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A Phase I Study Assessing the Safety, Tolerability, and Pharmacokinetics of Yinfenidone: A Novel, Potent Drug for Idiopathic Pulmonary Fibrosis Treatment in Healthy Chinese Subjects.

PURPOSE: Idiopathic pulmonary fibrosis (IPF) is a fatal interstitial lung disease with a median survival of only 2-3 years after diagnosis. Yinfenidone (HEC585) possesses the potential to inhibit the proliferation of pulmonary fibroblasts, making it a promising candidate for the treatment of IPF. This study assessed the safety, tolerability, pharmacokinetics, and metabolic profile of Yinfenidone hydrochloride capsule in healthy Chinese subjects. METHODS: This single-center, randomized, double-blind, placebo-controlled, single ascending-dose trial included seven dose groups(20, 50, 100, 200, 400, 600, and 800 mg). Each group enrolled8 healthy subjects: 6 received Yinfenidone hydrochloride capsules and 2 received matching placebo under fasting conditions. Serial pharmacokinetic (PK) blood samples were collected pre-dose and post-dose, liquid chromatography-tandem mass spectrometry was used to analyze the plasma concentrations of Yinfenidone. Additionally, metabolic biotransformation of Yinfenidone in plasma were conducted in the 100 mg dose group. Safety and tolerability endpoints were monitored via physical examinations, vital signs measurements, clinical laboratory tests, 12-lead electrocardiography (ECG), and adverse events (AEs) documentation throughout the trial. FINDINGS: Yinfenidone was rapidly absorbed, with a median maximum plasma concentration (Tmax) of 1.8-3.0 hours, and had a mean half-life (t1/2) ranging from 31.9 to 62.0 hours. Within the 20-100 mg dose range, systemic drug exposure generally increased with ascending dose, above 100 mg, exposure increased less than proportionally to dose. Metabolite profiling in the 100 mg group revealed that the parentcompound predominated in plasma, with metabolic pathways including mono-oxygenation and N-dealkylation. All reported AEswere mild, classified as Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1. No serious AEs observed; no subject discontinued the trial due to AEs. Single oral doses of 20-800 mg Yinfenidone hydrochloride capsules administered under fasting conditions demonstrated favorable safety and tolerability profiles in healthy Chinese subjects. IMPLICATIONS: Yinfenidone exhibited rapid absorption (median Tmax, 1.8-3.0 hours) and a long terminal t1/2 ranging from 31.9 to 62.0 hours in this single ascending-dose study, indicating that Yinfenidone can be taken once a day in subsequent clinical studies. Yinfenidone mainly exists in human plasma as the original drug and is metabolized through a variety of metabolic pathways. The AEs observed with Yinfenidone in this study, such as diarrhea, nausea, and dizziness, were similar to those reported with pirfenidone. Overall, Yinfenidone demonstrated a favorable safety and tolerability profile in this cohort of healthy subjects.

Adult

Cryostick pre-cooling reduces pain during intra-articular knee injections: a randomized, contralateral-controlled trial.

BACKGROUND: Intra-articular knee injections are essential for osteoarthritis management but often limited by "needle phobia" and procedural pain. The cryostick, a high-thermal-conductivity device, is a potential analgesic; however, evidence regarding its efficacy in reducing pain and bleeding is limited. The purpose of the study was to evaluate whether cryostick application reduces procedural pain, reduces bleeding, and improves patient satisfaction during intra-articular knee injections. METHODS: This randomized, contralateral-controlled trial included 50 patients (100 knees) with bilateral knee osteoarthritis. One knee received a 20-s cryostick protocol (-20&#xb0;C) immediately before injection; the contralateral knee received a standard injection. Primary outcome was pain intensity (100-mm VAS) during needle penetration and at 5-min post-injection. Secondary outcomes included bleeding area (mm2) and satisfaction (1-5 Likert scale). RESULTS: Cryostick application significantly reduced pain during needle penetration (Mean Difference [MD] -24.8&#xa0;mm; 95% CI -29.9 to -19.7; P&#xa0;<&#xa0;0.001) and at 5-min post-injection (MD -20.8&#xa0;mm; 95% CI -26.8 to -14.8; P&#xa0;<&#xa0;0.001). The Number Needed to Treat (NNT) to achieve the Minimal Clinically Important Difference (13&#xa0;mm) was 1.28 (95% CI 1.15-1.54) during penetration and 1.79 (95% CI 1.45-2.36) at 5-min post-injection. The bleeding area was significantly smaller with cryostick (MD -4.82&#xa0;mm2; P&#xa0;=&#xa0;0.014). Patients reported significantly higher satisfaction scores with the cryostick (4.10 vs 2.96; P&#xa0;<&#xa0;0.001). CONCLUSIONS: A 20-s cryostick application is a safe, well-tolerated, and effective adjunct for attenuating pain and bleeding during knee injections. This technically simple approach requires minimal complexity, offering an efficient, non-pharmacological tool to enhance patient comfort.

