Therapeutics and Clinical Risk Management最新文献

Background: The relationship between molecular phenotype and prognosis in high-grade gliomas (WHO III and IV, HGG) treated with radiotherapy and chemotherapy is not fully understood and needs further exploration.

Methods: The HGG patients following surgery and treatment with radiotherapy and chemotherapy. Univariate and multivariate Cox analyses were used to assess the independent prognostic factors. The nomogram model was established, and its accuracy was determined via the calibration plots.

Results: A total of 215 and 88 patients had grade III glioma and grade IV glioma, respectively. Grade III oligodendroglioma (OG-G3) patients had the longest mPFS and mOS than other grade III pathology, while grade III astrocytoma (AA-G3) patients were close to IDH-1 wildtype glioblastoma (GBM) and had a poor prognosis. The IDH-1 mutant group had a better mPFS and mOS than the IDH-1 wildtype group in all grade III patients, OG-G3 and AA-G3 patients. Furthermore, 1p/19q co-deletion group had a longer mPFS and mOS than 1p/19q non-deletion group in all grade III patients. IDH-1 mutation and 1p/19q co-deletion patients had the best prognosis than other molecular types. Also, the MGMT methylation and IDH-1 mutation or 1p/19q co-deletion group had a longer mPFS and mOS than the MGMT unmethylation and IDH-1 wildtype or 1p/19q non-codeletion of grade III patients. In addition, the low Ki-67 expression group had a better prognosis than high Ki-67 expression group in grade III patients. Univariate and multivariate COX showed that 1p/19q co-deletion and MGMT methylation were the independent prognostic factors for mPFS and mOS. The calibration curve showed that the established nomogram could well predict the survival based on these covariates.

Conclusion: The AA-G3 with IDH-1 wildtype, MGMT unmethylation or 1p/19q non-codeletion patients was resistant to radiotherapy and chemotherapy, has a poor prognosis and needs a more active treatment.

Background: The negative impacts of particulate matter with an aerodynamic diameter of 2.5 μm or less (PM_2.5) are well known. Patients undergoing maintenance hemodialysis (HD) have significantly higher blood cadmium levels (BCLs) than healthy individuals. As elemental cadmium can be found in the PM_2.5 particle fraction, we conducted this study to assess the effect of environmental PM_2.5 exposure and other clinical variables on BCLs in maintenance HD patients.

Patient and methods:  This cross-sectional study included 754 hD patients who had previously participated in a BCL study. Demographic, hematological, biochemical and dialysis-related data were collected for analysis. For each patient, the mean PM_2.5 concentrations in the living environment during the previous 12 and 24 months were recorded and analyzed.

Results: Of all patients, the median BCL of was 0.36 µg/L (range: 0.21, 0.79 µg/L). The mean PM_2.5 concentration was 28.45 ± 3.57 μg/m³ during the 12 months and 29.81 ± 3.47 μg/m³ during the 24 months, respectively. From a multivariate linear regression analysis, log BCL was positively associated with the mean PM_2.5 concentration during the previous 12 and 24 months. In addition, log BCL was positively associated with the number of days with PM_2.5 concentrations above the standard level during the previous 12 and 24 months. Moreover, according to the tertiles of days with a daily mean PM_2.5 concentration above the normal limit in the previous 24 months, patients with the highest exposure days exhibited a significantly higher BCL than those in the other two patient groups.

Conclusion: Chronic environmental exposure to PM_2.5 is significantly associated with BCLs in maintenance HD patients, and exposure to PM_2.5-bound cadmium may contribute to the harmful effects on health in this population. Further studies are needed to confirm these observations and to explore the underlying mechanisms.

Introduction and objectives: This study aimed to investigate the prevalence of recurrent and active epistaxis in adult patients presenting to the Emergency Department (ED) and explored the association of recurrent epistaxis with demographic characteristics, comorbidities and medications, and types of emergency interventions in adult epistaxis patients.

Methods: A retrospective cross-sectional study was conducted with data from Eds of two tertiary hospitals over three years, from January 2019 to January 2022. All adult patients aged ≥18 years with active epistaxis not resolved by pressure on the nose or head positioning were included. Demographic data, details of clinical presentation and clinical management were collected from the patient's electronic medical records.

Results: Of 404 patients, 73 (18.1%) revisited the ED with recurrence of epistaxis within 28 days. There was a male predilection in the study, with an average age of 55.4 ± 18.03. Most patients had unilateral (n = 328, 81.2%) and anterior (n = 376, 93.1%) nasal bleeding. Heart failure as a comorbidity was associated with a significantly increased risk of recurrent epistaxis (p = 0.001). The most common treatments included expandable polyvinyl acetate packs (EPAP) (n = 198, 49%); topical xylometazoline (n = 108, 26.7%); and chemical cautery (n = 57, 14.1%). EPAP for controlling initial bleeding was significantly associated with ED revisits due to epistaxis (p = 0.033).

Conclusion: The prevalence of recurrent epistaxis mostly occurs in older-aged males. Congestive heart failure may be an under-recognised risk factor for recurrent epistaxis. In patients with a high risk of epistaxis recurrence, other treatment modalities should be sought aside from expandable polyvinyl acetate packs as they can increase the risk of rebleeding.

Purpose: The debate over the effectiveness of platelet-rich plasma (PRP) versus hyaluronic acid (HA) in treating hip osteoarthritis (HOA) continues. This cross-sectional analysis of overlapping systematic reviews aims to evaluate the efficacy of intra-articular PRP compared to HA for HOA treatment. The goal is to guide decision-makers in selecting the most reliable systematic reviews and to provide treatment recommendations based on the best available evidence.

Methods: We conducted comprehensive searches of PubMed, EMBASE, and Cochrane Library databases to identify systematic reviews comparing intra-articular PRP and HA for HOA treatment. The methodological quality of these reviews was assessed, and relevant data were extracted. The Jadad algorithm was applied to determine which reviews provided the most robust evidence.

Results: Five systematic reviews were included, all categorized as Level-II evidence. The Assessment of Multiple Systematic Reviews scores ranged from 4 to 9, with a median score of 8. A high-quality systematic review was chosen according to the Jadad algorithm. It is suggested that there were no significant differences observed in the improvement of any short-term outcome scores (mean follow-up of 12.2 months for PRP, 11.9 months for HA), including the Western Ontario and McMaster Universities Osteoarthritis Index, the Visual Analog Scale for pain, and the Harris Hip Score, from pre-injection to post-injection between the groups.

Conclusion: There is inconsistency among the conclusions of the overlapping systematic reviews comparing intra-articular PRP and HA for HOA treatment. The best evidence indicates that PRP and HA injections yield similar short-term clinical benefits for patients with HOA. Further studies with larger sample sizes and longer follow-up periods are needed to provide more definitive conclusions.

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.