1.Construction and characterization of recombinant human coagulation factor Ⅶ stable transfected cell lines
Xiaoxiao LI ; Jiabin CHEN ; Jiajun LIU ; Zhifei ZHANG ; Sen ZOU ; Lihua ZHU ; Zhaoyong YANG
Acta Universitatis Medicinalis Anhui 2026;61(1):16-22
ObjectiveTo construct a stable monoclonal human embryonic kidney 293 (HEK293) cell line expressing recombinant human coagulation factor Ⅶ (rhFⅦ) and evaluate the expression level and procoagulant bioactivity of rhFⅦ. MethodsThe plasmid pCDNA3.1-EGFP-FⅦ was transfected into HEK293 cells to verify the effectiveness of the transfection system. The plasmid pCDNA3.1-FⅦ was transfected into HEK293 cells, and monoclonal stable transfected cell lines were selected using geneticin (G418). The transcription of the FⅦ gene was identified by reverse transcription polymerase chain reaction (RT-PCR). The expression level of rhFⅦ in the supernatant of the monoclonal stable transfected cell line was detected by sodium dodecyl sulfate-polyacrylamide gel electrophoresis and Western blot. The concentration of rhFⅦ was determined by enzyme-linked immunosorbent assay (ELISA), and the procoagulant activity of rhFⅦ was measured by human coagulation factor Ⅶ potency assay. ResultsHEK293 cells transfected with pcDNA3.1-EGFP-FⅦ showed green fluorescence, indicating that rhFⅦ was successfully expressed in the supernatant of HEK293 cells after transient transfection with pcDNA3.1-FⅦ. The monoclonal stable transfected cell line was obtained by G418 screening. RT-PCR identified that the FⅦ gene was integrated into the genome of the monoclonal stable transfected cell line. The cell viability was good as detected by Cell Counting Kit-8, and a single band of rhFⅦ was obtained by purification of the cell supernatant. The highest rhFⅦ expression was (1.27±0.09) mg/L, and the highest procoagulant activity was (380.29±13.80)%. ConclusionThe monoclonal HEK293 cell lines which can express rhFⅦ protein efficiently and stably with excellent procoagulant bioactivity is successfully screened.
2.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
3.Research Tackling Paradigm and Technological Layout Strategies Based on Erectile Dysfunction, A Clinical Dominant Disease of Traditional Chinese Medicine
Qi ZHAO ; Yun CHEN ; Baoxing LIU ; Xuejun SHANG ; Fei SUN ; Xiaozhi ZHAO ; Zhigang WU ; Chao SUN ; Peihai ZHANG ; Wanjun CHENG ; Xing ZHOU ; Zhan QIN ; Yufeng PAN ; Weiwei TAO ; Jianhuai CHEN ; Mei MO ; Xiaoxiao ZHANG ; Xing ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):291-299
To thoroughly implement the strategic deployment outlined in the Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine regarding research on dominant diseases of traditional Chinese medicine and to uphold the development philosophy of equal emphasis on traditional Chinese medicine and western medicine,the China Association of Chinese Medicine has fully played a leading academic role by systematically organizing and conducting a series of academic youth salons on clinical dominant diseases of traditional Chinese medicine. On September 13,2024,the 36th Youth Salon on Clinical Dominant Diseases was successfully held in Nanjing,focusing on the advantages of traditional Chinese medicine and the integrative traditional Chinese medicine and western medicine in the diagnosis and treatment of erectile dysfunction (ED). The conference brought together leading experts from traditional Chinese medicine,western medicine,and interdisciplinary fields,facilitating in-depth multidisciplinary discussions that led to key consensus on optimizing traditional Chinese medicine treatment protocols for ED,researching and developing new drugs of traditional Chinese medicine,and advancing interdisciplinary development in traditional Chinese medicine. This salon systematically sorted out the clinical strengths and distinctive features of traditional Chinese medicine in the diagnosis and treatment of ED. Based on current research foundations and clinical needs,it identified key directions for future scientific layout and scientific research tackling: (1) Standardization of syndrome differentiation system of traditional Chinese medicine for ED. (2) Optimization and standardization of intervention methods of integrated traditional Chinese medicine and western medicine. (3) High-quality clinical research guided by evidence-based medicine. (4) In-depth analysis of the pharmacological mechanisms of traditional Chinese medicine in the treatment of ED. (5) Clinical translation and application promotion of new drugs of traditional Chinese medicine. (6) Interdisciplinary integration and innovation in traditional Chinese medicine. For each research direction,key focus areas,expected objectives,and clinical value were further refined,along with the establishment of a scientifically sound priority funding level evaluation system. Therefore,building on the series of salons on the ED-focused dominant diseases of traditional Chinese medicine,this paper provides standardized guidance for clinical practice of traditional Chinese medicine in ED management,effectively contributing to the high-quality development of traditional Chinese medicine. It serves as a valuable reference for national scientific and technological strategic layout, research and development decision-making in new drugs of traditional Chinese medicine,research topic planning,and clinical guideline formulation.
