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.Construction of risk prediction model based on ultrasound signs of prenatal fetal and accessory for adverse pregnancy outcomes of patients with placental implantation disease
Changchun ZHANG ; Hongwei LIANG ; Yukun ZHOU
China Medical Equipment 2025;22(2):82-87
Objective:To construct a risk prediction model based on ultrasound signs of prenatal fetal and accessory for adverse pregnancy outcomes of patients with placental implantation disease.Methods:This study is a prospective study.A total of 120 pregnant women who underwent hospital delivery in Tangshan maternal and child health care hospital from January 2022 to June 2023 were selected as the research objects,including 39 cases with placenta implantation and 81 cases without placenta implantation.The cases with placenta implantation were divided into adverse pregnancy group(19 cases)and good pregnancy group(20 cases)according to the different pregnancy outcome.The placental location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line,and cervical sinusoids of all cases were compared.Logistic multivariate analysis was adopted to verify and construct the risk model of placenta implantation and adverse pregnancy outcomes.Results:There was significant difference in placental thickness between the cases with placenta implantation[(37.26±0.52)cm]and the cases without placenta implantation[(36.02±0.25)cm](t=14.127,P<0.05).There were significant differences between the two groups in the placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids(x2=4.061,5.112,8.381,4.771,17.021,32.341,P<0.05),respectively.There was significant difference in placental thickness between the adverse pregnancy group[(36.85±0.42)cm]and the good pregnancy group[(37.45±0.24)cm](t=5.440,P<0.05).There were statistically significant differences between the two groups in the cases number of placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids(x2=6.037,6.041,11.351,6.741,12.321,13.552,P<0.05),respectively.The results of multivariate analysis indicated that placental thickness,placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids were the risk factors for placenta implantation of pregnant women(OR=3.300,3.374,2.995,3.384,2.843,2.878,3.053,P<0.05),respectively.Placental thickness,placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids were respectively the risk factors that caused adverse pregnancy outcomes for pregnant women(OR=2.821,2.886,3.287,3.377,2.942,3.177,3.168,P<0.05).The result of receiver operating characteristic(ROC)curve indicated that the area under curve(AUC)values of the above model for placenta implantation and adverse pregnancy outcome were larger than 0.700.Conclusion:The prediction based on the model of ultrasound signs of prenatal fetal and accessory is more accurate,which can be used as important reference in clinically early diagnosis.
3.Construction of risk prediction model based on ultrasound signs of prenatal fetal and accessory for adverse pregnancy outcomes of patients with placental implantation disease
Changchun ZHANG ; Hongwei LIANG ; Yukun ZHOU
China Medical Equipment 2025;22(2):82-87
Objective:To construct a risk prediction model based on ultrasound signs of prenatal fetal and accessory for adverse pregnancy outcomes of patients with placental implantation disease.Methods:This study is a prospective study.A total of 120 pregnant women who underwent hospital delivery in Tangshan maternal and child health care hospital from January 2022 to June 2023 were selected as the research objects,including 39 cases with placenta implantation and 81 cases without placenta implantation.The cases with placenta implantation were divided into adverse pregnancy group(19 cases)and good pregnancy group(20 cases)according to the different pregnancy outcome.The placental location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line,and cervical sinusoids of all cases were compared.Logistic multivariate analysis was adopted to verify and construct the risk model of placenta implantation and adverse pregnancy outcomes.Results:There was significant difference in placental thickness between the cases with placenta implantation[(37.26±0.52)cm]and the cases without placenta implantation[(36.02±0.25)cm](t=14.127,P<0.05).There were significant differences between the two groups in the placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids(x2=4.061,5.112,8.381,4.771,17.021,32.341,P<0.05),respectively.There was significant difference in placental thickness between the adverse pregnancy group[(36.85±0.42)cm]and the good pregnancy group[(37.45±0.24)cm](t=5.440,P<0.05).There were statistically significant differences between the two groups in the cases number of placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids(x2=6.037,6.041,11.351,6.741,12.321,13.552,P<0.05),respectively.The results of multivariate analysis indicated that placental thickness,placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids were the risk factors for placenta implantation of pregnant women(OR=3.300,3.374,2.995,3.384,2.843,2.878,3.053,P<0.05),respectively.Placental thickness,placenta location,posterior low gyrus vocal cords of placenta,placental multiple lacunae,basal blood vessels,bladder line and cervical sinusoids were respectively the risk factors that caused adverse pregnancy outcomes for pregnant women(OR=2.821,2.886,3.287,3.377,2.942,3.177,3.168,P<0.05).The result of receiver operating characteristic(ROC)curve indicated that the area under curve(AUC)values of the above model for placenta implantation and adverse pregnancy outcome were larger than 0.700.Conclusion:The prediction based on the model of ultrasound signs of prenatal fetal and accessory is more accurate,which can be used as important reference in clinically early diagnosis.
