Palliative care is recognized as an effective measure to improve the quality of life for patients with end-stage diseases， and the significance and role of such patients participating in clinical trials to conquer major diseases has also become a broad consensus. However， due to the special physical， psychological， and social conditions of terminal trial participants， the ethical problems encountered in the trial process are more serious and complex. Drawing on ethical practice experience， these seemingly common phenomena and issues were deeply analyzed. Combined with the palliative care philosophy for end-stage patients， this paper proposed a series of improvement suggestions throughout the entire life cycle of clinical trials， hoping to promote the quality improvement of clinical research in which end-stage patients participate as subjects， while effectively protecting the safety and rights of the subjects and ensuring they receive appropriate palliative care during their participation in clinical trials or clinical-related scientific research.

Objective To analyze the related factors of prognosis in patients with primary Sjogren’s syndrome (SS) complicated with renal damage, and to provide reference for clinical development of personalized prevention and treatment measures. Methods A total of 508 patients with primary SS complicated with renal damage in the First Affiliated Hospital of Xinjiang Medical University from February 2020 to February 2022 were enrolled as study subjects. According to the prognosis status within 3 years, the enrolled patients were divided into good prognosis group (n=426) and poor prognosis group (n=82). Univariate and logistic multivariate regression analyses were adopted to analyze the influencing factors of poor prognosis. Results There were significant differences in hypertension, anemia, renal interstitial chronicity grading, and levels of globulin (GLO), immunoglobulin G (IgG) and hemoglobin between the two groups (P<0.05). Logistic multivariate analysis showed that concurrent hypertension, anemia, increased grade of renal interstitial chronicity, and elevated GLO and IgG levels were risk factors of poor prognosis in patients with primary SS complicated with renal damage, while hemoglobin level was a protective factor (OR: 1.962, 95%CI: 1.056-3.645; OR: 2.467, 95%CI: 1.153-5.278; OR: 17.796, 95%CI: 5.157-61.419; OR: 3.655, 95%CI: 1.812-7.372; OR: 5.732, 95%CI: 2.632-12.480; OR: 0.325, 95%CI: 0.165-0.640, P<0.05). Conclusion Patients with primary SS complicated with renal damage have a higher risk of poor prognosis, which is affected by factors such as hypertension, anemia, and GLO, IgG and hemoglobin levels. Clinically, it is necessary to take active prevention and treatment measures to improve the prognosis of patients.

Objective:To determine the erythromycin resistance of Bordetella pertussis isolates and their ptxP1 and ptxP3 phenotypic composition and compare clinical manifestations of children with pertussis caused by the two types of strains. Methods:This was a cross-sectional study, the pertussis cases diagnosed using bacterial culture from January 2019 to December 2022 in Beijing Children′s Hospital and the First People′s Hospital of Wuhu were collected.Any suspected Bordetella pertussis colonies were identified by the slide agglutination test.The susceptibility of isolates to erythromycin was detected by the E-test and K-B test.The ptxP gene was amplified by polymerase chain reaction and sequenced to determine its genotype. t-test, Mann-Whitney U-test, Chi-square test and Fisher′s exact test were use to statistical analysis. Results:A total of 192 strains of Bordetella pertussis were identified, including 188 (97.9%) erythromycin-resistant strains.Among the 188 strains, 30.3%(57/188) belonged to the ptxP1 genotype and 69.7%(131/188) belonged to the ptxP3 genotype.In children aged below 1 year old, the incidence of paroxysmal cough caused by infection with the ptxP3 strain was higher than that with the ptxP1 strain (57.1% vs.29.4%, P<0.05), and children infected with the ptxP3 strain were more likely to develop apnea or asphyxia (23.8% vs.17.6%), post-tussive vomiting (44.4% vs.32.4%), whooping cough (72.0% vs.50.0%) and pneumonia or bronchitis (85.7% vs.73.5%) compared to those infected with the ptxP1 strain, but the differences were not statistically significant(all P>0.05). In children aged 1 year old and above, the white blood cell count of children infected with the ptxP1 strain was higher than that of infections with the ptxP3 strain [13.5(9.9, 24.5)×10 9/L, 10.3 (7.0, 16.4)×10 9/L, P<0.05], and children infected with the ptxP1 strain were more likely to contract other pathogen infections than those infected with the ptxP3 strain (17.4% vs.4.4%, P>0.05). Conclusions:ptxP3 erythromycin-resistant Bordetella pertussis has become the main pathogen of pertussis.Infants with pertussis caused by the ptxP3 erythromycin-resistant strain show more significant manifestations and a higher possibility of severe symptoms than those infected with the ptxP1 erythromycin-resistant strain.