Humans

Assessment of Surgical Salvage Outcomes for Exposed Cranial Neuromodulating Devices.

OBJECTIVES: Implanted neuromodulating devices (NMDs) such as cochlear implants (CIs) and deep brain stimulators (DBSs) are commonly used in modern medicine. Rarely, complications arise post-operatively, including hardware exposure. Traditional teaching suggests that these devices require removal if exposed; however, surgical salvage is a high risk, high reward alternative. We review our single institution experience managing NMD exposure with surgical salvage. METHODS: Retrospective chart review was performed on individuals who had a NMD implanted and underwent an attempt at surgical salvage for exposure during the study period (January 01, 2021 through December 31, 2023). Study outcome success was defined as maintaining a functional NMD 1&#x2009;year after salvage was attempted. Surgical techniques associated with successful salvage were compared. RESULTS: Nine of 729 patients (1.2%) implanted with NMDs experienced hardware exposure during this 2-year study period. Nine subjects were referred for NMD salvage; however, only 6 of 9 subjects (66.7%, CI&#x2009;=&#x2009;3; DBS&#x2009;=&#x2009;3) underwent NMD salvage attempts. Four of the subjects had successful salvage demonstrated successful salvage with a functioning NMD and without wound healing concerns 1&#x2009;year after their salvage procedure. CONCLUSIONS: Classic teaching states that exposed NMDs require explantation. However, this approach necessarily imposes time without benefit from the NMD between explantation and reimplantation. Our experience demonstrates that surgical salvage can be a successful alternative for the majority (66.7%) of individuals.

Humans

Effect of Music on Pain, Anxiety, and Satisfaction During Intrauterine Device Application: A Randomized Clinical Trial.

This randomized controlled trial aimed to determine the effect of music played during intrauterine device (IUD) insertion on perceived pain, state anxiety, and satisfaction levels. The study was conducted with 70 women who applied to a maternal and child health and family planning center and were randomly assigned to the intervention and control groups using simple randomization. Data were collected using a Demographic Information Form, the State-Trait Anxiety Inventory (STAI-I), and the Visual Analog Scale (VAS), as well as Bluetooth speakers and the musical piece Evgeny Grinko-Valse. Participants in the intervention group listened to music before and during the IUD insertion procedure, whereas the control group received routine care only. Data were analyzed using SPSS version 26 with appropriate descriptive and inferential statistical methods. Women in the music group had significantly lower perceived pain (p&#x2009;<&#x2009;0.001) and state anxiety levels during the procedure (p&#x2009;=&#x2009;0.022), and significantly higher satisfaction levels compared with the control group (p&#x2009;<&#x2009;0.001). In addition, post-procedure state anxiety levels were positively correlated with pain intensity experienced during and after the procedure (r&#x2009;=&#x2009;0.542 and r&#x2009;=&#x2009;0.496, respectively; p&#x2009;<&#x2009;0.001), and negatively correlated with procedural satisfaction (r&#x2009;=&#x2009;-0.652; p&#x2009;<&#x2009;0.001). These findings suggest that listening to music during IUD insertion may help reduce pain and anxiety while potentially enhancing patient satisfaction. Trial Registration: NCT06215183.

Humans

Stapled versus hand-sewn intestinal anastomosis in pediatric surgery: A systematic review and meta-analysis.

