Therapeutics and Clinical Risk Management最新文献

Objective: To evaluate the anastomotic leakage (AL) rates in cancerous and non-cancerous intestinal anastomoses and analyze the general risk factors for AL.

Methods: The primary endpoint of this study is to investigate whether there is a difference in terms of AL between patients who underwent sigmoid colon resection + colorectal anastomosis due to primary colon cancer (Group 1) and patients with a completely healthy colorectal region who underwent sigmoid colon resection + colorectal anastomosis for use in the orthotopic bladder during radical cystoprostatectomy (Group 2). The secondary endpoint, considering all the patients, is to evaluate and investigate the risk factors affecting the AL rates.

Results: A total of 178 patients, including 63 (35.4%) patients in Group 1 and 115 (64.6%) patients in Group 2, were included in the study. The mean age of all patients was 61.7 ± 9.9 years, and there was no statistical difference between the mean ages of the groups (62.8 ± 11.3 vs 60.7 ± 6.1, p = 0.106, respectively). Thirty-six (20.2%) of the patients were female, and 142 (79.8%) were male. There was no significant difference between the groups in terms of AL in the postoperative period. Postoperative AL was seen in three patients (4.8%) and six patients (5.2%) in Group 1 and Group 2, respectively (p = 0.642). According to univariate and multiple logistic regression analysis, the risk of AL increased in patients with comorbidities, in the presence of previous abdominal surgery, in patients with high neutrophil-to-lymphocyte ratio, and patients with postoperative ileus (p values are 0.042, 0.010, 0.029 and 0.048, respectively).

Conclusion: Our data suggest that anastomosis due to colon cancer resection does not increase the risk of AL compared with healthy bowel anastomoses. In addition, some clinical factors have been found to compromise anastomotic safety and are risk factors for AL. In addition, some clinical factors have been found to endanger anastomotic safety and are risk factors for AL.

Background: Chemotherapy-induced nausea and vomiting (CINV) is a major burden for cancer patients, often poorly managed by conventional antiemetics, prompting exploration of medicinal plant therapies for better supportive care.

Objective: This systematic review critically evaluates medicinal plants for CINV, detailing bioactive compounds, diverse antiemetic mechanisms, and promising chemosensitizing and immunomodulatory properties.

Methods: A comprehensive literature search and critical analysis of studies investigating medicinal plants for CINV were performed.

Key findings: This review synthesizes evidence for 22 botanicals. Ginger (gingerols, shogaols) acts via 5-hydroxytryptamine 3 (5-HT₃) receptor antagonism and substance P/neurokinin-1 (NK-1) inhibition, and offers chemosensitization by downregulating P-glycoprotein. Cannabis (THC, CBD) modulates the endocannabinoid system and 5-HT₃ receptors for CINV relief and may enhance chemotherapy sensitivity. Mint (menthol, menthone) relaxes gastrointestinal smooth muscle and offers anti-inflammatory benefits. Chamomile (apigenin) has antispasmodic/anxiolytic effects; its apigenin also sensitizes cancer cells to chemotherapy. Turmeric (curcumin) acts on neurotransmitter systems, offers potent anti-inflammatory/antioxidant effects, and boosts chemosensitivity via NF-κB/P-gp modulation. Plants like Pinellia ternata, lemon, fennel, and licorice show varied mechanisms (gastrointestinal regulation, anti-inflammatory, neurotransmitter modulation). Many botanicals show chemosensitizing (inhibiting efflux pumps, promoting apoptosis) and immunomodulatory (affecting cytokines, immune cells) properties. Synergistic plant combinations (eg, ginger with P. ternata or turmeric) are noted for enhanced efficacy and safety.

Conclusion: Medicinal plants offer a compelling, multi-targeted approach for CINV management, with potential beyond symptomatic relief via their antiemetic, chemosensitizing, and immunomodulatory actions. Rigorous clinical trials are needed to integrate these botanicals into evidence-based supportive cancer care.

Purpose: Transcutaneous electrical acupoint stimulation (TEAS) has emerged as a promising non-pharmacological intervention to enhance postoperative recovery. However, its application during the post-anesthesia recovery period remains underexplored. This study investigated the impact of TEAS during the post-anesthesia recovery period on postoperative recovery quality in patients undergoing laparoscopic gynecological surgery.

