Therapeutics and Clinical Risk Management最新文献

Background: Chemotherapy-induced toxicities are a significant challenge in lung cancer treatment, leading to reduced treatment adherence, increased hospital readmissions, and lower quality of life. Oncology nursing plays a vital role in managing these toxicities through early assessment, patient education, and supportive care. This study aimed to evaluate the impact of a structured oncology nursing intervention on the management of chemotherapy-related toxicities in lung cancer patients.

Methods: This retrospective cohort study analyzed 313 patients with pathologically confirmed lung cancer who received first-line chemotherapy at Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, between January 2021 and December 2023. Patients were divided into two groups: the intervention group (n = 148) received comprehensive oncology nursing services, including toxicity education, symptom monitoring via telephone follow-up, early triage of adverse events, and individualized supportive care plans; the control group (n = 165) received standard care. Primary outcomes included the incidence and severity of grade ≥2 chemotherapy toxicities, unscheduled hospital visits, and treatment delays. Secondary outcomes included patient satisfaction and anxiety levels.

Results: The intervention group showed a significantly lower incidence of grade ≥2 neutropenia (18.2% vs 30.3%, P = 0.012), chemotherapy-induced nausea/vomiting (24.3% vs 39.4%, P = 0.006), and unplanned emergency visits (9.5% vs 19.4%, P = 0.018). Treatment delays due to unmanaged toxicity were also reduced (12.8% vs 23.0%, P = 0.021). Additionally, the intervention group reported lower anxiety scores (mean STAI: 34.7 vs 41.3, P < 0.001) and higher satisfaction (8.7 vs 7.4, P < 0.001).

Conclusion: Structured oncology nursing interventions significantly improve the management of chemotherapy-induced toxicities in lung cancer patients, reducing complications, enhancing treatment continuity, and improving psychological well-being.

Traditional Chinese Medicine (TCM) prioritizes highly individualized diagnosis and treatment, a principle that inherently conflicts with the standardized protocols of explanatory randomized controlled trials (RCTs). While pragmatic RCTs have been proposed to better reflect real-world TCM practice, their reliance on unblinded designs raises concerns about placebo effects and potential confounding biases, particularly for interventions like acupuncture. These methodological tensions highlight the need for innovative trial designs that can preserve TCM's personalized ethos while meeting the rigorous standards of evidence-based research. In response, we propose the T rans-paradigm Randomized-Individualized-Preference-Linked Efficacy/Effectiveness Evaluation for TCM (TRIPLE-TCM) framework-a hybrid trial design integrating explanatory RCTs, pragmatic RCTs, and partially randomized patient preference trials. TRIPLE-TCM employs a five-step procedure: (1) TCM pattern-guided recruitment to ensure diagnostic homogeneity; (2) hybrid randomization accommodating patient preferences; (3) semi-standardized interventions combining fixed core prescriptions with individualized adjustments; (4) a clinician-patient co-assessment model incorporating TCM-specific outcomes and validated biomarkers; and (5) cost-utility analyses to inform policy. This framework aims to balance internal and external validity while maintaining fidelity to TCM theory and clinical practice, providing a methodological bridge for TCM's broader acceptance. Further studies should validate its feasibility, reproducibility, and cross-cultural generalizability across diverse disease contexts and healthcare settings, advancing evidence-based integration of acupuncture and Chinese herbal medicine into global healthcare systems.

Aim: To investigate the predictive value of CT fractional flow reserve (CT-FFR) and fat attenuation index (FAI) based on Coronary CT Angiography (CCTA) for in-stent restenosis (ISR) in patients with CAD after PCI.

Methods: Patients with coronary heart disease who were followed up after coronary stent implantation were retrospectively collected, and clinical data, stent features and imaging characteristics were recorded. The Spearman test was used to analyze the correlation between CT-FFR, FAI and ISR. Univariate and multivariate logistic regression were used to determine the independent influencing factors of ISR, and a nomogram model was constructed.

