1.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
2.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
3.Rapid Qualitative Analysis Methods and Their Application in Implementation Science
Xuehan WEI ; Xiaoying CHEN ; Runze WANG ; Yingqian ZHANG ; Xuehan LIU ; Jin SUN ; Guoyan YANG ; Wei XIAO ; Chunli LU
Medical Journal of Peking Union Medical College Hospital 2026;17(2):546-556
Implementation science (IS) aims to systematically analyze and address the real-world gaps from evidence to practice and the influencing factors of the context. It is necessary to carry out qualitative research to gather relevant implementation outcomes. Nevertheless, traditional qualitative analysis has issues such as consuming a great deal of time and energy, and it is unable to promptly provide the crucial data required for implementation science research. The Rapid Qualitative Analysis (RQA) method, through semi-structured interviews and the adoption of techniques such as immediate data condensation and matrix analysis, can effectively shorten the cycle of qualitative data collection and data processing. RQA can promptly identify social determinants of health such as structural barriers, facilitators, and the behavioral characteristics of target groups. It provides a real-time basis for public health decision-making, the interpretation of complex social phenomena, and the process and effectiveness evaluation of research projects. Although RQA is difficult to conduct in-depth theoretical analysis based on grounded theory, its efficiency and flexibility make it the preferred tool for large-scale and time-sensitive research. Thus, it has been widely applied in implementation science research. This paper sorts out the core concepts and commonly used technical methods of RQA, as well as the differences between RQA and traditional qualitative analysis. It also explores the applications of RQA in intervention optimization, process evaluation, and implementation outcome evaluation. By integrating specific cases, this paper clarifies its application value in the field of implementation science. In the future, it is advisable to explore the integration of RQA with technologies such as artificial intelligence and big data, in order to bridge the gap between the transformation of scientific research achievements into practice. Under circumstances of limited resources or tight time constraints, RQA can be used to efficiently conduct implementation science research, providing convenient and scientific methodological and technical support for accelerating evidence-based practice.
4.Clinical Efficacy and Mechanism of Banxia Xiexin Tang-related Prescriptions in Treating Inflammation-cancer Transformation of Digestive System Based on Theory of Treating Different Diseases with Same Method: A Review
Xuhang SUN ; Chunli SHEN ; Dandan WEI ; Haojie GUO ; Yarui LI ; Jiaqi JI ; Xin PENG ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):256-270
Digestive system tumors are the leading cause of cancer incidence and mortality globally, and their occurrence and development generally follow the key pathological process of inflammation-cancer transformation. Therefore, intervening in the precancerous lesion stage is an important strategy to block malignant transformation of the disease and reduce the incidence rate of tumors. Banxia Xiexin Tang-related prescriptions (including Banxia Xiexin Tang, Shengjiang Xiexin Tang, and Gancao Xiexin Tang) originated from the Shanghan Zabinglun They follow the principle of pungent dispersing and bitter descending, combination of cold and warm medicinals, and tonifying deficiency and purging excess, which aligns with the core pathogenesis of digestive system precancerous lesions characterized by cold-heat intermingling and disorder of ascending and descending. These prescriptions are widely used in the clinical treatment of various digestive system inflammatory disorders such as atrophic gastritis, ulcerative colitis, and reflux esophagitis. This review systematically summarizes the theoretical basis, clinical evidence, and therapeutic mechanisms of such prescriptions in preventing and treating the inflammation-cancer transformation process in the digestive system. Clinical studies have shown that whether used alone or in combination with modern therapies, Banxia Xiexin Tang can effectively alleviate symptoms, repair histopathological changes, and improve patients' quality of life. Basic research further reveals that their efficacy stems from multi-target systemic regulatory effects: ameliorating the chronic inflammatory microenvironment, antagonizing oxidative stress, reshaping the gut microbiota, restoring the immune balance, regulating cell proliferation and apoptosis, etc. On the basis of the convergence of traditional Chinese and Western medicine understanding of inflammation-cancer transformation, this article constructs a research framework centered on regulating the inflammatory microenvironment homeostasis to systematically elucidate the mechanism of treating different diseases with the same method (Banxia Xiexin Tang). In view of the limitations of current research in terms of evidence level, disease-syndrome combination models, and overall mechanism analysis of compound prescriptions, this article proposes future research directions of integrating high-quality clinical research, systems biology, and cutting-edge technologies, providing a new theoretical basis and translational ideas for the precise prevention and control of digestive system tumors with traditional Chinese medicine.
