Driven by the growing practical need to accelerate drug development and the continuous innovation of trial design in recent years， the number of protocol amendments during clinical trials have gradually increased， and the changed contents have become more flexible and complex， which significantly heightens the difficulty of ethical review on amendments. Against this backdrop， it is of great importance to fully leverage the role and responsibilities of ethics committees， effectively control clinical trial risks， and ensure subject safety. This paper analyzed development trends of protocol amendments in recent years， sorted out requirements for protocol amendments in Chinese regulations and guiding principles， and examined difficulties of amendment ethical review in practical work. Based on these， targeted strategies and recommendations were proposed， namely， strengthening the integration with scientific review， enhancing the formal review， adjusting the scope of review according to approval notifications， and adopting appropriate review methods， with a view to providing insights and references for the management of the amendment ethical review in drug clinical trials.

Chronic post-surgical pain (CPSP) is a common long-term complication following lung surgery. Its high incidence significantly impacts patients’ quality of life and functional recovery, and imposes a substantial socioeconomic burden. This consensus aims to systematically establish a standardized integrated Chinese and Western medicine diagnostic and treatment framework for chronic post-lung surgery pain (CPLSP). Based on the latest domestic and international evidence-based medical research and multidisciplinary clinical experience, the working group comprehensively elaborates on core issues regarding CPLSP, including its definition, epidemiology, pathogenesis, clinical assessment, Western medical treatment, traditional Chinese medicine (TCM) treatment, and integrated strategies. The consensus emphasizes a patient-centered approach, adhering to the principles of multimodality, individualization, and stepwise management, highlighting the synergistic advantages of integrating Chinese and Western medicine throughout the entire perioperative management cycle encompassing "perioperative anti-inflammation, acute analgesia, and chronic rehabilitation." Through systematic literature retrieval and evidence integration, a total of 9 core recommendations were established to provide scientifically sound and clinically practical guidance.

Objective: To explore the association between dietary inflammatory index (DII) and elevated blood pressure among primary school students, and to analyze the mediating role of body mass index (BMI) in this association, so as to provide a scientific basis for the early prevention of childhood hypertension and dietary guidance. Methods: Research conducted based on the Ma anshan Child Growth Cohort in Anhui Province. From April to June 2024, 4 057 primary school students were selected as study subjects using a multi stage cluster sampling method. Dietary information was collected via Semi quantitative Food Frequency Questionnaire to calculate the DII score. BMI was obtained by measuring students height and weight. Elevated blood pressure was defined based on the Blood Pressure Reference Standards for Children Aged 3-17 Years. Logistic regression was used to analyze the association between DII scores and the risk of elevated blood pressure, and the Bootstrap method was employed to test for mediating effects. Results: The detection rate of elevated blood pressure among primary school students was 10.1% (408 cases). Multivariate Logistic regression analysis showed that, after adjusting for covariates such as gender and age, for each standard deviation increase in the DII score ( s =1.94), the risk of elevated blood pressure increased by 15% ( OR =1.15, 95% CI =1.04- 1.28 , P <0.05). Compared with the lowest quartile group of DII scores ( Q 1), students in the highest quartile group ( Q 4) had a 1.31-fold higher risk of elevated blood pressure ( OR =1.31, 95% CI =1.00-1.76, P <0.05). Restricted cubic spline results indicated a linear dose response relationship between DII scores and the risk of elevated blood pressure( P nonlinear =0.13). The mediation analysis revealed that BMI played a partial mediating role in the association between DII scores and elevated blood pressure. The mediation effect value was 0.06 (95% CI =0.04-0.08), accounting for 44.64% of the total effect. Conclusions DII scores are associated with elevated blood pressure among primary school students in Ma anshan City, and BMI plays a partial mediating role in this association. Promoting an anti inflammatory dietary pattern and weight control in early childhood should be emphasized to reduce the incidence of hypertension among primary school students.

