5.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
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.
6.Impact of different diagnostic criteria for assessing mild micro-hepatic encephalopathy in liver cirrhosis: an analysis based on a prospective, multicenter, real-world study
Xiaoyan LI ; Shanghao LIU ; Chuan LIU ; Hongmei ZU ; Xiaoqing GUO ; Huiling XIANG ; Yan HUANG ; Zhaolan YAN ; Yajing LI ; Jia SUN ; Ruixin SONG ; Junqing YAN ; Qing YE ; Fei LIU ; Lei HUANG ; Fanping MENG ; Xiaoning ZHANG ; Shaoqi YANG ; Shengjuan HU ; Jigang RUAN ; Yiling LI ; Ningning WANG ; Huipeng CUI ; Yanmeng WANG ; Chuang LEI ; Qinghai WANG ; Hongling TIAN ; Zhangshu QU ; Min YUAN ; Ruichun SHI ; Xiaoting YANG ; Dan JIN ; Dan SU ; Yijun LIU ; Ying CHEN ; Yuxiang XIA ; Yongzhong LI ; Qiaohua YANG ; Huai LI ; Xuelan ZHAO ; Zemin TIAN ; Hongji YU ; Xiaojuan ZHANG ; Chenxi WU ; Zhijian WU ; Shengqiang LI ; Qian SHEN ; Xuemei LIU ; Jianping HU ; Manqun WU ; Tong DANG ; Jing WANG ; Xianmei MENG ; Haiying WANG ; Zhenyu JIANG ; Yayuan LIU ; Ying LIU ; Suxuan QU ; Hong TAO ; Dongmei YAN ; Jun LIU ; Wei FU ; Jie YU ; Fusheng WANG ; Xiaolong QI ; Junliang FU
Chinese Journal of Hepatology 2023;31(9):961-968
Objective:To compare the differences in the prevalence of mild micro-hepatic encephalopathy (MHE) among patients with cirrhosis by using the psychometric hepatic encephalopathy score (PHES) and the Stroop smartphone application (Encephal App) test.Methods:This prospective, multi-center, real-world study was initiated by the National Clinical Medical Research Center for Infectious Diseases and the Portal Hypertension Alliance and registered with International ClinicalTrials.gov (NCT05140837). 354 cases of cirrhosis were enrolled in 19 hospitals across the country. PHES (including digital connection tests A and B, digital symbol tests, trajectory drawing tests, and serial management tests) and the Stroop test were conducted in all of them. PHES was differentiated using standard diagnostic criteria established by the two studies in China and South Korea. The Stroop test was evaluated based on the criteria of the research and development team. The impact of different diagnostic standards or methods on the incidence of MHE in patients with cirrhosis was analyzed. Data between groups were differentiated using the t-test, Mann-Whitney U test, and χ2 test. A kappa test was used to compare the consistency between groups. Results:After PHES, the prevalence of MHE among 354 cases of cirrhosis was 78.53% and 15.25%, respectively, based on Chinese research standards and Korean research normal value standards. However, the prevalence of MHE was 56.78% based on the Stroop test, and the differences in pairwise comparisons among the three groups were statistically significant (kappa = -0.064, P < 0.001). Stratified analysis revealed that the MHE prevalence in three groups of patients with Child-Pugh classes A, B, and C was 74.14%, 83.33%, and 88.24%, respectively, according to the normal value standards of Chinese researchers, while the MHE prevalence rates in three groups of patients with Child-Pugh classes A, B, and C were 8.29%, 23.53%, and 38.24%, respectively, according to the normal value standards of Korean researchers. Furthermore, the prevalence rates of MHE in the three groups of patients with Child-Pugh grades A, B, and C were 52.68%, 58.82%, and 73.53%, respectively, according to the Stroop test standard. However, among the results of each diagnostic standard, the prevalence of MHE showed an increasing trend with an increasing Child-Pugh grade. Further comparison demonstrated that the scores obtained by the number connection test A and the number symbol test were consistent according to the normal value standards of the two studies in China and South Korea ( Z = -0.982, -1.702; P = 0.326, 0.089), while the other three sub-tests had significant differences ( P < 0.001). Conclusion:The prevalence rate of MHE in the cirrhotic population is high, but the prevalence of MHE obtained by using different diagnostic criteria or methods varies greatly. Therefore, in line with the current changes in demographics and disease spectrum, it is necessary to enroll a larger sample size of a healthy population as a control. Moreover, the establishment of more reliable diagnostic scoring criteria will serve as a basis for obtaining accurate MHE incidence and formulating diagnosis and treatment strategies in cirrhotic populations.
