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.

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.

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.

AIM:To investigate the predictive value of central corneal thickness(CCT)and coefficient of variation(CV)of endothelial cell area for secondary glaucoma in patients with uveitis.METHODS: A retrospective study was conducted on uveitis patients admitted to our hospital from July 2023 to April 2025. Based on the occurrence of secondary glaucoma, patients were divided into an occurrence group and a non-occurrence group, and the clinical data of the two groups were compared. Univariate and multivariate Logistic regression analyses were performed to screen for factors affecting poor prognosis. The predictive value of CCT and CV for secondary glaucoma in patients with uveitis was analyzed using receiver operating characteristic(ROC)curves.RESULTS: A total of 100 uveitis patients(100 eyes)were included and categorized into an occurrence group(16 cases, 16 eyes)and a non-occurrence group(84 cases, 84 eyes), there were 9 males and 7 females in the occurrence group, with a mean age of 45.25±10.32 years, and there were 40 males and 44 females in the non-occurence group, with a mean age of 43.89±12.47 years. The CCT in the occurrence group was significantly lower than that in the non-occurrence group, while the CV was significantly higher than that in the non-occurrence group(both P<0.001). Multivariate Logistic regression analysis showed that CCT was a protective factor, and CV was a risk factor for secondary glaucoma in patients with uveitis(both P<0.01). The areas under the ROC curve(AUC)for CCT and CV in predicting secondary glaucoma were 0.794 and 0.792, respectively. The combined predictive model yielded an AUC of 0.888, with a sensitivity of 98.15% and a specificity of 67.74%, demonstrating good predictive efficacy.CONCLUSION: CCT and CV have certain clinical value in predicting secondary glaucoma in uveitis patients. The combined diagnostic approach demonstrates higher efficacy and serves as an auxiliary indicator for assessing the risk of secondary glaucoma in patients with uveitis, allowing for targeted clinical prevention and treatment measures.

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.

Objective To summarize and analyze the efficacy and influencing factors of second allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute leukemia relapsing after the first allo-HSCT. Methods Clinical data of 17 patients with acute leukemia who underwent second allo-HSCT at Peking University First Hospital from January 2005 to December 2024 were retrospectively analyzed. Results Among the 17 patients, 7 achieved long-term disease-free survival after second transplantation. The median progression-free survival after successful second transplantation was 7 months (range 8 days to 69 months). The relapse fatality was 24%, and the transplant-related fatality was 35%. Conclusions Second transplantation is an effective treatment for relapsed and refractory acute leukemia, but the relapse fatality and transplant-related fatality remain high. Patient age, time of relapse after the first transplantation and disease status before second transplantation are all factors that affect the efficacy of second transplantation. Younger age, late relapse and complete remission of disease before second transplantation are all beneficial for long-term disease-free survival after second transplantation.