4.Analysis of Clinical Prognostic Characteristics in Patients with Primary Sjögren's Syndrome-Related Renal Fanconi Syndrome
Xiaoxiao SHI ; Yuan DONG ; Jiahe JIANG ; Peng XIA ; Shuo ZHANG ; Yubing WEN ; Dong XU ; Fengchun ZHANG ; Limeng CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(2):358-369
Renal Fanconi syndrome (FS) is a rare renal manifestation of primary Sjögren's syndrome (pSS). This study aims to analyze the clinical and prognostic characteristics of patients with pSS-associated renal FS (pSS-FS) and provide insights for clinical management. Patients diagnosed with pSS-FS via renal biopsy at Peking Union Medical College Hospital from 1993 to 2024 were enrolled. Data collected included age, sex, clinical symptoms (xerostomia, xerophthalmia, skin purpura, arthralgia, polyuria, and systemic symptoms), laboratory findings [serum immunoglobulin G (IgG) and IgM, complement (C3, C4), antinuclear antibody, anti-Sjögren's syndrome-associated antigen A antibody (SSA), anti-SSB antibody, 24-hour urinary protein quantification, tubular proteinuria, serum creatinine, serum electrolytes], treatment, and follow-up information. Systematic assessments included the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score, pulmonary involvement (including non-infectious interstitial pneumonia, pulmonary fibrosis, pulmonary hypertension, etc.), hematological involvement (anemia, leukopenia, thrombocytopenia), etc. Efficacy evaluations encompassed improvements in immunological parameters, renal function, and tubular function. Group comparisons were performed using chi-square/Fisher's exact tests, A total of 38 patients with pSS-FS were included, with 37(97.4%) being female. The median age at pSS diagnosis was 43(37, 57) years. Xerostomia (76.3%) and xerophthalmia (71.1%) were the predominant clinical symptoms. The most common renal tubular dysfunctions were generalized aminoaciduria (96.9%), tubular proteinuria (96.0%), and hypokalemia (94.7%). The median eGFR was 52.57(32.04, 76.10)mL/(min·1.73 m2), with 60.5% (23/38) of patients having an eGFR below 60 mL/(min·1.73 m2).After six months of immunosuppressive therapy, including moderate-to-high-dose glucocorticoids, significant improvements were observed in immunological parameters (improvement rate: 69.2%), renal tubular function (89.5%), and renal function (44.4%). Following immunosuppressive treatment, the median eGFR increased from 54.95(33.06, 76.10)mL/(min·1.73 m2) to 65.56(56.24, 83.58)mL/(min·1.73 m2).Compared to patients with normal or mildly impaired baseline eGFR [≥ 60 mL/(min·1.73 m2)], those with significantly decreased baseline eGFR [< 60 mL/(min·1.73 m2)] were older (46 years This study reports the clinical characteristics of the largest single-center cohort of pSS-FS patients internationally, characterized by varying degrees of proximal renal tubular dysfunction and renal impairment. Timely initiation of immunosuppressive therapy, including glucocorticoids, is crucial, particularly for patients with significantly reduced eGFR, who may experience more substantial renal function improvement.