5.Comorbidity of hypertension, diabetes mellitus, and dyslipidemia among residents in a district of Beijing Municipality
HU Jiangong ; ZHANG Shiwei ; YOU Kai ; XIAO Chunli ; ZHAO Hongye ; WAN Yang ; WANG Fengshuang ; PENG Tao ; SUN Xinying
Journal of Preventive Medicine 2026;38(6):614-617,621
Objective:
To investigate the prevalence and affecting factors for the comorbidity of hypertension, diabetes mellitus, and dyslipidemia among residents aged 18-79 years in a certain district of Beijing Municipality, so as to provide the evidence for the formulation of comprehensive prevention and control measures for the integrated management of these diseases.
Methods:
From August 2022 to June 2023, residents aged 18-79 years in a certain district of Beijing Municipality were selected as study participants using a combination of multistage random sampling and proportional-to-population sampling. Demographic information, body mass index (BMI), and blood biochemical indicators were collected through questionnaires, physical examinations, and laboratory tests to analyze the prevalence of the comorbidity of hypertension, diabetes mellitus, and dyslipidemia. Multivariable logistic regression model was used to analyze the influencing factors for the comorbidity of hypertension, diabetes mellitus, and dyslipidemia among residents.
Results:
A total of 5 447 residents were surveyed, comprising 2 775 males (50.95%) and 2 672 females (49.05%). A total of 329 individuals had the comorbidity of hypertension, diabetes mellitus, and dyslipidemia, representing a prevalence of 6.04%. Multivariable logistic regression analysis showed that age ≥45 years (45-<60 years, OR=2.861, 95%CI: 2.028-4.037; 60-79 years, OR=4.505, 95%CI: 3.082-6.585), being married/cohabiting (OR=2.698, 95%CI: 1.282-5.677); and being divorced/widowed/separated (OR=3.229, 95%CI: 1.348-7.735), residents with a BMI classified as obese (OR=2.161, 95%CI: 1.362-3.428) and central obesity (OR=2.496, 95%CI: 1.751-3.559) had a higher risk of the comorbidity of hypertension, diabetes mellitus, and dyslipidemia.
Conclusions
In a certain district of Beijing, the comorbidity of hypertension, diabetes mellitus, and dyslipidemia among residents aged 18-79 years was associated with age, marital status, BMI, and central obesity. It is recommended that a multi-disease management model be adopted for high-risk populations to reduce the risk of the comorbidity of hypertension, diabetes mellitus, and dyslipidemia.
6.A novel dual-targeting strategy of nanobody-driven protein corona modulation for glioma therapy.
Yupei ZHANG ; Shugang QIN ; Tingting SONG ; Zhiying HUANG ; Zekai LV ; Yang ZHAO ; Xiangyu JIAO ; Min SUN ; Yinghan ZHANG ; Guang XIE ; Yuting CHEN ; Xuli RUAN ; Ruyue LIU ; Haixing SHI ; Chunli YANG ; Siyu ZHAO ; Zhongshan HE ; Hai HUANG ; Xiangrong SONG
Acta Pharmaceutica Sinica B 2025;15(9):4917-4931
Glioma represents the most prevalent malignant tumor of the central nervous system, with chemotherapy serving as an essential adjunctive treatment. However, most chemotherapeutic agents exhibit limited ability to penetrate the blood-brain barrier (BBB). This study introduced a novel dual-targeting strategy for glioma therapy by modulating the formation of nanobody-driven protein coronas to enhance the brain and tumor-targeting efficiency of hydrophobic cisplatin prodrug-loaded lipid nanoparticles (C8Pt-Ls). Specifically, nanobodies (Nbs) with fibrinogen-binding capabilities were conjugated to the surface of C8Pt-Ls, resulting in the generation of Nb-C8Pt-Ls. Within the bloodstream, Nb-C8Pt-Ls could bound more fibrinogen, forming the protein corona that specifically interacted with LRP-1, a receptor highly expressed on the BBB. This interaction enabled a "Hitchhiking Effect" mechanism, facilitating efficient trans-BBB transport and promoting effective brain targeting. Additionally, the protein corona interacted with LRP-1, which is also overexpressed in glioma cells, achieving precise tumor targeting. Computational simulations and SPR detection clarified the molecular interaction mechanism of the Nb-fibrinogen-(LRP-1) complex, confirming its binding specificity and stability. Our results demonstrated that this strategy significantly enhanced C8Pt accumulation in brain tissues and tumors, induced apoptosis in glioma cells, and improved therapeutic efficacy. This study provides a novel framework for glioma therapy and underscores the potential of protein corona modulation-based dual-targeting strategies in advancing treatments for brain tumors.
