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

Anticipatory anxiety is a negative emotion that arises when individuals encounter potential threats or uncertainties in the future. It is the core symptom of a variety of anxiety disorders, and is closely associated with the occurrence, severity, treatment outcome, and prognosis of anxiety disorders, which has garnered a growing amount of focus in clinical practice. Nevertheless, scientific research on anticipatory anxiety continues to face obstacles such as unclear pathological mechanisms, the absence of simple and consistent self-assessment tools, and effective interventions. To improve understanding of the role of anticipatory anxiety in the diagnosis and treatment of anxiety disorders, this study reviews pertinent domestic and international literature, and briefly introduces the concept, assessment and measurement, activation paradigm, pathological mechanisms, and interventions of anticipatory anxiety.

Objective To investigate the therapeutic effect of hypericin on acute pancreatitis(AP)in mice and its effect on NLRP3 inflammasome signaling pathway.Methods The AP model in mice was established with caerulein(CER).The mice were divided into the normal control group,the model group(AP group),the low-dose HY group(CER+HY 5 mg/kg group),the medium-dose HY group(CER+HY 10 mg/kg group)and the high-dose HY group(CER+HY 20 mg/kg group),with 10 mice in each group.The 266-6 mouse pancreatic acinar cancer cells were treated with cholecystokinin(CCK)and divided into the control group,the AP group,the CCK+HY 1 μmol/L group,the CCK+HY 2 μmol/L group and the CCK+HY 4 μmol/L group.The activities of amylase(AMS),lipase,trypsin and myeloperoxidase(MPO)in the serum of each group of mice,and levels of inflammatory factors interleukin(IL)-1β and tumor necrosis factor(TNF)-α were detected by enzyme-linked immunosorbent assay(ELISA).The expression of NOD-like receptor family protein 3(NLRP3)was detected by Western blot assay.The mRNA levels of NLRP3,caspase(Caspase)-1,IL-1β,TNF-α and IL-18 in pancreatic tissue of mice were detected by real-time quantitative PCR(q-PCR).The cell survival rate of cells in each group was detected by CCK8 method.The mRNA expression levels of NLRP3,Caspase-1 and IL-18 in each group of cells were detected by q-PCR.Results Compared with the normal control group,the levels of AMS,lipase,MPO,trypsin,IL-1β and TNF-α in serum of the model group,and the mRNA and protein expression levels of NLRP3,IL-1β,TNF-α,IL-18 and Caspase-1 in pancreatic tissue were increased(P＜0.01).Compared with the model group,the levels of AMS,IL-1β and TNF-α,the enzymatic activity of trypsin in serum,and the mRNA levels of IL-1β,TNF-α,IL-18 and Caspase-1 in pancreatic tissue were decreased in the low-,medium-and high-dose HY groups.The serum levels of lipase and MPO and the mRNA expression levels of NLRP3 in pancreatic tissue were decreased in the medium-and high-dose HY groups(P＜0.05).Compared with the AP group,the cell survival rates were increased in the CCK+HY 1 μmol/L group,the CCK+HY 2 μmol/L group and the CCK+HY 4 μmol/L group,and the mRNA levels of NLRP3,IL-18 and Caspase-1 were decreased in a dose-dependent manner(P＜0.05).Conclusion Hypericin can effectively treat AP in vivo and in vitro,and its therapeutic effect may be related to the regulation of NLRP3 inflammasome signaling pathway.

