1.Exploration on Surrogate Outcome Measures in Clinical Trials of Traditional Chinese Medicine for Diabetic Kidney Disease
Can CAO ; Weiwei SUN ; Tong MA ; Yaoxian WANG
Journal of Traditional Chinese Medicine 2025;66(8):790-794
Traditional Chinese medicine (TCM) has unique advantages in alleviating the symptoms of diabetic kidney disease (DKD) and slowing its progression. However, traditional clinical trials often use the occurrence of end-stage renal disease as the end point, requiring long-term follow-up, which increases trial complexity and costs, thereby limiting the feasibility of TCM clinical studies. This paper suggested that in clinical trials of TCM for DKD, both the estimated glomerular filtration rate (eGFR) change rate (≥30%) and eGFR slope can serve as potential surrogate outcome measures. If the intervention course is short (<1 year), the eGFR change rate (≥30%) is recommended as a surrogate outcome measure, whereas in long-term interventional studies (≥1 year), the eGFR slope may be more appropriate. Furthermore, based on biochemical indicators such as eGFR slope and urinary albumin-to-creatinine ratio (UACR) change rate, integrating TCM symptom evaluation, TCM syndrome evaluation, and quality of life scales can help develop internationally recognized patient-reported outcome measures (PROMs) for TCM clinical trials, which will be a key step in enhancing the evaluation system for the effectiveness of TCM in treating DKD.
2.Pathogenesis and treatment progress of flap ischemia-reperfusion injury
Bo HE ; Wen CHEN ; Suilu MA ; Zhijun HE ; Yuan SONG ; Jinpeng LI ; Tao LIU ; Xiaotao WEI ; Weiwei WANG ; Jing XIE
Chinese Journal of Tissue Engineering Research 2025;29(6):1230-1238
BACKGROUND:Flap transplantation technique is a commonly used surgical procedure for the treatment of severe tissue defects,but postoperative flap necrosis is easily triggered by ischemia-reperfusion injury.Therefore,it is still an important research topic to improve the survival rate of transplanted flaps. OBJECTIVE:To review the pathogenesis and latest treatment progress of flap ischemia-reperfusion injury. METHODS:CNKI,WanFang Database and PubMed database were searched for relevant literature published from 2014 to 2024.The search terms used were"flap,ischemia-reperfusion injury,inflammatory response,oxidative stress,Ca2+overload,apoptosis,mesenchymal stem cells,platelet-rich plasma,signaling pathways,shock wave,pretreatment"in Chinese and English.After elimination of irrelevant literature,poor quality and obsolete literature,77 documents were finally included for review. RESULTS AND CONCLUSION:Flap ischemia/reperfusion injury may be related to pathological factors such as inflammatory response,oxidative stress response,Ca2+overload,and apoptosis,which can cause apoptosis of vascular endothelial cells,vascular damage and microcirculation disorders in the flap,and eventually lead to flap necrosis.Studies have found that mesenchymal stem cell transplantation,platelet-rich plasma,signaling pathway modulators,shock waves,and pretreatment can alleviate flap ischemia/reperfusion injuries from different aspects and to varying degrees,and reduce the necrosis rate and necrosis area of the grafted flap.Although there are many therapeutic methods for skin flap ischemia/reperfusion injury,a unified and effective therapeutic method has not yet been developed in the clinic,and the advantages and disadvantages of various therapeutic methods have not yet been compared.Most of the studies remain in the stage of animal experiments,rarely involving clinical observations.Therefore,a lot of research is required in the future to gradually move from animal experiments to the clinic in order to better serve the clinic.