4.Progress of Research on Advanced Non-Small Cell Lung Cancer with HER-2 Mutation
Liang ZHANG ; Changliang YANG ; Peidong LI ; Ying CHENG
Cancer Research on Prevention and Treatment 2025;52(2):87-92
Anti-tumor drug research and development in non-small cell lung cancer (NSCLC) is rapidly developing, and the clinical application of high-throughput sequencing technology is also becoming widespread. Accordingly, researchers are focusing on human epidermal growth factor receptor-2 (HER-2) gene as a rare target of NSCLC, and a series of exploratory studies has been performed. Traditional chemotherapy and immunotherapy are unsatisfactory in the HER-2 mutant population, whereas the survival improvement of anti-HER-2 monoclonal antibodies and pan-HER inhibitors is limited. The development of antibody drug conjugate (ADC) ushers in a turning point for HER-2-mutated NSCLC, and new ADC drugs represented by trastuzumab deruxtecan are making a breakthrough. It opens up a new era of precision therapy for advanced HER-2-mutated NSCLC. Additionally, novel HER-2 inhibitors show very encouraging initial efficacy and safety, and clinical trials are ongoing. This review focuses on the latest progress of research on HER-2-mutated NSCLC.
5.Value of internal stratification analysis of abdominal wall muscles in predicting complications after orthotopic liver transplantation
Xin SHI ; Chongxiao LIANG ; Bei ZHANG ; Jiping WANG
Journal of Clinical Hepatology 2025;41(2):314-321
ObjectiveTo divide the muscle into different subzones according to different density ranges using the stratified analysis on the basis of myosteatosis, and to investigate the effect of muscle density changes on complications (Clavien-Dindo grade ≥Ⅲ) after orthotopic liver transplantation (OLT). MethodsA retrospective analysis was performed for the medical records of 145 patients who underwent OLT in The First Hospital of Jilin University from May 2013 to September 2020, and with the plain CT scan images of the largest level of lumbar 3 vertebrae of each patient as the original data, Neusoft Fatanalysis software was used to measure related muscle parameters. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. The chi-square test or Fisher test was for comparison of categorical data between two groups. RIAS software was used to extract clinical features and perform analysis and modeling, and three machine learning models of logistic regression (LR), support vector machine (SVM), and random forest (RFC) were constructed. The receiver operating characteristic (ROC) curve, the calibration curve, and the decision curve were plotted for each model to calculate the area under the ROC curve (AUC), sensitivity, specificity, precision, F1 score, and accuracy. ResultsThe three machine learning models of LR-C, SVM-C, and RFC-C were established based on the 7 clinical features before muscle stratification analysis, among which the RFC-C model had an AUC of 0.803, a sensitivity of 0.588, and a specificity of 0.778 in the test set. Among the models of LR-CS, SVM-CS, and RFC-CS established based on the 16 clinical features after muscle stratification analysis, the LR-CS and SVM-CS models had an AUC of 0.852 in the test set, with a sensitivity of 0.765 and 0.706, respectively, and a specificity of 0.889 and 0.926, respectively. Comparison of the AUC, sensitivity, specificity, precision, F1 score, and accuracy of each model in the test set before and after muscle stratification analysis showed that there were improvements in the parameters of the predictive model after muscle stratification analysis. Comparison of the decision curves and calibration curves of each predictive model showed that the LR-CS and SVM-CS models had good efficacy in predicting postoperative complications (Clavien-Dindo grade≥Ⅲ) in OLT patients. ConclusionOn the basis of myosteatosis, the division of the muscle into different subzones according to different densities using the stratified analysis has a certain value in predicting postoperative complications in patients with OLT.