Aim To predict and verify the potential mechanism of the compatibility of"ginseng-astragalus-pueraria"in protecting islet morphology and improving insulin resistance by using network pharmacology.Methods The active ingredients and targets of the horn medicine were obtained from three platforms:TC-MSP,TCMIP,and BATMAN.The targets of type 2 dia-betes mellitus(T2DM)were obtained from three plat-forms:TTD,OMIM,and disgeNET.The PPI network was constructed by using the STRING database and Cy-toscape 3.9.1;GO and KEGG analysis were per-formed;POCASA 1.1 was used to predict protein binding sites,and AutoDock Vina1.1.2 was used for docking and experimental verification.Results"Gin-seng-astragalus-pueraria"screened out 2 021 targets,of which 152 were closely related to T2DM,and 10 key genes and the AGE-RAGE signaling pathway were i-dentified.Molecular docking showed that quercetin had good binding to RAGE,INS,and PI3K.Experi-ments showed that the horn drug increased insulin binding rate and secretion index and reduced serum in-sulin level and insulin resistance index.These data benefited from"ginseng-astragalus-pueraria"reducing the expression of AGE-RAGE,activating PI3K-Akt,in-hibiting NF-κB,and reducing the expression of IL-6,IL-1β and TNF-α.Conclusion The study suggests that"ginseng-astragalus-pueraria"regulates the AGE-RAGE/PI3K-Akt/NF-κB signaling pathway,repairs damaged islet morphology,and improves insulin resist-ance.

Objective:To investigate the clinical effect of reconstruction of the degloving injury of thumb and finger with free perforator flap of superficial peroneal artery.Methods:This is a retrospective study. From June 2020 to June 2023, 18 superficial peroneal artery perforator flaps from 14 calves were used to treat 15 degloved digital wounds of 14 patients in the Department of Hand Surgery, Suzhou Ruihua Orthopaedic Hospital. There were 13 single digital degloving wounds and 1 two-digital degloving wounds. Of which, 3 digits were reconstructed with 2 free perforator flaps of ipsilateral superficial peroneal artery and 12 with a single free perforator flap of superficial peroneal artery. The size of wounds was 4.0 cm×2.0 cm-10.0 cm×4.0 cm, and the flaps were 5.0 cm×3.0 cm-12.0 cm×4.0 cm in size. The donor sites in calves were sutured layer by layer with absorptive sutures. Postoperative follow-ups were conducted through regular outpatient visits, phone calls or WeChat. Survival of flaps, postoperative complications, therapeutic effect of the flaps and patient satisfaction were observed.Results:There was no vascular compromise or wound infection of the flaps. All patients were included in the 4 to 36 months of postoperative follow-up, with an average of 9.86 months. All flaps had good appearance, without obvious swelling. Colour and texture of the flaps was close to the surrounding skin. The flaps had no obvious pigmentation or ulcer and scar hyperplasia at recipient site. Sensation of the flaps recovered to S 2 to S 3. There was no obvious scar hyperplasia, pain or dysfunction at donor sites. According to the comprehensive evaluation scale of flap, the scores were found at 81 to 91, with an average score of 85 in the 14 patients, and of whom 2 were excellent and 12 were good. Patient satisfaction was evaluated according to the Michigan Hand Outcomes Questionnaire (MHQ) and 10 patients were very satisfied and 4 were satisfied. Conclusion:Free perforator flap of superficial peroneal artery is one of the ideal flaps in reconstruction of degloving injury of thumb and fingers. It features constant and multiple perforators, reliable blood supply, high survival rate, flexible in design, thin and a small damage to the donor site.

Hand degloving injury represents one of the most severe forms of hand trauma, characterised by challenging treatment and a complex prognostic outcome. It is crucial to effectively utilise the degloved tissues in emergency or primary repair of a hand degloving injury. This consensus provides a comprehensive review of the existing literature on definition, classification, emergency assessment, debridement, judgment of skin viability, in situ repair of the degloved skin, and adjunctive treatment for degloving injury of hand. Based on conclusion of both domestic and international experiences, this expert consensus on the classification of hand degloving injury and the emergency repair with the avulsed skin is established, aiming to provide a guidance to surgeons on standardised treatment strategy and improve the management of hand degloving injury.

