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.Impact of X-ray irradiation on stored platelets and their mitochondrial function
Na WANG ; Ning AN ; Xiaoying WANG ; Dongyan YANG ; Xiaole ZHANG ; Yajuan WANG ; Jie CHEN ; Xingbin HU ; Chen CHEN
Chinese Journal of Blood Transfusion 2026;39(1):16-23
Objective: To investigate the effects of clinical routine X-ray irradiation dose (average irradiation dose: 29.7±0.54 Gy) on the function, apoptosis, activation state and mitochondrial function of platelets during in vitro storage, so as to provide experimental evidence for optimizing platelet irradiation strategies. Methods: A paired experimental design was adopted. Platelets were collected from 12 healthy donors, and each sample was equally divided into the irradiated group and the control group (non-irradiated). All samples were stored for 5 days under standard platelet preservation conditions (22±2℃, continuous oscillation). Flow cytometry was used to detect platelet count, apoptosis rate (Annexin V+ positive rate), activation markers (CD62P, PAC-1, CD42b) and reactive oxygen species (ROS) level. Meanwhile, mitochondrial-specific probes were used to evaluate changes in mitochondrial count, membrane potential and adenosine triphosphate (ATP) content. Additionally, transmission electron microscopy (TEM) was employed to observe the ultrastructure of platelets, with a focus on mitochondrial morphology, platelet membrane integrity and granule distribution. Results: Within 5 days of storage, the platelet count was (841±89.16)×10
/L in the irradiated group and (824.5±92.88)×10
/L in the control group, with no statistically significant difference between the two groups (P=0.54). The apoptosis rate was (4.94±1.39) % in the irradiated group and (5.50±0.83) % in the control group, showing no significant difference (P=0.31). For activation indicators, the CD62P expression rate was (24.32±7.57) % in the irradiated group versus (25.21±8.13) % in the control group (P=0.43). The PAC-1 positive rates were (12.15±4.43) % and (11.75±3.40) % in the irradiated group and control group, respectively (P=0.44). The CD42b expression rates were (12.14±4.43) % and (11.75±3.4) % in the two groups, respectively (P=0.47). The ROS levels were (31.98±8.1) % and (30.64±5.89) % in the two groups, respectively (P=0.45). No significant differences were found in the above indicators. For mitochondrial function indicators, the mitochondrial count was (55.88±11.49) % in the irradiated group and (53.5±7.24) % in the control group (P=0.57). The ATP contents were (42.45±5.29) % and (41.58±9.50) % in the irradiated group and control group, respectively (P=0.77). The relative membrane potential values were (59.53±10.89) % and (57.49±6.54) % in the two groups, respectively (P=0.47). No significant difference were observed on the mitochondrial function-related indicators. TEM further confirmed that the ultrastructure of platelets in the irradiation group was intact, the mitochondrial morphology was normal, and no pathological changes such as swelling or vacuolization were observed. Conclusion: This study evaluated the impact of conventional-dose X-ray irradiation on platelet storage quality, confirming that this dose does not significant impair platelet count, apoptosis rate, activation status, or mitochondrial function. This finding provides important experimental evidence for the clinical promotion of X-ray irradiation technology and suggests its potential as a safe alternative to γ irradiation. Future studies could further expand the sample size and extend the observation period to verify the effects of X-ray irradiation on long-term platelet storage and post-transfusion in vivo survival rate.
4.From tradition to modernity: the integrated development of medical humanities and narrative medicine
Xiaoxiong ZHU ; Lijia DU ; Yingru LIU ; Xiaoying ZHANG ; Jia NA ; Zhifen YANG
Chinese Medical Ethics 2026;39(2):201-206
Medical humanities consistently run through the entire process of medical development and educational reform. However, with the increasingly prominent dominance of evidence-based medicine in clinical practice, the medical humanities have gradually been weakened in both medical education and clinical practice. Narrative medicine, through telling and listening to patients’ stories, enhances healthcare professionals’ empathy, fosters doctor–patient communication, and facilitates a return to the humanistic essence of medical education and clinical practice. By sorting out and reviewing related literature and developmental trends both at home and abroad, this paper pointed out the existing structural problem of an imbalance between technological priority and humanistic care in medical education, focusing on how to achieve an effective integration of medical humanities and narrative medicine in medical education. This paper also systematically analyzed the significance of both medical humanities and narrative medicine in the medical education system and proposed promoting the deep embedding of narrative medicine in medical education from three entry points, namely, curriculum integration, interdisciplinary collaboration, and the construction of teaching evaluation systems. The aim was to provide theoretical support and practical experience for medical education reform, foster the coordinated development of professional competence and humanistic spirit among medical talents, and truly achieve the goal of cultivating well-rounded medical talents.
