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.

ObjectiveTo establish an ultra-performance liquid fingerprint and multi-components determination method for Naomaili granules. To evaluate the quality of different batches by chemometrics， and the anti-neuroinflammatory effects of water extract and main components of Naomaili granules were tested in vitro. MethodsThe similarity and common peaks of 27 batches of Naomaili granules were evaluated by using Ultra performance liquid chromatography （UPLC） fingerprint detection. Ultra-performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） technology was used to determine the content of the index components in Naomaili granules and to evaluate the quality of different batches of Naomaili granules by chemometrics. LPS-induced BV-2 cell inflammation model was used to investigate the anti-neuroinflammatory effects of the water extract and main components of Naomaili granules. ResultsThe similarity of fingerprints of 27 batches of samples was > 0.90. A total of 32 common peaks were calibrated， and 23 of them were identified and assigned. In 27 batches of Naomaili granules， the mass fractions of 14 components that were stachydrine hydrochloride， leonurine hydrochloride， calycosin-7-O-glucoside， calycosin，tanshinoneⅠ， cryptotanshinone， tanshinoneⅡ_A， ginsenoside Rb₁， notoginsenoside R₁， ginsenoside Rg₁， paeoniflorin， albiflorin， lactiflorin， and salvianolic acid B were found to be 2.902-3.498， 0.233-0.343， 0.111-0.301， 0.07-0.152， 0.136-0.228， 0.195-0.390， 0.324-0.482， 1.056-1.435， 0.271-0.397， 1.318-1.649， 3.038-4.059， 2.263-3.455， 0.152-0.232， 2.931-3.991 mg∙g^-1， respectively. Multivariate statistical analysis showed that paeoniflorin， ginsenoside Rg₁， ginsenoside Rb₁ and staphylline hydrochloride were quality difference markers to control the stability of the preparation. The results of bioactive experiment showed that the water extract of Naomaili granules and the eight main components with high content in the prescription had a dose-dependent inhibitory effect on the release of NO in the cell supernatant. Among them， salvianolic acid B and ginsenoside Rb₁ had strong anti-inflammatory activity， with IC₅₀ values of （36.11±0.15） mg∙L^-1 and （27.24±0.54） mg∙L^-1， respectively. ConclusionThe quality evaluation method of Naomaili granules established in this study was accurate and reproducible. Four quality difference markers were screened out， and eight key pharmacodynamic substances of Naomaili granules against neuroinflammation were screened out by in vitro cell experiments.

ObjectiveTo observe the clinical effectiveness and safety of Qingfei Shenshi Decoction （清肺渗湿汤） combined with western medicine for patients with bronchial asthma of heat wheezing syndrome， and to explore its potential mechanism of action. MethodsEighty-six participants with bronchial asthma of heat wheezing syndrome were randomly divided into treatment group and control group， each group with 43 participants. The control group received conventional western medicine， and the treatment group was additionally administered Qingfei Shenshi Decoction orally on the basis of the control group， 1 dose per day. Both groups were treated for 14 days. The primary outcome measure was clinical effectiveness； secondary outcome measures included traditional Chinese medicine （TCM） syndrome score， asthma control test （ACT） score， pulmonary function indices such as forced expiratory volume in 1 second （FEV₁）， forced vital capacity （FVC）， peak expiratory flow （PEF）， serum inflammatory factor levels including interleukin-4 （IL-4）， tumour necrosis factor-α （TNF-α）， and high-sensitivity C-reactive protein （hs-CRP）， and immune function indices including CD3⁺， CD4⁺， CD8⁺， CD4⁺/CD8⁺. All outcome measures were evaluated before and after treatment. Vital signs were monitored， and electrocardiography， blood routine， urine routine， liver function， and renal function tests were performed before and after treatment. Adverse events and reactions during the study were recorded. ResultsA total of 80 patients completed the trial with 40 in each group. The total clinical effective rate of the treatment group was 97.5% （39/40）， which was significantly higher than that of the control group （85.0%， 34/40， P＜0.05）. After treatment， both groups showed decreased TCM syndrome scores， IL-4， TNF-α， hs-CRP， and CD8⁺ levels， as well as increased ACT scores， CD3⁺， CD4⁺， CD4⁺/CD8⁺， FEV₁， FVC， and PEF levels （P＜0.05 or P＜0.01）. Moreover， the improvements in these indices were more significant in the treatment group than in the control group （P＜0.05 or P＜0.01）. No significant abnormalities in safety indicators were observed in either group， and no adverse events or reactions occurred. ConclusionQingfei Shenshi Decoction combined with conventional western medicine for patients with bronchial asthma of heat wheezing syndrome can effectively improve the clinical symptoms， pulmonary function， and clinical effectiveness， with good safety. Its mechanism may be related to reducing inflammatory factor levels and regulating T lymphocyte subsets to improve immune function.

