Therapeutics and Clinical Risk Management最新文献

Digital therapeutics (DTx) are an emerging medical therapy comprising evidence-based interventions that are regulatory approved for patient use, or are under development, for a variety of medical conditions, including hypertension, cancer, substance use disorders and mental disorders. DTx have significant potential to reduce the overall burden on healthcare systems and offer potential economic benefits. There is currently no specific legal regulation on DTx in the EU. Although European countries have similar approaches to digital health solutions, the adoption of DTx varies across the continent. The aim of this narrative review is to discuss the levels of adoption of DTx in Europe, and to explore possible strategies to improve adoption, with the goal of higher rates of adoption, and more consistent use of DTx across the continent. The article discusses the regulatory and reimbursement landscape across Europe; validation requirements for DTx, and the importance of co-design and an ecosystem-centric approach in the development of DTx. Also considered are drivers of adoption and prescription practices for DTx, as well as patient perspectives on these therapeutics. The article explores potential factors that may contribute to low rates of DTx adoption in Europe, including lack of harmonisation in regulatory requirements and reimbursement; sociodemographic factors; health status; ethical concerns; challenges surrounding the use and validation of AI; knowledge and awareness among healthcare professionals (HCPs) and patients, and data standards and interoperability. Efforts to improve rates of access to DTx and adoption of these therapeutics across Europe are described. Finally, a framework for improved uptake of DTx in Europe is proposed.

Study design: A Retrospective study.

Objective: Digital necrosis (DN) after replantation can cause some serious complication. Few articles focused on the risk factors of DN; therefore, we aim to investigate the risk factors of necrosis after multiple digital replantation.

Methods: We collected the data of patients receiving multiple digital replantation in our hospital between Jan. 2017 and Jan. 2024. Based on the necrosis or not after replantation, patients with DN were as necrosis group (NG), and patients without DN were as success group (SG). The demographics, comorbidities, and admission laboratory examinations of patients were computed by univariate analysis, logistic regression analysis, and receiver operating characteristic (ROC) curve analysis. We then construct a nomogram prediction model, plot ROC curves, calibration curves, and DCA decision curves using R language software.

Results: The survival rate in our study was 83.7% (278 of 332). Univariate analysis indicated that there were significant differences in the level of D-dimer, white blood cell, neutrophil, monocyte, monocyte-to-lymphocyte ratio, systemic immune-inflammation index, system inflammation response index, C-reactive protein (CRP), neutrophils/high density lipoprotein (HDL), monocytes/HDL were significantly higher in NG than in SG. However, logistic regression analysis showed that D-dimer and CRP were independent risk factors of DN, and we identified their cut-off values. Then, we constructed a nomogram prediction model with 0.7538 in AUC of the prediction model with good consistency in the correction curve and good clinical practicality by decision curve analysis.

Conclusion: The level of D-dimer and CRP was found to be closely related to DN. We constructed a nomogram prediction model that can effectively predict DN in patients with multiple digital replantation.

Purpose: To evaluate the efficacy and safety of intravenous tranexamic acid (TXA) in patients undergoing percutaneous kyphoplasty (PKP), and identify the factors influencing hidden blood loss (HBL).

Methods: This randomized, placebo-controlled trial included 146 patients undergoing PKP surgery from September 2023 to July 2024. Patients were randomly assigned into the TXA group (75 patients received 1.0 g/100mL TXA intravenously) and the placebo group (71 patients received 100mL of normal saline intravenously). Demographic and clinical characteristics were comparable between groups. HBL was calculated and compared on postoperative days 1 (POD1) and 3 (POD3). Visual analog scale (VAS) scores were also recorded preoperatively and during the follow-up. Multivariate logical regression analysis identified independent risk factors for HBL.