OBJECTIVE: To evaluate the effect of biodegradable magnesium alloy materials in promoting tendon-bone healing during rotator cuff tear repair and to investigate their potential underlying biological mechanisms. METHODS: Forty-eight 8-week-old Sprague Dawley rats were taken and randomly divided into groups A, B, and C. Rotator cuff tear models were created and repaired using magnesium alloy sutures in group A and Vicryl Plus 4-0 absorbable sutures in group B, while only subcutaneous incisions and sutures were performed in group C. Organ samples of groups A and B were taken for HE staining at 1 and 2 weeks after operation to evaluate the safety of magnesium alloy, and specimens from the supraspinatus tendon and proximal humerus were harvested at 2, 4, 8, and 12 weeks after operation. The specimens were observed macroscopically at 4 and 12 weeks after operation. Biomechanical tests were performed at 4, 8, and 12 weeks to test the ultimate load and stiffness of the healing sites in groups A and B. At 2, 4, and 12 weeks, the specimens were subjected to the following tests: Micro-CT to evaluate the formation of bone tunnels in groups A and B, HE staining and Masson staining to observe the regeneration of fibrocartilage at the tendon-bone interface after decalcification and sectioning, and Goldner trichrome staining to evaluate the calcification. Immunohistochemical staining was performed to detect the expressions of angiogenic factors, including vascular endothelial growth factor (VEGF) and bone morphogenetic protein 2 (BMP-2), as well as osteogenic factors at the tendon-bone interface. Additionally, immunofluorescence staining was used to examine the expressions of Arginase 1 and Integrin beta-2 to assess M1 and M2 macrophage polarization at the tendon-bone interface. The role of the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT) signaling pathway in tendon-bone healing was further analyzed using real-time fluorescence quantitative PCR. RESULTS: Analysis of visceral sections revealed that magnesium ions released during the degradation of magnesium alloys did not cause significant toxic effects on organs such as the heart, liver, spleen, lungs, and kidneys, indicating good biosafety. Histological analysis further demonstrated that fibrocartilage regeneration at the tendon-bone interface in group A occurred earlier, and the amount of fibrocartilage was significantly greater compared to group B, suggesting a positive effect of magnesium alloy material on tendon-bone interface repair. Additionally, Micro-CT analysis results revealed that bone tunnel formation occurred more rapidly in group A compared to group B, further supporting the beneficial effect of magnesium alloy on bone healing. Biomechanical testing showed that the ultimate load in group A was consistently higher than in group B, and the stiffness of group A was also greater than that of group B at 4 weeks, indicating stronger tissue-carrying capacity following tendon-bone interface repair and highlighting the potential of magnesium alloy in enhancing tendon-bone healing. Immunohistochemical staining results indicated that the expressions of VEGF and BMP-2 were significantly upregulated during the early stages of healing, suggesting that magnesium alloy effectively promoted angiogenesis and bone formation, thereby accelerating the tendon-bone healing process. Immunofluorescence staining further revealed that magnesium ions exerted significant anti-inflammatory effects by regulating macrophage polarization, promoting their shift toward the M2 phenotype. Real-time fluorescence quantitative PCR results demonstrated that magnesium ions could facilitate tendon-bone healing by modulating the PI3K/AKT signaling pathway. CONCLUSION Biodegradable magnesium alloy material accelerated fibrocartilage regeneration and calcification at the tendon-bone interface in rat rotator cuff tear repair by regulating the PI3K/AKT signaling pathway, thereby significantly enhancing tendon-bone healing.
Animals ; Rotator Cuff Injuries/metabolism* ; Rats, Sprague-Dawley ; Signal Transduction ; Wound Healing/drug effects* ; Alloys/pharmacology* ; Rats ; Proto-Oncogene Proteins c-akt/metabolism* ; Rotator Cuff/metabolism* ; Macrophages/metabolism* ; Magnesium/pharmacology* ; Phosphatidylinositol 3-Kinases/metabolism* ; Vascular Endothelial Growth Factor A/metabolism* ; Male ; Biocompatible Materials ; Bone Morphogenetic Protein 2/metabolism*

This study analyzes the global patents development and clinical applications of photon counting CT (PCCT) technology in the past 20 years, including the trends of global patent application, the patent portfolio planning, key innovations and technological evolution of top medical device companies. The study utilizes patent retrievals in incoPat database, and then carries out patent navigation analysis. At the same time, with reports of clinical trials and research, the advantages and prospects of PCCT in clinical diagnosis are sorted out. With the rapid growth of the number of patent applications for PCCT, the technologies and clinical trials are becoming increasingly mature. It is expected that in the next few years, more PCCT products will be launched to the market, bringing a more accurate and safe diagnostic experience to radiologists and patients.
Patents as Topic ; Photons ; Tomography, X-Ray Computed ; Humans

