules was constructed to achieve intelligent audit. At the same time, it was formed a closed-loop management system for pre reporting quality control, in-process group entry control, and post data analysis and assessment, which would prevent the risk of differentiated behaviors such as high coding and high sets, and ensure the reasonable use of medical insurance funds. By January 2024, the system had covered 89 ADRG groups, and improved the efficiency and quality of DRG grouping audit. Compared with February to May 2023, the monthly average rejection rate of medical records on the first page decreased by 9.4% after the system was put into operation (June to December 2023), and core medical indicators such as the number of DRG groups, medical insurance settlement cases, and time consumption index continued to improve. The practical experience could provide reference and inspiration for other hospitals in China.
9.Research and application of a new deep learning based strategy for platelet histogram review
Enming ZHANG ; Chao YANG ; Xianchun CHEN ; Yan LIN ; Taixue AN ; Haixia LI ; Yongjian HE ; Zhiwei LIU ; Limei FENG ; Wanying LIN ; Tie XIONG ; Kai QIU ; Ya GAO ; Lizhu HUANG ; Jing HE ; Chunyan WANG ; Dehua SUN ; Bo SITU ; Lei ZHENG
Chinese Journal of Laboratory Medicine 2025;48(9):1201-1206
Objective:To develop an artificial intelligence (AI)-based platelet review strategy to identify abnormal platelet histograms with no significant difference between initial impedance platelet count (PLT-I) and PLT-F results.Methods:This study included 5 119 routine blood analysis in Nanfang Hospital of Southern Medical University and its Ganzhou branch from July 2023 and March 2024. Specimens exhibiting abnormal platelet histograms and an initial platelet count >40×10?/L underwent review using the fluorescent platelet count (PLT-F) channel. Consistency of the results was defined as a difference between impedance platelet count (PLT-I) and PLT-F less than ±20% of the PLT-F results. A deep learning model was developed using platelet and red blood cell histogram data from a training set of 3 807 specimens. The model′s diagnostic performance was evaluated on an independent external validation set ( n=805) using receiver operating characteristic (ROC) curve analysis. Changes in the number of reviewed samples and sample turnaround time were analyzed to assess its clinical utility. Results:The deep learning model based on platelet and red blood cell histograms achieved an area under the ROC curve (AUC) of 0.854 in the training set. At a cutoff value of 0.1, the sensitivity was 0.954 and specificity was 0.358. The model could reduce review by 16.80% (190/1 131). In the validation set, the AUC was 0.805, with a sensitivity of 0.955 and specificity of 0.307, corresponding to a reduction of 17.41% (47/270) in reviewed specimens.Conclusion:The platelet review prediction model developed based on deep learning technology can efficiently identify samples with consistent results before and after review, reducing unnecessary reviews and shortening specimen testing time, thereby improving the efficiency of platelet test.
10.Value of cerebral cord blood flow ultrasound combined with glucose metabolism indexes in the diagnosis of preeclampsia with fetal growth restriction
Xiaoyue ZHANG ; Jingjing GAO ; Xiaozheng LIU ; Haixia GAO
International Journal of Laboratory Medicine 2025;46(8):971-975
Objective To explore the diagnostic value of brain cord blood flow ultrasound combined with glucose metabolism indexes in the patients with preeclampsia(PE)complicated with fetal growth restriction(FGR).Methods This study was a prospective cohort case-control study.A total of 198 PE patients admitted to the hospital from January 2017 to January 2022 were collected and divided into group A(PE patients com-plicated with FGR,101 cases)and group B(PE patients without FGR,97 cases)according to whether they were complicated with FGR.45 pregnant women with healthy prenatal examination in the hospital were se-lected as group C,and the differences of brain cord blood flow ultrasound indexes and glucose metabolism inde-xes among the three groups and the efficiency for diagnosing PE complicated with FGR were analyzed.Results Fast-ing blood glucose and fasting insulin levels in group A,group B and group C were gradually decreased(P<0.05).The peak systolic flow velocity/peak diastolic flow velocity(S/D),resistance index(RI)and pulsatility index(PI)of middle cerebral artery(MCA)of fetus in group A,group B and group C increased gradually(P<0.05).The levels of umbilical artery(UA)of fetus in group A,group B and group C decreased gradually(P<0.05).The area under the curve of fasting insulin,fasting blood glucose,S/D,RI and PI of MCA,S/D,RI,PI of UA and the combined detection were 0.782,0.748,0.765,0.836,0.805,0.758,0.811,0.795 and 0.895,respectively.The diagnostic efficiency of combined detection was higher than that of single diagnosis(Z=4.327,4.862,4.551,3.400,3.946,4.679,3.742,4.102,P<0.05).Conclusion The combined detection of glucose metabolism indexes and brain cord blood flow ultrasound indexes is of great value in the differential diagnosis of patients with PE complicated with FGR,and has good clinical application value.


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