Therapeutics and Clinical Risk Management最新文献

Purpose: No consensus has been established on the safety and effectiveness of out-of-hospital management of Vitamin K antagonists (VKA) therapy combining portable coagulometers and telemedicine. The present meta-analysis investigated the safety and effectiveness of this hybrid anticoagulants management model.

Methods: The PubMed, Embase, Cochrane, and Web of Science databases were searched for papers published before May 1, 2022. To reduce bias, only randomized controlled trials were included. RevMan 5.3 (Cochrane) software was used to evaluate and analyze clinical outcomes, including the effectiveness and safety of patient management approaches, determined by the time in the therapeutic range (TTR) and occurrence of thrombotic and bleeding events.

Results: Eight studies, comprising 3853 patients, were selected. The meta-analysis showed that anticoagulant management combining portable coagulometers and telemedicine significantly improved frequency of testing (mean difference [MD]= 12.95 days; 95% CI, 8.77-17.12; I²= 92%; P< 0.01) and TTR (MD= 9.50%; 95% CI, 3.16-15.85; I²= 87%; P< 0.01). Thromboembolism events were reduced (RR= 0.72; 95% CI, 0.51-1.01; I²= 0%; P= 0.05), but the results were not statistically significant. And no significant differences in major bleeding events, rehospitalization rate, mortality, or overall treatment cost existed between the two groups.

Conclusion: Although the safety of remote cardiovascular disease management is not superior to that of conventional outpatient anticoagulant management, it provides a more stable monitoring of coagulation status.

Purpose: This study aimed to evaluate the safety and efficacy of a combination of programmed death-1 (PD-1) inhibitor and regorafenib as second-line treatment for advanced hepatocellular carcinoma (HCC).

Patients and methods: We retrospectively analyzed the data of 38 patients with unresectable HCC who were treated with PD-1 inhibitor in combination with regorafenib as a second⁃line therapy as well as the data of 32 patients treated with regorafenib only therapy as a control. The clinical data, previous treatment strategies, follow-up imaging results, and adverse events during follow-ups were recorded. The mRECIST Criteria were used to evaluate the treatment outcome of intrahepatic lesions, and the Kaplan-Meier method was used to evaluate survival time.

Results: Up to the last follow-up, the rego-PD-1 group had higher objective response rate (39.5% vs 15.6%, P = 0.028), longer progression-free survival (median 5.9 vs 4.6 months; P = 0.044), and better overall survival (OS) (median 14.5 vs 9.5 months; P = 0.041) than the regorafenib only group. Among the 38 patients in rego-PD-1 group, 1 patient (2.7%) achieved complete response, 14 patients (36.8%) achieved partial response, 14 patients (36.8%) achieved stable disease, and 9 patients (23.7%) achieved progressive disease. Among the 32 patients in regorafenib alone, 5 (15.6%) achieved partial response, 12 (37.5%) achieved stable disease, and 15 (46.9%) achieved progressive disease. Regorafenib alone, Child-Pugh B, and tumors >3 were independent prognostic factors for poor OS. The difference in the incidence of grade 3/4 adverse events between the two groups was not statistically significant (36.8% vs 28.1%; P = 0.439). Grade ≥3 treatment-related adverse events included hypertension and diarrhea.

Conclusion: PD-1 inhibitor combined with regorafenib is a promising regimen in treating patients with unresectable HCC owing to its safety and effectiveness as well as low incidence of serious adverse events with its use.

Background: The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide. Herbal medicines can act as immunomodulators, anti-inflammatories, antioxidants, antimicrobials, and others depending on the type and content of the herbs used. Previous studies have shown that several types of herbs, such as Echinacea purpurea, Curcumin or Turmeric, Nigella sativa, and Zingiber officinale, have proven their effectiveness as herbal plants for COVID-19.

Methods: We conducted a comprehensive literature search through five databases, namely, PubMed, Scopus, Embase, Wiley, and ProQuest to assess the efficacy of phytopharmaceuticals until July 12, 2022. We used the Cochrane RoB 2.0 for the quality assessment of the study.

Results: Phytopharmaceuticals significantly improved patients' recovery rate (OR = 3.54; p < 0.00001) and reduced deaths (OR = 0.24; p < 0.0001) compared to the control group. Phytopharmaceuticals also performed as a protective factor for COVID-19 clinical symptoms, such as dyspnea (OR = 0.42; p < 0.05) and myalgia (OR = 0.31; p = 0.02) compared to the control group. However, there is no statistically significant effect on cough (OR = 0.76; p = 0.61) and fever (OR = 0.60; p < 0.20). The results were not affected by patients' covariates [hypertension, diabetes mellitus, and cardiovascular diseases (meta-regression p > 0.05)].

Conclusion: Herbal medicine has the potential as an adjuvant therapy in the management of COVID-19.

Purpose: Myocardial injury after non-cardiac surgery is closely related to major adverse cardiac and cerebrovascular event and is difficult to identify. This study aims to investigate how to predict the myocardial injury of thoracic surgery and whether intraoperative variables contribute to the prediction of myocardial injury.

