1.Exploring on Processing Mechanism of Enhanced "Invigorating Spleen and Stopping Diarrhea" Effect of Soil-fried Atractylodis Macrocephalae Rhizoma Based on "Microscopic Characterization, Chemical Analysis and Pharmacodynamic Evaluation" Trinity
Guoshun SHAN ; Yuyan XIAO ; Chu YUAN ; Xiuai CHEN ; Qimiao ZHAO ; Xiang LIU ; Hao WU ; Ke ZHANG ; Siqi LIU ; Yongduo YU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):182-193
ObjectiveTo analyze the processing mechanism underlying the enhanced effect of invigorating spleen and stopping diarrhea of soil-fried Atractylodis Macrocephalae Rhizoma(AMR) by analyzing the changes of microstructure, chemical composition and anti-ulcerative colitis(UC) activity before and after soil stir-frying. MethodsThe microstructure and elemental composition of AMR before and after soil stir-frying were analyzed by scanning electron microscopy-energy dispersive spectroscopy(SEM-EDS), to investigate the differences in microstructure and the underlying causes. Ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS) coupled with UNIFI 1.9.2 natural product analysis platform were used to analyze and identify the chemical constituents in raw and soil-fried products, and multivariate statistical methods including principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to explore the differences and sources of chemical constituents between them. A dextran sulfate sodium(DSS)-induced UC mouse model was established. The method of disease activity index(DAI) was used to evaluate the severity of intestinal inflammation. Hematoxylin-eosin(HE) staining was used to observe the pathological changes of colon tissue, enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of inflammatory factors, Real-time quantitative polymerase chain reaction(Real-time PCR) and Western blot were used to analyze the expressions of key genes and proteins involved in the intestinal mucosal barrier. The 16S rRNA sequencing was used to evaluate the diversity of intestinal flora, headspace gas chromatography-mass spectrometry(HS-GC-MS) was used to explore the levels of short-chain fatty acids(SCFAs) in feces. Base on the above findings, this paper investigated the effects of raw and soil-fried AMR on the biological, chemical, mechanical and immune barriers of model animals, and the differences in pharmacological effects and underlying mechanisms from the perspective of regulating the intestinal mucosal barrier in UC mice. ResultsSEM observation revealed numerous hearth soil particles on the surface of soil-fried AMR, accompanied by bubble-like bulges. At the same time, there were many cracks and folds on the surface of the hearth soil. EDS analysis revealed that the contents of Si, Al, Mg and Ca in soil-fried AMR were significantly higher than those of raw products, and these elements constituted the primary components of hearth soil. UPLC-Q-TOF-MS combined with database comparison was used to identify the chemical constituents of raw and soil-fried AMR. In positive ion mode, a total of 132 components were identified, primarily comprising three categories of terpenoids, polyphenols and amino acids. In negative ion mode, a total of 40 components were identified, primarily polyphenolic and glycoside compounds. Among them, the contents of sesquiterpenes and polyphenolic acids were changed significantly before and after processing. Soil-fried AMR could reduce the DAI score of UC mice, alleviate the shortening of colon length, reduce the levels of pro-inflammatory factors such as interleukin(IL)-17, IL-18, γ-interferon(IFN-γ) and tumor necrosis factor(TNF)-α in serum, increase the levels of anti-inflammatory factors such as secretory immunoglobulin A(sIgA), IL-10, IL-4 and transforming growth factor-β(TGF-β) in serum, increase the expressions of key genes and proteins of intestinal mucosal barrier such as tight junction protein-1(ZO-1), Occludin, Claudin-1 and mucin 2(MUC2) in colonic mucosa, and improve the disorders of intestinal flora diversity and the levels of SCFAs(P<0.05, P<0.01). The raw and stir-fried products of AMR also exhibited the aforementioned effects, but they were weaker than the soil-fried products. Additionally, the auxiliary material hearth soil also had a certain pharmacodynamic effect. ConclusionSoil-fried AMR can enhance the protective effect on intestinal mucosal barrier in UC mice. These changes or heating-induced alterations in the microscopic structure and chemical composition of AMR may be attributed to the dual effects of adsorption of hearth soil.
