Objective:To provide reference for improving the ability of Investigator-Initiated Trials (IIT) research ethics review in the new era by analyzing the situation of clinical research projects and ethical review in hospitals under the increasingly standardized management requirements of clinical research.Methods:Taking the IIT projects reviewed by the Ethics Committee of our Institute from 2012 to 2023 as examples, the development trend, types, characteristics and the situation of ethical review were comprehensively compared and analyzed.Results:From 2012 to 2023, the number of IIT projects in our hospital increased rapidly, especially the multi-center and high-risk projects. IIT researches in the field of oncology and neurology are hot topics at present. After the addition of scientific review, the passing rate of ethical review increased. After the promulgation of the new regulations, the application rate of follow-up examination increased to a certain extent.Conclusions:In view of the current types and distribution characteristics of IIT, as well as key weaknesses in ethical review, the ethics Committee should strengthen the qualification management of main researchers and research teams, standardize the annual follow-up review of IIT research through multiple channels such as research ethics education and information platform, promote the establishment of the responsibility system of research liaison officers, and improve the review process of off-label drug use research. High-risk IIT projects should strengthen ethical supervision, case-by-case reporting and tracking system, and vulnerable groups projects should strengthen ethical review and supervision of informed consent process, and explore the establishment of a high-quality ethical management system from the above aspects.

Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T _NANC), time to symptom improvement (T _SI), and time of hospital stay (T _HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T _NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.

Objective To explore the application effect of nursing intervention based on empow-erment theory in treatment of facial photoaging with fractional ablative fractional laser.Methods A total of 90 patients with facial photoaging who underwent fractional ablative fractional laser treatment were selected and divided into control group and observation group according to random number table method,with 45 cases in each group.The control group received routine nursing intervention,while the observation group received nursing intervention based on empowerment theory.The skin condi-tion,the incidence of adverse reactions,psychological state[Self-Rating Anxiety Scale(SAS),Self-Rating Depression Scale(SDS)]scores,and quality of life[Dermatology Life Quality Index(DLQI)]scores were compared between the two groups.Results After intervention,the percentages of skin characteristics such as enlarged facial pores,wrinkles,and spots in the observation group were higher than those in the control group;the incidence of adverse reactions in the observation group was lower than that in the control group(8.89％ versus 24.44％);the SAS scores,SDS scores,and total DLQI scores in the observation group were lower than those in the control group,with statistically sig-nificant differences(P＜0.05).Conclusion Nursing intervention based on empowerment theory can effectively improve the facial skin condition of patients with facial photoaging treated with fraction-al ablative fractional laser,reduce the incidence of adverse reactions,alleviate negative emotions,and enhance quality of life.

Cardiovascular disease remains a significant factor leading to patient mortality and influencing outcomes during the perioperative period.Dexmedetomidine is an α2-adrenergic receptor agonist with functions such as analgesia,sedation,and anti-anxiety.This review summarizes various types of findings regarding dexmedetomidine in myocardial ischemia/reperfusion injury and conducts in-depth discussions on the corresponding mechanisms of the results,aiming to further clarify the potential cardioprotective effects of dexmedetomidine in patients with heart diseases.

Objective:To explore the experiences of post-traumatic growth in patients with failed assisted reproductive technology (ART), providing a basis for individualized nursing interventions.Methods:This study was a qualitative study. From November to December 2023, purposive sampling was used to select ART failed patients at Reproductive Medicine Center of Affiliated Hospital of Nantong University as participants. Data was collected through semi-structured in-depth interviews, and Colaizzi 7-step analysis method was used to summarize and analyze the data and extract themes.Results:A total of 15 ART failed patients were included, their age was (31.8±3.6) years, years of infertility was (4.7±1.7) years. After analysis, a total of four themes and nine sub-themes were extracted, namely negative emotional experiences in the early stages of trauma (anxiety and depression, psychological stress) ; diversified support systems (family support, social support) ; positive coping styles (positive binary coping between spouses, individual coping) ; post-traumatic growth experiences (mobilizing one's own positive strength, strengthening altruistic awareness, and re-planning the future) .Conclusions:Infertility patients exhibit negative emotions after experiencing ART failure, but also experience post-traumatic growth. Medical and nursing staff should provide targeted guidance based on the psychological state of ART failed patients at different stages to improve their mental health.

