The structural characteristics and clinical application of embolic microspheres were summarized in this paper. According to evaluation experience and current regulatory registration evaluation requirements, registration evaluation concerns on embolic microsphere as medical device were analyzed from four aspects: administration attributes, product description, non-clinical studies and clinical evaluation, in order to provide references for the development and registration application of such products and improve the efficiency of registration application.
Microspheres ; Device Approval ; Embolization, Therapeutic/instrumentation*

Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.

Objective To evaluate the value of ultrasound scoring system combined with serum levels of creatine kinase(CK),vascular endothelial growth factor(VEGF),and alpha-fetoprotein(AFP)in predicting the degree of placental implantation in parturients.Methods A total of 137 pregnant women with placental implantation disorders who were admitted to Xi'an Daxing Hospital from January 2020 to January 2024 were enrolled in this retrospective study.Pathological examination revealed 101 cases of adhesion type and 36 cases of implantation and penetration types.Clinical data were collected.All the patients underwent ultrasonic examination and were scored using an ultrasound scoring system.Multivariate Logistic regression analysis was employed to assess the factors influencing the degree of placental implantation.The predictive value of the ultrasound scoring system and serum markers for the degree of placental implantation was analyzed using receiver operating characteristic(ROC)curves.Results The transfusion rate of allogeneic red blood cell and ultrasound score in patients with implantation and penetration types were significantly higher than those in patients with adhesion type(55.56%vs.14.85%,5.97±1.23 vs.2.52±1.20,P<0.05).Serum levels of CK,VEGF and AFP in patients with implantation and penetration types were also significantly higher than those in patients with adhesion type([151.94±51.02]U/L vs.[121.37±43.01]U/L,[251.64±52.09]pg/mL vs.[151.67±31.08]pg/ml,[234.95±43.01]ng/mL vs.[205.64±35.12]ng/ml,P<0.05).Ultrasound findings such as the disappearance of the clear zone,abnormal placental lacunae,disruption of the bladder boundary,thinning of the myometrium,placental protrusion,extrusion of local tissue,high vascularization between the uterus and bladder,high vascularization behind the placenta,vascular bridges,and direct blood vessels in the placental bed were significantly more frequent in patients with implantation and penetration types compared to the adhesion type(P<0.05).Multivariate Logistic regression analysis indicated that allogeneic red blood cell transfusion rate,ultrasound score,and serum levels of CK,VEGF and AFP were independent risk factors for a higher degree of placental implantation,with odds ratios of 5.363,1.810,1.015,1.019,and 1.020(95%CI:1.410-20.404,1.197-2.736,1.000-1.030,1.004-1.035,1.002-1.038,P<0.05).The combined predictive value of ultrasound scoring and serum levels of CK,VEGF and AFP showed the highest sensitivity(94.40%)and specificity(97.00%)for the degree of placental implantation in patients with implantation and penetration types,with a Youden index of 0.914 and an AUC of 0.937(95%CI:0.874-0.999).Conclusion The ultrasound scoring system combined with serum CK,VEGF and AFP can effectively predict the severity of placental implantation.This combined approach offers high sensitivity and specificity for identifying high-risk cases of implantation and penetration types of placental implantation,thereby aiding clinicians in optimizing management and intervention strategies for pregnant women.

Integrated traditional Chinese and Western medicine refers to a clinical diagnosis and treatment model that incorporates the essence of traditional Chinese medicine in regard to treatment decisions based on syndrome differentiation and a reliance on modern western medicine as the basis of diagnosis and treatment.It is an organic combination of the two,with each bringing its own strengths into full play and complementing those of the other.After the founding of the People's Republic of China,the development of the integrated traditional Chinese and Western medicine has been increasingly valued.The unique advantages of the integration of traditional Chinese and Western medicine have been continuously utilized,resulting in fruitful achievements in theoretical inheritance and innovation and in the prevention and treatment of major diseases.Furthermore,integrated traditional Chinese and Western medicine has become a unique system of medicine of China.This article provides a review and elaboration of the entire process of the integration of traditional Chinese and Western medicine,including its significance,status of development,and achievements.It is suggested that,in the field of integrated traditional Chinese and Western medicine,efforts should made to delve into classic theories,identify the right entry points for integration,reconstruct and improve the theoretical system of integrated traditional Chinese and Western medicine by combining the cutting-edge achievements of modern medicine,and focus on enhancing clinical efficacy.

