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.Guidelines for the perioperative diagnosis and treatment of oncogene-driven non-small cell lung cancer (2026)
Weidong WANG ; Yongbin LIN ; Hui TIAN ; Gaofeng LI ; Shun XU ; Yongde LIAO ; Haitao MA ; Junfeng LIU ; Chundong GU ; Xiaolong YAN ; Shumin WANG ; Daqiang SUN ; Jianyang LIU ; Tao XUE ; Shaohua MA ; Zhigang LI ; Shuanghu YUAN ; Gen LIN ; Ling CAI ; Jianping ZHOU ; Wenzhao ZHONG ; Naixin LIANG ; Yi HAN ; Junfeng WANG ; Weidong ZHANG ; Xin WANG ; Lianjuan CHEN ; Lunxu LIU ; Xiuyi ZHI ; Lanjun ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(09):1337-1353
Lung cancer constitutes the most prevalent and lethal malignant tumor in China. Approximately 85% of lung cancer diagnoses correspond to the non-small cell histological subtype [non-small cell lung cancer (NSCLC)]. Despite surgery being the mainstay for early-stage disease, postoperative recurrence remains high and adjuvant chemotherapy offers limited benefit. In recent years, targeted therapy has demonstrated substantial advantages in driver mutation-positive NSCLC. To this end, the Lung Cancer Medical Education Committee of the Chinese Medical Education Association developed guidelines based on a systematic review of evidence through November 2025, using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach and a modified Delphi method. Focusing on epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), and addressing ROS proto-oncogene 1 (ROS1), B-Raf proto-oncogene serine/threonine kinase (BRAF) V600E mutation, and mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping, the guideline covers molecular testing, neoadjuvant/adjuvant therapy, perioperative strategies, minimal residual disease monitoring, and postoperative surveillance. It defines testing requirements, specifies stage-directed and subtype-specific treatments, and standardizes minimal residual disease monitoring. These recommendations emphasize precision and feasibility to improve survival and quality of life.
3.Targeting functional cure of hepatitis B and establishing a China-specific evaluation benchmark for novel hepatitis B drugs: Interpretation of Q&A Document for the technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection
Xie’er LIANG ; Yanhang GAO ; Junqi NIU ; Jinlin HOU
Journal of Clinical Hepatology 2026;42(8):1778-1781
Achieving the functional cure (clinical cure) of hepatitis B is the primary goal of current clinical hepatology and novel drug research and development. In 2023, the Center for Drug Evaluation, National Medical Products Administration, issued Technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection to establish a top-level regulatory framework. Supporting Q&A documents for public consultation were released in July 2026 to provide practical policy guidance for the research and development of novel hepatitis B drugs, which has far-reaching implications for clinical investigators, innovative pharmaceutical enterprises, and the development of hepatology.
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.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
7.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
8.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%.
9.Electroencephalographic characteristics of mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes
Journal of Apoplexy and Nervous Diseases 2025;42(12):1119-1125
Objective To investigate the electroencephalographic (EEG) manifestations of children with mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (MELAS), to explore the EEG characteristics of such patients and their correlation with neuroimaging findings, and to provide a reference for the early clinical diagnosis of MELAS. Methods A retrospective analysis was performed for the EEG and neuroimaging data of 11 children who were admitted to Department of Pediatric Neurology, The First Hospital of Jilin University, from January 2016 to December 2024 and were diagnosed with MELAS by genetic testing. Results There were varying degrees of EEG background abnormalities in the children with MELAS. Interictal epileptiform discharges predominantly involved the posterior head region. Seizures mainly manifested as focal seizures, frequently originating from the posterior head regions. Serial EEG and neuroimaging examinations showed changes in lesion sites over time, with consistent localization of lesions in more than half of the cases based on the two examinations, predominantly involving the posterior head regions. Conclusion In clinical practice, most children with MELAS have the initial manifestation of seizures, and the possibility of MELAS should be considered in case of the characteristic changes in EEG and imaging examinations, so as to provide help for early identification and diagnosis.
