With the widespread application of robotic technology in surgery, multiple robot-assisted laparoscopic endoscopic surgical systems are currently in the R&D phase, highlighting an urgent need for establishing a scientific and standardized quality evaluation framework. In 2024, the National Medical Products Administration issued the standard YY/T 1941-2024, entitled Robotically-assisted Laparoscopic Surgical System, which specifies performance requirements and test methods for such systems. This standard provides critical guidance for the development of innovative products, technological advancement, and regulatory oversight. The standard offers clear definitions of relevant terminology and systematically standardizes the quality evaluation methods for these products across six key aspects: manual controller performance, instrument arm performance, system operational performance, safety protection functions, robotic surgical instruments, and software. This article interprets the core indicators outlined in the standard, aiming to assist clinicians in gaining a deeper understanding of the performance parameters of these systems and to support manufacturers in conducting quality assessments and risk analyses during product development, thereby promoting high-quality progress in the industry and related products.

Objectives:This study aims to investigate the association between Chinese visceral adiposity index(CVAI)and the risk of cardiovascular disease(CVD),and explore the sex differences.Methods:Participants were screened from the three sub-cohorts of Prediction for Atherosclerotic Cardiovascular Disease Risk in China(China-PAR)project,baseline information on body measure and biochemistry examinations were collected from 1998,2000-2001,and 2007-2008,separately.Participants were followed up to 2015.Cohort-stratified Cox proportional risk models were used to analyze the relationship between CVAI,both in continuous(per standard deviation increase)and categorical(quartiles,with Q1 as reference)scales,and CVD risk in the total population,men and women.The multiplicative interaction between sex and CVAI on CVD risk were calculated.Restricted cubic spline regression was employed to investigate the dose-response relationship.Results:A total of 98 464 participants without CVD at baseline were included.During the 723 508 person-years of follow-up,3 605 CVD events were recorded.After multivariate adjustment,the HRs(95％CIs)of CVD were 1.25(1.20-1.29),1.09(1.04-1.15),and 1.54(1.46-1.64)for per standard deviation increment in CVAI in the general population,men and women,respectively.Besides,compared with Q1 group,the HRs(95％CIs)in Q4 group were 1.87(1.67-2.10),1.33(1.14-1.54)and 3.84(3.09-4.78),correspondingly,and the effect of CVAI on the risk of CVD was significantly higher in women than in men(Pinteraction<0.05).Additionally,there was a positive dose-response relationship between CVAI and the risk of CVD.Conclusions:Elevated CVAI is an independent risk factor for CVD,especially in women.

Background::Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.Methods::A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.

Per- and polyfluoroalkyl substances (PFAS) are a class of persistent organic pollutants widely present in the environment. They can enter the human body through multiple pathways such as air, water, and diet, and tend to bioaccumulate. In recent years, increasing attention has been paid to the potential impacts of PFAS exposure on male reproductive health. This review systematically summarizes the characteristics of PFAS exposure in men and its effects on semen quality. Epidemiological evidence indicates that PFAS exposure is significantly associated with reduced sperm concentration, motility, and normal morphologyrate. Mechanistic studies suggest that PFAS may induce male reproductive toxicity through various pathways, including germ cell cytotoxicity, dysfunction of Sertoli cells, endocrine disruption, oxidative stress, and epigenetic regulation. This review aims to integrate current evidence to support the assessment of male reproductive risks associated with PFAS exposure and to inform the development of preventive strategies.

