[Research Status of Nanomaterial Medical Device and Discussion on Biological Evaluation].

In recent years, China has made great progress in basic nanomedicine, nanotoxicology and nanobiology research. Nanotechnology has been continuously applied in biomaterial and medical device, more and more medical devices applying nanomaterials are developed and manufactured. In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices, this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad, and discussed the current challenges in biological evaluation of nanomaterial medical devices, with a view to providing ideas for the safety evaluation and research of related products.

Massilia soli sp. nov., isolated from soil.

A Gram-stain-negative, catalase- and oxidase-positive and aerobic bacterium, designated strain R798T, was isolated from soil in South Korea. Cells were motile rods by means of a single polar flagellum. Growth of strain R798T was observed at 15-35 °C (optimum, 25-30 °C), pH 5.0-8.0 (optimum, 6.0) and 0-1.5 % NaCl (optimum, 0.3 %). Strain R798T contained ubiquinone-8 as the sole isoprenoid quinone, summed feature 3 (C16 : 1 ω7c and/or C16 : 1 ω6c) and C16 : 0 as the major fatty acids and phosphatidylglycerol and phosphatidylethanolamine as the major polar lipids. The DNA G+C content of strain R798T calculated from the whole genome sequence was 63.3 mol%. Phylogenetic analyses based on the 16S rRNA gene and whole genome sequences revealed that strain R798T formed a distinct phyletic lineage within the genus Massilia. Strain R798T was most closely related to Massilia eurypsychrophila B528-3T with a 98.0 % 16S rRNA gene sequence similarity. Average nucleotide identity and digital DNA-DNA hybridization values between strain R798T and the type strain of M. eurypsychrophila were 79.2 and 22.7 %, respectively. Based on the phenotypic, chemotaxonomic and molecular analyses, strain R798T represents a novel species of the genus Massilia, for which the name Massilia soli sp. nov. is proposed. The type strain is R798T (=KACC 22114T=JCM 34601T).

Cupriavidus cauae sp. nov., isolated from blood of an immunocompromised patient.

A novel Gram-stain-negative, facultative aerobic and rod-shaped bacterium, designated as MKL-01T and isolated from the blood of immunocompromised patient, was genotypically and phenotypically characterized. The colonies were found to be creamy yellow and convex. Phylogenetic analysis based on 16S rRNA gene and whole-genome sequences revealed that strain MKL-01T was most closely related to Cupriavidus gilardii LMG 5886T, present within a large cluster in the genus Cupriavidus. The genome sequence of strain MKL-01T showed the highest average nucleotide identity value of 92.1 % and digital DNA-DNA hybridization value of 44.8 % with the closely related species C. gilardii LMG 5886T. The genome size of the isolate was 5 750 268 bp, with a G+C content of 67.87 mol%. The strain could grow at 10-45 °C (optimum, 37-40 °C), in the presence of 0-10 % (w/v) NaCl (optimum, 0.5%) and at pH 6.0-10.0 (optimum, pH 7.0). Strain MKL-01T was positive for catalase and negative for oxidase. The major fatty acids were C16 : 0, summed feature 3 (C16 : 1 ω7c/C16 : 1 ω6c and/or C16 : 1 ω6c/C16 : 1 ω7c) and summed feature 8 (C18 : 1 ω7c and/or C18 : 1 ω6c). The polar lipid profile consisted of phosphatidylglycerol, phosphatidylethanolamine, two unidentified phospholipids and one unidentified polar lipid. Moreover, strain MKL-01T contained ubiquinone Q-8 as the sole respiratory quinone. Based on its molecular, phenotypic and chemotaxonomic properties, strain MKL-01T represents a novel species of the genus Cupriavidus; the name Cupriavidus cauae sp. nov. is proposed for this strain. The type strain is MKL-01T.

Safety and tissue remodeling assay of small intestinal submucosa meshes using a modified porcine surgical hernia model.

In studies to date, meshes based on extracellular matrix (ECM) have been extensively used in clinical applications. Unfortunately, little is known about the function of the immunogenic residual, absorbable profile during the tissue repair process. Moreover, there needs to be a recognized preclinical animal model to investigate the safety and efficacy of extracellular matrix meshes. Herein, we designed and fabricated a kind of SIS mesh followed by a scanned electron micrograph characterization and tested α-Gal antigen clearance rate and DNA residual. In order to prove the biocompatibility of the SIS mesh, cell viability, chemotaxis assay and local tissue reaction were assessed by MTT and RTCA cytotoxicity test in vitro as well as implantation and degradation experiments in vivo. Furthermore, we developed a stable preclinical animal model in the porcine ventral hernia repair investigation, which using laparoscopic plus open hybridization method to evaluate tissue adhesion, explant mechanical performance, and histologic analysis after mesh implantation. More importantly, we established a semi-quantitative scoring system to examine the ECM degradation, tissue remodeling and regeneration in the modified porcine surgical hernia model for the first time. Our results highlight the application prospect of the improved porcine ventral hernia model for the safety and efficacy investigation of hernia repair meshes.

