1.Application and regulatory challenges of organoid technology in medical field
Weilu CHENG ; Zehua WANG ; Yidan ZHANG ; Yinghui LIU
Chinese Journal of Tissue Engineering Research 2025;29(1):202-210
BACKGROUND:3D organoids have characteristics that resemble physiological tissues and to some extent mimic organ function,making them excellent models for applications ranging from basic development/stem cell research to personalized medicine. OBJECTIVE:To review and discuss the types of diseases and application areas such as tumor modeling that organoids can be applied to,as well as their regulatory status and challenges. METHODS:With"organoid,stem cell,disease model,3D printing technology,medical field"as Chinese and English search terms,we searched PubMed,Elsevier,WanFang,and CNKI databases to summarize and analyze organoid products at home and abroad,summarize the application of organoid technology in the medical field,and prospect the future development of organoid products in the medical field. RESULTS AND CONCLUSION:Organoids can break the limitations of traditional cell and animal models,avoid the ethical problems existing in clinical research,and have a high similarity to the source organ,a more similar performance to the physiology and pathology of human systems,and genetic stability,which has great advantages in current research.Organoids have been applied in the following fields:efficacy evaluation studies(preclinical models),including intestinal organoids,kidney organoids,liver organoids,gallbladder organoids,lung organoids,brain organoids,heart organoids,skin organoids,and reproductive system organoids;research on infectious diseases;cancer research and precision therapy;regenerative medicine;immune organoids.Although the United States,the European Union and China do not have perfect regulatory provisions,they are trying to promote the formulation of organoid regulatory laws and regulations.In China,although no organoid medical device products have been listed for the time being,its related regenerative medicine products have made breakthroughs.
2.Sleep duration and risk of cardiovascular and metabolic comorbidity in middle-aged and elderly people: a cohort study
Jiahong YIN ; Ying GAO ; Junfang YOU ; Jie CHENG ; Weilu CHEN ; Li LIU ; Qing ZHANG ; Haiyan SU
Chinese Journal of Health Management 2025;19(7):523-529
Objective:To understand the relationship between sleep duration and cardiovascular and metabolic comorbidities (CMM) in middle-aged and elderly people in China.Methods:This study was a prospective cohort study, based on the data of China Health and Retirement Tracing Survey (CHARLS) from 2011 to 2015, and included middle-aged and elderly people aged≥45 years in the cohort study. Age, gender, marital status, residence, education, smoking status, alcohol status, body mass index, history of diabetes, history of dyslipidemia, history of hypertension, history of stroke, history of heart disease, history of mental illness, depression scale score were collected. Multivariate logistic regression was used to analyze the association between daily sleep duration and the risk of CMM onset and to construct four models with stepwise adjusted covariates. A stratified analysis was established based on demographic factors, lifestyle factors, metabolic factors, cardiovascular and cerebrovascular factors, and psychological factors. Meanwhile, a subgroup analysis was established according to different combinations of cardiovascular and metabolic diseases to explore the association between sleep length and the risk of CMM in different populations.Results:A total of 297 (4.4%) of the 6 788 included participants experienced CMM. In the multivariate logistic regression, the RR value (95% CI) for the risk of CMM for>9 h was 1.99 (1.86-2.08) and 1.78 (1.64-1.92), respectively (all P<0.001). The stratified analysis showed that the risk of CMM incidence between sleep duration<7 h and>9 h was associated in people with different age, sex, residence, smoking status, drinking status, body mass index, hypertension, hypertension, diabetes, heart disease, stroke, dyslipidemia, and depression (all P<0.05). Subgroup analysis showed that sleep duration<7 h with both diabetes, heart disease and stroke had the highest risk of CMM ( RR=1.95, 95% CI: 1.65-2.14). Conclusion:In the middle-aged and elderly group in China, there is a U-shaped association between sleep duration and CMM, that is, insufficient or too long sleep duration throughout the day is related to the increased risk of CMM.
