Conectar
To explore associations between adverse birth outcomes and childhood overweight at 3–8 years of age.
A prospective cohort study.
Six central urban districts of Tianjin, China.
1681 woman–child pairs.
1681 woman–child pairs were followed up for 8 years in Tianjin, China. Demographic and clinical information including birth outcomes was collected longitudinally, commencing from first antenatal care visit till postpartum period. Offspring height and weight were measured at 3–8 years of age. High and low weight/length ratios (WLR) at birth were, respectively, defined as ≥90th and ≤10th gestational week and sex-specific percentiles. Overweight for children at 3–5 and 6–8 years of age were, respectively, defined as body mass index (BMI)-for-age and -sex above the 2 z-score and 1 z-score curves of the WHO’s child growth standards. Binary logistic regression analysis was used to obtain ORs and 95% CI with a stepwise backward selection method to select independent predictors.
Childhood overweight.
Of 1681 children, 10.7% (n=179) and 27.8% (n=468) developed overweight at 3–5 and 6–8 years of age, respectively. Large for gestational age (LGA) was associated with increased risk of overweight at 3–5 years of age (aOR: 1.86, 95% CI: 1.27 to 2.72) while high WLR at birth was associated with increased risk of overweight at 6–8 years of age (1.82, 1.41 to 2.34). Low WLR at birth was associated with decreased risk of overweight at 6–8 years of age (0.52, 0.30 to 0.90).
LGA and high WLR at birth predicted childhood overweight at 3–5 and 6–8 years of age, respectively. Low WLR at birth was associated with decreased risk of childhood overweight at 6–8 years of age.
This study measures the differences in inpatient performance after a points-counting payment policy based on diagnosis-related group (DRG) was implemented. The point value is dynamic; its change depends on the annual DRGs’ cost settlements and points of the current year, which are calculated at the beginning of the following year.
A longitudinal study using a robust multiple interrupted time series model to evaluate service performance following policy implementation.
Twenty-two public general hospitals (8 tertiary institutions and 14 secondary institutions) in Wenzhou, China.
The intervention was implemented in January 2020.
The indicators were case mix index (CMI), cost per hospitalisation (CPH), average length of stay (ALOS), cost efficiency index (CEI) and time efficiency index (TEI). The study employed the means of these indicators.
The impact of COVID-19, which reached Zhejiang Province at the end of January 2020, was temporary given rapid containment following strict control measures. After the intervention, except for the ALOS mean, the change-points for the other outcomes (p0.05), the uptrend of the CEI mean in tertiary institutions alleviated (p0.05).
This study showed a positive effect of the DRG policy in Wenzhou, even during COVID-19. The policy can motivate public general hospitals to improve their comprehensive capacity and mitigate discrepancies in treatment expenses efficiency for similar diseases. Policymakers are interested in whether the reform successfully motivates hospitals to strengthen their internal impetus and improve their performance, and this is supported by this study.
In view of the serious ageing of China’s population and the low desire of elderly people to purchase institutionalised elderly care services, we explored the willingness of Chinese elderly people to purchase institutionalised elderly care services and its influencing factors.
This was a cross-sectional study. Three multivariate logistic regression analysis models of the willingness of elderly people to purchase institutionalised elderly care services were established (model 1: ‘reluctance – willingness’; model 2: ‘reluctance – hesitation’; and model 3: ‘hesitation – willingness’) to explore the factors that influence elderly people’s willingness to purchase institutionalised elderly care services.
This study was based on the 2022 Psychology and Behaviour Investigation of Chinese Residents database.
Research data from 4123 older adults who met the requirements of this study were screened from the database.
Of the 4123 respondents, roughly equal numbers had negative and positive attitudes towards purchasing institutionalised senior care services (1125, 27.3% vs 1079, 26.2%, respectively), and 1919 (46.5%) had hesitant attitudes. The analysis of model 1 showed that medical insurance participation, the number of children and siblings, chronic diseases and per capita monthly household income had an influential effect on the willingness of elderly people to purchase institutional care. In model 2, we found that factors such as per capita monthly household income and anxiety led to hesitancy among older adults to purchase institutionalised senior care services. In model 3, we further found that social support and health literacy led to a shift from hesitation to willingness to purchase institutionalised elderly care services.
