The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.
Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.
Primary healthcare in rural China.
27 health practitioners from township health centres assigned to the intervention arm.
A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.
Not applicable.
Data were analysed using thematic analysis.
The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.
The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.
ISRCTN30652037 (01/12/2020).
To investigate how leadership support influences nurses' innovation behaviour through the chain mediation of creativity, role identity and knowledge sharing.
Despite the recognised role of leadership in fostering innovation, the mechanisms linking leadership support to nurses' innovative behaviours remain under explored. Clarifying how creativity, role identity and knowledge sharing mediate this relationship is critical for optimising nursing practices.
This was a quantitative cross-sectional study.
A cross-sectional survey was conducted in March 2024 to collect data using the Leadership Innovation Support Scale, Creativity Role Identity Scale, Knowledge Sharing Scale and Nurses' Innovative Behavior Scale. Descriptive analysis, correlation analysis and chain-mediated effect analysis were performed using SPSS 26.0.
We found a positive relationship between leadership support and nurses' innovation behaviour; creativity role identity and knowledge sharing played a mediating role in this relationship. Moreover, there was a significant chain mediating effect of creativity role identity and knowledge sharing on the relationship between leader support and nurses' innovation behaviour.
Creativity role identity and knowledge sharing act as a chain-mediated mechanism between leadership support and nurses' innovative behaviours. Therefore, hospital managers should focus on the level of leadership support for innovation among nurses and implement targeted measures focusing on creativity role identity and knowledge sharing to improve nurses' innovation.
To promote the development of innovation in healthcare institutions, motivating nurses' innovative behaviour has become a key focus. Based on role identity theory and social exchange theory, this study explores the chain mediation effects of innovative role identity and knowledge sharing between leadership support and nurses' innovative behaviour. This suggests that supervisors can enhance support to help nurses better recognise their role in the innovation process, promoting the exchange of experiences and sharing of innovative outcomes, thereby further stimulating the overall innovation ability of the team.
None.
The treatment of chronic wounds in the Aged is often difficult. Masquelet technique is used for the treatment of infected large segmental bone defects as it provides an adequate blood supply for bone and soft tissue reconstruction. In this study, a two-stage wound management strategy was used, consisting of covering the initial wound with bone cement and skin grafting under induced membranes. From September 2020 to September 2022, 20 Aged patients with chronic refractory wounds of the lower extremities with exposed bone or tendons were recruited in the Department of Wound Repair Surgery of the Second Affiliated Hospital of Wenzhou Medical University. Each patient was reconstructed according to a two-stage process. In the first stage, while treating the patient's underlying disease, several debridements were first performed on the wound; subsequently, the Masquelet technique was applied to seal the wound with antibiotic bone cement. Four to 6 weeks later, the second stage was initiated—after confirming the sufficient formation of wound induced membranes, the bone cement was removed, and free skin grafts were finally used to cover the chronic refractory wounds on the extremities. The area of the defects ranged from 4.5 × 3.0 cm to 15.0 × 6.0 cm, and all soft tissue defects were associated with tendon or bone exposure. After the surgery, patients attended regular outpatient visits and were followed up by telephone and video to observe the healing of the wounds and whether there were any complications in the donor site. The Lower Extremity Function Scale (LEFS) score was used to evaluate the functional recovery of the lower extremities. We found that all implants survived without necrosis or infection. All 20 cases were followed up regularly after surgery for 3 to 12 months, with a mean of 7.6 months. In the first stage, Induced Membranes induction was performed 1–4 times, with an average of (1.3 ± 0.7) times, and in the second stage, free skin grafting was performed on the induction membrane, and all 20 cases of skin grafting survived without necrosis or infection; the appearance and texture of the skin in the grafted area were satisfactory, and the postoperative LEFS score was (69.83 ± 10.82). Finally, our strategy for the management of chronic refractory wounds in the Aged can achieve satisfactory clinical results, reduce surgical risk, be simple and reliable, and be an effective addition to the repair modality.
To assess Chinese medical staff’s knowledge and attitudes towards insomnia and explore their association with mental health status.
A multicentre cross-sectional survey conducted across hospitals in China using convenience sampling.
Multiple hospitals across different regions of China; level of care primarily secondary.
A total of 654 medical staff enrolled from 23 hospitals between April and June 2023, with 420 (64.22%) nurses. Inclusion criteria encompassed hospital staff involved in patient care; exclusion criteria included those on leave or unwilling to participate. Data on sex and ethnicity were collected but not specified in the abstract.
