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.Analysis of Clinical Prognostic Characteristics in Patients with Primary Sjögren's Syndrome-Related Renal Fanconi Syndrome
Xiaoxiao SHI ; Yuan DONG ; Jiahe JIANG ; Peng XIA ; Shuo ZHANG ; Yubing WEN ; Dong XU ; Fengchun ZHANG ; Limeng CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(2):358-369
Renal Fanconi syndrome (FS) is a rare renal manifestation of primary Sjögren's syndrome (pSS). This study aims to analyze the clinical and prognostic characteristics of patients with pSS-associated renal FS (pSS-FS) and provide insights for clinical management. Patients diagnosed with pSS-FS via renal biopsy at Peking Union Medical College Hospital from 1993 to 2024 were enrolled. Data collected included age, sex, clinical symptoms (xerostomia, xerophthalmia, skin purpura, arthralgia, polyuria, and systemic symptoms), laboratory findings [serum immunoglobulin G (IgG) and IgM, complement (C3, C4), antinuclear antibody, anti-Sjögren's syndrome-associated antigen A antibody (SSA), anti-SSB antibody, 24-hour urinary protein quantification, tubular proteinuria, serum creatinine, serum electrolytes], treatment, and follow-up information. Systematic assessments included the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score, pulmonary involvement (including non-infectious interstitial pneumonia, pulmonary fibrosis, pulmonary hypertension, etc.), hematological involvement (anemia, leukopenia, thrombocytopenia), etc. Efficacy evaluations encompassed improvements in immunological parameters, renal function, and tubular function. Group comparisons were performed using chi-square/Fisher's exact tests, A total of 38 patients with pSS-FS were included, with 37(97.4%) being female. The median age at pSS diagnosis was 43(37, 57) years. Xerostomia (76.3%) and xerophthalmia (71.1%) were the predominant clinical symptoms. The most common renal tubular dysfunctions were generalized aminoaciduria (96.9%), tubular proteinuria (96.0%), and hypokalemia (94.7%). The median eGFR was 52.57(32.04, 76.10)mL/(min·1.73 m2), with 60.5% (23/38) of patients having an eGFR below 60 mL/(min·1.73 m2).After six months of immunosuppressive therapy, including moderate-to-high-dose glucocorticoids, significant improvements were observed in immunological parameters (improvement rate: 69.2%), renal tubular function (89.5%), and renal function (44.4%). Following immunosuppressive treatment, the median eGFR increased from 54.95(33.06, 76.10)mL/(min·1.73 m2) to 65.56(56.24, 83.58)mL/(min·1.73 m2).Compared to patients with normal or mildly impaired baseline eGFR [≥ 60 mL/(min·1.73 m2)], those with significantly decreased baseline eGFR [< 60 mL/(min·1.73 m2)] were older (46 years This study reports the clinical characteristics of the largest single-center cohort of pSS-FS patients internationally, characterized by varying degrees of proximal renal tubular dysfunction and renal impairment. Timely initiation of immunosuppressive therapy, including glucocorticoids, is crucial, particularly for patients with significantly reduced eGFR, who may experience more substantial renal function improvement.
3.Construction of integrated platform for emergency clinical scientific research based on big data.
Gongxu ZHU ; Yunmei LI ; Xiaohui CHEN ; Yanling LI ; Yongcheng ZHU ; Haifeng MAO ; Zhenzhong QU ; Kunlian LI ; Sai WANG ; Guangqian YANG ; Huijing LU ; Huilin JIANG
Chinese Critical Care Medicine 2023;35(11):1218-1222
OBJECTIVE:
To explore clinical rules based on the big data of the emergency department of the Second Affiliated Hospital of Guangzhou Medical University, and to establish an integrated platform for clinical research in emergency, which was finally applied to clinical practice.