The number of children, number of siblings, per capita monthly income of the family, medical insurance participation, health status, health literacy and social support were found to be the main factors influencing the purchase of institutionalised care by elderly individuals.
To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it.
Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales.
Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022.
Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022.
Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines.
Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended.
The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.
A meta-analysis was conducted to comprehensively evaluate the impact of cluster nursing interventions on the prevention of pressure ulcers (PUs) in intensive care unit (ICU) patients. Computer searches were performed in databases including Embase, Google Scholar, Cochrane Library, PubMed, Wanfang and China National Knowledge Infrastructure for randomized controlled trials (RCTs) implementing cluster nursing interventions for PUs prevention in ICU patients, with the search period covering the database inception to November 2023. Two researchers independently screened the literature, extracted data and conducted quality assessments. Stata 17.0 software was employed for data analysis. Overall, 17 RCTs involving 1463 ICU patients were included. The analysis showed that compared with conventional nursing, cluster nursing interventions significantly reduced the incidence of PUs (odds ratio: 0.24, 95% confidence intervals [CI]: 0.17–0.34, p < 0.001) and also significantly improved the levels of anxiety (standardized mean difference [SMD]: −1.39, 95% CI: −1.57 to 1.22, p < 0.001) and depression (SMD: −1.64, 95% CI: −2.02 to 1.26, p < 0.001) in ICU patients. This study indicates that the application of cluster nursing interventions in ICU patients can effectively reduce the incidence of PUs, as well as improve patients' anxiety and depression levels, thereby enhancing their quality of life, which is worth clinical promotion and application.
Neoadjuvant chemoimmunotherapy is becoming an increasingly important part of the management of lung cancer to facilitate surgical resection. This study aimed to summarize the treatment-related adverse events (TRAEs) and wound complications of neoadjuvant chemoimmunotherapy in non-small cell lung cancer (NSCLC). Eligible studies of neoadjuvant chemoimmunotherapy for NSCLC were identified from PubMed, Embase and Web of Science. The endpoints mainly included TRAEs and wound complications. Stata18 software was used for statistical analysis with p < 0.05 considered statistically significant. Twenty studies including a total of 1072 patients were eligible for this study. Among the patients who received neoadjuvant chemoimmunotherapy, the pooled prevalence of any grade TRAEs was 77% (95% confidence interval [CI] [0.64–0.86]), grade 1–2 TRAEs was 77% (95% CI [0.58–0.89]) and grade ≥3 TRAEs was 26% (95% CI [0.16–0.38]). Surgery-related complications rate was 22% (95% CI [0.14–0.33]). Among the wound complications, the pooled rate of air leakage was 10% (95% CI [0.04–0.23]), pulmonary/wound infection was 8% (95% CI [0.05–0.13]), bronchopleural fistula was 8% (95% CI [0.02–0.27]), bronchopulmonary haemorrhage was 3% (95% CI [0.01–0.05]), pneumonia was 5% (95% CI [0.02–0.10]), pulmonary embolism was 1% (95% CI [0.01–0.03]), pleural effusion was 7% (95% CI [0.03–0.14]) and chylothorax was 4% (95% CI [0.02–0.09]). Overall, neoadjuvant chemoimmunotherapy in NSCLC results a high incidence of grade 1–2 TRAEs but a low risk of increasing the incidence of ≥3 grade TRAEs and wound complications. These results need to be confirmed by more large-scale prospective randomized controlled trials and studies.
This study aims to comprehensively compare the effects of unicondylar knee arthroplasty (UKA) and high tibial osteotomy (HTO) on wound infection and pain in patients with medial knee osteoarthritis. A computerized search was conducted in Embase, PubMed, Google Scholar, China National Knowledge Infrastructure, Cochrane Library and Wanfang databases, from database inception to October 2023, for studies comparing UKA and HTO for medial knee osteoarthritis. Studies selection, data extraction and study quality evaluation were independently conducted by two researchers. Stata 17.0 software was employed for data analysis. Overall, 10 studies involving 870 patients with medial knee osteoarthritis were included. It was found that the UKA group had significantly lower wound visual analogue scale scores compared to the HTO group (SMD = -0.53, 95%CI: −0.87 to −0.20, p < 0.001). The incidence of wound infection in the UKA group was higher than in the HTO group (OR = 1.92, 95%CI: 0.65–5.69, p = 0.240), and the incidence of complications was lower (OR = 0.89, 95%CI: 0.52–1.54, p = 0.684), though these differences were not statistically significant. This study indicates that UKA is effective in alleviating postoperative wound pain in medial knee osteoarthritis. However, the rates of postoperative wound infection and complications are comparable to those of HTO. Clinicians should consider factors such as patient age and disease severity in making individualized treatment decisions.