5.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.
6.Production of GTKO pigs and kidney xenotransplantation from pigs to rhesus macaques
Yan WANG ; Yue CHANG ; Chang YANG ; Taiyun WEI ; Xiaoying HUO ; Bowei CHEN ; Jiaoxiang WANG ; Heng ZHAO ; Jianxiong GUO ; Hongfang ZHAO ; Xiong ZHANG ; Feiyan ZHU ; Wenmin CHENG ; Hongye ZHAO ; Kaixiang XU ; Ameen Jamal MUHAMMAD ; Zhendi WANG ; Hongjiang WEI
Organ Transplantation 2025;16(4):526-537
Objective To explore the construction of α-1,3-galactosyltransferase (GGTA1) gene-knockout (GTKO) Diannan miniature pigs and the kidney xenotransplantation from pigs to rhesus macaques, and to assess the effectiveness of GTKO pigs. Methods The GTKO Diannan miniature pigs were constructed using the CRISPR/Cas9 gene-editing system and somatic cell cloning technology. The phenotype of GTKO pigs was verified through polymerase chain reaction, Sanger sequencing and immunofluorescence staining. Flow cytometry was used to detect antigen-antibody (IgM) binding and complement-dependent cytotoxicity. Kidney xenotransplantation was performed from GTKO pigs to rhesus macaques. The humoral immunity, cellular immunity, coagulation and physiological indicators of the recipient monkeys were monitored. The function and pathological changes of the transplanted kidneys were analyzed using ultrasonography, hematoxylin-eosin staining, immunohistochemical staining and immunofluorescence staining. Results Single-guide RNA (sgRNA) targeting exon 4 of the GGTA1 gene in Diannan miniature pigs was designed. The pGL3-GGTA1-sgRNA1-GFP vector was transfected into fetal fibroblasts of Diannan miniature pigs. After puromycin selection, two cell clones, C59# and C89#, were identified as GGTA1 gene-knockout clones. These clones were expanded to form cell lines, which were used as donor cells for somatic cell nuclear transfer. The reconstructed embryos were transferred into the oviducts of trihybrid surrogate sows, resulting in 13 fetal pigs. Among them, fetuses F04 and F11 exhibited biallelic mutations in the GGTA1 gene, and F04 had a normal karyotype. Using this GTKO fetal pig for recloning and transferring the reconstructed embryos into the oviducts of trihybrid surrogate sows, seven surviving piglets were obtained, all of which did not express α-Gal epitope. The binding of IgM from the serum of rhesus monkey 20# to GTKO pig PBMC was reduced, and the survival rate of GTKO pig PBMC in the complement-dependent cytotoxicity assay was higher than that of wild-type pig. GTKO pig kidneys were harvested and perfused until completely white. After the left kidney of the recipient monkey was removed, the pig kidney was heterotopically transplanted. Following vascular anastomosis and blood flow restoration, the pig kidney rapidly turned pink without hyperacute rejection (HAR). Urine appeared in the ureter 6 minutes later, indicating successful kidney transplantation. The right kidney of the recipient was then removed. Seven days after transplantation, the transplanted kidney had good blood flow, the recipient monkey's serum creatinine level was stable, and serum potassium and cystatin C levels were effectively controlled, although they increased 10 days after transplantation. Seven days after transplantation, the levels of white blood cells, lymphocytes, monocytes and eosinophils in the recipient monkey increased, while platelet count and fibrinogen levels decreased. The activated partial thromboplastin time, thrombin time and prothrombin time remained relatively stable but later showed an upward trend. The recipient monkey survived for 10 days. At autopsy, the transplanted kidney was found to be congested, swollen and necrotic, with a small amount of IgG deposition in the renal tissue, and a large amount of IgM, complement C3c and C4d deposition, as well as CD68+ macrophage infiltration. Conclusions The kidneys of GTKO Diannan miniature pigs may maintain normal renal function for a certain period in rhesus macaques and effectively overcome HAR, confirming the effectiveness of GTKO pigs for xenotransplantation.