2.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
3.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
4.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
5.Study on the extraction, separation and purification process of Actinoside E
Fangliang QIAO ; Yiping JIANG ; Tianshuang XIA ; Aijun LIU ; Kai ZHAO ; Hailiang XIN
Journal of Pharmaceutical Practice and Service 2026;44(3):137-143
Objective To optimize the extraction, separation and purification process of Actinoside E. Methods Single factor experiment combined with orthogonal test was used to determine the optimal extraction process of Actinoside E using its content as an index. The extracts were separated and purified by optimizing the chromatographic conditions of macroporous resin, silica gel and ODS column. Results 25 times amount of 55% ethanol with heating reflux at 95℃ for one hour were used as the optimal extraction process of Actinoside E. The optimum separation and purification process was as follows: D101 macroporous resin column was eluted with 7 BV of 50% ethanol, silica gel column was eluted with 5 BV of ethyl acetate-ethanol(10∶1)and 50% methanol eluted fraction was purified repeatedly by ODS column to obtain Actinoside E. The transfer rate of Actinoside E in the whole process was 53.70%, the yield was 0.35%, and the purity was 99.9%. Conclusion The process is stable and viable, which can provide material foundation for the development and utilization of Actinoside E.
6.Changing trajectories of sleep problems and teacher support among first year junior high school students
FAN Xuemei, LIU Guangzeng, CHENG Gang, PAN Yangu, ZHAO Zhanfeng, ZHU Zhengguang, ZHANG Dajun
Chinese Journal of School Health 2026;47(2):241-245
Objective:
To examine the changing trajectories of sleep problems and teacher support among first year middle school students and their covariant relationship,so as to provide theoretical basis for the prevention strategy of sleep problems for the first year junior high school students.
Methods:
In September 2020, a multistage cluster random sampling method was used to select 1 027 first year junior high school students from two schools of Anshun and Guiyang cities in Guizhou Province for survey and follow up assessments (T1:September 2020, T2:October 2020, T3:November 2020, T4:December 2020). The Student Perceived Teacher Support Behavior Questionnaire and Pittsburgh Sleep Quality Index Scale were administered to assess sleep problems and teacher support among first year junior high school students. Spearman correlation analysis was used to examine the relationship between sleep problems and teacher support. A multivariate latent growth curve model was employed to analyze the changing trajectories and covariant relationship between teacher support and sleep problems, followed by a multi group analysis.
Results:
For first year junior high school students, teacher support scores at T1-T4 were 4.00 (3.47, 4.53), 4.00 (3.47, 4.58), 3.95 (3.47, 4.61) and 4.00 (3.48, 4.67), respectively; sleep problem scores were 0.83 (0.50, 1.17), 0.67 (0.50, 1.17), 0.83 (0.50, 1.17) and 0.67 (0.33, 1.17), respectively. Spearman correlation analysis revealed that teacher support and sleep problems were negatively correlated across all four period ( r =-0.28 to -0.14, all P <0.01). Teacher support perceived by students showed a linear increasing trend (intercept=3.98, slope=0.02), while sleep problems showed a linear decreasing trend (intercept=0.86, slope= -0.02 ) (all P <0.05). The multivariate latent growth model indicated that the rate of increase in teacher support after enrollment effectively predicted the rate of decrease in sleep problem levels ( β=-0.34, P <0.01). Multigroup analysis showed that the covariant relationship was not moderated by gender or boarding status (both P >0.05).
Conclusions
The increase in teacher support experienced by first year junior high school students during the transition period after enrollment, accompanied by a reduction in sleep problems, constitutes a dynamic protective process. The process is not moderated by gender or boarding status.
