[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

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.

Objective To explore the feasibility,safety and effectiveness of ultrasound-guided biopsy of pancreatic lesions with exophytic and backward growth morphology.Methods Fifty-three patients with pancreatic lesions with exophytic and backward growth morphology who underwent ultrasound-guided biopsy were retrospectively collected.Conventional ultrasonic manifestations of lesions were observed,and the technical success rate,complication rate,repeat puncture rate,as well as the sensitivity,specificity and accuracy of biopsy were recorded.Results Totally 61 lesions were detected,with the maximum diameter of 1.4-7.3 cm and the median maximum diameter of 2.7 cm,located in pancreatic uncinate process(26/61,42.62％),head(12/61,19.67％),neck(13/61,21.31％)and body(10/61,42.62％),respectively,mainly presented as hypoechogenic(61/61,100％)and borderless(60/61,98.36％)masses tending to invade blood vessels(51/61,83.61％)and pancreatic ducts(40/61,65.57％).The technical success rate,complication rate and repeat puncture rate of ultrasound-guided biopsy was 100％(61/61),1.89％(1/53)and 21.31％(13/61),respectively,and the sensitivity,specificity and accuracy of biopsy diagnosis was 75.00％(45/60),100％(1/1)and 75.41％(46/61),respectively.Conclusion Ultrasound-guided biopsy was safe and feasible for pancreatic lesions with exophytic and backward growth morphology,but its diagnostic efficacy should be improved.

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.

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.

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.

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.

[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

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.

Objective To explore the feasibility,safety and effectiveness of ultrasound-guided biopsy of pancreatic lesions with exophytic and backward growth morphology.Methods Fifty-three patients with pancreatic lesions with exophytic and backward growth morphology who underwent ultrasound-guided biopsy were retrospectively collected.Conventional ultrasonic manifestations of lesions were observed,and the technical success rate,complication rate,repeat puncture rate,as well as the sensitivity,specificity and accuracy of biopsy were recorded.Results Totally 61 lesions were detected,with the maximum diameter of 1.4-7.3 cm and the median maximum diameter of 2.7 cm,located in pancreatic uncinate process(26/61,42.62％),head(12/61,19.67％),neck(13/61,21.31％)and body(10/61,42.62％),respectively,mainly presented as hypoechogenic(61/61,100％)and borderless(60/61,98.36％)masses tending to invade blood vessels(51/61,83.61％)and pancreatic ducts(40/61,65.57％).The technical success rate,complication rate and repeat puncture rate of ultrasound-guided biopsy was 100％(61/61),1.89％(1/53)and 21.31％(13/61),respectively,and the sensitivity,specificity and accuracy of biopsy diagnosis was 75.00％(45/60),100％(1/1)and 75.41％(46/61),respectively.Conclusion Ultrasound-guided biopsy was safe and feasible for pancreatic lesions with exophytic and backward growth morphology,but its diagnostic efficacy should be improved.