The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

【Objective】 To construct a prognostic model of clear cell renal cell carcinoma (ccRCC) based on endoplasmic reticulum stress (ERS)-related long non-coding ribonucleotides (lncRNA),so as to explore the correlation between immune cell infiltration and prognosis of ccRCC patients,and to search for new drugs for the treatment of ccRCC. 【Methods】 The transcriptome and clinical data of cancerous and paracancerous tissues of ccRCC were obtained from the TCGA database.The ERS-associated gene set was obtained from the MSigDB database.ERS co-expressed lncRNAs were screened with Pearson correlation analysis.ERS-related lncRNA (ERSRL) with prognostic significance were screened with Lasso regression,univariate and multivariate Cox regression analyses,and a prognostic model was constructed.The risk value of each sample was calculated according to the prognostic model formula.The patients were divided into high- risk and low- risk groups for survival difference analysis.The predictive performance of the prognostic model was evaluated with survival curve,receiver operating characteristic (ROC) curve and calibration curve.The infiltration of immune cells in high-and low-risk groups was analyzed with CIBERSORT database.The relationship between ERSRL and drug sensitivity was analyzed with GDSC database to identify drugs with potential efficacy against ccRCC. 【Results】 A total of 9 lncRNAs with independent prognostic significance were screened to construct the prognostic model.Kaplan-Meier analysis showed significant survival differences between the high- and low-risk groups.Univariate and multivariate Cox regression analyses showed that age,grade,stage and risk score could be used as independent prognostic factors.The area under the ROC curve (AUC) of the 1-,3-,and 5-year survival rates of the training set were 0.754 (95%CI:0.659-0.848),0.744 (95%CI:0.667-0.815),and 0.759 (95%CI:0.662-0.820),respectively,and the C-index was 0.777 (95%CI:0.759-0.796).Immune infiltration results showed that plasma cells,activated memory CD4⁺T cells,regulatory T cells,M0 macrophages,and activated mast cell infiltration levels were higher in the high-risk group than those in the low-risk group.Drug susceptibility analysis identified 12 drugs with potential curative effects on ccRCC,including AZD8055. 【Conclusion】 Based on 9 ERSRLs,a prognostic model for ccRCC patients was constructed,and 12 drugs with potential therapeutic effects were screened,including AZD8055.

Objective:To investigate the omics mechanism of SARS-related immune injury and predict targeted therapeutic drugs through clinical bioinformatics analysis of the transcriptome data of SARS virus in order to provide reference for clinical treatment of COVID-19.Methods:The transcriptome data of SARA virus were collected from the Gene Expression Oibus (GEO) and used to screen differential genes. Enrichment analysis and protein interaction analysis were performed to investigate the mechanism of immune damage associated with SARS. A platform of epigenetics in precision medicine (EpiMed) was established to predict potential therapeutic drugs.Results:The mechanism of SARS-related immune injury was complex, involving affecting the function of immune cells through signaling pathways such as Toll-like receptors, increasing cytokines in plasma through Th17 signaling pathway and inducing autoimmune responses after autoantibodies were generated by molecules such as IL-6, NF-κB, and TNF. Drugs such as Chuanqiong and Etanercept might have therapeutic effects on SARS-related immune damage.Conclusions:SARS virus could cause abnormal expression of many immune-related molecules and signaling pathways. Drugs such as Chuanqiong and Etanercept might have therapeutic effects on SARS-related immune damage. This study might provide reference for clinical treatment of COVID-19.

