Standardized clinical trial reporting is crucial for ensuring the scientific validity,reproducibility,and clinical translational value of reported results.The Consolidated Standards of Reporting Trials(CONSORT)statement,an internationally recognized guideline for randomized controlled trials(RCTs),has become an important reference standard for writing research papers in medicine since the 2010 version of CONSORT was published.With advancements in scientific research methodologies and the emergence of new forms of clinical trials,the CONSORT working group released an updated version in April 2025,published in journals such as The BMJ.Herein,we provide a systematic interpretation of the core revisions of CONSORT 2025,as well as a comparison with CONSORT 2010 to highlight the key differences.By providing practical,example-based recommendations,we aim to help domestic researchers apply the new guidelines efficiently,thereby improving the quality of clinical trial reports authored by domestic researchers.

A high-quality clinical trial protocol is the cornerstone for ensuring the scientific integrity and ethical compliance of a study.The Standard Protocol Items:Recommendations for Interventional Trials(SPIRIT)has become the international benchmark for developing clinical trial protocols since its release in 2013.To adapt to the developing trends of open science and patient-centered principles,the SPIRIT group completed a comprehensive update in 2025.While retaining its core structure,this updated guideline introduces a new open science module and incorporates several new elements,including patient and public involvement,trial monitoring,and data sharing,alongside substantial revisions of five pre-existing items.In this article,we critically examine the core revisions in SPIRIT 2025 and,through analysis of representative case studies,illustrate the practical application of the new reporting guideline in drafting trial protocols.Our goal is to to provide Chinese researchers with a valuable reference for understanding and implementing this new reporting guideline,thereby enhancing the quality and rigor of clinical trial protocols developed in the country.

Objective To summarize and analyze the clinical efficacy of negative pressure suction bell in the treatment of young children (≤6 years) with pectus excavatum. Methods The relevant clinical medical records of the children with pectus excavatum who received negative pressure suction bell treatment in the Outpatient Department of Children’s Hospital of Chongqing Medical University from May 2019 to January 2023 were collected. The age, sex, type, severity, depth of depression, duration of use and prognosis of children with pectus excavatum were retrospectively analyzed. Results A total of 100 pediatric patients were ultimately included in the study, comprising 74 males and 26 females. The age distribution was 57 patients aged 0-3 years and 43 patients aged 3-6 years. All patients were prescribed and used a negative pressure suction device for at least 3 months, after which they returned to our department's outpatient clinic for follow-up. The treatment demonstrated clinical effectiveness in 99 patients, yielding an efficacy rate of 99.00%. The excellent/good rate was 52.00%, and the complication rate was 8.00%. After treatment, the Haller index and the depth of sternal depression were reduced compared with those before treatment (P<0.001), and there was no statistical difference in the effective rate and excellent/good rate between different genders, different ages, different types of pectus excavatum, or different severity (P＞0.05). Conclusion Negative pressure suction bell is safe and effective in the treatment of young children (≤6 years) with pectus excavatum, and the correction effect has nothing to do with gender, type and severity.

Objective:To investigate the predictive value of thrombus enhancement (TE) and thrombus permeability in cardioembolic thrombus with acute middle cerebral artery occlusion based on CT.Methods:The clinical and image data of 93 patients with acute middle cerebral artery occlusion who were admitted to the First Affiliated Hospital of Soochow University within 12 hours after onset from January 2020 to July 2022 were retrospectively analyzed. According to the TOAST criteria, the patients were divided into the cardioembolism (CE) group (43 cases) and the large artery atherosclerosis (LAA) group (50 cases). All patients received noncontrast CT and CT angiography, and then thrombus permeability [thrombus attenuation increase (TAI), void fraction (ε)] and TE were assessed. Independent sample t-test, Mann-Whitney U test and χ2 test were used in univariable analysis between two groups. Multivariable logistic regression analysis was used to explore the independent influencing factors for cardioembolic stroke and establish a logistic model. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the predictive value of TAI, ε, TE and the logistic model in cardioembolic thrombus with acute middle cerebral artery occlusion. Results:There were statistically significant differences in sex, atrial fibrillation, hypertension, diabetes mellitus, smoking, baseline National Institutes of health stroke scale (NIHSS), TAI, ε and TE between the CE group and the LAA group ( P<0.05). Binary logistics regression analysis showed that TAI (OR=1.300, 95%CI 1.147-1.473, P<0.001), hypertension (OR=0.116, 95%CI 0.025-0.535, P=0.006) and baseline NIHSS (OR=1.165, 95%CI 1.040-1.304, P=0.008) were independent influencing factors for cardioembolic thrombus. The ROC curve indicated that the logistic model predicted cardioembolic thrombus with the highest AUC of 0.907 (95%CI 0.848-0.966). TE predicted cardioembolic thrombus with the highest sensitivity of 90.7%. Conclusion:TE and thrombus permeability have application value for predicting cardioembolic thrombus with acute middle cerebral artery occlusion based on CT.