Patients and methods: In this single-center, randomized, double-blinded, sham-controlled trial, 100 patients undergoing elective gynecological laparoscopic surgery were randomly allocated to receive either TEAS or sham stimulation at bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Sanyinjiao (SP6) acupoints for 30 minutes during the post-anesthesia recovery period in the post-anesthesia care unit (PACU). The primary outcome was the Quality of Recovery-15 (QoR-15) score assessed on postoperative days (POD) 1, 2, and 3. Secondary outcomes included pain, postoperative nausea and vomiting (PONV), recovery times, and adverse events.

Results: Ninety-seven patients completed the study, with 48 in the TEAS group and 49 in the Sham group. The TEAS group exhibited significantly higher QoR-15 scores on POD 1 compared to the Sham group, with improvements in emotional state, physical comfort, and pain dimensions. On POD 2, the TEAS group had significantly higher pain dimension scores. The TEAS group also reported lower resting VAS scores on POD 1 and lower exercise VAS scores on POD 1 and 2. The incidence of PONV was lower on POD 1, with fewer patients requiring rescue antiemetics. Additionally, the TEAS group experienced shorter times to first flatus and ambulation. Adverse events were comparable between the groups, with no local skin irritation noted in the TEAS group.

Conclusion: TEAS applied during the post-anesthesia recovery period significantly improves early postoperative recovery quality, reduces pain and PONV, and accelerates functional recovery in patients undergoing gynecological laparoscopic surgery.

Background: Pleural reaction (PR) frequently occurs during computed tomography (CT) -guided lung puncture procedures, and its development is influenced by various factors. This study aims to identify the risk factors associated with PR in CT-guided percutaneous lung nodule localization (CT-PLNL) procedures.

Methods: This retrospective study included 467 patients who underwent video-assisted thoracic surgery (VATS) at Nanjing Drum Tower Hospital between January 2022 and December 2023, all of whom had received CT-PLNL. Clinical data, including medical records, imaging findings, and laboratory results, were collected. Univariate analysis and Least Absolute Shrinkage and Selection Operator (LASSO) regression identified independent risk factors for PR. Binary logistic regression was performed to further analyze these factors. Receiver Operating Characteristic (ROC) curves were plotted to assess model performance, and Bootstrap validation evaluated discriminative ability. Calibration curves and decision curve analysis (DCA) were conducted to compare predicted versus actual probabilities and assess clinical applicability.

Results: The incidence of PR was 5.35% (25/467). Significant variables from univariate analysis and LASSO regression were analyzed by logistic regression. Age, intrapulmonary needle path adjustment, inadequate anesthesia, and a history of diabetes were identified as independent risk factors for PR. ROC curves showed Area Under the Curve (AUC) values indicating excellent discriminative ability. Calibration curves showed appropriate fit, and DCA demonstrated high clinical applicability.

Conclusion: Younger age groups, intraprocedural needle adjustments, inadequate anesthesia, and diabetes were independent risk factors for PR after CT-PLNL. Optimizing anesthesia, avoiding unnecessary needle manipulations, and perioperative glucose monitoring in diabetic patients may mitigate PR risks and enhance procedural safety.

Background: Biologics, particularly anti-TNF agents, have transformed the management of inflammatory bowel disease (IBD), but concerns about their perioperative safety persist.

Objective: This study evaluates the knowledge, attitudes, and practices of surgeons in Saudi Arabia regarding the preoperative management of IBD patients undergoing surgery while on biological treatments.

Methods: A cross-sectional survey was conducted among 115 surgeons. Participants included general and colorectal surgeons with extensive experience in IBD management. Data were analyzed to assess knowledge, attitudes, and practices related to the impact of biologics, corticosteroids, and immunomodulators on wound healing and postoperative complications.

Results: The response rate of 67.8% and Most surgeons (74.4%) believed biologics negatively affect wound healing, despite evidence suggesting their safety. Corticosteroids were unanimously recognized for their adverse effects, while immunomodulators were widely perceived as safe. A majority preferred tapering biologics and corticosteroids 4 weeks preoperatively but continued immunomodulators. Differences between specialties were observed, with colorectal surgeons demonstrating greater adherence to evidence-based guidelines compared to general surgeons, who expressed more concerns about biologics' risks.

Conclusion: This study identifies a persistent gap between evidence and practice in the perioperative management of IBD patients on biologics among Saudi surgeons, with general surgeons often stopping biologics due to safety concerns despite evidence of their safety, while colorectal surgeons are more likely to follow current guidelines. Unnecessary cessation may increase disease flare risk, highlighting the need for targeted education and multidisciplinary collaboration to optimize surgical outcomes.