Results: The HBL in the TXA group was 183.78±115.48mL on POD 1 and 240.65±114.73mL on POD 3, which was significantly lower than the placebo group at 251.30±235.58mL on POD1 (P=0.032) and 384.94±223.18mL on POD3 (P<0.001). The drop in hemoglobin in the TXA group was generally lower than that of the placebo group on POD1 (4.72±3.54 vs 7.62±8.38 g/L, P=0.007), but showed no significant difference on POD 3. The drop in hematocrit in the TXA group was significantly lower than that in the placebo group on POD1 (1.91±1.21% vs 2.65±2.42%, P=0.023) and POD3 (2.49±1.23% vs 3.92±2.09%, P<0.001). Additionally, the VAS scores on POD1 (2.28±0.88 vs 2.82±0.98, P<0.001) and POD3 (1.95±0.75 vs 2.25±0.69, P=0.011) were lower in the TXA group than in the placebo group. Multivariate logical regression analysis revealed that the use of TXA (P<0.001), injury time (P<0.001), number of punctures (P=0.004), cement leakage (P=0.001), and restoration of vertebral height (P=0.002) were significantly correlated with HBL.

Conclusion: A single of 1g dose of intravenous TXA reduces HBL and early postoperative pain in PKP patients without increasing the complication rate. The use of TXA, injury time, number of punctures, cement leakage, and restoration of vertebral height were risk factors for HBL in PKP surgery. (ChiCTR2300075428).

Background: Recognizing factors that predict non-operative management (NOM) failure for patients with small bowel obstruction (SBO) aids in limiting surgical intervention when needed. This study investigated the predictive factors for NOM failure in SBO patients in a resource-limited setting.

Material and method: A retrospective study included 165 patients who were diagnosed with SBO and were admitted and managed at Althora General Hospital, IBB, Yemen, from April 2022 to March 2024. Patients' baseline characteristics and profiles along with factors associated with failure of NOM were investigated and analyzed with univariate and multivariate analysis.

Results: 51 (30.4%) of included cohorts were managed non-operatively. The mean age was 47.7±16.9 years, and males were disproportionally presented (62.7%). The majority of patients presented with abdominal pain (96.1%). Failure of NOM was seen in 18 (35.3%) patients and intra-operative findings were adhesive bands, volvulus, intussusception, and mesenteric ischemia in 7 (38.9%), 5 (27.8%), 4 (22.2%), and 2 (11.1%) patients, respectively. Bowel resection was performed in 11 (61.1%), and 4 of them needed a colostomy diversion. Postoperative complications occurred in 13 (25.5%) patients, including fever, paralytic ileus, surgical site infection, and reoperation in 13 (25.5%), 5 (9.8%), 4 (7.8%), and 2 (3.9%) patients, respectively. Sixteen patients were discharged, and two patients died due to mesenteric ischemia. Among NOM successful patients, recurrence has occurred in 8 patients. In multivariate analysis, poor bowel wall enhancement (OR: 8.59; 95% CI: 1.14-64.59, p=0.037) and high level of obstruction (OR: 11.64; 95% CI: 1.34-100.85, p=0.026) in computed tomography (CT) scan were independently associated with NOM failure.

Conclusion: Poor bowel wall enhancement and significant obstruction on CT images are critical indicators for selecting SBO patients requiring urgent surgery. However, evaluating the advantages of surgical intervention versus NOM demands a comprehensive analysis of surgical risks, comorbidities, and the presence of bowel strangulation or ischemia.

Background: Evaluating risk factors for bleeding events in robot-assisted partial nephrectomy (RAPN) for renal angiomyolipoma (RAML) is essential for improving surgical outcomes.

Methods: We performed a retrospective analysis of patients who underwent RAPN for renal masses between May 2019 and June 2023 at a single medical center, categorizing them into AML and non-AML groups. We assessed demographic data, perioperative complications, and postoperative outcomes. Preoperative imaging was reviewed to calculate R.E.N.A.L and PADUA nephrometry scores. Receiver operating characteristic (ROC) curve analysis was used to evaluate the accuracy of risk factors related to estimated blood loss (EBL) and blood transfusion.

