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.Multimodal ultrasound and ultrasound-guided fine-needle aspiration biopsy for distinguishing benign and malignant thyroid nodules of C-TIRADS grade 4
Di ZHONG ; Di TANG ; Xiaoqiang GAO ; Haixia LI ; Hongbo WANG ; Ying LIU
Chinese Journal of Medical Imaging Technology 2024;40(2):182-185
Objective To compare the value of multimodal ultrasound and ultrasound-guided fine-needle aspiration biopsy(US-FNAB)for distinguishing benign and malignant thyroid nodules of Chinese thyroid imaging reporting and data system(C-TIRADS)grade 4.Methods Data of 247 thyroid nodules in 201 patients were retrospectively analyzed,including 193 malignant and 54 benign noes.Taken postoperative pathology as the gold standards,the value of multimodal ultrasound,i.e.the combination of conventional ultrasound,shear wave elastography(SWE)and contrast-enhanced ultrasound(CEUS)and US-FNAB for distinguishing benign and malignant thyroid nodules were compared.Results The sensitivity,specificity,accuracy,misdiagnosis rate and rate of missed diagnosis of conventional ultrasound for diagnosing malignant thyroid nodules was 86.53%,59.26%,80.57%,40.74%and 13.47%,respectively,of SWE was 78.76%,74.07%,77.73%,25.93%and 21.24%,respectively,of CEUS was 90.16%,77.78%,87.45%,22.22%and 9.84%,respectively,while of multimodal ultrasound was 97.93%,88.89%,95.95%,11.11%and 2.07%,respectively,and of US-FNAB was 89.64%,96.30%,91.09%,3.70%and 10.36%,respectively.The sensitivity,specificity and accuracy of multimodal ultrasound for distinguishing benign and malignant thyroid nodules were higher,while the misdiagnosis rate and missed diagnosis rate were lower than those of conventional ultrasound,SWE and CEUS alone.The sensitivity,accuracy and misdiagnosis rate of multimodal ultrasound were higher,while its specificity and missed diagnosis rate were both lower than those of US-FNAB(all P<0.05).Conclusion For distinguishing benign and malignant thyroid nodules of C-TIRADS grade 4,multimodal ultrasound had higher sensitivity and accuracy but higher misdiagnosis rate,while US-FNAB had higher specificity but also higher missed diagnosis rate.
3.Changes of Immunological Indexes and Blood Routine in Treatment of Aplastic Anemia by Yiqi Yangxue Prescription
Yaoyin ZHANG ; Chaochang ZHANG ; Jiaqi HE ; Wenru WANG ; Yubin DING ; Jinhuan WANG ; Ruirong XU ; Haixia DI ; Jiangwei WAN ; Qifeng LIU ; Haixia WANG ; Antao SUN ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(12):97-104
ObjectiveTo investigate the immunological characteristics of the patients with aplastic anemia (AA) and elevated hemogram parameters treated with Yiqi Yangxue prescription combined with Western medicine and the predictive effects of immunological indexes on elevated hemogram parameters, thus providing a reference for the prediction of the treatment efficacy and the adjustment of the treatment regimen. MethodA retrospective study was conducted, involving 77 AA patients treated with Yiqi Yangxue prescription combined with Western medicine for 6 months in 19 medical institutions including Xiyuan Hospital, China Academy of Chinese Medical Sciences from September 2018 to March 2021. The patients were assigned into two groups according to the elevations in hemogram parameters [including hemoglobin (HGB), white blood cell count (WBC), platelet (PLT), and absolute neutrophil count (ANC)] after 6 months of treatment. One group had the elevation <50%, and the other group had the elevation ≥50% compared with the baseline. The clinical and immunological characteristics were compared between the two groups. Result① Compared with the group with HGB elevation<50%, the group with HGB elevation≥50% showed elevated level of CD3+ human leukocyte antigen-DR (HLA-DR)+ and increased proportion of patients with T-helper cell type 2 (Th2)<5%, CD8+≥50%, and CD3+HLA-DR+≥9% before treatment (P<0.05, P<0.01). The multivariate Logistic regression analysis showed that CD8+≥50% before treatment was the independent influencing factor for HGB elevation ≥50% [odds ratio (OR)=12.000, 95% confidence interval (CI) 2.218, 64.928, P<0.01]. ② Compared with the group with WBC elevation<50%, the group with WBC elevation≥50% showed increased proportion of patients with CD3+HLA-DR+<6% and T-box transcription factor (T-bet)≥200% before treatment (P<0.05). The multivariate Logistic regression analysis showed that CD3+HLA-DR+<6% (OR=2.998, 95%CI 1.036, 8.680, P<0.05) and T-bet≥200% (OR=3.634, 95%CI 1.076, 12.273, P<0.05) before treatment were independent influencing factors for WBC elevation≥50%. ③ Compared with the group with PLT elevation<50%, the group with PLT elevation≥50% presented lowered Th1 and CD3+HLA-DR+ levels and increased proportion of patients with Th1<12%, CD4+≥6%, and CD3+HLA-DR+<5% before treatment (P<0.05, P<0.01). The multivariate Logistic regression analysis showed that CD3+HLA-DR+<5% before treatment was the independent influencing factor for PLT elevation≥50% (OR=16.190, 95%CI of 3.430 to 76.434, P<0.01). ④ Compared with the group with ANC elevation<50%, the group with ANC elevation≥50% showed no significant changes in the hemogram parameters before treatment. ConclusionAs for the AA patients with rapid elevation in HGB, Yiqi Yangxue prescription combined with Western medicine demonstrate significant effects in the patients with Th2<5% and CD3+HLA-DR+≥9%, especially those with CD8+≥50%. As for the AA patients with rapid elevation in WBC, the therapy was particularly effective in the patients with CD3+HLA-DR+<6% and T-bet≥200%. As for the AA patients with rapid growth in PLT, the therapy was particularly effective in the patients with Th1<12% and CD4+≥6%, especially those with CD3+HLA-DR+<5%.