Endodontic microsurgery (EMS) is an oral surgical procedure that utilizes the magnification and illumination provided by a microscope. Fine instruments are used to remove periapical diseased tissues, resect the root apex, and tightly seal the root canal system, aiming to promote the healing of periapical tissues and retain the affected tooth whenever possible. Precise localization and resection of the root apex have always been challenging in EMS. The application of digital technology in EMS can address many issues in traditional endodontic microsurgery. Digital technology offers advantages such as optimizing surgical planning, providing precise positioning guidance, and enhancing operational accuracy. Currently, the commonly used digital technologies in EMS include static and dynamic navigation technologies and oral surgical robots. Static navigation technology enhances surgical predictability through precise preoperative planning and guided fabrication, yet is constrained by its inability to adjust during surgery. Dynamic navigation technology excels in real-time tracking and intraoperative flexibility but demands high hand-eye coordination from surgeons and may be hindered by bulky handheld devices. Oral surgical robots reduce hand tremors and human error in surgery with their high precision, stability, and ability to adjust in real time, but their clinical applicability is limited and their cost is high. In clinical practice, tailored combinations of these technologies can be applied based on case complexity. For simple cases with well-defined anatomy, static navigation alone may suffice. For complex anatomical cases, static navigation can provide initial planning, supplemented by dynamic navigation for real-time guidance or robotic systems for high-precision execution. This paper discusses the workflow, clinical application status and advantages and limitations of these three digital technologies in EMS. The continuous development of digital technology is expected to simplify the operation process, improve the navigation accuracy, and reduce the operation cost. It is believed that with continuous improvement and optimization, these technologies will effectively break through the current bottleneck of the cost of equipment, operation complexity, and accuracy enhancement. These technologies are also expected to further expand the application boundaries, providing more minimally invasive, precise, and time-saving personalized treatment solutions for endodontic diseases.

The surgical management of empyema (excluding those caused by mycobacterium tuberculosis and non-tuberculous mycobacteria) is rapidly evolving towards minimally invasive, precise, and stepwise approaches. The traditional three-stage classification (exudative, fibrinopurulent, and organizing) has limitations in guiding dynamic clinical decision-making. For the first time, this consensus explicitly identifies two critical junctures in the pathological progression of empyema: "early transformation" (stage Ⅰ to Ⅱ) and "late transformation" (stage Ⅱ to Ⅲ), and thereby constructs a corresponding "identification-early warning-intervention" stepwise therapeutic framework. The consensus emphasizes that proactive debridement via video-assisted thoracoscopic surgery should be performed during the early transformation phase to halt disease progression. Conversely, during the late transformation phase, therapeutic goals should be rationally adjusted to prioritize adequate drainage, avoiding futile pleural decortication. Moreover, the consensus underscores the pivotal role of precise perioperative etiological diagnosis (e.g. metagenomic nest-generation sequencing) and standardized anti-infective therapy. Integrating practical experiences from multiple thoracic surgery centers in China and relevant evidence-based literature, this consensus formulates recommendations on the precise definitions of staging, surgical indications for each phase, key technical points, perioperative management, and training systems. It aims to promote the standardized and individualized surgical management of empyema, ultimately optimizing patient prognosis.

Objective To investigate the expression characteristics of the transcription factor E2F2 in clear cell renal cell carcinoma (ccRCC), its impact on patient prognosis, and its potential role in the tumor immune microenvironment, with validation using clinical samples and functional assays. Methods RNA sequencing data and clinical information of ccRCC patients were obtained from the TCGA database; GSE53757 and GSE66272 datasets were downloaded from the GEO database as external validation cohorts. The expression difference of E2F2 between ccRCC tissue and normal tissue was compared, and the relationship between E2F2 expression and clinical pathological characteristics was analyzed. Kaplan-Meier (KM) survival analysis with log-rank test was performed to evaluate the effects of E2F2 on overall survival (OS), progression-free survival (PFS), and disease-specific survival (DSS). The prognostic efficacy of E2F2 in predicting 1-, 3- and 5-year survival was evaluated using receiver operating characteristic (ROC) curve. GSEA was performed to identify E2F2-related signaling pathways, and the ESTIMATE and CIBERSORT algorithms were used to assess the relationship between E2F2 expression level and tumor immune cell infiltration and immune microenvironment. Twenty pairs of surgically resected and pathologically confirmed ccRCC tissues and matched adjacent non-tumor tissues were collected from our hospital, and immunohistochemistry (IHC) was performed to detect the protein expression of E2F2. Human ccRCC cell line 786-O was used for functional assays;shRNA was used to knock down E2F2 expression (constructing stable shE2F2#1 and shE2F2#2 cell lines), and qRT-PCR and Western blot were performed to verify knockdown efficiency, followed by MTT, colony formation, and Transwell migration assays to evaluate the effects of E2F2 on the biological behaviors of ccRCC cells. Results E2F2 was significantly upregulated in ccRCC tissues (the same results in the verification set). Higher E2F2 expression was associated with advanced histological grade, clinical stage and higher TNM classification (P＜0.05). KM analysis showed that patients in the E2F2 high-expression group had worse OS, PFS, and DSS (P=0.019, 0.036, ＜0.001); the ROC curves showed area under the curve (AUC) of E2F2 of predicting 1-, 3- and 5- year survival of ccRCC patients were 0.844, 0.851 and 0.815, respectively. GSEA revealed that the E2F2 low-expression group was enriched in multiple metabolism-related pathways, whereas the E2F2 high-expression group was associated with immune-related pathways. Immune analysis demonstrated that high E2F2 expression was associated with increased immune scores, increased proportion of immune cells, higher tumor mutation burden, and potentially stronger immunotherapy response. IHC results showed that the E2F2 immunoreactivity score in ccRCC tissues was significantly higher than that in adjacent non-tumor tissues (P＜0.05). Functional assays indicated that E2F2 knockdown significantly inhibited the proliferation, colony formation, and migration of ccRCC cells. Conclusion E2F2 is highly expressed in ccRCC and may be involved in tumorigenesis and progression through modulation of the immune microenvironment. Its expression level is closely associated with patient prognosis, and E2F2 has the potential to serve as a prognostic biomarker and immunotherapeutic target in ccRCC.

