Drug clinical trials constitute a critical link in new drug development and an essential means to verify the safety and efficacy of pharmaceuticals. The protection of participants’ rights and interests and the prevention of risks directly affect the scientific ethics and social credibility of the trials. Vulnerable groups， due to restricted autonomous decision-making capacities or special social status， are more susceptible to safety risks. Children are a typical representative of vulnerable groups. Their physiological particularities， cognitive limitations， and dependence collectively epitomize the universal protection demands of vulnerable research participants. Taking children as an instance， this paper analyzes the current weak links in the protection of pediatric research participants. Integrating advanced international experience with domestic practical demands， it comprehensively identified protection risk points at every stage and constructed a multi-stakeholder collaborative mechanism for the full-process protection of pediatric research participants. This mechanism incorporated seven main entities， including drug regulatory authorities， sponsors， researchers， and ethics committees， covering the pre-trial， intra-trial， and post-trial phases to meet the requirements of full-chain and multi-dimensional protection. It provided references for the subsequent establishment of a systematic protection mechanism for vulnerable populations.

OBJECTIVE To investigate the mechanism of pachymic acid on renal injury in pregnancy induced hypertension （PIH） rats by regulating the silent information regulator transcript 1/peroxisome proliferator-activated receptor γ coactivator-1α （Sirt1/PGC-1α） pathway. METHODS Pregnant SD rats were prepared by co-caging and PIH model was induced using N-nitro-L- arginine methyl ester （L-NAME） method. PIH rats were randomly divided into model group， L-pachymic acid （low-dose pachymic acid， 10 mg/kg） group， H-pachymic acid （high-dose pachymic acid， 20 mg/kg） group， and H-pachymic acid+EX527 （20 mg/kg pachymic acid+10 mg/kg EX527） group， with 6 rats in each group. Another 6 normal pregnant rats were selected as blank group. Each group was given relevant medicine or solvent intragastrically or intraperitoneally daily， once a day， for 28 consecutive days. After the last administration， 24 h urinary protein and tail artery systolic blood pressure （SBP） were measured in pregnant rats from each group， along with the levels of serum creatinine （Scr）， blood urea nitrogen （BUN），uric acid （UA）， and cystatin C （Cys-C）. The contents of superoxide dismutase （SOD）， malondialdehyde （MDA）， glutathione peroxidase （GSH-Px）， and 8-hydroxy-2′-deoxyguanosine （8-OHdG） in renal tissue， as well as the mRNA and protein expression levels of Sirt1 and PGC-1α， were also determined. Meanwhile， renal histopathological changes in rats from each group were evaluated using hematoxylin-eosin （HE） staining and periodic acid-Schiff （PAS） staining. RESULTS Compared with model group， L-pachymic acid group and H-pachymic acid group exhibited significant decreases in 24 h urine protein quantification， tail artery SBP， Scr， BUN， UA， Cys-C levels， glomerulosclerosis index score of renal tissue， renal tubular injury score， the percentage of PAS positive area， MDA and 8-OHdG （P＜0.05）. Conversely， the contents of SOD and GSH-Px， along with the mRNA and protein expression levels of Sirt1 and PGC-1α， were significantly increased （P＜0.05）. Moreover， these improvements were more pronounced in H-pachymic acid group （P＜0.05）. Compared with H-pachymic acid group， the aforementioned indicators in pregnant rats from the H-pachymic acid+EX527 group showed significant reversal （P＜0.05）. CONCLUSIONS Pachymic acid significantly ameliorates renal injury induced by PIH in rats， potentially through activation of the Sirt1/PGC-1α pathway.

Objective: To explore the characteristics of the diversity and composition of oral microbial flora with age, and to provide a reference for understanding the succession of oral microecology at different ages. Methods: Oral rinse 16S rRNA (V4 region) sequencing data from 9 021 participants 14-69 years of age in the 2009-2012 National Health and Nutrition Examination Survey (NHANES) were analyzed. Alpha diversity (Observed OTUs, Faith’s PD, Shannon Index), beta diversity (Bray-Curtis and UniFrac), and genus-level composition were examined using weighted generalized linear models (GLMs), including quadratic terms for age and adjusting for key covariates (gender, race/ethnicity, BMI, smoking status, and periodontitis severity). Results: Alpha diversity demonstrated a clear inverted U-shaped trajectory across age, peaking at 25-30 years old and declining thereafter. This trend remained consistent across sex, race, smoking, and periodontal health strata. Beta diversity analyses revealed a modest but steady age-related shift in community structure. Genus-level analyses revealed that Rothia, Prevotella_6, and Lactobacillus increased steadily with age, while Haemophilus, Porphyromonas, and Corynebacterium declined significantly. Notably, potential periodontopathogens, such as Fusobacterium and Treponema_2, peaked in early adulthood before declining with age. Conclusion Age is an important driver of oral microbial succession, and the oral microbiome exhibits dynamic changes across different life stages. Future longitudinal and multi-omic studies are warranted to elucidate the mechanisms underlying these age-related trajectories.