METHODS:
Based on the hospital information system (HIS), laboratory information system (LIS), emergency specialty system, picture archiving and communication systems (PACS) and electronic medical record system of the Second Affiliated Hospital of Guangzhou Medical University, the structural and unstructured information of patients in the emergency department from March 2019 to April 2022 was extracted. By means of extraction and fusion, normalization and desensitization quality control, the database was established. In addition, data were extracted from the database for adult patients with pre screening triage level III and below who underwent emergency visits from March 2019 to April 2022, such as demographic characteristics, vital signs during pre screening triage, diagnosis and treatment characteristics, diagnosis and grading, time indicators, and outcome indicators, independent risk factors for poor prognosis in patients were analyzed.
RESULTS:
(1) The data of 338 681 patients in the emergency department of the Second Affiliated Hospital of Guangzhou Medical University from March 2019 to April 2022 were extracted, including 15 modules, such as demographic information, triage information, visit information, green pass and rescue information, diagnosis information, medical record information, laboratory examination overview, laboratory information, examination information, microbiological information, medication information, treatment information, hospitalization information, chest pain management and stroke management. The database ensured data visualization and operability. (2) Total 140 868 patients with pre-examination and triage level III and below were recruited from the emergency department database. The gender, age, type of admission to the hospital, pulse, blood pressure, Glasgow coma scale (GCS) and other indicators of the patients were included. Taking emergency admission to operating room, emergency admission to intervention room, emergency admission to intensive care unit (ICU) or emergency death as poor prognosis, the poor prognosis prediction model for patients with pre-examination and triage level III and below was constructed. The receiver operator characteristic curve and forest map results showed that the model had good predictive efficiency and could be used in clinical practice to reduce the risk of insufficient emergency pre-examination and triage.
CONCLUSIONS
The establishment of high-quality clinical database based on big data in emergency department is conducive to mining the clinical value of big data, assisting clinical decision-making, and improving the quality of clinical diagnosis and treatment.
Adult
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Humans
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Big Data
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Emergency Service, Hospital
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Triage/methods*
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Intensive Care Units
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Hospitalization
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Retrospective Studies
4.Clinical significance of different stratification of platelet count in primary acute myeloid leukemia in children
Yanhong JIANG ; Yang JIAO ; Guangyi CHEN ; Jiahe SHENG ; Qingxia XU
Chinese Journal of Applied Clinical Pediatrics 2021;36(3):204-209
Objective:To analyze the clinical characteristics of primary acute myeloid leukemia (AML) (non-M3 type) in children suffering from different levels of platelet count(PLT).Methods:In the Tumor Hospital of Zhengzhou University from January 2014 to December 2018, laboratory and clinical data of 247 de novo primary AML pediatric patients were retrospectively reviewed.According to the PLT before treatment, patients were divided into very low platelet group (VLG), low platelet group (LG) and non-lowing platelet group (NLG), with<50×10 9/L, ≥50×10 9/L but <125×10 9/L and ≥125×10 9/L as the boundaries.All patients were followed up until June 30, 2019.Meanwhile, the follow-up data was obtained by consulting medical records or by telephone.SPSS 17.0 software was applied for data analysis. Results:In general clinical features, a different group of hemoglobin (Hb) content, fusion gene AML- ETO and clinical risk stratification were statistically significant in different PLT groups ( χ2=11.270, 12.115 and 12.848, respectively, all P<0.05). However, the differences of other indicators in different groups of PLT were not statistically significant (all P>0.05). There were no statistically significant differences in terms of 3-year disease-free survival(DFS) rate (59.3%, 36.3%, 50.4%) among the 3 groups (all P>0.05). The median total survival(OS)time(40.5 months)and 3-year OS rate(41.0%) of NLG patients were significantly higher than those of VLG(23.1 months, 30.1%)and LG(14.1 months, 18.2%)patients, with statistically significant differences( χ2=7.798 and 6.553, respectively, all P<0.05). The univariate analysis of gender, white blood cell(WBC), Hb, PLT, lactic dehydrogenase(LDH), FLT3-ITD, NPM1, DNMT3A, CEPBA, C-KIT, AML-ETO, molecular genetic prognosis, complete remission(CR), and hemopoietic stem cell transplantation(HSCT) displayed that DNMT3A mutation was an adverse factor that affects patients′ OS ( χ2 =5.834, P<0.05), and the positive factors that influences OS were non-reducing PLT before treatment, and obtaining CR and subsequent HSCT ( χ2=7.798, 79.168, and 31.337, respectively, all P<0.05). Multi-factor analysis revealed that the independent protective factors that affect patients′ OS were the non-reducing PLT before treatment, and obtaining CR and subsequent HSCT( Wald=42.760, 15.918, and 10.183, respectively, all P<0.05). Conclusions:Before treatment, non-reducing PLT is a protective factor for primary childhood AML patients, and the prognosis is satisfying.
