Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Aim To systematically investigate the ac-tive components,targets,and regulatory pathways of Po-lygonum capitatum in intervening atherosclerosis(AS)through network pharmacology,molecular docking and animal experiments.Methods Active components of Polygonum capitatum and AS-related targets were screened and identified through database searches.Protein-protein interaction(PPI)network analysis was performed using the STRING database,followed by GO and KEGG enrichment analyses via the David plat-form.Molecular docking validation was conducted with AutoDock.An AS model was established in Syrian golden hamsters fed a high-fat diet.Predicted pathways and targets were validated using qPCR,ELISA,and histopathological assessment of aortic and hepatic tis-sues via HE staining.Results Network pharmacology identified 27 potential active components of Polygonum capitatum(primarily flavonoids such as quercetin and luteolin)and 110 drug-disease intersection targets,in-cluding core targets MMP-9,ALB,and AKT1.GO and KEGG analyses enriched 593 and 125 pathways,re-spectively,with the NF-κB inflammatory pathway,TNF signaling pathway and lipid metabolism/atherosclerosis pathways highlighted as key mechanisms.Animal ex-periments demonstrated that Polygonum capitatum im-proved serum lipid profiles(reduced TC,TG,LDL-C)in AS hamsters,suppressed the MMP-9/NF-κB signa-ling pathway(downregulated MMP-9,p65 phosphoryla-tion,TNF-α,and IL-6),and inhibited VSMC synthetic phenotypic transformation(upregulated α-SMA and myocardin)by downregulating MCPIP1.Additionally,Polygonum capitatum ameliorated aortic lesions and he-patic lipid deposition in AS hamsters.Conclusions Polygonum capitatum alleviates AS by synergistically regulating the MMP-9/NF-κB/MCPIP1 axis through flavonoid components,suppressing vascular inflammato-ry cascades and maintaining VSMC contractile pheno-types.This reflects Polygonum capitatum's multi-com-ponent,multi-pathway,and multi-target characteristics in combating AS.

Aim To systematically investigate the ac-tive components,targets,and regulatory pathways of Po-lygonum capitatum in intervening atherosclerosis(AS)through network pharmacology,molecular docking and animal experiments.Methods Active components of Polygonum capitatum and AS-related targets were screened and identified through database searches.Protein-protein interaction(PPI)network analysis was performed using the STRING database,followed by GO and KEGG enrichment analyses via the David plat-form.Molecular docking validation was conducted with AutoDock.An AS model was established in Syrian golden hamsters fed a high-fat diet.Predicted pathways and targets were validated using qPCR,ELISA,and histopathological assessment of aortic and hepatic tis-sues via HE staining.Results Network pharmacology identified 27 potential active components of Polygonum capitatum(primarily flavonoids such as quercetin and luteolin)and 110 drug-disease intersection targets,in-cluding core targets MMP-9,ALB,and AKT1.GO and KEGG analyses enriched 593 and 125 pathways,re-spectively,with the NF-κB inflammatory pathway,TNF signaling pathway and lipid metabolism/atherosclerosis pathways highlighted as key mechanisms.Animal ex-periments demonstrated that Polygonum capitatum im-proved serum lipid profiles(reduced TC,TG,LDL-C)in AS hamsters,suppressed the MMP-9/NF-κB signa-ling pathway(downregulated MMP-9,p65 phosphoryla-tion,TNF-α,and IL-6),and inhibited VSMC synthetic phenotypic transformation(upregulated α-SMA and myocardin)by downregulating MCPIP1.Additionally,Polygonum capitatum ameliorated aortic lesions and he-patic lipid deposition in AS hamsters.Conclusions Polygonum capitatum alleviates AS by synergistically regulating the MMP-9/NF-κB/MCPIP1 axis through flavonoid components,suppressing vascular inflammato-ry cascades and maintaining VSMC contractile pheno-types.This reflects Polygonum capitatum's multi-com-ponent,multi-pathway,and multi-target characteristics in combating AS.

Objective To investigate the feasibility of constructing an animal model for training of otoscopic anatomy and surgical operation using living guinea pigs.Methods Eight healthy adult guinea pigs were used as ex-perimental animals to construct a model of endoscopic operation by opening the upper tympanic cavity and abrading the upper wall of the external acoustic meatus to establish a space for endoscopic observation and operation.The an-atomical opening of the temporal bone and basic surgical steps were performed by the same resident on eight guinea pigs.The resident assessed the difficulty and completion of the endoscopic operation and measured various dimen-sions,including the anteroposterior and superior/inferior diameters of the mastoid process,the posterolateral wall of the upper tympanic cavity,and the upper wall of the external acoustic meatus,as well as the maximal depth of entry of the endoscope.Results The fine structures of guinea pig tympanic chamber were clearly displayed under otoen-doscopy.Except for the two steps of free preservation of the chorda tympani nerve and exposure of the stapes after removal of the ossicles,the other steps,such as separation of the tympanic membrane from the malleus,exposure of the malleus-anvil complex,removal of the cochlea shell to observe the cochlea axis,and exposure of the tympanic segment of the facial nerve under the endoscope,were all easily accomplished.The anterior and posterior diameters of the mastoid after opening were 3.56±0.21 and 3.89±0.16 mm,respectively,and the anterior and posterior di-ameters of the upper tympanic cavity and the upper wall of the external acoustic meatus after opening were 5.60±0.09 and 6.02±0.10 mm,respectively.The maximum depth of entry of the otoscopic endoscope was 15.14±0.24 mm.Conclusion Using guinea pig as an animal model for otoscopic surgery training can provide a more realis-tic surgical experience,which is helpful for beginners to be trained in the basic surgical skills of otoscopic surgery and otoscopic anatomy.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

