1.Statistical considerations in the design of albumin clinical trials
Yuanyuan KONG ; Chen YAO ; Jidong JIA
Journal of Clinical Hepatology 2025;41(3):420-423
Albumin is widely used in clinical practice, and the rationality of trial design directly affects the reliability of research findings and clinical application value. This article reviews the key statistical considerations in the design of albumin clinical trials, including the selection of primary endpoints, the establishment of statistical hypotheses and non-inferiority margins, clinical evaluation criteria for ascites improvement, sample size, and interim analyses, in order to provide methodological guidance for clinical researchers to optimize clinical trial design and enhance its scientific rigor and feasibility.
2.Neutrophil activation is correlated with acute kidney injury after cardiac surgery under cardiopulmonary bypass
Tingting WANG ; Yuanyuan YAO ; Jiayi SUN ; Juan WU ; Xinyi LIAO ; Wentong MENG ; Min YAN ; Lei DU ; Jiyue XIONG
Chinese Journal of Blood Transfusion 2025;38(3):358-367
[Objective] To explore the relationship between neutrophil activation under cardiopulmonary bypass (CPB) and the incidence of cardiac surgery-associated acute kidney injury (CS-AKI). [Methods] This prospective cohort study enrolled adult patients who scheduled for cardiac surgery under CPB at West China Hospital between May 1, 2022 and March 31, 2023. The primary outcome was acute kidney injury (AKI). Blood samples (5 mL) were obtained from the central vein before surgery, at rewarming, at the end of CPB, and 24 hours after surgery. Neutrophils were labeled with CD11b, CD54 and other markers. To assess the effect of neutrophils activation on AKI, propensity score matching (PSM) was employed to equilibrate covariates between the groups. [Results] A total of 120 patients included into the study, and 17 (14.2%) developed AKI. Both CD11b+ and CD54+ neutrophils significantly increased during the rewarming phase and the increases were kept until 24 hours after surgery. During rewarming, the numbers of CD11b+ neutrophils were significantly higher in AKI compared to non-AKI (4.71×109/L vs 3.31×109/L, Z=-2.14, P<0.05). Similarly, the CD54+ neutrophils counts were also significantly higher in AKI than in non-AKI before surgery (2.75×109/L vs 1.79×109/L, Z=-2.99, P<0.05), during rewarming (3.12×109/L vs 1.62×109/L, Z=-4.34, P<0.05), and at the end of CPB (4.28×109/L vs 2.14×109/L, Z=-3.91, P<0.05). An analysis of 32 matched patients (16 in each group) revealed that CD11b+ and CD54+ neutrophil levels of AKI were 1.74 folds (4.83×109/L vs 2.77×109/L, Z=-2.72, P<0.05) and 2.34 folds (3.32×109/L vs 1.42×109/L, Z=-4.12, P<0.05), respectively, of non-AKI at rewarming phase. [Conclusion] Neutrophils are activated during CPB, and they can be identified by CD11b/CD54 markers. The activated neutrophils of AKI patients are approximately 2 folds of non-AKI during the rewarming phase, with disparity reached peak between groups during rewarming. These findings suggest the removal of 50% of activated neutrophils during the rewarming phase may be effective to reduce the risk of AKI.
3.STAR Guideline Terminology(Ⅱ): Clinical Question Formulation, Evidence Retrieval and Appraisal, and Recommendation Development
Di ZHU ; Haodong LI ; Zijun WANG ; Qianling SHI ; Hui LIU ; Yishan QIN ; Yuanyuan YAO ; Zhewei LI ; Hongfeng HE ; Jinhui TIAN ; Long GE ; Yaolong CHEN ;
Medical Journal of Peking Union Medical College Hospital 2025;16(3):756-764
To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development. A systematic search was conducted in guideline development manuals and relevant methodological literature, covering publications up to October 25, 2024. Terminology related to the three aforementioned stages of related to guideline development was extracted from the included literature, standardized, and refined through consensus meetings to finalize a comprehensive terminology list and definitions. A total of 30 guideline development manuals and 15 methodological articles were included, and 23 core terms were identified. It is recommended to develop a standardized and scientifically sound guideline terminology system with unified naming, clear definitions, and alignment with the linguistic environment and usage habits in China. At the same time, it is essential to strengthen terminology training for both guideline developers and users based on this system, in order to deepen their correct understanding and proper application of guideline terminology.