Objective To investigate the effect of AU-rich element RNA-binding factor 1(AUF1)on the proliferation,apoptosis,and migration abilities of hepatocellular carcinoma(HCC)cells and possible mechanisms,and to clarify the role and molecular mechanism of AUF1 in the progression of HCC.Methods The UALCAN and TCGA-HCC databases were used to analyze the expression of AUF1 in pan-cancer and investigate the association of the expression level of AUF1 with the clinicopathological features and prognosis of HCC patients.CCK-8 assay,cell apoptosis assay,and Transwell chamber assay were used to investigate the function of AUF1 at the cellular level,and RNA-seq assay was used to investigate transcriptome changes in HCC cells after AUF1 knockdown.The t-test was used for comparison of continuous data between two groups;the Kaplan-Meier method was used to plot survival curves,and the log-rank test was used for comparison of survival rates.Results There were abnormal mRNA and protein expression levels of AUF1 in various tumor tissues compared with normal tissue(P<0.05).The mRNA expression level of AUF1 was positively correlated with the degree of HCC malignancy and the poor prognosis of early-stage HCC(P<0.05).Compared with the control group,the overexpression of exogenous AUF1 in HCC cells promoted the proliferation of HCC cells and inhibited the apoptosis and migration of HCC cells,while AUF1 knockdown inhibited HCC cell proliferation and promoted the apoptosis and migration of HCC cells.The RNA-seq analysis showed that AUF1 knockdown mainly affected the Wnt/β-catenin pathway and downregulated the protein expression level of β-catenin.Conclusion The abnormal expression of AUF1 is associated with the prognosis of early-stage HCC,and AUF1 may exert an oncogenic effect by activating the Wnt signaling pathway.

Objective:To study the clinicopathological features of Sjogren′s syndrome (SS) with liver injury and to improve the understanding of this disease.Methods:Forty-nine patients with SS complicated with liver injury were collected from Beijing Ditan Hospital, Capital Medical University from October 2008 to January 2022. All patients underwent ultrasound-guided liver biopsy, and all specimens were stained with HE. The histopathologic characteristics were observed and the pathologic indexes were graded. Immunohistochemical stains for CK7, CK19, CD38, MUM1 and CD10 were performed by EnVision method; and special histochemical stains for reticulin, Masson′s trichrome, Rhodanine, Prussian blue, periodic acid Schiff (PAS) and D-PAS stains were conducted .Results:The age of patients ranged from 31 to 66 years, including 3 males and 46 females. SS combined with drug-induced liver injury was the most common (22 cases, 44.9%), followed by autoimmune liver disease (13 cases, 26.5%, including primary biliary cholangitis in eight cases, autoimmune hepatitis in 3 cases, and PBC-AIH overlap syndrome in 2 cases), non-alcoholic fatty liver disease (NAFLD, 9 cases, 18.4%) and other lesions (5 cases, 10.2%; including 3 cases of nonspecific liver inflammation, 1 case of liver amyloidosis, and 1 case of porto-sinusoidal vascular disease). Among them, 28 cases (57.1%) were associated with obvious interlobular bile duct injury, mainly in SS combined with PBC group and drug-induced liver injury group. Twenty-three cases (46.9%) were associated with hepatocyte steatosis of varying degrees. In SS with autoimmune liver disease group, ISHAK score, degree of fibrosis bile duct injury, bile duct remodeling, lymphocyte infiltration of portal area, and plasma cell infiltration, MUM1 and CD38 expression; serum ALP and GGT, IgM; elevated globulin; positive AMA, proportion of AMA-M2 positive and IgM positive were all significantly higher than those in other groups(all P<0.05). Serum ALT, direct bilirubin and SSA positive ratio in SS combined with drug liver group were significantly higher than those in other groups(all P<0.05). The serum total cholesterol level in SS combined with PBC group ( P=0.006) and NALFD group ( P=0.011) were significantly higher than those in other groups ( P<0.05). Conclusions:The pathologic manifestations of SS patients with liver injury are varied. The inflammatory lesions of SS patients with autoimmune liver disease are the most serious, and the inflammatory lesions of SS patients with non-alcoholic fatty liver disease and non-specific inflammation are mild. Comprehensive analysis of liver histopathologic changes and laboratory findings is helpful for the diagnosis of SS complicated with different types of liver injury.

Objective:To investigate the clinicopathological characteristics of rashes in monkeypox patients through a series of skin biopsies, and examine their pathological features and the most effective tests.Methods:Patients with monkeypox virus infection admitted to Beijing Ditan Hospital from June to August 2023 were identified. Among them, 24 patients underwent skin biopsies for clinical pathological study that were included in this study. Clinical information, rash pictures, and nucleic acid test results were analyzed using histopathology, immunohistochemistry, RNAscope ? hybridization and electron microscopy. Results:All 24 patients were male, including 14 patients with concurrent human immunodeficiency virus infection. Their average age was (32.3±5.4) years. The nucleic acid test confirmed monkeypox virus infection. The clinical feature of monkeypox rashes was solitary rather than clustered distribution, with rashes occurring in similar phase, distinguishing it from herpesvirus. The rashes in these patients were mostly scattered, with an average of (13.0±11.8) rashes, and most commonly present in the perineum, face, limbs, and trunk. The three main pathological features of these rashes were ballooning degeneration of the epidermal spinous cell layer, the characteristic intra-cytoplasmic Guarnieri′s bodies and significant infiltration of inflammatory cells in whole dermal layer. Immunohistochemistry, RNAscope ? hybridization, and electron microscopy can all effectively detect the monkeypox virus. Electron microscopy showed viral replication in various types of skin cells. Conclusions:The study describes the pathological features of monkeypox virus rashes. Pathological examination of skin biopsy samples is helpful to diagnose these rashes. The study suggests that the monkeypox virus has a unique epitheliotropic affinity and can infect various types of cells in the skin.