Objective:To establish the sensitive quality indicators for cardiovascular nursing based on the RAND Corporation University of California, Los Angeles (RAND-UCLA) expert consensus method, so as to lay the foundation for scientific and standardized quality management of cardiovascular nursing.Methods:Relevant literature was searched on China National Knowledge Infrastructure, WanFang Data, VIP, China Biomedical Literature Database, Cochrane Library, PubMed, EMbase and CINAHL. The search period was from database establishment to August 31, 2021. We used the Johns Hopkins evidence-based nursing practice model for evidence-based analysis and summary, and referred to documents on cardiovascular nursing quality indicators to form an indicator pool. From May 23 to July 12, 2022, 17 experts were selected to apply the RAND-UCLA expert consensus method to inquire about the indicators.Results:The effective response rates of the first and third rounds of the questionnaire were both 100.00% (17/17) , and the authority coefficients of the experts were 0.87 and 0.88, respectively. Among the 18 indicators in the third round of expert consultation, the consistency degree of importance and operability of all indicators was less than 1.00. Finally, 18 sensitive quality indicators for cardiovascular nursing were established.Conclusions:The consistency and coordination of experts in this study are good, and the nursing sensitive indicators formed have scientific characteristics, cardiovascular specialty characteristics, and good operability.

Background::Sepsis is a serious disease caused by infection. Aminophylline has anti-asthma and anti-inflammatory effects. We aimed to explore the safety and effect of aminophylline in sepsis.Methods::We conducted a clinical randomized controlled trial involving 100 patients diagnosed with sepsis within 48 h after intensive care unit (ICU) admission in two sites. All patients were randomized in a 1:1 ratio to receive standard therapy with or without aminophylline. The primary clinical outcome was all-cause mortality at 28 days.Results::From September 27, 2018 to February 12, 2020, we screened 277 septic patients and eventually enrolled 100 patients, with 50 assigned to the aminophylline group and 50 to the usual-care group. At 28 days, 7 of 50 patients (14.0%) in the aminophylline group had died, compared with 16 of 50 (32.0%) in the usual-care group ( P = 0.032). Cox regression showed that the aminophylline group had a lower hazard of death (hazard ratio = 0.312, 95% confidence interval: 0.129-0.753). Compared with the usual-care group, patients in the aminophylline group had a longer survival time ( P = 0.039 by the log-rank test). The effects of aminophylline on vasopressor dose, oxygenation index, and sequential organ failure assessment score were time-dependent with treatment. There were no significant differences in total hospitalization days, ICU hospitalization days, and rates of serious adverse events (all P > 0.05). No adverse events were observed in the trial. Conclusions::Aminophylline as an adjunct therapy could significantly reduce the risk of death and prolong the survival time of patients with sepsis.Trial registration::ChiCTR.org.cn, ChiCTR1800019173.

