Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.
This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.
The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.
Body image dissatisfaction (BID) is relatively common in Chinese female undergraduates. This study aims to explore the reasons for BID among female undergraduates to develop effective early intervention strategies.
A qualitative research approach was used through semi-structured interviews, allowing for an in-depth understanding of the experiences of participants.
The study was conducted from April 2024 to November 2024 at Yibin University in Sichuan province, China.
The study involved 25 female undergraduates with an average age of 19.8±1.3 years. These participants were selected to provide rich qualitative data about their experiences and views regarding BID.
The participants showed a high level of BID, and the thematic analysis revealed five overarching themes regarding the causes of BID among female undergraduates: (1) individual factors; (2) media factors; (3) family factors; (4) peer factors; and (5) overall societal impact.
The thematic analysis revealed that dissatisfaction with body image among female undergraduates is a multidimensional issue influenced by various factors, including individual and sociocultural elements. The conclusion emphasises the necessity of strengthening comprehensive intervention measures to address these influencing factors.
Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.
A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.
In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.
This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.
ANZCTR 386960
The prevalence of pulmonary nodules (PNs) has been rising in China, but PN patients’ perceptions towards the management remain underexplored. This study aimed to investigate the knowledge, attitudes and behaviours (KAB) regarding PN management among Chinese patients.
A cross-sectional study was conducted to evaluate the KAB scores using a self-designed questionnaire.
The study included 519 PN patients (275 males, aged 41.07±19.47) diagnosed at Wenzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medicine University between November 2022 and January 2023. Participants completed a self-designed questionnaire assessing their KAB regarding PN management.
The primary outcomes included mean scores for KAB, with secondary outcomes examining correlations and associations with demographic factors.
The mean KAB scores were 4.24±2.93 (range: 0–10), 17.97±4.88 (range: 0–32) and 31.30±11.98 (range: 0–52). Pearson’s correlation analysis revealed a weakly positive correlation between knowledge and behaviour (r=0.248, p
PN patients demonstrate insufficient knowledge and moderate attitudes and behaviours regarding PN management. These findings highlight the need for targeted educational interventions to improve understanding among PN patients.
The retention of a critical mass of human resources is currently an urgent priority for China’s older adults’ care sector. This study investigated the relationship between social support and turnover intention among employees in older adults caring social organisations (SOs) and focused on studying the mediating role of job satisfaction.
Cross-sectional study.
Older adults caring for SOs in Anhui, Chongqing and Shanghai, China.
A hybrid sampling method was applied to this study, which encompassed multistage stratified sampling and targeted sampling. Questionnaires were administered to 1433 employees of SOs caring for the elderly from November 2019 to August 2023.
A generalised linear model was employed to examine factors associated with turnover intention. Spearman correlation analysis was used to investigate the relationships between key variables. Finally, the mediating effects among the study variables were examined using structural equation modelling.
The overall median scores (IQR) for employees’ turnover intention and social support were 10.00 (6.00) and 72.00 (14.00), respectively. The total effect on turnover intention comprised the direct effect of social support on turnover intention (β =–0.165, SE =0.040, 95% CI =–0.243 to –0.087) and the indirect effect of social support on turnover intention through job satisfaction (β =–0.079, SE =0.016, 95% CI =-0.111 to –0.049).
The study elucidated the indirect influence of social support on turnover intention among employees in older adults caring SOs, mediated by job satisfaction.
To assess career satisfaction among Chinese nurses, explore influencing factors, and examine the mediating role of role breadth self-efficacy (RBSE) in the relationship between subjective age and career satisfaction.
A multi-centre, cross-sectional study.
Between June and October 2024, 2033 questionnaires were distributed to nurses across seven geographic regions in China, collecting data on demographics, subjective age, RBSE, and career satisfaction. Descriptive statistics, Pearson correlation analysis, multiple linear stepwise regression, and path analysis were used to identify determinants of career satisfaction and test the mediating effect of RBSE.
The effective response rate was 97%. Chinese nurses reported moderate-to-high career satisfaction, younger subjective age relative to chronological age, and moderate RBSE levels. Multivariate linear regression analysis identified education level, work institution, salary, weekly working hours, subjective age, and RBSE as significant predictors of career satisfaction. Path analysis revealed a significant negative association between subjective age and career satisfaction (β = −0.23, p < 0.001), which was partially mediated by RBSE (indirect effect = −0.11, 95% CI: −0.18 to −0.05).
