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.Distribution of traditional Chinese medicine syndromes in intrahepatic cholestasis of pregnancy and its association with perinatal outcomes
Jin CHEN ; Dan YANG ; Qianrong LI ; Yan SANG ; Zhi YU ; Jiao XU ; Xuemei WANG ; Heying HUANG ; Xue TANG ; Lin ZHUANG ; Xiaoyin WANG
Journal of Clinical Hepatology 2025;41(11):2343-2350
ObjectiveTo investigate the distribution of traditional Chinese medicine (TCM) syndromes in intrahepatic cholestasis of pregnancy (ICP) and its association with perinatal outcomes, and to provide a basis for precise treatment based on TCM syndrome differentiation. MethodsA cross-sectional study was conducted among 275 patients with ICP who were admitted to The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from April 2023 to April 2025. A hierarchical cluster analysis was used to summarize TCM syndromes. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups, and the chi-square test was used for comparison of categorical data between groups. A multivariate Logistic regression analysis was used to identify the clinical features significantly associated with TCM syndrome. ResultsThe cluster analysis identified three core TCM syndromes among the 275 patients with ICP, i.e., liver-gallbladder damp-heat syndrome (45.8%), syndrome of blood deficiency generating wind (30.9%), and liver depression and spleen deficiency syndrome (23.3%). There was a significant difference in the distribution of TCM syndromes between different groups stratified by maternal age at delivery, parity, history of ICP recurrence, gestational weeks at disease onset, total bile acid (TBA), alanine aminotransferase (ALT), and comorbidity with gestational diabetes mellitus (GDM) (all P<0.05). The multivariate Logistic regression analysis showed that<34 gestational weeks at disease onset was significantly associated with all three syndromes (damp-heat: odds ratio [OR]=3.769, P<0.001; blood deficiency: OR=4.031, P<0.001; liver stagnation: OR=3.552, P<0.001). Liver-gallbladder damp-heat syndrome was associated with maternal age ≥35 years at disease onset (OR=2.048, P=0.014), parity ≥2 times (OR=1.921, P=0.034), history of ICP recurrence (OR=2.404, P=0.030), ALT ≥200 U/L (OR=2.051, P=0.018), comorbidity with GDM (OR=1.944, P=0.029), and TBA ≥40 μmol/L (OR=2.542, P=0.024). The syndrome of blood deficiency generating wind syndrome was associated with maternal age ≥35 years (OR=2.939, P=0.003), parity ≥2 time (OR=3.222, P=0.003), history of ICP recurrence (OR=3.809, P=0.010), ALT ≥200 U/L (OR=2.889, P=0.006), comorbidity with GDM (OR=3.711, P=0.001), and comorbidity with hypertensive disorders of pregnancy (OR=4.472, P=0.011). Liver depression and spleen deficiency syndrome was associated with TBA ≥40 μmol/L (OR=2.995, P=0.044). The analysis of perinatal outcomes showed that there were significant differences in mode of delivery, gestational weeks at the time of delivery, postpartum blood loss, and neonatal birth weight between the three groups with different TCM syndromes (all P<0.05). ConclusionLiver-gallbladder damp-heat syndrome, syndrome of blood deficiency generating wind, and liver depression and spleen deficiency syndrome are the main TCM syndrome types in ICP, and the distribution of TCM syndromes is closely associated with clinical factors and perinatal outcomes, which provides a basis for precise TCM syndrome differentiation and individualized treatment.
7.Application of scenario simulation teaching combined with progressive cases in pediatric nursing teaching
Yuan BAI ; Chunfen WANG ; Xuemei WANG ; Xiaohui WEI ; Jiao LI
Chinese Journal of Medical Education Research 2024;23(11):1545-1549
Objective:To investigate the application effect of scenario simulation teaching combined with progressive cases in pediatric nursing teaching.Methods:A total of 60 nursing students who studied in Department of Pediatric Internal Medicine in Yan'an University Affiliated Hospital from July 2022 to November 2023 were selected as subjects, and according to the order of admission, they were divided into control group and observation group, with 30 students in each group. The students in the control group received traditional teaching, while those in the observation group received scenario simulation teaching combined with progressive case teaching. The two groups were assessed in terms of learning outcomes and degree of satisfaction with teaching. SPSS 22.0 was used to perform the chi-square test and the t-test. Results:There was a significant difference in theoretical assessment score between the control group and the observation group [(83.56±5.29) vs. (87.02±6.08), t=7.56, P=0.006]. Compared with the control group, the observation group had significantly higher scores of nursing operation proficiency, problem-solving ability, communication and coordination ability, emergency response ability, humanistic care, psychological care, and nursing service attitude ( P<0.001). Compared with the control group, the observation group also had a significantly higher total score and significantly higher scores of teaching contents, teaching arrangement, teaching effect, and overall learning gain ( P<0.001). Conclusions:The application of scenario simulation teaching combined with progressive cases in pediatric nursing teaching can effectively improve teaching quality and degree of satisfaction, enhance knowledge reserve and attitude of nursing interns, and promote the development of pediatric nursing.
8.Advances in construction and applications of quantitative adverse outcome pathways in toxicology
Mintao LI ; Jiahui CHEN ; Beibei JIANG ; Jie GAO ; Jiali ZOU ; Qianru ZHOU ; Xiaofeng YAN ; Shuquan LUO ; Huadong ZHANG ; Jinyao CHEN ; Xuemei LIAN ; Jiao HUO
Chinese Journal of Pharmacology and Toxicology 2024;38(6):473-480
"Toxicity Testing in the 21st Century—A Vision and Strategy"proposed by the National Research Council of US has brought innovative directives and objectives for toxicity evaluation and risk assessment,pushing forward the next generation of toxicity testing and risk assessment.In this initiative,the concept of adverse outcome pathways(AOPs)has emerged as a prominent methodology,capturing the attention of toxicologists and researchers due to its promising applications in recent years.The quantitative AOP(qAOP)is an extension of the adverse outcome pathway,which is built upon the foundational qualitative adverse outcome pathway model and leverages mathematical frame-works to depict dose-response and/or response-response relationships.This article reviews the princi-ples and advancement surrounding qAOP,introduceds two prevalent methodologies for constructing qAOP,Bayesian network models and regression models,and demonstrates diverse applications of qAOP.Actual cases are used to underscore the transformative role of qAOP in contemporary toxicology and risk assessment practices.
10.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.

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