This study is to improve the quality standard and supply the scientific basis for Anemarrhenae Rhizoma and its raw processed products. Steroidal saponin including timosaponin BⅡ, timosaponin AⅢ and flavonoids including neomangiferin and mangiferin were selected as the indicative components. Silica gel G thin layer chromatography(TLC) and polyamide TLC were used to detect the two types of compounds, respectively. The contents of timosaponin BⅡ and timosaponin AⅢ were determined by HPLC-ELSD and the content of neomangiferin, mangiferin and isomangiferin were determined by HPLC-UV. Moisture, total ash and acid insoluble ash were determined according to Chinese Pharmacopoeia(2015 edition). And 80% ethanol was selected as the solvent and the content determination of total extract were determined. The fingerprints of Anemarrhenae Rhizoma and its raw processed products were established by HPLC-UV and HPLC-ELSD. The results showed that the methods of TLC and HPLC have been successfully stablished. There are 2 and 3 peaks which have been identified by HPLC-ELSD and HPLC-UV, respectively. The HPLC fingerprint methods are specific and can be used to identify and quality control for Anemarrhenae Rhizoma and its raw processed products in the mass. Comparing to Chinese Pharmacopoeia(2015 edition), the TLC identification and content determination were revised and the total extract determination and HPLC fingerprints were added in the present study. Our results can be used as the scientific basis of quqlity control for Anemarrhenae Rhizoma and its raw processed products.
Anemarrhena ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; Reference Standards ; Rhizome

This paper reviewed recent advances in clinical and basic researches of scalp acupuncture based on evoked potentials (EPs).The role and significance of various EPs in scalp acupuncture were analyzed and compared.Eventrelated potentials (ERPs) which occupied leading position in EPs application nowadays and the latest advances in the related components of its action were combined to make a prospect of the scientific research methods of scalp acupuncture in the treatment of cerebral apoplexy and other diseases.

Objective To explore the effect of pedicle fixation for treatment of thoracolumbar burst fractures in patients with osteoporosis,and to provide more evidence for the treatment.Methods Retrospectively analyzed the clinical data of 121 patients with osteoporotic vertebral burst fracture from June 2012 to October 2015.And these patients were divided into two groups according to different operation methods, namely the control group (n=56) who were given short segment fixation and the observation group (n=65) who were given single segment fixation.The visual analogue scale(VAS),Oswestry disability index(ODI),vertebral height,kyphotic angle and bone mineral density of the two groups were analyzed before surgery and 3 days,1 month,3 months and 12 months after surgery.Results The VAS score,ODI score,vertebral height,and Cobb angle of the injured vertebra were significantly improved in both of the two groups,and the difference was statistically significant (P<0.05).The VAS score of the observation group was better than that of the control group 3 days after surgery with statistically significant difference (P<0.05).But there was no significant difference 3 months,6 months and 12 months after surgery(P>0.05).The ODI score of the observation group was better than that of the control group 3 days and 3 months after surgery with statistically significant difference (P<0.05),and there was no significant difference between the two groups till the end of follow-up.Pedicle fixation at the injured vertebra significantly improved the vertebral height and Cobb angle with statistically significant difference (P<0.05).And the anti-osteoporosis treatment significantly increased the bone mineral density (P<0.05).Conclusion Pedicle fixation at the injured vertebra is useful in pain relief as well as function and anatomical structure restoring.And anti-osteoporosis treatment is necessary for the bone mineral density increase.

This study was aimed to explore the immediate effect mechanism of the middle 2/5 of the vertex-temporal anterior oblique line in the treatment of stroke by scalp acupuncture using event-related brain potential (ERP).A total of 30 stroke cases who met the inclusion criteria and 25 healthy subjects were selected.Patients in both groups were treated by scalp acupuncture,with stimulation on the middle 2/5 of the vertex-temporal anterior oblique line on the right side.ERP was detected before acupuncture and 10 min after acupuncture in both groups.The muscle strength and neurological deficit score of the stroke group were also detected.At the end of the experiment,the movement-related cortical potentials (MRCPs) of both the left and right hand were extracted from the ERP.The results showed that after 10 min scalp acupuncture stimulation,the neurological deficit score of the stroke group was lower than that of the pretreatment (P ＜ 0.05);the muscle strength rating was higher than before (P ＜ 0.05).Before and after acupuncture,the amplitude of MRCPs on the diseased side of the stroke group was significantly decreased compared to before (P ＜ 0.05).It was concluded that the immediate effect of scalp acupuncture treatment of hemiplegia patients with stroke was definite.Its mechanism may be that acupuncture stimulates the motor cortex through the vertex-temporal anterior oblique line,reduces the energy loss of brain motion planning,activates the damaged brain movement related area cortex neurons,improves the processing efficiency of movement in the brain,so as to promote the improvement of hemiplegic limb motor function immediately.And we also observed that the healthy side brain has a compensatory effect,which suggested that in our clinical scalp acupuncture,bilateral stimulation may be more effective.