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Hoy — Diciembre 16th 2025Tus fuentes RSS

Effects and safety of dapagliflozin in paediatric hereditary kidney disease: protocol for a multicentric, prospective, open and randomised crossover study (DAPA-PedHKD)

Por: Zhang · W. · Dou · Y. · Liu · J. · Liu · T. · Yan · W. · Shen · Q. · Xu · H. · Zhai · Y.
Introduction

Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.

Methods and analysis

DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2, and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.

Trial registration number

NCT06890143.

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Effect of electroacupuncture on postoperative gastrointestinal dysfunction in patients with perioperative oesophageal cancer: study protocol for a randomised controlled trial

Por: Pan · B. · Xu · J. · Liu · H. · Jiang · H. · Jiang · G. · Zhai · X. · Hong · J.
Introduction

Postoperative gastrointestinal dysfunction (PGD) is a common complication in patients with oesophageal cancer (OC). This complication is also a crucial factor affecting the prognosis of patients and increasing their medical burden. Gastrointestinal decompression and gastrointestinal motility-promoting oral drugs can partially relieve the symptoms, but some limitations of these treatment methods remain. Alternative therapies offer a new option for postoperative patients. This experiment will evaluate the safety and efficacy of electroacupuncture for PGD in patients with OC.

Methods and analysis

From January 2024 to December 2025, 156 patients with perioperative EC will be recruited from three Grade-A tertiary hospitals in China. The participants will be randomly assigned to one of the three groups: electroacupuncture plus standard treatment group, sham electroacupuncture plus standard treatment group and standard treatment group at a 1:1:1 ratio (with the treatment conducted four sessions). The follow-up period is 30 days. The primary outcome indicator is the time of first defecation. The secondary outcome indicators are the time of first exhaust, quality of life after surgery, length of hospital stay after surgery, tolerance time for semiliquid and solid foods, time of first ambulation, I-FEED scores, demand for postoperative analgesics and defecation drugs, European Quality of Life-5 Dimensions-5 Levels scores, Hospital Anxiety and Depression Scale scores and changes in laboratory examination indicators. All adverse reactions will be recorded.

Ethics and dissemination

This study has been approved by the ethics committee of the First Affiliated Hospital of Naval Medical University (No CHEC-2024–209). Written informed consent was obtained from all participants before the formal start of the clinical trial. The results of the clinical trial will be disseminated in peer-reviewed publications.

Trial registration number

ITMCTR2024000118.

Patients sense of gain experience and its influencing factors: a cross-sectional study in Foshan, China

Por: Xia · P. · Liang · B. · Zeng · Q. · Wang · L. · Zhai · L. · Li · M. · Chen · L. · Yang · H. · He · H. · Xu · X. · Gong · W.
Objectives

Patients’ sense of gain experience (PSGE) is the comprehensive feeling throughout the treatment process, which is a critical benchmark for evaluating comprehensive medical and health system reform in China. This study aims to assess the current status of PSGE in public hospitals and identify important associated factors, providing evidence-based recommendations for improving healthcare services.

Design

This was a cross-sectional study conducted from October to November 2023.

Setting

A total of 14 public hospitals in Foshan, Guangdong Province, China.

Participants

There were 3223 responses, including 1592 from outpatients and 1631 from inpatients.

Primary outcome measure

PSGE was assessed across five domains: time accessibility, service accessibility, cost affordability, patient participation and efficacy predictability. Participants were also asked to provide an overall rating of the PSGE.

Results

The overall score for PSGE was 4.47±0.53 (mean±SD), with service accessibility receiving the highest score (4.68±0.50) and affordability the lowest (4.17±0.86). Secondary hospitals scored an overall PSGE of 4.55±0.50, while tertiary hospitals scored 4.42±0.54. Key factors associated with PSGE were overall satisfaction (β=0.164, p

Conclusions

This study found that patients reported a positive PSGE with service accessibility but reported a less positive PSGE with cost affordability. A tier-based disparity was evident, with secondary hospitals outperforming tertiary hospitals in overall PSGE outcome. Stronger PSGE was positively associated with higher scores in overall satisfaction, treatment satisfaction, satisfaction with medical reforms, patient loyalty and hospital reputation. Demographic and institutional factors, such as hospital level, patient type and household registration, were associated with the PSGE. Efforts can be focused on enhancing clinicians’ willingness and competence in discussing treatment costs during clinical encounters. It is essential for policymakers to address disparities in healthcare experiences among patient groups across hospital tiers to advance equitable, patient-centred systems.