Pharyngocutaneous fistula (PCF) is a major complication after total laryngectomy, with significant morbidity and mortality. Whether mechanical stapler closure of the pharynx reduces fistula rates compared to hand-sewn techniques remains unclear. We conducted an updated systematic review and meta-analysis to clarify this question. Five databases were systematically searched from inception through November 2023 for studies comparing stapler versus suture closure for fistula outcomes after laryngectomy. Odds ratios (OR) were pooled using random-effects models and fixed-effects models. Subgroup and sensitivity analyses were performed. Risk of bias was appraised using NHLBI tools. Nine studies with 803 patients were included. Mechanical closure significantly reduced fistula incidence versus suture closure (OR = 0.57, 95% CI 0.34–0.95, p = 0.03). Subgroup analysis found that stapling's protective effect varied by patient age, country/region, linear stapler size and female percentage. Stapling reduced fistula odds by 80% in the Turkey subgroup (OR = 0.20, 95% CI 0.09–0.50) but showed no benefit in other regions. Patients <60 years showed an 84% fistula reduction with stapling (OR = 0.17, 95% CI 0.06–0.45), whereas older subgroups did not. Linear stapler size of 60 mm significantly reduced fistula occurrence while 75 mm did not. There was no evidence that low female percentage mitigated stapling benefits. Mechanical stapler closure after total laryngectomy meaningfully reduces the likelihood of postoperative PCF formation compared to hand-sewn closure, especially for patients younger than 60 years old. The absolute risk reduction supports its utility to prevent this complication.
Diabetic foot ulcers (DFUs) are a serious chronic complication of diabetes mellitus and a leading cause of disability and death in diabetic patients. However, current treatments remain unsatisfactory. Although macrophages are associated with DFU, their exact role in this disease remains uncertain. This study sought to detect macrophage-related genes in DFU and identify possible therapeutic targets. Single-cell datasets (GSE223964) and RNA-seq datasets (GSM68183, GSE80178, GSE134431 and GSE147890) associated with DFU were retrieved from the gene expression omnibus (GEO) database for this study. Analysis of the provided single-cell data revealed the distribution of macrophage subpopulations in the DFU. Four independent RNA-seq datasets were merged into a single DFU cohort and further analysed using bioinformatics. This included differential expression (DEG) analysis, multiple machine learning algorithms to identify biomarkers and enrichment analysis. Finally, key results were validated using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and Western bolt. Finally, the findings were validated using RT-qPCR and western blot. We obtained 802 macrophage-related genes in single-cell analysis. Differential expression analysis yielded 743 DEGs. Thirty-seven macrophage-associated DEGs were identified by cross-analysis of marker genes with macrophage-associated DEGs. Thirty-seven intersections were screened and cross-analysed using four machine learning algorithms. Finally, HMOX1 was identified as a potentially valuable biomarker. HMOX1 was significantly associated with biological pathways such as the insulin signalling pathway. The results showed that HMOX1 was significantly overexpressed in DFU samples. In conclusion, the analytical results of this study identified HMOX1 as a potentially valuable biomarker associated with macrophages in DFU. The results of our analysis improve our understanding of the mechanism of macrophage action in this disease and may be useful in developing targeted therapies for DFU.