4.Distribution of pupil diameter and its association with myopia in school age children
Chinese Journal of School Health 2025;46(8):1194-1197
Objective:
To investigate the distribution of pupil diameter and its association with myopia in school age children, providing ideas into the mechanisms of the role of pupil diameter in the onset and development of myopia.
Methods:
Adopting a combination of stratified cluster random sampling and convenience sampling method, 3 839 children from six schools in Shandong Province were included in September 2021. Pupil diameters distribution was analyzed by age, sex, and myopic status. Pearson correlation analysis was used to assess the relationship between pupil diameter and cycloplegic spherical equivalent (SE), as well as axial length (AL) and other variables. Propensity score matching (PSM) was applied to match myopic and non myopic children at a 1∶1 ratio based on age and sex. A generalized linear model (GLM) was constructed with pupil diameter as the dependent variable to identify independent factors influencing pupil size and its association with myopia.
Results:
The mean pupil diameter of school age children was (5.77±0.80)mm. Pupil diameter exhibited a significant increasing trend with age ( F =49.34, P trend < 0.01). Myopic children had a significantly larger mean pupil diameter [(6.10±0.73)mm] compared to non myopic children [(5.62±0.79)mm] with a statistically significant difference( t=18.10, P <0.01). Multivariable GLM analysis, adjusted for age, amplitude of accommodation, and uncorrected visual acuity, revealed a negative correlation between pupil diameter and cycloplegic SE (before PSM: β =-0.089, after PSM: β =-0.063, both P <0.01).
Conclusions
Myopic school age children exhibite larger pupil diameters than their non myopic counterparts. Pupil diameter may serve as a potential indicator for monitoring myopia development in school age children.
5.Comparison of clinical features of nephrotic syndrome after haploidentical and matched donor hematopoietic stem cell transplantation.
Wei SUN ; Yuanyuan ZHANG ; Yuhong CHEN ; Yuqian SUN ; Yifei CHENG ; Fengrong WANG ; Huan CHEN ; Yao CHEN ; Chenhua YAN ; Xiaodong MO ; Wei HAN ; Lanping XU ; Yu WANG ; Xiaohui ZHANG ; Kaiyan LIU ; Xiaojun HUANG
Chinese Medical Journal 2024;137(4):478-480
6.Study on pathogenesis and laboratory diagnosis of a family with von Willebrand disease caused by c.1117C>T/c.7288-9T>G compound heterozygous mutation
Zhongzhou TAN ; Yao LU ; Linzi MIAO ; Yuanyuan LI ; Zijing ZHU ; Yinan SONG ; Yan GONG ; Chenxue QU
Chinese Journal of Clinical Laboratory Science 2024;42(2):121-125
Objective To explore the diagnosis of clinically suspicious von Willebrand disease(vWD)in a family and its pathogene-sis.Methods The pedigree information and the biological specimen were collected from the clinically suspected VWD patient and her family members(4 persons in total)in Peking University First Hospital.The levels of platelet count(PLT),activated partial thrombo-plastin time(APTT),vWF antigen(vWF:Ag),vWF activity(vWF:Ac)and FⅧ activity(FⅧ:C)were detected,and vWF risto-cetin cofactor(vWF:RCo)assay,ristocetin-induced platelet aggregation assay(RIPA)and vWF collagen binding(vWF:CB)assay were performed for phenotype diagnosis.The peripheral blood genomic DNAs were extracted from the proband and her family members to perform whole-exome sequencing for identifying the mutation of vWF gene,The mutation site was analyzed by using bioinformation tools to explore the pathogenesis of the proband.Results The APTT of proband(m 1)was slightly prolonged and her vWF:Ag,vWF:Ac,vWF:RCo and vWF:CB were significantly decreased.There was no obvious aggregation in RIPA assay(1.0 mg/mL and 1.25 mg/mL).In her father(Ⅱ3),APTT,FⅧ:C,vWF:Ag,vWF:Ac and vWF:CB were normal,but vWF:RCo was slightly decreased.In her mother(Ⅱ4),APTT,FⅧ:C,vWF:Ag,vWF:RCo and vWF:CB were all normal,but vWF:Ac significantly decreased.In her brother(Ⅲ2),APTT and FⅧ:C were normal,but vWF:Ag,vWF:Ac,vWF:RCo and vWF:CB were reduced to varying degrees.In all the family members(father,mother and brpther),no apparent aggregation in RIPA(1.0 mg/mL)was shown.Genetic analysis showed that the proband(Ⅲ1)carried a compound heterozygous mutation of vWF gene c.7288-9T>G and c.1117C>T,her father(Ⅱ3)carried vWF gene c.7288-9T>G heterozygous mutation,and vWF gene c.1117C>T heterozygous mutation was presented in both mother(Ⅱ4)and brother(Ⅲ2).Conclusion According to the results of laboratory tests,the proband was diagnosed as type 2A vWD.The hetero-zygous mutation in vWF gene c.1117C>T and c.7288-9T>G may be the molecular mechanism leading to type 2A vWD in the proband.