Objective:To screen differentially expressed long non-coding RNA (lncRNA) in exosomes of the brain extracellular space in mice with traumatic brain injury (TBI) and explore their biological roles in brain injury repair.Methods:Twenty-four C57BL/6J male mice were randomly divided into TBI group and control group with 12 in each group. The TBI group was treated with drill craniostomy followed by hydraulic impact while the control group was treated with drill craniostomy only. The brain tissue samples were collected at 3 hours after TBI. The exosomes from the brain extracellular space were isolated with papain digestion combined with an exosome isolation kit, the appearance of the exosomes was observed by phosphotungstic acid negative staining under a transmission electron microscope, and western blot was used to identify the exosomal marker proteins cluster of differentiation 63 (CD63), tumor susceptibility gene 101 (TSG101) and heat shock protein 70 (HSP70). After exosome identification, RNA libraries were constructed and subjected to library quality control, whole transcriptome sequencing was performed to detect, characterize and annotate lncRNA. Subsequently, the RNA high-throughput sequencing results were verified by randomly selecting five differentially expressed lncRNA. Moreover, the accuracy of the RNA high-throughput sequencing results was verified by qRT-PCR. The differentially expressed lncRNA were screened afterwards. Finally, bioinformatics analysis of differentially expressed lncRNA was performed, i.e., gene ontology (GO) analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) signaling pathway analysis were performed based on differentially expressed lncRNA-related genes.Results:(1) Identification of exosomes: the exosomes were cup-shaped with clear and intact membranes and diameters of 30-100 nm. Western blot confirmed the presence of typical exosome markers of the exosomes, such as CD63, TSG101, and HSP70, as well as astrocyte marker glial fibrillary acidic protein (GFAP), all of which were found in the brain tissue. (2) Validation of lncRNA high-throughput sequencing data accuracy: the 4/5 sequencing accuracy indicated that the sequencing results of lncRNAs were largely reliable. (3) Screening of differentially expressed exosomal lncRNAs after TBI: compared with the control group, a total of 442 lncRNA were significantly differentially expressed in the TBI group, including 255 up-regulated and 187 down-regulated lncRNA. (4) Bioinformatics analysis of differentially expressed lncRNAs after TBI: GO analysis showed that the differentially expressed lncRNA mainly involved in cell localization, cognition, learning or memory, were closely related to the composition of the nucleus and organelles and the binding processes of proteins, oxygen, and kinases. KEGG pathway analysis showed that upregulated lncRNA were mainly enriched in the mitogen activated protein kinase (MAPK) signaling pathway, while downregulated lncRNA were mainly enriched in the endocytosis pathway. The pathway relation network showed that MAPK signaling pathway played a key role in downstream regulation.Conclusions:There are significant differences in lncRNA expression profiles of the exosomes in the extracellular spaces of the brain cells in mice with TBI, and the differentially expressed lncRNA may mediate the process of neuronal repair, body prognosis and learning ability recovery after TBI by participating in MAPK and endocytosis signaling pathways.

Severe open tibiofibular fractures account for approximately 28.1% of all open fractures. Among them, Gustilo-Anderson type IIIB/C fractures present significant clinical challenges due to associated bone and soft tissue defects, high infection rates, and risk of amputation. Inadequate preoperative assessment may lead to suboptimal emergency surgical planning or intraoperative complications. Historically, external fixation was often preferred, but this approach has been associated with limitations such as restricted joint mobility, delayed bone union, joint stiffness, and disuse osteoporosis, resulting in poor functional recovery. With advancements of debridement techniques, standardization of antibiotic use, and popularization of early soft tissue coverage, early internal fixation has gained broader acceptance. Nevertheless, controversies persist regarding the choice of fixation method, timing of definitive fixation, use of reamed versus unreamed intramedullary nailing, and necessity of fibular fixation. To standardize the diagnosis and early management of severe open tibiofibular fractures, reduce complication rates, and improve functional recovery, the Society of Microsurgery of the Chinese Medical Association organized a panel of domestic experts to develop the Evidence-based guideline for the diagnosis and early fixation of severe open tibiofibular fractures ( version 2025), using evidence-based methodology. The guidelines provided 12 recommendations covering diagnostic and early fixation strategies of severe open tibiofibular fractures, aiming to provide clinicians with scientifically grounded and standardized guidance.