BACKGROUND: Intestinal anastomosis is a core procedure in pediatric gastrointestinal surgery, performed for conditions such as necrotizing enterocolitis, intestinal atresia, Hirschsprung's disease, and inflammatory bowel disease. Although stapled anastomosis (SA) may improve operative efficiency, its safety and effectiveness compared with hand-sewn anastomosis (HA) in children remain uncertain. This meta-analysis compared clinical outcomes of SA and HA in pediatric patients. METHODS: The study followed PRISMA guidelines and was prospectively registered in PROSPERO (CRD420251177257). A systematic search of PubMed, Dimensions, and the Cochrane Library was conducted through June 2025. Studies including children under 7 years undergoing intestinal SA or HA were eligible. Two reviewers independently performed study selection, data extraction, and risk-of-bias assessment using ROB 2 and ROBINS-I tools. Statistical analysis was conducted using Comprehensive Meta-Analysis software (v3) with a random-effects model. RESULTS: Eleven studies involving 903 patients met inclusion criteria, including two randomized controlled trials. Of these, 333 patients underwent SA and 570 underwent HA. SA was associated with significantly shorter operative time (mean difference [MD] = -19.26 min; 95% CI: -24.24 to -14.28; p < 0.001) and earlier initiation of oral feeding (MD = -2.32 days; 95% CI: -3.78 to -0.86; p = 0.002). No significant differences were found in anastomotic leakage, stricture formation, reoperation rate, or length of hospital stay. CONCLUSIONS: Stapled anastomosis appears as safe as hand-sewn techniques in pediatric intestinal surgery while offering shorter operative duration and faster postoperative feeding recovery. Selective use of stapled techniques is supported when anatomically feasible, though further multicenter randomized trials are needed.

Humans

Endoscopic Ultrasound-Guided Versus Transjugular Portal Pressure Measurements: Systematic Review and Meta-Analysis.

PURPOSE: Published reviews of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) have emphasized feasibility and safety. We performed a systematic review and meta-analysis specifically to evaluate how closely EUS-based portal pressure measurements track invasive comparator measurements in prospective paired studies and to summarize agreement, technical success, and adverse events. METHODS: We searched major databases through January 2026 for prospective cohorts reporting same-patient EUS-based portal pressure measurement and invasive hemodynamic measurements. Correlations were pooled with random-effects models and analyzed separately for studies comparing EUS-PPG with hepatic venous pressure gradient (HVPG) and studies comparing EUS-based portal measurements with direct portal venous pressure. Agreement and threshold discordance were summarized descriptively. RESULTS: Six prospective cohorts (127 attempted procedures) were included. In studies using HVPG as the comparator, the pooled correlation was 0.82 (95% CI, 0.72-0.89; I2&#x2009;=&#x2009;0%). In studies comparing EUS-based portal measurements with direct portal venous pressure, the pooled correlation was 0.86 (95% CI, 0.72-0.93; I2&#x2009;=&#x2009;16.9%). Technical success was 95.3%. EUS-PPG-attributed adverse events occurred in 2.4% of procedures, with no procedure-related deaths. Agreement data were limited. Reported limits of agreement were wide (approximately -&#xa0;6 to&#x2009;+&#x2009;7&#xa0;mmHg), and discrepancies of 5&#xa0;mmHg or greater occurred in 4 of 30 paired measurements. CONCLUSIONS: EUS-based portal pressure measurement is feasible and shows a strong association with invasive hemodynamic comparators, but the evidence base remains small (six cohorts, 127 attempted procedures). Further study will be necessary to establish patient-level agreement, procedural reproducibility, EUS-specific clinically significant portal hypertension thresholds, and whether HVPG-based decision thresholds can be transferred to EUS-derived measurements.

Humans

Physician-Modified Fenestrated Stent-Grafts Planned Using Three-Dimensional Techniques for Complex Aortic Pathology: A Systematic Review and Meta-Analysis.