Objective:To analyze the inflammatory mechanism and potential intervention drugs related to angiotensin converting enzyme 2 (ACE2) inhibitory mutations in order to provide reference for the treatment of corona virus disease 2019 (COVID-19).Methods:The data of lung adenocarcinoma with ACE2 mutations were screened from the cancer genome atlas (TCGA) database. The data were analyzed by R program language edgeR package and cluster Profiler package, gene ontology (GO)functional enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis. Using String online analysis website for protein-protein interaction (PPI) network analysis, screening out the core genes, and finally using the Epigenomic Precision Medicine Prediction Platform (EpiMed) for multi-group association analysis of key genes, and drug candidates prediction.Results:A total of 1 005 differential genes were obtained, of which 91 were up-regulated and 914 down-regulated. A total of 71 GO were enriched, including 45 items related to biological processes, 16 items related to cell components, and 10 items related to molecular function. A total of 13 KEGG pathways were enriched, mainly in inflammatory pathways, various viral infectious diseases, transcriptional regulation, drug metabolism and protein digestion and absorption pathways. The differentially expressed genes were introduced into String online analysis website for PPI network analysis, a total of 252 proteins were obtained, and 10 core genes were H2A clustered histone 16(HIST1H2AL), H3 clustered histone 2 (HIST1H3B), H3 clustered histone 7 (HIST1H3F), H3 clustered histone 11 (HIST1H3I), H3 clustered histone 3 (HIST1H3C), H2B clustered histone 3 (HIST1H2BB), H2B clustered histone 6 (HIST1H2BI), H4 clustered histone 2 (HIST1H4B), H1-4 linker histone (HIST1H1E), H2A clustered histone 4 (HIST1H2AB). Interferon-α, resveratrol, celecoxib, heartleaf houttuynia herb, weeping forsythia capsule, dexamethasone, Chinese pulsatilla root, tumor necrosis factor-α inhibitors, liquorice root and famciclovir might be drugs for the treatment of ACE2 mutation-related inflammation.Conclusions:Inflammation associated with ACE2 inhibitory mutations is similar to the pathogenesis of COVID-19, which could lead to disease by promoting the activation of inflammatory pathways such as mitogen-activated protein kinase (MAPK), the Janus kinase signal transducer and activator of transcription (JAK/STAT), mammalian target of rapamycin (mTOR). Celecoxib, interferon and resveratrol may have the potential therapeutic effects on COVID-19.

During pandemic of corona virus disease 2019 (COVID-19), emergency orthopedic trauma is commonly seen. It is particularly important to ensure the emergency treatment quality of orthopedic trauma but avoid cross-infection between doctors and patients. The double-buffered diagnosis and treatment mode refers to the model of patients first undergoing medical observation in the comprehensive buffer ward and the inpatient buffer rooms of various disciplines after admission to confirm the exclusion of COVID-19 and then receiving specialist diagnosis and treatment. The authors summarize the experiences of using the double-buffered diagnosis and treatment model in the Department of Orthopedics, Renmin Hospital of Wuhan University during the prevention and control of COVID-19 pandemic so as to provide a reference for treatment of orthopedic patients.

Objective:To analyze the mechanism and potential intervention drugs of acute lung injury caused by severe acute respiratory syndrome coronavirus (SARS-CoV) infection in order to provide reference for the treatment of COVID-19.Methods:Gene Expression Omnibus (GEO) announcement database was used to screen coronavirus transcriptome data, and R language package was used for differential expression analysis and Kyoto Gene and Genome Encyclopedia (KEGG) and Gene Ontology (GO) enrichment analysis. A protein-protein interaction (PPI) network analysis was carried out by using STRING online analysis website, and the key genes were screened. Then the Epigenomic Precision Medicine Prediction Platform (EpiMed) was used to analyze the association of key genes and predict potential therapeutic drugs.Results:Based on the whole genome expression profile data of SARS-CoV, a total of 3 606 differential genes were screened, including 2 148 up-regulated and 1 458 down-regulated. GO enrichment is mainly related to viral infection, leukocyte migration and adhesion, acute inflammation and collagen secretion. KEGG enrichment is mainly related to signal transduction, acute inflammation, immune response and so on. Ten key genes related to lung injury, such as PTPRC, TIMP1, ICAM1 and IL1B, were screened by protein interaction network analysis. EpiMed platform predicted that pulsatilla chinensis, polygonum cuspidatum, tumor necrosis factor-α inhibitors, famciclovir, fluvastatin and other drugs have potential therapeutic effects.Conclusions:SARS-CoV infection can cause lung injury by activating a series of inflammation-related molecules. Drugs that may be effective in the treatment of coronavirus infections, including pulsatilla chinensis, polygonum cuspidatum, tumor necrosis factor-α inhibitors, famciclovir and fluvastatin.