Ethical review represents the core of the scientific and technological ethical governance， and its quality depends on the participation of ethics. The absence of ethics and ethical experts will compromise the quality of the review. According to the spirit of the Guidelines on Strengthening the Governance over Ethics in Science and Technology， this paper analyzed the process of separating scientific and technological ethics from the field of scientific research morality， clarified the ethical attributes of ethical review， and argued that scientific research and technological innovation activities originated from ethics. On this basis， the fundamental principle of “ethics first” was proposed， aiming to proactively embed ethical considerations throughout the entire process of scientific and technological activities. This principle was the primary requirement for ensuring governance effectiveness and can also eliminate the risk of ethics being obscured in ethical governance. In practice， “ethics first” manifested specifically in dimensions such as prioritizing academic systems， prioritizing publicity， education， and training， as well as further advancing ethical considerations.

Bowel sounds are important acoustic physiological signals that reflect gastrointestinal motility and have significant clinical value in the evaluation of postoperative ileus， intestinal obstruction， and inflammatory bowel diseases. Conventional auscultation is highly subjective and often irreproducible， making continuous and objective monitoring difficult. With advances in microelectronics and signal processing technologies， wearable devices have enabled long-term， dynamic， and noninvasive acquisition of bowel sound signals. Meanwhile， ecological momentary assessment （EMA）， characterized by real-time and repeated data collection of individual behaviors and physiological states in realistic situations， provides a novel methodological framework to overcome the limitations of momentary bowel sound monitoring and to facilitate context-based interpretation. This review systematically summarizes the development of wearable bowel sound monitoring technologies， outlining three stages of the technological evolution stationary acquisition， dedicated portable systems， and wearable long-term monitoring. The clinical application value of bowel sound monitoring in multiple scenarios， including irritable bowel syndrome and inflammatory bowel diseases， is also discussed. Furthermore， the theoretical framework of EMA is introduced for the first time in the field of bowel sound monitoring， and its potential value， application scenarios， and methodological challenges are explored. The integration of wearable technology with the EMA framework may provide a theoretical basis for constructing an，individualized long-term gastrointestinal motility monitoring system with high ecological validity， to optimize postoperative care， improve home management of chronic gastrointestinal diseases， and advance precision health monitoring. Future efforts should focus on key issues such as equipment standardization， clinical validation， and algorithmic interpretability to accelerate progress in this field.

Objective:To construct and verify a prediction and evaluation model based on dual-energy computed tomography(CT)radiomics for lymph node metastasis in gastric cancer,so as to provide more accurate and reliable method before lymph node in gastric cancer occurs metastasis.Methods:A total of eighty patients with gastric cancer admitted to Handan Central Hospital from January 2021 to December 2024 were retrospectively selected,and they were divided into a modeling group(48 cases)and a verification group(32 cases)using a random number table method according to a ratio of 3 to 2.The influencing factors were analyzed,and predictive model was constructed and verified by using univariate and binary logistics regression.The patients'general information,tumor size,differentiation degree,lesion location,and carbohydrate antigen 125(CA125),carbohydrate antigen 199(CA199)and carcinoembryonic antigen(CEA)were compared between two groups.Results:There were not significant differences in age,gender,body mass index(BMI),tumor size,degree of differentiation,lesion location in the modeling group(P>0.05).In the modeling group,the immunity concentration(IC)was(20.66±2.85)μg/mL,and normal immunity concentration(nIC)was(0.45±0.06)μg/mL,and the slope was(3.52±0.30).The three indicators were respectively(21.09±3.25)μg/mL,(0.47±0.05)μg/mL,(3.49±0.42)in verification group.There were significant differences in the three indicators among two groups(t=3.277,5.287,2.918,P<0.05).There were not significant differences in the tumor-related detection indicators between two groups(P>0.05).The results of binary logistics regression analysis showed that IC,nIC,and slope were influential factors in lymph node metastasis of gastric cancer(OR=2.564,1.647,1.786,P<0.05).The constructed prediction model by using Python Scikit-learn showed favorable appearance in the calibration curve with a slope closed to 1,which indicated a high degree of consistency between predicted risks and actual risks.Receiver operating characteristic(ROC)curve analysis showed that the area under curve(AUC)of the modeling group was 0.896(95%CI:0.8154～0.9167),and the sensitivity and specificity were respectively 84.60%and 80.69%.The above three indicators were respectively 0.853(95%CI:0.7982～0.8671),86.66%and 80.00%in the verification group.Conclusion:A prediction and evaluation model for lymph node metastasis of gastric cancer based on dual-energy CT radiomics is successfully constructed,and its predictive efficiency and clinical application value are verified.