7.Seroprevalence and influencing factors of low-level neutralizing antibodies against SARS-CoV-2 in community residents
Shiying YUAN ; Jingyi ZHANG ; Huanyu WU ; Weibing WANG ; Genming ZHAO ; Xiao YU ; Xiaoying MA ; Min CHEN ; Xiaodong SUN ; Zhuoying HUANG ; Zhonghui MA ; Yaxu ZHENG ; Jian CHEN
Shanghai Journal of Preventive Medicine 2025;37(5):403-409
ObjectiveTo understand the seropositivity of neutralizing antibodies (NAb) and low-level NAb against SARS-CoV-2 infection in the community residents, and to explore the impact of COVID-19 vaccination and SARS-CoV-2 infection on the levels of NAb in human serum. MethodsOn the ground of surveillance cohort for acute infectious diseases in community populations in Shanghai, a proportional stratified sampling method was used to enroll the subjects at a 20% proportion for each age group (0‒14, 15‒24, 25‒59, and ≥60 years old). Blood samples collection and serum SARS-CoV-2 NAb concentration testing were conducted from March to April 2023. Low-level NAb were defined as below the 25th percentile of NAb. ResultsA total of 2 230 participants were included, the positive rate of NAb was 97.58%, and the proportion of low-level NAb was 25.02% (558/2 230). Multivariate logistic regression analysis indicated that age, infection history and vaccination status were correlated with low-level NAb (all P<0.05). Individuals aged 60 years and above had the highest risk of low-level NAb. There was a statistically significant interaction between booster vaccination and one single infection (aOR=0.38, 95%CI: 0.19‒0.77). Compared to individuals without vaccination, among individuals infected with SARS-CoV-2 once, both primary immunization (aOR=0.23, 95%CI: 0.16‒0.35) and booster immunization (aOR=0.12, 95%CI: 0.08‒0.17) significantly reduced the risk of low-level NAb; among individuals without infections, only booster immunization (aOR=0.28, 95%CI: 0.14‒0.52) showed a negative correlation with the risk of low-level NAb. ConclusionsThe population aged 60 and above had the highest risk of low-level NAb. Regardless of infection history, a booster immunization could reduce the risk of low-level NAb. It is recommended that eligible individuals , especially the elderly, should get vaccinated in a timely manner to exert the protective role of NAb.
8.Exploratory Study on the Theory of the Spatiotemporal Structure of Visceral Manifestation
Houfang MA ; Xiaoying XU ; Linghao MENG ; Haili ZHANG ; Nannan SHI
Journal of Traditional Chinese Medicine 2025;66(16):1629-1634
The "integrated time-space" perspective of life in traditional Chinese medicine holds that structure and function respectively belong to the realms of space and time. The orderly integration of time and space not only supports the existence and development of life, but also serves as the foundation for biological evolution. Based on this standpoint, this paper proposes the spatiotemporal structural theory of visceral manifestation, characterized by the fusion of time and space, the integration of internal and external dimensions, and the absence of primary or secondary distinctions. Using the individual human body as the boundary, it delineates the man and nature spatiotemporal structure, based on the theory of the "correspondence between man and nature", and the internal spatiotemporal structure of the living body. The man and nature spatiotemporal structure, with yin-yang and the five phases as its core, reveals the correspondence and connectivity between the external environment and the internal zang-fu organs within the spatiotemporal dimension. The internal temporal structure of the body refers to the collective physiological rhythms related to the zang-fu organs, while the spatial structure refers to the tangible forms, spatial positions, and connective structures of the zang-fu organs. The proposal of the spatiotemporal structural theory of visceral manifestation represents a rational reconstruction and practical exploration of the essential connotations of visceral manifestation, aiming to provide new perspectives for subsequent theoretical research and clinical applications.