Objective To evaluate the safety and efficacy of precise hepatectomy in treatment of hepatolithiasis. Methods Clinical data of 93 patients with hepatolithiasis who underwent hepatectomy in Anhui Provincial Hospital between January 2013 and January 2017 were analyzed retrospectively. The patients were divided into precise hepatectomy group (precise group, n=59) and conventional resection group (conventional group, n=34) according to different surgical procedures. There were 28 males and 31 females in precise group, with an average age of (56±5) years old. There were 18 males and 16 females in conventional group, with an average age of (56±4) years old. The informed consents of all patients were obtained and the local ethical committee approval was received. The operation time, intraoperative blood loss, postoperative length of stay, postoperative ALT, AST level between two groups were compared by t test or Kruskal-Wallis rank sum test. The incidence of postoperative complication was compared by Chi-square test. Results The operation time was (210±61) min in precise group, significantly longer than (157±60) min in conventional group (t=1.586, P<0.05). The intraoperative blood loss was (386±99) ml in precise group, significantly less than (518±153) ml in conventional group (t=-1.421, P<0.05). The median postoperative length of stay was 8(6-10) d in precise group, significantly shorter than 10(8-15) d in conventional group (Z=-2.018, P<0.05).The ALT and AST level at postoperative 1 d was respectively (214±87) and (368±106) U/L in precise group, significantly lower than (594±133) and (625±165) U/L in conventional group, (t=-3.395, -2.047; P<0.05). The incidence of postoperative complication was 8.5% (5/59) in precise group, significantly lower than 23.5%(8/34) in conventional group (χ2=4.066, P<0.05). Conclusions Compared with conventional hepatectomy, precise hepatectomy possesses advantages of smaller surgical trauma, less intraoperative blood loss and lower incidence of postoperative complication. It has better clinical application value.

Objective To evaluate the application of three-dimensional visualization technique in precise hepatectomy for patients with massive hepatocellular carcinoma (HCC). Methods 64 patients with massive HCC who underwent hepatectomy in Anhui Provincial Hospital Affiliated to Anhui Medical University between January 2014 and January 2016 were enrolled in this prospective study. The informed consents of all patients were obtained and the local ethical committee approval was received. According to the will of patients and their families, these patients were divided into precise group and conventional group. There were 34 cases in precise group, including 28 males and 6 females, with an average age of (54±6) years old. There were 30 cases in conventional group, including 26 males and 4 females, with an average age of(56±7) years old. In precise group, liver volume, tumor location and size and relation with the adjacent vessels were assessed precisely, and surgical protocol was planned and simulated using CT three-dimensional visualization technique before operation. Precise hepatectomy was performed using cavitron ultrasound surgical aspirator (CUSA) or ultrasonic scalpel with the guidance of color Doppler ultrasound. Patients were treated according to the concept of enhanced recovery after surgery after operation. Patients in conventional group received routine CT or MRI before operation, liver resection with clamping method was performed and the porta hepatis was occluded using Pringle maneuver during the operation. Patients received routine nursing and rehabilitation treatments after operation. Intraoperative situation and postoperative liver function of patients between both groups were compared by t test, and the rates were compared by Chi-square test. Results The median length of operation was 229(57-352) min in precise group, significantly more than 138(61-282) min in conventional group (Z=1.752, P<0.05). The postoperative 1 d ALT and AST was respectively 425(24-1 299) and 390(15-1 484) U/L in precise group, significantly lower than 574(42-3 533) and 670(76-3 795) U/L in conventional group (Z=-2.099, -2.677; P<0.05). The postoperative length of hospital stay was 6.2(3.0-19.0) d in precise group, significantly less than 9.5(5.0-30.0) d in conventional group (Z=-2.387, P<0.05). Postoperative complications occurred in 3 patients in precise group and 9 patients in conventional group, where significant difference was observed (χ2=4.691, P<0.05). No death case was observed in precise group, while 1 case died of postoperative liver failure in conventional group. Conclusions Compared with conventional liver resection, three-dimensional visualization technique can be used in precise hepatectomy for patients with massive HCC. It has the advantages of less trauma, higher safety and faster postoperative recovery.

