Journal of Clinical Medicine最新文献

Background: SGLT2 inhibitors are key therapies in heart failure (HF), but their combined multidomain effects have not been analyzed together. Methods: We conducted a PROSPERO-registered (CRD420251235850) systematic review and meta-analysis of all randomized controlled trials (RCTs) comparing SGLT2i (dapagliflozin, empagliflozin, canagliflozin, sotagliflozin) with placebo in adults with HF, regardless of ejection fraction or diabetes status. We searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, and Web of Science through 1 February 2025. Outcomes were grouped into four domains: (1) clinical events, (2) symptoms/health status (Kansas City Cardiomyopathy Questionnaire, KCCQ), (3) functional capacity (6 min walk distance, peak VO₂), and (4) cardiac remodeling/energetics (cardiac MRI, 31P-MRS). We used random-effects models with Hartung-Knapp adjustment and assessed heterogeneity by I² and prediction intervals. Results: Eleven RCTs with 23,812 patients (HFrEF, HFmrEF, HFpEF, and acute or recently decompensated HF) were included. SGLT2i lowered the risk of cardiovascular death or first HF hospitalization by 23% (HR 0.77, 95% CI 0.72-0.82; p < 0.0001; I² = 28%; prediction interval 0.68-0.87), with similar effects across ejection fraction, diabetes status, and presentation type. All-cause and cardiovascular mortality dropped by 12% (HR 0.88, 95% CI 0.81-0.96) and 14% (HR 0.86, 95% CI 0.78-0.95), respectively. SGLT2i improved KCCQ-Clinical Summary Score by 4.6 points (95% CI 3.4-5.8; p < 0.0001) and increased the odds of a ≥5-point improvement (OR 1.49, 95% CI 1.32-1.68; NNT = 12). Six-minute walk distance increased by 21.8 m (95% CI 9.4-34.2; p = 0.001), and mechanistic trials showed significant reverse remodeling (ΔLVEDV -19.8 mL, ΔLVEF +6.1%; both p < 0.001). No improvement was observed in myocardial PCr/ATP ratio. Safety was favorable, with no excess ketoacidosis or severe hypoglycemia. Conclusions: This multidomain synthesis demonstrates that SGLT2 inhibitors provide consistent, robust reductions in mortality and hospitalizations, while also delivering early, clinically meaningful improvements across multiple patient-centered domains. These results establish SGLT2i as a foundational component of contemporary HF management.

Background and Objectives: ACTIVA BioACTIVE Restorative is a resin-ionomer hybrid marketed as a bioactive material for pediatric restorations, yet its specific performance in primary teeth has not been systematically synthesized. The study aim was to evaluate clinical and laboratory outcomes of ACTIVA in primary dentition compared with established restorative materials. Methods: Following a PRISMA-aligned, OSF-registered protocol, PubMed, Scopus, and Web of Science were searched to 18 October 2025 for full-text clinical trials and in vitro studies involving ACTIVA in primary teeth or primary dentin. Eligible designs included randomized or prospective clinical studies and standardized in vitro experiments. Primary outcomes were clinical and radiographic success; secondary outcomes included placement time, shear bond strength, and calcium-ion release. Results: Three randomized clinical trials (86 children, 305 restorations) and one in vitro study met the inclusion criteria. At 12 months, clinical success with ACTIVA ranged from 97.5 to 97.8% versus 95.0-97.8% for bulk-fill and conventional composites. At 24 months, a split-mouth trial reported clinical success of 93.0% for ACTIVA and 95.3% for compomer, with radiographic success of 86.0% and 88.3%, respectively, remaining within the predefined non-inferiority margin. ACTIVA required a mean of 2.4 ± 0.6 min less placement time than compomer. In vitro, shear bond strength to primary dentin was higher for ACTIVA than for an RMGIC (4.29 ± 0.65 vs. 2.47 ± 0.32 MPa), with greater calcium-ion release at 21 days (0.77 ± 0.13 vs. 0.53 ± 0.12 ppm). Conclusions: Within 1-2 years of follow-up, ACTIVA shows clinical performance in primary molars comparable to compomer, bulk-fill, and conventional composites, while offering shorter placement time and favorable bio-interactive behavior.