BACKGROUND: Complex aortic pathology involving the visceral arteries remains a significant therapeutic challenge. Open repair is associated with considerable perioperative risk, particularly in patients with multiple comorbidities, while standard endovascular aneurysm repair (EVAR) is often not feasible because of inadequate proximal sealing zones. Fenestrated and branched endovascular repair (F/BEVAR) represents an established treatment strategy; however, the use of custom-made devices is limited by manufacturing time and availability. Physician-modified stent grafts (PMSGs) have therefore emerged as a pragmatic alternative. Three-dimensional planning techniques have been increasingly used to facilitate accurate graft modification. The aim of this systematic review and meta-analysis was to evaluate the effectiveness and safety of PMSG procedures planned with three-dimensional techniques. Technical success, target vessel patency, early mortality, endoleak occurrence, and reintervention rates were analyzed. METHODS: A systematic search was conducted in the PubMed/MEDLINE and Embase databases. Studies describing the use of physician-modified fenestrated stent grafts planned with three-dimensional tools were included. Meta-analyses were performed using a random-effects model with restricted maximum likelihood estimation. A logit transformation was used for the analysis of proportions. RESULTS: The analysis included five studies involving 172 patients. The estimated weighted mean follow-up duration was 14.9 months. The overall technical success rate was 92.9% (95% confidence interval [CI]: 84.5-96.9%), with low-to-moderate heterogeneity. Target vessel patency was 96.9% (95% CI: 93.6-98.5%). Early mortality was 5.5% (95% CI: 2.1-13.3%). The incidence of endoleaks was 13.3% (95% CI: 5.8-27.4%), with significant heterogeneity among studies. Reinterventions were reported in 6.6% of patients (95% CI: 2.3-17.5%). CONCLUSION: The results indicate that PMSG procedures planned with three-dimensional techniques are associated with a high rate of technical success and preserved patency of target vessels in patients with complex aortic pathology. The observed variability in endoleak and reintervention rates likely reflects differences in anatomical complexity and patient selection among studies. Further prospective studies are needed to confirm long-term outcomes.

Humans

Endovascular thrombectomy versus best medical therapy for acute vertebrobasilar artery occlusion in patients with low NIHSS scores: a&#xa0;meta-analysis.

OBJECTIVE: The efficacy of endovascular thrombectomy (EVT) for acute vertebrobasilar artery occlusion (VBAO) presenting with mild symptoms (National Institutes of Health Stroke Scale [NIHSS] score &#x2264;10) remains uncertain. This meta-analysis aimed to compare the effectiveness and safety of EVT versus best medical therapy (BMT) in this population. METHODS: We systematically searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials from inception to September 2025 for comparative studies. The primary outcome was 90-day excellent functional outcome (modified Rankin Scale [mRS] score 0-1). Secondary outcomes included functional independence (mRS 0-2), symptomatic intracranial hemorrhage (sICH), and all-cause mortality. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using a random-effects model. RESULTS: Seven observational studies involving 3,107 patients were included. In unadjusted analyses, EVT was associated with a higher rate of excellent functional outcome (OR 2.17; 95% CI 1.58-2.96) but not with functional independence (OR 1.58; 95% CI 0.90-2.77). After adjustment for confounders, EVT was associated with higher rate of excellent functional outcome (OR 2.86; 95% CI 1.89-4.31) and functional independence (OR 1.91; 95% CI 1.01-3.62). Safety outcomes including sICH and mortality did not differ significantly between groups. CONCLUSION: In patients with acute VBAO and mild symptoms, EVT may be associated with superior functional outcomes compared to BMT alone, without a significant increase in procedural risks. These findings suggest a potential role for EVT in selected patients with low NIHSS scores and underscore the need for confirmation in randomized trials.

Humans

Prognostic Value of Frailty in Aortic Surgery: A Systematic Review and Meta-Analysis Comparing Frailty Assessment Tools.

BACKGROUND: Frailty is increasingly recognized as an important determinant of outcomes after aortic vascular surgery, but assessment methods vary substantially and the optimal tool for risk stratification remains uncertain. This systematic review and meta-analysis evaluated the prognostic value of preoperative frailty and compared the predictive performance of different frailty instruments in aortic surgery. METHODS: PubMed, Embase, and Cochrane Library were searched from inception to April 27, 2026. Eligible studies included patients undergoing open, endovascular, or hybrid aortic procedures involving abdominal, thoracic, thoracoabdominal, arch, and proximal aortic diseases, including aneurysms and dissections, assessed frailty preoperatively, and reported postoperative outcomes. RESULTS: Thirty studies comprising 419,459 patients were included. Frailty was associated with higher early mortality (odds ratio [OR] 2.20; 95% confidence interval [CI] 1.54-3.14) and late mortality (hazard ratio 2.18; 95% CI 1.64-2.90). Frail patients also had increased risks of major complications (OR 2.52; 95% CI 1.22-5.19), acute kidney injury (OR 1.64; 95% CI 1.34-2.02), and nonhome discharge (OR 5.50; 95% CI 3.05-9.92). Associations were consistent across surgical approaches and aortic segments. Judgment-based or phenotype-like tools yielded higher effect estimates than deficit-accumulation indices, although differences were not statistically significant; among index-based tools, Modified Frailty Index (mFI)-11 outperformed mFI-5. CONCLUSION: Preoperative frailty strongly predicts mortality, morbidity, and loss of functional independence after open, endovascular, and hybrid aortic surgery across different aortic segments and pathologies, including aneurysmal and dissecting aortic disease. Routine frailty assessment may improve risk stratification and perioperative decision-making.