Mitigating Nurse Turnover in Urban China: Income Inequality and Nurse–Patient Relationships as Moderators of Occupational Stress

ABSTRACT

Aim

This study examined the moderating effects of income inequality and nurse–patient relationships on the association between occupational stress and nurse turnover intentions in large urban hospitals in China, providing evidence for developing targeted retention strategies.

Design

A cross-sectional study.

Methods

Data from 13,298 nurses in 46 hospitals in Xi'an, China (October–December 2023) were analysed using hierarchical regression to assess associations between occupational stress, organisational and professional turnover intentions and the moderating roles of the expected income achievement rate (calculated as [actual/expected income] × 100%) and nurse–patient relationship quality.

Results

Eighty-three percent of nurses reported moderate-to-severe occupational stress. Compared to nurses experiencing mild stress, those with moderate/severe stress demonstrated significantly higher organisational and professional turnover intentions. After adjusting for covariates, significant interaction effects were observed. Higher expected income achievement rate showed a modest but significant moderating effect, associated with reduced turnover intentions. While the nurse–patient relationship also moderated this relationship, its protective effect was attenuated under conditions of severe stress. Despite small effect sizes, the consistent patterns and theoretical coherence of these interactions warrant further investigation.

Conclusion

Occupational stress significantly predicts nurse turnover intentions in urban Chinese hospitals, with income inequality and nurse–patient relationship quality serving as modifiable moderating factors. Interventions should integrate equitable compensation, nurse–patient relationship enhancement programmes and stress management initiatives.

Impact

This study demonstrates that equitable income consistently buffers the effects of occupational stress on nurse turnover, while nurse–patient relationships show stress-level-dependent moderation. By implementing region-specific compensation benchmarks and structured communication training, healthcare policymakers can effectively address economic security and relational care quality in workforce stabilisation.

Reporting Method

The study has been reported following the STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

Embedding a Palliative Care Nurse Consultant Within a General Medicine Ward: A Prospective Exploratory Study

ABSTRACT

Aim

To describe patient outcomes for patients at high risk of mortality (with a prognosis of three months or less to live) where a Palliative Care Nurse Consultant (PCNC) was embedded in a General Medicine team. To explore patients and/or their carers feedback and allied health, nursing professionals' perspectives on integrating a palliative care approach in the General Medicine ward.

Design

Prospective exploratory study.

Methods

SQUIRE reporting guidelines was adopted for the study reporting. This study was conducted over six weeks in a general medicine ward at Monash Medical Centre in Melbourne, Australia. Participants were 20 patients aged > 65 years with non-malignant, chronic conditions at high risk of mortality within three months and had 18 nursing and allied health professionals involved in their care. Quantitative data were analysed descriptively and qualitative survey data were analysed thematically.

Results

Twenty patients participated, with an average age of 87 years. 55% spoke a language other than English. PCNC interventions, focused on care coordination and family liaison, were found to facilitate timely referrals to other support services, improve communication and better address end-of-life care needs. Healthcare professionals recognised the benefits of PCNC involvement; however, a key qualitative theme was staff reluctance to raise palliative care needs due to perceived role boundaries and limited confidence. While PCNC presence improved communication and advocacy, barriers included time constraints and patient/family resistance.

Conclusion

Embedding a PCNC in a general medicine team appears to enhance care coordination and support timely palliative care integration. Addressing barriers and optimising workflow can improve patient, carer and clinician experience as well as improve resource utilisation.

Implications for the Profession and/or Patient Care

The model has the potential to enhance patient-centred care and clinician support in acute general medicine settings.

Impact

The research will have an impact on acute care settings, particularly general medicine units, by informing models of integrated palliative care for patients with complex needs and enhancing staff capability and confidence in providing timely, person-centred care.

Patient or Public Contribution

Patients or members of the public were not involved in the design, conduct, analysis or manuscript preparation of this study. The project was a prospective observational study with limited scope and resources, which did not include a formal patient or public involvement component.

Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multicentre, randomised controlled trial with an extension phase

Por: Yu · C. · Yang · H. · Zhang · B. · Chen · S. · Yang · S. · Li · F. · Zhu · W. · Zhai · B. · Wu · T. · Zhao · S. · Zhang · W. · Tong · X. · Duan · Y. · Zhang · L. · Chao · Y. · Wu · J. · Zhu · X. · Wang · K. · Ye · X. · Zhang · X. · Xu · X. · Cheng · H. · Liu · J. · Zhang · J. · Wang · Y. · Zhang · Z. · Ya
Introduction

Diabetes is a significant modifiable risk factor for cognitive dysfunction. There are currently no effective treatments that delay or reverse the progression of cognitive dysfunction. Accumulating evidence demonstrates that specific antidiabetes medications hold promise in improving cognitive function. However, the comparative effects of various antidiabetic drug classes on cognitive protection remain to be fully elucidated. This study aims to investigate and compare the cognitive benefits of liraglutide, empagliflozin and linagliptin on achieving mild cognitive impairment (MCI) remission in individuals with type 2 diabetes (T2D).

Methods and analysis

The LIGHT-MCI trial is an investigator-initiated, multicentre, open-label, parallel-group, randomised, superiority trial involving T2D patients with MCI, consisting of a 48-week core study followed by an extension phase through to 76 weeks. A total of 396 participants will be randomly allocated 1:1:1 to receive liraglutide, empagliflozin or linagliptin treatment. The primary outcome measure is the efficacy difference of liraglutide, empagliflozin and linagliptin in achieving MCI remission in individuals with T2D. The key secondary outcome measures include changes in scores of general cognition and various cognitive subdomains (including processing speed, executive function, immediate memory, visuospatial construction ability, language, attention and delayed memory), basic and instrumental daily living ability, MRI-derived normalised measures of total brain volume, cerebral microstructures, cortical and nuclear volume, white matter hyperintensity, volume, white matter microstructural integrity, odour-induced brain activation and resting-state functional connectivity, olfactory function and metabolic parameters.

Ethics and dissemination

The LIGHT-MCI trial has received approval from the Ethics Committees of the Drum Tower Hospital Affiliated to Nanjing University Medical School (2022-092-02) and other participating centres in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation for Good Clinical Practice (ICH GCP E6). Informed consent is required for participation. Findings from this trial are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.

Trial registration number

NCT05313529.

Kun-Qi birth cohort (KQBC) study for the incidence, aetiology and risk factors of chronic kidney disease in Chinese children: a cohort profile

Por: Shen · Y. · Liu · T. · Liu · J. · Han · X. · Wu · J. · Xie · L. · Chen · X. · Xu · B. · Sun · Y. · Xu · S. · Zhang · Q. · Xie · N. · Zhang · L. · Ji · J. · Mo · W. · Liu · Y. · Shi · X. · Shen · J. · Qiu · W. · Huang · J. · Shen · Q. · Zhai · Y. · Xu · H. · On behalf of the KQBC group · Xu · Zhai · She
Purpose

The Kun–Qi birth cohort (KQBC) was established to investigate the incidence, aetiology and risk factors of chronic kidney disease (CKD) in early childhood (0–6 years). Additionally, the study analysed developmental phenotypic trajectories and their associated paediatric diseases.

Participants

Infants registered or residing in Kunshan and Qidong, Jiangsu Province, who participated in the Chinese Child Healthcare Programme (0–6 years) were enrolled. The baseline population was stratified into enhanced and basic cohorts. General characteristics, periconceptional and perinatal information and health check-up data were collected from each participant. Dual screening (urinary ultrasound and urine dipstick tests) was conducted during scheduled check-ups. Structured CKD questionnaires were administered, and biosamples (urine and dried blood spots) were obtained for the long-term storage and analysis using standard procedures. Based on the proposed referral procedure, participants with abnormal results were referred for further diagnosis and evaluation.

Findings to date

The KQBC enrolled 10 127 infants (5392 boys and 4735 girls) with a mean age of 2.11±1.68 months. Urinary system ultrasound and urine dipstick screening showed positivity rates of 8.9% (900/10 083) and 6.5% (532/8233), respectively. Baseline ultrasound screening facilitated timely surgical intervention in six children. Among the 7965 respondents, only 13% demonstrated awareness of paediatric CKD. Additionally, 7273 dried blood spots and 7990 urine specimens were collected and stored. A paediatric CKD screening platform was developed.