Antibody-drug conjugates （ADCs） are a novel class of anti-tumor agents composed of a targeted monoclonal antibody， a cytotoxic drug， and a linker connecting the two. They combine the high specificity of antibodies with the potent cytotoxicity of chemotherapeutic agents. Triple-negative breast cancer （TNBC） is characterized by high aggressiveness， elevated risks of recurrence and metastasis， and poor prognosis， largely due to the lack of effective therapeutic targets. This review summarizes the research progress of ADCs in the treatment of TNBC. It has been found that ADCs targeting human epidermal growth factor receptor 2 （such as trastuzumab deruxtecan）， trophoblast cell surface antigen 2 （such as sacituzumab govitecan and datopotamab deruxtecan）， zinc transporter LIV-1 （such as ladiratuzumab vedotin）， HER-3 （such as patritumab deruxtecan）， epidermal growth factor receptor （such as AVID100）， and glycoprotein non-metastatic melanoma protein B （such as glembatumumab vedotin） have all demonstrated promising therapeutic effects against TNBC. Despite challenges including acquired resistance and treatment-related toxicities， ADCs are undoubtedly reshaping the therapeutic landscape for TNBC and are expected to occupy a more central position in TNBC treatment in the future.

Objective: To establish an accurate and rapid typing method for Rh typing of samples from patients who have received recent blood transfusions by utilizing the difference in osmotic fragility between fresh and old red blood cells. Methods: A lysing solution suitable for destroying old RBCs was prepared. Sixty-one samples collected in our hospital in 2024 with Rh typing of double groups were treated with the lysing solution to remove the old allogeneic red blood cells while preserving the patient's own fresh red blood cells, followed by repeat Rh typing tests. Results: For 61 samples with Rh typing in double groups, 41 were accurately detected identified through the red blood cell lysis method, yielding an identification rate of 67.21%. No significant difference was observed compared to the detection rate of the commonly used capillary centrifugation modified method (χ =0.103, P>0.05). Conclusion: The red blood cell lysis method provides a novel and rapid experimental approach for clinical use in processing Rh-typed samples that are of double groups, thereby offering a basis for Rh compatibility blood transfusion.

Despite breakthroughs in immunotherapy for solid tumors, significant variations in treatment efficacy persist. Up to 80% of cancer patients suffer from malnutrition, which leads to: lymphoid atrophy and reduced T-cell reserves; deficiency of substrates required for T-cell activation and expansion; concurrent inflammation hindering T-cell infiltration into tumors; and cachexia accelerating PD-1 antibody clearance. Clinical studies confirm that severe malnutrition significantly impairs immune responses and increases the risk of treatment toxicity. Therefore, implementing standardized nutritional therapy is crucial for optimizing the reserve, activation, expansion, and infiltration capacity of immune cells, thereby providing a sound immune system foundation for immunotherapy. Immunonutrition therapy, by enhancing immunonutrients such as arginine, omega-3 polyunsaturated fatty acids, and nucleotides, reduces the secretion of pro-inflammatory mediators and promotes T-cell activation and proliferation. This enhances anti-tumor immune responses, prolongs survival, and advances cancer treatment towards multimodal combination and precision approaches.

Due to the moist environment in the mouth, there are many challenges that arise, such as difficult biofilm removal, short drug retention time, and low tissue repair efficiency, while treating dental caries, periodontal disease, and other oral diseases. As a biomimetic biomaterial, polydopamine (PDA) possesses multifunctional properties, including mussel-inspired adhesion and stimuli-responsive drug release. PDA adhesion properties originate from its surface catechol and amino functional groups, which maintain strong wettability in aqueous environments. With smart responsiveness encompassing photothermal, pH, and enzymatic stimuli, PDA enables controlled drug release under specific conditions. Additionally, PDA exhibits antibacterial, anti-inflammatory, and osteoblast-promoting functions, thus demonstrating significant application potential in the treatment of oral diseases. In hard tissue therapies, specifically for dental caries, PDA promotes enamel remineralization by inducing hydroxyapatite crystal growth and enhances dentin collagen mineralization through Ca2+ chelation while inhibiting cariogenic bacteria. In mandibular defect repair, functionalized PDA coatings on bone implants facilitate mesenchymal stem cell adhesion and differentiation, activate osteogenic signaling pathways, and synergistically promote vascularization to improve bone-implant integration. For soft tissue treatments, specifically for periodontitis, PDA alleviates alveolar bone resorption via antibacterial and anti-inflammatory effects coupled with osteoclast inhibition. In denture stomatitis management, PDA’s strong wet adhesion prolongs drug retention, while its photothermal effect and reactive oxygen generation provide both broad-spectrum antibacterial activity and wound healing promotion. This review summarizes PDA’s synthesis mechanisms and biological functions, with an emphasis on its therapeutic applications in oral diseases, providing innovative strategies for oral healthcare.