4.Analysis of Predictive Factors for Efficacy of Yiqi Yangxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia in Non-elderly Adults
Chaochang ZHANG ; Rui LI ; Jian LIU ; Yubin DING ; Jinhuan WANG ; Qifeng LIU ; Ruirong XU ; Haixia WANG ; Haixia DI ; Antao SUN ; Yonggang XU ; Xiupeng YANG ; Feng LIU ; Rou MA ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(20):88-98
ObjectiveTo explore the predictive factors for the efficacy of Yiqi Yangxue prescription combined with western medicine in treating aplastic anemia (AA) in non-elderly adults, so as to provide a reference for predicting the prognosis of this therapy. MethodA retrospective study was conducted with the clinical data of non-elderly adult AA patients who visited 19 hospitals including Xiyuan Hospital of the China Academy of Chinese Medical Sciences from September 2018 to March 2021 and were treated with Yiqi Yangxue Prescription combined with western medicine. According to the efficacy evaluation results at the 6th month of treatment, the patients were assigned into effective and ineffective groups. The two groups were compared in terms of the gender, age, disease classification [non-severe aplastic anemia (NSAA)/severe aplastic anemia (SAA)], course of disease, family history, complications, history of drug allergy, baseline blood routine examination [hemoglobin (HGB), white blood cell (WBC), neutrophil (ANC), platelet (PLT), and reticulocyte (Ret)], T lymphocyte subsets, degree of proliferation of nucleated cells in bone marrow, and expression of T-bet and GATA-3. ResultA total of 101 non-elderly adult AA patients were enrolled in this study, including 81 in the effective group and 20 in the ineffective group. The effective group had a higher proportion of the patients without a history of drug allergy than the ineffective group (P<0.05). The body height, body weight, gender, age, disease classification, course of disease, family history, and complications showed no significant differences between two groups. The effective group had higher levels of ANC and PLT before treatment (P<0.05) and higher proportion of patients with ANC≥1.6×109/L and PLT≥25×109/L (P<0.05, P<0.01) than the ineffective group. The baseline levels of WBC, HGB, and Ret showed no significant statistical differences between two groups. The levels of CD3+HLA-DR+T cells in the effective group before treatment was higher than that in the ineffective group (P<0.05). The levels of CD3+CD19-T cells, CD4+T cells, CD8+T cells, Th1 cells, Th2 cells, and CD3+CD25+T cells showed no significant statistical differences between two groups before treatment. The proportion of patients with active bone marrow nucleated cells proliferation in the effective group before treatment were significantly higher than that in the ineffective group, while the proportion of patients with reduced or extremely reduced proliferation were significantly lower than that in the ineffective group (P<0.05). The expression levels of T-bet and GATA-3 genes had no significant differences between two groups before treatment. The multivariate binary logistic regression analysis showed that the ANC level before treatment and history of drug allergy were independent influencing factors for efficacy (P<0.05, P<0.01), while other indicators were not influencing factors for efficacy. The receiver operating characteristic (ROC) curve was applied to analyze the predictive value of the ANC level before treatment in the treatment of AA in non-elderly adults with Yiqi Yangxue prescription combined with western medicine. The area under the curve was 0.679 (P<0.05), with the critical value of 1.595×109/L, the sensitivity of 0.42, and the specificity of 0.95. ConclusionThe history of drug allergy, pre-treatment ANC, PLT, CD3+HLA-DR+ T cell levels, and proliferation of nucleated cells in bone marrow before treatment are predictive factors for the efficacy of Yiqi Yangxue prescription combined with western medicine in treating AA in non-elderly adults. This therapy tends to be more effective for the patients with no history of drug allergy, higher ANC and PLT levels before treatment, especially those with ANC≥1.6×109/L, PLT≥25×109/L, and higher CD3+ HLA-DR+T cell levels and the more active proliferation of nucleated cells in bone marrow before treatment.