Objective:To develop a modified University of Wisconsin preservation solution (UW solution) containing α 2-adrenergic receptor agonists (dexmedetomidine) and noble gases (argon) and investigate its protective effect on the isolated amputated skeletal muscle of rats. Methods:Sixty male SD rats were selected to establish a hindlimb cold preservation/perfusion model and were divided into blank control group, hypothermic storage group, UW solution perfusion group, and modified UW solution perfusion group using a random number table, with 15 rats in each group. Simultaneously, a cold preservation model of rat skeletal muscle myoblasts (L6 cells) was established and the rats were also divided into four groups in the same way. Animal models were prepared in different ways: In the blank control group, the hindlimbs received no special treatment; In the hypothermic storage group, the amputated hindlimbs were stored in a dry centrifuge tube at 4℃ for 18 hours; In the UW solution perfusion group, the amputated hindlimbs were perfused with UW solution and then stored in a centrifuge tube containing UW solution at 4℃ for 18 hours; In the modified UW solution perfusion group, the amputated hindlimbs were perfused with modified UW solution (containing 0.1 nmol/L dexmedetomidine and 50% volume fraction of argon) and then stored in a centrifuge tube containing the modified UW solution at 4℃ for 18 hours. Cell models were treated as follows: In the blank control group, L6 cells were cultured under standard conditions; In the hypothermic storage group and UW solution group, L6 cells were treated with conventional culture medium or UW solution, stored in argon-filled sealed bags at 4℃ for 8 hours, and then rewarmed and cultured for 6 hours; In the modified UW solution group, L6 cells were treated with the modified solution, stored in argon-filled sealed bags at 4℃ for 8 hours, and then rewarmed and cultured for 6 hours. After sample collection, skeletal muscle morphology, tissue edema and ultrastructure features were assessed by HE staining, wet-to-dry weight ratio, and transmission electron microscopy, respectively. Additionally, L6 cell morphology was examined by light microscopy. L6 cell viability was determined by cell counting kit-8 (CCK-8) assay (expressed as absorbance A value). Expression levels of glutathione peroxidase 4 (GPX4) protein in both skeletal muscle tissue and L6 cells were evaluated by immunofluorescence staining and Western blot, respectively.Results:After 18 hours of in vitro preservation of rat isolated amputated limbs, the following results were obtained: (1) HE staining results showed that the muscle fiber morphology of the modified UW solution perfusion group was close to that of the blank control group. Moreover, the area ratio of skeletal muscle cells in the modified UW solution perfusion group was significantly higher than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). (2) The wet-dry weight ratio results showed that there was no statistically significant difference among the modified UW solution perfusion group, the blank control group and UW solution group ( P>0.05), with significantly lower ratios in all three groups than that in the hypothermic storage group ( P<0.05). (3) Transmission electron microscopy results revealed that the modified UW solution perfusion group showed no statistically significant differences in ultrastructural metrics, including myofiber diameter, sarcomere length, mitochondrial short-axis/long-axis ratio, and mitochondrial cristae count, compared with those in the blank control group ( P>0.05), and performed significantly better than both the hypothermic storage group and UW solution perfusion group ( P<0.05). (4) Morphological observation of L6 cells showed that the cellular morphology was regular in the modified UW solution perfusion group, close to that in the blank control group, while it was severely damaged in the hypothermic storage group. Moreover, the cells were reduced in number and partially damaged in the UW solution group. The sequence of cell viability expressed as absorbance A value was blank control group >modified UW solution perfusion group > UW solution perfusion group > hypothermic storage group, with statistically significant differences among the four groups ( P<0.05). (5) Immunofluorescence staining showed that there was no statistically significant difference in fluorescence intensity of GPX4 protein expression between the modified UW solution perfusion group and blank control group ( P>0.05), while the fluorescence intensity was higher in the modified UW solution perfusion group than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). Western blot analysis showed that the relative expression level of GPX4 in the modified UW solution group was significantly lower than that in the blank control group ( P<0.05), but higher than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). Conclusion:The modified UW solution can stabilize the expression level of GPX4 protein, thereby inhibiting ferroptosis and alleviating cold preservation injury in both rat amputated isolated limb skeletal muscle tissue and L6 cells.