Complex fractures present significant challenges in orthopaedic surgery, particularly in terms of postoperative wound healing. Nutritional status plays a crucial role in the recovery process, with early nutritional support potentially influencing wound healing outcomes. This meta-analysis aimed to assess the impact of early nutritional interventions on postoperative wound healing and scar formation in patients with complex fractures. From an initial pool of 1742 articles, 7 studies were selected for analysis. The results revealed that preoperative nutritional support significantly improved early wound healing, as indicated by lower REEDA scores (SMD = −14.06, 95% CI: [−16.79, −11.32], p < 0.01) 1 week post-surgery. Furthermore, there was a notable reduction in scar formation, as demonstrated by lower Manchester Scar Scale scores (SMD = −25.03, 95% CI: [−30.32, −19.74], p < 0.01) 3 months post-surgery. These findings highlight the importance of incorporating nutritional strategies into the management of complex fractures to optimize postoperative recovery.
This study aims to investigate the role of anoikis-related genes in diabetic foot (DF) by utilizing bioinformatics analysis to identify key genes associated with anoikis in DF. We selected the GEO datasets GSE7014, GSE80178 and GSE68183 for the extraction and analysis of differentially expressed anoikis-related genes (DE-ARGs). GO analysis and KEGG analysis indicated that DE-ARGs in DF were primarily enriched in apoptosis, positive regulation of MAPK cascade, anoikis, focal adhesion and the PI3K-Akt signalling pathway. Based on the LASSO and SVM-RFE algorithms, we identified six characteristic genes. ROC curve analysis revealed that these six characteristic genes had an area under the curve (AUC) greater than 0.7, indicating good diagnostic efficacy. Expression analysis in the validation set revealed downregulation of CALR in DF, consistent with the training set results. GSEA results demonstrated that CALR was mainly enriched in blood vessel morphogenesis, endothelial cell migration, ECM-receptor interaction and focal adhesion. The HPA database revealed that CALR was moderately enriched in endothelial cells, and CALR was found to interact with 63 protein-coding genes. Functional analysis with DAVID suggested that CALR and associated genes were enriched in the phagosome component. CALR shows promise as a potential marker for the development and treatment of DF.
Shame has an important impact on the mental health and quality of life of patients. The shame in patients with ureterostomy after cystectomy remains unclear. This survey aimed to evaluate the status quo and influencing factors of shame in patients with ureterostomy after cystectomy, to provide support for the clinical care. Patients with ureterostomy after cystectomy treated in the wound stomy clinic of a third-class hospital from 1 June 2022 to 31 July 2023 were included. General data questionnaire and social impact scale (SIS) were used for data collection. Univariate and multiple linear regression analysis were performed to evaluate the influencing factors of shame in patients with ureterostomy after cystectomy. One hundred and sixty four patients with ureterostomy after cystectomy were included. The total score of shame in patients with ureterostomy was (60.75 ± 6.31), which was in the high level. Age (r = 0.442), home place (r = 0.427), per capita monthly household income (r = 0.605), self-care ability (r = 0.597) and complications of stoma (r = 0.542) were correlated with the SIS score in patients with ureterostomy after cystectomy (all p < 0.05). Multiple linear regression analyses indicated that age, home place, per capita monthly household income, self-care ability and complications of stoma were the influencing factors of SIS score in patients with ureterostomy after cystectomy (all p < 0.05). The five variables explained 64.5% of the patients' sense of shame variation. Patients with ureterostomy after cystectomy have a serious sense of shame in the early stage after operation and there are many influencing factors. Health care providers should take early nursing interventions targeted on those influencing factors to reduce the patients' sense of shame.
Following pancreatic resection, there may be a variety of complications, including wound infection, haemorrhage, and abdominal infection. The placement of drainage channels during operation may decrease the chances of postoperative complications. However, what kind of drainage can decrease the rate of postoperative complications is still a matter of debate. The purpose of this research is to evaluate the efficacy of both active and passive drainage for post-operation wound complications. From the beginning of the database until November 2023, EMBASE, the Cochrane Library and the Pubmed database have been searched. The two authors collected 2524 related studies from 3 data bases for importation into Endnote software, and 8 finished trials were screened against the exclusion criteria. Passive drainage can decrease the incidence of superficial wound infection in postoperative patients with pancreas operation (Odds Ratio [OR], 1.30; 95% CI, 1.06–1.60 p = 0.01); No statistically significant difference was found in the incidence of deep infections among the two groups (OR, 1.51; 95% CI, 0.68–3.36 p = 0.31); No statistical significance was found for the rate of haemorrhage after active drainage on the pancreas compared with that of passive drainage (OR, 0.72; 95% CI, 0.29–1.77 p = 0.47); No statistically significant difference was found in the rate of death after operation for patients who had received a pancreas operation in active or passive drainage (OR, 0.90; 95% CI, 0.57–1.42 p = 0.65); On the basis of existing evidence, the use of passive abdominal drainage reduces postoperative surface wound infections in patients. But there were no statistically significant differences in the risk of severe complications, haemorrhage after surgery, or mortality. However, because of the limited sample size of this meta-analysis, it is necessary to have more high-quality research with a large sample size to confirm the findings.
