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 observe the effects and mechanism of Guiqi Yiyuan Ointment on immune function in 12C6+ beam bystander-effect rats.Methods Totally 60 Wistar rats were randomly divided into blank group,model group,positive control group,and TCM low-,medium-,and high-dosage groups,with 10 rats in each group.TCM low-,medium-,and high-dosage groups were given 1.2,2.4,and 4.8 g/kg Guiqi Yiyuan Ointment for gavage,and the blank group,model group and positive control group were given equal dose of sodium chloride solution for gavage for 14 days.Positive control group received intraperitoneal injection of amifostine 30 minutes before modeling.On the 15th day,except the blank group,the other groups were given 4 Gy 12C6+ beam of single irradiation on the right lung.After irradiation,each group was given gavage for 3 days.The general condition of rats was observed,peripheral blood leukocyte(WBC),red blood cell(RBC),hemoglobin(Hb),platelet(PLT)levels were detected,ELISA was used to detect the contents of serum interleukin(IL)-4 and interferon-γ(IFN-γ),lung and spleen organ indices were calculated,HE staining was used to observe the pathological morphology of left lung and spleen tissues,and flow cytometry was used to detect the proportion of CD4+ and CD8+ T lymphocytes in the spleen,qPCR was used to detect the expressions of T-bet and GATA-3 mRNA in right lung and spleen tissues.Results Compared with the blank group,the model group rats showed a decrease in peripheral blood WBC,an increase in RBC,Hb,PLT,and an decrease in serum IL-4 and IFN-γ contents;the organ indices of left lung and spleen was significantly reduced,the alveoli were deformed,the alveolar walls became thicker,the alveolar cavities shrank,the lung tissue was significantly bleeding,the spleen tissue structure was severely damaged,the splenic sinus cavity became narrower,and the splenic cord showed fibrous hyperplasia;the proportion of CD4+ T lymphocytes and CD4+/CD8+ ratio in spleen tissue of the model group decreased,while the proportion of CD8+ T lymphocytes increased,the expression of T-bet mRNA in the left lung and spleen tissues decreased,while the expression of GATA-3 mRNA increased,with statistical significance(P<0.05).Compared with the model group,the positive control group and TCM medium-and high-dosage groups showed an increase in peripheral blood WBC,an decrease in RBC,Hb,PLT,an increase in serum IL-4 and IFN-γ contents;the index of left lung and spleen organs increased in TCM high-dosage group;the pathological damage of left lung and spleen tissues in each treatment group alleviated to varying degrees,while the proportion of CD4+ T lymphocytes and CD4+/CD8+ ratio in spleen tissue of the positive control group and TCM high-dosage group increased,the proportion of CD8+ T lymphocytes decreased,the expression of T-bet mRNA in left lung and spleen tissues increased,and the expression of GATA-3 mRNA decreased,with statistical significance(P<0.05).Conclusion Guiqi Yiyuan Ointment can alleviate the lung and spleen injury of rats induced by 12C6+ beam radiation.Its mechanism is related to regulating the proportion of CD4+,CD8+ T lymphocytes and the expression of T-bet and GATA-3,and recovering cellular immune function.

Purpose/Significance A prediction model is constructed based on real-world data to achieve prediction and early screening of type 2 diabetic microvascular complications.Method/Process Based on the real world data of Nanjing Drum Tower Hospital in the past 10 years,a particle swarm optimization based deep belief network(PSO-DBN)prediction model for microvascular complica-tions in type 2 diabetes mellitus is constructed by taking test results and medical record documents into consideration.Result/Conclusion The PSO-DBN model can predict diabetic microvascular complications,and the performance is better than that of random forest and sup-port vector machine(SVM)benchmark models,it provides references for the research of disease prediction model of real-world data.