Results: Among 255 patients, 71 (27.8%) had AML, and 184 (72.2%) had non-AML. The average age was 54.5 years, with 80.2% of the AML group being female. The median tumor size was 50.2 mm. The AML group had larger tumor diameters (50.2 mm vs 34.9 mm) but shallower depths (16.1 mm vs 21.7 mm). Median R.E.N.A.L and PADUA scores were 6.5 and 8.2, respectively, with a median EBL of 128.2 mL. Blood transfusion was required in 15.5% of cases. Tumor diameter, depth, R.E.N.A.L score, and PADUA score significantly correlated with EBL, while BMI, tumor diameter, and R.E.N.A.L score correlated with blood transfusion. The AUCs for predicting EBL and blood transfusion were 0.778 and 0.771 for tumor diameter, and 0.661 and 0.711 for R.E.N.A.L score.

Conclusion: RAPN might be a safe option for RAML, with tumor diameter being the most accurate predictor of EBL and blood transfusion. These findings can improve preoperative assessments and surgical planning.

Objective: This study aims to summarize the clinical characteristics of skull base osteoradionecrosis (ORN) with the internal carotid artery (ICA) involvement and to distill the key surgical techniques that can enhance the protective measures for ICA.

Methods: We conducted a retrospective, observational study over a six-year period from February 2017 to May 2023. We included patients who were diagnosed with osteoradionecrosis with invasion of the internal carotid artery and collected their demographic information, pathology results, complication rates, ect. The goal was the alleviated rate after the surgery and the anatomic consideration during the surgery. We compared the verbal rating score (VRS) of headache pre- and post-operation by the Wilcoxon rank-sum test.

Results: A retrospective analysis was conducted on 19 patients diagnosed with ORN, with a mean age of 53.73 yr (range, 32-68 yr). Among them, 17 patients (89.47%) were nasopharyngeal carcinoma (NPC), 1 patient (5.23%) was squamous cell carcinoma of the sphenoid sinus, and 1 patient (5.23%) had adenoid cystic carcinoma. After the surgery, 1 fatality occurred within 2 months, which was attributed to a severe parapharyngeal space infection.1 patient succumbed to ICA rupture two days post-operation. Additionally, 1 patient experienced ORN recurrence 2 years after the initial surgery. The mean follow-up period for the study was 37.47 mo (range 2 -77 mo). The alleviation rate was 89.4%. The results revealed a significant decrease in VRS after the surgery (Z=-3.921, P=0.000). Finally, we summarized clinical evidences of ICA involvement, such as the formation of pseudoaneurysm.

Conclusion: A four-quadrant division of SBORN as a standardized and systematic approach is meaningful to guide surgical intervention for osteoradionecrosis. There are relevant clinical and imaging evidences that can predict the rupture of ICA.

Background: Low cardiac output syndrome (LCOS) after pericardiectomy is associated with high morbidity and mortality. This study aimed to assess the effect of levosimendan on postoperative LCOS in the patients with constrictive pericarditis.

Methods: Patients were retrospectively enrolled, and those receiving the treatment of levosimendan were assigned in the LEVO (+) group, and others were in the LEVO (-) group. Postoperative outcomes including durations of intubation, vasoactive agents using, ICU stay, hospital stay and mortality were compared between the two groups.

Results: A total of 32 patients were eligible for analysis, 19 of whom were in the LEVO (+) group, and 13 of whom were in the LEVO (-) group. The LEVO (+) group was associated with shorter postoperative duration of intubation (P < 0.001), vasopressor using (P = 0.006), ICU stay (P = 0.001) and hospital stay (P = 0.042), and less incidence of acute liver or kidney injury (P = 0.046). There were no significant differences in 30-day mortality and 1-year mortality between the LEVO (+) group and the LEVO (-) group. The prevalence of adverse events in the LEVO (+) group was acceptable.

Conclusion: Levosimendan could be administered in the patients with constrictive pericarditis developing LCOS after pericardiectomy to enhanced postoperative recovery.

Purpose: We conducted a prospective, real-world study to evaluate the efficacy and safety of balanced propofol sedation (BPS) in bronchoscopy and identify an advantageous sedation regimen for such procedures.