Results: A total of 378 patients were ultimately included. Among them, there were 120 cases in the ISR group and 258 cases in the non-ISR group. Multivariate analysis revealed that CT-FFR_2cm, ΔCT-FFR, FAI_lesion, stent length, ΔCT-FFR/length, hyperlipidemia, and lipoprotein(a) are independent predictors of ISR. The ROC analysis demonstrated that ΔCT-FFR had the highest predictive accuracy for ISR, with an AUC of 0.923 (95% CI: 0.889-0.957). Several clinical prediction models were developed, among which Model 3 displayed the highest predictive performance (AUC: 0.958, 95% CI, 0.932-0.984). A statistically significant difference was observed between Model 1 and Model 2 (AUC: 0.925 vs 0.950, P < 0.05). However, no significant difference was found between Model 1 and Model 3 (AUC: 0.925 vs 0.928, P > 0.05).

Conclusion: ΔCT-FFR and peri-stent FAI, as independent predictors of ISR after PCI in patients with coronary heart disease, have a high predictive value for ISR. In addition, the FAI around the stent has incremental value for CT-FFR. It is worth noting that, compared with clinical data, imaging features show higher predictive value.

Purpose: Serum cholinesterase (SChE) is a pleiotropic biomarker that is closely related to malnutrition, systemic inflammation, and hepatocyte injury. However, the utility of SChE in patients undergoing percutaneous coronary intervention (PCI) remains unclear. This study sought to investigate the associations between SChE and contrast-associated acute kidney injury (CA-AKI) as well as mortality in patients undergoing PCI.

Patients and methods: We retrospectively observed 1,696 patients at a tertiary hospital from January 2016 to December 2018. CA-AKI was defined as an increase in serum creatinine ≥50% or 0.3 mg/dL within 48 h after contrast medium exposure.

Results: During hospitalization, 198 patients (11.7%) developed CA-AKI. Restricted cubic spline (RCS) and receiver operating characteristic (ROC) analysis demonstrated that SChE levels were negatively correlated with CA-AKI and had predictive value (AUC, 0.655; 95% CI, 0.613-0.697). Multivariable regression analysis showed that patients in low-SChE group (≤7.5 kU/L) had a higher risk of developing CA-AKI (OR, 1.80; 95% CI, 1.21-2.67) compared to those in the high-SChE group (>7.5 kU/L). Regarding prognosis, SChE levels were also negatively associated with long-term mortality and were capable of predicting 90-day mortality (AUC, 0.826; 95% CI, 0.760-0.892). Patients in the low-SChE group had significantly higher long-term mortality risks (HR, 2.56; 95% CI, 1.55-4.32). Mediation analyses further indicated that CA-AKI partially mediated the relationship between SChE and short-term mortality, with a mediation proportion of 12.79%.

Conclusion: Low SChE is an independent risk factor for CA-AKI and a poor prognosis after PCI. Short-term mortality associated with SChE levels is partially mediated through the occurrence of CA-AKI. It is recommended that clinicians evaluate SChE levels prior to PCI and adjust hydration therapy according to SChE levels.

Objective: To compare the clinical efficacy, neurofactor changes, and prognosis in elderly patients with spontaneous intracerebral hemorrhage (ICH) treated with endoscopic surgery versus conventional craniotomy.

Methods: A retrospective analysis was conducted on 88 elderly patients with spontaneous ICH admitted from July 2021 to April 2024. Based on surgical method, patients were assigned to either the conventional craniotomy group (n=44) or the endoscopic surgery group (n=44). Surgical efficacy (hematoma evacuation rate, surgical duration, intraoperative blood loss), short-term prognosis (ICU stay, hospital stay, GOS, NIHSS, ADL scores), serum neurofactors (SOD, NSE, NGF, BDNF), inflammatory markers (WBC, CRP, PCT), and complication rates were compared.

Results: (1) The endoscopic group had significantly shorter surgical time and lower blood loss than the craniotomy group (P<0.05), with similar hematoma evacuation rates (P>0.05). (2) ICU and hospital stays were significantly shorter in the endoscopic group (P<0.05). Postoperative GOS and ADL scores were higher, and NIHSS scores were lower in the endoscopic group at 3 months (P<0.05). (3) Compared with preoperative levels, both groups showed a decreasing trend in SOD and NSE and an increasing trend in NGF and BDNF after surgery, with the observation group showing more significant and sustained changes over time (P < 0.05). (4) Although postoperative inflammatory markers increased in both groups, the observation group had milder elevations and faster downward trends (P < 0.05). (5) The complication rate was lower in the endoscopic group (6.82% vs 22.73%, P<0.05).