5.Comparison of Corneal Biomechanical Properties Based on Data from Uniaxial Tensile Test under Fast and Slow Loading
Di ZHANG ; Haixia ZHANG ; Zheng ZENG ; Ziwei YUAN ; Wei WANG ; Lin LI
Journal of Medical Biomechanics 2022;37(4):E669-E675
Objective To compare the corneal biomechanical parameters identified from uniaxial tensile test under fast and slow loading. Methods The stress-strain and stress relaxation data were obtained from uniaxial tensile tests on corneal strips from 15 healthy adult rabbits at average loading rate of 0.16 mm/s and 0.02 mm/s, respectively. A visco-hyperelastic model was applied to analyze the loading and unloading data from the fast tensile tests, where the model parameter set was denoted by Gvh. The first-order Ogden model and second-order Prony series model were used to fit stress-strain and stress relaxation data from the slow tensile tests, respectively, in which the model parameter set was denoted by Gvh. Correlation analysis was used to compare the correlation of parameters between Gvh and GOP. Results All the goodness-of-fits to the three data sets were greater than 0.95. There were significant differences in 5 (μ, A1, A2, τ1, τ2,) of the 6 parameters between Gvh and GOP (P<0.05), and the Ogden model parameters was positively correlated between the two groups. Conclusions There are differences in corneal biomechanical parameters identified by data from uniaxial tensile tests under fast and slow loading. The results provide a preliminary research basis for further exploring the use of clinical data to identify corneal biomechanical properties.
6.Avian influenza A (H7N9) virus: from low pathogenic to highly pathogenic.
William J LIU ; Haixia XIAO ; Lianpan DAI ; Di LIU ; Jianjun CHEN ; Xiaopeng QI ; Yuhai BI ; Yi SHI ; George F GAO ; Yingxia LIU
Frontiers of Medicine 2021;15(4):507-527
The avian influenza A (H7N9) virus is a zoonotic virus that is closely associated with live poultry markets. It has caused infections in humans in China since 2013. Five waves of the H7N9 influenza epidemic occurred in China between March 2013 and September 2017. H7N9 with low-pathogenicity dominated in the first four waves, whereas highly pathogenic H7N9 influenza emerged in poultry and spread to humans during the fifth wave, causing wide concern. Specialists and officials from China and other countries responded quickly, controlled the epidemic well thus far, and characterized the virus by using new technologies and surveillance tools that were made possible by their preparedness efforts. Here, we review the characteristics of the H7N9 viruses that were identified while controlling the spread of the disease. It was summarized and discussed from the perspectives of molecular epidemiology, clinical features, virulence and pathogenesis, receptor binding, T-cell responses, monoclonal antibody development, vaccine development, and disease burden. These data provide tools for minimizing the future threat of H7N9 and other emerging and re-emerging viruses, such as SARS-CoV-2.
Animals
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COVID-19
;
China/epidemiology*
;
Humans
;
Influenza A Virus, H7N9 Subtype
;
Influenza in Birds/epidemiology*
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Influenza, Human/prevention & control*
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Poultry
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SARS-CoV-2
7.Role and mechanism of FOXG1 in invasion and metastasis of colorectal cancer.