3.Exploration on Rules of Medication and Clinical Application of Zhongwan Point Based on Association Rules
Xin TIAN ; Yaqi YAO ; Zezhou ZHANG ; Weilu CHENG ; Shaozong CHEN
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(3):642-650
Objective To observe the rules of medication and clinical application of Zhongwan(RN12)point,thus to provide reference for the selection of acupoints in clinical treatment.Methods Collect the Zhongwan point-involved prescriptions in the literature of the last 20 years in China National Knowledge Infrastructure(CNKI),China Science and Technology Journal Database(VIP)and Wanfang Data Knowledge Service Platform,conduct strict screening,organize and record all the acupoints involved in the prescriptions,of which met the acupoint selection criteria,into Excel tables,then use IBM SPSS Statistics 25.0 software,IBM SPSS Modeler 18.0 software,Cytoscape 3.10.1 software,apriori algorithm to analyze the rules of medication and clinical application of Zhongwan point.Results After screening,a total of 781 articles with 830 acupoint-involved prescriptions were included,involves 183 acupoints and 135 diseases.With the leading five acupoints which ranked in decending order of selection was as follows:Zusanli(ST36),Neiguan(PC6),Tianshu(ST25),Guanyuan(BL26)and Qihai(RN6).The distribution of acupoints with the highest frequency of use in combination acupoints was Zusanli(61.205%support),and the meridians with a higher frequency of use in Zhongwan point-involved prescriptions were the foot-yangming stomach meridian,the foot-taiyang bladder meridian,and the conception vessel(CV),with the combination acupoints dominated by the specific acupoints of Xiahe points,He points,front-Mu points,collateral points,Shu Points,and original points,the advantageous diseases were characterized by intractable hiccups,gastritis,functional dyspepsia and so on.Among them,the diseases pertain to the digestive system were the most involved,followed by endocrine system diseases.Conclusion The data mining analysis yielded that there are certain rules to be followed in the acupoints combination of Zhongwan point,and it exerts some efficacy in the treatment of certain advantageous diseases,which can provide references for clinical treatment and scientific research.
4.Efficacy and safety of immunotherapy combined with chemotherapy as conversion therapy for initially unresectable locally advanced esophageal squamous cell carcinoma
Huilai LYU ; Mingbo WANG ; Chunyue GAI ; Fan ZHANG ; Yonggang ZHU ; Yu LIU ; Jiachen LI ; Weilu DING ; Shi XU ; Zhenhua LI ; Bokang SUN ; Wenda GAO ; Ziqiang TIAN
Chinese Journal of Surgery 2025;63(11):1023-1030
Objective:To evaluate the efficacy and safety of immunotherapy combined with chemotherapy as conversion therapy for initially unresectable locally advanced esophageal squamous cell carcinoma.Methods:This retrospective case series study analyzed clinical and pathological data of 32 patients with initially unresectable locally advanced esophageal squamous cell carcinoma who received immunotherapy combined with chemotherapy at the Department of Thoracic Surgery, the Fourth Hospital of Hebei Medical University, from June 2020 to December 2024. The cohort included 27 males and 5 females, with an age ( M(IQR)) of 61(9)years (range:46 to 73 years). Five patients were diagnosed with stage Ⅲ, 27 with stage ⅣA. All patients received PD-1 inhibitor sintilimab combined with nedaplatin and albumin-bound paclitaxel. Radiological evaluations were performed every two cycles, the multidisciplinary team evaluation was conducted to determine conversion to resectable status, and patients with successful conversion underwent radical esophagectomy. Follow-up was conducted via telephone or outpatient visits every 3 to 6 months after the last treatment. The primary endpoint was R0 resection rate, secondary endpoints included objective response rate (ORR), pathological complete response (pCR) rate, major pathological response (MPR) rate, event-free survival (EFS), disease-free survival (DFS) in patients with R0 resection, overall survival (OS) and safety. Kaplan-Meier method was used to plot survival curves and estimate median EFS, DFS, OS rates and their 95% CI. The 95% CI for ORR, pCR rate, MPR rate, and downstaging rate were calculated using the Clopper-Pearson method. Results:The median treatment cycle of 2(1) (range:2 to 8). As of June 2025, the median follow-up was 32.5(13.5)months (range:6.4 to 59.1 months). Among the 32 patients, 9 experienced progression or recurrence, including 2 with liver and lymph node metastases, 2 with lung metastases, 2 with thoracic vertebral metastases, and 3 with mediastinal lymph node metastases. After conversion therapy, 29 patients underwent surgery, achieving an R0 resection rate of 84.4% (95% CI:67.2% to 94.7%), a pCR rate of 27.6% (95% CI:12.7% to 47.2%), and an MPR rate of 55.2% (95% CI:35.7% to 73.6%). Grade 3 or higher surgical complications occurred in 6.9%(2/29) of patients, and grade 3 or higher treatment-related adverse events were observed in 15.6%(5/29). Among the 32 patients, the ORR was 56.3% (95% CI:37.7% to 73.6%),the 3-year EFS rate and OS rate was 59.4% (95% CI:40.8% to 86.4%) and 59.7% (95% CI:40.0% to 89.0%) respectively. Conclusion:Immunotherapy combined with chemotherapy demonstrates high conversion rates and favorable safety in the conversion therapy of initially unresectable locally advanced esophageal squamous cell carcinoma, representing a promising treatment strategy.