Conclusion: Compared to conventional craniotomy, endoscopic hematoma evacuation in elderly ICH patients results in milder inflammatory responses, more favorable neurofactor changes, fewer complications, and improved recovery. However, these findings require further validation due to the retrospective design and limited sample size.

Purpose: The optimal strategy for body temperature management during cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. This study aimed to assess whether intentionally cooling the core body temperature (CBT) to hypothermia (<35°C) before the HIPEC phase improves postoperative outcomes.

Patients and methods: In this retrospective cohort study, we analyzed 73 patients who underwent CRS plus HIPEC, grouped by CBT immediately before HIPEC: CBT ≥ 35°C (n=51) and CBT < 35°C (n=22). Primary outcomes including time to extubation and Clavien-Dindo classification. Secondary outcomes including length of stay (LOS), ICU stay, postoperative acute kidney injury (AKI) and reintubation event. Intraoperative parameters such as hemodynamic status, blood loss, transfusion requirements, and intravenous (IV) fluid amount were also compared.

Results: Compared to the normothermia group, patients in the hypothermia group had significantly longer time to extubation (median 11.5 vs 8.0 hours, p = 0.0314), greater blood loss (median 350 vs 150 mL, p = 0.0045), higher leukocyte-poor red blood cells transfusion units (p = 0.0016) and increased total IV fluid amount (p = 0.0049). Delayed extubation, defined as occurring more than 12 hours after surgery, appeared to be independently associated with hypothermia (odds ratio [OR] 6.31, 95% confidence interval [CI] 1.11-35.70, P = 0.037) and total IV fluid administration (per 100 mL; OR 1.05, 95% CI 1.00-1.10, P = 0.042) in multivariate analysis.

Conclusion: Actively inducing hypothermia before the HIPEC phase did not demonstrate improved postoperative outcomes and may be associated with delayed extubation, greater blood loss, higher transfusion requirements, and increased IV fluid administration.

Purpose: This study aims to evaluate and compare the efficacy and safety of endotracheal intubation in the lateral versus supine position, with both approaches combined with airway surface anesthesia, in patients undergoing gastrointestinal endoscopic surgery.

Patients and methods: A total of 128 patients undergoing gastrointestinal endoscopic surgery under general anesthesia with intubation were randomized into a lateral (L, n=64) or supine (S, n=64) intubation group, both receiving airway surface anesthesia, between January and March 2025. The primary outcome measure was intubation time, while secondary outcomes included changes in intraoperative vital signs, number of intubation attempts, first-pass success rate, positioning time, healthcare worker satisfaction, and postoperative complications.

Results: No significant differences were found between the two groups in terms of age, sex, height, weight, BMI, ASA classification, and airway assessment (P > 0.05). Mean intubation times differed slightly between groups (S group: 37.4±7.6s, 95% CI 35.5-39.3; L group: 40.1±8.5s, 95% CI 38.0-42.2). The non-inferiority margin (δ) for this study was 6s, and the upper limit of the L group's confidence interval (42.2s) was below the threshold of 39.3 + 6s. Thus, lateral position intubation was not inferior to supine intubation in terms of intubation time. There were no significant differences between the groups in the number of intubation attempts or first-pass success rate (P > 0.05). However, during positioning, the S group experienced greater hemodynamic fluctuations and a longer positioning time compared to the L group, and these differences were statistically significant (P < 0.05). Neither group showed any dental injuries or hypoxemia, and there were no significant differences in adverse reactions between the groups (P > 0.05).

Conclusion: Compared with conventional supine intubation, lateral position endotracheal intubation with airway surface anesthesia achieves similar efficacy while providing better hemodynamic stability, faster positioning, and higher provider satisfaction.

Purpose: We primarily evaluated the relationship between postoperative complications and long-term survival in patients undergoing major gastrointestinal surgery. Secondarily, we investigated the relationship between the severity and the number of complications and long-term survival. While postoperative complications are prevalent after major abdominal surgery and associated with increased mortality, the effect of their severity and accumulation remains insufficiently explored.

Patients and methods: 1989 adult patients undergoing major gastrointestinal surgery between July 2010 and April 2022 were retrospectively studied. Complications were classified using the Clavien-Dindo system. Kaplan-Meier analysis assessed long-term survival, Cox proportional hazards regression with time-dependent coefficients evaluated the impact of complications on mortality.