7.Analysis of the disease burden of hypertensive heart disease among individuals aged≥60 years globally and in China from 1990 to 2021
Jiali LI ; Chunzhen REN ; Fan LIU ; Keyan WANG ; Zhijiang BI ; Xiaoxiao ZHAO ; Lixin KE ; Haibo WANG ; Wenxi PENG ; Zhifei WANG ; Qiang ZHANG ; Peng XU ; Yingdong LI ; Xiuxiu DENG ; Xinke ZHAO ; Cuncun LU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(02):281-290
Objective To systematically analyze the characteristics of the disease burden of hypertensive heart disease (HHD) in the elderly (≥60 years) globally and in China from 1990 to 2021, and to predict its future trends from 2022 to 2040, with the aim of providing data support for optimizing comprehensive prevention and control strategies for HHD. Methods Based on the Global Burden of Disease (GBD) 2021 database, the number of prevalent cases and disability-adjusted life years (DALYs) of HHD in the elderly were extracted for the world, China, and five regions categorized by sociodemographic index (SDI). Joinpoint regression was used to analyze the temporal trends of age-standardized prevalence rate and age-standardized DALYs rate of HHD in the elderly. A three-factor decomposition method was applied to evaluate the relative contributions of aging, population growth, and epidemiological changes to the variations in the elderly HHD burden. Additionally, a Bayesian age-period-cohort model was used to predict the elderly HHD burden from 2022 to 2040. Results In 2021, the number of prevalent elderly HHD cases reached 10 283 000 globally and 3 412 400 in China, representing increases of 179.20% and 159.20% respectively, compared with 1990. The DALYs of elderly HHD were 18 812 700 person-years globally and 4 731 400 person-years in China, rising by 76.08% and 29.45% respectively from 1990. Meanwhile, the growth rates of the number of prevalent cases and DALYs of elderly HHD varied across different SDI regions. From 1990 to 2021, the age-standardized prevalence rate of elderly HHD in China, as well as the age-standardized DALYs rate of elderly HHD both globally and in China, showed significant downward trends (all average annual percentage changes<0, all P<0.001). In 2021, the 70-74 years age group accounted for the highest proportion of prevalent cases and DALYs of elderly HHD, both globally and in China. Decomposition analysis revealed that population growth was the dominant factor driving the increase in the elderly HHD burden across all regions. The prediction model results indicated that the number of prevalent cases and DALYs of elderly HHD would continue to rise globally and in China from 2022 to 2040, with the growth rate of the elderly HHD burden in China between 2021 and 2040 expected to exceed the global average. Conclusion Over the past 32 years, although the age-standardized disease rates of elderly HHD have mainly shown a downward trend globally and in China, the absolute number of the disease burden has increased substantially. The projection model indicates a continued upward trajectory, with the growth rate in China higher than the global average. Therefore, there is an urgent need to implement precise prevention and control strategies to effectively mitigate the disease burden of elderly HHD.
8.Effect and mechanism of folic acid-modified NK cell-derived exosomes delivering reovirus against ovarian cancer
YE Rui1,2 ; DAI Xiaofeng3 ; LIU Xiong1 ; CHEN Liang4 ; ZHANG Jing5 ; ZHANG Yingchun5 ; GUO Ting6 ; ZHAO Xing1,2
Chinese Journal of Cancer Biotherapy 2026;33(2):120-131