Objective:To summarize the drug resistance characteristics of clinical pathogen isolates in a tuberculosis specialized hospital from 2017 to 2023，and understand the distribution characterisitics of pathogens and their resistance to antimicrobial agents.Methods:The isolates from January 2017 to December 2023 were identified and subjected to drug susceptibility tests using the VITEK 2-compact system. The susceptibilities of the isolates to antimicrobial agents were determined by the minimum inhibitory concentration（MIC）methods according to the CLSI（2023）guideline. The data of detection of different kinds of bacteria，specimen distribution and the detection rates of major drug-resistant gram-negative bacteria in hospital antimicrobial resistance were analyzed. Chi square test were performed to analyze one or more sets of data related to detection rate or drug resistance rate by SPSS 17.0.Results:A total of 9 993 isolates were detected，among which 9 079（90.9%）were gram-negative bacteria and 914（9.1%）were gram-positive bacteria. From 2017 to 2022，among all gram-negative isolates，the top three most frequently isolated pathogens were Klebsiella pneumonia，followed by Pseudomonas aeruginosa and Acinetobacter baumannii. The overall resistance rates to carbapenems in Acinetobacter baumannii， Pseudomonas aeruginosa， Klebsiella pneumonia，and Escherichia coli were 43.7%（495/1 133），19.4%（276/1 423），8.4%（279/3 304），3.6%（19/521），respectively. The overall detection rates of ceftriaxone/ciprofloxacin-resistant Klebsiella pneumonia（CTX/CRO-R-KPN），or Escherichia coli（CTX/CRO-R-ECO），and quinolone-resistant Escherichia coli（QNR-ECO）were 19.5%（644/3 304），57.6%（300/521），77.4%（403/521），respectively. The difference in resistance rates between imipenem-resistant and imipenem-susceptible Klebsiella pneumoniae was statistically significant（ P<0.05）. Except for CTX/CRO-R-ECO（ χ2=7.9 ，P>0.05），significant differences were observed in the detection rates of other major drug-resistant gram-negative bacteria in hospital（ P<0.05）. The detection of some drug-resistant strains showed an upward trend in recent years. Carbapenem-resistant Acinetobacter baumannii， Pseudomonas aeruginosa，and Escherichia coli exhibited higher resistance rate to other antibiotics. Conclusions:The detection rates of major drug-resistant gram-negative bacteria have increased in the past two years. Carbapenem-resistant strains exhibit relatively high resistance rate to cephalosporin and quinolone antibiotics. Although carbapenem antibiotics remain effective against Enterobacteriaceae，strengthened antimicrobial resistance monitoring and control of multidrug-resistant bacteria spread are necessary.

Objective To investigate the role of Sneathia sanguinegens(S.sanguinegens)in the development of unexplained recurrent spontaneous abortion(URSA).Methods A case-control study was conducted to analyze the vaginal flora characteristics of 65 patients with URSA and 18 healthy controls through 16S rRNA gene sequencing.Toxicity profile of S.sanguinegens on human cervical cancer cells(ME-180),human umbilical vein endothelial cells(HUVEC)and human placental choriocarcinoma cells(JEG-3)was analyzed at the cellular level to assess the mechanism of it in adverse pregnancy outcomes.And S.sanguinegens was used to infect C57BL/6J mice to explore the toxic effect on living organisms.Results The relative abundance of Sneathia was increased in patients with URSA compared with healthy controls.It was positively correlated with the number of miscarriages,and was attributed to S.sanguinegens.We also found that S.sanguinegens damaged ME-180,JEG-3 and HUVEC cells.The degree of cellular damage was related to the level of S.sanguinegens added.Intravenous infection with S.sanguinegens caused inflammatory damage in several organs and extramedullary hematopoiesis in the spleen.Conclusion S.sanguinegens is closely related to URSA and should be emphasized in patients with high vaginal bacterial load.