Humans

Virtual, Augmented, and Mixed Reality Technologies in Neurosurgical Training: Enhancing Skills and Surgical Outcomes: A Systematic Review.

OBJECTIVE: To systematically review the role of virtual reality (VR), augmented reality (AR), and mixed reality (MR) in neurosurgical education and training. DESIGN: Systematic review conducted in accordance with the PRISMA guidelines. SETTING: A comprehensive search was performed across PubMed/MEDLINE, Scopus, Web of Science, and Google Scholar for English-language studies published between 1 January 2020 and 30 April 2026. PARTICIPANTS: Studies involving neurosurgeons, fellows, residents, and medical students (maximum sample size: n = 48) were included. RESULTS: Of 7,204 initially identified studies, 25 met the inclusion criteria. VR was primarily used for surgical simulation (100% of VR studies) and anatomical education (62.5%). AR demonstrated broader applications, including preoperative planning (40%) and intraoperative support (30%). MR was evenly distributed across simulation, planning, and intraoperative support (40% each). The most frequently improved outcomes were training effectiveness (52%) and technical proficiency (44%). Methodological quality scores, assessed using the Modified Medical Education Research Study Quality Instrument (MMERSQI), ranged from 39.5 to 84.5, indicating varied rigor. CONCLUSION: VR, AR, and MR technologies show potential to enhance surgical precision, technical skills, and educational outcomes in neurosurgical training. However, standardization of methodologies and cost-effective solutions remain essential. Future research should focus on long-term clinical impact and integration of AI-driven training models.

Virtual Reality

Civil liability in oral & maxillofacial surgery: &#x391; systematic review.

Maxillofacial surgery is a surgical specialty with anatomical, functional, and aesthetic requirements, which makes it a field at increased risk of medical negligence and subsequent legal claims. The review was conducted in accordance with the PRISMA guidelines and used international medical and legal databases. Studies that analyzed court decisions, insurance claims, or recorded compensation data related to maxillofacial surgery were included. The extracted data included, among others, the year and country of publication, the causes of action, and the amounts of financial compensation. Most lawsuits originate from countries with developed medical liability systems, primarily the United States and the United Kingdom, and there has been an increasing trend in publications over the last two decades. The most common causes of lawsuits involve nerve injuries, delayed or incorrect diagnoses, technical errors during surgery, and inadequate informed consent. The amounts of compensation vary widely, from lower five-digit amounts in milder cases to particularly high amounts in cases of permanent functional or aesthetic damage, placing a significant overall financial burden on health systems. Medical negligence in maxillofacial surgery constitutes an important forensic and socioeconomic issue. Understanding the causes of lawsuits and their financial consequences can help improve clinical practice, inform patients, and prevent legal disputes.

Humans

Choice of Anesthesia in Microelectrode Recording-guided Deep Brain Stimulation Surgery for Parkinson's Disease (CHAMPION): A Noninferiority Randomized Controlled Trial.