5.Effect of maternal pyrethroid pesticides exposure during pregnancy on lymphocytes in 1-year-old children: A birth cohort study
Zhiye QI ; Xia XIAO ; Shuqi CHEN ; Dandan ZHAO ; Xiaoxiao SONG ; Yan LI
Journal of Environmental and Occupational Medicine 2026;43(4):402-409
Background Pyrethroid pesticides (PYRs) can cross the placental barrier to cause intrauterine fetal exposure, which may lead to developmental immunotoxicity (DIT). However, the specific effect of maternal PYR exposure during pregnancy on the cellular immune function of 1-year-old children remains unclear. Objective To explore the effect of PYRs exposure throughout the entire pregnancy on peripheral blood lymphocytes in 1-year-old children and potential sensitive window period of PYRs exposure. Methods A birth cohort was established by enrolling pregnant women in their first trimester and following them and their infants until one year of age. Ultra-high performance liquid chromatography-tandem mass spectrometry was used to detect the levels of PYRs metabolites, including 3-phenoxybenzoic acid (3PBA), 4-fluoro-3-phenoxybenzoic acid (4F3PBA), and cis-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropane carboxylic acid (cis-DBCA), in the urine of pregnant women during the first trimester (gestational weeks 6-12), the second trimester (gestational weeks 21-24), and the third trimester (gestational weeks 33-36). Peripheral blood leukocyte and lymphocyte counts were measured in children at 12 months of age using the Coulter principle combined with flow cytometry. Exposure levels of PYRs metabolites in each trimester were divided into low, moderate, and high exposure groups based on the 25th (P25) and 75th (P75) percentiles. Meanwhile, participants were classified as having repeated high or low exposure if their metabolite levels were > P75 or <P25 in at least two trimesters, respectively, while all others were categorized as having repeated moderate exposure. Generalized linear models were used to analyze the associations between trimester-specific and repeated PYRs metabolite exposure levels and the peripheral blood white blood cell (WBC) and lymphocyte counts in children aged 1 year. Results A total of 336 mother-child pairs were included in this study. For the pregnant women, the total detection rates of maternal urinary 3PBA, 4F3PBA, and cis-DBCA across the three trimesters of pregnancy were 80.5%, 100.0%, and 81.3%, respectively; and median creatinine-corrected concentrations were 0.24, 0.36, and 0.42 μg·g−1, respectively. In children aged 1 year, the mean WBC and lymphocyte counts in peripheral blood were (8.9±2.0)×109·L−1 and (5.7±1.6)×109·L−1, respectively. The results of the generalized linear model analysis indicated that compared to the low exposure group, the high cis-DBCA exposure group during the third trimester of pregnancy had significantly lower peripheral blood WBC count (β=−0.87, 95%CI: −1.51, −0.23) and lymphocyte count (β=−0.64, 95%CI: −1.15, −0.13); and the repeated high-exposure group of cis-DBCA had significantly lower peripheral blood WBC count (β=−1.34, 95%CI: −2.34, −0.34) and lymphocyte count (β=−0.80, 95%CI: −1.60, −0.01) than the repeated low exposure group. Similarly, the repeated moderate-exposure group of cis-DBCA had a significantly lower peripheral blood WBC count (β=−0.83, 95%CI: −1.59, −0.07) than the repeated low exposure group. Conclusion High maternal exposure to PYRs with cis-DBCA as the major metabolite exposure is associated with decreased peripheral leukocyte and lymphocyte counts in children aged 1 year, and repeated high-level exposure throughout gestation appears to exacerbate DIT in offspring. The third trimester of pregnancy maybe a sensitive window for children's DIT induced by exposure to PYRs during pregnancy.