Background: Neurocognitive complications are common after cardiac surgery, and postoperative cognitive decline remains a clinically relevant concern in patients undergoing heart valve surgery. This impairment may persist over time and negatively affect quality of life and increase mortality risk. This review aimed to explore the potential benefits of cognitive training in patients after heart valve surgery. Methods: We systematically searched PubMed, Embase, Cochrane Library, and Scopus to identify articles published from database inception to 19 June 2025. Studies that investigated the effects of cognitive training in patients who underwent heart valve surgery were included. Results: A total of 1506 articles were identified. After title and abstract screening, 1476 articles not meeting the inclusion criteria were excluded. Thirty full-text articles were assessed for eligibility, of which four studies were ultimately included in this review. Cognitive training was found to significantly improve cognitive outcomes and health-related quality of life, with benefits sustained for up to 12 months postoperatively. Conclusions: This review highlights cognitive training as a promising, feasible, and effective intervention for preserving cognitive function in patients following heart valve surgery. By enhancing neuroplasticity, cognitive training may prevent or mitigate cognitive decline across multiple domains. Further large-scale studies are warranted to confirm the efficacy of this treatment in this patient population.

Background/Objectives: Achieving gross total resection is crucial in the surgical management of pituitary neuroendocrine tumors (PitNETs). However, PitNETs with anterosuperior extension remain challenging to completely remove using the conventional transsellar approach (TSA) due to limited access to the anterior suprasellar region. This study evaluated the efficacy and safety of a modified TSA (mTSA) that involves additional removal of the tuberculum sellae and planum sphenoidale (PS) bones without expanding the dural incision. Methods: We retrospectively reviewed 104 patients with nonfunctioning PitNETs who underwent endoscopic transsphenoidal surgery between 2017 and 2022. Seventy-seven patients were treated with the conventional TSA and 27 with the mTSA. Tumor configuration and accessible area were measured on pre- and postoperative MR imaging and CT. The ratio of the accessible to total tumor area was calculated on mid-sagittal images. Surgical outcomes and postoperative complications were compared between groups. Results: Gross total resection was achieved in all patients. Tumors treated with mTSA were larger (median height, 32 mm vs. 25 mm; p < 0.001) and showed greater anterosuperior extension. The mTSA increased the median accessible tumor area from 70% to 88%, with a median PS removal distance of 4.4 mm. Postoperative complications were minimal: cerebrospinal fluid leakage (3%), meningitis (3%), transient ocular movement disturbance (2%), and transient visual worsening (1%). No hemorrhage or anosmia occurred. Conclusions: The mTSA safely expands the surgical corridor to the anterior suprasellar region, enhancing accessibility and enabling complete resection without dural incision. This approach balances surgical radicality and safety in PitNETs with anterosuperior extension.

Background/Objectives: Hereditary Hemorrhagic Telangiectasia (HHT) is an autosomal dominant vascular dysplasia characterized by recurrent epistaxis, anemia, and visceral arteriovenous malformations. Epistaxis is the most frequent and disabling manifestation, with limited effective pharmacological options. Propranolol, a non-selective beta-blocker with vasoconstrictive and antiangiogenic properties, has shown benefit in other vascular anomalies but remains scarcely studied in HHT. This study aimed to evaluate the effect of oral propranolol on nasal bleeding in patients with HHT. Methods: A retrospective observational study including 151 adults with HHT (44 treated with propranolol, 107 untreated) was conducted using data from an Institutional HHT Registry from a referral center. Baseline demographic and clinical variables were recorded. Outcomes at 6 months included changes in hemoglobin, adherence to nasal hygiene, use of bleeding-related therapies, and improvement in epistaxis frequency and intensity according to the Sadick-Bergler scale. Logistic regression models were adjusted for confounders and indication bias using inverse probability of treatment weighting (IPTW). Results: After IPTW adjustment, propranolol was significantly associated with reduced frequency of epistaxis (adjusted OR: 3.8; 95% CI: 1.3-11.2; p = 0.016), while no effect was observed on intensity. Hemoglobin levels increased modestly in both groups without a significant difference. Patients without propranolol showed greater antifibrinolytic use, whereas adherence to nasal care remained stable among treated patients. Conclusions: Oral propranolol reduced nasal bleeding frequency in HHT, even among patients with greater baseline severity. Given its accessibility, safety, and potential to lessen treatment burden, it may represent a valuable adjunct therapy. This study represents the largest cohort of HHT patients treated with propranolol reported to date. Randomized trials including standardized bleeding scores and patient-reported outcomes are warranted to confirm clinical and quality-of-life benefits.