3.Application of artificial intelligence and automated scripts in3D printing brachytherapy
Wentai LI ; Jiandong ZHANG ; Zhihe WANG ; Xiaozhen QI ; Yan DING ; Baile ZHANG ; Wenjun MA ; Yao ZHAI ; Weiwei ZHOU ; Yanan SUN ; Xin ZHANG
Chinese Journal of Radiological Health 2025;34(3):419-425
Objective To explore the efficiency improvement in segmenting neural network with the application of Transformer + U-Net artificial intelligence (AI) and modeling with the application of Python scripts in three-dimensional (3D) printing brachytherapy. Methods A Transformer + U-Net AI neural network model was constructed, and Adam optimizer was used to ensure rapid gradient descent. Computed tomography or magnetic resonance imaging data of patients were standardized and processed as self-made data sets. The training set was used to train AI and the optimal result weight parameters were saved. The test set was used to evaluate the AI ability. Python programming language was used to write an automated script to obtain the output segmentation image and convert it to the STL file for import. The source applicator and needle could be automatically modeled. The time of automatic segmentation and modeling and the time of manual segmentation and modeling were entered by two people, and the difference was verified by paired t-test. Results Dice similarity coefficient (DSC), mean intersection over union (MIOU), and Hausdorff distance (HD95) were used for evaluation. DSC was
4.Study on Influencing Factors of Nurses’ Willingness to Participate in Humanistic Nursing Training
Jianjing WANG ; Li MA ; Yilan LIU ; Wenjing ZHU ; Weiwei CHEN ; Yingzi LI ; Lifang REN ; Hongzhen XIE
Chinese Medical Ethics 2024;35(4):445-453
In order to understand nurses’ willingness to participate in humanistic nursing training and its influencing factors, and provide reference for managers to understand the current situation and improve nurses’ enthusiasm for humanistic nursing training. The convenience sampling method was used to investigate 23 707 nurses in 28 provinces (autonomous regions and municipalities directly under the central government) through a self-designed questionnaire distributed on the Internet. The results showed that 98.1% of nurses thought that participating in humanistic nursing related training was helpful to clinical work, but only 88.6% of the respondents were willing to participate in humanistic nursing training. Thirty factors were analyzed from four aspects of basic characteristics of individuals, cognitive relevant experience and organizational atmosphere. Fifteen factors had significant significance in binary Logistic regression analysis (P<0.05). Among them, the factors that had a positive impact on training willingness were: marriage, education, professional title, post establishment, agree with humanistic care is the basic duty of a nurse praised, experience of being praised at work, family support, rapport with patients, passion of colleagues to participate in training, sustained high-quality care demonstration activities, join the humanistic care related organization, hospital reimbursement of training expenses (OR value of 6.559~1.113, P<0.001). The OR value of humanistic nursing as a nurse’s responsibility was 6.559 and the 95%CI was 5.585~7.702. The factors that hindered nurses from participating in training were: work occupied most of time and energy, think humanistic nursing is abstract and difficult to understand, think the mastered humanistic knowledge and skills meet the needs of work (OR value of 0.657~0.722, P<0.001). Through the analysis, it is considered that nurses have a extremely consistent high recognition of the significance of humanistic nursing training, but their willingness to receive training is affected by many factors such as individual experience, cognitive attitude and organizational atmosphere. In order to realize nurses’ high recognition of humanistic nursing training to high enthusiasm of behavior, the aspects of individual cognition and organizational atmosphere must be discussed.
5.Research progress of electrical impedance tomography in positive end-expiratory pressure titration
Xiaoyu MA ; Dehui FAN ; Weiwei WANG
The Journal of Clinical Anesthesiology 2024;40(2):185-189
Appropriate positive end-expiratory pressure(PEEP)level is an important component of protective lung ventilation strategy.PEEP can maintain the openness of alveoli and reduce lung collapse in-jury.Although individualized PEEP application has been increasingly recognized by clinical physicians,the optimal PEEP titration method is still controversial.Electrical impedance tomography(EIT)is a non-inva-sive and radiation-free imaging technique that can be used to dynamically assess lung function at the bedside.EIT presents changes in impedance during ventilation as dynamic images,which can reflect altera-tions in ventilation and gas distribution before and after PEEP adjustments.Therefore,EIT can be utilized to tailor individualized PEEP.This article provides a brief overview of the basic principles and monitoring pa-rameters of EIT.It elucidates the PEEP titration method under the guidance of EIT in clinical applications(PEEPEIT),aiming at enhancing the understanding of the advantages and limitations of EIT and providing reference for the setting of individualized PEEP.
