The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
Nanostructures/classification* ; Equipment and Supplies/classification*

Working memory is an executive memory process that includes encoding, maintenance, and retrieval. These processes can be modulated by transcranial alternating current stimulation (tACS) with sinusoidal waves. However, little is known about the impact of the rate of current change on working memory. In this study, we aimed to investigate the effects of two types of tACS with different rates of current change on working memory performance and brain activity. We applied a randomized, single-blind design and divided 81 young participants who received triangular wave tACS, sinusoidal wave tACS, or sham stimulation into three groups. Participants performed n-back tasks, and electroencephalograms were recorded before, during, and after active or sham stimulation. Compared to the baseline, working memory performance (accuracy and response time) improved after stimulation under all stimulation conditions. According to drift-diffusion model analysis, triangular wave tACS significantly increased the efficiency of non-target information processing. In addition, compared with sham conditions, triangular wave tACS reduced alpha power oscillations in the occipital lobe throughout the encoding period, while sinusoidal wave tACS increased theta power in the central frontal region only during the later encoding period. The brain network connectivity results showed that triangular wave tACS improved the clustering coefficient, local efficiency, and node degree intensity in the early encoding stage, and these parameters were positively correlated with the non-target drift rate and decision starting point. Our findings on how tACS modulates working memory indicate that triangular wave tACS significantly enhances brain network connectivity during the early encoding stage, demonstrating an improvement in the efficiency of working memory processing. In contrast, sinusoidal wave tACS increased the theta power during the later encoding stage, suggesting its potential critical role in late-stage information processing. These findings provide valuable insights into the potential mechanisms by which tACS modulates working memory.
Humans ; Memory, Short-Term/physiology* ; Male ; Female ; Young Adult ; Transcranial Direct Current Stimulation/methods* ; Brain/physiology* ; Adult ; Electroencephalography ; Single-Blind Method

Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

Objective To investigate the expression and clinical significance of extracellular nicotinamide phosphate ribose transferase(eNAMPT)and soluble programmed death ligand 1(sPD-L1)in serum of pa-tients with sepsis secondary to severe pancreatitis(SAP).Methods A total of 92 SAP patients admitted to the hospital from February 2019 to February 2022 were selected as(SAP grou),and divided into a sepsis group(42 cases)and a non-sepsis group(50 cases).Moreover,50 patients with mild to moderate pancreatitis who were diagnosed and treated at the same time were selected as the disease control group,and 50 healthy in-dividuals who underwent the physical examination in the hospital during the same pariod were selected as the healthy control group.Enzyme linked immunosorbent assay was used to detect serum levels of eNAMPT and sPD-L1.Pearson correlation analysis was used for correlation analysis.Multivariate Logistic regression analy-sis was used to analyze factors affecting the occurrence of secondary sepsis in SAP.The predictive value of ser-um eNAMPT,sPD-L1 and their combination in the secondary sepsis of SAP was conducted by receiver operat-ing characteristic(ROC)curve.Results The serum levels of eNAMPT and sPD-L1 in the SAP group were higher than those in the disease control group and the healthy control group,and the differences were statisti-cally significant(P＜0.05).The Acute Physiology and Chronic Health Evaluation Ⅱ(APACHE Ⅱ)score,Sequential Organ Failure Assessment(SOFA)score,white blood cell count,C-reactive protein,pancreatic nec-rosis,systemic inflammatory response syndrome,multiple organ failure,serum eNAMPT and sPD-L1 in the sepsis group were higher than those in the non-sepsis group,and the differences were statistically significant(P＜0.05).There was a positive correlation between serum eNAMPT,sPD-L1 and APACHE Ⅱ score,SOFA score in sepsis SAP patients(P＜0.05).Serum eNAMPT and sPD-L1 were independent risk factors for sec-ondary sepsis in SAP patients.The area under the curve(AUC)of the combination of serum eNAMPT and sPD-L1 for predicting secondary sepsis in SAP patients was 0.916(95％CI:0.868-0.947),which was signif-icantly larger than 0.846(95％CI:0.791-0.879)and 0.830(95％CI:0.774-0.861)of the single indicator detections,and the differences were statistically significant(Z=4.129,4.885,P＜0.001).Conclusion The serum eNAMPT and sPD-L1 levels in patients with sepsis secondary to SAP are elevated,which are related to the severity of the disease.The combination of serum eNAMPT and sPD-L1 has high predictive value for sec-ondary sepsis in SAP.