5.PCGF6 regulates stem cell pluripotency as a transcription activator via super-enhancer dependent chromatin interactions.
Xiaona HUANG ; Chao WEI ; Fenjie LI ; Lumeng JIA ; Pengguihang ZENG ; Jiahe LI ; Jin TAN ; Tuanfeng SUN ; Shaoshuai JIANG ; Jia WANG ; Xiuxiao TANG ; Qingquan ZHAO ; Bin LIU ; Limin RONG ; Cheng LI ; Junjun DING
Protein & Cell 2019;10(10):709-725
Polycomb group (PcG) ring finger protein 6 (PCGF6), though known as a member of the transcription-repressing complexes, PcG, also has activation function in regulating pluripotency gene expression. However, the mechanism underlying the activation function of PCGF6 is poorly understood. Here, we found that PCGF6 co-localizes to gene activation regions along with pluripotency factors such as OCT4. In addition, PCGF6 was recruited to a subset of the super-enhancer (SE) regions upstream of cell cycle-associated genes by OCT4, and increased their expression. By combining with promoter capture Hi-C data, we found that PCGF6 activates cell cycle genes by regulating SE-promoter interactions via 3D chromatin. Our findings highlight a novel mechanism of PcG protein in regulating pluripotency, and provide a research basis for the therapeutic application of pluripotent stem cells.
7.Allogeneic peripheral blood stem cell transplantation complicated with megaloblastic anemia: two cases report and literatures review
Yanhong JIANG ; Guangyi CHEN ; Jiahe SHENG ; Qingxia XU
Chinese Journal of Organ Transplantation 2018;39(10):615-619
Objective Combined with the medical records of two patients with megaloblastic anemia (MA) after allogeneic hematopoietic stem cell transplantation (AHSCT),the relevant literature was reviewed.Methods The medical records of two patients with MA after AHSCT were analyzed retrospectively.The primary disease was diagnosed by analyzing the blood cells,bone marrow cell morphology,cell chemical dyeing,bone marrow biopsy and immune classification.After AHSCT,MA was diagnosed through bone marrow cell morphology,folic acid and vitamin B12 detection.Results AT 32nd day after transplantation,bone marrow cells morphological examination of case 1 showed:nucleated cells proliferation activity,granulocytes proliferation activity,giant rod nucleus granulocytes visible;different stages of the red blood cells proliferation activity,higher proportion of immature red blood cells,most of whose nucleus developed later than the cytoplasm;megakaryocytes and platelets scattered distribution.Blood contents of folic acid and VB12 were far below the reference range.After administration of folic acid and VB12 for 2 weeks,routine blood test showed the volume of red blood cells returned to normal.Reexamination of bone marrow cell morphology showed megaloblastic cells disappeared.Three months after transplantation,bone marrow cells morphological examination in case 2 showed:nucleated cells proliferation activity,low granulocytes proliferation,giant rod nucleus granulocytes visible;different stages of the red blood cells proliferation activity,higher proportion of orthochrmatic normoblasts,most of whose nucleus developed later than the cytoplasm;scattered distribution of megakaryocytes and platelets.Blood contents of folic acid were far below the reference range,but the content of VB12 was normal.After administration of folic acid and VB12 for 2 weeks,the routine blood test showed the volume of red blood cells returned to normal.The reexamination of bone marrow cell morphology showed megaloblastic cells disappeared.Conclusion After AHSCT,attention should be paid to the detection of folic acid and VB12 in vivo.Folic acid and VB12 are timely supplemented when necessary to avoid the occurrence of MA in patients with AHSCT.