6.Analysis of Animal Models of Retinitis Pigmentosa Based on Diagnostic Features of Chinese and Western Medicine
Xiaoyu LI ; Lina LIANG ; Jiefeng CHEN ; Xiaoxiao ZHU ; Yina QI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):198-203
Retinitis pigmentosa (RP) is the most common hereditary blinding eye disease in clinical practice, with the pathogenesis remaining unclear. Patients experience progressive apoptosis of retinal photoreceptor cells, accompanied by degeneration of retinal pigment epithelium (RPE) cells. Current Western medical treatments mainly focus on gene therapy and stem cell transplantation, showing limited efficacy. In contrast, clinical observations have confirmed the therapeutic effects of traditional Chinese medicine (TCM) treatments. Establishing an RP animal model that aligns with the diagnostic features of both TCM and Western medicine could help combine the strengths of both approaches, thereby broadening the treatment options for RP. This study categorizes and summarizes the existing RP animal models in terms of classification, types, inheritance patterns, and alignment with clinical manifestations. It is found that current RP models are primarily derived from natural animal models such as RD mice and RCS rats, transgenic animal models like RPE-65 knockout mice and rhodopsin gene knockout mice, and chemically induced models such as those created by monochromatic light exposure or N-ethyl-N-nitrosourea (ENU) administration. These three categories of models focus more on detecting RP-related histopathological, molecular biological, and cellular immunological indicators, but offer limited observation of the overall characteristics of the disease and lack insight into syndrome differentiation. Although RP is a congenital genetic disease, its progression is influenced by acquired factors such as environment, constitution, emotions, and care. Current models do not fully capture the characteristics of this disease. Therefore, establishing an RP animal model based on the diagnostic features of both TCM and Western medicine will have significant implications for future experimental and clinical research.
7.Analysis of Animal Models of Retinitis Pigmentosa Based on Diagnostic Features of Chinese and Western Medicine
Xiaoyu LI ; Lina LIANG ; Jiefeng CHEN ; Xiaoxiao ZHU ; Yina QI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):198-203
Retinitis pigmentosa (RP) is the most common hereditary blinding eye disease in clinical practice, with the pathogenesis remaining unclear. Patients experience progressive apoptosis of retinal photoreceptor cells, accompanied by degeneration of retinal pigment epithelium (RPE) cells. Current Western medical treatments mainly focus on gene therapy and stem cell transplantation, showing limited efficacy. In contrast, clinical observations have confirmed the therapeutic effects of traditional Chinese medicine (TCM) treatments. Establishing an RP animal model that aligns with the diagnostic features of both TCM and Western medicine could help combine the strengths of both approaches, thereby broadening the treatment options for RP. This study categorizes and summarizes the existing RP animal models in terms of classification, types, inheritance patterns, and alignment with clinical manifestations. It is found that current RP models are primarily derived from natural animal models such as RD mice and RCS rats, transgenic animal models like RPE-65 knockout mice and rhodopsin gene knockout mice, and chemically induced models such as those created by monochromatic light exposure or N-ethyl-N-nitrosourea (ENU) administration. These three categories of models focus more on detecting RP-related histopathological, molecular biological, and cellular immunological indicators, but offer limited observation of the overall characteristics of the disease and lack insight into syndrome differentiation. Although RP is a congenital genetic disease, its progression is influenced by acquired factors such as environment, constitution, emotions, and care. Current models do not fully capture the characteristics of this disease. Therefore, establishing an RP animal model based on the diagnostic features of both TCM and Western medicine will have significant implications for future experimental and clinical research.