BACKGROUND: Deep brain stimulation for Parkinson's disease is often performed under conscious sedation or general anesthesia. However, anesthetic agents may influence intraoperative microelectrode recording, and the optimal anesthesia method for microelectrode recording remains unclear. This study compared general anesthesia and conscious sedation in preserving microelectrode recording signal intensity during deep brain stimulation. METHODS: In this prospective, noninferiority randomized controlled trial, patients with Parkinson's disease (United Kingdom Brain Bank criteria) undergoing elective bilateral surgery were randomized 1:1 to the conscious sedation or the general anesthesia group. During surgery, a desflurane anesthetic titrated against the quality of the electrophysiologic signal was applied in the general anesthesia group, whereas patients in the conscious sedation group received dexmedetomidine anesthesia. The primary outcome was the proportion of patients with high-quality microelectrode recording (normalized root mean square greater than 2.0), assessed postoperatively off-line. Secondary outcomes included operation and recording duration, 6-month clinical efficacy, and complication rates. RESULTS: Of 188 randomized patients (94 general anesthesia, 93 conscious sedation), desflurane anesthesia was noninferior for high normalized root mean square proportion (89.4% vs . 90.3%; difference, -0.96%; 95% CI, -9.62 to 7.70). The general anesthesia group had shorter operative time (difference, -9.07&#x2009;min; 95% CI, -13.99 to -4.14; P < 0.001). At 6 months, changes in Unified Parkinson's Disease Rating Scale score (difference, -2.50; 95% CI, -7.20 to 2.20; P = 0.297), levodopa equivalent daily dose (difference, -58.4&#x2009;mg; 95% CI, -133.56 to 16.75; P = 0.128), and complication rates (general anesthesia: 10.9% vs . conscious sedation: 8.9%; P = 0.655) were comparable between the groups. CONCLUSIONS: General anesthesia is noninferior to conscious sedation for microelectrode-guided subthalamic nucleus deep brain stimulation, providing equivalent signal intensity and clinical outcomes while improving procedural efficiency, supporting its use as a valid clinical option.

Humans

High-flow nasal cannula oxygenation in sedated endoscopy for high-risk obstructive sleep apnea patients: study protocol for a multicentre randomised controlled trial.

BACKGROUND: Hypoxemia is the most common adverse event during sedated gastrointestinal endoscopy. Patients with high obstructive sleep apnea (OSA) risk (STOP-Bang &#x2265;5) are susceptible due to sedation-induced loss of upper airway tone exacerbating airway collapsibility. Although high-flow nasal cannula (HFNC) benefits general at-risk populations, its efficacy in this specific cohort remains uncertain, as its mild positive pressure falls far below therapeutic continuous positive airway pressure levels for moderate-to-severe OSA, questioning its ability to stent the collapsible airway. Our prior proof-of-concept study in this cohort observed a 5% incidence of hypoxemia with HFNC, confirming feasibility and safety and justifying this confirmatory trial. METHODS: This prospective, multicenter, randomized controlled single-blind trial will enroll 600 adults (STOP-Bang score &#x2265;5) undergoing elective sedated gastroenteroscopy across three centers. Participants will be 1:1 randomized (stratified by center) to HFNC (30&#x2009;L/min pre-oxygenation, 60&#x2009;L/min post-induction) or conventional nasal cannula (6&#x2009;L/min). Both groups receive standardized propofol-alfentanil sedation. The primary outcome is the proportion of patients with at least one episode of hypoxemia (SpO2 75%-90% <60&#x2009;s). Secondary outcomes include the proportion of patients with at least one episode of severe hypoxemia (SpO2 <75% or 75%&#x2264;SpO2<90% &#x2265;60&#x2009;s), the proportion with subclinical respiratory depression (90%&#x2264;SpO2<95%), and the frequency of other adverse events. DISCUSSION: This trial will provide definitive evidence on HFNC's efficacy in high-risk OSA patients, addressing whether it can overcome pressure limitations to prevent hypoxemia. Results are expected to inform sedation management guidelines, establish a new standard of care for this subgroup, and enhance procedural safety. TRIAL REGISTRATION: The trial was registered at the ClinicalTrials.gov on 14 December 2025 (NCT07307560).

Humans

Autologous Fibrin Glue in Pterygium Surgery as an Alternative to Commercial Fibrin Glue.