7.Application of Ancient Books in Clinical Practice Guidelines and Expert Consensus of Traditional Chinese Medicine: Current Status and Methodological Recommendations
Changhao LIANG ; Dingran YIN ; Jing CUI ; Xinshuai YAO ; Xinyi GU ; Yifei YAN ; Wanting LIU ; Yingqiao WANG ; Yingqi CHANG ; Haoyu DONG ; Mengqi LI ; Yuanyuan LI ; Yutong FEI
Journal of Traditional Chinese Medicine 2024;65(8):801-809
ObjectiveTo explore the current status and issues regarding the application of ancient books in clinical practice guidelines and expert consensus of traditional Chinese medicine (TCM) published in China, and to provide methodological recommendations for the incorporation of ancient books in the development of TCM guidelines. MethodsWe searched China National Knowledge Infrastructure (CNKI), WanFang Data, VIP, SinoMed, PubMed, Embase, as well as six industry websites including China Association of Chinese Medicine, National Group Standards Information Platform, and Chinese Association of the Integration of Traditional and Western Medicine,etc. TCM clinical practice guidelines or expert consensus issued during January 1st, 2017, to November 26th, 2022 were searched. Clinical practice guidelines or expert consensus that explicitly referred to ancient books were included, and the content regarding the searching for ancient books, sources of access to ancient books, methods of evaluating the level of evidence, methods of evaluating the level of recommendation, and methods of evaluating the evidence for the ancient books were analysed. ResultsA total of 1,215 TCM clinical practice guidelines or expert consensus were retrieved, with 442 articles explicitly mentioning the application of ancient books, including 300 (67.87%) clinical practice guidelines and 142 (32.13%) expert consensus. Sixty of the 442 publications explicitly reported that ancient books searching had been conducted (13.57%); among these 60 publications 27 (45.00%) explicitly reported ancient books searching strategies, and the most frequent method was manual searching with a total of 24 articles (40.00%). The most popular search source was Chinese Medical Dictionary, a TCM classics database, with a total of 18 articles. 197 articles (44.57%) explicitly reported the evaluation criteria for the level of evidence, of which 141 articles (71.57%) involved the evaluation criteria for the ancient books; 413 articles (93.44%) mentioned ancient books in the recommendations, and only the source of formula name was mentioned in 409 (99.03%) of the publications. ConclusionThe current application of ancient books in TCM clinical practice guidelines and expert consensus is limited, with issues of non-standard searching and evaluation methods. Standar-dization and uniformity are needed in evidence grading and recommendation standards. Future research should clarify the scope and methods of applying ancient book, emphasize their integration with modern research evidence, and enhance their value and quality in the development of TCM clinical practice guidelines.
8.Safety and cost-benefit analysis of patients without gastric tube after thoracolaparoscopic esophagectomy: A prospective cohort study
Yuanyuan YIN ; E ZHENG ; Huanhuan LI ; Mei YANG ; Li YAO ; Chunlin ZHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(05):728-732
Objective To compare the safety and comfort of patients with or without postoperative gastric tube placement after esophageal cancer surgery, and analyze the cost and nursing time of gastric tube placement. Methods The patients with esophageal cancer undergoing minimally invasive surgery in West China Hospital of Sichuan University in 2021 were enrolled. The patients were divided into a gastric tube indwelling group and a non gastric tube indwelling group according to whether the gastric tube was indwelled after the operation. The safety and comfort indicators of the two groups were compared. Results A total of 130 patients were enrolled. There were 66 patients in the gastric tube indwelling group, including 53 males and 13 females, aged 61.80±9.05 years and 64 patients in the non gastric tube indwelling group, including 55 males and 9 females, aged 64.47±8.00 years. Six patients in the non gastric tube indwelling group needed to place gastric tube 1 to 3 days after the operation due to their condition. There was no statistical difference in the incidence of postoperative complications between the two groups (P>0.05). The subjective comfort of patients in the gastric tube indwelling group was significantly lower than that in the non gastric tube indwelling group (P<0.001), and the incidence of foreign body sensation in the throat of patients in the gastric tube indwelling group was higher than that in the non gastric tube indwelling group (P<0.001). The average nursing time in the gastric tube indwelling group was about 59.58 minutes, and the average cost of gastric tube materials and nursing was 378.24 yuan per patient. Conclusion No gastric tube used after operation for appropriate esophageal cancer patients will not increase the incidence of postoperative complications (pulmonary infection, anastomotic leakage, chylothorax), but can increase the comfort of patients, save cost and reduce nursing workload, which is safe, feasible and economical.