Mechanism of remodeling and local effects in vivo of a new injectable cosmetic filler.

By studying the local effects of a new type of injectable cosmetic filler implanted into the animal to explore the mechanism of remodeling and cosmetic effect of this kind of product. Take 12 rabbits and select 4 implantation points on both sides of the spine, respectively, and implant the test sample (PLLA) and negative control sample (HDPE) into the subcutaneous tissues on both sides. In the same way, take another 12 rabbits and implant the marketing control sample (cross-linked sodium hyaluronate) and negative control sample (HDPE) into the subcutaneous tissues on both sides. The animals were executed at 1 week, 4 weeks, 13 weeks and 52 weeks respectively, and Hematoxylin-Eosin staining, Masson trichrome staining and immunofluorescence staining were performed to characterize the local effects in vivo and the expression of type I collagen (Col. I), type III collagen (Col.III) and matrix metalloproteinase 9 (MMP-9). Good histocompatibility of the test sample and the marketing control sample were found. The foreign body reaction of marketing control sample was more intense than that of the test sample after 13 weeks. The foreign body reaction of testing sample was more intense after 52 weeks, while that of the marketing control sample was more stable. With the process of tissue repair, the collagen fibers of test samples and marketing control samples gradually increased after implantation. Type I collagen was mainly found inside the fiber capsule, while type III collagen was mainly found outside. The positive expression of matrix metalloproteinase 9 gradually increased, the positive expression of test samples increased significantly after 52 weeks, while that of marketing control samples did not change significantly. Good histocompatibility of PLLA filler is found. Matrix metalloproteinase 9 participates in foreign body reaction and collagen formation, which can reflect the process of tissue remodeling.

Tongmai Zhuke decoction restrains the inflammatory reaction of macrophages for carotid artery atherosclerosis by up-regulating lincRNA-Cox2.

To explore the mechanism of Tongmai Zhuke decoction for promoting blood circulation by taking carotid artery atherosclerosis (CAA) as an example, two sets of in-depth transcriptomic data as well as two sets of single-cell RNA sequencing data related to the macrophages in CAA were included. STAR and DCC software were used to process in-depth transcriptomic data in order to measure the expression level of LncRNAs as well as mRNA according to FPKM analysis. Single-cell RNA sequencing data from Illumina NovaSeq 6000 were further analyzed by CellRanger channel, CellRanger count, Seurat R package, DoubletFinder package, CCA algorithm, LogNormalize, principal-component analysis, t-SNE and ToppGene online tools. Based On unsupervised clustering, a total of four diverse cell populations with distinct transcriptional features were found in human carotid atherosclerotic plaques. The macrophages were further annotated as the "effector cell" in the pathologic process of CAA, based on the expression of CD68+/CD440-. A total of 84 up-regulated genes and 58 down-regulated linc-RNAs were identified in samples with carotid atherosclerotic plaques. Thereinto, lincRNA-Cox2 is the most down-regulated LincRNA. For the macrophages in carotid atherosclerotic plaques, expression level of Il6, Ccl3, Ccl4 Il10 and Tnfa were significantly up-regulated, while Timp1 significantly down-regulated comparing with healthy carotid sample. The expression level of lincRNA-Cox2 was significantly increased in macrophages after treated by Tongmai Zhuke decoction, while Cxcl10, Ccl3, Ccl4, Cxcl2, Ccl5, and Ccl19 were significantly decreased. Collectively, Tongmai Zhuke decoction could restrain the inflammatory reaction of macrophages for carotid artery atherosclerosis by up-regulating lincRNA-Cox2.

Meta-Analysis of Dynamic Electrocardiography in the Diagnosis of Myocardial Ischemic Attack of Coronary Heart Disease.

