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 effects of anlotinib on the malignant phenotype of glioma cells by regulating the nuclear factor-κB （NF-κB） signaling pathway. METHODS Human glioma T98G cells were cultured in vitro， and 5-fluorouracil was used as positive control to investigate the effects of different concentrations of anlotinib （5， 10， 20 μmol/L） on the ability of proliferation， adhesion， migration and invasion， the expressions of epithelial-mesenchymal transition （EMT） related proteins [E-cadherin， N-cadherin， vimentin and fibronectin （FN）]. NF- κB signaling pathway inhibitor （BAY 11-7082） and activator （prostratin） were additionally used to verify the possible mechanism of the above effects of anlotinib. RESULTS Anlotinib with 5， 10， 20 μmol/L could significantly decrease the activity of cell proliferation （except for 5 μmol/L anlotinib group）， migration rate， and the number of adherent cells and invasive cells， could significantly up-regulate the expression of E-cadherin protein while down-regulate the expressions of N-cadherin， vimentin and FN protein （P＜0.05）； the effect of 20 μmol/L anlotinib was similar to that of positive control （P＞0.05）. Compared with 10 μmol/L anlotinib， pathway inhibitor could significantly decrease the ability of proliferation， adhesion， migration and invasion， and the expressions of N-cadherin， vimentin， FN and phosphorylated NF-κB p65 protein， while could significantly up-regulate the expression of E-cadherin protein （P＜0.05）； above indexes were reversed significantly by pathway activator （P＜0.05）. CONCLUSIONS Anlotinib may inhibit the proliferation， adhesion， migration and invasion of human glioma T98G cells， which may be associated with the inhibition of the NF-κB signaling pathway， thus inhibiting cell EMT-like processes.

Objective     To compare the clinical effects of coronary artery bypass grafting (CABG) via the left anterior small thoracotomy (LAST) versus lower-end sternal splitting (LESS) approach in the treatment of coronary heart disease. Methods     The patients who underwent LAST CABG in Tianjin Chest Hospital from October 2015 to December 2020 were allocated to an observation group (LAST group), and the patients who underwent LESS CABG at the same period were allocated to a LESS group. Propensity score matching method was applied with a ratio of 1∶1. The baseline data, perioperative data and grafts data were compared between the two groups after matching. Results     Before matching, there were 110 patients in the LAST group, and 206 patients in the LESS group. After matching, there were 110 patients in each group. In the LAST group, there were 83 males and 27 females with an average age of 60.6±8.3 years. In the LESS group, there were 80 males and 30 females with an average age of 61.0±9.6 years. There was no statistical difference in baseline data between the two groups after matching (P>0.05). The hospital stay time (t=2.255, P=0.025) and ventilator using time (t=−2.229, P=0.027) in the LAST group were significantly shorter than those in the LESS group. There were no statistical differences between the two groups in the postoperative hospital stay time, ICU stay time, postoperative left ventricular ejection fraction, postoperative left ventricular end-diastolic diameter, average number of grafts, secondary intubation, secondary thoracotomy, postoperative wound infection, sternal complications, postoperative atrial fibrillation, postoperative pulmonary infection or main adverse cardiovascular and cerebrovascular events (P>0.05). There was no statistical difference in the distribution of target vessels in the anterior descending branch, diagonal branch or posterior descending branch between the two groups (P>0.05). The grafts of the LAST group were significantly more than those of the LESS group in the area of obtuse marginal branch and posterior ventricular branch, and the grafts of the LESS group were significantly more than those of the LAST group in the area of right coronary artery (P<0.05). Post-operative computerized tomography angiography indicated that 1 patient in the LAST group had obtuse marginal branch vein bridge vessel occlusion, and the bridge vessels in the other patients were unobstructed. Conclusion     Minimally invasive CABG via both LAST and LESS approaches is safe and effective. LAST approach can achieve complete revascularization for multi-vessel lesions, and it is safe and reliable, with the advantages of less trauma and aesthetic appearance. However, it requires a certain learning curve of surgical techniques and certain surgical indications.