7.Effect of heterologous expression of Scenedesmus quadricauda malic enzyme gene SqME on photosynthetic carbon fixation and lipid accumulation in tobacco leaves.
Yizhen LIU ; Mengyuan LI ; Zhanqian LI ; Yushuang GUO ; Jingfang JI ; Wenchao DENG ; Ze YANG ; Yan SUN ; Chunhui ZHANG ; Jin'ai XUE ; Runzhi LI ; Chunli JI
Chinese Journal of Biotechnology 2025;41(7):2829-2842
Microalgae possess high photosynthetic efficiency, robust adaptability, and substantial biomass, serving as excellent biological resources for large-scale cultivation. Malic enzyme (ME), a ubiquitous metabolic enzyme in living organisms, catalyzes the decarboxylation of malate to produce pyruvate, CO2, and NAD(P)H, playing a role in multiple metabolic pathways including energy metabolism, photosynthesis, respiration, and biosynthesis. In this study, we identified the Scenedesmus quadricauda malic enzyme gene (SqME) and its biological functions, aiming to provide excellent target genes for the genetic improvement of higher plants. Based on the RNA-seq data from S. quadricauda under the biofilm cultivation mode with high CO2 and light energy transfer efficiency and small water use, a highly expressed gene (SqME) functionally annotated as ME was cloned. The physicochemical properties of the SqME-encoded protein were systematically analyzed by bioinformatics tools. The subcellular localization of SqME was determined via transient transformation in Nicotiana benthamiana leaves. The biological functions of SqME were identified via genetic transformation in Nicotiana tabacum, and the potential of SqME in the genetic improvement of higher plants was evaluated. The ORF of SqME was 1 770 bp, encoding 590 amino acid residues, and the encoded protein was located in chloroplasts. SqME was a NADP-ME, with the typical structural characteristics of ME. The ME activity in the transgenic N. tabacum plant was 1.8 folds of that in the wild-type control. Heterologous expression of SqME increased the content of chlorophyll a, chlorophyll b, and total chlorophyll by 20.9%, 26.9%, and 25.2%, respectively, compared with the control. The transgenic tobacco leaves showed an increase of 54.0% in the fluorescence parameter NPQ and a decrease of 30.1% in Fo compared with the control. Moreover, the biomass, total lipids, and soluble sugars in the transgenic tobacco leaves enhanced by 20.5%, 25.7%, and 9.5%, respectively. On the contrary, the starch and protein content in the transgenic tobacco leaves decreased by 22.4% and 12.2%, respectively. Collectively, the SqME-encoded protein exhibited a strong enzymatic activity. Heterologous expressing of SqME could significantly enhance photosynthetic protection, photosynthesis, and biomass accumulation in the host. Additionally, SqME can facilitate carbon metabolism remodeling in the host, driving more carbon flux towards lipid synthesis. Therefore, SqME can be applied in the genetic improvement of higher plants for enhancing photosynthetic carbon fixation and lipid accumulation. These findings provide scientific references for mining of functional genes from S. quadricauda and application of these genes in the genetic engineering of higher plants.