Future plans

According to our plan, the KQBC will be followed up for 3–6 years to investigate the incidence, aetiology and risk factors of early onset CKD. In-depth developmental phenotypes, such as urinary multiomics and ultrasound imaging, should be studied for longitudinal paediatric kidney health. We aim to develop multimodal risk prediction models by integrating genomics and artificial intelligence algorithms. The KQBC also enables prospective cohort studies addressing extensive research questions.

Trial registration number

NCT06018831.

Efficacy and safety of acupuncture for IgA vasculitis abdominal pain: protocol for a systematic review and meta-analysis

Por: Zhao · P. · Ren · X. · Zhai · W.-S.
Introduction

Abdominal pain is one of the most common symptoms in patients with IgA vasculitis (IgAV), adversely affecting both physical and mental health. Clinical studies have demonstrated that acupuncture can quickly alleviate pain and reduce the duration of abdominal pain episodes. Given its growing acceptance in clinical practice, acupuncture is increasingly being adopted for managing IgAV-related abdominal pain. The objective of this systematic review is to evaluate and synthesise evidence regarding the efficacy and safety of acupuncture for IgAV abdominal pain.

Methods and analysis

Eight databases will be systematically searched from their inception to 1 June 2025: China National Knowledge Infrastructure, Chinese Biomedical Literature Database (China Biology Medicine), VIP Database, Wanfang Database, PubMed, Embase, Cochrane Library and Web of Science. Only randomised controlled trials investigating acupuncture for IgAV abdominal pain, published in Chinese or English, will be included. Two independent researchers will perform study selection, data extraction and risk-of-bias assessment. The primary outcomes include symptom and sign scores and time to abdominal pain resolution. Secondary outcomes comprise recurrence rate, incidence of adverse events and urinalysis results. Risk of bias will be evaluated using the Cochrane Risk of Bias Tool (V.2.0). Meta-analyses will be conducted using Review Manager software (V.5.3). For continuous data, we will calculate standardised mean differences with 95% CIs. For dichotomous outcomes, relative risks and 95% CIs will be calculated. Subgroup analyses will be performed where feasible. The overall evidence quality will be graded using the Grading of Recommendations Assessment, Development, and Evaluation approach.

Ethics and dissemination

Ethical approval is not required for this study as it does not involve the collection of primary patient data. The results of this meta-analysis will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD42023483770

Cognitive behavioural therapy and related interventions for sleep disorders in children and adults with autism spectrum disorder: protocol for a systematic review and meta-analysis

Por: Zhai · Q. · Wu · Y. · Wu · Y. · Ji · Y. · Li · Y. · Xu · R. · Zhong · Y. · Xiao · B. · Zhou · L.
Introduction

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterised by deficits in social communication and repetitive behaviours, often accompanied by sleep disturbances. These sleep problems, including prolonged sleep latency and fragmented sleep, affect more than half of autistic individuals, exacerbating functional impairments and diminishing quality of life. Cognitive behavioural therapy (CBT) has shown promise in addressing sleep disturbances in ASD, with preliminary studies indicating improvements in sleep quality. However, no systematic review has comprehensively summarised the effects of CBT on sleep in autistic individuals.

Methods and analysis

This systematic review and meta-analysis will synthesise evidence on the efficacy of CBT for improving sleep quality in individuals with ASD. We will search multiple databases (eg, PubMed, Web of Science) for studies published until May 2025. Inclusion criteria encompass randomised controlled trials, single-arm studies and observational studies involving children and adults with ASD and moderate sleep problems. Interventions targeting sleep quality using CBT techniques will be considered. Data extraction will focus on study details, participant information, intervention specifics and sleep outcome measures (eg, total sleep time, sleep onset latency, etc). Risk of bias will be assessed using tools such as Cochrane Risk of Bias Tool V.2, Risk Of Bias In Non-randomised Studies—of Interventions and Review Manager 5.3. A meta-analysis will be conducted using Stata 18, with heterogeneity evaluated using the I² statistic and Cochran’s Q test.

Ethics and dissemination

Given that the dataset for this investigation is derived from publicly accessible databases, there is no direct interaction with patients; thus, ethical approval is not required.

PROSPERO registration number

CRD42025643701.

Telitacicept for systemic lupus erythematosus: protocol of a systematic review and meta-analysis

Por: Ren · X. · Zhao · P. · Zhang · J. · Yu · X. · Zhai · W.
Introduction

Systemic lupus erythematosus (SLE) is a chronic and complex multisystem autoimmune disease with high mortality. Telitacicept is a new strategy for the treatment of SLE, inhibiting the maturity, proliferation and differentiation of B cells, and thus, reduces disease activity. However, the effectiveness and safety of telitacicept in patients with SLE are not yet established.