The career satisfaction of Chinese nurses is at a moderately high level; the influencing factors include the intensity of nursing work and salary levels. There is a certain difference between the subjective age and the chronological age of Chinese nurses. RBSE partly mediates the relationship between subjective age and career satisfaction.
Valuing the breadth of nurses' roles, self-efficacy, and subjective age may help improve job satisfaction.
What problem did the study address?: This study elucidates the present level of career satisfaction among nurses in China and the variables affecting it. What were the main findings?: The subjective age of Chinese nurses influences career satisfaction, with RBSE partly mediating the connection between subjective age and career satisfaction. Where and on whom will the research have an impact?: This study presents novel variables of subjective age and RBSE in the investigation of factors influencing career satisfaction among Chinese nurses, offering new avenues for enhancing career satisfaction in this demographic in the future.
We adhered to STROBE guidelines for cross-sectional research.
This study did not include patient or public involvement in its design, conduct, or reporting.
This study aimed to examine the level of vicarious posttraumatic growth among intensive care unit nurses in China and explore the mediating role of death coping ability in the relationship between moral resilience and vicarious posttraumatic growth.
A multicentre, cross-sectional study was conducted in accordance with the STROBE guidelines.
Between January and March 2025, a questionnaire survey was conducted among 666 intensive care unit nurses from nine tertiary Grade A hospitals across five provinces in China. Participants completed three standardised instruments: the Rushton Moral Resilience Scale, the Coping with Death Scale–Short Version, and the Vicarious Posttraumatic Growth Inventory. We used IBM SPSS 27.0 for descriptive statistics, univariate analyses, and correlation analyses, and employed AMOS 27.0 to perform structural equation modelling for testing mediation effects.
Intensive care unit nurses demonstrated a moderate level of vicarious posttraumatic growth. Moral resilience was positively associated with both death coping ability and vicarious posttraumatic growth. Death coping ability was found to play a partial mediating role in the relationship between moral resilience and vicarious posttraumatic growth.
Moral resilience and death coping ability are key factors associated with vicarious posttraumatic growth among intensive care unit nurses. Nurses with stronger moral resilience are more likely to cope constructively with death-related stress, which may support psychological growth in trauma-intensive environments.
This study highlights the need to enhance intensive care unit nurses' moral and emotional capacities through ethics education, emotional coping training, and institutional support strategies. Strengthening these competencies may foster professional development and mental wellbeing in critical care settings.
Colonoscopy is an essential procedure for the early diagnosis of colorectal conditions; however, over 60% of patients undergoing non-sedated colonoscopy report moderate to severe pain. This study aims to investigate the central analgesic mechanisms of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA). A multimodal approach combining electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to assess pain-related brain activity, with artificial intelligence applied to model the relationship between objective neurophysiological signals and subjective pain experience.
This is a single-centre, randomised, double-blind, controlled trial involving 60 patients undergoing colonoscopy without anaesthesia. Participants will be randomly allocated (1:1) to either an electrical stimulation group receiving TENS-WAA or a sham stimulation group. EEG and fNIRS data will be acquired before, during and after the procedure. The primary outcome is the analysis of EEG-fNIRS signals to characterise cerebral responses associated with pain modulation. Secondary outcomes include patient-reported pain using the Visual Analogue Scale (VAS), total colonoscopy duration and the correlation between EEG-fNIRS indicators and VAS scores. A deep learning framework will be used to enhance pain prediction accuracy.
This study has received ethical approval from the Ethics Committee of Changhai Hospital, Shanghai (approval reference CHEC2025-006), and has been registered at ClinicalTrials.gov. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed academic journals and at relevant scientific conferences, regardless of outcome, contributing to evidence-based, non-pharmacological pain management strategies.
ClinicalTrials.gov, NCT06813703.
Chronic venous disease, particularly lower extremity varicose veins (VVs) and incompetent perforating veins (IPVs), is a prevalent condition associated with significant morbidity, including venous ulcers and post-surgical recurrence. Current diagnostic modalities for IPVs—such as digital subtraction angiography, CT venography, magnetic resonance venography and conventional ultrasound—are limited by ionising radiation, operator dependency or inadequate spatial resolution. Ultrasound tomography (UT), an emerging automated 3D imaging technology, offers comparable resolution, wider field of view and reduced operator bias compared with conventional ultrasound. Preliminary studies suggest UT improves IPV detection rates, yet its diagnostic accuracy and clinical utility remain unvalidated in large-scale trials. This study aims to evaluate UT’s diagnostic performance and its impact on surgical outcomes in a paired-design and randomised controlled trial (RCT), addressing a critical gap in non-invasive venous assessment.