Objective:To investigate effect of reperfusion injury following different ischemic duration on skeletal muscle in rats.Methods:A model of ischemia/reperfusion injury (IRI) was established by unilateral clamping femoral artery and additional application of tourniquet in skeletal muscle of hind limbs in 35 male Wsitar rats. According to different ischemia time, the animals were assigned to 2-hour ischemia and 24-hour reperfusion (I2R24 group), 2.5-hour ischemia and 24-hour reperfusion (I2.5R24 group), 3-hour ischemia and 24-hour reperfusion (I3R24 group), 4-hour ischemia and 24-hour reperfusion (I4R24 group) and sham group, with 7 rats per group. At the end of reperfusion, gastrocnemious tissues and plasma samples were collected and analyzed. The ratio of wet ∶ dry weight (W/D) was used to measure muscle edema. The assay of 3-(4, 5-Dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide (MTT) was conducted to evaluate muscle viability. HE staining was executed to observe histopathological changes. Immunofluorescence staining was performed to assess the levels of C1q, C3b/c, tissue factor (TF), fibrinogen (FN), bradykinin receptor 1 (BR1), BR2, vascular cell adhesion molecule-1 (VCAM-1), E-selectin, fibrinogen-like protein-2 (FGL-2) and myeloperoxidase (MPO) in muscle tissues. ELISA method was used to determine the concentrations of interferonγ (IFN-γ), interleukin7 (IL-7), IL-18, macrophage inflammatory1α (MIP-1α) and monocyte chemotactic protein 1 (MCP-1) in plasma.Results:With prolongation of ischemia time and subsequent reperfusion, tissue edema became severe gradually. The ratio of W/D was 5.3±0.2, 6.1±0.3, 6.9±0.2, 7.6±0.3 in I2R24, I2.5R24, I3R24 and I4R24 groups, higher than that in sham group (4.5±0.1) (all P<0.01). Muscle viability got decreased gradually. Muscle viability was (62.4±3.5)%, (45.3±3.3)%, (35.4±3.4)%, (27.1±5.9)% in I2R24, I2.5R24, I3R24 and I4R24 groups, lower than that in sham group［(93.8±7.2)%］(all P<0.01). Histopathological changes became aggravated gradually. The most severe group was I4R24 group, with the most severe myocyte injury, interstitial edema and extensive inflammatory infiltration, followed by I3R24, I2.5R24 and I2R24 groups in order. There was normal structure integrity and neatly arranged myocyte in sham group. Meanwhile, levels of C1q, C3b, FN, BR1, VCAM-1, E-selectin and FGL-2 got increased gradually. The highest levels for these factors were seen in I4R24 group, followed by I3R24 group, I2.5R24 group, I2R24 group and sham group in order. The rough ratio of the number of positive MPO cells/total cell number under high lens (×200) were increased gradually, with the highest level in I4R24 group, followed by I3R24 group, I2.5R24 group, I2R24 group and sham group in order. However, expression of TF and BR2 were not altered significantly among the groups. Plasma levels of INF-γ, IL-7, IL-18, MIP-1α and MCP-1 elevated gradually with prolongation of ischemia time (all P<0.01). The sequence was the sham group, I2R24 group, I2.5R24 group, I3R24 group and I4R24 groups for levels of these factors from low to high (all P<0.01). Conclusion:Reperfusion after prolongation of ischemia duration can increase the activation of complement, coagulation, kinin and endothelial cells as well as the release of inflammatory factors, and thus aggravate the degree of skeletal muscle tissue injury.

Objective:To investigate the clinical application of the free medial plantar artery perforator flap for soft tissue defect reconstruction of the weight-bearing surface of the heel.Methods:The clinical data of patients with soft tissue defects in the weight-bearing surface of the heel were analyzed retrospectively, which were reconstructed with the free medial plantar artery perforator flaps in the Second Hospital of Tangshan from April 2011 to November 2017. The medial plantar artery was anastomosed with the posterior tibial artery. The venae comitantes were anastomosed with the great saphenous vein. The cutaneous branch of the medial plantar nerve was also anastomosed with the saphenous nerve. The donor sites were covered with full-thickness skin grafting. The survival condition, sensory function, countour, stability, and donor site scars were observed during follow-up.Results:A total of 11 patients with soft tissue defects in the weight-bearing surface of the heel were enrolled. There were six males and five females aged 24-41 years (mean, 31.3 years). All flaps survived uneventfully. Patients were followed up 11-56 months (mean 18.5 months). The appearance and function recovery of the flaps were satisfactory with 6-13 mm two-point discrimination(2-PD). No ulcer occurred. All patients returned to a normal walk.Conclusions:It is a feasible way for one-staged reconstruction of the combined loss of Achilles tendon and soft tissue in the heel by using free anterolateral femoral artery perforator flap with fascia lata, which has the advantages of good functional recovery, less trauma, short curing course, the satisfactory contour, and protective sensation achievable.

Objective:To investigate the clinical application of the free medial plantar artery perforator flap for soft tissue defect reconstruction of the weight-bearing surface of the heel.Methods:The clinical data of patients with soft tissue defects in the weight-bearing surface of the heel were analyzed retrospectively, which were reconstructed with the free medial plantar artery perforator flaps in the Second Hospital of Tangshan from April 2011 to November 2017. The medial plantar artery was anastomosed with the posterior tibial artery. The venae comitantes were anastomosed with the great saphenous vein. The cutaneous branch of the medial plantar nerve was also anastomosed with the saphenous nerve. The donor sites were covered with full-thickness skin grafting. The survival condition, sensory function, countour, stability, and donor site scars were observed during follow-up.Results:A total of 11 patients with soft tissue defects in the weight-bearing surface of the heel were enrolled. There were six males and five females aged 24-41 years (mean, 31.3 years). All flaps survived uneventfully. Patients were followed up 11-56 months (mean 18.5 months). The appearance and function recovery of the flaps were satisfactory with 6-13 mm two-point discrimination(2-PD). No ulcer occurred. All patients returned to a normal walk.Conclusions:It is a feasible way for one-staged reconstruction of the combined loss of Achilles tendon and soft tissue in the heel by using free anterolateral femoral artery perforator flap with fascia lata, which has the advantages of good functional recovery, less trauma, short curing course, the satisfactory contour, and protective sensation achievable.