The many-banded krait, Bungarus multicinctus, has been recorded as the animal resource of JinQianBaiHuaShe in the Chinese Pharmacopoeia. Characterization of its venoms classified chief phyla of modern animal neurotoxins. However, the evolutionary origin and diversification of its neurotoxins as well as biosynthesis of its active compounds remain largely unknown due to the lack of its high-quality genome. Here, we present the 1.58 Gbp genome of B. multicinctus assembled into 18 chromosomes with contig/scaffold N50 of 7.53 Mbp/149.8 Mbp. Major bungarotoxin-coding genes were clustered within genome by family and found to be associated with ancient local duplications. The truncation of glycosylphosphatidylinositol anchor in the 3'-terminal of a LY6E paralog released modern three-finger toxins (3FTxs) from membrane tethering before the Colubroidea divergence. Subsequent expansion and mutations diversified and recruited these 3FTxs. After the cobra/krait divergence, the modern unit-B of β-bungarotoxin emerged with an extra cysteine residue. A subsequent point substitution in unit-A enabled the β-bungarotoxin covalent linkage. The B. multicinctus gene expression, chromatin topological organization, and histone modification characteristics were featured by transcriptome, proteome, chromatin conformation capture sequencing, and ChIP-seq. The results highlighted that venom production was under a sophisticated regulation. Our findings provide new insights into snake neurotoxin research, meanwhile will facilitate antivenom development, toxin-driven drug discovery and the quality control of JinQianBaiHuaShe.

Adult ; Humans ; Acute Disease ; Leukemia

OBJECTIVE: To investigate a previously uncharacterized function of Sijunzi Decoction (SJZD) in inhibition of gastric cancer stem cells (GCSCs). METHODS: MKN74 and MKN45, two CD44 positive gastric cancer cell lines with stem cell properties were used. The cells were divided into 2 groups. Treatment group was treated with SJZD (1-5 mg/mL) for indicated time (48 h-14 days). The control group was treated with equal volume of phosphate buffered saline. Cell Counting Assay Kit-8 were used to measure cell viability. Spheroid colony formation and GCSCs marker expression were performed to determine GCSCs stemness. Cell fractionation and chromatin immunoprecipitation assays were used to assess the distribution and DNA-binding activity of β-catenin after SJZD treatment, respectively. RESULTS: SJZD treatment repressed cell growth and induced apoptosis in MKN74 and MKN45 cell lines (P<0.05). Moreover, SJZD dramatically inhibited formation of spheroid colony and expression of GCSC markers in GC cells (P<0.05). Mechanistically, SJZD reduced nuclear accumulation and DNA binding activity of β-catenin (P<0.05), the key regulator for maintaining CSC stemness. CONCLUSION SJZD inhibits GCSCs by attenuating the transcriptional activity of β-catenin.
Cell Line, Tumor ; DNA/metabolism* ; Drugs, Chinese Herbal/pharmacology* ; Humans ; Neoplastic Stem Cells/metabolism* ; Stomach Neoplasms/genetics* ; beta Catenin/metabolism*

Objective: To analyze the epidemiological characteristics of pulmonary tuberculosis (TB) in Guangdong province from 2016 to 2020 and provide evidence for the prevention and control of pulmonary TB. Methods: Descriptive epidemiological methods were used to analyze the incidence data of pulmonary TB reported in Guangdong from 2016 to 2020. Dynamic geometric series averaging and circular distribution methods were used to reveal the epidemic pattern. Results: A total of 356 748 pulmonary TB cases were reported in Guangdong from 2016 to 2020. The reported incidence of pulmonary TB decreased from 71.82/100 000 to 50.40/100 000 (trend χ²=6 905.57,P<0.001) , with an annual decline rate of 8.47%. Results from the circular distribution methods showed that the incidence peak would occur on May 4^th-5^th (Z=1 176.96,P<0.05), and the incidence was relatively higher in May compared with other months. The area distribution of the pulmonary TB epidemic was uneven, and the reported average annual incidence was in the order of the eastern area (72.15/100 000), the northern area (68.14/100 000), the western area (65.31/100 000) and the Pearl River Delta area (60.05/100 000). Results of dynamic geometric series averaging analysis showed a declining trend in the reported incidence of pulmonary TB in all areas, except Dongguan, with the average growth rate less than 0.00. The decline rate in the eastern area (-10.90%) and northern area (-10.63%) was higher than the provincial average (-8.47%). The male to female ratio of the cases was 2.63∶1 (258 562∶98 186). The reported average annual pulmonary TB incidence in men (88.37/100 000) was higher than that in women (36.86/100 000), the difference was significant (χ²=75.19, P<0.001). The reported incidence of pulmonary TB generally increased with age (trendχ²=123 849.44, P<0.001), and reached peak in age group ≥65 years (164.54/100 000). Dynamic geometric series averaging analysis showed an increasing trend of the reported pulmonary TB incidence in age groups 5-14 years and 15-24 years, with the average growth rate of 0.05% and 3.60%. Conclusions: The reported annual incidence of pulmonary TB showed a declining trend year by year in Guangdong from 2016 to 2020. However, an increasing incidence was reported in children and adolescents. Active case finding should be strengthened in the elderly and other key populations. With comprehensive TB prevention and control measures, it is still necessary to pay attention to the prevention and control of pulmonary TB in men, low-income groups and less developed areas in Guangdong and strengthen the comprehensive prevention and control in winter and spring.
Adolescent ; Child ; Aged ; Female ; Humans ; Male ; Child, Preschool ; Tuberculosis, Pulmonary/epidemiology* ; Epidemics ; Poverty ; Rivers ; China/epidemiology*