Objective:To evaluate the design methodology and efficacy of skin excision in sitting and supine positions of blepharoplasty.Methods:A retrospective study was performed on 31 female patients who received double eyelid surgery at the Department of Plastic and Aesthetic Surgery, Affiliated Hospital of Qingdao University, from January to June 2021. The patients ′ ages varied from 18 to 37 years, with a mean age of (26.5±5.2) years. Of the patients, 27 exhibited single eyelids, while 4 presented with shallow double eyelids. All patients demonstrated laxity of the upper eyelid skin. The method of utilizing the sitting and supine positions was employed to determine the extent of skin excision, subsequently leading to full-incision double eyelid surgery. Follow-up was performed through clinic visits and WeChat to monitor double eyelid morphology, complications, and evaluate patient satisfaction. Results:All 31 patients successfully underwent the surgical procedure. Postoperative follow-up duration varied from 3 to 12 months. The double eyelid lines manifested as natural and seamless, with suitable width. All patients exhibited satisfactory eyelid closure, with no instances of ectropion or incomplete eyelid closure. Skin laxity of the upper eyelid was significantly ameliorated in all instances. The patient satisfaction rate was 100% (31/31).Conclusions:The sitting and supine position for executing skin excision in double eyelid surgery is straight forward to implement. Postoperative outcomes demonstrate natural and seamless double eyelid contours, with adequate rectification of upper eyelid skin laxity.

Objective:To clarify the content on exercise training in patients with connective tissue disease-associated pulmonary arterial hypertension through a scoping review.Methods:Using the scoping review methodological framework proposed by Arksey and O'Malley as a guide, Chinese and English databases such as PubMed, Embase, Wanfang Data, and China National Knowledge Infrastructure were searched to screen the literature on exercise training for patients with connective tissue disease-associated pulmonary arterial hypertension. The search period was from database establishment to April 30, 2024. Two researchers extracted basic information of the included literature, content of the pre-exercise training assessment, exercise training program, and outcome indicators.Results:A total of 13 articles were included. The content of the pre-exercise training assessment in patients with connective tissue disease-associated pulmonary arterial hypertension was not standardized. The type of exercise training was based on aerobic, resistance and respiratory training, with a focus on home exercise. The main outcome indicators included the 6-minute walk distance, cardiopulmonary function, quality of life, and muscle strength.Conclusions:There are various types of exercise training for patients with connective tissue disease-associated pulmonary arterial hypertension, which are safe and feasible. Future research should focus on conducting home-based exercise training programs and constructing core outcome indicators to assess the effectiveness of exercise training.

In recent years,robot-assisted technology has become increasingly sophisticated in the field of orthopedic surgical navigation.To ensure surgical safety and protect patient rights,corresponding products must undergo rigorous and standardized pre-market quality evaluations.In 2023,the National Medical Products Administration issued the sectoral standard YY/T 1901-2023 Requirements and Test Methods for Orthopaedic Surgical Navigation Equipment Employing Robotic Technology.This standard specifies the performance require-ments for robotic orthopedic surgical navigation systems across ten key aspects:general requirements,robotic arm positioning device performance,tracking device performance,system performance,installation repeatability,protective functions,orthopedic powered surgical instruments,liquid cooling,positioning acces-sory requirements,and software requirements.Additionally,it standardizes quality evaluation methods,provi-ding significant guidance for advancing robotic technology,accelerating product market entry,and strengthe-ning regulatory oversight.This article analyzes the key components of the standard to facilitate better quality assessment of products and promote high-quality development within the industry.

In recent years,with the rapid development of the artificial intelligence(AI)medical device industry,regulatory authorities have been continuously strengthening quality control over datasets.In 2024,the National Medical Products Administration(NMPA)issued the significant industry standard YY/T 1949-2024 Artificial Intelligence Medical Devices—Particular Requirements for Datasets:Color Fundus Photographs of Dia-betic Retinopathy,which is China's first specialized standard for evaluating dataset quality in AI medical devices targeting a specific disease area.Under the existing general standards framework for AI medical devices,this standard focuses specifically on diabetic retinopathy fundus photograph datasets,systematically proposing spe-cialized quality requirements and testing methods.Its implementation will provide clear technical guidance for dataset manufacturers,help improve the development quality of AI-assisted diagnostic software for diabetic retinopathy,and promote standardized industry advancement.