ObjectiveTo explore the application value of individualized surgical treatment based on the CT portal venograpy (CTPV) classiifcation in cirrhotic portal hypertension.MethodsOne hundred and iffty-six patients with cirrhotic portal hypertension who received surgical treatment in Anhui Province Hospital between June 2010 and December 2014 were enrolled in this prospective study. According to different surgical procedures, the patients were divided into two groups: the individualized surgery based on CTPV classiifcation group (classification group) and traditional surgery group (traditional group). Among the 84 patients in the classiifcation group, 56 were males and 28 were females with the age ranging from 19 to 67 years old and the median of 45 years old. Among the 72 patients in the traditional group, 47 were males and 25 were females with the age ranging from 23 to 62 years old and the median of 43 years old. The informed consents of all patients were obtained and the local ethical committee approval was received. The patients in the classiifcation group underwent individualized surgery according to the pre-operative CTPV classiifcation, while the patients in the traditional group underwent splenectomy + pericardial devascularization. The effects of two surgical procedures on the portal hypertension, intraoperative and postoperative conditions and postoperative survival rate of the patients were observed. The observation indexes of two groups were compared usingt test and survival analysis was conducted using Kaplan-Meier method and Log-rank test.ResultsThe postoperative free portal pressure (FPP) in the classiifcation group was (27±3) cmH2O (1 cmH2O=0.098 kPa), signiifcantly lower than (33±8) cmH2O in the traditional group (t=-3.355,P<0.05). The FPP decrease range before and after surgery in the classiifcation group was (13±6) cmH2O, signiifcantly higher than (9±5) cmH2O in the traditional group (t=3.016,P<0.05). The length of surgery and intraoperative blood loss in the classiifcation group were respectively (188±84) min and (378±49) ml, significantly less than (240±76) min and (463±57) ml in the traditional group (t=-2.687,-3.015;P<0.05). The postoperative length of stay and hospitalization expense in the classiifcation group were respectively (12±4) d and (31 000 ± 15 000) yuan, signiifcantly lower than (15±5) d and (36 000±15 000) yuan in the traditional group (t=-2.061,-2.104;P<0.05). The 1, 3-year accumulative survival rate were respectively 94.05% and 85.71% in the classiifcation group, and were respectively 87.50% and 68.05% in the traditional group. The overall survival rate in the classiifcation group was signiifcantly higher than that in the traditional group (χ2=7.000,P<0.05).ConclusionsPre-operative CTPV classification and individualized surgical treatment for patients with cirrhotic portal hypertension can effectively reduce the portal vein pressure and has the advantages of smaller injury and better prognosis.

OBJECTIVETo detect the expression of Nodal in hepatocellular carcinoma (HCC), and explore its relationship with angiogenesis and epithelial-mesenchymal transition (EMT).

METHODSFrom September 2006 to June 2010, the 16 self-paired frozen HCC specimens were collected and the expression of Nodal was detected by qPCR and Western blot. The 10 normal liver tissues and 96 cases of HCC tumor and paracarcinomatous tissues were collected. The expression of Nodal and relationship among Nodal, clinicopathological characteristics of HCC and patients' prognosis were detected and analyzed using immunohistochemistry. The expressions of Nodal, Vimentin and CD34 in 96 HCC tumor tissues were detected by immunohistochemistry, and then judgment relationship between the expression of Nodal, EMT and angiogenesis.

RESULTSImmunohistochemistry showed that Nodal mainly expressed in the cytoplasm. The high expression rate of Nodal in HCC tumor tissues was 72.9% (70/96), which was remarkably higher than that in paracarcinomatous tissues (8.3%) and normal liver tissues (0) (χ(2) = 83.001 and 24.470, both P < 0.001). qPCR and Western blot analysis showed that the expression level of Nodal in HCC was significantly higher than that in paracarcinomatous and normal tissues (P < 0.05). The high expression of Nodal in HCC was correlated with tumor size (χ(2) = 15.318, P = 0.000), alpha-fetoprotein (χ(2) = 3.850, P = 0.049), indocyanine green retention rate at 15 minutes (χ(2) = 6.590, P = 0.010), and invasion and metastasis (χ(2) = 17.824, P = 0.000). High expression of Nodal was positively correlated with high microvascular density in HCC (t = 3.070, P = 0.006), but not with Vimentin (r = 0.198, P = 0.053). Survival analysis showed that accumulated survival rate of patients with high expression of Nodal was significantly less than that the low expression (χ(2) = 487.053, P < 0.001). The Cox multivariate analysis demonstrated that high expression of Nodal was independent risk factors for cumulative survival in patients with hepatocellular carcinoma after a curative resection (RR = 2.757, 95%CI: 1.450-5.240, P = 0.002).

CONCLUSIONSNodal does not participate in EMT of HCC, but can promote angiogenesis, and it could be used as a predictor of poor prognosis.

Adult ; Aged ; Carcinoma, Hepatocellular ; blood supply ; metabolism ; Epithelial-Mesenchymal Transition ; Female ; Humans ; Liver Neoplasms ; blood supply ; metabolism ; Male ; Middle Aged ; Neovascularization, Pathologic ; Nodal Protein ; metabolism ; Prognosis ; Vimentin ; metabolism