Objective This study aims to evaluate the risk, clinical outcomes, and age-specific characteristics of AED-associated SCARs in minors compared to adults using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods A retrospective analysis was conducted using FAERS data from 2013 to Q3 2024. SCAR cases associated with AED use were identified and stratified by age groups (adults and minors) and further subdivided into pediatric age categories (0–2 years, 2–6 years, 6–12 years, and 12–18 years). Disproportionality analysis using reporting odds ratios (RORs) was performed to assess the risk of SCARs in minors compared to adults. Drug-specific and age-stratified analyses were conducted to elucidate patterns of SCAR occurrence and severity. Results Among 48,411 adverse drug reaction (ADR) cases in minors, 2,472 (5.11%) were classified as SCARs. Minors exhibited significantly higher RORs for SCARs compared to adults, with the most pronounced risk signals observed for SJS-TEN overlap (ROR: 10.16, 95% CI: 7.27–14.21), SJS (ROR: 4.36, 95% CI: 4.03–4.73), and DRESS (ROR: 3.75, 95% CI: 3.53–3.98). SCARs in minors were associated with severe outcomes, including hospitalization (52.27%), life-threatening events (19.66%), and death (5.10%). Age-stratified analysis revealed distinct patterns of SCAR occurrence and severity across pediatric age groups. For example, infants (0–2 years) exhibited the highest ROR for DRESS (ROR: 83.01), while children aged 6–12 years showed the highest ROR for SJS-TEN overlap (ROR: 217.44). Lamotrigine (LTG), levetiracetam (LEV), and carbamazepine (CBZ) were the most frequently implicated AEDs, accounting for 33.37%, 21.44%, and 10.84% of pediatric SCAR cases, respectively. Notably, the median time to onset of SCARs was significantly shorter in minors (437 days) compared to adults (1,497 days, P < 0.0001). Conclusions Minors face significantly higher AED-SCAR risk with earlier onset and greater severity, with marked heterogeneity across pediatric age groups. Lamotrigine showed the strongest association, but levetiracetam—often perceived as safer—ranked second in absolute SCAR reports, warranting a more cautious clinical approach. These findings underscore the need for age-specific monitoring and enhanced pharmacovigilance. Future research should prioritize prospective cohort studies, pharmacogenomics, and the development of databases that can track AED combination therapy risks in minors, a critical missing safety evidence gap.
Background Digital health can connect clinical documentation, quality management, decision support, and value assessment. Traditional Chinese medicine (TCM) therapies, however, remain represented mainly by isolated tools and disease-specific studies. Objective To conduct a preliminary scoping review and formulate a conceptual framework for digital whole-process management of TCM therapies. Methods We reviewed 307 studies. Screening was limited to publication year, titles, and abstracts. A total of 44 articles were ultimately included and classified as direct TCM digitalization studies, transferable digital-management studies, or TCM clinical-background studies. Conclusions This study is a preliminary scoping review and conceptual proposal. Although the framework is largely speculative, it can serve as a preliminary reference and provide transferable empirical support for exploratory applications in the field of TCM, provided that terminology development, workflow testing, prospective validation, regulatory review, and multicenter evaluation are completed prior to clinical deployment.
Continuous glucose monitoring (CGM) has evolved from an adjunctive display technology into a source of data for therapeutic decision-making, hypoglycemia alerts and automated insulin delivery. This transition has made calibration a safety-critical function. Factory-calibrated CGM removes routine user calibration but does not eliminate calibration itself; responsibility shifts to manufacturing control, sensor coding, embedded estimation, validation evidence and runtime safety governance. This Review examines the technical basis of calibration, the progression from user-calibrated to factory-calibrated CGM and the future development of intelligent adaptive no-user-calibration systems. We distinguish technically supported component methods from their developmental integration into a system that maintains calibration state during use. Evaluation of such systems will need to extend beyond mean absolute relative difference (MARD) to include performance in high-risk scenarios, consistency across algorithm versions, confidence output and regulatory evidence linking analytical performance, clinical safety and real-world use.
Objective To evaluate the dose-related effects of intraoperative sub-anesthetic esketamine on acute postoperative pain, neuropathic pain, and early quality of recovery in patients undergoing debridement for diabetic foot ulcers, and to explore a reasonable dose for further clinical investigation. Methods A total of 180 patients with diabetic foot ulcers and painful diabetic peripheral neuropathy who were scheduled for elective debridement under sacral plexus block anesthesia at Tianjin Medical University Chu Hsien-I Memorial Hospital between June 2025 and May 2026 were enrolled. Patients were randomly assigned in a 1:1:1:1 ratio to Group N (normal saline), Group E1 (esketamine 0.15 mg/kg), Group E2 (esketamine 0.25 mg/kg), or Group E3 (esketamine 0.35 mg/kg). The study drug was infused intravenously over 30 min, beginning 5 min after surgical incision. Numerical Rating Scale (NRS), Chinese Version of the Neuropathic Pain Symptom Inventory (CV-NPSI), and Quality of Recovery-15 (QoR-15) scores were assessed preoperatively and at 24, 48, and 72 h postoperatively. Patient-controlled intravenous analgesia (PCIA) demand counts, rescue analgesic use, and adverse events during the first 72 postoperative hours were also recorded. Results A total of 177 patients were included in the final analysis. Baseline characteristics were comparable among the four groups (p > 0.05). NRS scores were significantly lower in Groups E2 and E3 than in Groups N and E1 at 24, 48, and 72 h postoperatively (p < 0.05). CV-NPSI total scores were significantly lower in Groups E2 and E3 at 48 and 72 h, but not at 24 h. The QoR-15 pattern varied by time point: at 24 h, Group E2 scored higher than Groups N and E1, whereas Group E3 scored higher than Group N but did not differ significantly from Groups E1 or E2; at 48 h, Group E3 scored higher than the other groups; and at 72 h, Groups E2 and E3 scored higher than Groups N and E1. Groups E2 and E3 also had fewer recorded PCIA demands and rescue analgesic administrations than Groups N and E1 (p < 0.05). No statistically significant differences in adverse-event incidence were detected, although the number of events was small. Conclusion Intraoperative esketamine at 0.25 and 0.35 mg/kg was associated with lower postoperative NRS scores, lower CV-NPSI scores at 48 and 72 h, and fewer analgesic demands than normal saline or 0.15 mg/kg. No statistically significant difference was detected between the two higher doses for NRS or CV-NPSI outcomes; however, equivalence was not formally tested. Esketamine 0.25 mg/kg may be a reasonable dose for further evaluation, while conclusions regarding comparative safety remain preliminary.
