Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Human genetic resources are valuable for life science research and pharmaceutical industry.Competitions for human genetic resources and the relevant techniques and industries have increasingly become intense among countries with the the implementation of precision medicine strategy and the maturity of gene editing technology.In the context of scientific progress and efficiency,the Organisation for Economic Co-operation and Development,the most important international economic organization,has proposed solutions to technological development and research paradigm changes from the perspective of national and global public interests.The United States,Japan,the United Kingdom,and some other developed countries have also released their policies and guidelines on the sharing of genetic resource data.In this article we analyzed these policies and guidelines,with an attempt to further improve the administration of human genetic resource sharing in China and promote the legal sharing and effective use of these resources.
China ; Guidelines as Topic ; Human Genetics ; Humans ; Information Dissemination

Objective To investigate the prevalence of main chronic diseases and explore its influencing factors among urban residents in Liaoning Province. Methods Using multistage stratified and cluster random sampling method, 30 953 urban residents of 14 districts were investigated with a standard questionnaire and physical examination. The logistic regression was applied to explore the influencing factors of main chronic diseases. Results The prevalence rate of chronic diseases was 39.25% and the standardized prevalence rate was 32.29%. The top three chronic diseases were hypertension, diabetes mellitus, and dyslipidemia, and the standardized prevalence rates were 21.13%, 9.48% and 5.25%. The results of the logistic regression analysis showed that the three chronic diseases shared older age(OR: 1.266-7.325)and overweight or obesity(OR:1.107-2.982)as the risk factors .In addition, there existed certain interactions among hypertension, diabetes mellitus and dyslipidemia(OR: 2.424-3.121). Conclusion Hypertension, diabetes mellitus and dyslipidemia which shared older age, overweight and obesity as the risk factors are the main chronic diseases to damage the health of urban residents in Liaoning. The corresponding prevention and treatment strategies should be taken based on the key groups and related influencing factors.

Block chain, as a decentralized, trustless database technology program with an intact information trans-parency and a privacy protection function, can be use to construct a highly effective and reliable transmission sys-tem and promote the Internet to become an infrastructure in building the society-trusted network. Block chain is of significant advantages in optimizing the business processes, reducing the operation cost and improving the synergis-tic efficiency in financial industry, and is thus rapidly applied in other industries. The construction of health and medical big data is faced with the challenge of both information security and privacy protection in health field. Block chain is characterized by high fault tolerance, unaltered infrastructure and privacy protection function, and has thus a large room for its application in medical treatment, pharmaceutical industry, medical insurance and ge-nomics.

Objective To provide the reference for researchers to understand the current situation in telemedicine by studying its hotspots with visual representation.Methods The cluster of Web of Science(WOS)-covered papers on telemedicine in the past 10 years was analyzed by bibliographic co-occurrence analysis combined with the dual cluster software gcluto.Results The hotspots in studies of telemedicine at present were centralized on system con-struction,evaluation analysis and data output.Conclusion Telemedicine,an important means for the rational allo-cation of medical resources,needs its researchers to integrate their study and new technologies,improve their medi-cal service level and promote the equality of medical service.

OBJECTIVEObstructive sleep apnea-hypopnea syndrome (OSAHS) may cause serious morbidities, such as systemic hypertension, diabetes, and cor pulmonale. However, currently no many reports on study of OSAHS in children are available. This study aimed to explore the effects of OSAHS on children's multiple systems.

METHODA total of 89 cases of children who came to the Sleep Treatment Center in the authors' hospital from March 2009 to December 2010 with snoring were tested with overnight polysomnography (PSG). They were classified into mild OSAHS group (n = 59, mean age of 5.71, SD = 2.46) and moderate to severe group (n = 30, mean age of 5.30, SD = 2.73) based on the PSG results, and 100 healthy children were selected as the control group (n = 100, mean age of 6 years, SD = 2.98). Data including height, weight, body mass index and blood pressure, peripheral blood routine, blood lipids, glucose and insulin, electrocardiogram and echocardiography were collected. Patients' adenoid face and abnormal occlusion were also recorded. Comparisons of the data were made among those groups.