OBJECTIVE: To carry out prenatal diagnosis for a fetus with Pallister-killian syndrome (PKS). METHODS: The fetus was found to have limb malformations at 23rd gestational week. With informed consent from its parents, amniotic fluid sample was taken from the fetus and subjected to chromosomal karyotyping, chromosomal microarray analysis (CMA) and fluorescence in situ hybridization (FISH) assay. RESULTS: G-banding analysis suggested the fetus has a mos47,XY,+mar[55]/46,XY[10] karyotype. CMA analysis of the cultured amniocytes with CytoScan 750K microarray revealed a segmental tetrasomy duplication of 12p13.33p11.1. FISH confirmed a 70% mosaicism of tetrasomy 12p in the metaphase amniocytes with 12pter/12qter probes. CONCLUSION Combined use of G-banding karyotyping, CMA and FISH analysis has enabled diagnosis of PKS in the fetus. Although short limb is a common feature of PKS, unequal femur length has not been reported previously, which has expanded the spectrum of PKS-associated limb abnormalities.
Chromosome Disorders/genetics* ; Chromosomes, Human, Pair 12/genetics* ; Female ; Fetus ; Humans ; In Situ Hybridization, Fluorescence ; Mosaicism ; Pregnancy ; Prenatal Diagnosis

Objective To evaluate the application of combinatorial probe anchor synthesis (cPAS)?based high?throughput low coverage whole genome sequencing in chromosomal aberration detection in spontaneous miscarriage. Methods From September 2015 to May 2017, spontaneous miscarriage samples were collected from Inner Mongolia Maternal and Child Health Care Hospital. Those samples were further analyzed with two independent methods, fluorescence in situ hybridization (FISH) and low coverage whole genome sequencing on the BGISEQ?500 high?throughput platform. The performance of low coverage whole genome sequencing was assessed by comparing to FISH results. Results In 595 spontaneous miscarried specimens, low coverage whole genome sequencing revealed 144 cases (24.2%, 144/595) chromosomal abnormalities, of which a subset of 137 cases (23.0%, 137/595) were detected as aneuploidies, 2 cases (0.3%, 2/595) as mosaicisms and 5 cases (0.8%, 5/595) as copy number variation (≥5 Mb). Conclusion cPAS?based high?throughput low coverage whole genome sequencing is a reliable method in detecting chromosomal aberrations inspontaneous abortion tissues, including chromosome aneuploidies, mosaicisms and copy number variation (≥5 Mb).

Objective: To evaluate the application of combinatorial probe anchor synthesis (cPAS)-based high-throughput low coverage whole genome sequencing in chromosomal aberration detection in spontaneous miscarriage. Methods: From September 2015 to May 2017, spontaneous miscarriage samples were collected from Inner Mongolia Maternal and Child Health Care Hospital. Those samples were further analyzed with two independent methods, fluorescence in situ hybridization (FISH) and low coverage whole genome sequencing on the BGISEQ-500 high-throughput platform. The performance of low coverage whole genome sequencing was assessed by comparing to FISH results. Results: In 595 spontaneous miscarried specimens, low coverage whole genome sequencing revealed 144 cases (24.2%, 144/595) chromosomal abnormalities, of which a subset of 137 cases (23.0%, 137/595) were detected as aneuploidies, 2 cases (0.3%, 2/595) as mosaicisms and 5 cases (0.8%, 5/595) as copy number variation (≥5 Mb). Conclusion cPAS-based high-throughput low coverage whole genome sequencing is a reliable method in detecting chromosomal aberrations inspontaneous abortion tissues, including chromosome aneuploidies, mosaicisms and copy number variation (≥5 Mb).

Objectives To determine the short term relationship between the number of old allergic rhinitis(AR) patients and the air quality index(AQI) data in autumn and winter in Beijing.Methods Between October 2015 and December 2015,the AQI index data and the number of old outpatients with AR in Beijing Hospital were collected and the relation between them was evaluated by Pearson correlation analysis.Results The AR patients aged over 60 were 1 892 cases (36.72％ of the total number of outpatients).The males were 953 (50.4％),The females were 939 (49.6％).The number of old outpatients with AT changed from 4/d to 39/d.When the AQI rised,the total number of old outpatients was increased;however,when the AQI rised to a certain extent,especially to the serious pollution value (＞300),the number of old outpatients was declined.Pearson correlation analysis showed that there was a negative correlation between the amount of old AR patients and the AQI in the high incidence of air pollution seasons in Beijing (r=0.311,P＜0.01).Conclusions Air pollution is one of the most important reasons for the increased rate of AR patients in the elderly.