Objective:To carry out a scoping review on eHealth literacy in patients with cardiovascular disease to sort out eHealth literacy from four aspects of concepts, assessment tools, influencing factors and interventions, with a view to informing future research and practice.Methods:Based on Arksey and O'Malley's framework for reporting scoping reviews, the literature on eHealth literacy in patients with cardiovascular disease was systematically searched in PubMed, Web of Science, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure, VIP, Wanfang Data, and China Biomedical Database. The search period was from database establishment to May 3, 2024. Literature was screened, summarized and analyzed.Results:A total of 23 papers were included. The concepts and theoretical frameworks on eHealth literacy had their own focus, but no consensus was reached. The most commonly used tool to assess eHealth literacy in patients with cardiovascular disease was the eHealth Literacy Scale. The influencing factors included four aspects of demographic sociological and disease-related factors, psycho-cognitive factors, eHealth literacy knowledge and skills, and other factors. Interventions to improve eHealth literacy among patients with cardiovascular disease primarily included eHealth literacy training and use of portal-related digital toolkit.Conclusions:Currently there is no specific assessment tool for eHealth literacy for cardiovascular disease patients. In the future, eHealth literacy assessment tools need to be revised and improved according to the population characteristics and cultural background of cardiovascular disease patients. E-health literacy among patients with cardiovascular disease is at a moderately low level and is influenced by multiple factors. The influencing factors can be analyzed in depth through large-sample cross-sectional studies or longitudinal studies, and then a variety of intervention programs can be constructed at home or in the community with the help of multimedia and apps, with a view to improving the e-health literacy of patients with cardiovascular diseases.

Objective:To systematically analyze the prevalence and influencing factors of psychiatric comorbidities in refractory epilepsy (RE) .Methods:The literature on the prevalence and/or influencing factors of psychiatric comorbidities in adults with RE was electronically searched in China National Knowledge Infrastructure, WanFang Data, VIP, China Biomedical Database, PubMed, Web of Science, Embase, CINAHL, OVID, UpToDate, and Cochrane Library. The search period was from the establishment of the database to July 31, 2024. Two researchers independently conducted literature screening, quality assessment and data extraction, and used RevMan 5.4 for Meta-analysis.Results:A total of 11 papers were included, with a total sample size of 1 953 cases, with a prevalence of 52.00% (cross sectional studies) and 53.00% (cohort studies) . Gender [ OR=4.76, 95% CI (3.69, 6.15) ] , epilepsy disease perception [ OR=1.10, 95% CI (1.01, 1.19) ] , seizure type [ OR=1.63, 95% CI (1.23, 2.15) ] , seizure frequency [ OR=1.54, 95% CI (1.04, 2.29) ] , epileptogenic foci location [ OR=2.72, 95% CI (1.69, 4.37) ] , disease duration [ OR=1.76, 95% CI (1.39, 2.24) ] , and medication [ OR=3.26, 95% CI (2.09, 5.08) ] were the influencing factors of psychiatric comorbidity in RE. Conclusions:The prevalence of psychiatric comorbidities in patients with RE is high, and studies of influencing factors lack specificity. Clinical monitoring of this population should be strengthened, and relevant influencing factors should be comprehensively analyzed to provide intervention targets for early preventive management and to safeguard the long-term management of patients with epilepsy.

Objective:To analyze the risk factors for muscle cramps in maintenance hemodialysis patients and construct a nomogram prediction model.Methods:It was a retrospective cohort study. Patients undergoing regular hemodialysis at the Blood Purification Center of the Fourth Hospital of Hebei Medical University (West and East Campuses) from June 2023 to December 2023 were enrolled in this study. Patients were divided into a muscle cramps group and a non-muscle cramps group based on whether cramps occurred during or after dialysis. Patients from the West Campus were allocated to the training set, while those from the East Campus were assigned to the validation set, with an approximately 5∶1 ratio. Multivariate logistic regression analysis was used to identify risk factors for muscle cramps in the training set. A nomogram prediction model was constructed using R software. Model performance was evaluated using the receiver operating characteristic curve (ROC), calibration curve, and decision curve analysis in both the training and validation sets.Results:A total of 498 maintenance hemodialysis patients were enrolled, including 409 in the training set (22.98% incidence of muscle cramps) and 89 in the validation set. Multivariate logistic regression analysis revealed that heart failure history ( OR=8.566, 95% CI 2.448-29.979, P=0.001), pre-dialysis corrected narrowed inferior vena cava width ( OR=0.531, 95% CI 0.433-0.650, P<0.001), increased ultrafiltration rate ( OR=1.002, 95% CI 1.001-1.003, P=0.002), decreased hemoglobin level ( OR=0.971, 95% CI 0.948-0.994, P=0.014), and decreased serum albumin ( OR=0.886, 95% CI 0.799-0.982, P=0.021) were independent associated factors for muscle cramps in the training set. The nomogram model based on these factors demonstrated an area under the ROC curve ( AUC) of 0.813 (95% CI 0.760-0.866, P<0.001) in the training set, with a Brier score of 0.129, indicating stable predictive performance. In the validation set, the area under of the ROC curve was 0.821 (95% CI 0.731-0.911, P<0.001) with a Brier score of 0.142. The decision curve showed that the model provided high clinical net benefit when the risk threshold probability for muscle cramps ranged from 0.22 to 0.77. Conclusion:Combined heart failure, narrowed inferior vena cava width, increased ultrafiltration rate, and decreased hemoglobin and serum albumin levels were the independent correlated factors for muscle spasm in maintenance hemodialysis patients. The nomogram model constructed based on these risk factors holds significant clinical value for predicting muscle cramps in maintenance hemodialysis patients.