Objective To systematically evaluate the risk prediction models for postoperative delirium in adults with cardiac surgery. Methods The SinoMed, CNKI, Wanfang, VIP, PubMed, EMbase, Web of Science, and Cochrane Library databases were searched to collect studies on risk prediction models for postoperative delirium in cardiac surgery published up to January 29, 2025. Two researchers screened the literature according to inclusion and exclusion criteria, used the PROBAST bias tool to assess the quality of the literature, and conducted a meta-analysis of common predictors in the model using Stata 17.0 software. Results A total of 21 articles were included, establishing 45 models with 28733 patients. Age, cardiopulmonary bypass time, history of diabetes, history of cerebrovascular disease, and gender were the top five common predictors. The area under the curve (AUC) of the 45 models ranged from 0.544 to 0.98. Fourteen out of the 21 studies had good applicability, while the applicability of the remaining seven was unclear; 20 studies had a high risk of bias. Meta-analysis showed that the incidence of postoperative delirium in adults with cardiac surgery was 18.6% [95%CI (15.7%, 21.6%)], and age [OR=1.045 (1.036, 1.054), P<0.001], history of cerebrovascular disease [OR=1.758 (1.459, 2.057), P<0.001], gender [OR=1.732 (1.430, 2.034), P<0.001], mini-mental state examination score [OR=3.930 (1.859, 8.309), P<0.001], and length of ICU stay [OR=5.586 (4.289, 6.883), P<0.001] were independent influencing factors for postoperative delirium after cardiac surgery. Conclusion The risk prediction models for postoperative delirium after cardiac surgery have good predictive performance, but there is a high overall risk of bias. In the future, large-sample, multicenter, high-quality prospective clinical studies should be conducted to construct the optimal risk prediction model for postoperative delirium in adults with cardiac surgery, aiming to identify and prevent the occurrence of postoperative delirium as early as possible.

Objective: To explore the association between dietary inflammatory index (DII) and elevated blood pressure among primary school students, and to analyze the mediating role of body mass index (BMI) in this association, so as to provide a scientific basis for the early prevention of childhood hypertension and dietary guidance. Methods: Research conducted based on the Ma anshan Child Growth Cohort in Anhui Province. From April to June 2024, 4 057 primary school students were selected as study subjects using a multi stage cluster sampling method. Dietary information was collected via Semi quantitative Food Frequency Questionnaire to calculate the DII score. BMI was obtained by measuring students height and weight. Elevated blood pressure was defined based on the Blood Pressure Reference Standards for Children Aged 3-17 Years. Logistic regression was used to analyze the association between DII scores and the risk of elevated blood pressure, and the Bootstrap method was employed to test for mediating effects. Results: The detection rate of elevated blood pressure among primary school students was 10.1% (408 cases). Multivariate Logistic regression analysis showed that, after adjusting for covariates such as gender and age, for each standard deviation increase in the DII score ( s =1.94), the risk of elevated blood pressure increased by 15% ( OR =1.15, 95% CI =1.04- 1.28 , P <0.05). Compared with the lowest quartile group of DII scores ( Q 1), students in the highest quartile group ( Q 4) had a 1.31-fold higher risk of elevated blood pressure ( OR =1.31, 95% CI =1.00-1.76, P <0.05). Restricted cubic spline results indicated a linear dose response relationship between DII scores and the risk of elevated blood pressure( P nonlinear =0.13). The mediation analysis revealed that BMI played a partial mediating role in the association between DII scores and elevated blood pressure. The mediation effect value was 0.06 (95% CI =0.04-0.08), accounting for 44.64% of the total effect. Conclusions DII scores are associated with elevated blood pressure among primary school students in Ma anshan City, and BMI plays a partial mediating role in this association. Promoting an anti inflammatory dietary pattern and weight control in early childhood should be emphasized to reduce the incidence of hypertension among primary school students.