5.Drospirenone and ethinyl estradiol tablets in the management of early pregnancy-related uterine arteriovenous fistula: a 4-case series with efficacy evaluation
Xuhui ZHU ; Chongyi ZHANG ; Weilu CHEN ; Pu ZHOU ; Wenying FU ; Yanhua YU ; Chongjie JIN ; Xiaohu GUO ; Zhiqin CHEN
Chinese Journal of Reproduction and Contraception 2025;45(9):940-944
Uterine arteriovenous fistula (UAVF), a relatively rare vascular anomaly, may lead to life-threatening hemorrhage and poses diagnostic and management challenges for primary hospitals during initial encounters. This article reports four cases of UAVF treated with Drospirenone and ethinyl estradiol tablets at Department of Gynaecology, Zhuji Maternal and Child Health Hospital between 2023 and 2024. Combined with literature review, we systematically analyzed the etiological mechanisms, clinical characteristics, and diagnostic-therapeutic strategies of this condition, with particular focus on evaluating the efficacy and safety of conservative pharmacological management. By summarizing case features and individualized treatment protocols, this study aims to provide clinical references for early identification, accurate diagnosis, and rational intervention of UAVF, thereby reducing risks of massive hemorrhage and long-term complications while improving patient prognosis.
6.A morphological description of the humerus based on statistical shape model
Weilu GAO ; Zhengfeng JIA ; Changsen YANG ; Jiantao LI ; Xiuyun SU ; Licheng ZHANG
Journal of Capital Medical University 2025;46(5):765-769
Objective To construct a high-precision statistical shape model of the humerus and systematically describe its anatomical variation patterns.Methods In this study,a statistical shape model of the humerus was constructed using the three-dimensional model data of 60 collected humerus cases.The principal component analysis method was adopted to reveal the main patterns of humerus anatomical variations and their contribution rates.Results The results showed that the first five principal components(PC01-PC05)collectively explained 96.6%of the total anatomical variations.Among them,PC01 and PC02 were the main components,contributing 66.6%and 23.5%of the variations respectively.PC01 mainly reflects the scaling effect of the overall size(length/width)of the humerus,while PC02 reveals the length variation characteristics independent of the overall scaling,which may reflect individualized differences.The subsequent principal components(PC03-PC05)depicted the local morphological characteristics and fine changes of the proximal and distal humerus.Conclusion The statistical shape model constructed in this study provides a reliable digital basis for personalized prosthesis design,surgical planning and biomechanical simulation.
7.Drospirenone and ethinyl estradiol tablets in the management of early pregnancy-related uterine arteriovenous fistula: a 4-case series with efficacy evaluation
Xuhui ZHU ; Chongyi ZHANG ; Weilu CHEN ; Pu ZHOU ; Wenying FU ; Yanhua YU ; Chongjie JIN ; Xiaohu GUO ; Zhiqin CHEN
Chinese Journal of Reproduction and Contraception 2025;45(9):940-944
Uterine arteriovenous fistula (UAVF), a relatively rare vascular anomaly, may lead to life-threatening hemorrhage and poses diagnostic and management challenges for primary hospitals during initial encounters. This article reports four cases of UAVF treated with Drospirenone and ethinyl estradiol tablets at Department of Gynaecology, Zhuji Maternal and Child Health Hospital between 2023 and 2024. Combined with literature review, we systematically analyzed the etiological mechanisms, clinical characteristics, and diagnostic-therapeutic strategies of this condition, with particular focus on evaluating the efficacy and safety of conservative pharmacological management. By summarizing case features and individualized treatment protocols, this study aims to provide clinical references for early identification, accurate diagnosis, and rational intervention of UAVF, thereby reducing risks of massive hemorrhage and long-term complications while improving patient prognosis.