RESULTMild OSAHS and moderate to severe group had significantly higher prevalence of adenoid face (23.7%, 26.7%), and abnormal occlusion (74.6%, 60.0%) than that in control group (0, 40%) (P < 0.05). There were no significant differences in terms of BMI between the OSAHS group and the control group, but the weight (kg) and height (cm) in the mild OSAHS group (23.3 ± 10.1, 114.9 ± 16.2) and moderate to severe group (21.9 ± 8.4, 110.8 ± 13.3) were lower than those of the control group (31.8 ± 10.1, 136.1 ± 15.1) (all P < 0.05). Compared with the control group, the level of HDL-C (mmol/L)and insulin (mU/L) in moderate and severe group decreased [(1.20 ± 0.30) vs. (1.40 ± 0.27), 2.79 (0.84 - 16.16) vs. 4.92 (0.76 - 16.80), P < 0.05], while the LDL-C (mmol/L) increased [(2.61 ± 0.75) vs. (2.32 ± 0.62), P < 0.05]. The red blood cell counts (× 10(12)/L) and the blood platelet counts (× 10(9)/L) in the mild OSAHS (4.93 ± 0.37, 292.92 ± 75.64) and moderate and severe OSAHS group (5.23 ± 0.22, 292.50 ± 63.05) were significantly higher in contrast to the control group (4.70 ± 0.31, 255.60 ± 69.12) (all P < 0.05), systolic blood pressure (mmHg) in mild group (98.54 ± 10.44) and moderate to severe group (99.13 ± 19.13) was significantly higher compared to control group (87.88 ± 11.37), and the heart rate (beats/min) in moderate to severe group (94.43 ± 10.64) was higher than those in control group (87.12 ± 16.20) (all P < 0.05). The mild OSAHS and moderate and severe OSAHS group had decreased right ventricular internal diameter [(14.24 ± 1.64) mm, (13.17 ± 2.07) mm ], increased main pulmonary artery diameter [(17.05 ± 3.33) mm, (16.33 ± 3.14) mm] and the thickness of right ventricular wall [(3.43 ± 0.26) mm, (3.57 ± 0.20) mm] compared to control group [ (16.10 ± 2.96) mm, (14.11 ± 2.52) mm, (3.32 ± 0.25) mm] (all P < 0.05).

CONCLUSIONOSAHS in children may be associated with craniofacial malformations, and may contribute to slow growth and development, elevated blood viscosity and blood pressure, metabolic abnormalities, and change cardiac structure.

Blood Pressure ; Body Mass Index ; Case-Control Studies ; Child ; Child, Preschool ; Echocardiography ; Female ; Humans ; Insulin ; Male ; Maxillofacial Abnormalities ; Polysomnography ; Sleep Apnea, Obstructive ; complications

The collected information is an attempt to cover the more recent developments in the phytochemistry and pharmacology of this genus. During the past years, alkaloids, flavonoids, volatile oils, organic acids, polysaccharides, tannins and phenolic constituents have been isolated from Ephedra. Pharmacological studies are described according to hypoglycemic effects, anticoagulated blood properties, depressurization, immunosuppressive activity, antioxidation and antivirus activity and so on. The information summarized here is intended to provid a rational foundation for the futher development and utilization of Ephedra which is rich in China.
Alkaloids ; chemistry ; isolation & purification ; Animals ; Ephedra ; chemistry ; classification ; Flavonoids ; chemistry ; isolation & purification ; Hypoglycemic Agents ; pharmacology ; Immunosuppressive Agents ; pharmacology ; Molecular Structure ; Plant Stems ; chemistry ; Plants, Medicinal ; chemistry ; Polysaccharides ; isolation & purification ; pharmacology