Primary outcomes included insomnia knowledge and attitudes, assessed by a structured questionnaire. Secondary outcomes encompassed mental health status, measured via the Depression-Anxiety-Stress Scale (DASS)-21 (stress, anxiety and depression). The interactions between these variables were analysed using structural equation modelling (SEM).
Of the participants, 392 (59.94%) reported insomnia symptoms. The median scores for insomnia knowledge and attitudes were 16.0 (range 0–24) and 27.0 (range 7–35), respectively. The median DASS-21 score was 30.0; 189 (28.90%) experienced stress, 400 (61.16%) anxiety and 302 (46.18%) depression. SEM analysis indicated that night shift work (β=–0.101, p=0.024) and job satisfaction (β=–0.258, p
Medical staff showed limited understanding of insomnia and a high prevalence of stress, anxiety and depression. Targeted education, optimised shift scheduling and accessible mental health support are recommended to promote staff well-being and improve care quality. Nevertheless, the findings should be interpreted with caution because of the cross-sectional design and convenience sampling method.
Investigate the epidemiological characteristics of outpatients initially diagnosed with skin ulcers who were ultimately confirmed to have cutaneous malignant tumours, and provide a diagnostic and therapeutic basis for the occurrence of secondary diseases in chronic wounds. We conducted a retrospective study analysing clinical data from patients initially diagnosed with skin ulcers at our hospital between July 2021 and February 2025, and analysed the epidemiological characteristics of malignant transformation in these ulcer cases. Among 128 patients initially diagnosed with skin ulcers, 16 cases (12.5%) were confirmed with cutaneous malignancies. The malignant group had a significantly higher mean age (69.44 ± 11.30 years) compared to the non-malignant group (58.39 ± 17.88 years; t = 5.752, p = 0.01). The distribution of lesion sites differed significantly between the malignant and non-malignant groups (χ2 = 30.498, p < 0.01). In the malignant group, the head and neck (41.2%) and trunk & extremities (41.2%) were the predominant sites. The most common malignancy was squamous cell carcinoma (SCC). The trunk & extremities was the most frequent site (62.5%). The second was basal cell carcinoma, which mainly occurs in the head and neck (80.0%). The mean duration of ulceration was 4.5 years. The primary treatment modality was surgical excision (11 cases, 68.8%). Approximately one-seventh of skin ulcer cases were confirmed as cutaneous malignancies. This finding underscores the significance of skin ulcers as potential malignant lesions, highlighting the need for clinicians to maintain a high index of suspicion and promptly perform histopathological examinations to improve early detection rates of skin cancers.
To investigate whether pneumoconiosis increases the risk of cataract.
Nationwide population-based retrospective cohort study.
Taiwan’s National Health Insurance database, which covers >99% of the population.
The study included 19 841 adults newly diagnosed with pneumoconiosis between 2001 and 2020 and 79 364 age-matched and sex-matched individuals without pneumoconiosis. Participants with a prior history of cataract were excluded.
The primary outcome was incident cataract identified through International Classification of Diseases diagnostic codes. Subgroup analyses were performed to evaluate cataract risk across different strata of age, sex and comorbidity. In addition, among patients with pneumoconiosis, we conducted a secondary analysis evaluating the association between systemic corticosteroid use and cataract development.
During follow-up, the incidence of cataract was significantly higher in the pneumoconiosis cohort (38.9 vs 35.3 per 1000 person-years). Patients with pneumoconiosis had an increased risk of cataract after adjustment for age, sex and comorbidities (adjusted HR (aHR)=1.22, 95% CI 1.18 to 1.26). Elevated risks were observed in both men (aHR=1.22, 95% CI 1.18 to 1.26) and women (aHR=1.20, 95% CI 1.13 to 1.29). All age groups showed increased risks, with the highest estimate observed among patients aged ≥75 years (aHR=1.24, 95% CI 1.19 to 1.30). Subgroup analyses showed an increased risk in patients with pneumoconiosis who had no comorbidities (aHR=1.12, 95% CI 1.07 to 1.18). In a secondary analysis, systemic corticosteroid exposure was not significantly associated with cataract development (adjusted OR=0.65, 95% CI 0.39 to 1.09).
