Therapeutics and Clinical Risk Management最新文献

Purpose: Smooth removal of the tracheal tube post-laparoscopic surgery is crucial. Dexmedetomidine suppresses airway reflexes and mitigates stress responses. This study sought to assess the effect of dexmedetomidine nasal spray on extubation-related stress response and delayed extubation after laparoscopic surgery.

Patients and methods: This study involved 124 patients scheduled for laparoscopic surgery, who were randomly allocated to one of two groups: the dexmedetomidine nasal spray group (Group D, n=62) and the control group (Group C, n=62). 30 min before the end of the surgery, Group D was administered 100 μg of the dexmedetomidine nasal spray, while Group C was given an equivalent volume of normal saline nasal spray. Extubation events and extubation time were documented. Hemodynamic data, Ramsay sedation scale (RSS), NRS scores, postoperative nausea and vomiting (PONV), and total recovery time were evaluated during medication administration and the subsequent postoperative recovery period.

Results: The rate of smooth tracheal extubation was significantly higher in Group D than in Group C (93.5% vs 64.5%, p < 0.001). Extubation time was markedly reduced in Group D compared to Group C (p = 0.045). Hemodynamic characteristics were comparable across the two groups, but MAP was higher in Group C at 1 and 10 min after extubation (p < 0.05), and HR was higher at 1 and 3 min after extubation (p < 0.05). More favorable sedation was achieved in Group D at 30 min postoperatively (p = 0.025). No significant changes were observed in postoperative PO₂ and PCO₂, NRS pain score, and the incidence of PONV between the groups.

Conclusion: Dexmedetomidine nasal spray safely and effectively ameliorated extubation-related stress response following laparoscopic surgery, resulting in smoother extubation. Furthermore, it facilitated the maintenance of hemodynamic stability, shortened extubation time, and provided better postoperative sedation.

Objective: This study aimed to analyze the regions and extent of modifications made to the final mandibular complete denture model designed using the bio-functional prosthetic system (BPS), compared to the initial model, utilizing digital scanning technology.

Methods: Twenty individuals with edentulism requiring mandibular restoration using BPS were included in the study. Digital scans of the initial and final gypsum models of the edentulous mandible were obtained. The models were aligned, registered, and analyzed for modification zones using Geomagic Warp software.

Results: Statistically significant differences were observed in three specific regions: the posterior fossa of the mylohyoid, the submandibular gland region, and the labial vestibule (p < 0.05). In contrast, differences in the posterior molar pad area were minimal (p > 0.05). Overall, the final model exhibited significant deviations from the initial model (p < 0.05), with the greatest variation observed in the posterior fossa of the mylohyoid and the least variation in the posterior molar pad area.

Conclusion: The final mandibular complete denture model, constructed using BPS, demonstrates improved accuracy in representing mucosal movement, shape, and positioning under occlusal pressure compared to the initial model. The posterior fossa of the mylohyoid, submandibular gland region, and labial vestibule exhibited enhanced delineation of mucosal movement boundaries, contributing to a more precise functional representation.

Objective: To evaluate the incidence, characteristics, and risk factors of complications related to anesthesia complication in ASA Class III patients undergoing combined esophagogastroduodenoscopy (EGD) and colonoscopy under total intravenous anesthesia (TIVA).

Materials and methods: This prospective cohort study was conducted from April 1, 2024, to February 11, 2025. Data collected included baseline characteristics (age, sex, comorbidities, functional capacity, nutritional status, smoking, fasting and medications) and intraoperative/postoperative parameters (anesthetic technique, sedative dosing, IV fluids, complications, and 24-hour status). Descriptive statistics, univariate analysis, and binary logistic regression were applied.