Booster vaccinations are highly recommended in combating the SARS-CoV-2 Omicron variant and its subvariants. However, the optimal booster vaccination strategies and related immune mechanisms with different prior vaccinations are under-revealed. In this study, we systematically evaluated the immune responses in mice and hamsters with different prime-boost regimens before their protective efficacies against Omicron were detected. We found that boosting with Ad5-nCoV, S_WT-2P or S_Omicron-6P induced significantly higher levels of neutralization activities against Omicron variants than CoronaVac and ZF2001 by eliciting stronger germinal center (GC) responses. Specifically, S_Omicron-6P induced even stronger antibody responses against Omicron variants in CoronaVac and Ad5-nCoV-primed animals than non-Omicron-specific vaccines but with limited differences as compared to Ad5-nCoV and S_WT-2P. In addition, boosting with a specific vaccine has the potential to remodel the existing immune profiles. These findings indicated that adenovirus-vectored vaccines and mRNA vaccines would be more effective than other types of vaccines as booster shots in combating Omicron infections. Moreover, the protective efficacies of the vaccines in booster vaccinations are highly related to GC reactions in secondary lymphatic organs. In summary, these findings provide timely important information on prime-boost regimens and future vaccine design.

Objective To investigate the relationship between the mRNA expression levels of colony stimulating factor 2 receptor subunit beta CSF2RB and granase A(GZMA)in peripheral blood mononuclear cells(PBMC)of patients with acute myocardial infarction(AMI)and ventricular remodeling after percutaneous coronary intervention(PCI).Methods A total of 161 AMI patients admitted to the First Affiliated Hospital of Hebei North University from February 2022 to August 2023 were selected as the study objects,and were further divided into non-remodeling group(n=105)and remodeling group(n=56)according to whether ventricular remodeling was possible.A total of 85 patients with coronary heart disease who did not have myocardial infarction were taken as control group.The clinical data of patients were collected,and the expression levels of CSF2RB and GZMA mRNA in peripheral blood mononuclear cells were detected by real-time fluorescence quantitative PCR.Cardiac structural parameters were detected by echocardiography,and the relationship between CSF2RB and GZMA mRNA levels and cardiac structural parameters was analyzed by Pearson correlation.The influencing factors of ventricular remodeling in AMI patients were analyzed by univariate and Logistic regression,and P<0.05 was considered statistically significant.Results The mRNA expression of CSF2RB(1.15±0.28 vs 1.80±0.37),GZMA(0.85±0.16 vs 1.15±0.26),Cys C and Hcy levels were compared between the two groups,and the differences were statistically significant(t=-39.002～-4.854,all P<0.05).The follow-up was up to August 2024.Among 161 AMI patients who underwent PCI,56 cases had ventricular remodeling.The expression level of CSF2RB mRNA(1.85±0.31),GZMA mRNA(1.27±0.29)in the reconstructed group were significantly higher than that in the non-reconstructed group(1.71±0.34,1.12±0.30),and the differences were statistically significant(t=2.564,3.057,all P<0.001).LAD,LVEDD,LVPWTd and IVST in the postoperative reconstruction group were higher than those in the non-reconstruction group(t=11.247～26.008),and LVEF was lower than that in the reconstruction group(t=-15.271),with statistical significance(all P<0.001).The level of CSF2RB and GZMA in AMI patients was positively correlated with LAD,LVEDD,LVPWTd and IVST(rCSF2RB mRNA=0.657～0.754,rGZMA mRNA=0.512～0.745),and negatively correlated with LVEF(r=-0.684,-0.754),with statistical significance(all P<0.05).There was a statistically significant differences in the levels of Cys C and Hcy between the reconstructed group and non-reconstructed group after the use of aldehyed steroid receptor antagonsts(t=5.495,20.710,30.906,all P<0.05).Logistic regression analysis showed that CSF2RBmRNA＞1.79,GZMAmRNA＞1.18,Hcy＞20.15μmol/L and no use of aldosterol receptorantagonists were independent risk factors for ventricular remodeling in AMI patients.LVEF＞58.11%was an independent protective factor for ventricular remodeling in AMI patients(Wald χ2=1.137～3.206,P<0.05).Conclusion The expression levels of CSF2RB and GZMA in PBMC of AMI patients were significantly increased.CSF2RB and GZMA are independent risk factors for postoperative ventricular remodeling in patients with AMI,and can be used as potential diagnostic markers for ventricular remodeling after acute myocardial infarction.