6.Qizhi Zhoufei Granule Alleviate Chronic Obstructive Pulmonary Disease by Regulating Th1/Th2 Immunologic Balance Through Notch Signaling Pathway
Ruofei MA ; Miao SU ; Jintian LI ; Juan LI ; Yi ZHANG ; Weiwei XU ; Jiachen JIANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):179-189
Objective To investigate the role of homologous genes absent from the wings of drosophila melanogaster(Notch)signaling pathway in the imbalance of helper T cells 1(Th1)and helper T cells 2(Th2)and the intervention mechanism of Qizhi Zhoufei Granule in chronic obstructive pulmonary disease(COPD).Methods Ten of seventy Wistar rats were selected as the blank control group,and the other rats were established by cigarette smoking combined(CS)with tracheal infusion of lipopolysaccharide(LPS).The COPD model was established by randomly selecting 3 rats in the control group and the model group to verify the success of the model.At the end of modeling,gavage administration was performed.The rats in the model group were randomly divided into model control group,positive control group(67.5 μg·kg-1)and Qizhi Zhoufei Granule high,medium and low treatment group(3.24,1.62,0.81 g·kg-1).Each group was treated with normal saline,dexamethasone acetate suspension and Qizhi Zhoufei Granule suspension at high,medium and low doses.The rats in the blank control group were given the same volume of normal saline as the model control group.After modeling with 28 days and treatment with 28 days,peak inspiratory flow(PIF)and peak expiratory flow(PEF)were detected by the animal lung function test system.Rats were killed to extract lungs,spleen,serum and bronchoalveolar lavage fluid(BALF),hematoxylin-eosin(HE)staining was used to evaluate the pathological changes of lung tissues.The level of tumor necrosis factor-α(TNF-α)in serum and BALF was determined by enzyme-linked immunosorbent assay(ELISA).Flow cytometry was used to detect Th1/Th2 cells in spleen.Immunohistochemistry(IHC)and western blot were used to detect Notch1,Hes1 and Hey1 protein levels in lung tissues.Real-time fluorescence quantitative polymerase chain reaction(Real-Time PCR)was used to detect Notch1,Hes1 and Hey1 gene expression levels in lung tissues.Result Compared with the blank control group,the lung function of the model control group was significantly decreased(P<0.05),inflammatory cell infiltration and bronchial structure destruction occurred in the lung tissue,TNF-α content in serum and BALF increased significantly(P<0.05),the percentage of spleen Th1 cells was significantly decreased(P<0.05),and the percentage of Th2 cells was significantly increased(P<0.05),the protein and mRNA expressions of Notch1,Hes1 and Hey1 in lung tissues were significantly increased(P<0.05),the differences were statistically significant;Compared with the model control group,the lung function of rats in each administration group was significantly increased(P<0.05),the pathological injury of lung tissue was alleviated,TNF-α content in serum and BALF decreased significantly(P<0.05),the percentage of spleen Th1 cells was significantly increased(P<0.05),the percentage of Th2 cells was significantly decreased(P<0.05),the lung tissue of Notch1,Hes1,Hey1 protein and mRNA expression were significantly decreased(P<0.05),the differences were statistically significant.Conclusion Qizhi Zhoufei Granule regulate Th1/Th2 balance by inhibiting Notch signaling pathway,thereby improving pulmonary function and pathological injury,and affecting immune function in COPD rats.