9.Discussion on Research Paradigm and Layout Based on Disease (Psoriasis) Specifically Responding to Traditional Chinese Medicine
Liu LIU ; Xiaoying SUN ; Mei MO ; Zihan FANG ; Yaqiong ZHOU ; Bin LI ; Xiaoxiao ZHANG ; Xin LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):203-211
To implement the Opinions of the State Council of the Central Committee of the Communist Party of China on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine, delve into the diseases specifically responding to traditional Chinese medicine (TCM), and serve the building of advantageous specialties, clinical talent cultivation, national research layout, and academic innovation, the Chinese Association of Chinese Medicine sponsored the salons in multiple fields to discuss the diseases specifically responding to TCM. On August 26, 2023, the 25th salon on the diseases specifically responding to TCM was held in Shanghai. In view of the advantages of TCM and integrated traditional Chinese and Western medicine in the diagnosis and treatment of psoriasis, Chinese and western medicine experts and interdisciplinary researchers carried out extensive and in-depth discussions and formed specific suggestions and consensus on the diagnosis and treatment of psoriasis with TCM and integrated traditional Chinese and Western medicine. However, there was still a lack of detailed research path. Under the guidance of the Chinese Association of Chinese Medicine, this paper analyzes the problems in the diagnosis and treatment of psoriasis from the occurrence and development of psoriasis. According to the advantages and characteristics of TCM and integrated traditional Chinese and Western medicine in the diagnosis and treatment of psoriasis, this paper puts forward the main points of research layout for psoriasis from the three aspects of psoriasis diagnosis and treatment, comorbidity prevention, and chronic disease management as follows: ① optimization of the syndrome differentiation system for psoriasis, ② optimization of assessment indicators for psoriasis, ③ recurrence mechanisms of psoriasis, ④ construction and research of TCM prevention and treatment of psoriasis recurrence, ⑤ construction of the comorbidity spectrum and TCM theoretical system of psoriasis, ⑥ comorbidity mechanisms of psoriasis. Furthermore, this article proposed the research layout and directions, expected goals and values, and funding priorities. Therefore, on the basis of the series of salons about psoriasis as a disease specifically responding to TCM, this article puts forward the research paradigm of psoriasis, aiming to facilitate the high-quality development of TCM and provide reference for the national research layout, the research and development of new TCM preparations, the selection of research topics, and the formulation of guidelines and consensus.
10.Relationship among occupational stress, work-related rumination, and sleep quality in emergency medical dispatchers in some areas of China
Xiaoying SHI ; Qing ZHANG ; Zhongyuan YAN ; Qin ZHANG ; Dan XU
Journal of Environmental and Occupational Medicine 2025;42(8):932-938
Background The increasing demand for emergency services coupled with the special working environment has exacerbated occupational stress and work-related rumination among emergency medical dispatchers, which is noteworthy for its impact on dispatchers' sleep quality. Objective To explore the relationship among occupational stress, work-related rumination, and sleep quality of emergency medical dispatchers, so as to provide reference for improving sleep quality and maintaining physical and mental health of this occupational group. Methods A total of 386 emergency medical dispatchers from 16 provinces and municipalities including Beijing, Shanghai, Tianjin, Inner Mongolia, Zhejiang, Shanxi, Jiangxi, Anhui, Hubei, Hebei, Henan, Sichuan, Guizhou, Yunnan, Fujian, and Hainan of China were investigated with the Chinese version of Effort-Reward Imbalance Questionnaire, Work-Related Rumination Questionnaire, and Insomnia Severity Index. Spearman correlation was used to analyze the association among occupational stress, work-related rumination, and sleep quality. A structural equation model was constructed, with occupational stress as independent variable, the two dimensions of work-related rumination as mediating variables, and sleep quality as dependent variable, respectively. Bootstrap testing was then used to verify potential mediating effect of work-related rumination on the relationship between occupational stress and sleep quality among the emergency medical dispatchers. Results Among the enrolled emergency medical dispatchers, the effort-reward imbalance (ERI) index was 1.03, the score of affective rumination was 15.35±5.26, the score of problem-solving rumination was 17.64±4.63, and the total score of sleep quality was 21.10±6.53. Their ERI index was positively correlated with affective rumination scores (r=0.636, P<0.01), but not with problem-solving rumination scores (P>0.05). Their ERI index, affective rumination scores, and problem-solving rumination scores were positively correlated with sleep quality scores (P<0.05). The direct effect size of occupational stress on sleep quality was 0.627, the indirect effect size of affective rumination was 0.124, and the mediating effect of affective rumination accounted for 16.4% of the total effect (0.755), while the problem-solving rumination had no mediating effect on the relationship between occupational stress and sleep quality. Conclusion Occupational stress and affective rumination in emergency medical dispatchers can predict their sleep quality. Occupational stress can directly affect sleep quality, and indirectly affect it through affective rumination. Managers should pay attention to and evaluate the affective rumination level of emergency medical dispatchers, so as to take corresponding intervention measures to reduce their occupational stress and improve their sleep quality.

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