Objective To investigate the epidemiological characteristics of malaria and provide a basis for developing improved prevention and control measures. Methods Data were obtained from the Chinese Disease Prevention and Control Information System. Malaria surveillance data for Nanning City from January 1,2023, to December 31,2024, were exported from the Infectious Disease Reporting Information Management Subsystem. The characteristics of the two groups of malaria cases were compared. Results A total of 103 imported malaria cases were reported in Nanning City in 2024, representing a 38.32% decrease compared with the same period of the previous year. No statistically significant difference were observed between cases reported in 2023 and 2024 in terms of average age, gender ratio, proportion of parasite species, and monthly reporting distribution;however, statistically significant differences were found in the proportion of reporting areas and current residence areas(χ2= 13.572 and 10.355, respectively; P = 0.001 and 0.035, respectively). The proportion of cases reported in Shanglin County and the proportion of cases residing in Shanglin County were both lower than those during the same period of the previous year. Conclusions The high aggregation of imported malaria cases in Nanning City has decreased. Medical institutions in areas other than Shanglin County should strengthen their vigilance against malaria.

Objective To investigate the risk factors for postoperative recurrence and metastasis in patients with T1 stageⅢ/Ⅳ clear cell renal cell carcinoma(ccRCC), and to analyze the influence of surgical methods on prognosis, so as to provide prognostic evaluation and treatment guidance for clinical practice. Methods A retrospective analysis was conducted on 398 patients diagnosed with T1 stage Ⅲ/Ⅳ ccRCC who underwent either partial nephrectomy(PN)or radical nephrectomy(RN)at Jiangsu Province Hospital during Jan. 2008 and Sep. 2022. The patients were divided into recurrence group(n=49)and non-recurrence group(n=349)according to whether the tumor recurred during the follow-up period. The general, clinical data and prognosis were compared between the two groups. Univariate and multivariate Cox regression analyses were used to explore the factors influencing disease-free survival(DFS)and overall survival(OS)after surgery. Subgroup analysis using Kaplan-Meier curves was performed for T1a and T1b patients. Results During the median follow-up of 67(42, 98)months, the recurrence group was characterized by older age, larger tumor diameter, higher proportion of T1b stage, and more complex tumor anatomy. Univariate and multivariate Cox regression analyses showed that age ≥55 years and R.E.N.A.L. score ≥7 were independent risk factors for poorer DFS and OS(P＜0.05). Subgroup analysis revealed that PN or RN did not significantly affect DFS or OS in T1a patients and OS in T1b patients, while RN significantly improved DFS in T1b patients(P＜0.05). Conclusion Age ≥55 years and R.E.N.A.L. score ≥7 are independent risk factors for poor DFS and OS in highgrade T1 ccRCC patients. For T1b patients, RN may improve DFS.