Methods: The prospective study included adult patients with high cardiovascular risk who underwent elective thoracic surgery from May 2022 to October 2022. Multivariate logistic regression was used to establish a model with baseline variables and a model with baseline and intraoperative variables. We compare the predictive performance of two models for postoperative myocardial injury.

Results: In general, 31.5% (94 of 298) occurred myocardial injury. Age ≥65 years old, obesity, smoking, preoperative hsTnT, and one-lung ventilation time were independent predictors of myocardial injury. Compared with baseline model, the intraoperative variables improved model fit, modestly improved the reclassification (continuous net reclassification improvement 0.409, 95% CI, 0.169 to 0.648, P<0.001, improved integrated discrimination 0.036, 95% CI, 0.011 to 0.062, P<0.01) of myocardial injury cases, and achieved higher net benefit in decision curve analysis.

Conclusion: The risk stratification and anesthesia management of high-risk patients are essential. The addition of intraoperative variables to the baseline predictive model improved the performance of the overall model of myocardial injury and helped anesthesiologists screen out the patients at the greatest risk for myocardial injury and adjust anesthesia strategies.

Purpose: In this prospective observational study, an ultrasonographic measurement of antral cross-sectional area (ACSA) was conducted to evaluate the gastric content and volume as well as to identify high-risk stomach in non-pregnant adult surgical patients adhering to preanesthetic fasting guidelines.

Patients and methods: Fasted patients undergoing gastrointestinal endoscopy under sedation were included. Ultrasonographic measurements of ACSA were conducted in both semi-recumbent and right lateral decubitus positions before endoscopic procedures. Gastroscopy was employed to guide the measurement of suctioned gastric volume (GV). Ultrasonography was performed to assess gastric contents and identify patients with high-risk stomach. The relationship between ACSA and suctioned GV was also evaluated.

Results: ACSA was evaluated in 736 out of 782 patients. A significant positive correlation was discovered between ACSA in the right lateral decubitus position and suctioned GV, which was more reliable than in the semi-recumbent position. To analyze high-risk stomach with a GV > 100 mL, the cutoff value of ACSA in the right lateral decubitus was found to be 7.5 cm², with the AUC, sensitivity and specificity of 0.80 (95% CI, 0.76-0.82; P<0.001), 82.4% and 67.3%, respectively. A novel mathematical model based on ACSA to estimate GV in non-pregnant fasted adults was presented.

Conclusion: Ultrasonographic measurement of ACSA can assist anesthesiologists in estimating the risk of pulmonary aspiration of gastric contents during general anesthesia and sedation.

Introduction: Obstructive sleep apnea (OSA) is a public health problem that affects children. Although continuous positive airway pressure (CPAP) therapy is effective, the CPAP adherence rate in children is varied. This study aimed to evaluate the CPAP adherence rate and factors associated with CPAP adherence in children with OSA using a systematic review.

Methods: The inclusion criteria were observational studies conducted in children with OSA and assessed adherence of CPAP using objective evaluation. The literature search was performed in four databases. Meta-analysis using fixed-effect model was conducted to combine results among included studies.

Results: In all, 34 studies that evaluated adherence rate and predictors of CPAP adherence in children with OSA were included, representing 21,737 patients with an average adherence rate of 46.56%. There were 11 calculations of factors predictive of CPAP adherence: age, sex, ethnicity, body mass index, obesity, income, sleep efficiency, the apnea-hypopnea index (AHI), severity of OSA, residual AHI, and lowest oxygen saturation level. Three different factors were linked to children with adherence and non-adherence to CPAP: age, body mass index, and AHI.

Conclusion: The CPAP adherence rate in children with OSA was 46.56%. Young age, low body mass index, and high AHI were associated with acceptable CPAP adherence in children with OSA.

Objective: Accurate preoperative localization of abnormal parathyroid glands is crucial for successful surgical management of secondary hyperparathyroidism (SHPT). This study was conducted to compare the effectiveness of preoperative MRI, 4D-CT, and ultrasonography (US) in localizing parathyroid lesions in patients with SHPT.

Methods: We performed a retrospective review of prospectively collected data from a tertiary-care hospital and identified 52 patients who received preoperative MRI and/or 4D-CT and/or US and/or ^99mTc-MIBI and subsequently underwent surgery for SHPT between May 2013 and March 2020. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of each imaging modality to accurately detect enlarged parathyroid glands were determined using histopathology as the criterion standard with confirmation using the postoperative biochemical response.

Results: A total of 198 lesions were identified intraoperatively among the 52 patients included in this investigation. MRI outperformed 4D-CT and US in terms of sensitivity (P < 0.01), specificity (P = 0.455), PPV (P = 0.753), and NPV (P = 0.185). The sensitivity and specificity for MRI, 4D-CT, and US were 90.91%, 88.95%, and 66.23% and 58.33%, 63.64%, and 50.00%, respectively. The PPV of combined MRI and 4D-CT (96.52%) was the highest among the combined 2 modalities. The smallest diameter of the parathyroid gland precisely localized by MRI was 8×3 mm, 5×5 mm by 4D-CT, and 5×3 mm by US.