8.Clinical feature between FLT3-ITD mutation type and wild type de novo primary AML
Yanhong JIANG ; Jiahe SHENG ; Qingxia XU ; Guangyi CHEN
The Journal of Practical Medicine 2017;33(23):3975-3980
Objective To investigate the difference of clinical features between FLT3-ITDmt and FLT3-IT-Dwt de novo primary acute myeloid leukemia(AML). Methods Clinical data of 31 FLT3-ITDmt and 113 FLT3-ITDwt de novo primary AML patients from January 2015 to December 2016 were retrospectively reviewed and ana-lyzed by Student′s test,chi-square test or rank sum test according to the types of clinical data. Results There were statistically significant differences in WBC,RBC,HGB of peripheral blood and the mutation of DNMT3A gene(statistical values:705.000;-2.535;-2.290 and 5.715 respectively,all P < 0.05)in 2 types of AML. Conclusion When compared with FLT3-ITDwt de novo primary AML patients,FLT3-ITDmt ones have the fea-tures of higher WBC,lower RBC and HGB of peripheral blood,and are more likely to be associated with mutation in the DNMT3A gene.
9.Association of arteriosclerosis with mild cognitive impairment in type 2 diabetics
Gang CHEN ; Shali YANG ; Jiahe LIU ; Hong LI ; Jin YAO ; Feihuan FU ; Jixing LIANG ; Huibin HUANG ; Liantao LI ; Qiqin JIANG ; Lixiang LIN
Chinese Journal of Endocrinology and Metabolism 2010;26(11):971-972
Montreal cognitive assessment(MoCA, Beijing Version) was chosen as cognition assessment implement. 63 patients suffering from type 2 diabetes mellitus with mild cognitive impairment (MCI) were chosen to form a research group, and 27 patients with type 2 diabetes mellitus and normal cognitive function served as a control group. It was found that atherosclerosis played an important role in the pathogenesis of MCI in type 2diabetes, therefore, early prevention and management of atherosclerosis may help to improve the cognitive function.
10.Effects of hesperidin against lipid-oxidation and its effects on transcription of MCP-1
Guiyu LOU ; Yu JIANG ; Jiahe PENG ; Minzhang QIAN ;
Journal of Third Military Medical University 2003;0(08):-
Objective To evaluate the antioxidant effect of hesperidin and its effect on transcription of monocyte chemoattractant protein 1 (MCP 1) in rabbits with dietary atherosclerotic lesions. Methods (1) Low density lipoprotein (LDL) was isolated from healthy human plasma by sequential ultra centrifugation and oxidized by copper. The contents of malondialdehyde (MDA) were measured at different dosages of the drug and at different reaction time. (2) Atherosclerotic model of rabbits was established by feeding rabbits with high lipid diet and immune injury. A total of 18 rabbits were divided randomly into three groups: control group, model group, and hesperidin group ( n =6 in each group). Rabbits in the control group were fed with common diet, those in the model group with high lipid diet, and those in the hesperidin group with high lipid diet plus hesperidin. After 10 experimental weeks, blood samples were collected from the marginal ear veins for the detection of the contents of MDA and nitric oxide (NO). The rabbits were sacrificed for the isolation of the thoracic aorta. MCP 1 mRNA transcription in the thoracic aorta was detected by RT PCR. Results Hesperidin could significantly inhibit MDA production in a dose dependent manner in vitro ( P

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