The purpose of the meta-analysis was to evaluate and compare the photodynamic therapy's effectiveness in treating infected skin wounds. The results of this meta-analysis were analysed, and the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) were calculated using dichotomous or contentious random- or fixed-effect models. For the current meta-analysis, 6 examinations spanning from 2013 to 2021 were included, encompassing 154 patients with infected skin wounds were the used studies' starting point. Photodynamic therapy had a significantly lower wound ulcer size (MD, −4.42; 95% CI, −7.56–−1.28, p = 0.006), better tissue repair (MD, −8.62; 95% CI, −16.76–−0.48, p = 0.04) and lower microbial cell viability (OR, 0.13; 95% CI, 0.04–0.42, p < 0.001) compared with red light exposure in subjects with infected skin wounds. The examined data revealed that photodynamic therapy had a significantly lower wound ulcer size, better tissue repair and lower microbial cell viability compared with red light exposure in subjects with infected skin wounds. However, given that all examinations had a small sample size, consideration should be given to their values.
Kawasaki disease (KD) is one of the most challenging diseases that is defined as an acute vasculitis that affects the coronary arteries primarily in children. It causes complications if left untreated at early stages, ultimately leading to death. Corticosteroids have been recognized to treat and cause great impact on the patients with KD. Glucocorticoid is one of the main corticosteroids that are being used to treat KD and cutaneous wounds. However, ineffectiveness of a few glucocorticoids can limit the efficacy of this treatment. This study particularly aimed to elucidate the impact of glucocorticoids on cutaneous wounds in KD. To perform the meta-analysis, a comprehensive literature survey was conducted to unveil the studies and research conducted on Kawasaki patients that revealed different glucocorticoids in the form of specific interventions influencing KD. The literature was searched using numerous keywords, screened and data was extracted to perform the meta-analysis and then it was conducted using the metabin function of R package meta. A total of 2000 patients from both intervention and control groups were employed to carry out the meta-analysis to analyse and evaluate the impact of glucocorticoids on curing KD and cutaneous wounds in patients. The results disclosed that glucocorticoids along with other steroids, mainly IVIG (intravenous immunoglobulin), was an effective intervention to patients suffering from Kawasaki. The results depicted significant outcomes with the values (risk ratio [RR]: 1.08, 95% confidence interval [CI]: 0.58–2.00, p < 0.01) and enlightened the fact that adopting different glucocorticoids may significantly improve the efficacy of skin lesions along with KD. Hence, interventions of glucocorticoids must be utilized in the clinical practice to reduce the incidence of skin wounds and adverse effects caused due to KD.
We conducted this study aimed to examine the impact of evidence-based nursing interventions on postoperative wound pain and complications after surgery for finger tendon injury. A total of 86 patients treated for finger tendon injuries at our hospital from January 2021 to October 2023 were selected and randomly divided into an experimental group and a control group. The control group received conventional nursing care, while the experimental group received evidence-based nursing interventions. The study compared the postoperative wound pain intensity, incidence of complications and patient satisfaction with nursing care between the two groups. The analysis revealed that compared with conventional care, evidence-based nursing interventions significantly reduced the level of wound pain (p = 0.034) and the incidence of complications (4.65% vs. 18.60%, p = 0.043). It also increased patient satisfaction with the nursing care (97.67% vs. 83.72%, p = 0.026). The study indicates that the application of evidence-based nursing interventions for patients with finger tendon injuries can reduce postoperative wound pain, decrease the incidence of complications and enhance patient satisfaction with nursing care.