6.Latent profile analysis of hospice care attitudes among nurses in a geriatric hospital
Lingyu WANG ; Liang BI ; Xuejing WANG ; Changchun LUO ; Zongjuan MA
Chinese Journal of Modern Nursing 2025;31(20):2679-2685
Objective:To explore the latent categories of hospice care attitudes among nurses in a geriatric hospital and to analyze the characteristic differences among these categories.Methods:A total of 434 in-service nurses from Beijing Geriatric Hospital were selected by convenience sampling from April to May 2024. Data were collected using the general information questionnaire, the Chinese version of the Frommelt Attitude Toward Care of the Dying Scale Form B, the Self-Efficacy in Coping with Death Scale, and the General Well Being Schedule. Latent profile analysis was used to identify potential categories of hospice care attitudes, and Logistic regression analysis was conducted to examine influencing factors.Results:A total of 434 questionnaires were distributed, and 431 valid responses were received, with a valid response rate of 99.31% (431/434). The hospice care attitudes of the 431 nurses were categorized into two latent profiles: "negative attitude-low communication willingness type" (55.45%, 239/431) and "positive attitude-high caring type" (44.55%, 192/431). Logistic regression analysis showed that participating in palliative care continuing education within the past year, having discussed death with patients, perceiving difficulties in caring for dying patients, self-efficacy in coping with death, and subjective well-being were statistically significant influencing factors of the latent categories of hospice care attitudes ( P<0.05) . Conclusions:Hospice care attitudes among nurses in geriatric hospitals can be classified into two latent categories: "negative attitude-low communication willingness type" and "positive attitude-high caring type". These are influenced by many factors. Nursing administrators should develop targeted interventions to support nurses in coping with stressors effectively and improving the quality of life of terminally ill patients.
7.Three-dimensional (3D) printing-assisted freeze-casting of processed pyritum-doped β-tricalcium phosphate biomimetic scaffold with angiogenesis and bone regeneration capability.
Chenxu WEI ; Zongan LI ; Xiaoyun LIANG ; Yuwei ZHAO ; Xingyu ZHU ; Haibing HUA ; Guobao CHEN ; Kunming QIN ; Zhipeng CHEN ; Changcan SHI ; Feng ZHANG ; Weidong LI
Journal of Zhejiang University. Science. B 2025;26(9):863-880
Bone repair remains an important target in tissue engineering, making the development of bioactive scaffolds for effective bone defect repair a critical objective. In this study, β-tricalcium phosphate (β-TCP) scaffolds incorporated with processed pyritum decoction (PPD) were fabricated using three-dimensional (3D) printing-assisted freeze-casting. The produced composite scaffolds were evaluated for their mechanical strength, physicochemical properties, biocompatibility, in vitro pro-angiogenic activity, and in vivo efficacy in repairing rabbit femoral defects. They not only demonstrated excellent physicochemical properties, enhanced mechanical strength, and good biosafety but also significantly promoted the proliferation, migration, and aggregation of pro-angiogenic human umbilical vein endothelial cells (HUVECs). In vivo studies revealed that all scaffold groups facilitated osteogenesis at the bone defect site, with the β-TCP scaffolds loaded with PPD markedly enhancing the expression of neurogenic locus Notch homolog protein 1 (Notch1), vascular endothelial growth factor (VEGF), bone morphogenetic protein-2 (BMP-2), and osteopontin (OPN). Overall, the scaffolds developed in this study exhibited strong angiogenic and osteogenic capabilities both in vitro and in vivo. The incorporation of PPD notably promoted the angiogenic-osteogenic coupling, thereby accelerating bone repair, which suggests that PPD is a promising material for bone repair and that the PPD/β-TCP scaffolds hold great potential as a bone graft alternative.
Calcium Phosphates/chemistry*
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Animals
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Bone Regeneration
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Rabbits
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Tissue Scaffolds
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Printing, Three-Dimensional
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Humans
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Human Umbilical Vein Endothelial Cells
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Neovascularization, Physiologic
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Osteogenesis
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Tissue Engineering/methods*
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Biomimetic Materials
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Cell Proliferation
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Angiogenesis
8.Five-year outcomes of metabolic surgery in Chinese subjects with type 2 diabetes.