Results: Of 403 ASA Class III patients enrolled, 393 were analyzed after excluding 10 for inadequate bowel prep or early termination due to malignancy. A total of 207 patients (52.7%) experienced at least one complication. Common complications included transient hypotension (40.2%), desaturation (15.8%), and airway obstruction (15.5%). Less frequent events were bradycardia (4.1%), hypoxia (1.8%), hypertension (1.8%), tachycardia (0.3%) and respiratory depression (0.5%). Five independent risk factors were significantly associated with complications: preexisting cardiovascular disease - odds ratio (OR=1.678), respiratory disease (OR=1.877), functional capacity < 4 metabolic equivalents (METs), (OR=1.851), nutritional screening score ≥1 (OR =1.518), and single - dose bowel prep regimen (OR=1.614). Complications were more common in women, patients aged 65 years or older, and inpatients, although the difference in hospitalization and outpatient was not statistically significant. Patients with complications received lower total doses of propofol and fentanyl per weight per hour. Dexmedetomidine use was significantly associated with complications among inpatients (p = 0.015). The duration of the procedure was longer in patients with complications (p = 0.002).

Conclusion: Anesthesia-related complications were frequent among ASA Class III patients who underwent combined EGD and colonoscopy under TIVA, particularly cardiovascular and respiratory events. Identification of five preprocedural risk factors supports the need for improved risk stratification and individualized sedation planning to optimize safety in this high-risk group.

Purpose: To describe the clinical outcomes, complications, and logistical challenges of pediatric living donor liver transplantation (LT) in Jordanian children referred abroad, in the absence of a national transplant program.

Patients and methods: This retrospective study reviewed all pediatric cases referred to the Jordanian Center for Organ Transplantation (JCOT) for LT between 2019 and 2023. Data were collected from JCOT records and follow-up interviews with caregivers. Variables included patient demographics, indications for transplantation, donor-recipient relationships, post-operative complications, survival outcomes, and financial aspects.

Results: A total of 31 children were referred for LT, of whom 20 (64.5%) successfully underwent living donor liver transplantation abroad-primarily in Turkey-while 11 (35.5%) remained on the waiting list. Biliary atresia (25%) was the most common indication, followed by Alagille syndrome and progressive familial intrahepatic cholestasis (each 20%). Primary hyperoxaluria, Crigler-Najjar syndrome, and maple syrup urine disease were also observed. Parents were the most frequent donors (70%). The most common complications were bile duct leakage (35%), portal vein thrombosis (20%), and infections (15%). The 5-year post-transplant survival rate was 90%. Among the waiting list group, four children (36.4%) died before receiving a transplant. No children underwent transplantation for pediatric acute liver failure during the study period. The average cost per transplant covered by the Ministry of Health was $61,071, excluding out-of-pocket expenses borne by families.

Conclusion: This study highlights the feasibility and challenges of transborder pediatric liver transplantation in Jordan. While clinical outcomes for transplanted children were favorable, significant barriers remain, including delayed referrals, financial strain, and mortality among waitlisted patients. These findings underscore the urgent need to establish a national pediatric liver transplant program to improve timely access and long-term care for children with end-stage liver disease in Jordan.

Background: Distal tibial defects following refractory osteomyelitis pose a significant orthopedic challenge, necessitating effective reconstruction. The Ilizarov bone transport technique is a potential treatment option, but its clinical outcomes specifically for distal tibial infectious defects need further evaluation.

Methods: In this retrospective observational single-arm study, we analyzed the clinical data of 22 patients who had undergone multiple debridements for refractory distal tibial osteomyelitis (DTO) and had associated bone defects, and were subsequently treated with the Ilizarov bone transport technique. Following debridement surgery, bone transport treatment was administered. Regular X-ray examinations, rehabilitation guidance, and follow-up were conducted to assess infection control, bone healing, limb function recovery, and complications. Therapeutic effects were evaluated using the Association for the Study and Application of Methods of Ilizarov (ASAMI), Visual Analog Scale (VAS) score, Activities of Daily Living (ADL) score, and American Orthopaedic Foot & Ankle Society (AOFAS) score improvement.

Results: The mean follow-up was 29.32±20.92 months, with an average of 3.77±1.83 debridements. All bone defects healed, though 5 patients later required ankle arthrodesis. Complications included pin tract infection (n=10), axial deviation (n=3), ankle joint stiffness (n=2), non-union at the docking site (n=2), and delayed consolidation (n=2). At the last follow-up, ASAMI bone results: 15 excellent, 5 good, 2 poor (90.9% superiority rate). ASAMI functional results: 6 excellent, 14 good, 1 fair, 1 poor (90.9% superiority rate). VAS decreased from 4.86±0.83 to 0.5±0.66 (p<0.001). ADL improved from 80 (78.75-85) to 92.5 (90-95) (p<0.001). AOFAS score increased from 32 (25-38.25) to 82 (77-87.5) (p<0.001), with an 86.4% overall superiority rate.