7.Traditional Chinese medicine monomer in the prevention and treatment of flap necrosis by regulating"autophagy"
Suilu MA ; Zhijun HE ; Tao LIU ; Yan LI ; Yuanxu HE ; Bo HE ; Weiwei WANG ; Xiaotao WEI
Chinese Journal of Tissue Engineering Research 2024;28(1):153-158
BACKGROUND:In recent years,it has been found that some traditional Chinese medicine monomers can alleviate oxidative stress and apoptosis of the skin flap,promote vascular regeneration of the skin flap and prevent skin flap necrosis by activating autophagy. OBJECTIVE:To review the research progress of traditional Chinese medicine monomer regulating autophagy in preventing flap necrosis. METHODS:The Chinese and English key words were"traditional Chinese medicine(TCM),autophagy,skin flaps".The first author searched the relevant articles published in CNKI and PubMed databases from January 2010 to October 2022.A total of 196 articles were retrieved in the preliminary screening and then screened according to the inclusion and exclusion criteria.The quality assessment was conducted by reading the literature titles and abstracts.Finally,55 articles were summarized. RESULTS AND CONCLUSION:(1)The regulation of autophagy is mediated by AMPK/mTOR,PI3K/AKT and other signaling pathways.Activation of autophagy can alleviate the oxidative stress and apoptosis of the flap,promote the regeneration of blood vessels in the flap,and prevent flap necrosis.(2)Terpenoids(Betulinic acid,Andrographolide,Notoginseng Triterpenes,Catalpa),phenolic compounds(Resveratrol,Curcumin,Gastrodin),phenolic acids(Salvianolic acid B)and steroid compounds(Pseudoginsenoside F11)in traditional Chinese medicine monomers can alleviate oxidative stress and apoptosis of skin flap by regulating related signaling pathways to activate autophagy,promote skin flap angiogenesis and promote skin flap survival.(3)Studying the research progress of traditional Chinese medicine monomer to prevent flap necrosis by regulating autophagy can provide a reference and theoretical basis for traditional Chinese medicine to prevent flap necrosis and promote flap healing in the clinic.
8.Improving the strategy of mesenchymal stem cells in treatment of flap ischemia-reperfusion injury
Bo HE ; Zhijun HE ; Jinpeng LI ; Tao LIU ; Suilu MA ; Xiaotao WEI ; Weiwei WANG ; Jing XIE
Chinese Journal of Tissue Engineering Research 2024;28(19):3097-3103
BACKGROUND:Mesenchymal stem cells have great potential in the treatment of ischemia-reperfusion injury of skin flaps.However,their defects and the decline of their role in the treatment of ischemia-reperfusion injury of skin flaps restrict their wide application. OBJECTIVE:To review the strategies for improving the treatment of ischemia-reperfusion injury of skin flaps with mesenchymal stem cells,and provide a reference for its further theoretical research and clinical application. METHODS:Relevant documents included in CNKI,WanFang and PubMed were searched.The Chinese and English search terms were"mesenchymal stem cell,ischemia-reperfusion adjustment of skin flap,mesenchymal stem cells,stem cells,skin flap,ischemia-reperfusion injury,pretreatment,gene modification,biomaterial packaging,joint application".The relevant documents since 2007 were retrieved,and the documents with little relationship between the research content and the article theme,poor quality and outdated content were eliminated through reading the article,and finally 75 documents were included for summary. RESULTS AND CONCLUSION:(1)Mesenchymal stem cells can inhibit inflammatory reactions,resist oxidative stress and induce angiogenesis,which has great potential in the treatment of skin flap ischemia-reperfusion injury.(2)Although mesenchymal stem cells have shown great potential in the treatment of skin flap ischemia-reperfusion injury,their shortcomings in treatment have limited their widespread clinical application.Through pre-treatment(cytokines,hypoxia,drugs,and other pre-treatment mesenchymal stem cells),gene-modified mesenchymal stem cells,biomaterial encapsulation of mesenchymal stem cells,as well as the combined use of mesenchymal stem cells and other drugs or therapeutic methods,can not only overcome the shortcomings of mesenchymal stem cells in treatment,but also improve their therapeutic effectiveness in skin flap ischemia-reperfusion injury.(3)Therefore,further improving the effectiveness of mesenchymal stem cells in treating skin flap ischemia-reperfusion injury and exploring its therapeutic potential are of great significance for the research of mesenchymal stem cells and the treatment of skin flap ischemia-reperfusion injury.