This study combines a paired diagnostic trial and a prospective, triple-blind RCT. In the paired trial (n=84), patients with VVs (Clinical-Etiological-Anatomical-Pathophysiological C2–C5) receive both conventional ultrasound and UT combined with Doppler examination to compare IPV detection sensitivity against surgical findings. The RCT (n=264) randomises patients to conventional ultrasound group (control group) or conventional ultrasound+UT group (intervention group). After examination, all patients undergo standardised treatment (radiofrequency ablation with sclerotherapy and selective IPV ligation), with follow-up extending to 5 years. The primary endpoint is 1-year recurrence rates and secondary endpoints, including 3-month, 3-year and 5-year recurrence rates, as well as Venous Clinical Severity Scores, quality of life and Aberdeen Varicose Vein Questionnaire scores.
The study has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital (approval number: 2024-132). Written informed consent will be obtained from each participant, and final results will be published in peer-reviewed journals.
The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier: ChiCTR2500097289.
by Haoyang Zhou, Jinfeng Yang, Na Li, Jinying Li, Jianxin Ran, Yan Zheng, Yifan Long, Fang Cheng, Yuanpeng Liao
BackgroundSarcopenia is an age-associated disorder characterized by a progressive decline in skeletal muscle mass, strength, and physical function. The condition is linked to low levels of anabolic hormones such as insulin-like growth factor 1 (IGF-1), with its downstream phosphatidylinositol 3 kinase (PI3K)/ protein kinase B (AKT)/ forkhead box protein O3 (FOXO3) signaling pathway. There is growing evidence that resistance training (RT) or vibration training (VT) could improve physical functioning in individuals with sarcopenia. However, the related physiological influence of exercise on sarcopenia remains elusive.
MethodThis prospective randomized controlled trial will be conducted among 96 participants, aged between 65 and 80 years. In participants, sarcopenia diagnosis will be confirmed based on the Asian Working Group for Sarcopenia criteria, and participants will be randomized into either control, RT, VT, or RVT (combined RT and VT) groups. The intervention will last 12 weeks, with assessments performed at baseline, 12 weeks (after intervention), and 24 weeks (follow-up). The primary outcomes will include skeletal muscle mass, handgrip strength, and gait speed. Secondary outcomes comprise IGF-1 concentrations, PI3K/AKT and FOXO3 protein activity, quality of life, and timed-up-and-go test performance assessments.
DiscussionThis clinical study aims to elucidate the potential modulation of molecular mechanisms in vivo for combined RT and VT in sarcopenia patients and to identify the effects of the intervention on physical function.
Trial registrationChiCTR, ChiCTR2400083643. Registered on April 29, 2024.
To investigate the educational value of combining intraoperative explanations with laparoscopic surgical video reviews for teaching the local anatomy of the stomach.
Thirty resident physicians undergoing standardised training in our hospital, including undergraduate resident physicians and clinical-type postgraduates in surgery who had not participated in radical gastrectomy for gastric cancer, were selected as study subjects. They were randomly divided into an experimental group and a control group, with 15 participants in each group. The experimental group received instruction through intraoperative explanations combined with laparoscopic surgical video reviews, while the control group participated in surgery without additional instructional methods. After the teaching sessions, both groups underwent clinical practice assessments, theoretical examinations and evaluations of teaching satisfaction. The distribution of the data was assessed using the Shapiro-Wilk normality test along with Quantile-Quantile plots. Two-way analysis of variance was employed to evaluate the main effects and interaction effects of clinical practice scores across different groups and student types. Statistical power was examined through post hoc power analysis.
The clinical practice assessment results, theoretical examination scores and teaching satisfaction ratings of the experimental group were significantly higher than those of the control group, with all differences reaching statistical significance (p
Combining intraoperative explanations with laparoscopic surgical video reviews for teaching local anatomy during distal gastrectomy is more effective than participation in surgery alone. This approach allows students to review surgical videos at their convenience, enhancing their understanding and mastery of local anatomical structures and significantly improving the quality of local anatomy education for resident physicians.