Pneumoconiosis is associated with an increased risk of cataract. Routine ophthalmologic surveillance should be considered in pneumoconiosis management.
by Thea Lynne Hedemann, Yun Lu, Sofia Campitelli, Lisa D. Hawke, Nelson Shen, Sarah Saperia, Brett D. M. Jones, Gillian Strudwick, Chelsey R. Wilks, Wei Wang, Marco Solmi, Michael Grossman, Muhammad Ishrat Husain, Nicole Kozloff, George Foussias, Muhammad Omair Husain
BackgroundYouth at clinical high risk (CHR) for psychosis often experience emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functional impairment. Dialectical behaviour therapy (DBT) is an evidence-based intervention that improves emotion regulation, clinical outcomes, and functioning across psychiatric populations. Digital adaptations (d-DBT) may enhance accessibility and engagement for CHR youth, but acceptability and potential benefits in this group are unknown.
ObjectiveTo adapt d-DBT for CHR youth and evaluate the acceptability of delivering it to this population, as well as the feasibility of a larger-scale clinical trial.
MethodsThis mixed-methods clinical trial has two phases. In Phase 1, d-DBT will be adapted for CHR youth in collaboration with a lived-experience youth advisory group. In Phase 2, an assessor-masked randomized controlled trial will compare d-DBT (n = 30) with treatment as usual (n = 30). The intervention consists of eight weekly modules, with primary outcomes assessing acceptability, usability, and trial feasibility. Secondary outcomes include changes in emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functioning.
ConclusionsWe anticipate that d-DBT will be acceptable to CHR youth and that conducting a larger trial will be feasible. Preliminary findings may demonstrate improvements in emotion regulation, psychiatric symptoms, suicidality, and functioning. Results will guide further refinement of the intervention and inform the design of a confirmatory clinical trial.
Trial registrationClinicalTrials.gov #NCT06928935
To investigate, in a prospective cohort study, the association between cognitive impairment and cardiovascular disease (CVD), to quantify the extent to which uncontrolled risk factors mediate this association, and to explore whether the mediation effect varies across sex and age groups.
Prospective cohort study.
UK Biobank, a large population-based cohort study in the UK.
A total of 152 155 participants without prevalent CVD or dementia at baseline were included. The mean age was 56.3±8.2 years, and 44.0% were male.
Cardiovascular death and composite cardiovascular outcomes, assessed using Cox proportional-hazards models and mediation analyses.
During a median follow-up of 13.03–13.87 years, 1474 cardiovascular deaths and 21 518 composite cardiovascular outcomes were recorded. Participants with cognitive impairment (n=23 146; 15.2%) exhibited higher proportions of lifestyle, metabolic and psychological risks (p
Cognitive impairment is associated with increased risks of cardiovascular death and composite cardiovascular outcomes. Uncontrolled lifestyle, cardiometabolic and psychological risk factors partially mediate this association, highlighting the importance of comprehensive management to improve cardiovascular prognosis in this population.
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.
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.
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.
To explore stakeholder perceptions on sugar-sweetened beverage (SSB) policies for Chinese children and adolescents and facilitators and challenges for policy implementation.
This study followed the sector governance analysis framework, which included three steps: context analysis, mapping stakeholders and stakeholder analysis. Context analysis comprised policy and literature reviews of existing domestic and international measures, complemented by expert consultation to clarify the policy context and identify relevant stakeholders. Guided by these insights, we mapped stakeholders for key informant interviews, in-depth interviews and focus group discussions to explore stakeholders’ perceptions of SSB policies. Qualitative data were collected and analysed through a thematic analysis approach.
Shanghai and Chongqing, China, July to August 2022.
37 stakeholders including policymakers, nutrition experts, industry and consumers (primary caregivers of children and adolescents aged 6–17 years).
Context and stakeholder analyses indicated rising SSB consumption among Chinese youth since 2000. Qualitative interviews reflected the absence of national policies due to inadequate policymaker awareness. Although policymakers and nutrition experts supported SSB policies, consumers were worried about their personal choices being affected and the industry feared innovation challenges and profit loss. Multiple stakeholders mentioned that a comprehensive national standard is lacking, which is needed to facilitate national policy roll-out. An initial focus on health education is suggested to raise awareness among policymakers and consumers to foster a supportive environment for SSB policy development.