Results: Median age was 64 years (IQR 53-74); 41.8% female and 63.0% of patients were diagnosed with malignancy. Elective procedures comprised 73.0% of cases. Complications occurred in 74.6% of patients. Mortality was higher in patients with complications (32.0%, 95% CI 29.7%-34.5%), compared to those without (21.7%, 95% CI 18.3-25.6%; P<0.001). Severe complications (Clavien-Dindo Grade ≥III) were associated with a 15.01-fold higher hazard of mortality within 18 months postoperatively (95% CI 6.83-33.0; P<0.001).

Conclusion: Postoperative complications significantly reduce long-term survival following major gastrointestinal surgery. Both their severity and frequency are critical determinants of poorer outcomes, emphasizing the need for effective prevention strategies.

Background: Cardiovascular diseases (CVDs) are a major contributor to premature mortality, disability, and reduced quality of life globally. Assessing CVD risks is central to primary prevention, prompting the development of numerous tools to predict CVD risks for the general population. However, it is unclear which tools are recommended in clinical practice in the Middle East region.

Aim: This scoping review aims to identify, review, and summarize the available literature on CVD risk assessment tools recommended for the general population in the Middle East region.

Methods: The scoping review synthesized the literature on CVD risk assessment tools recommended for the general population in the Middle East region. It followed PRISMA-ScR guidelines, covering searches in the Web of Science (WOS), Medline, and Scopus databases. English-language articles published between 2015 and 2024 that focused on the primary prevention of CVDs in sixteen Middle Eastern countries were included.

Results: Seventeen articles met the inclusion criteria. The studies were distributed over Cyprus (n=1), Iran (n=7), Saudi Arabia (n=4), Qatar (n=1), the United Arab Emirates (n=3), and Egypt (n=1). Various tools are recommended in these countries, including validated Western tools such as ACC/AHA Pooled-Cohort Equations (PCE), Systematic Coronary Risk Evaluation 2 (SCORE 2), World Health Organization charts (WHO/ ISH) for the Eastern Mediterranean region (EMR), Cardiovascular Disease Risk Algorithm (QRISK3), and PREDICT. Some studies in Iran, Saudi Arabia, the United Arab Emirates, and Egypt focused on developing new CVD risk tools tailored for national use.

Conclusion: Current studies on CVD risk assessment are limited and have been conducted in six Middle Eastern countries. These studies recommend various tools, including both validated Western models and locally developed frameworks. However, the limitations of existing tools and the gaps in current research underscore the need for further studies to develop or recalibrate models that account for country-specific CVD risk factors across the region.

Purpose: Dental injury is a known complication of endotracheal intubation during general anesthesia (GA), yet data on its incidence and associated risk factors remain limited. This study aimed to evaluate the incidence, risk factors, and outcomes of dental injury in patients undergoing GA.

Patients and methods: This retrospective case-control study was conducted between January 2021 and June 2024. A total of 42,826 patients underwent GA during the study period; 72 cases of dental injury were identified from the departmental database. Controls were time-matched patients who underwent surgery in the same anatomical region, using a case-to-control ratio of 1:4. Univariable and multivariable logistic regression analyses were performed to identify independent risk factors for dental injury.

Results: The incidence of dental injury was 0.17%. Univariate analysis identified the following factors as associated with dental injury: age ≥ 60 years, pre-existing dental pathology, Mallampati classification ≥ 3, anticipated difficult intubation, and difficult airway. In the multivariable logistic regression analysis, pre-existing dental pathology (adjusted OR 3.87, 95% CI: 1.92-7.81, p < 0.001), anticipated difficult intubation (adjusted OR 4.99, 95% CI: 1.84-13.50, p = 0.002), and difficult intubation (laryngoscopic view grade ≥ 3) (adjusted OR 10.56, 95% CI: 4.24-26.29, p < 0.001) remained significant independent predictors of dental injury during GA. The most common complication was bleeding.

Conclusion: Dental injury during GA is uncommon, with an incidence of 0.17%. Pre-existing dental pathology, anticipated difficult intubation, and poor laryngoscopic view (grade ≥ 3) were identified as independent risk factors. Awareness and thorough preoperative assessment of these factors may help reduce the risk of dental injury and related complications.