Nicotiana/genetics*
;
Photosynthesis/physiology*
;
Malate Dehydrogenase/biosynthesis*
;
Plant Leaves/genetics*
;
Scenedesmus/enzymology*
;
Carbon Cycle/genetics*
;
Lipid Metabolism/genetics*
;
Plants, Genetically Modified/metabolism*
8.Development and test of an integrated automatic quality control system for HDR afterloader
Chunli LUO ; Jie ZHANG ; Longtao XIE ; Yuliang SUN ; Lang YU ; Jie QIU
China Medical Equipment 2025;22(5):38-41
Objective:An integrated automatic quality control system(automatic quality control instrument)for high dose rate(HDR)afterloader was independently developed.This system was used to measure the placement accuracy,residence time and activity of the radioactive source,so as to assess the accuracy and stability of this system in quality assurance.Methods:The automatic quality control system was connected to the Flexitron type of HDR afterloader through a connecting tube.Quality assurance(QA)plans with different resident positions,clearances,and times were designed for measurement and verification.The measurement length was 1079-1119 mm,and the measurement time was 2-10 s,and the measurement activity was 14,326-28,653 μGy·m2·h-1.The measurements were repeated once per one week in three months,so as to determine the consistency of the measurement parameters in a longer period of time.The measurement results of the placement accuracy,resident time and activity of radioactive source of the HDR 192Ir radioactive source were analyzed.Results:The plate ionization chamber was used to measure the activity of radioactive source.In three months,the measurement deviation of the activity of radioactive source was 1.17%,and the fitted activity decay curve was consistent with the expected decay curve of radioactive source.The measurement accuracies of the positioning of radioactive source were respectively 0.46,0.18,0.23,0.25,and 0.15 mm when the interval step sizes of resident times were respectively 2,3,5,8,and 10 mm,all of them were<1 mm.The measurement accuracy of time was(4.90±0.04)s when the resident time was 5 s.In the measurement accuracy of different resident times(1,2,3,5 and 10s)of same step size,the deviation of them was less than 0.5s.When the resident time was the shortest,the deviation between the read-out value of the automatic system software of quality control and the actually resident time was(0.09±0.04)s.The measurement accuracy gradually stabilized with the increasing of resident times.Conclusion:The automatic quality control instrument can complete the measurements for the positioning accuracy,the accuracy of resident time and the activity of radioactive source,and achieve rapidly and accurately periodic quality assurance.
9.Characteristics of pathogen spectrum and clinical significance of bronchoalveolar lavage fluid metagenomic next-generation sequencing in malignant tumor patients with pulmonary infections
Xu CHEN ; Chunli JIAN ; Qiao YANG ; Linpeng ZHENG ; Dingqin CAI ; Juan LI ; Jianguo SUN
Journal of Chongqing Medical University 2025;50(6):742-749
Objective:To investigate the characteristics of pathogen spectrum and the clinical significance of bronchoalveolar lavage fluid(BALF)metagenomic next-generation sequencing(mNGS)in malignant tumor patients with pulmonary infections.Methods:A retrospective analysis was performed for the patients with malignant tumor who were admitted to department of oncology,the Second affiliated hospital of army medical university,from January 2021 to December 2024.All patients developed respiratory symptoms dur-ing treatment and were diagnosed with pulmonary inflammation based on lung imaging findings,and BALF mNGS and sputum cul-ture were used for pathogen detection.A descriptive analysis was used to summarize the clinical data of patients and the distribution of pathogens,which was compared between patients with different cancer types and metastatic statuses.BALF mNGS and sputum cul-ture were compared in terms of diagnostic performance.Results:A total of 127 patients were enrolled,among whom 70.9%had non-small cell lung cancer,15.0%had small cell lung cancer,and 14.1%had other malignancies.The patients with distant metastasis ac-counted for 48.0%.A total of 145 BALF mNGS tests were performed,among which 84 tests(57.9%)yielded positive results for patho-gens,and 13 tests detected polymicrobial infections,accounting for 15.5%(13/84).A total of 121 pathogenic strains were identified,with fungi(41.3%)and Gram-negative bacteria(39.7%)as the main pathogens,and common pathogens for infection included Pneumo-cystis jirovecii(16.5%),Candida albicans(11.6%),Haemophilus influenzae(11.6%),Klebsiella pneumoniae(10.7%),Pseudomonas ae-ruginosa(10.7%),and Staphylococcus aureus(8.3%).There was a significant difference in the distribution of pathogens between the pa-tients with different types of cancer and statuses of distant metastasis,but Pneumocystis jirovecii remained the most common pathogen for opportunistic infection across all subgroups.A total of 70 patients underwent both sputum culture and BALF mNGS,and the posi-tive rate of sputum culture was only 16.0%,which was significantly lower than that of BALF mNGS(χ2=35.52,P<0.001).The concor-dance rate between sputum culture and BALF mNGS was 48.1%.Conclusion:BALF mNGS can accurately reveal the complex patho-gen spectrum in malignant tumor patients with pulmonary infections,especially the high-risk opportunistic pathogens such as Pneumo-cystis jirovecii.For patients with negative results of sputum culture,BALF mNGS can significantly improve the detection rates of patho-gens and polymicrobial infections.