8.Strategies for Building an Artificial Intelligence-Empowered Trusted Federated Evidence-Based Analysis Platform for Spleen-Stomach Diseases in Traditional Chinese Medicine
Bin WANG ; Huiying ZHUANG ; Zhitao MAN ; Lifeng REN ; Chang HE ; Chen WU ; Xulei HU ; Xiaoxiao WEN ; Chenggong XIE ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(1):95-102
This paper outlines the development of artificial intelligence (AI) and its applications in traditional Chinese medicine (TCM) research, and elucidates the roles and advantages of large language models, knowledge graphs, and natural language processing in advancing syndrome identification, prescription generation, and mechanism exploration. Using spleen-stomach diseases as an example, it demonstrates the empowering effects of AI in classical literature mining, precise clinical syndrome differentiation, efficacy and safety prediction, and intelligent education, highlighting an upgraded research paradigm that evolves from data-driven and knowledge-driven approaches to intelligence-driven models. To address challenges related to privacy protection and regulatory compliance in cross-institutional data collaboration, a "trusted federated evidence-based analysis platform for TCM spleen-stomach diseases" is proposed, integrating blockchain-based smart contracts, federated learning, and secure multi-party computation. The deep integration of AI with privacy-preserving computing is reshaping research and clinical practice in TCM spleen-stomach diseases, providing feasible pathways and a technical framework for building a high-quality, trustworthy TCM big-data ecosystem and achieving precision syndrome differentiation.
9.Clinical Advantages of Traditional Chinese Medicine in Treatment of Childhood Simple Obesity: Insights from Expert Consensus
Qi ZHANG ; Yingke LIU ; Xiaoxiao ZHANG ; Guichen NI ; Heyin XIAO ; Junhong WANG ; Liqun WU ; Zhanfeng YAN ; Kundi WANG ; Jiajia CHEN ; Hong ZHENG ; Xinying GAO ; Liya WEI ; Qiang HE ; Qian ZHAO ; Huimin SU ; Zhaolan LIU ; Dafeng LONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):238-245
Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance, while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine (TCM) has a long history in the prevention and management of this condition, demonstrating eight distinct advantages, including systematic theoretical foundation, diversified therapeutic approaches, definite therapeutic efficacy, high safety profile, good patient compliance, comprehensive intervention strategies, emphasis on prevention, and stepwise treatment protocols. Additionally, TCM is characterized by six distinctive features: the use of natural medicinal substances, non-invasive external therapies, integration of medicinal dietetics, simple exercise regimens, precise syndrome differentiation, and diverse dosage forms. By combining internal and external treatments, TCM facilitates individualized regimen adjustment and holistic regulation, demonstrating remarkable effects in improving obesity-related metabolic indicators, regulating constitutional imbalance, and promoting healthy behaviors. However, challenges remain, such as inconsistent operational standards, insufficient high-quality clinical evidence, and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment, conducting multicenter randomized controlled trials, and fostering interdisciplinary integration, so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.
10.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Atopic Dermatitis
Junfeng LIU ; Xiumei MO ; Mei MO ; Hongyi LI ; Ying LIN ; Xiaoxiao ZHANG ; Dacan CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):244-252
Atopic dermatitis (AD) is a common pruritic and chronic inflammatory dermatosis in clinical practice and is one of the diseases responding specifically to traditional Chinese medicine (TCM). With the launch of biological agents and small molecule drugs and the development and implementation of guidelines of diagnosis and treatment, clinical pathways of treatment of moderate to severe AD, and consensus on the whole-process management of AD, the clinical efficacy of moderate to severe AD has been significantly improved. However, there are still many unmet clinical needs that require more effective methods to meet. In response to the Opinions of the CPC Central Committee and the State Council on Facilitating the Inheritance, Innovation, and Development of Traditional Chinese Medicine and the spirit of the National Conference on TCM, the China Association of Chinese Medicine organized more than 20 experts in TCM dermatology, Western medicine dermatology, interdisciplinary fields, and industries to discuss the difficulties and advantages of TCM in the treatment of AD. TCM treatment for AD can not only improve rash and relieve itching but also solve many concomitant syndromes. The abundant external treatment methods of TCM have advantages for different special populations and rash characteristics. The concept of treating disease before its onset in TCM is in line with the chronic disease management mode of prevention and treatment of atopic march and prevention of recurrence. In addition, TCM therapy can reduce the use of topical glucocorticoids and has good safety. Regarding the comorbidity of AD, equal emphasis on TCM and Western medicine and multidisciplinary joint treatment should be advocated to achieve maximum benefit for patients. The exchange of TCM and Western medicine has clarified the positioning and advantages of TCM intervention in AD, providing guidance for clinical and scientific research.

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