Yuqian BAO ; Hui LIANG ; Pin ZHANG ; Cunchuan WANG ; Tao JIANG ; Nengwei ZHANG ; Jiangfan ZHU ; Haoyong YU ; Junfeng HAN ; Yinfang TU ; Shibo LIN ; Hongwei ZHANG ; Wah YANG ; Jingge YANG ; Shu CHEN ; Qing FAN ; Yingzhang MA ; Chiye MA ; Jason R WAGGONER ; Allison L TOKARSKI ; Linda LIN ; Natalie C EDWARDS ; Tengfei YANG ; Rongrong ZHANG ; Weiping JIA
Chinese Medical Journal 2025;138(4):493-495
9.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
10.Quality Evaluation of Black Panacis Quinquefolii Radix Based on Neuroprotective Spectrum-effect Relationship
Yuting YANG ; Shuyun LIANG ; Shanshan LI ; Yulong YANG ; Ziqi YANG ; Guangzhi CAI ; Liru ZHAO ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):149-156
ObjectiveTo clarify the neuroprotective effect of black Panacis Quinquefolii Radix(PQR) and explore its active ingredients, with the aim of establishing an activity-oriented quality evaluation method. MethodsTransgenic Tg(HuC∶EGFP) zebrafish was used to establish a neuronal injury model by aluminum chloride immersion. Different doses(10, 20 mg·L-1) of PQR and black PQR ethanol extracts were administered. The neuroprotective effects of PQR and black PQR were compared by analyzing the fluorescent area and intensity of zebrafish neurons. Based on ultra-performance liquid chromatography(UPLC), a fingerprint profile of black PQR was established, followed by principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA). Differential components were screened using the criteria of variable importance in the projection(VIP) value>1 and P<0.05. The neuroprotective activity of 14 batches of black PQR was assessed, and Spearman correlation analysis was used to identify saponins related to neuroprotective activity, which were then validated. Based on the above results, active marker components were determined, and an UPLC method was established for their quantitation with clear content limits. ResultsPharmacological efficacy results showed that both PQR and black PQR at different doses could significantly improved neuronal damage in zebrafish. At a dose of 20 mg·L-1, black PQR demonstrated superior efficacy(P<0.05). The fingerprint similarities of 14 batches of black PQR were>0.94, with 26 common peaks identified. Through comparison with the reference standards, 8 components were confirmed, including peak 1(ginsenoside Rg1), peak 2(ginsenoside Re), peak 5(ginsenoside Rb1), peak 9(ginsenoside Rd), peak 16[ginsenoside 20(S)-Rg3], peak 17[ginsenoside 20(R)-Rg3], peak 18(ginsenoside Rk1), and peak 19(ginsenoside Rg5). The results of PCA and OPLS-DA indicated that there were differences in saponins among black PQR samples from different origins, and 12 differential components were screened. All 14 batches of black PQR exhibited good protective effects on zebrafish neurons, with Shaanxi-produced black PQR showing superior protective effects compared to the other three production regions. Spearman correlation analysis revealed that a total of 11 components, including ginsenosides 20(S)-Rg3, 20(R)-Rg3, Rk1 and Rg5, showed a significant positive correlation with the neuroprotective effect in zebrafish(P<0.05). The activity validation results indicated that ginsenosides 20(S)-Rg3, 20(R)-Rg3, Rk1 and Rg5 were the primary components responsible for the neuroprotective effects of black PQR. Quantitative analysis showed that the content of ginsenoside 20(S)-Rg3 in 14 batches of black PQR ranged from 0.17% to 0.52%, and the repair rate of neuronal damage ranged from 42.77% to 97.83%. ConclusionBased on the fingerprint and neuronal protective activity, the spectrum-effect related quality control model of black PQR was established, with ginsenoside 20(S)-Rg3 as the quality control index, and the neuronal damage repair rate≥60% as the evaluation standard, the minimum limit of ginsenoside 20(S)-Rg3 in black PQR should be≥0.20%.

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