7.Extraction of effective components of Psoralea corylifolia and efficacy evaluation in the treatment of vitiligo
Xuemei YU ; Zhenghua WU ; Guorong FAN
China Pharmacy 2023;34(14):1676-1680
OBJECTIVE To extract the effective components of Psoralea corylifolia and evaluate its efficacy in the treatment of vitiligo. METHODS The concentrations of psoralen, isopsoralen, neobavaisoflavone, corylin, psoralidin, corylifolinin, and bakuchiol in P. corylifolia extract were determined by ultra-performance liquid chromatography. Based on the analytic hierarchy process (AHP) and Plackett-Burman design, with the concentrations of the 7 components as evaluation indexes and the crushing degree, ethanol concentration, and soaking time as factors, the extraction process of P. corylifolia was optimized by Box-Behnken response surface methodology and the validation test was conducted. Zebrafish were divided into blank control group, positive control group (8-methoxypsoralen, 10.8 μg/mL), and low-, medium-, and high-concentration groups of P. corylifolia extract (500, 1 000, 2 000 μg/mL), with 6 fish in each group. The effects of P. corylifolia extract on the melanin production of zebrafish were studied by density analysis. RESULTS The best extraction process was P. corylifolia powder over 60 meshes and soaked in 80% ethanol for 72 hours. The average comprehensive score of three validation experiments was 98.27, with an RSD of 1.36%, and the relative error was 1.02% compared with the predicted value of the fitting equation (97.28). Compared with the blank control group, the melanin pigmentation of zebrafish in the low-, medium-, and high-concentration groups of P. corylifolia extract was significantly increased (P<0.01). CONCLUSIONS The optimized extraction process of P. corylifolia is reasonable and feasible, and the obtained P. corylifolia extract can significantly promote the production of melanin in zebrafish.
8.Mechanism of Xianglian Huazhuo Prescription Against Chronic Atrophic Gastritis Based on Network Pharmacology and Experimental Verification
Jie WANG ; Yunxiao GAO ; Hongyu MA ; Xuemei JIA ; Yuxi GUO ; Pengli DU ; Danyang ZHAO ; Tong ZHANG ; Bolin LI ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(18):161-168
ObjectiveTo explore the mechanism of Xianglian Huazhuo prescription in the treatment of chronic atrophic gastritis (CAG) based on network pharmacology and animal experiments,so as to provide scientific basis for clinical application. MethodThe possible targets and pathways of Xianglian Huazhuo prescription in the treatment of CAG were obtained based on the prediction of network pharmacology. The CAG rat model was induced by sodium salicylate,N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) and hunger and satiety disorder. Then the CAG rats were treated with Xianglian Huazhuo prescription and morodan for 60 days. After administration,the rats were sacrificed,and the content of interleukin-6 (IL-6),tumor necrosis factor-α (TNF-α),interleukin-1β (IL-1β) and vascular endothelial growth factor (VEGF) in serum was determined by enzyme linked immunosorbent assay(ELISA). In addition, the protein expression of Bad and Bcl-2 in gastric mucosa was detected by immunohistochemistry (IHC). ResultA total of 241 active components of Xianglian Huazhuo prescription and 53 core targets were obtained. Xianglian Huazhuo prescription affected multiple biological processes,such as cell proliferation and apoptosis,inflammatory reaction,regulation of DNA metabolism,and cell response to redox,as well as phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt),TNF,mitogen-activated protein kinase (MAPK),cancer and cancer-related signaling pathways. The animal model verification showed that Xianglian Huazhuo prescription lowered the levels of IL-6,TNF-α,IL-1β and VEGF in serum of CAG rats,and reduced the protein expression of Bad and Bcl-2 in gastric tissue. ConclusionXianglian Huazhuo prescription could regulate PI3K/Akt signal pathway and improve gastric mucosal injury in CAG by participating in biological processes such as cell proliferation,apoptosis and inflammation.