Patients and methods: The participants were placed in four groups based on their sedation regimen (exposure factor): the M-S group (midazolam + sufentanil for traditional sedation), R-S group (remimazolam + sufentanil for traditional sedation), M-S-P group (midazolam + sufentanil + propofol for BPS), and R-S-P group (remimazolam + sufentanil + propofol for BPS). The primary outcomes included satisfaction metrics (satisfaction of the patients, endoscopic physicians, and nurses) and follow-up questionnaires. The secondary outcomes included time metrics (induction time, recovery time, and discharge time), dosage metrics (induction dose, maintenance dose, and total dose of each sedative), completion rate of sedation, intraprocedural dose, and frequency of lidocaine spray in the airway, and incidence of adverse reactions.

Results: In total, 418 subjects were included in this study. Compared to traditional sedation, both BPS groups significantly increased the satisfaction of patients, endoscopic physicians, and nurses (P < 0.05) and reduced the incidence of intraprocedural wakefulness (P < 0.05). Additionally, induction and recovery of the BPS group were rapid, with high sedation completion rates and no increase in the incidence of intraprocedural and postprocedural adverse reactions (P < 0.05). The RSP group was better than the MSP group in terms of various time metrics and postprocedural adverse reactions.

Conclusion: BPS can be safely and effectively applied during bronchoscopy, with remimazolam and sufentanil combined with a small dose of propofol being an optimal medication regimen.

Participants: This study enrolled 294 patients admitted to the Thyroid Surgery Department of the First Hospital of Shanxi Medical University between April and July 2024. Patients were randomly assigned to either the control group (145 patients) or the experimental group (149 patients).

Interventions: The control group received traditional adhesive tape fixation for drains, while the experimental group utilized a newly developed fixation patch combined with a unique "C" and "S" fixation method. Both groups employed vertical negative pressure drainage.

Specific objectives or hypotheses: The aim of this study was to assess the clinical effectiveness and patient satisfaction with a novel surgical drain fixation patch and method in the context of thyroid surgery. The hypothesis was that the novel fixation patch and method would reduce drain-related adverse events, improve patient comfort, and increase patient satisfaction.

Outcomes: The experimental group exhibited significantly lower rates of drain-related adverse events, including displacement, infection, and leakage, compared to the control group (3.40% vs 53.10%, P < 0.05). Additionally, patients in the experimental group reported lower neck/throat pain scores (mean score: 0.84 vs 1.40 in the control group, P < 0.05) and experienced no drain pulling pain (0% vs 1.16% in the control group, P < 0.05). Furthermore, the need for patch replacements was virtually eliminated in the experimental group (0% vs 70.86% in the control group, P < 0.05). Patient satisfaction with the fixation method was significantly higher in the experimental group (83.3% vs 46.9% in the control group, P < 0.05).

Randomization: Patients were randomly assigned to the control and experimental groups, ensuring the fairness and reliability of the study.

Trial registration: The study was retrospectively registered with the China Clinical Trial Registry (ChiCTR2400087677) on August 1, 2024.

Background: Myoclonus is a common problem during induction of anesthesia with etomidate. A variety of agents, including opioids and lidocaine, reduced the incidence of myoclonus. However, there is no reported literature evaluating the effect of esketamine pretreatment on etomidate-induced myoclonus. We investigated the influence of pretreatment with esketamine on the incidence of etomidate-induced myoclonus.

Methods: This is a prospective, double-blind, and randomized controlled trial. One hundred patients aged 18-65 scheduled for elective surgery under general anesthesia (including urology surgery, gynaecology surgery, general surgery, and thoracic surgery) were randomly allocated into two groups, each consisting of 50 patients. Esketamine was pretreated with 0.1 mg/kg 60 s before the initiation of etomidate in Group ESK, while normal saline was administered as the placebo (Group C). During the first 1 minute after etomidate administration, myoclonus incidence and severity were assessed. In addition, we measured the hemodynamic changes and side effects of esketamine before administering etomidate.

Results: In group ESK, 14 patients (28%) had myoclonus (degrees of myoclonus: mild 2, moderate 7, severe 5), and 32 patients (64%) in group C (mild 6, moderate 5, severe 21) (P< 0.001). In group ESK, myoclonus incidence and severity were significantly lower than in group C (P< 0.001).

Conclusion: Esketamine 0.1mg/kg IV pretreatment significantly reduce the incidence and the severity of severe myoclonus of etomidate-induced myoclonus without significant adverse effects.