Background/Objectives: Investigating how placement of a contralateral breast implant in the context of unilateral implant-based breast reconstruction influences aesthetic and patient-reported outcomes. Methods: A retrospective analysis was performed on a single-center prospectively maintained database (January 2021-March 2025) including patients who underwent unilateral implant-based breast reconstruction in association with a contralateral implant placement or not. Exclusion criteria were bilateral implant-based reconstruction or autologous reconstruction, follow-up of less than 6 months and missing data. Demographics and complications were analyzed. Aesthetic outcomes were evaluated by independent blinded surgeons using the Kroll Scale, patient satisfaction was investigated with the BREAST-Q Reconstruction Module v2.0. Statistical analysis used the Student's t-test, Multivariate regression analysis and Mann-Whitney U test with significance set at p < 0.05. Results: The study group included 21 patients (40.4%) who received a contralateral implant, while the control group included 31 patients (59.6%) who did not receive a contralateral implant. Patients who received contralateral implants showed a significant improvement in cosmetic outcomes evaluated with the Kroll Scale and a raw increment, without statistical significance, in BREAST-Q scores in all subsections investigated (Psychosocial well-being, Sexual well-being and Satisfaction with breasts). Conclusions: Placing a contralateral breast implant in the context of unilateral implant-based breast reconstruction significantly improves aesthetic outcomes and correlates with higher patient satisfaction scores for the reconstructed breast, compared to placing no contralateral implant, without increasing the overall complication rate.

Background/Objectives: Topical steroid withdrawal syndrome is an underrecognized (and at times controversial) diagnosis, predominantly seen in individuals with a history of prolonged medium- to high-potency steroid use with sudden cessation. We aim to present topical steroid withdrawal clinical cases along with a narrative review of the literature to better characterize this understudied phenomenon. Methods: A total of 16 patients with a history of topical steroid withdrawal were enrolled in an IRB-approved clinical trial (NCT04864886). Participants underwent clinical assessments at the National Institutes of Health, including a history and physical examination, photography, genome sequencing, and comprehensive blood work. A follow-up survey assessed symptom activity and functional impact. Results: All patients reported severe itch, heat and photosensitivity, erythema, skin dryness, and pain. A total of 11 patients exhibited elevated IgE levels, 9 patients noted metallic-smelling skin, and 4 had peripheral blood eosinophilia. Symptomatic relief was observed with dupilumab, berberine, naltrexone, and various home remedies including topical ointments, vitamins, and probiotics, though effectiveness varied and often required trial and error. At follow-up, most respondents reported partial but ongoing symptoms, with several describing residual itch and intermittent interference with daily activities. Some participants continued therapeutic interventions, such as berberine, over two years after their initial evaluation. Conclusions: Our findings report improvement in patient symptoms such as itch and detail emerging management strategies that have not been discussed before. Improved recognition, physician consensus, and systemic evaluation of therapeutic options are needed to guide care and enhance quality of life for affected patients.