Conclusion: Bone transport post - debridement is a valuable salvage for reconstructing distal tibial defects post-refractory osteomyelitis, with high safety, healing rate, and good efficacy. However, further comparative studies are warranted to confirm its advantages over other treatments.

Background: Ruyi Zhenbao Pills (RZPs) and Baimai Ointment (BMO), prescribed Tibetan formulations, have been confirmed as having a neuroprotective role in animal and cell models of stroke. However, the effects of RZPs and BMO in individuals with acute ischemic stroke (AIS) remain unclear. This is the first multicenter, large-sample, controlled trial to evaluate the therapeutic potential of traditional Tibetan medicine-specifically the RZP and BMO-in the treatment of AIS, thereby extending ethno-pharmacological evidence into modern stroke care.

Methods: A multi-arm, randomized, double-blind, placebo controlled clinical trial was conducted at 21 hospitals in China between December 2020 and September 2022. The inclusion criteria are as follows: individuals diagnosed as AIS, 18 to 75 years of age and within 14 days of AIS onset. Subjects were randomly assigned in a 1:1:1:1 ratio to RZPs+BMO, RZPs, BMO, or placebo. The primary outcome was change of Fugl-Meyer assessment (FMA) score from baseline to day 90.

Results: Four hundred and twenty-three participants were recruited and randomly allocated to the RZPs+BMO group (n=108), RZPs group (n=108), BMO group (n=99), or placebo group (n=108). The change from baseline to D90 in FMA score was 31.22 (SD 16.64) with RZPs+BMO, 29.25 (15.92) with RZPs, 29.88 (15.42) with BMO, and 19.20 (14.38) with placebo (RZPs+BMO group versus placebo group, P< 0.001).

Conclusion: Among Chinese patients suffering from AIS, combined RZPs and BMO therapy improved significantly the primary outcome of 90-day motor functions compared with placebo with acceptable safety, indicating that RZPs and BMO might be an effective therapeutic strategy in patients with AIS.

Purpose: Evidence that left bundle branch area pacing (LBBAP) is more effective than conventional right ventricular (RV) pacing in enhancing left atrial (LA) outcomes is lacking. The aim of this study was to investigate LA outcomes using 2-dimensional speckle tracking echocardiography (2D-STE) and real-time 3-dimensional echocardiography (RT-3DE) at 6-months of follow-up in patients that received LBBAP, RV septal pacing (RVSP), or RV apical pacing (RVAP).

Methods: A total of 90 patients with normal left ventricular ejection fraction (LVEF) underwent dual-chamber pacemaker implantation for bradycardia at Beijing Anzhen Hospital between January 2021 and July 2021. Patients were divided into three groups based on the pacing site: LBBAP, RVSP, or RVAP.

Results: There were no significant differences in baseline characteristics and echocardiographic findings among patients that received LBBAP, RVSP, or RVAP. At 6-months of follow-up, left atrial volume index (LAVI), LA reservoir strain (LASr), LA contractile strain (LASct), global longitudinal strain (GLS), global circumferential strain (GCS), and synchronization parameters (Tmsv-16SD, Tmsv-12SD, Tmsv-6SD, longitudinal Tε-dif, circumferential Tε-dif) were significantly improved in patients that received LBBAP, while they had significantly worsened with RVSP and RVAP. Compared to baseline, at 6-months of follow-up, patients that received LBBAP had significantly improved LASr (28.17±10.12% vs 35.4±17.17%, P=0.024), LASct (-12.03±2.15% vs -17.53±7.37%, P=0.045), E/e' ratio(12.61±3.8 vs 10.85±3.75,P=0.014) and LVEF (65.74±7.90% vs 68.81±5.92%, P=0.023). The 6-minute walking distance significantly increased at 6-months of follow-up compared to baseline in all patients, but the increase was most prominent for LBBAP (403.00±98.46 m vs. 469.34±59.32m, P=0.015). LBBAP was associated with a lower risk of new-onset atrial fibrillation.