Background: The primary analysis of the ANNIE study demonstrated promising anti-tumor activity of the niraparib-anlotinib combination in platinum-resistant recurrent ovarian cancer (PROC). We report updated overall survival (OS) and safety data and the management of key treatment-emergent adverse event (TEAE) from the ANNIE study.

Methods: In the multi-center, single-arm, Phase 2 ANNIE study, enrolled patients received oral niraparib 200 mg or 300 mg (baseline bodyweight-directed) once daily and anlotinib 10 mg (12 mg before protocol amendment) once daily on days 1-14 of each 21-day cycle. Safety management involved a multidisciplinary team comprising specialist physicians, who performed monitoring and intervention for key comorbidities and TEAEs.

Results: Forty patients were enrolled. After a median follow-up of 19.0 months, the updated median OS was 18.2 months (95% confidence interval: 12.1-not evaluable). The most common TEAEs were hypertension (n=22, 55%), leukopenia (n=18, 45%), hand-foot syndrome (n=17, 43%), thrombocytopenia (n=15, 38%), neutropenia (n=14, 35%), and hypertriglyceridemia (n=12, 30%). Hypertension and cardiovascular events were mostly managed by early interventions using beta-blockers. Hypertriglyceridemia was mostly managed using atorvastatin and simvastatin. Hematological toxicities were consistent with prior studies and no severe hematologic events occurred. Protocol amendment was implemented to reduce the incidence of hand-foot syndrome, while topical glucocorticoids and non-steroidal anti-inflammatory drugs were used in patients with apparent symptoms.

Conclusion: The updated OS analysis showed sustained long-term efficacy of niraparib-anlotinib in PROC patients. The safety data reflected satisfactory tolerability and adverse event management, supporting the involvement of a multidisciplinary disease management team in ovarian cancer care.

Clinical trial registration: NCT04376073.

Background: Many ICU survivors experience post-ICU physical, cognitive, or mental impairments. In ICU survivors with solid malignancies, post-ICU impairments can impede further cancer treatments and negatively impact their outcomes. This study aimed to investigate post-ICU mortalities and their risk factors at ICU discharge in ICU survivors with solid malignancies.

Methods: In this retrospective cohort study, adult patients with solid malignancies who were unexpectedly admitted to the medical ICU of a tertiary hospital between 2016 and 2022 and survived to ICU discharge were included. Data at ICU discharge were collected from electronic medical records. In-hospital and 1-year mortality and their risk factors were analyzed.

Results: Of the 708 ICU survivors, 25.1% died in the hospital, and 61% died within one year. At ICU discharge, 20.9% had delirium, 3.8% had coma, and 80.6% had impaired mobility. Respiratory support, including bilevel positive airway pressure (BiPAP), high-flow nasal cannula (HFNC), or other oxygen therapies was used in 88.7% of patients. Delirium (adjusted OR 1.73; 95% CI 1.04-2.87; p = 0.035), coma (adjusted OR 5.63; 95% CI 2.09-16.17; p < 0.001), limited mobility (adjusted OR 2.41; 95% CI 1.22-5.14; p = 0.015), and use of BiPAP (adjusted OR 21.63; 95% CI 5.36-99.57; p < 0.001) or HFNC (adjusted OR 7.08; 95% CI 2.45-23.99; p < 0.001) were independently associated with in-hospital mortality. One-year survival was significantly lower in patients with delirium (35%, p < 0.001), coma (26%, p < 0.001), limited mobility (37%, p = 0.003), or those receiving respiratory support at ICU discharge (35%, p < 0.001).

Conclusion: A considerable portion of ICU survivors with solid malignancies died in the hospital or within one year after ICU discharge in our study. Cognitive, mobility, and pulmonary impairments at ICU discharge were significant risk factors for both in-hospital and long-term mortality.

Objective: This study aimed to evaluate the prognostic significance of the preoperative neutrophil-to-albumin ratio (NAR) in patients with advanced gastric cancer undergoing radical gastrectomy.

Methods: A retrospective analysis was conducted involving 526 patients diagnosed with locally advanced gastric adenocarcinoma who underwent radical gastrectomy between January 2017 and December 2019. Preoperative NAR values were calculated using neutrophil count and serum albumin levels obtained within 24 hours of admission. Patients were stratified into high-NAR and low-NAR groups using an optimal cut-off value determined by receiver operating characteristic analysis. Kaplan-Meier curves, univariate, and multivariate Cox regression analyses were used to evaluate overall survival and recurrence-free survival.