OBJECTIVE T o carry out the health economics evaluation and cost-benefit analysis of the type b Hae-mophilus influenzae(Hib)vaccination for the children who were hospitalized due to Hib infection so as to provide evidence for public health policies.METHODS The children who were diagnosed with Hib-related respiratory tract infections or meningitis and were hospitalized in respiratory medicine department,infection management depart-ment,emergency rooms and neurology department of Jiangxi Provincial Children's Hospital from Jan.1,2021 to Dec.31,2023 were recruited as the research subjects.Based on a 1∶1 matching condition,the matching variables included four items such as the same age for the admission to the hospital,same gender,same department and same grade of disease severity.The children for whom the primary immunization of Hib vaccination(including Hib monovalent vaccine and Hib-containing combination vaccine)were completed and the integrity of vaccination infor-mation could be checked out were assigned as the intervention group,while the children for whom the primary im-munization of Hib vaccination was not completed were chosen as the control group.The clinical data,vaccination data and the data such as length of hospital stay and hospitalization cost were collected from the children.The cost-benefit of the Hib vaccination among the children with Hib infection was observed.RESULTS A total of 622 hospi-talized children who were detected with Hib-positive respiratory tract infections or meningitis were enrolled in the study,and 73 children(20 children from infection management department,27 children from respiratory medi-cine department,26 children from emergency rooms)were finally included in the intervention group after matc-hing and multiple rounds of screening,73 children were chosen as the control group based on a 1∶1 matching con-dition.The male children accounted for 57.53％(42 cases)in both groups,and the female children accounted for 42.47％(31 cases)in both groups.With the respect to the length of hospital stay,it was 7.00(5.00,8.00)days in the intervention group,7.00(6.00,8.00)days in the control group(Z=-0.341,P=0.733).In terms of the hospitalization cost,it was 7 756.17(6 617.92,10 617.69)yuan in the intervention group,9 040.65(8 033.76,10 935.84)yuan in the control group(Z=-2.795,P=0.005).The cost of Hib vaccination was 343.03 yuan per capita in the intervention group,and the benefit-cost ratio(BCR)was 1∶3.74(343.03 yuan/1 284.48 yuan).CONCLUSIONS The Hib vaccination can save the hospitalization cost and has high cost effectiveness.It is sugges-ted that the Hib vaccination should be promoted and the coverage rate of Hib vaccination should be raised among the age-eligible children.

Objective To understand the real-life experiences of patients with chronic obstructive pulmonary disease(COPD)in disease self-control and to inform clinical nursing practice.Methods From March to May 2024,a phenomenological research method was used to conduct semi-structured interviews with 15 patients with COPD who were either outpatients or inpatients in a tertiary hospital in Suzhou City,China,and the data were analyzed using the Colaizzi 7-step analysis method.Results Totally 3 themes and 9 sub-themes were extracted,namely self-control challenges due to cognitive deficits(lack of knowledge leads to ambiguous control direction;cognitive bias hinders control strategy formulation;negative perception leads to control avoidance),weakening trend of self-control behaviors(decision-making conflicts between immediate indulgence and delayed gratification;lack of reinforcement mechanisms leads to psycho-emotional depletion;external temptations lead the self to imitate bad behavior),urgent need for multiple supports to help with self-control(the desire for continuity and stability of family support,the need for professionalism and accuracy of healthcare guidance,and the expectation for rationality and matching of resource allocation).Conclusion Healthcare professionals should pay attention to the real experience of COPD patients in the process of disease self-control,help them effectively deal with the challenges of disease self-control,strengthen self-control behaviors,and satisfy their diversified needs by strengthening the support of families,professionals,and the community to improve poor outcomes and reduce the cost of healthcare services.