Conclusion: In pacemaker-dependent patients, LBBAP achieved better LA strain, LV strain, and LV synchronization than RVSP or RVAP at 6-months of follow-up.

Objective: Emerging evidence suggests that low doses of sulfamethoxazole-trimethoprim (TMP-SMX) may offer protection against Pneumocystis jiroveci pneumonia (PJP) in kidney transplant recipients. However, cases of PJP following the withdrawal of prophylaxis have been documented. This study aimed to investigate the relationship between the occurrence of PJP and different regimes of low-dose TMP-SMX prophylaxis.

Methods: This retrospective observational study was conducted in the First Affiliated Hospital of Zhejiang University in China. Recipients diagnosed with PJP were included, and four controls were matched for each case based on transplantation time, age, and sex. Multivariate conditional logistic regression was employed to compare the odds of PJP occurrence among different TMP-SMX regimens.

Results: From January 1, 2017, to December 31, 2020, 1763 patients underwent kidney transplantation at our center. Thirty-one patients developed PJP post-transplantation, and 124 patients without PJP were included as controls. One patient developed PJP during the prophylaxis period, and the others occurred after TMP-SMX discontinuation, resulting in a PJP incidence rate of 1.36% over the follow-up period. Compared to controls, the PJP group received a significantly lower cumulative TMP-SMX dose (median: 57 single-strength dose [SSD] tablets vs 100 tablets; p = 0.001) and had a shorter prophylaxis duration (median: 6.00 months vs 10.00 months; p = 0.004). They also exhibited higher CMV infection rates (29.0% vs 4.8%, p < 0.001), elevated serum creatinine levels at discharge (174.80μmol/L vs 134.58 μmol/L, p = 0.018), and reduced CD 4⁺ cell counts (354.12/L vs 542.58/L, p = 0.05). Multivariate analysis revealed that a higher cumulative TMP-SMX dose was significantly associated with a lower risk of PJP (p = 0.005). Subgroup analysis indicated that at least 6 months of TMP-SMX prophylaxis is necessary for PJP prevention in recipients on quarter-strength daily (SMX/TMP 100/20 mg, p = 0.022) or half-single strength daily (SMX/TMP 200/40 to 400/80 mg, p = 0.005) regimens.

Conclusion: An adequate prophylactic duration of either quarter-strength daily TMP-SMX or half-single strength daily TMP-SMX may protect kidney transplant recipients from PJP.

Background: Acute ischemic stroke (AIS) requires rapid treatment. Although alteplase is a standard thrombolytic therapy, its limited availability in low-resource settings presents a challenge. Lumbrokinase, a fibrinolytic enzyme isolated from earthworms, has been proposed as an adjunct treatment option. This meta-analysis evaluated efficacy and safety in addition to supportive care.

Methods: A systematic review of randomized controlled trials (RCTs) was conducted using multiple databases through July 2024 following PRISMA guidelines. The risk of bias was assessed using RoB 2.0, and evidence quality was graded using GRADE. Publication bias was evaluated using funnel plots. Meta-analyses employed a random-effects model and reported odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals. Primary outcomes included the Barthel Index and NIHSS scores, and secondary outcomes included adverse events and laboratory results.

Results: A total of 35 RCTs published between 2010 and 2024 were included. Compared with supportive care alone, lumbrokinase adjunct therapy significantly improved Barthel Index scores (MD = 15.17; 95% CI: 14.60 to 15.74) and reduced NIHSS scores (MD = -2.01; 95% CI: -2.06 to -1.97). Safety analyses revealed no significant increase in adverse events including gastrointestinal discomfort (OR = 1.00; 95% CI: 0.32 to 3.16) and GI bleeding (OR = 1.42; 95% CI: 0.55 to 3.67). Laboratory assessments indicated improvements in aPTT (MD = 1.93; 95% CI: 1.58 to 2.28), platelet aggregation rate (MD = -205.86; 95% CI, -206.77 to -204.96), and D-dimer levels (MD = -0.04; 95% CI: -0.05 to -0.03).

Conclusion: Lumbrokinase may safely improve stroke outcomes; however, limited evidence warrants cautious use and further high-quality trials.