Objective:This study evaluates the performance of chemiluminescence assay, which is designed to detect Hepatitis D Virus (HDV) Immunoglobulin G (IgG) antibodies.Methods:A comparative analysis was conducted among chemiluminescence anti-HDV IgG reagent, the magnetic particle-based domestic reagent A and domestic reagent B, and the Robo Gene HDV RNA kit, using 1909 HBsAg-positive plasma samples. This comparison aimed to delineate clinical specificity and detection accuracy. The anti-HDV IgG reagent precision was assessed at three different concentration levels following the Clinical Laboratory Standards Institute EP5-A2 guidelines. The specificity of the assay was validated using 200 HAV IgM positive, 545 HBsAg-positive but anti-HDV IgG-negative, 350 anti HCV positive plasma samples and 200 healthy human blood samples. Additionally, a concordance study was conducted with 545 HBsAg-positive and 37 anti-HDV IgG-positive plasma samples, comparing the anti-HDV IgG reagent against reagent A.Results:1 909 HBsAg-positive plasma samples were tested using 3 anti HDV IgG reagent and 1 HDV RNA reagent, 19 samples were identified as anti-HDV IgG-positive. The anti-HDV IgG demonstrated superior accuracy and specificity. The assay exhibited excellent precision, with intra-assay coefficient of variation (CV) values ranging from 1.57% to 4.30%, and inter-assay CV values between 1.71% and 4.67% for detecting samples at high, medium, and low concentration levels. Concordance with Reagent A showed consistent results in both positive and negative detections.Conclusion:In this study, the anti-HDV IgG reagent (chemiluminescence method) displayed outstanding specificity in detecting clinical samples and exhibited a high conformity rate with commercialized reagents, making it potentially suitable for screening anti-HDV IgG in HBsAg-positive samples.

Objective:This study aims to evaluate the quality and explore the preliminary clinical applications of a domestically developed hepatitis D virus nucleic acid quantification reagent (abbreviated as"domestic HDV RNA reagent").Methods:The sensitivity and accuracy of the reagent were evaluated in accordance with the WHO HDV RNA international standard, employing the Bio-Rad CFX Opus 96 real-time fluorescence quantitative PCR analysis system. Serial dilutions of pseudo-viruses or cell culture-derived virus were used to determine the linear range of the domestic HDV RNA reagent. Specificity was assessed using positive samples of HAV, HBV, HCV infection, and HEV national reference materials. Precision was evaluated with samples at both high and low concentrations. In a comparative analysis, 30 HDV IgG positive samples were tested using both the domestic HDV RNA reagent and the RoboGene HDV RNA kit based on the ABI 7500 FAST DX system. The Pearson correlation coefficient (r) was used to examine the correlation between the two reagents.Results:The domestic HDV RNA reagent demonstrated a high sensitivity of up to 6 IU/ml, consistent with that of the comparator reagent. The calibration curve for WHO HDV RNA standards had a slope of -3.286, with an amplification efficiency of 101.6%. The linear detection range spanned from 10 to 10 8 IU/ml for eight HDV genotypes. The domestic HDV RNA reagent exhibited exceptional specificity, without cross-reactivity observed with HAV, HBV, HCV, or HEV. Accuracy assessments at five concentration levels met the required standards, with intra-assay precision coefficient of variation ( CV) ranging from 1.20% to 4.20%, and inter-assay precision CV from 1.20% to 7.90%. The detection results for HDV IgG positive samples were highly correlated with the comparator reagent ( r=0.984, P<0.001), achieving a diagnostic accuracy of 100% compared to sequencing results. Conclusion:In this study, the domestic HDV RNA reagent possesses excellent specificity, accuracy, precision, and a broad linear range, attaining a sensitivity level on par with international reagents of the same type.

Objective:To explore the influencing factors of abnormal blood pressure and electrocardiogram (ECG) in occupational motor vehicle drivers.Methods:In January 2024, a cluster sampling method was used to study 606 occupational motor vehicle drivers from a transportation service enterprise in Beijing who completed occupational health examination in 2023 in Peking University Third Hospital as observation group and 596 non-occupational motor vehicle drivers as control group. The data of personal history, occupational history, blood pressure and ECG were collected, and the effects of occupational motor vehicle driving on hypertension and ECG were analyzed by multivariate logistic regression.Results:The age of workers in the observation group was (34.1±7.8) years old, and the length of service was (7.0±7.1) years. The age of the control group was (33.8±7.6) years old, and the working age was (7.7±6.5) years. There was no significant difference in age and length of service between the two groups ( t=0.62, -1.90, P=0.538, 0.057). Systolic blood pressure (133.0±14.7) mmHg, diastolic blood pressure (83.7±11.6) mmHg, hypertension detection rate of 33.0% (200/606), ECG abnormality detection rate of 39.9% (242/606). They were significantly higher than those in the control group [ (127.8±14.4) mmHg, (77.5±11.0) mmHg, 24.7% (147/596), 31.0% (185/596) ], and the differences were statistically significant ( P<0.05). Multivariate logistic regression analysis showed that occupational motor vehicle driving were risk factors for hypertension and abnormal ECG ( OR= 1.210, 1.578; 95% CI: 1.145-1.231, 1.237-2.012; P<0.001) . Conclusion:Occupational motor vehicle driving may increase the risk of hypertension and abnormal ECG in workers.