Although SSB intake is rising among Chinese children, policymakers’ insufficient awareness and the lack of national standards hinder SSB policy development and implementation. Strategies that raise health knowledge and awareness among policymakers and consumers should be prioritised for now to assist future introduction of SSB standards and related policies.
Proximal humeral fractures are increasingly common, particularly among older people, whereas the prognosis of surgical treatments for these fractures remains substantially uncertain. In China, where the ageing population is rapidly growing, high-quality prospective data on surgical outcomes, complications and cost-effectiveness are lacking. To address this gap, we propose to initiate a prospective, multicentre cohort study on surgical treatment for proximal humeral fractures in China—Cohort of Acute Shoulder Trauma (CAST) study.
The CAST is a multicentre, prospective cohort study enrolling patients with acute proximal humeral fractures undergoing surgical treatments at eight hospitals in China between May 2024 and December 2029. Patients can receive any of the surgical treatment methods which include percutaneous Kirschner wire fixation, external fixation, open reduction and internal fixation using locking plates or intramedullary nails, suture anchors and shoulder arthroplasty. We will collect patient-reported outcome measures (Quick Disabilities of the Arm, Shoulder and Hand), Constant-Murley, American Shoulder and Elbow Surgeons, EuroQol 5-Dimension and Visual Analogue Scale), physical examination results, imaging assessments (based on X-rays, ultrasound, CT and MRI scans), laboratory tests (including inflammatory cytokines) and data on medical costs. We will follow patients at 1 day, and at 1 month, 3 months, 6 months, 12 months and 24 months postoperatively. The planned sample size is 1500 patients.
The study protocol has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University (Approval No. 2024-ky-104(K)). Written informed consent will be obtained from all participants. Findings from the CAST study will be disseminated through peer-reviewed journals and academic conferences.
ChiCTR2500109651.
Spiritual well-being (SpWB) is a critical yet often underexplored component of holistic care for patients with advanced cancer. This study aimed to assess the SpWB and quality of life (QOL) levels and examine their correlation among patients receiving palliative care at a tertiary cancer centre in Kerala, India.
Institution-based cross-sectional observational study among patients with advanced cancer conducted between August 2023 and December 2024.
The outpatient department of a major tertiary-level, autonomous cancer centre under the Government of Kerala, India.
398 patients with advanced cancer aged 18 and above.
SpWB and QOL were measured using validated Malayalam versions of the Functional Assessment of Chronic Illness Therapy–Spiritual well-being Expanded Version and European Organisation for Research and Treatment of Cancer, Quality of Life Core 30 questionnaires, respectively. Data collection included patient self-reports or assistance by a medical social worker.
The median (IQR) age of participants was 59 (51–65) years; most were married (94.5%) and from an upper-lower socioeconomic background (55%). Hinduism was the predominant religion (67.1%). Almost all patients (99%) were aware of their diagnosis, but only 62.3% knew their prognosis. The median (IQR) SpWB score was 67.5 (57–76), significantly higher in females (p=0.02). The median (IQR) QOL score was 50 (41.7–66.7). SpWB was positively correlated with QOL (r=0.766, p
SpWB showed a strong positive correlation with QOL among patients with advanced cancer. Enhancing SpWB may play a pivotal role in improving overall QOL in palliative care settings.
Dexamethasone is commonly used to prevent postoperative nausea and vomiting (PONV). However, PONV is an unresolved complex problem; even with preoperative dexamethasone administration, 14.0%–26.3% of patients undergoing minimally invasive endoscopic procedures still experience PONV within 24 hours postoperatively. Compared with dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, two to five times that of traditional water-soluble dexamethasone, with fewer adverse events. This trial aims to assess the efficacy and safety of preoperative dexamethasone palmitate administration on postoperative PONV.
The INDEX trial is a multicentre, open-label, randomised, positive-controlled trial. A total of 588 patients will be recruited from three centres in China. Eligible patients are adults (aged 18–65 years) who undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia. Eligible patients will be randomly assigned (1:1) to the dexamethasone palmitate or dexamethasone group. Patients in the dexamethasone palmitate group will receive intravenous injection of 8 mg of dexamethasone palmitate (containing 5 mg of dexamethasone), and those in the dexamethasone group will receive 5 mg of dexamethasone after anaesthesia induction and before surgical incision. The primary endpoint will be the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes will include the incidence of PONV, postoperative nausea, postoperative vomiting, number of vomiting or retching episodes, severity of PONV, participant satisfaction, use of rescue antiemetic drugs and quality of postoperative recovery. The safety of participants will be monitored. A primary analysis will be conducted to evaluate between-group differences in the incidence of PONV in the intention-to-treat population and within the first 24 hours postoperatively. We will also perform a sensitivity analysis to evaluate the effect of missing values in the outcome parameters on the results. There is no plan to conduct an interim analysis.
