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 investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.

AIM: To explore the risk factors of retinal detachment after stage II vitrectomy in patients with open ocular trauma.METHODS: Retrospective analysis. Totally 278 patients(278 eyes)with open ocular trauma who received stage II vitrectomy in the hospital were included from April 2020 to July 2023. According to the postoperative retinal detachment status, they were divided into detachment group(48 eyes)and non-detachment group(230 eyes). The basic clinical conditions of the two groups of patients were compared, and the factors affecting retinal detachment were analyzed.RESULTS: Univariate analysis revealed that there were statistical differences in wound length, injured area, surgical time after injury, and history of retinal detachment/lesion between the two groups(all P<0.05). Logistics multivariate regression analysis showed that wound length greater than 10 mm, surgical time after injury more than 1 wk, and history of retinal detachment/lesion were risk factors for retinal detachment in patients with open ocular trauma after stage II vitrectomy(all P<0.05).CONCLUSION: The occurrence of retinal detachment in patients with open ocular trauma after stage II vitrectomy is mainly related to the severity of trauma, surgical time after injury and history of ocular retinopathy. It is necessary to perform surgical treatment for patients as soon as possible.

OBJECTIVE To study the effect of fluoropezil on embryo-fetal developmental toxicity and toxicokinetics in rabbits,and provide reference for clinical medication.METHODS According to the sequence of pregnancy,pregnant rabbits were divided into five groups:vehicle control group(1%hydroxy-propyl methylcellulose+1.5%polyethylene glycol 400 aqueous solution),positive control group(cyclo-phosphamide 18 mg·kg-1),and fluoropezil(3.6,9.0 and 22.5 mg·kg-1)groups.The vehicle control group and the fluoropezil groups were ig administrated on the 6th to 18th day of gestation(GD6-18)while the positive control group was ig given cyclophosphamide on GD6-20.The pregnant rabbits were sacri-ficed on GD28,and the embryo-fetal development was detected.Sex hormone levels of pregnant rabbits on GD5,GD18 and GD28 were detected by ELISA method.Blood samples with toxokinetics were collected for concomitant toxic generation at the first and last administration,and drug concentrations in fetal,placenta and amniotic fluid were detected with liquid chromatography tandem mass spectrometry(LC-MS/MS).RESULTS Fluoropezil 3.6,9.0 and 22.5 mg·kg-1 had no significant effect on body mass,mass gain,food consumption,pregnancy outcomes,fetal appearance,viscera,skeletal and physical growth and development of pregnant rabbits.Only on GD18 or GD28,the levels of follicle stimulating hormone,estra-diol and progesterone in each dose group fluctuated to some extent.The combined toxokinetics results indicated that fluoropezil could cross the placental barrier of the rabbits,but did not accumulate in preg-nant rabbits or fetuses.Fetal mass,crown-rump length and uterus mass in the cyclophosphamide group were lower than those in the vehicle control group.The appearance and bone of the cyclophos-phamide group were positive.CONCLUSION The no observed adverse effect level(NOAEL)of fluoro-pezil toxicity on rabbit embryo-fetal development is 22.5 mg·kg-1,which is 125 times of the effective dose.At the dosage level of 22.5 mg·kg-1,Cmax is 1093 μg·L-1,and AUC(0-24 h)6650 μg·h·L-1 on GD18.

Temporomandibular joint (TMJ) diseases are common clinical conditions. The number of patients with TMJ diseases is large, and the etiology, epidemiology, disease spectrum, and treatment of the disease remain controversial and unknown. To understand and master the current situation of the occurrence, development and prevention of TMJ diseases, as well as to identify the patterns in etiology, incidence, drug sensitivity, and prognosis is crucial for alleviating patients′suffering.This will facilitate in-depth medical research, effective disease prevention measures, and the formulation of corresponding health policies. Cohort construction and research has an irreplaceable role in precise disease prevention and significant improvement in diagnosis and treatment levels. Large-scale cohort studies are needed to explore the relationship between potential risk factors and outcomes of TMJ diseases, and to observe disease prognoses through long-term follw-ups. The consensus aims to establish a standard conceptual frame work for a cohort study on patients with TMJ disease while providing ideas for cohort data standards to this condition. TMJ disease cohort data consists of both common data standards applicable to all specific disease cohorts as well as disease-specific data standards. Common data were available for each specific disease cohort. By integrating different cohort research resources, standard problems or study variables can be unified. Long-term follow-up can be performed using consistent definitions and criteria across different projects for better core data collection. It is hoped that this consensus will be facilitate the development cohort studies of TMJ diseases.