Eye injury poses a significant challenge to the global burden of blindness. Using the Global Burden of Disease (GBD) database, this study aims to comprehensively assess the latest global burden of eye injury and examine its relationship with the Socio-Demographic Index (SDI).
Observational study.
Population-based data on eye injury from the GBD 2021 database, covering the period 1990–2021.
Primary outcomes included incidence, prevalence and years lived with disability (YLDs) due to eye injury. Secondary outcomes included temporal trends analysed using joinpoint regression, age-period-cohort effects, health inequality indices (Slope Index of Inequality (SII) and Concentration Index) and decomposition analysis of contributing factors.
From 1990 to 2021, global eye injury incidence (in thousands) increased from 33 702.80 (95% uncertainty interval (UI): 27 271.41 to 44 086.12) to 39 996.91 cases (95% UI: 32 341.74 to 52 215.74), while age-standardised incidence rates (ASIR) declined from 622.73 to 503.26 per 100 000 population (average annual percent change (AAPC): –0.63, 95% confidence interval (CI) –0.81 to –0.46, p75 years). Health inequality between SDI regions narrowed (SII decreased from 3.10 to 2.21 per 100 000), with population growth contributing 207.93% to increased incidence.
The burden of eye injury exhibits distinct patterns across development levels, requiring tailored interventions: occupational safety for young adults in developing regions and fall prevention for the elderly in developed areas. Prevention strategies should align with regional economic development stages, emphasising workplace safety in industrialising regions while maintaining robust healthcare accessibility.
Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.
This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.
Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).
Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.
To describe the perspectives of individuals receiving haemodialysis regarding health literacy in fluid management.
A qualitative descriptive approach using directed content analysis of interviews from an explanatory mixed methods study.
Semi-structured individual interviews were conducted from September 2020 to February 2021 with 28 individuals receiving haemodialysis who had attended a prior quantitative study. A directed qualitative content analysis approach was used to identify categories and subcategories emerging from the data.
Six categories of health literacy were identified: (1) active health management, (2) engagement with healthcare providers, (3) understanding and support from healthcare providers, (4) social support, (5) health information literacy and (6) navigation of the healthcare system.
Based on their real-life experience, individuals receiving haemodialysis have unique health literacy needs regarding fluid management. A comprehensive understanding of these unique needs is crucial in creating person-centered interventions to address inadequate fluid restriction.
Interventions to address inadequate fluid restriction should be person-centered, considering each individual's unique health literacy needs. This involves conducting a comprehensive assessment of individuals' health literacy needs, empowering individuals to actively engage in health, engaging the entire support network and facilitating health information literacy in line with individuals' preferences.
This study offers detailed insights into the health literacy needs related to fluid management in individuals undergoing haemodialysis. The findings could inform the development of person-centered fluid management strategies for these individuals.
We adhered to the Consolidated Criteria for Reporting Qualitative Research checklist.
No patient or public contribution.
To understand the current situation of nurses' compassion competence and analyse the characteristics and influencing factors of different categories of nurses' compassion competence based on latent profile analysis, to provide a theoretical basis for formulating targeted compassion training programmes.
A cross-sectional study.
From June to October 2023, 550 nurses from tertiary grade A hospitals in Shandong province were selected by convenience sampling and investigated by utilising a demographic characteristics questionnaire, the Compassion Competence Scale for the Nurses, the Mindful Attention Awareness Scale and the Maslach Burnout Inventory-Human Service Survey. Latent profile analysis was performed to explore the potential categories of nurses' compassion competence, and single-factor analysis and logistic regression analysis were used to explore the related influencing factors.
A total of 513 nurses were included. The compassion competence of nurses could be divided into four categories: the compassion competence deficient group (7.56%), the compassion competence low-imbalanced group (15.35%), the compassion competence high-balanced group (50.38%) and the compassion competence excellent group (26.70%). Department, years of working, humanistic care training experience, whether work is supported by colleagues and leaders, mindfulness and job burnout were the influencing factors of different potential categories (all p < 0.05).
There are four categories into which nurses' compassion competency can be categorised. Nursing managers and medical institutions can formulate precise training methods that enhance nurses' compassion competency based on the traits of various nurse categories in order to improve the quality of nursing service.
The results of this study help to understand the categories and heterogeneity of nurses' compassion competence and provide a basis for nursing managers and medical institutions to improve the compassion competence of different categories of nurses.