Background and Aims: Patients with coronary artery disease (CHD) are prone to early myocardial ischemia; early diagnosis of myocardial ischemia is of great significance in judging disease progression and guiding clinical intervention. However, reports on the accuracy of dynamic electrocardiogram (ECG) in the diagnosis of myocardial ischemia in patients with CHD are inconsistent. The purpose of the current meta-analysis was to analyze the efficacy of ECG in the diagnosis of myocardial ischemia attack in CHD. Methods: Chinese database (Wanfang, VIP, and CNKI) and English database (PubMed, Web of Science, Embase, SinoMed, and Cochrane Library) were searched. A study on the collection of dynamic ECG in the diagnosis of myocardial ischemic attack of coronary heart disease to extract data and calculate sensitivity (Sen), specificity (Spe), positive likelihood ratio (+LR), negative likelihood ratio (- LR), and diagnostic odds ratio (DOR). Draw summary receiver operating characteristic curves (SROC), and calculate area under curve (AUC). Stata 15 software was used for meta-analysis. Results: Twenty-seven literatures were included in this study. Meta-analysis results showed that Sen = 0.78 (95% CI: 0.73~0.82), Spe = 0.76 (95% CI: 0.68~0.82), +LR = 2.79 (95% CI: 2.17~3.59), -LR = 0.33 (95% CI: 0.27~0.40), AUC = 0.84 (95% CI: 0.80~0.87), and DOR = 9.66 (95% CI: 6.13~15.21). Subgroup analysis showed that the sensitivity of 12-lead ECG was higher than that of 3-lead ECG. The sensitivity and specificity of ST segment and QTc interphase changes were higher than those of ST segment changes alone (P < 0.05). Conclusion: Dynamic ECG has high application value in the diagnosis of myocardial ischemia attack of coronary heart disease. But it is difficult to achieve a satisfactory level of use alone. ST segment combined with QTc interval observation can improve the diagnostic accuracy. Synchronous observation of ST segment and QTc interval can improve the diagnostic efficiency.

Expressions of serum adiponectin and visfatin in patients with hypertension in cerebrovascular accidents and analysis of risk factors.

OBJECTIVE: To determine the expressions of serum adiponectin and visfatin in patients with hypertension and cerebrovascular accidents and to analyze the risk factors. METHODS: Data of 161 patients with hypertension treated in The Affiliated Hospital of Shandong University of Traditional Chinese Medicine from March 2019 to July 2021 were retrospectively analyzed. There were 72 patients with cerebrovascular accidents assigned to an occurrence group. The remaining 89 patients without cerebrovascular accidents were assigned to a non-occurrence group. The two groups were compared in terms of the coagulation function (activated partial thromboplastin time, prothrombin time, and fibrinogen), liver function (aspartate aminotransferase (AST), glutamic pyruvic transaminase (GPT), albumin and total bilirubin (TB)), blood lipid indexes (cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL)), serum adiponectin, and visfatin levels. Pearson's correlation coefficient was performed to analyze the correlation of serum adiponectin and visfatin with blood lipid indexes. Logistics regression was performed to analyze the risk factors of stroke in patients with hypertension. RESULTS: The two groups were similar in terms of sex, age, education level, smoking, drinking, and diabetes histories (P>0.05). There were more patients ≥65 years old with body mass index ≥20 kg/m2 and with hyperlipidemia in the occurrence group than those in the non-occurrence group (P<0.05). The two groups were not notably different in activated partial thromboplastin time, prothrombin time, fibrinogen, AST, GPT, albumin, TB, total cholesterol, and HDL (P>0.05). The occurrence group showed significantly higher triglyceride, LDL and adiponectin levels, and a notably lower visfatin level than the non-occurrence group (P<0.05). Adiponectin showed a positive correlation with triglyceride and a negative association with LDL (P<0.05). Visfatin showed only a negative correlation with triglyceride (P<0.05), but no correlation with LDL (P>0.05). A multivariate logistics regression analysis reported that hyperlipidemia, triglyceride, LDL, adiponectin, and visfatin were independent risk factors for stroke in patients with hypertension (P<0.05). CONCLUSION: Serum adiponectin and visfatin were differentially expressed in patients with both hypertension and stroke. Our regression analysis revealed that serum adiponectin and visfatin were independent risk factors for stroke in patients with hypertension.

Minor and major circRNAs in virus and host genomes.

As a special type of noncoding RNA, circular RNAs (circRNAs) are prevalent in many organisms. They can serve as sponges for microRNAs and protein scaffolds, or templates for protein translation, making them linked to cellular homeostasis and disease progression. In recent years, circRNAs have been found to be abnormally expressed during the processes of viral infection and pathogenesis, and can help a virus escape the immune response of a host. Thus, they are now considered to play important functions in the invasion and development of viruses. Moreover, the potential application of circRNAs as biomarkers of viral infection or candidates for therapeutic targeting deserves consideration. This review summarizes circRNAs in the transcriptome, including their classification, production, functions, and value as biomarkers. This review paper also describes research progress on circRNAs in viral infection (mainly hepatitis B virus, HIV, and some human herpes viruses) and aims to provide new ideas for antiviral therapies targeting circRNAs.