Objective To investigate the levels and clinical significance of serum secreted frizzled related protein 5(SFRP5),soluble cell adhesion molecule-1(sICAM-1),and Fetuin-B in patients with type 2 diabetes mellitus(T2DM)complicated with metabolic syndrome(MS).Methods A total of 142 T2DM patients ad-mitted in the Jiamusi Hospital of Infectious Diseases from April 2021 to April 2023 were selected as the study subjects.T2DM patients were grouped into MS group(n=75)and non MS group(n=67)based on whether they had MS.Enzyme linked immunosorbent assay(ELISA)was applied to determine the expression levels of serum SFRP5,sICAM-1,and Fetuin-B.Logistic regression was applied to analyze and determine the influen-cing factors of complicated MS in T2DM patients.The diagnostic efficacy of SFRP5,sICAM-1,and Fetuin-B in T2DM patients with MS was analyzed by establishing receiver operating characteristic(ROC)curve.Results There were statistically significant differences in HDL-C and HOMA-IR between the MS group and the non MS group(P＜0.05).Compared with the non MS group,the serum SFRP5 level in the MS group de-creased(P＜0.05),while the sICAM-1 and Fetuin-B levels increased(P＜0.05).Logistic regression analysis showed that SFRP5 and HDL-C were protective factors for the development of MS in T2DM patients(P＜0.05),while sICAM-1,Fetuin-B,and HOMA-IR were risk factors for the development of MS in T2DM pa-tients(P＜0.05).The combination of serum SFRP5,sICAM-1 and Fetuin-B had the largest area under the curve in diagnosing MS in T2DM patients,and its evaluation efficacy was obviously better than that of the in-dividual diagnosis of serum SFRP5,sICAM-1,and Fetuin-B(Zcombination-SFRP5=2.466,P=0.014,Zcombination-SICAM-1=3.550,P＜0.001,Zcombination-Fetuin-B=3.697,P＜0.001).Conclusion The serum SFRP5 level in patients with T2DM complicated with MS decreases,while sICAM-1 and Fetuin-B levels increase.The combination of the three has a good effect in diagnosing complicated MS in T2DM patients.

Objective To explore the relationship between hemoglobin/red blood cell distribution width ra-tio(Hb/RDW)and chemotherapy sensitivity and prognosis in patients with oral squamous cell carcinoma(OSCC).Methods A total of 150 patients with advanced OSCC admitted to the hospital from January 2017 to January 2021 were selected into the study group.150 patients with other oral diseases who were diagnosed and treated for non-OSCC in the hospital during the same period were selected into the control group.Another 100 healthy subjects who underwent physical examination in the hospital during the same period were selected into the healthy group.Patients with OSCC were treated with chemotherapy,and blood routine indexes were detec-ted by automatic blood analyzer,and Hb/RDW ratio was calculated.Hb,RDW and Hb/RDW ratio were com-pared between the two groups and the relationship between Hb/RDW ratio and the sensitivity and prognosis of OSCC patients with chemotherapy were analyzed.The factors affecting the sensitivity of OSCC patients to chemotherapy were explored by multivariate Logistic regression.Results Hb and Hb/RDW in the study group were significantly lower than those in the control group and the healthy group,and RDW levels were significantly higher than those in the control group and the healthy group(P＜0.05).The patients with OS-CC were divided into high Hb/RDW group and low Hb/RDW group using the median Hb/RDW ratio(8.16)as the cut off value.The total effective rate of chemotherapy in Hb/RDW high ratio group was 70.67％,which was higher than that in Hb/RDW low ratio group 53.33％(P＜0.05).According to the sensitivity of chemo-radiotherapy,the study group was divided into sensitive group(n=103)and resistant group(n=47).The proportion of patients with stage Ⅳ,low differentiation and lymph node metastasis in resistance group was higher than that in sensitive group(P＜0.05).Multivariate Logistic regression analysis shows that TNM stage Ⅳ(OR=2.512,95％CI:1.588-3.973),low tumor differentiation(OR=2.237,95％CI:1.427-3.938),lymph node metastasis(OR=2.821,95％CI:1.607-4.951),Hb/RDW≤8.16(OR=3.540,95％CI:2.001-6.261)were risk factors for chemotherapy sensitivity in cases with OSCC(P＜0.05).The 3-year survival rate of OSCC cases in the high Hb/RDW group was 74.67％(56/75)and that in the low Hb/RDW group was 58.67％(44/75),There was a statistically significant difference in the 3-year survival rate between two groups(x2=4.320,P=0.038).Conclusion Hb/RDW is low expression in patients with OSCC,and is re-lated to the sensitivity and prognosis of patients with chemotherapy,which is expected to be a potential mark-er for predicting the sensitivity and prognosis of OSCC.