The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.

Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.

The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.

Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.

Objective    To assess the feasibility and safety of ultra-micro 5 mm single-port endoscopic thoracic sympathicotomy in selected patients with primary palmar hyperhidrosis. Methods    From March 1, 2018 to February 1, 2021, 90 patients with primary palmar hyperhidrosis who underwent ultra-micro 5 mm single-port endoscopic thoracic sympathicotomy at the Thoracic Surgery Department of the University of Hong Kong-Shenzhen Hospital. There were 47 males and 43 females, with a median age of 26.0 (22.0, 31.0) years. During the operation, T3 and/or T4 thoracic sympathetic nerve chain was transected using an ultra-micro 5 mm single-port incision near the areola or under the axilla. The surgical data of the patients were retrospectively reviewed and analyzed. Results     All patients successfully completed the operation without major bleeding during the operation and no conversion to thoracotomy. There was no death or serious complication during the perioperative period. The operation time was 43.0 (23.0, 60.0) min, and the intraoperative blood loss was 2.0 (1.0, 2.0) mL. In the perioperative period, only one patient needed a tiny chest tube indwelling. The symptoms of hyperhidrosis on the hands all disappeared after the operation. The pain score on the postoperative day was 2.0 (2.0, 2.0) points. The hospital stay after surgery was 1.0 (1.0, 1.0) d. In the first month after the operation, the symptoms of hyperhidrosis on the hands were significantly relieved compared with those before the operation. The surgical incisions healed well, the wounds were concealed, and there was no wound infection or poor healing. The patients' satisfaction with the surgical incisions was 100.0%. After the operation, 14 (15.6%) patients had mild compensatory hyperhidrosis, 5 (5.6%) patients had moderate compensatory hyperhidrosis, and no patient had severe compensatory hyperhidrosis. Overall satisfaction rate was 94.0%. Conclusion     The clinical application of ultra-micro 5 mm single-port endoscopic thoracic sympathicotomy in selected patients with primary palmar hyperhidrosis is safe and feasible. The surgical wound is extremely small and hidden, the operation time is short, the pain is very slight, and the clinical outcome is good. It can fully meet the patients' pursuit of beauty.

Objective To investigate the efficacy and safety of lenvatinib in patients with unresectable hepatocellular carcinoma (HCC) previously treated with tyrosine kinase inhibitor (TKI). Methods A retrospective analysis was performed for the clinical data of 76 patients with unresectable HCC who were treated with lenvatinib in Beijing Ditan Hospital, Capital Medical University, from January 2019 to January 2020, and according to the treatment method, they were divided into TKI previously untreated group with 49 patients and TKI treatment-experienced group with 27 patients. The patients were observed till one year after enrollment, adjustment of treatment regimen, tumor progression, or death. The two groups were compared in terms of progression-free survival (PFS) time, objective response rate (ORR), disease control rate (DCR), and incidence rate of adverse events. The t -test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Wilcoxon rank-sum test was used for comparison of categorical data between two groups; the Kaplan-Meier method was used for survival analysis, and the log-rank test was used for comparison between groups. Results There were no significant differences between the TKI previously untreated group and the TKI treatment-experienced group in median PFS time (115 days vs 72 days, P =0.148), ORR (36.7% vs 18.5%, P =0.098), DCR (65.3% vs 55.6%, P =0.402), and incidence rates of grade ≥3 adverse events (24.5% vs 18.5%, P =0.550). Conclusion Patients with unresectable HCC previously treated with TKI can benefit from lenvatinib and have good safety, with similar results to those treated with TKI for the first time.