PURPOSE: The aim of this study was to evaluate the efficacy and safety of autologous fibrin glue in pterygium surgery, comparing it with commercial fibrin glue in terms of postoperative complications, graft stability, and recurrence rate. METHODS: A prospective, randomized, double-blind study was conducted, involving 42 patients with primary pterygium who underwent autologous conjunctival-limbal transplantation. The graft was fixed using autologous fibrin glue (Group 1, G1) or commercial fibrin glue (Group 2, G2). All patients underwent surgery performed by the same surgeon and were reevaluated on postoperative days 7, 30, 90, and 180 by an independent observer, assessing clinical parameters in the preoperative, intraoperative, and postoperative periods. RESULTS: No cases of severe adverse events were reported. Complete graft dehiscence occurred in 1 patient from G1. The G2 group had more cases of subconjunctival hemorrhage ( P = 0.0355). Pyogenic granuloma was observed in 1 patient from G2 and 2 patients from G1. There was no significant difference in recurrence rates between the groups (15% in G1 vs. 5% in G2; P = 0.2918). In both groups, graft dimensions tended to decrease slightly in the early postoperative period, followed by stabilization. CONCLUSIONS: Autologous fibrin glue demonstrated efficacy and safety comparable to commercial fibrin glue, making it a viable alternative to conjunctival graft fixation in primary pterygium surgery.

Humans

Evaluation of intravenous sedation in dental implant surgeries: A prospective cohort study.

PURPOSE: This study aimed to evaluate the impact of intravenous sedation on patient-centered outcomes during implant and bone augmentation surgeries. METHOD: A prospective observational cohort study included 40 patients undergoing placement of &#x2265;3 implants, with or without bone augmentation. Patients underwent surgery under either intravenous sedation (n = 20) or local anesthesia alone (n = 20), according to routine clinical decision-making and patient preference. The sedation group received intravenous sedation with a multimodal regimen comprising remimazolam, dexmedetomidine, alfentanil, and low-dose esketamine, whereas the control group received local anesthesia only. Patient-reported outcome measures, hemodynamic parameters (SBP, DBP, HR, SpO2), postoperative pain (0-10 scale), and OHRQoL (OHIP-14) were recorded from baseline through 7 days post-surgery. RESULTS: Intravenous sedation was associated with significantly lower intraoperative pain (0.5 [IQR: 0&#x223c;2.75] vs. 3.25 &#xb1; 2.40, p = 0.003), anxiety (1 [IQR: 0&#x223c;2.75] vs. 4 [IQR: 3&#x223c;6], p = 0.001), and experienced discomfort (2 [IQR: 1&#x223c;3.75] vs. 4.15 &#xb1; 2.16, p = 0.016), and shortened perceived treatment duration (2.90 &#xb1; 2.34 vs. 5 [IQR: 4&#x223c;5], p = 0.020). Early postoperative pain was lower in the sedation group from Days 1-4 (p = 0.003-0.010). Hemodynamic parameters were more stable under sedation, with lower SBP (116.42 &#xb1; 13.32 vs. 144.11 &#xb1; 17.42 mmHg, p < 0.001), DBP (73.21 &#xb1; 10.28 vs. 82.37 &#xb1; 11.03 mmHg, p = 0.012), and HR (71.00 [IQR: 62.50&#x223c;79.25] vs. 85.00 &#xb1; 10.72 bpm, p = 0.021). OHRQoL scores favored the sedation group in swallowing, diet, malaise, and daily activities, particularly during the first three postoperative days (p=0.006-0.040). CONCLUSION: Intravenous sedation may enhance the patient experience during implant and/or bone augmentation procedures by reducing intraoperative pain and anxiety, improving hemodynamic stability, and promoting better early-postoperative recovery and OHRQoL. These findings suggest that intravenous sedation provides a safe and effective alternative for implant dentistry surgery, particularly for anxious or pain-sensitive individuals.

Humans

Factors associated with successful integration of pharmacists into residential aged care teams: A qualitative study.

BACKGROUND: Australia's Aged Care Onsite Pharmacist program aims to support quality use of medicines in residential aged care homes. This is a novel role introduced into existing teams in a complex environment. Factors associated with successful integration since implementation are currently unknown. AIM: This study aims to explore the perspectives of pharmacists and other stakeholders within aged care homes regarding successful integration of the novel aged care pharmacist service into healthcare teams. METHODS: A qualitative approach, using interpretive descriptive methodology, was used to explore perspectives. Semi-structured focus groups and interviews with pharmacists, nursing and care staff, allied health professionals, general practitioners, residents, and family members were undertaken. Data were collected via Zoom&#x2122;, audio- and video-recorded, and transcribed verbatim. Two researchers undertook inductive thematic analysis to identify key themes. RESULTS: 30 participants across focus groups, focus-group interviews, interviews, and member-checking processes contributed. An overarching theme of proactivity and showing a genuine interest in others underpinned three key themes. Theme 1: Pharmacists needed to be seen, through physical presence and availability, as well as developing a distinct identity. Theme 2: Pharmacists needed to build trust, through collaboration in real time and demonstrating value. Theme 3: Pharmacists needed to develop an understanding of the aged care home environment, including social and contextual norms, as well as procedures, routines and roles. DISCUSSION: This research complements existing understandings of interprofessional collaboration and teamwork amongst healthcare professionals. Themes were interlinked; we used a sensitising framework, social cognitive theory, to present and explain the findings and interactions that can support pharmacist integration into existing teams. Aged care services should structure onboarding to prioritise early visibility, clarify roles and organisational needs, and foster in-person collaboration. Pharmacists should demonstrate proactivity and an authentic interest in all staff, residents and families.