Haixia WU ; Cheng QIAN ; Chungang LIU ; Junyu XIANG ; Di YE ; Zhenfang ZHANG ; Xianquan ZHANG
Chinese Journal of Biotechnology 2018;34(5):752-760
This study was aimed to investigate the effect of Forkhead Box G1 (FOXG1) on the epithelial-mesenchymal transition (EMT) of colorectal cancer (CRC) cells and the underlying mechanism. For this purpose, FOXG1 lentiviral interference (shRNA) plasmid and expression plasmid were constructed. Western blotting was used to analyze the expression of FOXG1 protein in five CRC cells, namely RKO, SW480, SW620, LoVo and DLD-1. The shRNA fragment of FOXG1 (shFOXG1) was designed and synthesized. Recombinant plasmids were obtained with the aid of DNA recombination technique. Double digestion and sequencing were used to identify the recombinant plasmids, and then lentivirus packaging, purification and stable transfection were carried out. Additionally, stable CRC cell lines were screened out. The changes of FOXG1 knockdown and overexpression efficiency, E-cadherin, Vimentin, Fibronectin, Snail, Twist mRNA and protein were investigated respectively by Western blotting and qRT-PCR analysis. Furthermore, the changes of cell morphology after knockdown and cell migration ability were evaluated respectively with optical microscopy, scratch test and Transwell assay. FOXG1 had the highest protein expression in RKO and the lowest in DLD-1 among the five CRC cells. Compared with those of the control group, the cell morphology in FOXG1 knockdown RKO group was changed from spindle into round or polygonal shape, cell polarization was enhanced and tight junction assembly was acclerated while cell migration distance was noticeably decreased. Moreover, the number of cells invaded and migrated through chambers was significantly reduced. Among these key factors of EMT, the expression of E-cadherin was increased while the expressions of Vimentin, Fibronectin, Snail and Twist were decreased. The opposite was the case in the overexpressed FOXG1 group. The overexpression of FOXG1 in CRC promoted the invasion and metastasis of CRC cells and played a crucial role in regulating the EMT. Thus, FOXG1 might be a novel therapeutic target in CRC treatment.
8.Effect of remote post-ischemic conditioning on the prognosis of elderly patients with acute cerebral infarction
Haixia LI ; Qian GUO ; Yuezhen SHEN ; Di LUO ; Xinqiang WANG
Chinese Journal of Geriatrics 2018;37(11):1218-1222
Objective To observe the effect of remote post-ischemic conditioning(RPIOC)on the cerebral blood flow,neural function and prognosis of patients with acute cerebral infarction and the risk factors for short-term prognosis.Methods 133 patients with acute cerebral infarction in the Second Hospital of Beijing from January 2016 to December 2017 were selected,and randomly divided into the RIPOC group(66 cases,with RPIOC)and the control group(67 cases,without RIPOC).In the first day after hospital,patients in the RIPOC group were given RIPOC,which was tightening the left aim with a tonometer bandage for 5 minutes per time and 2 times a day at an interval of 5 minutes.All patients were provided routine treatment.All patients' cerebral blood flow,neural function and survival data were recorded.Recovery was assessed by modified Rankin Scale(mRS)180 d after stroke.Logistic regression was used to evaluate the risk factors for prognosis.Results Of the 133 patients enrolled,there were 67 males.The mean age was (73.1 ± 10.1)year.Basic clinical characteristics,neural function and cerebral blood flow were similar between groups(P>0.05).After 10 d treatment,cerebral blood flow and neural function was significantly increased (P<0.05)in the RIPOC group.After 180 d follow up,the RIPOC group had significantly higher rate of adverse cerebrovascular events(P<0.05).Logistic regression analyses demonstrated that advanced age(P =0.003),hypertension(P =0.03)and high NIHSS score(P =0.005)were all risk factors for prognosis.Conclusions RIPOC can enhance the cerebral blood flow,activities of daily living,limb function and prognosis.However,it does not reduce the risk of mortality.Advanced age,hypertension and high NIHSS score are risk factors for short-term prognosis.
9.RDAWA-based reader-driven acquisition of library holdings
Haixia XU ; Yingxia XU ; Di WU
Chinese Journal of Medical Library and Information Science 2015;(2):67-70
A collective intelligent perception-supported and RDAWA-based reader-driven acquisition model of li-brary holdings was proposed with the development of academic library holdings as its background .The design ideas of RDAWA were described , the master framework of RDAWA was analyzed , the considerations in design of RDAWA that simplified the input procedure and met the reading requirements of readers were elaborated with the biblio-graphic information database , data analysis module and acquisition order generation algorithm summarized .
10.Development and evaluation of an inquiry scale for diagnosis of heart system syndromes in traditional Chinese medicine.
Guoping LIU ; Yiqin WANG ; Ying DONG ; Naiqing ZHAO ; Zhaoxia XU ; Fufeng LI ; Haixia YAN ; Peng QIAN ; Rui GUO ; Xiaodan ZHANG ; Dan DI
Journal of Integrative Medicine 2009;7(1):20-4
To develop an inquiry scale for diagnosis of heart system syndromes, and to discuss the provisional standardization of the inquiry method in traditional Chinese medicine (TCM).

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