Ethical approval was obtained from the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY 2025-041-02-01). The results will be disseminated in open-access publications and plain-language summaries.
Microvascular obstruction (MVO) is a common complication following primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse clinical outcomes. MVO is a dynamic, multifactorial process shaped by factors spanning the myocardial infarction–reperfusion continuum and by PPCI-related microcirculatory injury, which leaves current early risk stratification—often a static snapshot—with limited power to anticipate its evolution. Renalase, a cardioprotective enzyme, exhibits a post-reperfusion surge that parallels MVO development; periprocedural renalase release may likewise be driven by overlapping mechanisms along the ischaemia–reperfusion pathway. This hypothesis-generating observation supports evaluating the delta-Renalase (periprocedural change in serum renalase) as a candidate association-based biomarker. Accordingly, this study aims to assess whether delta-Renalase is independently associated with MVO in patients with STEMI after PPCI and to evaluate its incremental predictive value, without causal inference.
The Renalase and MicroVascular Obstruction Study (ReMVOS) is a prospective, single-centre, observational cohort study conducted at a nationally accredited chest pain centre in China. We will enrol 266 patients with consecutive STEMI with symptom onset within 12 hours who undergo PPCI. The exposure variable is delta-Renalase, calculated as the increase in serum renalase levels at 24 hours post-PPCI relative to the preprocedural baseline. The primary outcome is the presence of MVO, assessed by cardiovascular magnetic resonance (CMR) performed 2–5 days post-PPCI. Secondary outcomes include infarct size and peak global longitudinal strain quantified by CMR, major adverse cardiovascular events within 90 days and peak oxygen pulse from cardiopulmonary exercise testing (CPET) at the 90-day visit. The independent association and predictive value of delta-Renalase will be evaluated using a prespecified multivariable logistic regression model.
This protocol has been approved by the Ethics Committee of the Third Xiangya Hospital of Central South University (approval No. K24655). All patients will provide written informed consent prior to enrolment. The findings of this study will be disseminated through publications in peer-reviewed international medical journals and presentations at relevant academic conferences.
Tuberculosis (TB) is a common cause of infertility in humans, especially in regions with high TB prevalence. However, the impact of latent TB infection (LTBI) on pregnancy outcomes following assisted reproduction in patients with infertility remains unclear. This systematic review and meta-analysis aimed to assess significant differences in pregnancy outcomes after assisted reproduction between infertile patients with and without LTBI.
Systematic review and meta-analysis using the Grading of Recommendation, Assessment, Development and Evaluation approach.
PubMed, Embase and Web of Science were searched from inception to 1 September 2025.
Case–control or cohort studies comparing assisted reproduction outcomes between infertile patients with and without LTBI, diagnosed via tuberculin skin test or interferon-gamma release assay, were included. Outcomes of interest were clinical pregnancy rate, miscarriage rate and live birth rate.
Two independent reviewers used standardised methods to search, screen and code included studies, extracted data and assessed study quality using the Newcastle-Ottawa Scale. Meta-analysis was performed using a fixed-effects model. Heterogeneity was evaluated with the I² statistic. Sensitivity analysis was performed using the leave-one-out method, and publication bias was assessed using funnel plots and Egger’s test.
Four studies met the inclusion criteria for this meta-analysis. The included studies showed low heterogeneity for clinical pregnancy rate (I²=45.9%), miscarriage rate (I²=0%) and live birth rate (I²=8.9%). The miscarriage rate was significantly higher in the LTBI group than in the non-LTBI group (OR 1.14; 95% CI 1.00 to 1.31; p=0.049). No significant differences were observed between the two groups in terms of clinical pregnancy rate (OR 0.98; 95% CI 0.91 to 1.06; p=0.692) and live birth rate (OR 0.96; 95% CI 0.88 to 1.04; p=0.305). Sensitivity analysis confirmed the robustness of the miscarriage rate outcome. Publication bias was low for clinical pregnancy and miscarriage rates but potential bias was detected for live birth rate (Egger’s test p=0.029). The overall certainty of evidence was rated as low due to the observational nature of included studies and limited number of studies.
