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

Objective To investigate the clinical features and maternal and fetal outcomes of acute pancreatitis in pregnancy(APIP)and the risk factors for disease aggravation,and to establish a predictive model.Methods A retrospective analysis was performed for 52 APIP patients who were admitted to Affiliated Hospital of Zunyi Medical University from January 2017 to December 2022,and according to disease severity,they were divided into mild acute pancreatitis(MAP)group with 32 patients,moderate-severe acute pancreatitis(MSAP)group with 8 patients,and severe acute pancreatitis(SAP)group with 12 patients.The logistic regression analysis was performed for the clinical data of each group,and the receiver operating characteristic(ROC)curves were plotted to assess the value of risk factors in predicting the severity of APIP.A one-way analysis of variance was used for comparison of normally distributed continuous data between multiple groups,and the least significant difference t-test was used for further comparision between two groups.The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between multiple groups,and the Wilcoxon rank-sum test was used for further comparision between two groups;the chi-square test was used for comparison of categorical data between groups.Results Of all patients in terms of etiology,26(50%)had hyperlipidemic pancreatitis,20(38.4%)had biliary pancreatitis,and 6(11.5%)had idiopathic pancreatitis.In terms of gestational week,1 patient(1.9%)was in early pregnancy,25(48.1%)were in mid-pregnancy,and 26(50.0%)were in late pregnancy.A total of 10 patients(19.2%)had acute respiratory distress syndrome(ARDS),among whom 9(90%)required respiratory support.There were significant differences between the patients with different severities of APIP in aspartate aminotransferase,alanine aminotransferase,blood urea nitrogen,blood glucose,C-reactive protein(CRP),international normalized ratio(INR),pneumonia,ARDS,sepsis,hepatic insufficiency,and coagulation dysfunction(all P<0.05).The univariate analysis showed that the severity of APIP was associated with blood glucose,blood urea nitrogen,CRP,and pneumonia(all P<0.05),and pneumonia was a risk factor for the aggravation of APIP(odds ratio=18.938,95%confidence interval:1.020—351.747,P=0.048).CRP,blood glucose,blood urea nitrogen,and INR used in combination had a larger area under the ROC curve than each index used alone(0.954 vs 0.778/0.796/0.721/0.801).Conclusion Pneumonia is a risk factor for the aggravation of APIP,and the combination of CRP,blood glucose,blood urea nitrogen,and INR can be used to predict the severity of APIP.

Objective:To identify the pathogenic characteristics of a suspected gonadal mosaicism Becker muscular dystrophy (BMD) family, and provide provide basis for pregnancy selection of similar families.Methods:A BMD family admitted to Hunan Jiahui Genetics Hospital from June 2012 to September 2019 was systematically reviewed. The medical history and family history of the proband were checked, and multiplex ligation-dependent probe amplification was used to detect the deletion/duplication of 79 exons of the Duchenne muscular dystrophy (DMD) gene in the proband, fetuses, and parents. Moreover, potential variants were verified by combining PCR amplification, short tandom repeat polymorphic linkage analysis, and real-time fluorescence quantitative PCR. High-quality embryos are screened for transplantation after preimplantation genetic testing for monogenic (PGT-M). And amniotic fluid was collected in the second trimester for prenatal diagnostic verification.Results:According to the phenotype analysis of the proband, the initial clinical diagnosis was BMD, and the exon 45-50 deletion in DMD gene was detected. The mutation was not detected in the mother′s peripheral blood, but when she was pregnant again, the prenatal diagnosis showed that the fetus had the same deletion mutation as the proband. Neither of two vitro embryos tested by PGT-M has the deletion mutation, then single embryo transfer was performed nor was pregnancy successful. After confirmation of prenatal diagnosis during pregnancy, a normal baby girl was born by full-term cesarean section.Conclusions:This BMD family was a family with two consecutive BMD homodeletion mutations, and the mutation of the DMD gene was not detected in the peripheral blood of the proband′s mother and two embryonic cells, suggesting that the mother may be a gonad chimeric carrier of this deletion mutation. The combined application of prenatal diagnosis and PGT-M provides a reference approach to effectively avoid the birth of similar children.