Objective:To determine the prognostic factors in elderly patients with sepsis and to establish a prognostic model for predicting short-term mortality based on nutrition risk screening scores(NRS-2002).Methods:Demographic details,clinical information,data on biological marker of 426 elderly patients with sepsis were collected and NRS-2002 score were calculated within the first 24 hours of hospital admission.In a 7∶3 ratio,these patients were randomly divided into the training group and the validation group.The Lasso regression model was used to reduce data dimensions and select features.Cox regression analysis was conducted to analyze prognostic signature,based on which a nomogram was developed,and its predictive accuracy was evaluated.Results:Lasso regression analysis and multiple Cox regression analysis showed that albumin,urea nitrogen,lactic acid,and NRS-2002 score were independent risk factors that affected the 30-day prognosis of elderly patients with sepsis(P＜0.05).The areas under the receiver operating characteristic curves of the nomogram in the training and validation groups were 0.772(95%CI:0.734-0.812)and 0.730(95%CI:0.695-0.766),respectively.The calibration curves were fitted well in the two groups.Conclusion:The construction of prognostic nomogram based on NRS score can help clinicians timely assess the early risk of death in elderly patients with sepsis and accordingly take proactive measures.

Objective To systematically retrieve relevant research on the application of exercise intervention dur-ing hematopoietic stem cell transplantation for hospitalized children at home and abroad,to generalize and summa-rize the content of exercise intervention,the effect of intervention,and safety monitoring,with the purpose of provid-ing reference bases for the clinical application of exercise intervention in the future.Methods In accordance with the scoping review framework,we systematically retrieved databases including Web of Science,PubMed,Scopus,Cochrane Library,Embase,CINAHL,CNKI,VIP Database,Wanfang Data and China Biomedical Literature Database,with a retrieval timeframe from database establishment to May 19,2023.Based on the criteria for inclusion and ex-clusion of literature,we screened,summarized,extracted,and analyzed the literature.Results A total of 17 pieces of literature were included,including 5 randomized controlled trials,9 quasi-experimental studies,and 3 mixed-method studies.There were 4 categories of exercise including aerobic,anti-gravity,resistance,and stretching;most of the ex-ercises were of low to moderate intensity;the exercise interventions had a positive impact on muscle strength,quali-ty of life,cardiorespiratory function,body composition,and hematological indices;the safety monitoring consisted of red blood cell,hemoglobin,and platelet counts,temperature,joint and muscle pains,as well as falls,and syringe shedding.Conclusion The application of exercise intervention is safe and feasible,with a positive effect on chil-dren with hematopoietic stem cell transplantation in muscle strength,quality of life.Medical staff should combine with the clinical situation to formulate a reasonable and unified exercise program and to carry out scientific and standardized exercise management.

Objective To observe the clinical efficacy of Yinlian Gargle in the treatment of acute radiation-induced oropharyngeal mucositis after nasopharyngeal carcinoma radiotherapy.Methods Thirty-two patients with nasopharyngeal carcinoma,who had received first radiation,were randomly split into two groups:the trial group(19 cases)and the control group(13 cases).After all groups were treated with radiotherapy and chemotherapy,the control group was given rinse treatment with saline whereas the trial group was given Yinlian Gargle.The incidence of severe acute radiation-induced oropharyngeal mucositis,the duration and intensity of oropharyngeal discomfort and pain(NRS score),quality of life(QOL-NPC score),duration and intensity of radiation-induced side effects(SE-QOL-NPC score)and symptoms of dry mouth(SE1 score)were monitored before and after intervention in two groups.Results The incidence of grade Ⅲ or above radiation-induced oropharyngeal mucositis until the sixth week of radiotherapy in the trial group was considerably lower than that in the control group(P＜0.001),while the incidence of grade I or above radiation-induced oropharyngeal mucositis at 1 month after radiotherapy in the trial group was obviously lower than that in the control group(P＜0.001).The NRS score of pharyngeal discomfort of the trial group was lower than that of the control group starting from the second week of radiotherapy(P＜0.05).The NRS score of oral and oropharyngeal pain was lower than that of the control group starting from the fourth week of radiotherapy(P＜0.05).The SE1 score of the trial group was higher than that of the control group starting from the fifth week of radiotherapy(P＜0.05).After one month of the completion of the radiotherapy,the NRS score of pharyngeal discomfort and the NRS score of oral and oropharyngeal pain in the trial group were lower than those of the control group(P＜0.001).The QOL-NPC score,SE-QOL-NPC score,and SE1 score were all higher than those in the control group(P = 0.05 or P＜0.05).Conclusion Patients with nasopharyngeal cancer can greatly reduce their risk of developing severe acute radiation-induced oropharyngeal mucositis,effectively delay and relieve related symptoms,and enhance quality of life by consistently using Yinlian Gargle during radiotherapy.Additionally,a month after the completion of radiotherapy,it still has positive therapeutic effects on acute radiation-induced oropharyngeal mucositis.