Objective:To investigate the clinical characteristics and prognosis of T-lymphoblastic lymphoma (T-LBL).Methods:A retrospective case series study was conducted. Clinical data of patients diagnosed with T-LBL at the Affiliated Hospital of Jining Medical University from January 2013 to March 2023 were retrospectively analyzed, and their clinical characteristics and prognosis were statistically analyzed.Results:A total of 22 T-LBL patients were included. Among them, there were 19 males (86.4%) and 3 females (13.6%), and the median age at onset was 19.5 (15, 28) years old. Based on Ann Arbor staging, 3 cases (13.6%) were classified as stage Ⅰ-Ⅱ, while 19 cases (86.4%) were stage Ⅲ-Ⅳ; 10 cases (45.5%) presented with B symptoms, 12 cases (54.5%) without B symptoms; 16 cases (72.7%) showed elevated lactic dehydrogenase (LDH) level. At onset, 7 patients (31.8%) had mediastinal masses, 3 patients (13.6%) had central nervous system involvement, and 17 patients (77.3%) had bone marrow involvement. The overall response rate (ORR) and complete remission rate among the 22 patients were 81.82% (18/22) and 31.82% (7/22), respectively. The ORR was 84.21% (16/19) in 19 patients treated with ALL-like regimens. Among 3 patients treated with NHL-like regimens, 1 case achieved complete remission and 1 case achieved partial remission. Seven patients received allogeneic hematopoietic stem cell transplantation, with a median overall survival (OS) time of 22 months; the median OS time of patients without allogeneic hematopoietic stem cell transplantation was 14 months. The 3-year OS rates in the allogeneic hematopoietic stem cell transplantation group and group without allogeneic hematopoietic stem cell transplantation were 64.30% and 16.00%, and the difference in OS between the two groups was statistically significant ( P = 0.043). Two patients with disease progression prior to transplantation died of multidrug-resistant bacterial infections after transplantation. Conclusions:T-LBL is rare, and it is a highly aggressive tumor that predominantly occurs in adolescent males. Allogeneic hematopoietic stem cell transplantation can prolong OS, reduce relapse and improve the prognosis of patients.

ObjectiveTo evaluate the effectiveness of stone needle thermocompression and massage compared to flurbiprofen gel patch in relieving chronic musculoskeletal pain in the shoulder and back， and to explore the potential mediating mechanism through muscle elasticity. MethodsA total of 120 patients with chronic musculoskeletal pain in the shoulder and back were randomly assigned to either stone needle group or flurbiprofen group， with 60 patients in each. The stone needle group received stone needle thermocompression and massage for 30 minutes， three times per week； the flurbiprofen group received flurbiprofen gel patch twice daily. Both groups were treated for 2 weeks. Pain improvement， as the primary outcome， was assessed using the Global Pain Scale （GPS） at baseline， after 2 weeks of treatment， and again 2 weeks post-treatment. To explore potential mechanisms， a mediator analysis was conducted by measuring changes in superficial and deep muscle elasticity using musculoskeletal ultrasound at baseline and after the 2-week treatment period. ResultsThe stone needle group showed significantly greater pain relief than the flurbiprofen group 2 weeks post-treatment. After adjusting for confounders related to pain duration， the between-group mean difference was -8.8 ［95% CI （-18.2， -0.7）， P＜0.05］. Part of the therapeutic effect was mediated by changes in deep muscle elasticity， with a mediation effect size of -1.5 ［95% CI （-2.0， -0.9）， P = 0.024］， accounting for 17.9% of the total effect. ConclusionStone needle thermocompression and massage can effectively relieve chronic musculoskeletal pain in the shoulder and back， partly through a mediating effect of improved deep muscle elasticity.