Electroencephalography
10.Quality Evaluation of Zhuye Shigao Granules and Its Therapeutic Effect on Mice with Cold-dampness Pestilence Attacking Lung Syndrome
Haihong LI ; Jiaqi SHEN ; Liwen LIANG ; Ziqi YANG ; Yuting YANG ; Shuyun LIANG ; Zhiliang SUN ; Jiannan LI ; Guangzhi CAI ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):182-190
ObjectiveTo establish a quality evaluation method for Zhuye Shigao granules(Zhuye Shigaotang) based on fingerprint and determination of index components, and to investigate the therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome. MethodsThe fingerprint of Zhuye Shigao granules was established by high performance liquid chromatography(HPLC), and the methods for determination of total calcium, orientin, isoorientin, ginsenosides Rg1, Re and Rb1 and other 2 index components were established. Fifty ICR mice were randomly divided into the blank group, model group, Zhuye Shigao granules low, medium and high dose groups(9.3, 18.6, 37.2 g·kg-1·d-1), with 10 mice in each group. In addition to the blank group, the model mice with cold-dampness pestilence attacking lung syndrome was prepared by nasal drip of lipopolysaccharide combined with cold-dampness environment. Each administration group was given the corresponding liquid by gavage according to the dose, while the blank group and model group were given the same volume of normal saline by gavage. Then, the body temperature and organ index of mice in each group were measured, hematoxylin-eosin(HE) staining was used to investigate the lung tissue injury of mice in each group, and enzyme-linked immunosorbent assay(ELISA) was used to detect the changes of tumor necrosis factor-α(TNF-α), interleukin(IL)-lβ, IL-6, IL-10 levels in serum and lung tissue, as well as immunoglobulin(Ig)A and IgM levels in serum. ResultsThe fingerprint similarity of 10 batches of Zhuye Shigao granules was>0.950, and 20 common peaks were calibrated. Seven of them were identified, including peak 11(isoorientin), peak 12(orientin), peak 14(apioside liquiritin), peak 15(liquiritin), peak 17(apioside isoliquiritin), peak 19(isoliquiritin) and peak 20(liquiritigenin). The results of quantitative analysis showed that the content range of each index component in 10 batches of Zhuye Shigao granules was as follows:Total calcium of 9.978-11.294 mg·g-1, isoorientin of 0.033-0.041 mg·g-1, orientin of 0.046-0.055 mg·g-1, ginsenoside Rg1+ginsenoside Re of 0.748-0.762 mg·g-1, ginsenoside Rb1 of 0.151-0.197 mg·g-1, liquiritin of 1.106-1.366 mg·g-1, glycyrrhizic acid of 0.904-1.182 mg·g-1. Compared with the blank group, the body temperature of mice in the model group was significantly increased, the organ indexes of liver, lung and spleen were significantly decreased, the organ index of thymus was significantly increased, HE staining of lung tissue showed infiltration of inflammatory cells, a small amount of serous exudation was observed in the alveoli, and lung tissue was damaged. After the intervention of Zhuye Shigao granules, the pathological changes were improved compared with the model group. The expression levels of IL-1β, IL-6 and TNF-α were significantly increased, the expression level of IL-10 was significantly decreased in serum and lung tissue. The levels of IgA and IgM in serum were significantly decreased(P<0.01). Compared with the model group, the body temperature, the organ indexes and immune factor levels in serum and lung tissue of mice in the Zhuye Shigao granules medium and high dose groups were significantly reduced(P<0.05, P<0.01). ConclusionIn this study, the quality evaluation of Zhuye Shigao granules was carried out based on fingerprint combined with determination of index components, and the fingerprint of four herbs(Lophatheri Herba, Ophiopogonis Radix, Pinelliae Rhizoma and Glycyrrhizae Radix et Rhizoma) in this formula and the determination of 8 index components were established. The therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome may be related to inhibiting inflammatory response and mediating immune regulation.

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