Chronic hepatitis B virus (HBV) infection is one of the major public health issues of ongoing global concern. Due to inadequate understanding of the HBV life cycle, there is a lack of effective drugs to cure chronic hepatitis B. During HBV replication, covalently closed circular DNA (cccDNA) serves as the template for viral replication and can be transcribed to produce five viral RNAs of 3.5, 2.4, 2.1 kb and 0.7 kb in length, which are translated to produce HBeAg, core protein, polymerase (P) protein, HBsAg and HBx proteins, respectively. Among them, the 3.5 kb pregenomic RNA (pgRNA) is also the template for viral reverse transcription. Polymerase protein recognizes and binds to the capsid assembly signal on the pgRNA to initiate capsid assembly and reverse transcription. Recent studies have revealed that the processes of splicing, nuclear export, stability, translation, and pgRNA encapsidation of HBV RNAs are regulated by a post-transcriptional regulatory network within the host cell and depend on unique post-transcriptional regulatory elements in the HBV RNA structure. The aim of this review is to overview the post-transcriptional regulatory mechanisms of HBV RNA and their applications in the study of HBV antiviral therapeutics, with the aim of providing new ideas for the development of new drugs targeting HBV RNA.

Objective To establish a method for the determination of baicalin in Chaiguijiebiao granule by high performance liquid chromatography(HPLC)and further improve the quality standards of Chaiguijiebiao granule.Methods The sample of Chaiguijiebiao granule was treated by ultrasound to prepare the test product solution.Specificity test,linear relationship test,precision test,repeatability test,and sample recovery test were investigated by HPLC.On the basis of qualified methodology,the content of baicalin in 3 batches of Chaiguijiebiao granule was determined.Results The concentration of baicalin in the 3 batches of samples was 4.07 mg/g,4.11 mg/g and 4.40 mg/g,respectively.Preliminary quality standard of Chaiguijiebiao granule was established,with baicalin content ranging from 4.0 to 4.5 mg/g.Conclusion The HPLC method is simple,accurate and reliable,and can be used for the determination of baicalin in Chaiguijiebiao granule.

Objective To investigate the effect of cyclin D1 (with CCND1 as the gene name) on HBV replication and its potential mechanism. Methods With reference to GSE84044 dataset, the Spearman's rank correlation analysis was used to investigate the correlation between the expression levels of genes in liver tissue and serum HBV DNA load in patients with HBV-related liver fibrosis. Cyclin D1 and cyclin D1 T286A mutant were transiently expressed in the HBV cell replication model, and time-resolved immunofluorescence and quantitative real-time PCR were used to measure the levels of HBsAg/HBeAg and HBV DNA in cell culture supernatant; Western blot was used to measure the level of HBV core protein in cells; reverse-transcription quantitative real-time PCR was used to measure the level of HBV RNA in cells; dual-luciferase reporter assay was used to observe the effect of cyclin D1 on the activity of HBV basic core promoter (BCP). GSE83148 dataset was used to investigate the correlation between CCND1 and HBV-related regulatory factors. The independent samples t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. Results The analysis of GSE84044 data showed that 7 cell cycle genes were significantly negatively correlated with HBV DNA load in liver tissue of the patients with HBV-related liver fibrosis (all r < -0.3, all P < 0.05), which included the CCND1 gene ( r =-0.474, P < 0.001). Exogenous expression of cyclin D1 and cyclin D1 T286A mutant reduced the levels of HBsAg, HBeAg, and HBV DNA in culture supernatant of the HBV replication cell model, as well as the levels of HBV core protein and HBV RNA in cells. Exogenous expression of cyclin D1 significantly inhibited the transcriptional activity of HBV BCP. The expression level of CCND1 in liver tissue of chronic hepatitis B patients was significantly positively correlated with the expression of APOBEC3G ( r =0.575, P < 0.001), SMC5 ( r =0.341, P < 0.001), and FOXM1 ( r =0.333, P < 0.001) which inhibited HBV replication, while it was significantly negatively correlated with the expression of the HBV entry receptor NTCP ( r =-0.511, P < 0.001) and HNF1α as the transcription factor for positive regulation of HBV replication ( r =-0.430, P < 0.001). Overexpression of cyclin D1 in HepG2 cells reduced the transcriptional levels of HNF1α and NTCP. Conclusion Cyclin D1 inhibits HBV transcription and replication possibly by downregulating the expression of HNF1α and NTCP.