Objective:To explore the in vitro antibacterial effects of low-intensity pulsed ultrasound (LIPUS) combined with 3.5 g/L povidone iodine solution on the biofilm of methicillin-resistant staphylococcus aureus (MRSA). Methods:Immature (cultured for 24 hours) and mature (cultured for 72 hours) MRSA biofilms were established on the surfaces of glass slides or confocal dishes. They were randomly divided into 4 groups ( n=9) according to different intervention methods. In the control group, glass slides or confocal dishes were placed in 500 mL of physiological saline for 3 minutes; in the PI group, glass slides or confocal dishes were placed in 500 mL of 3.5 g/L povidone iodine solution for 3 minutes; in the LIPUS group, glass slides or confocal dishes were placed in 500 mL of physiological saline and simultaneously intervened with LIPUS for 3 minutes; in the LIPUS & PI group, glass slides or confocal dishes were placed into 500 mL of 3.5 g/L povidone iodine solution and simultaneously intervened with LIPUS for 3 minutes. After intervention, confocal microscopy (CLSM) and scanning electron microscopy (SEM) were used to observe and compare the structure, morphology, bacterial survival, and viable cell count of the MRSA biofilms among the 4 groups. Results:On the MRSA biofilms cultured for 24 and 72 hours, CLSM and SEM observed sparse biofilms in the LIPUS group and LIPUS & PI group, and also a large number of dead bacteria in the LIPUS & PI group. On the MRSA biofilms cultured for 24 hours, the bacterial colony counts in the control group, PI group, LIPUS group, and LIPUS & PI group were (1.21±0.45)×10 6 CFU/mL, (3.38±2.81)×10 3 CFU/mL, (1.82±0.37)×10 3 CFU/mL, and (69.67±27.93) CFU/mL, respectively. Except for the comparison between PI group and LIPUS group, which showed no statistically significant difference ( P>0.05), there were statistically significant differences between the other groups when compared pairwise ( P<0.05). On the MRSA biofilms cultured for 72 hours, the bacterial colony counts in the control group, PI group, LIPUS group, and LIPUS & PI group were (3.01±0.70)×10 6 CFU/mL, (1.80±1.52)×10 5 CFU/mL, (2.10±0.52)×10 3 CFU/mL, and (68.67±19.55) CFU/mL, respectively. There were statistically significant differences between the 4 groups when compared pairwise ( P<0.05). Conclusions:Application of LIPUS or 3.5 g/L povidone iodine alone for 3 minutes on the immature or mature MRSA biofilms in vitro only leads to partial antibacterial activity. However, LIPUS can enhance the in vitro antibacterial effect of 3.5 g/L povidone iodine on the MRSA biofilms at different maturity levels.

In order to realize the diagnosis of slit lamp in cross-regional patients and improve the real-time and convenience of diagnosis,a remote slit lamp diagnosis platform based on Internet of Things(IoT)technology is designed.Firstly,the feasibility of remote slit lamp is analyzed.Secondly,the IoT platform architecture of doctor/server/facility(D/S/F)is proposed and a remote slit lamp is designed.Finally,the performance of the remote slit lamp diagnostic platform is tested.The platform solves the communication problem of distributed slit lamps and realizes respectively numerical control of multi-area slit lamp by multi-eye experts.The test results show that the remote control delay of the platform is less than 20 ms,which supports multiple experts to diagnose multiple patients separately.

Children with certain comorbidities and immunocompromising conditions are highly vulnerable to SARS-CoV-2 infection. Vaccination against SARS-CoV-2 is an important strategy to reduce death， critical illness and overall disease burden. With the evolving and increasing transmission of SARS-CoV-2， universal vaccination is essential to achieve this goal. Children with special medical conditions are considered as the priorities for SARS-CoV-2 vaccination. However， vaccine hesitancy towards the implementation of SARS-CoV-2 vaccination currently remains an urgent challenge. In order to promote the sustainable vaccination for those children in Shanghai as well as China， Shanghai municipal center for disease control and prevention， together with the national children’s medical center， children’s hospital of Fudan university and the expert group on immunization planning of the Shanghai preventive medicine association， organized a consensus expert working group to formulate the evidence-based recommendations and implementation suggestions for children with common chronic diseases， allergy history， diseases involving adverse events related to vaccination， and immunocompromising conditions， based on the published evidence of SARS-CoV-2 vaccination for populations and children with special medical conditions.

Based on qi-depression constitution， we systematically sorted out and summarized the manifestations of specific symptoms and prescriptions of qi-depression constitution. It is believed that a series of syndromes can be developed due to the imbalance in patients with qi-depression constitution. The four most common syndromes inclinic were summarized as liver depression， deficient depression， phlegm-heat depression， and stagnation. “Liver depression” resulted from liver failing to free flow of qi， then qi stagnated， so Xiaoyao Powder （逍遥散） was recommended as treatment for liver qi depression， spleen deficiency and blood insufficiency； Danzhi Xiaoyao Powder （丹栀逍遥散） for liver depression and spleen deficiency， depression transforming into fire； Bentun Decoction （奔豚汤） for liver depression transforming into fire， upward rushing of qi counterflow. “Deficient depression” resulted from long-term mental disorder and will consume qi and blood potentially to qi and blood deficiency， so Ganmai Dazao Decoction （甘麦大枣汤） was recommended as treatment for deficiency of both heart and spleen， and heart and spleen failing to tonify； Baihe Dihuang Decocotion （百合地黄汤） for heart and lung with yin deficiency， spirit and soul failing to guard. “Phlegm-heat depression” resulted from disturbance of qi movement， affecting the transportation of essence， blood and body fluids， gathering dampness and forming phlegm into heat. Banxia Houpo Decoction （半夏厚朴汤） was recommended as treatment for liver depression and failing to transportation， phlegm coagulation and qi stagnation； Chaihu （or Chaiqin） Wendan Decoction （柴胡（芩）温胆汤） for liver depression and phlegm-heat harassing internally， and disharmony of gallbladder and stomach； self-made Shugan Jieyu Decoction （舒肝解郁汤） for liver-qi stagnation and phlegm-fire harassing internally. “Stagnation” resulted from stagnation of Qi and blood， accumulation of turbid phlegm， and forming stasis over time， so Yueju Pill （越鞠丸） was recommended as treatment for liver depression and failing to transportation， phlegm-fire with damp diet and blood depression； self-made Rupi Sanjie Decoction （乳癖散结汤） for liver depression， stagnation of Qi and blood.