Objective:To explore the influencing factors of abnormal blood pressure and electrocardiogram (ECG) in occupational motor vehicle drivers.Methods:In January 2024, a cluster sampling method was used to study 606 occupational motor vehicle drivers from a transportation service enterprise in Beijing who completed occupational health examination in 2023 in Peking University Third Hospital as observation group and 596 non-occupational motor vehicle drivers as control group. The data of personal history, occupational history, blood pressure and ECG were collected, and the effects of occupational motor vehicle driving on hypertension and ECG were analyzed by multivariate logistic regression.Results:The age of workers in the observation group was (34.1±7.8) years old, and the length of service was (7.0±7.1) years. The age of the control group was (33.8±7.6) years old, and the working age was (7.7±6.5) years. There was no significant difference in age and length of service between the two groups ( t=0.62, -1.90, P=0.538, 0.057). Systolic blood pressure (133.0±14.7) mmHg, diastolic blood pressure (83.7±11.6) mmHg, hypertension detection rate of 33.0% (200/606), ECG abnormality detection rate of 39.9% (242/606). They were significantly higher than those in the control group [ (127.8±14.4) mmHg, (77.5±11.0) mmHg, 24.7% (147/596), 31.0% (185/596) ], and the differences were statistically significant ( P<0.05). Multivariate logistic regression analysis showed that occupational motor vehicle driving were risk factors for hypertension and abnormal ECG ( OR= 1.210, 1.578; 95% CI: 1.145-1.231, 1.237-2.012; P<0.001) . Conclusion:Occupational motor vehicle driving may increase the risk of hypertension and abnormal ECG in workers.

OBJECTIVE To explore the effect of changing lifestyle diet in the treatment of laryngeal reflux disease(LRPD).METHODS A total of 92 patients with LRPD who received outpatient treatment in the Second Affiliated Hospital of Fujian Medical University from January 2022 to June 2023 were selected as the study control,divided into control group(46 cases)and treatment group(46 cases).The control group was treated with conventional acid suppression and gastric motogenic therapy.The treatment group was treated on the basis of the control group with giving guidance on lifestyle and diet.The changes of reflux symptom index scale(RSI)and reflux sign score scale(RFS)and the clinical efficacy of the two groups were compared 8 weeks and 12 weeks after treatment.RESULTS RSI total score was improved 8 weeks after treatment compared with before treatment in both RSI control group and treatment group(P＜0.05).The total RSI score of 12 weeks after treatment was improved compared with that of 8 weeks after treatment in both control and treatment groups(P＜0.05).The total RFS score at 8 weeks after treatment was improved in both control group and treatment group compared with before treatment(P＜0.05).Compared with 8 weeks after treatment,the total RFS score in both control group and treatment group was improved(P＜0.05).After 8 weeks of treatment,the total effective rate of the control group(60.9%)was compared with that of the treatment group(71.7%),and there was no significant difference between the two groups(χ2=1.335,P=0.513).After 12 weeks of treatment,the total effective rate of the control group(73.9%)was compared with the total effective rate of the treatment group(91.3%),and the difference between the two groups was statistically significant(χ2=6.226,P=0.044).CONCLUSION The change of lifestyle and diet should become an important part of the treatment of LRPD.By adjusting the unhealthy lifestyle and diet,the symptoms of patients can be significantly reduced and better clinical efficacy can be obtained.

Objective To explore artificial reconstruction vs artificial intelligence reconstruction in coronary artery volume rendering(VR).Methods A total of 110 coronary heart disease(CHD)patients were enrolled in the study,and underwent computed tomography arteriography.Artificial reconstruction(artificial group)and artificial intelligence reconstruction(intelligent group)were conducted in coronary artery VR.The image quality of VR and curved planar reconstruction(CPR),the diagnosis coincidence rate of arterial stenosis,and vascular reconstruction score were compared between two groups.Results The VR image quality of intelligent group was significantly higher than that of artificial group,with excellence rate of 90.91%vs 80.00%;and intelligent group scored higher than artificial group in CPR image quality(P<0.05).The differences in the diagnostic coincidence rates of arterial vessels(RCA,LAD,LCX)with no stenosis,slight stenosis,moderate stenosis,and vascular occlusion between two groups were trivial(P>0.05),while the two groups differed significantly in the diagnosis coincidence rates of mild stenosis and severe stenosis(P<0.05).The mean total score,the median value of the 3 main branches+posterior descending branch+intermediate branch+diagonal branch+blunt margin branch,and the median value of the other vascular branches were all significantly increased in intelligent group as compared with artificial group(P<0.05).Conclusion Artificial intelligence reconstruction has higher application value than artificial reconstruction in coronary artery VR.

Objective:This study aimed to explore the management system and procedures for broad consent in healthcare institutions for the effective and efficient implementation of broad consent, to protect the rights and interests of research participants, and to improve research efficiency.Methods:Using the 6W2H analysis method, key decision points such as background, goal orientation, operating mode, time node, applicable scope, key roles, procedure operation, and operating costs were explored and analyzed.Results:Broad consent should be implemented to protect the rights and interests of research participants as the primary core goal, and collaborate with multiple departments to establish a matching management system.Conclusions:The implementation of broad consent still faces many challenges. It is necessary to improve the scientific ethics governance system, increase the popularization of science to win public support, and strengthen the supervision of personal information protection.