9.Effect of fisetin against venous thrombosis in rats and its mechanism
Lihui LONG ; Shuang WEI ; Qing LIU ; Yang YAO ; Juanni DONG ; Yuanyuan CHANG ; Enhui WEN
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(3):383-387
Objective To analyze the effect of fisetin against venous thrombosis in rats.Methods Seventy SD rats were randomly divided into the following groups:sham-operation group,model group,fisetin 45 mg/kg,15 mg/kg,5 mg/kg groups,and aspirin group(47 mg/kg).The corresponding medication was administered by gavage once a day consecutively(the sham-operation group and the model group were given 0.5%carboxymethyl cellulose sodium solution with 10 mL/kg,respectively)for 7 consecutive days.One hour after the last administration,the rats were anesthetized,the lower part of the intersection of inferior vena cava and left renal vein was ligated with silk thread(no ligation in the sham-operation group),and the abdominal wall was sutured.Two hours later,the abdominal cavity was reopened,the other venous branches 1.5 cm away from the ligation site were closed with the artery clamp,and blood was collected from the abdominal aorta.The anticoagulant ratio of 3.8%sodium citrate∶whole blood was 1∶9.The venous thrombus 1 cm down from the ligation point of the intersection of inferior vena cava and left renal vein was cut and the thrombus was separated.The residual blood was dried with filter paper,weighed and recorded.Plasma was taken after anticoagulant blood centrifugation.The levels of plasma antithrombin-Ⅲ(AT-Ⅲ),protease C(PC),plasminogen(PLG),and plasminogen activator inhibitor(PAI-1)were detected by ELISA kits.Results Compared with the model group,the weight of thrombus in fisetin 45 mg/kg group and aspirin 47 mg/kg group decreased(P<0.01).The content of AT-Ⅲ in three fisetin groups increased(all P<0.05).The content of PC in fisetin 45 mg/kg increased(P<0.05).The content of PLG and PAI-1 in fisetin 45 mg/kg group decreased(both P<0.05).Conclusion Fisetin has the effect against venous thrombosis in vivo,and the effect is related to the upregulation of AT-Ⅲ and PC and the downregulation of PLG and PAI-1.
10.Meta-integration and ethical reflections of medical students'experience in digital storytelling teaching
Chenyang HOU ; Yuanyuan ZHANG ; Ju HAN ; Chou YAO ; Ying LI ; Meng LI
Chinese Medical Ethics 2024;37(11):1331-1339
Objective:To explore the learning experience of medical students in digital storytelling teaching,providing a theoretical basis for the practice and research of digital storytelling teaching.Methods:Qualitative research and mixed-method research containing qualitative studies on medical students'experiences in digital storytelling teaching were retrieved from domestic and foreign databases,with a retrieval time limit from database establishment to January 2024.The quality evaluation criteria for qualitative research from JBI Evidence-Based Healthcare Center were used to evaluate the quality of the included literature,and the meta-integration method was used to systematically integrate and analyze the results.Results:A total of 12 articles were included,44 research results were extracted,and 11 new categories were summarized and integrated into 3 integration results,including medical students benefit greatly from digital storytelling teaching;the unique advantages of digital storytelling as an emerging teaching tool;and the obstacles of digital storytelling in education.Conclusion:Medical students hold a positive attitude towards the teaching mode of digital storytelling and have gained a good learning experience from it.However,there are shortcomings such as the uneven quality of digital storytelling resources,and some medical students'unsuitability for the learning mode of digital storytelling.Further research is needed on ethical issues arising from the teaching mode of digital storytelling.


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