Acute lung injury (ALI), as a common clinical emergency, is pulmonary edema and diffuse lung infiltration caused by inflammation. The lack of non-invasive alert strategy, resulting in failure to carry out preventive treatment, means high mortality and poor prognosis. Stimulator of interferon genes (STING) is a key molecular biomarker of innate immunity in response to inflammation, but there is still a lack of STING-targeted strategy. In this study, a novel STING-targeted PET tracer, [¹⁸F]FBTA, was labeled with high radiochemical yield (79.7 ± 4.3%) and molar activity (32.5 ± 2.9 GBq/μmol). We confirmed that [¹⁸F]FBTA has a strong STING binding affinity (K_d = 26.86 ± 6.79 nmol/L) and can be used for PET imaging in ALI mice to alert early lung inflammation and to assess the efficacy of drug therapy. Our STING-targeted strategy also reveals that [¹⁸F]FBTA can trace ALI before reaching the computed tomography (CT) diagnostic criteria, and demonstrates its better specificity and distribution than [¹⁸F]fluorodeoxyglucose ([¹⁸F]FDG).

Objective:To analyze the relationship between stress hyperglycemia (SHG) and the prognosis of acute myocardial infarction (AMI) without diabetes mellitus (DM).Methods:Using a retrospective cohort study method, 396 AMI patients without DM or impaired glucose tolerance (IGT) and admitted glycated hemoglobin A 1c (HbA 1c)≤6.0% from January 2018 to December 2020 in Xuanwu Hospital, Capital Medical University were selected. Among them, 238 patients did not have SHG at admission (group A), 85 patients had SHG at admission but their blood glucose level did not reach the diagnostic criteria for DM (group B), and 73 patients had SHG at admission and their blood glucose level reached the diagnostic criteria for DM (group C). The baseline data and the incidence of main adverse cardiovascular and cerebrovascular events (MACCE) were recorded. Multivariate Cox regression was used to analyze the independent risk factors of MACCE after discharge in AMI patients without DM. Results:The incidence of MACCE after discharge in group B and group C was significantly higher than that in group A: 29.4% (25/85) and 35.6% (26/73) vs. 18.5% (44/238), the incidence in group C was significantly higher than that in group B, and there was statistical difference ( P<0.05). Multivariate Cox regression analysis result showed that SHG on admission was an independent risk factor for MACCE after discharge in AMI patients without DM ( P<0.05), and LVEF on admission was an independent protective factor for MACCE after discharge in AMI patients without DM ( P<0.01). Conclusions:SHG on admission is the independent risk factor of MACCE in AMI patient without DM. Early detection, assessment and proper intervention measures based on clinical reality should be advocated for the AMI patients with SHG to further improve the prognosis.

Objective:To investigate the epidemiological characteristics and transmission chain of COVID-19 in two families, and to provide scientific evidence for effective prevention and control measures.Methods:Field epidemiological investigation was conducted for the COVID-19 cases occurred in two families and the close contacts in a county of Baotou city in Inner Mongolia Autonomous Region. Descriptive statistical analysis on epidemiological data was conducted.Results:The infection source of the COVID-19 cases in the two families was a man who had living history in Wuhan. After his return, his parents were infected by him. A few days later, the members of a neighbor family were found to be infected, and relatives of this family were also infected after dining together repeatedly. Finally, ten confirmed cases and three suspected cases of COVID-19 were detected in the two families.Conclusions:Human-to-human transmission of COVID-19 can occur not only in a family but also in neighborhoods. The cases in two families had close relationship, indicating the necessity to strengthen the health education about COVID-19 prevention and control and the management of groups at high risk to reduce the incidence of COVID-19 in families and neighborhoods.