G protein-coupled receptor (GPR) 40, as one of GPRs family, plays a potential role in regulating glucose and lipid metabolism. To study the effect of GPR40 novel agonist SZZ15-11 on hyperglycemia and hyperlipidemia and its potential mechanism, spontaneous type 2 diabetic KKA^y mice, human hepatocellular carcinoma HepG2 cells and murine mature adipocyte 3T3-L1 cells were used. KKA^y mice were divided into four groups, vehicle group, TAK group, SZZ (50 mg·kg^-1) group and SZZ (100 mg·kg^-1) group, with oral gavage of 0.5% sodium carboxymethylcellulose (CMC), 50 mg·kg^-1 TAK875, 50 and 100 mg·kg^-1 SZZ15-11 respectively for 45 days. Fasting blood glucose, blood triglyceride (TG) and total cholesterol (TC), non-fasting blood glucose were tested. Oral glucose tolerance test and insulin tolerance test were executed. Blood insulin and glucagon were measured via enzyme-linked immunosorbent assay (ELISA). After mice′s execution, liver tissue was harvested to test TG and TC content. Then pathological morphology of liver was observed through hematoxylin-eosin (HE) staining, and the lipid metabolism relative signal pathway was analyzed by Western blot and RT-PCR. The experiments were approved by the Institutional Animal Care and Use Committee of the Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College. At the same time, Akt phosphorylation level in HepG2 cells and adiponectin in 3T3-L1 cells treated with TNFα were measured with Western blot. The results show that SZZ15-11 not only decreased blood glucose and lipid, improved insulin sensitivity, but also increased fasting blood glucagon and promoted insulin secretion after glucose loading in KKA^y mice. Additionally, SZZ15-11 alleviated hepatic steatosis and liver dysfunction in KKA^y mice. In liver tissue, SZZ15-11 increased AMPKα phosphorylation level and cholesterol metabolism relative gene Abcg8 transcription. In HepG2 cells, SZZ15-11 increased Akt phosphorylation level. In adipocyte 3T3-L1, SZZ15-11 recovered the decreased adiponectin expression by TNFα. This study proved that GPR40 agonist SZZ15-11 could be a candidate compound for regulating glucolipid metabolic disorder.

Objective To investigate the depression level of postpartum women at the 12th month and its correlation with infant health status.Methods Selecting mothers and infants who underwent prenatal examinations and successfully gave birth at Obstetrics and Gynecology Hospital,Fudan University from Dec 1,2020 to Feb 28,2021 as the research subjects.The Chinese version of the Edinburgh Postpartum Depression Scale(EPDS)was used to evaluate the depression level of postpartum women at the 12th month.A general information questionnaire was conducted to investigate the length,weight,feeding method,medical treatment for any reason,and sleep duration of infants at the age of 12 months.The neurodevelopmental assessment form for infants aged 11-15 months was used to assess their neurodevelopmental status at the age of 12 months.Results Among the 538 postpartum women,55 cases had an EPDS score≥9,and the rate of postpartum depression(PPD)was 10.223%.The depression level of postpartum women at the 12th month was negatively correlated with the duration of infant night sleep(P=0.019)and the total duration of sleep(P=0.017).It is negatively correlated with the fine motor development(P=0.036),social development(P=0.017)and total neurological development score of infants(P=0.047).There is no correlation with infant physical growth(length and weight),feeding methods,or medical treatment for various reasons.Conclusion PPD has a negative impact on the sleep duration,fine motor development,and social development of infant,affecting the baby's neurological development.It is necessary to pay long-term attention to the mental health of the postpartum women in order to promote the healthy growth of the baby.