Conclusion: MRI has superior diagnostic performance compared with other modalities as a first-line imaging study for patients undergoing renal hyperparathyroidism, especially for ectopic or small parathyroid lesions. We suggest performing US first for diagnosis and then MRI to make a precise localization, and MRI proved to be very helpful in achieving a high success rate in the surgical treatment of renal hyperparathyroidism in our own experience.

Objective: The optimal red blood cell transfusion strategy for children remains unclear. We developed an individualized red blood cell transfusion strategy for children and tested the hypothesis that transfusion guided by this strategy could reduce blood exposure, without increasing perioperative complications in children.

Methods: In this randomized controlled clinical trial, 99 children undergoing noncardiac surgeries who had blood loss of more than 20% total blood volume were randomly assigned to an individualized-strategy group using Pediatric Perioperative-Transfusion-Trigger Score or a control group. The amount of transfused red blood cell was counted, and patients were followed up for postoperative complications within 30 days.

Results: Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group (p < 0.05). During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs 1.33±1.20 Red-Blood-Cell units per patient, p = 0.02). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs 18%, p = 0.160). No significant difference was found in the other outcomes.

Conclusion: This trial proved that red blood cell transfusion guided by the individualized strategy reduced perioperative blood exposure in children, without increasing the incidence of severe complications. This conclusion needs to be reaffirmed by larger-scale, multicenter clinical trials.

Purpose: The study aims at investigating the impact of polymedication and aging in the prevalence of multiple drug-drug interactions (DDIs) on HCV patients treated with sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB).

Patients and methods: This is a retrospective analysis based on administrative data covering around 6.9 million individuals. Patients treated with SOF/VEL or GLE/PIB over November 2017-March 2020 were included. Index date corresponded to SOF/VEL or GLE/PIB first prescription during such period; patients were followed up for treatment duration. Analyses were then focused on patients with ≥2 comedications at risk of multiple DDIs. The severity and the effect of multiple DDI were identified using the Liverpool University tool.

Results: A total of 2057 patients with SOF/VEL and 2128 with GLE/PIB were selected. Mean age of SOF/VEL patients was 58.5 years, higher than GLE/PIB ones (52.5 years) (p < 0.001), and patients >50 years were more present in SOF/VEL vs GLE/PIB cohorts: 72% vs 58%, (p < 0.001). Most prescribed co-medications were cardiovascular, alimentary and nervous system drugs. Proportion of patients with ≥2 comedications was higher in SOF/VEL compared to GLE/PIB cohort (56.5% vs 32.3%, p < 0.001). Those at high-risk of multiple DDIs accounted for 11.6% (N = 135) of SOF/VEL and 19.6% (N = 135) of GLE/PIB (p < 0.001) patients with ≥2 comedications. Among them, the potential effect of DDI was a decrease of DAA serum levels (11% of SOF/VEL and GLE/PIB patients) and an increased concentration of comedication serum levels (14% of SOF/VEL and 42% of GLE/PIB patients).

Conclusion: This real-world analysis provided a thorough characterization on the burden of polymedication regimens in HCV patients treated with SOF/VEL or GLE/PIB that expose such patients to an increased risk of DDIs. In our sample population, SOF/VEL regimen was more frequently detected on elderly patients and on those with ≥2 comedications at risk of multi-DDI, ie, among patients characterized by higher rates of comorbidities and polypharmacy.

Objective: Hip ankylosis is a prevalent condition in patients with Ankylosing spondylitis (AS) that can significantly impact their psychological well-being. This study aimed to investigate the impact of Total Hip Arthroplasty (THA) on anxiety and depression among AS patients.

Methods: 62 AS patients undergoing primary THA were recruited and separated into two groups based on preoperative hip motion. The 40 patients with hip mobility of 0° were assigned to group A, and others were assigned to group NA. Self-rating Anxiety Scale (SAS), Self-rating Depression scale (SDS), Harris hip scores (HHS) and 36-Item Short Form Survey (SF-36) were obtained one week before and there, six and twelve months after THA.

Results: The study found that AS patients in group A had significantly higher levels of anxiety and depression (SAS score = 75.05±2.79, SDS index score = 0.74±0.02) compared to group B (SAS score = 54.58±3.35, SDS index score= 0.64±0.03, P=0.01). However, both groups showed significant improvements in anxiety and depression scores from there to twelve months after THA (P<0.001). Correlation analyses revealed that the improvement in group NA was associated with hip pain relief (p<0.001), while the improvement in group A was related to joint function, disease duration, age at THA and spine imaging lesions (p<0.001).

Conclusion: Some degree of anxiety and depression was present in both groups of AS patients. Levels of depression and anxiety were higher in patients with combined hip ankylosis. And their improvement was associated with improved hip function and quality of life after THA. Hip pain relief played a significant role in patients without hip joint ankylosis. The impact of the degree of lesion on spinal imaging on psychological status needs to be considered in both groups.