Infertile patients with LTBI might have a higher miscarriage rate after assisted reproduction compared with non-LTBI patients, although no differences were observed in clinical pregnancy or live birth rates. These results, particularly regarding miscarriage, should be interpreted with caution due to the limitations of the available evidence. Further high-quality studies are needed to strengthen the evidence base.
CRD42024605623.
by Mengsi Peng, Peng Shen, Kyung-In Joung, Kwang Joon Kim
BackgroundAlthough metformin is the first-line medicine for type 2 diabetes (T2D), its safety profile in adolescents remains poorly understood. This study seeks to investigate the adverse events linked to metformin use in adolescents diagnosed with T2D.
MethodsData from the Food and Drug Administration Adverse Event Reporting System (FAERS), spanning Q1 2004 to Q2 2024, were retrospectively analyzed in this study. Adverse reactions were standardized using the Medical Dictionary for Regulatory Activities, then significant adverse drug reaction signals were identified through disproportionality analysis employing reporting odds ratio (ROR) and information component (IC) methods.
ResultsOf 17,956,653 FAERS reports, 80,187 involved metformin, including 973 in adolescents (10–19 years), with 174 cases were identified with a T2D indication. Analysis at the system organ class level revealed that congenital, familial, and genetic disorders [ROR: 8.8 (4.0, 19.3); IC: 2.2 (1.1, 2.9)] and pregnancy conditions [ROR: 4.9 (2.5, 9.5); IC: 1.8 (0.8, 2.5)] showed the most significant signals. At the preferred term (PT) level, three signals were identified across all sexes and subgroups: treatment noncompliance [ROR: overall 4.14 (2.44, 7.02), male 4.27 (2.00, 9.12), and female 4.65 (2.22, 9.74); IC: overall 1.67 (0.88, 2.22), male 1.60 (0.46, 2.36), and female 1.74 (0.60, 2.50)], lactic acidosis [IC: overall 2.99 (1.91, 3.72), male 2.53 (0.76, 3.61), and female 2.76 (1.34, 3.67)], and gastrointestinal disorder [ROR: overall 13.09 (4.73, 36.23), male 54.33 (6.05, 487.96), female 5.34 (1.10, 25.84)]. Neurological disorders were observed only in males, while pregnancy-related adverse effects and renal disorders occurred exclusively in females. Additionally, the study identified potential new signals not documented in metformin labeling, including areflexia, muscle weakness, ataxia, decreased vibratory sense, rhabdomyolysis, substance use, and axillary pain.
ConclusionThe study reveals a complex safety profile of metformin in adolescents with T2D, warranting further research to confirm risks.
Post-induction hypotension (PIH) is a critical concern in elderly surgical patients and is associated with adverse postoperative outcomes. This trial aims to compare the effects of propofol, etomidate and remimazolam on the incidence of PIH in older adults undergoing non-cardiac surgery.
In this single-centre, triple-arm, randomised controlled trial, 210 patients aged ≥80 years with American Society of Anaesthesiologists physical status I–III undergoing elective non-cardiac surgery will be recruited. All patients will receive general anaesthesia with endotracheal intubation. Patients will be randomised (1:1:1) to receive propofol, remimazolam or etomidate for anaesthesia induction (n=70 per group). The primary outcome is the incidence of PIH (mean arterial pressure (MAP) 30% from baseline, vasopressor requirements, bradycardia, injection pain, myoclonus, postoperative delirium, and cardiac, cerebral and renal complications during hospitalisation.
This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024-380). The results will be peer-reviewed for publication in a scientific journal.