Background/Objectives: Thoracic minimally invasive spine surgery (MISS) offers reduced tissue trauma and faster recovery compared with open approaches, but its adoption remains limited due to technical complexity and uncertainty regarding complication rates. This study aimed to synthesize the available evidence on overall and approach-specific complications of thoracic MISS using tubular, uniportal endoscopic, and biportal endoscopic techniques. Methods: Following PRISMA guidelines (PROSPERO CRD42024594316), PubMed, Medline, Embase, and Cochrane Library were searched from January 2013 to March 2024 for studies reporting complication rates after thoracic MISS in adults. Eligible studies included tubular, uniportal, or biportal approaches. Study quality was assessed using the Newcastle-Ottawa Scale. Complication data were extracted and summarized descriptively, with reported rates stratified by surgical approach. Results: Nine studies (234 patients) were included, all retrospective with moderate risk of bias. Across included studies, reported overall complication rates following thoracic MISS ranged from 0% to 42.9%. Stratified by surgical approach, reported complication rates ranged from 0% to 11.8% across six tubular studies, 9.7% to 20.0% across two uniportal endoscopic studies, and 42.9% in a single small biportal endoscopic study. Neural injuries and dural tears were the most frequently reported complications, with reported rates ranging from 0% to 14.3% and 0% to 3.6%, respectively. Symptomatic cerebrospinal fluid leaks and revision surgeries were less common, with reported rates ranging from 0% to 11.8% and 0% to 3.2%, respectively. Conclusions: Thoracic MISS demonstrates a low overall complication rate, particularly for tubular approaches. However, findings should be interpreted with caution given the small number of included studies, retrospective designs, and clinical heterogeneity. Larger comparative investigations are needed to better define safety profiles and support broader adoption of thoracic MISS techniques.

Background/Objectives: Postoperative nausea and vomiting (PONV) remains a frequent and clinically relevant complication following open lumbar discectomy (OLD) under general anesthesia. The present study represents a secondary, post hoc analysis of a randomized controlled trial originally designed to investigate the effects of infiltration anesthesia (IA) on postoperative pain perception and opioid consumption. The objective of this analysis was to explore the incidence of PONV in patients undergoing OLD under adequacy of anesthesia (AoA)-guided general anesthesia, with or without IA. Methods: This secondary analysis included 94 patients undergoing OLD under AoA-guided general anesthesia with fentanyl titration based on the surgical pleth index (SPI). Patients were randomized to receive IA with 0.2% ropivacaine (RF) or bupivacaine (BF) plus 50 µg fentanyl, or no IA (control). PONV was assessed as early (in the post-anesthesia care unit), late (in the neurosurgical ward), and overall (within 48 h postoperatively). Opioid consumption and Apfel risk scores were also analyzed. All analyses related to PONV were exploratory. Results: PONV occurred in 12.8% of patients, with no significant differences between study groups. Postoperative morphine consumption was significantly lower in the RF group than in the control group (2.7 ± 5.3 mg vs. 7.1 ± 5.9 mg; p < 0.05). Higher pre-induction SPI values were observed in patients who experienced early PONV (73.1 ± 9.7 vs. 59.5 ± 17.2; p < 0.05); however, this exploratory finding requires confirmation in larger studies. Conclusions: In this secondary, post hoc analysis, no significant differences in PONV incidence were observed between anesthetic groups in patients undergoing OLD under AoA-guided general anesthesia. The observed association between pre-induction SPI values and early PONV should be interpreted cautiously and requires confirmation in adequately powered prospective studies.

Background/Objectives: Congenital cleft earlobes are a rare deformity with variable degrees of severity. Because no widely accepted classification or corrective methods exist, we report a case of a 7-year-old boy who presented with a right defective-type cleft earlobe that was successfully reconstructed. We also elucidate the various types of congenital cleft earlobes and corrective methods through a scoping review of the literature. Methods: PubMed searches were performed using the terms ear deformity and cleft earlobe. We analyzed 14 articles to establish a classification system for congenital cleft earlobe and to identify appropriate corrective methods. Results: Our case was successfully reconstructed using a simple local flap technique that can be easily applied to defective-type cleft earlobes of moderate to severe degree. Based on this case and our systematic analysis, we have synthesized existing classification systems and surgical techniques for correcting congenital cleft earlobes according to subtype. Conclusions: We present a unified classification system for congenital cleft earlobes consisting of four subtypes based on external appearance: defective type, simple type, tag with or without hypoplasia, and triple lobe. Various reconstructive techniques-including simple suture, Z-plasty, Y-V advancement, and flap procedures-can be applied according to the specific earlobe subtype.