Few studies have shown that radial artery (RA), which is used as a secondary arterial graft, offers superior results compared with right internal thoracic artery (RIMA) in coronary artery bypass grafting (CABG). In a meta-analysis of observational studies starting in 2023, we looked at the effect of re-operation on postoperative infection and haemorrhage in CABG with RA vs. RIMA. The electronic database up to October 2023 was examined in the course of the research. Analysis was carried out on the clinical trials of postoperative wound infections and haemorrhage re-surgery. Among 912 trials associated with CABG, we selected 8 trials to be included in the final data analysis. The main results were secondary wound infection and re-operation after surgery. The odds ratios (OR) and confidence intervals (CIs) were computed on the basis of a randomized or fixed-effect model of wound infection and re-operation. Seven trials showed a significant reduction in the risk of wound infection in RA treated as a secondary artery transplant compared with RIMA (OR, 1.60; 95% CI, 1.03, 2.47 p = 0.04); Four trials showed that RIMA was not significantly different from RA in the rate of re-operation for postoperative bleeding (OR, 1.31; 95% CI, 0.60, 2.88 p = 0.50). In CABG, RA is used as a secondary arterial conduit graft to lower the risk of wound infection in CABG patients.
Achilles tendon ruptures are common in athletes, requiring surgical intervention. However, the risk of surgical site infections (SSIs) post-surgery poses significant challenges. This study aims to analyse the risk factors and microbial aetiology associated with SSIs in athletes undergoing Achilles tendon repair. A comprehensive retrospective analysis was conducted from May 2021 to July 2023. The study included 25 patients with SSIs (case group) and 50 patients without SSIs (control group) post Achilles tendon repair surgery. Inclusion criteria encompassed patients with medically confirmed Achilles tendon ruptures who underwent surgical repair. Exclusion criteria included prior tendon pathologies and significant chronic illnesses. Diagnostic criteria for SSIs involved symptoms like elevated body temperature and localized tenderness, along with laboratory confirmations such as positive microbiological cultures. The study utilized VITEK® 2 for bacterial identification and involved statistical analyses like univariate and multivariate logistic regression. The study identified Staphylococcus aureus as the primary pathogen in SSIs. Significant risk factors included lack of prophylactic antibiotic use, presence of diabetes, open wounds and prolonged surgery duration. Univariate analysis revealed stark contrasts in these factors between infected and non-infected groups, while multivariate analysis underscored their importance in SSI development. S. aureus emerged as the predominant pathogen in SSIs post Achilles tendon repair. Critical risk factors such as absence of prophylactic antibiotics, diabetes, open wounds and extended surgery duration play a vital role in SSIs. Addressing these factors is essential for better postoperative outcomes in Achilles tendon repair surgeries.
At present, it is still controversial whether patients in intensive care unit (ICU) use tracheal intubation with or without cuff. This paper evaluates the effect of tracheal intubation with and without cuff on overall complication rate of patients with intubation in ICU. The database of PubMed, Embase, Conchrane Library and Web of Science was searched by computer, and the clinical research on intubation with and without cuff in ICU was collected. The time range was from the database establishment to November 2023. Literature was independently screened, information was extracted, and quality was assessed by two researchers. Finally, there were nine studies included, with 11 068 patients (7391 in cuff group and 3677 in non-cuff group). The results showed that the overall complication rate of cuff group was significantly lower than that of non-cuff group, and that of cuff group (RR = 0.53, p < 0.01). In addition, compared with the non-cuff group, the cuff group had a lower number of tracheal intubation changes [RR = 0.05, p < 0.01] and a lower incidence of aspiration pneumonia (RR = 0.45, p = 0.01). Compared with the non-cuff group, the cuff group had a higher incidence of oral mucosal ulcers and pharyngitis (RR = 1.99, p = 0.04), while the cuff group had a lower incidence of laryngeal edema (RR = 0.39, p < 0.01). In ICU intubation patients, the use of cuffs reduces overall complication rate in comparison to patients without cuffs. Therefore, patients with intubation in ICU can recommend tracheal intubation with cuff.
The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.
The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.
The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.
The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.
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