ChiCTR2400090800.
by Mengzhi Cheng, Jianbin Zhang, Lili Jin, Caihua Yu, Zhonghai Xie, Dong Li, Qinhua Gu, Qibin Shen
Primary results of the CORIN trial indicated that, compared with chemotherapy, icotinib significantly improved 3-year disease-free survival (DFS) in patients with Epidermal Growth Factor Receptor (EGFR)-mutated stage IB non-small cell lung cancer (NSCLC). However, evidence regarding the outcomes of adjuvant icotinib in patients with high-risk factors remains limited. This retrospective study evaluated the efficacy and safety of adjuvant icotinib in patients with EGFR-mutated high-risk stage IB NSCLC. We enrolled 37 patients with completely resected EGFR-mutated high-risk stage IB NSCLC. The median follow-up time was 31 months, and the 3-year DFS rate was 91.4%. Two patients experienced disease recurrence and were successfully switched to osimertinib upon identification of an EGFR (T790M) mutation. Although overall survival (OS) and central nervous system (CNS)-DFS data were not mature, no deaths or central nervous system metastases were observed by the end of follow-up. 29 (78.4%) patients experienced grade 1–2 adverse events (AEs), no grade 3 or higher AEs occurred. This study suggests a potential DFS benefit and well-tolerated profile of adjuvant icotinib in patients with EGFR-mutated high-risk stage IB NSCLC. However, longer-term follow-up is necessary to assess the long-term outcomes.This study aimed to investigate the knowledge, attitude and practice (KAP) of patients living with functional gastrointestinal disorders (FGIDs) toward their diseases.
A web-based cross-sectional study was conducted.
The gastroenterology outpatient department of Zhejiang Hospital of Traditional Chinese Medicine, Zhejiang, China.
The study enrolled 503 patients with FGIDs from the Gastroenterology Outpatient Department of our hospital between September and October 2023.
Not applicable for cross-sectional study.
Participants completed a self-designed questionnaire that collected sociodemographic information and assessed KAP scores. The primary outcome measures were KAP scores.
The mean KAP scores were 6.57±2.76 (possible range: 0–10) for knowledge, 30.00±4.08 (possible range: 7–35) for attitude and 30.16±4.92 (possible range: 8–40) for practice. Pearson’s correlation analysis indicated a positive and moderate correlation between knowledge and attitude (r=0.330, p
Patients with FGIDs demonstrated moderate knowledge, positive attitudes and moderate practices regarding their disease. Drinking habits and household income reportedly influenced their KAP outcomes. Targeted educational interventions are warranted to enhance practice behaviours among patients with FGIDs.
Talaromycosis is a severe fungal infection caused by Talaromyces marneffei that predominantly affects people living with HIV (PLWH), particularly in southern China where it contributes substantially to AIDS-related mortality. While liposomal amphotericin B (L-AMB) is preferred for induction therapy due to its superior safety profile over conventional amphotericin B deoxycholate (AmBD), the efficacy of a single high-dose L-AMB regimen in talaromycosis remains unestablished. Furthermore, current guidelines recommend initiating antiretroviral therapy (ART) within 1 week of antifungal treatment, though real-world evidence in Chinese populations is limited. This study aims to evaluate the efficacy and safety of single high-dose L-AMB for AIDS-associated talaromycosis and provide clinical evidence on early initiation of bictegravir/emtricitabine/tenofovir alafenamide fumarate (B/F/TAF) in this population.
This multicentre, randomised controlled phase II clinical trial compares the efficacy and safety of single high-dose L-AMB (10 mg/kg), followed by itraconazole capsule 200 mg every 12 hours for the remaining 13 days of induction therapy, versus AmBD (0.5 mg/kg/day for 14 days) as induction therapy for AIDS-associated talaromycosis in PLWH adults with microbiologically confirmed diagnosis. Eligible participants (n=116) will be randomly assigned (1:1) at four Chinese centres to receive either treatment, followed by 10 weeks of itraconazole capsule consolidation therapy and secondary prophylaxis until CD4+ T-lymphocyte counts exceed 100 cells/mm3 for ≥6 months, with ART initiated within 7 days of antifungal treatment according to current ART guidelines. The primary endpoint is clinical resolution rate after induction, while secondary endpoints include overall survival, organ function recovery and adverse event incidence.
This study was approved by the Institutional Review Board of Shanghai Public Health Clinical Centre (Approval No. 2025-S039-01) and the ethics committees of all participating study centres: Guiyang Public Health Treatment Centre, Mengchao Hepatobiliary Hospital of Fujian Medical University and Chest Hospital of Guangxi Zhuang Autonomous Region. All procedures were conducted in accordance with the ethical standards of the Declaration of Helsinki and national regulations. Written informed consent was obtained from all participants prior to enrolment. The findings of this study will be disseminated through publications in international peer-reviewed journals and presentations at scientific conferences. Participants who express interest in the study results will be provided with a summary report following the release of the primary findings.
ClinicalTrials. gov NCT06926569.