8.A morphological description of the humerus based on statistical shape model
Weilu GAO ; Zhengfeng JIA ; Changsen YANG ; Jiantao LI ; Xiuyun SU ; Licheng ZHANG
Journal of Capital Medical University 2025;46(5):765-769
Objective To construct a high-precision statistical shape model of the humerus and systematically describe its anatomical variation patterns.Methods In this study,a statistical shape model of the humerus was constructed using the three-dimensional model data of 60 collected humerus cases.The principal component analysis method was adopted to reveal the main patterns of humerus anatomical variations and their contribution rates.Results The results showed that the first five principal components(PC01-PC05)collectively explained 96.6%of the total anatomical variations.Among them,PC01 and PC02 were the main components,contributing 66.6%and 23.5%of the variations respectively.PC01 mainly reflects the scaling effect of the overall size(length/width)of the humerus,while PC02 reveals the length variation characteristics independent of the overall scaling,which may reflect individualized differences.The subsequent principal components(PC03-PC05)depicted the local morphological characteristics and fine changes of the proximal and distal humerus.Conclusion The statistical shape model constructed in this study provides a reliable digital basis for personalized prosthesis design,surgical planning and biomechanical simulation.
9.Regulatory requirements and enlightenment from U.S FDA on medical devices used in treating benign prostatic hyperplasia
Jing LIU ; Zijing ZHOU ; Weilu CHENG ; Yidan ZHANG ; Yaohua LI
China Medical Equipment 2025;22(6):158-162
Benign prostatic hyperplasia(BPH)is the main reason of causing lower urinary tract symptoms(LUTS)in middle-aged and elderly men,and LUTS can disrupt patients'sleep patterns and interfere with their daily life.With the development of aging,BPH has produced a significant impact on public health,and caused serious social problems and economic burdens.There are various technical approaches for medical devices used in treating BPH,including laser,electrosurgery,focused ultrasound,microwave,stent,and liquid jet removal system,etc.This article summarized the pathogenesis,clinical manifestations,and general overview for guidelines of diagnosis and treatment for BPH.It also reviewed the guiding principle of Food and Drug Administration(FDA)for medical devices used in treating BPH,and focused on analyzing the main contents of non-clinical study,animal study(including animal model,test method,observation time points and evaluation indicators)and clinical study(including selection for control groups,inclusion and exclusion criteria,study endpoint and study duration),so as to provide some enlightenments for the verification,validation and technical evaluation for such products.
10.Regulatory requirements and enlightenment from U.S FDA on medical devices used in treating benign prostatic hyperplasia
Jing LIU ; Zijing ZHOU ; Weilu CHENG ; Yidan ZHANG ; Yaohua LI
China Medical Equipment 2025;22(6):158-162
Benign prostatic hyperplasia(BPH)is the main reason of causing lower urinary tract symptoms(LUTS)in middle-aged and elderly men,and LUTS can disrupt patients'sleep patterns and interfere with their daily life.With the development of aging,BPH has produced a significant impact on public health,and caused serious social problems and economic burdens.There are various technical approaches for medical devices used in treating BPH,including laser,electrosurgery,focused ultrasound,microwave,stent,and liquid jet removal system,etc.This article summarized the pathogenesis,clinical manifestations,and general overview for guidelines of diagnosis and treatment for BPH.It also reviewed the guiding principle of Food and Drug Administration(FDA)for medical devices used in treating BPH,and focused on analyzing the main contents of non-clinical study,animal study(including animal model,test method,observation time points and evaluation indicators)and clinical study(including selection for control groups,inclusion and exclusion criteria,study endpoint and study duration),so as to provide some enlightenments for the verification,validation and technical evaluation for such products.

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