All participants were nurses who completed an electronic questionnaire related to this study.
Postoperative arrhythmias are common and clinically significant complications. They are a cause of increased morbidity and mortality rates in surgical patients. Although various pharmacological and procedural strategies have been explored for preventing postoperative arrhythmia, evidence regarding their effectiveness remains inconsistent. The stellate ganglion block (SGB) has emerged as a promising alternative to reduce the occurrence of postoperative arrhythmias. By summarising the existing evidence, this meta-analysis aims to assess the effectiveness of SGB in preventing postoperative arrhythmias.
We will review literature from January 1970 to April 2025 using MEDLINE, Cochrane CENTRAL and Embase. Studies eligible for inclusion will be randomised controlled trials and observational studies reporting postoperative arrhythmia incidence in surgical patients who received preoperative or intraoperative SGB. We will include articles in the following languages: English, Spanish, Chinese or Portuguese. Secondary outcomes are SGB-related complications. The risk of bias will be determined by Rob-2 and ROBINS-I tools. Meta-analyses, reporting relative risks or ORs with 95% confidence intervals will be performed when at least three studies report the same outcome under comparable conditions. Quality of evidence will be evaluated using GRADE guidelines.
We will use information from previously published manuscripts found in reputable databases, and ethical approval is not necessary.
CRD420251029643.
This study aims to examine the prevalence of elevated blood pressure (BP) among adolescents aged 13–17 years in Shiyan city, Hubei province, China. Additionally, it analyses the distribution characteristics and potential factors influencing elevated BP, providing a scientific foundation for the prevention and management of hypertension in adolescents.
Cross-sectional study.
A total of 11 schools in central China.
From October 2023 to January 2024, a cross-sectional study involving 8534 students aged 13–17 years from 11 schools in central China was conducted. Convenience sampling was used to select participants, and data were collected through questionnaires and medical physical examinations.
This study used physiological measurement to assess BP levels, while questionnaire surveys and anthropometric measurements were employed to identify associated factors.
The overall detection rate of elevated BP was 22.7% (20.2% for boys and 25.6% for girls). Increased body mass index (BMI) (OR: 1.026, 95% CI: 1.003 to 1.048), neck circumference (OR: 1.099, 95% CI: 1.073 to 1.126) and chest circumference (OR: 1.015, 95% CI: 1.007 to 1.023) were associated with an increased risk of elevated BP. Conversely, longer screen time was linked to a lower risk of elevated BP (OR: 0.961, 95% CI: 0.942 to 0.98). Girls (OR: 1.592, 95% CI: 1.419 to 1.787) were at higher risk than boys. Additionally, not consuming meat or poultry (OR: 2.029, 95% CI: 1.171 to 3.514) was identified as a risk factor for elevated BP.
The distribution of elevated BP among adolescents exhibited population heterogeneity. Elevated BP was found to be associated with higher BMI, neck circumference and chest circumference, as well as the absence of meat consumption. Additionally, targeted attention to girls is essential for preventing elevated BP.
by Ruilan Lin, Ru Qin, Yunlong Zhang, Yao Guan, Boheng Wu, Shangyang Li, Shenhong Qu, Yulin Yuan
BackgroundThis study aims to assess the diagnostic value of the Epstein-Barr virus (EBV) BNLF2b antibody(P85-Ab), alone or in combination with VCA-IgA, Rta-IgG, and Zta-IgA antibodies, in the context of nasopharyngeal carcinoma (NPC).
MethodsThe study included 100 NPC patients and 100 healthy controls. Chemiluminescent microparticle immunoassay was utilized to measure P85-Ab levels in the serum samples of both NPC patients and healthy controls. Additionally, the ELISA method was employed to detect serum levels of VCA-IgA, Rta-IgG, and Zta-IgA antibodies. The study analyzed the roles of serum P85-Ab in conjunction with VCA-IgA, Rta-IgG, and Zta-IgA antibodies in the diagnosis of NPC.
ResultsSerum levels of P85-Ab, VCA-IgA, Rta-IgG, and Zta-IgA antibodies in NPC patients were significantly higher than those in the normal control group (P Conclusion
The combined detection of P85-Ab with VCA-IgA, Rta-IgG, and Zta-IgA antibodies demonstrates high diagnostic value for nasopharyngeal carcinoma. Serum P85-Ab may serve as a potential marker for the diagnosis of NPC.
The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.
This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.
This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.