9.An Exploration to Carry Out Ideological and Political Education of "Loving Experimental Animals and Reverencing for Life" for Medical Students
Chen HUANG ; Youmin HU ; Yan LIU ; Wenwen NI ; Xuemei FENG ; Yanxia WANG ; Weifang RONG
Chinese Medical Ethics 2022;35(8):921-924
To implement the fundamental task of the Ministry of Education on carrying out curriculum ideological and political education and promoting colleges and universities to implement the morality education, this study tried to carry out ideological and political education for medical students in "medical functional science experimental course", and organically integrated the ideological and political elements of "loving experimental animals and reverencing for life" into the teaching of this course. This paper explored the implementation process and effect evaluation of ideological and political courses from the aspects of teaching objects, design, objectives, in-class and off-class practical activities, and analyzed the current problems and future directions. In order to provide beneficial ideas for the ideological and political construction of college curriculum and help cultivate excellent and innovative medical talents with warmth and feelings.
10.Changes and significance of T follicular regulatory cells/T follicular helper cells and related cytokines in peripheral blood of children with dust mite allergic asthma
Xiao TONG ; Fang GONG ; Chaojiao GUAN ; Yucen JIANG ; Bingjie ZHANG ; Xuemei ZHOU ; Tuo JI ; Weihong SHEN
Chinese Journal of Applied Clinical Pediatrics 2022;37(23):1793-1796
Objective:To explore the changes of T follicular regulatory (T FR) cells/T follicular helper (T FH) cells and their related cytokines in peripheral blood of children with dust mite allergic asthma, and their clinical significance. Methods:A total of 25 children with acute dust mite allergic asthma (the asthma group) in Affiliated Hospital of Jiangnan University from January to December 2021 and 16 age- and sex-matched healthy volunteers (the healthy control group) at the same time were enrolled in the retrospective study.The percentages of peripheral T FR cells and T FH cells of the 2 groups were measured by flow cytometry.The plasma levels of cytokines[interleukin (IL)-10, IL-21] of the 2 groups were assessed by the flow cytometric microsphere-based array technology.The specific IgE (sIgE) levels of dust mites in 2 groups were detected by fluorescence enzyme immunoassay.The percentage of eosinophils in peripheral blood detected by blood cell analyzer.Data between groups were compared by t-test, and the correlation among indicators was analyzed by Spearman rank correlation analysis. Results:The asthma group had evident T FR cells/T FH cells immune imbalance.Compared with the healthy control group, the asthma group had a significantly lower T FR cells level[(0.11±0.03)% vs.(0.13±0.03)%], a significantly higher T FH cells level[(5.07±1.75)% vs.(3.80 ± 1.60)%], and a significantly lower ratio of T FR cells /T FH cells(0.02±0.01 vs.0.05±0.03) ( t=2.29, 2.30, 3.71; all P<0.05). Compared with the healthy control group, the asthma group had a significantly higher IL-21 level[(547.85±195.13) ng/L vs.(404.94±110.41) ng/L], and a significantly lower IL-10 level[(10.18±3.49) ng/L vs.(14.79±5.65) ng/L] ( t=2.60, 3.15; all P<0.05). The ratio of T FR cells/T FH cells in asthma group was negatively correlated with sIgE ( r=-0.444 2, P=0.026 1), but not related to the eosinophil percentage ( r=-0.135 2, P=0.519 3). Conclusions:Children with dust mite allergic asthma suffer from T FR cells/T FH cells subset imbalance.The imbalanced T FR cells, T FH cells and their related cytokines IL-10 and IL-21 may play a role in regulating the production of asthma sIgE.

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