10.Study on the improvement effects and mechanism of proanthocyanidins on steroid-induced osteonecrosis of the femoral head in rabbits
Chunli WU ; Liting LIU ; Xuting ZHAO ; Ruifen SUN ; Wenxuan WANG
China Pharmacy 2025;36(20):2519-2524
OBJECTIVE To study the improvement effects and mechanism of proanthocyanidins (PACs) on steroid-induced osteonecrosis of the femoral head (SONFH) in rabbits based on the receptor-interacting protein kinase 1 (RIPK1)/RIPK3/mixed lineage kinase domain-like protein (MLKL) signaling pathway. METHODS SONFH model in rabbits was induced by injecting Escherichia coli endotoxin+methylprednisolone. The successfully modeled rabbits were randomly divided into Model group (normal saline), low-dose PACs group (PACs-L group, 11 mg/kg), high-dose PACs group (PACs-H group, 22 mg/kg), high-dose PACs+ RIPK1 activator (rRIPK1) group (PACs-H+rRIPK1 group, 22 mg/kg PACs+4 μg/kg rRIPK1), along with a control group (normal saline), with 6 rabbits in each group. Each administration group was given relevant medicine once a day intragastrically/via injection, for 4 consecutive weeks. After the last administration, the levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in rabbit serum were measured. The changes in the microstructure of rabbit femurs, including bone mineral density (BMD), trabecular thickness (Tb.Th), trabecular number (Tb.N), and trabecular separation (Tb. Sp) were examined. The histopathological features of rabbit femoral tissues were observed, and the apoptotic status of cells within the rabbit femoral tissues was detected. The mRNA expressions of vascular endothelial growth factor (VEGF) and bone morphogenetic protein 2 (BMP2) in rabbit femoral tissues were determined. The expressions of RIPK1/RIPK3/MLKL signaling pathway-related proteins in femoral tissues were detected. RESULTS Compared with the Control group, serum contents of TNF-α and IL-6, Tb.Sp, empty bone cavity rate, cell apoptosis rate, phosphorylation levels of RIPK1, RIPK3 and MLKL in femoral tissue were significantly increased in the Model group (P<0.05). BMD, Tb.Th, Tb.N, as well as the mRNA expression of VEGF and BMP2, along with protein expression of caspase-8, in the femoral tissues were all decreased (P<0.05). The bone cells in the femoral tissue were unevenly distributed, and the trabeculae were arranged sparsely. Compared with the Model group, the aforementioned quantitative indicators (P<0.05) and pathological changes in all dosage groups of PACs showed significant improvements. Compared with the PACs-H group, the aforementioned quantitative indicators (P<0.05) and pathological changes in the PACs-H+rRIPK1 group showed significant reversal. CONCLUSIONS PACs can ameliorate SONFH in rabbits, and its mechanism of action may be related to the inhibition of the activation of the RIPK1/RIPK3/MLKL signaling pathway, suppression of apoptosis in femoral tissue cells, and promotion of angiogenesis.


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