[摘 要] 目的:开发新型溶瘤呼肠孤病毒(Reo)递送系统,以克服中和抗体对Reo的中和作用并提升其肿瘤靶向性。方法:通过切向流过滤联合超高速离心法制备自然杀伤细胞外泌体(NKexo),叶酸(FA)修饰后采用挤压法包载Reo,构建FA-NKexo-Reo递送系统;通过透射电镜(TEM)、纳米粒径分析、蛋白质印迹(WB)法、核磁共振氢谱及流式细胞术等技术表征其理化性质;采用CCK-8、流式细胞术、Transwell实验及激光共聚焦显微镜评估FA-NKexo-Reo递送系统体外细胞毒性及细胞摄取能力;通过人卵巢癌裸鼠皮下移植瘤模型评价FA-NKexo-Reo的肿瘤靶向性、疗效及安全性。结果:FA-NKexo-Reo粒径为(94.0 ± 28.5)nm,Zeta电位为(-21.26 ± 1.57)mV,包封率达(49.7 ± 15.6)%;在中和抗体的存在下,FA-NKexo-Reo对卵巢癌细胞SKOV3和A2780仍可表现出显著的细胞毒性(P < 0.01);荷瘤鼠活体成像显示FA-NKexo-Reo肿瘤靶向性显著优于NKexo组,肿瘤抑制率提升60%(P < 0.001)。结论:成功制备FA-NKexo-Reo递送系统,在中和抗体的存在下,FA-NKexo-Reo可保护并靶向递送Reo到高表达叶酸受体的卵巢癌细胞,从而增强Reo的抗肿瘤作用。
9.SNORA71A regulates the malignant biological behaviors of esophageal squamous cell carcinoma TE-1 cells via the TLR3/PD-L1 expression
SHEN Supenga ; LIANG Jiaa ; CAO Shirua ; ZHAO Yanb ; DONG Zhiminga ; LIU Leic
Chinese Journal of Cancer Biotherapy 2026;33(2):147-154
[摘 要] 目的:探讨核仁小RNA(snoRNA)71A通过TLR3/PD-L1通路对食管鳞状细胞癌(ESCC)细胞增殖、迁移及侵袭能力的影响。方法:qPCR检测52例ESCC患者的配对肿瘤组织、癌旁组织,以及人ESCC细胞中SNORA71A的表达情况。将反义寡核苷酸(SNORA71A-ASO-29、SNORA71A-ASO-102和NC-ASO)或小干扰RNA(siTLR3、siTLR3-NC)分别转染至人ESCC TE-1细胞,分别记为SNORA71A-ASO1组、SNORA71A-ASO2组、NC-ASO组及siTLR3组、siNC组。另外将过表达质粒pcDNA3.1-SNORA71A和pcDNA3.1空载体质粒分别转染至TE-1细胞,分别记为SNORA71A组和Vector组。细胞功能学实验(MTS实验、划痕愈合实验,以及Transwell侵袭实验)评估各组细胞在敲低或过表达SNORA71A后增殖、迁移和侵袭能力的变化。高通量转录组测序筛选SNORA71A下游作用靶基因,基因本体论(GO)和京都基因与基因组百科全书(KEGG)功能富集分析预测SNORA71A下游作用靶基因可能参与的生物学过程和信号通路。qPCR检测测序筛选出的下游作用靶基因TLR3在ESCC组织以及细胞中的表达。同时,qPCR和WB检测TE-1细胞在敲低或过表达TLR3后PD-L1 mRNA和蛋白质表达变化。细胞功能学实验检测TLR3敲低对SNORA71A所促进的TE-1细胞恶性生物行为(增殖、迁移、侵袭)的影响。结果:在52例ESCC患者的肿瘤组织以及ESCC细胞中SNORA71A表达均呈高水平(P < 0.01或P < 0.05)。敲低SNORA71A抑制TE-1细胞增殖、迁移和侵袭(P < 0.01或P < 0.05),过表达SNORA71A则促进TE-1细胞增殖、迁移和侵袭(P < 0.01或P < 0.05)。高通量转录组测序筛选到TLR3为SNORA71A下游作用靶基因。TLR3在ESCC组织以及TE-1细胞中呈低表达(P < 0.01或P < 0.05)。TLR3正向调控PD-L1 mRNA和蛋白质表达(P < 0.01或P < 0.05)。细胞功能学实验中,TLR3可以部分削弱SNORA71A对PD-L1表达的调控(P < 0.01)。结论:SNORA71A通过调控TLR3/PD-L1通路调节TE-1细胞增殖、迁移和侵袭。
10.Interpretation of the 2026 version 1-3 update to the NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer and Chinese clinical practice
Kejia ZHAO ; Jiandong MEI ; Lunxu LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(04):535-542
The management of non-small cell lung cancer is rapidly advancing toward precision and individualized care. The National Comprehensive Cancer Network (NCCN) has recently released the 2026 version 1, 2, and 3 updates of the NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. These updated guidelines introduce significant revisions in several core areas, including the adoption of the AJCC 9th Edition TNM Staging System, optimization of recommendations for lung cancer screening and mediastinal staging, updates on perioperative immunotherapy and targeted therapy strategies, and the inclusion of emerging biomarkers such as neuregulin 1 (NRG1) fusions and mesenchymal-epithelial transition factor (MET) protein overexpression. This article provides a systematic interpretation of these key updates and focuses on integrating international guidelines with clinical practice in China. Specifically, considering the high prevalence of epidermal growth factor receptor (EGFR) mutations in the Chinese population, it analyzes the first-line positioning of osimertinib- and lazertinib-based combination regimens and evaluates the clinical value of domestic third-generation tyrosine kinase inhibitors. In response to the NCCN's cautious stance on “conversion therapy” for initially unresectable disease, the article elaborates on China’s exploratory efforts and the evolving evidence base for conversion strategies utilizing programmed death receptor 1 (PD-1) inhibitors (e.g., tislelizumab, toripalimab). Furthermore, it clarifies the “dual-track” diagnostic approach distinguishing MET pathway mutations from protein overexpression. Aimed at aligning with China’s clinical context, this review seeks to offer clinicians a practical reference that synthesizes cutting-edge international perspectives with local applicability.


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