Polycystic ovary syndrome （PCOS） is a common reproductive-endocrine and metabolic disorder in women of reproductive age， and chronic low-grade inflammation is closely associated with its pathogenesis. Studies have confirmed that the abnormal activation of NOD-like receptor protein 3 （NLRP3） inflammasome， a key complex of the innate immune system， not only mediates the formation of local ovarian inflammatory microenvironment， but also deeply participates in the processes of hyperandrogenemia， follicular developmental arrest and systemic insulin resistance in PCOS patients. A variety of single-herb medicines and their active ingredients （such as ginsenosides， evening primrose oil， safflower yellow， etc.）， as well as compound prescriptions including Jianpi yishen huazhuo formula， Bushen huatan formula and Bushen huoluo decoction， can effectively alleviate chronic low-grade inflammation related to PCOS， ameliorate insulin resistance， hyperandrogenemia and abnormal ovarian microenvironment by inhibiting the abnormal activation of NLRP3 inflammasome， and ultimately promote follicular development and the recovery of ovulatory function. Nevertheless， the methodological quality of existing studies is generally low， and clinical translation is still restricted by the heterogeneity of experimental models， unclear pharmacodynamic material basis and lack of high-quality evidence-based data. Multi-omics technologies should be adopted in future research to further analyze the compatibility rules of Chinese herbal compound prescriptions， and stratified studies should be carried out according to different phenotypes of PCOS.

ObjectiveTo explore the mechanism by which Qifu Lizhong decoction restores intestinal mucosal barrier function in ulcerative colitis （UC） by regulating the myosin light chain kinase （MLCK）/phosphorylated myosin light chain （p-MLC） signaling pathway. MethodsA rat model of UC with spleen-kidney Yang deficiency syndrome and an in vitro intestinal barrier injury model were established. In vivo experiments were conducted to evaluate the body weight， disease activity index （DAI） scores， and changes in colonic pathological morphology in each group of rats. Enzyme-linked immunosorbent assay （ELISA） was used to measure the levels of tumor necrosis factor-α （TNF-α）， interleukin-1β （IL-1β）， and myeloperoxidase （MPO）. Transmission electron microscopy （TEM） was employed to observe the morphology and structure of tight junctions （TJ） in rat colonic epithelium. In vitro experiments were conducted to observe the morphology of F-actin in human colon adenocarcinoma cell line-2（Caco-2） cells by phalloidin staining. Combining both in vivo and in vitro approaches， immunohistochemistry （IHC）， immunofluorescence （IF）， and Western blot were applied to detect the expression and phosphorylation levels of TJ proteins ［zonula occludens-1 （ZO-1）， Occludin， Claudin-1］ as well as key proteins in the MLCK/p-MLC signaling pathway. ResultsIn vivo experiments demonstrated that， compared with the normal group， the model group exhibited significant body weight loss， elevated DAI scores and histopathological scores （P<0.01）， increased colonic TNF-α， IL-1β， and MPO levels （P<0.01）. TJ structures were disrupted， and the expression of ZO-1， Occludin， and Claudin-1 was significantly reduced （P<0.05， P<0.01）. The protein expression levels of myosin light chain （MLC）， MLCK， phosphorylated （p）-MLC， and p-MLCK significantly increased （P<0.01）. Compared with the model group， all Qifu Lizhong decoction dose groups exhibited increased body weight， as well as significantly decreased DAI scores and histopathological scores （P<0.05， P<0.01）. The colonic levels of MPO， TNF-α， and IL-1β were significantly reduced （P<0.05， P<0.01）. In the Qifu Lizhong decoction + inhibitor group， the expression of TJ proteins ZO-1， Occludin， and Claudin-1 significantly increased （P<0.01）， while the protein expression levels of MLC， MLCK， p-MLC， and p-MLCK were significantly reduced （P<0.01）. In vitro experiment results showed that， compared with the normal group， the TNF-α group exhibited disordered cytoskeletal architecture， weakened fluorescence signals of ZO-1， Occludin， and Claudin-1， and significantly elevated protein expression levels of MLC， MLCK， p-MLC， and p-MLCK （P<0.01）. Compared with the TNF-α group， the Qifu Lizhong decoction + inhibitor group restored the ordered arrangement of the F-actin cytoskeleton， normalized the expression and localization of TJ proteins ZO-1， Occludin， and Claudin-1， and significantly decreased the protein expression levels of MLC， MLCK， p-MLC， and p-MLCK （P<0.01）. ConclusionQifu Lizhong decoction may exert its therapeutic effects on UC by inhibiting the MLCK/p-MLC signaling pathway， thereby stabilizing TJ structure and repairing intestinal barrier integrity.