Humans

Comparative efficacy of percutaneous vertebroplasty combined with minimally invasive pedicle screw fixation versus percutaneous vertebroplasty alone in the treatment of elderly osteoporotic vertebral compression fractures.

The study aimed to assess the comparative efficacy of percutaneous vertebroplasty (PVP) combined with minimally invasive pedicle screw fixation versus PVP alone in elderly patients with osteoporotic vertebral compression fractures (OVCF). Ninety-four elderly patients with OVCF were randomly classified into the control (47 patients) and combined (47 patients) groups. The control group received PVP, while the combined group received PVP combined with minimally invasive pedicle screw fixation. Perioperative indicators such as intraoperative blood lose, operative time, and hospitalization time were recorded. Pain was assessed using the VAS before and at baseline and 1, 3, and 7 days postoperatively. At 1 and 3 days postoperatively, Serum CRP levels, WBC, and neutrophil counts were measured postoperatively. Radiographic outcomes (vertebral height ratio and Cobb angle), ADL scores, JOA scores, and ODI were evaluated preoperatively and at 3 months post-operation. Postoperative complications were documented. Baseline characteristics were comparable. The combined group showed superior pain relief, vertebral height restoration, Cobb angle correction, functional recovery, and reduced inflammatory markers (CRP, WBC, neutrophils) postoperatively (all P&#x2009;<&#x2009;0.05). Blood loss and hospital stay were shorter in the combined group, though operative time was longer (P&#x2009;<&#x2009;0.05). Complication rates did not differ significantly (P&#x2009;>&#x2009;0.05). PVP combined with minimally invasive pedicle screw fixation yields better outcomes in elderly OVCF patients by enhancing pain control, vertebral height, and functional recovery without increasing perioperative risk.

Humans

A randomized study of antibiotic prophylaxis after hypospadias repair in children.

BACKGROUND AND OBJECTIVE: Antibiotic resistance is a challenge in contemporary world. Urethroplasty for hypospadias is one of the most common urological surgeries performed around the world, yet, there is still no consensus on the use of antibiotics pre- and post-operatively. Our objective was to analyze the effectiveness of antibiotic prophylaxis and therapy before, during, and after hypospadias repair in children. METHODS: A prospective randomized trial was carried out including patients with coronal hypospadias who underwent urethroplasty performed by one surgeon. Urethral catheters were used in all cases for 10 days. Study participants were randomly assigned in a 1:1:1 ratio to receive a single intraoperative administration of antibiotics (Group I); an intraoperative antibiotic prophylaxis and antibiotic therapy for 10 days until the removal of urethral catheter (Group II); no antibiotic administration (Group III). Randomization was performed using computer-generated permuted blocks with randomly varying block sizes, prepared by an independent statistician. The results were analyzed using the analysis of variance (ANOVA). The following criteria were compared: postoperative functional complications, such as: urethral fistula, stenosis, diverticulum; wound infection symptoms: hyperemia of surgical site, pain during palpation, and symptomatic urinary tract infection. RESULTS: A total of 300 patients were included in the study. Two patients (2%) in Group I, two patients (2%) in Group II, and four patients (4%) in Group III had urethral fistulas, requiring surgery 6 months after primary repair, yet without statistical difference between groups. We found no significant difference in frequency of symptomatic UTIs between three groups (p = 0.182). CONCLUSION: There is no effect of antibiotic prophylaxis and therapy on the frequency of postoperative surgical and infectious complications after urethroplasty for coronal hypospadias repair in children.

Humans