Methods and analysis

Five English databases (Pubmed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature) and four Chinese databases (China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database and Sinomed) will be searched from database inception to 1 June 2025. Two investigators will independently conduct study selection, data extraction and quality assessment. Outcomes include disease activity, incidence of flares, organ damage, several immune-related laboratory parameters and adverse events. Risk ratio with 95% CI and mean difference or standardised mean difference will be used as measures of effect sizes, in order to pool the data using either a random-effect model or fixed-effect model according to the heterogeneity of studies. Subgroup analysis and sensitivity analysis will be performed to explore the source of heterogeneity and evaluate the robustness of the results. We will use the Risk of Bias 2 tool and Risk of Bias In Non-Randomized Studies of Interventions tools to assess the quality of the included studies, and use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system to assess the certainty of evidence.

Ethics and dissemination

No ethical approval is required since this review is based on previously published studies. The findings of this study will be presented at international conferences or published in a peer-reviewed journal.

PROSPERO registration number

CRD42024558180.

Ethical and Regulatory Challenges of Generative Artificial Intelligence in Healthcare: A Chinese Perspective

ABSTRACT

Aim

To provide practical insights that delve into the ethical issues and regulatory implications of generative artificial intelligence (GenAI) in healthcare. Ethical Challenges and Regulatory Impact in China is used as an example.

Background

Despite China's efforts to strike a delicate balance between protecting public welfare and promoting technological advancement, numerous unresolved issues persist in the practical integration of generative artificial intelligence into healthcare settings.

Conclusion

Key issues such as data application, privacy protection, cost-effectiveness and regulatory remain areas of ambiguity that require clarification. Stringent ethical guidelines, data privacy protection measures and continuous supervision and evaluation of artificial intelligence decisions will help enhance the expected benefits of GenAI in healthcare.

Relevance to Clinical Practice

The potential use of GenAI in healthcare has garnered widespread attention, emerging as a significant global research topic. However, its application in this domain presents substantial ethical and regulatory challenges. Compared to other fields, GenAI's role in healthcare is more sensitive and complex, necessitating an urgent assessment of its ethical implications for future development and deployment. Challenges and ethical considerations are particularly pronounced in developing countries with limited healthcare resources.

The Relationship Between Dyadic Coping and Mental Health in Stroke Survivors and Their Spouse Caregivers: An Actor‐Partner Interdependence Model

ABSTRACT

Aim

To investigate the relationship among dyadic coping, mental health and the individual and mutual influences on stroke survivors and their spouse caregivers.

Design

A cross-sectional descriptive study was conducted in China from November 2019 to August 2020. The STROBE checklist was used to report the present study.

Methods

The analysis included 224 dyads of stroke survivors and their spouse caregivers in China. Data on stroke survivors and their spouse caregivers were collected using the Dyadic Coping Inventory (DCI), the Patient Health Questionnaire nine-item scale (PHQ-9) and the Generalised Anxiety Disorder seven-item scale (GAD-7). The dyadic analysis was conducted based on the Actor-Partner Interdependence Model (APIM).

Results

Regarding actor effects, spouse caregivers' dyadic coping and perceived dyadic coping had a negative predictive effect on their own anxiety and depression. Stroke survivors' perceived dyadic coping had a negative effect on their own depression. Regarding partner effects, spouse caregivers' perceived dyadic coping also had a negative predictive effect on the depression of the patients. In contrast, stroke survivors' perceived dyadic coping was positively associated with spouse caregivers' anxiety and depression. These findings suggested that mental health of stroke survivors and their spouse caregivers was affected by various dyadic coping dimensions.

Conclusions

Our research has the potential to contribute to the understanding dyadic coping and mental health of stroke survivor-spouse caregiver dyads. The findings reveal that the coping strategies employed by stroke couples are closely related to the mental health of both partners.

Impact

This study provides evidence for the significant impact of dyadic coping on the psychological well-being of stroke survivors and their spouse caregivers. Therefore, dyadic interventions aiming at strengthening dyadic coping may have positive effects on their mental health.

Patient or Public Contribution

This study directly involved the patients and family caregivers in hospital settings.

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