Results: The optimal NAR cut-off value was identified as 2.8. Patients with high NAR exhibited significantly worse overall survival and recurrence-free survival compared to the low-NAR group. High NAR was significantly associated with advanced tumor stage, incomplete resection status, administration of chemotherapy and radiotherapy, and poor histological differentiation (all P < 0.0001). Multivariate analyses confirmed NAR as an independent prognostic factor for both overall survival (HR=2.67; 95% CI, 1.97-4.25; p = 0.002) and recurrence-free survival (HR=3.51; 95% CI, 1.58-5.26; p = 0.003).

Conclusion: The preoperative neutrophil-to-albumin ratio is an independent and reliable prognostic biomarker for overall and recurrence-free survival in patients with advanced gastric cancer undergoing radical gastrectomy. Due to its accessibility, simplicity, and predictive value, the neutrophil-to-albumin ratio can effectively facilitate risk stratification, personalized clinical decision-making, and targeted interventions to improve patient outcomes.

Purpose: This study aimed to compare the cost-effectiveness of the double plasma molecular adsorption system sequential low-volume plasma exchange (DPMAS+LPE) versus conventional plasma exchange (PE) in treating early-stage hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF).

Patients and methods: A total of 215 early-stage HBV-ACLF patients were assigned to either DPMAS+LPE or conventional PE groups. After propensity score matching (1:1), 101 matched pairs were analyzed. We compared 30- and 90-day survival rates and direct medical costs from the healthcare payer's perspective. Cost-effectiveness analysis was performed with a willingness-to-pay (WTP) threshold of $12,681 and $38,043, equivalent to 1 and 3 times China's 2023 per capita GDP. Univariate and probabilistic sensitivity analyses (Bootstrap method) were used to assess parameter uncertainty.

Results: Over the 90-day follow-up period, the DPMAS+LPE group had numerically higher survival rates compared to the PE group, but this difference was not statistically significant (91.04% vs 83.07%, Logrank: P=0.094). Compared to PE, DPMAS+LPE showed no economic benefit at 30 days. At 90 days, each 1% increase in the survival rate with DPMAS+LPE required an additional $3013.68 in medical costs, demonstrating cost-effectiveness. In the cirrhosis subgroup, the 90-day average total medical cost of the DPMAS+LPE group was lower than that of the PE group. At a WTP threshold of $12,681, the probability of DPMAS+LPE being cost-effective was 14% at 30 days and 75% at 90 days. At a WTP of $38,043, these probabilities increased to 45% and 90%, respectively. Univariate sensitivity analysis demonstrated that variations in the 90-day survival rates and costs for both groups still favored DPMAS+LPE within the 95% confidence interval. However, when the number of DPMAS+LPE treatments exceeded 4.4, it was no longer cost-effective.

Conclusion: Compared to PE, DPMAS+LPE demonstrated cost-effectiveness at 90 days in early-stage HBV-ACLF patients, particularly those with cirrhosis. While DPMAS+LPE can be considered a suitable artificial liver therapy option for early-stage HBV-ACLF, careful consideration must be given to the number of treatments to ensure cost-effectiveness.

Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high internal validity. However, their vacuum-like research environment and standardized treatment approaches face significant challenges in traditional Chinese medicine (TCM), which emphasizes Treatment Tailored to Individual and Treatment Based on Syndrome Differentiation, focusing on personalized treatment according to a patient's constitution, age, gender, and lifestyle, and diagnosis based on specific syndromes. This approach lacks systematic modern clinical research and unified standards, conflicting with RCTs' standardized design, thus limiting TCM trials and posing serious challenges to its modernization and internationalization. This study systematically collected and categorized data on the registration status, study type, design, interventions and control measures, research objectives, primary outcome measures of registered trials by searching the ClinicalTrials.gov using TCM-related keywords. It reveals the current status and distribution patterns of TCM clinical registration trials. Evidence suggests that TCM clinical trials urgently need to seek a balance between standardized research and individualized treatment to address the limitations of RCTs in the TCM field, like implementation difficulties and the neglect of individual differences. To address this, the paper proposes an innovative research framework centered on pragmatic RCTs, highlighting randomization based on patient preferences to gather real-world evidence. Additionally, it suggests constructing a multidimensional core information set for standardized diagnosis of TCM syndromes by integrating disease and syndrome data to enhance diagnostic scientificity and increase the credibility and international acceptance of TCM clinical trials. The introduction of this framework effectively integrates the traditional characteristics of TCM with modern scientific methods, providing essential theoretical support and innovative solutions for the design and implementation of TCM clinical research, thereby enhancing TCM's role in global health.