9.Action mechanism and advantages of mesenchymal stem cells for treating flap ischemia-reperfusion injury
Bo HE ; Zhijun HE ; Tao LIU ; Suilu MA ; Xiaotao WEI ; Weiwei WANG
Chinese Journal of Tissue Engineering Research 2024;28(25):4065-4071
BACKGROUND:Mesenchymal stem cells are used in flap ischemia-reperfusion injury due to their antioxidant and inflammatory inhibition,and angiogenesis induction. OBJECTIVE:To review the mechanism and latest treatment progress of mesenchymal stem cells in the treatment of flap ischemia-reperfusion injury,and to provide a basis for further theoretical research and clinical rational application. METHODS:We searched the relevant articles indexed in CNKI,WanFang and PubMed databases.Chinese and English search terms were"mesenchymal stem cells;flap ischemia reperfusion injury;conditioned medium;exosomes;oxidative stress;inflammatory reactions;angiogenesis".Relevant literature since 2010 was searched,and 74 articles were finally included after excluding the literature that had little to do with the topic of the article,poor quality and outdated content. RESULTS AND CONCLUSION:(1)Mesenchymal stem cells play significant roles in antioxidation,inhibition of inflammation and induction of angiogenesis and have great potential in the treatment of flap ischemia-reperfusion injury.(2)However,the defects of mesenchymal stem cells themselves and the decline of therapeutic effect in recent years have put the development and application of mesenchymal stem cells into a bottleneck period,and the research on the plasticity of mesenchymal stem cells conditioned medium and its exosomes and mesenchymal stem cells came into being,and the therapeutic effect was significantly better than the use of mesenchymal stem cells alone.(3)Therefore,a more comprehensive understanding of the mechanism of action and the latest treatment progress of mesenchymal stem cells in the treatment of flap ischemia-reperfusion injury is of great significance for the research of mesenchymal stem cells and the treatment of flap ischemia-reperfusion injury.
10.Relationship between statin drugs and bone density:a drug target-mediated Mendelian randomization study
Weiwei MA ; Yong XIONG ; Honggu CHEN ; Wenzhuo HUANG ; Xin HUANG ; Xiaohong ZHOU
Chinese Journal of Tissue Engineering Research 2024;28(27):4340-4345
BACKGROUND:Observational studies have suggested that statin drugs may have a protective effect on bone density,making them a potential treatment option for osteoporosis. OBJECTIVE:To evaluate the causal relationship between drug target-mediated lipid phenotypes and bone mineral density(BMD)using Mendelian randomization methods. METHODS:We obtained single nucleotide polymorphismsrelated to statin drugs and BMD data from the IEU Open GWAS database.The primary analysis method was the inverse variance weighted method,and we also used weighted median,simple median,weighted mode,and MR-Egger regression.We usedβ values and 95%confidence intervals(CI)to assess the causal relationship between statin drugs and BMD.Additionally,we conducted sensitivity analyses to validate the results,assessed heterogeneity using Cochran's Q test,examined for horizontal pleiotropy using the MR-Egger intercept test,and performed leave-one-out analyses to determine if individual or multiplesingle nucleotide polymorphism influenced the results. RESULTS AND CONCLUSION:There was a significant association between the statin target of action,3-hydroxy-3-methyl glutaryl coenzyme A reductase-mediated low-density lipoprotein cholesterol,and heel bone BMD(β=-0.086,95%CI:-0.117 to-0.055,P=5.42×10-8)and whole-body BMD(β=-0.193,95%CI:-0.288 to-0.098,P=7.35×10-5).The findings of this study support the protective effect of statin drugs on BMD.These findings not only deepen our understanding of the relationship between cholesterol-related genes and bone health but also reveal potential therapeutic targets for improving BMD.

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