The complexity of oral ulcerations poses considerable diagnostic and therapeutic challenges to oral specialists. The expert consensus was conducted to summarize the diagnostic work-up for difficult and complicated oral ulcers, based on factors such as detailed clinical medical history inquiry, histopathological examination, and ulceration-related systemic diseases screening. Not only it can provide a standardized procedure of oral ulceration, but also it can improve the diagnostic efficiency, in order to avoid misdiagnosis and missed diagnosis.
Consensus ; Humans ; Oral Ulcer/therapy*

OBJECTIVE:To explore the situation of anti-cold compound preparations for children,and provide reference for clinical rational drug use. METHODS:The drug instructions of anti-cold compound preparations for children were collected from our hospital and analyzed statistically in recpects of drug components,specifications,formulations and dosages of those prepara-tions;typical irrational prescriptions from Jan. to May 2015 were also analyzed. RESULTS & CONCLUSIONS:40 kinds of an-ti-cold compound preparations for children were currently used in our hospital,including 14 chemical drugs and 26 Chinese medi-cine,in which,15 were not specified in the drug instructions for pediatric dosage (accounting for 37.5%). Anti-cold compound preparations had many kinds,varied largely in specifications and dosages. The children with same constitution and age take differ-ent drugs according to the drug instructions,the dosages of the same component are greatly different,the child dosages in the drug instructions need to be further improved. There are problems of irrational drug use in our hospital, such as repeated medication, medicine incompatibility,in appropriate dose.

Objective To investigate nursing students′ cultural ability of two Shanghai vocational colleges in order to provide the scientific basis of teaching methods and clinical practice for improving nursing students′cultural ability. Methods By adopting inventory for assessing the process of cultural competence among health care professionals revised ( IAPCC-R ) , 529 nursing students in two vocational colleges were investigated. Results The average score of nursing students′cultural competence was (65. 53 ± 6. 50), 91. 1%of the students were in general level; 8. 1% of the students were in high level, 0. 8% nursing students were without cultural competence, no one was found as a proficient person in this area. There was significant difference between students in different colleges (t=3. 714,P<0. 001); There was no significant difference among students in different grades (F=3. 714,P=0. 452). Conclusions Generally nursing students′ cultural ability in Shanghai was not high, so efforts are needed to increase the humanities curriculums in colleges and teaching staffs′culture ability as well as the examinations of cultural ability, which are very important for nursing students to provide professional humanistic care services for patients after they work in hospital as nurses.

Background and purpose:Lung cancer is the leading cause of cancer-related deaths worldwide. Approximately 15%of all histological types consist of small cell lung cancer (SCLC). Chemotherapy is one of the major treatment methods. Though the current front-line standard chemotherapy regimen for SCLC is active in most SCLC cases, however, the disease recurs shortly after the ifrst successful treatment with multi-drug resistance phenotype. Our previously study showed that zinc ifnger protein X-linked (ZFX) was overexpressed in SCLC cells. This study aimed to investigate the expression of ZFX in SCLC tissues, and to clear their possible associations with clinical parameters and provide basis for therapy of SCLC. Methods:A total of 98 surgical specimens of small cell lung cancer were collected. The expression of ZFX was examined by quantiifcational real-time polymerase chain reaction in 78 specimens taken from patients with complete clinical data. Results:The expression of ZFX was signiifcantly increased in extensive stages than in limited stages. The expression of ZFX was associated with tumor stage, the sensitivity of chemotherapy, and survival times (all P<0.05), no data was found correlated with gender and ages (P>0.05). Conclusion: ZFX expression might be associated with the development of SCLC, and may be a potential prognosis predictor.

Background and purpose:MicroRNAs (miRNAs, miR) are directly involved in cancer initiation, progression and metastasis. Alterations of miRNAs expression in cancer tissue may be reflected in circulation. We attempted to investigate the expression and clinical signiifcance of plasma miR-221 in patients with small cell lung cancer (SCLC). The plasma and tissues levels of miR-221 in 51 SCLC patients and 20 controls were evaluated and compared among various clinicopathological characteristics. Methods: Confirmation of higher miR-221 levels in primary SCLC tissues than normal lung tissues. Evaluation of plasma miR-221 concentrations by comparing results from 51 consecutive SCLC patients and 20 healthy volunteers. Evaluation of the assay for monitoring tumour dynamics in SCLC patients. Results:Expression of miR-221 was signiifcantly higher in SCLC tissues than in para-carcinoma tissues and normal lung tissues. Plasma miR-221 concentrations were signiifcantly higher in SCLC patients than those in normal people (P<0.05). The expression of plasma miR-221 was not associated with gender, and age (P>0.05), correlated with significantly chemosensitivity, overall survival and clinical stage (P<0.05). Cox regression analysis indicated that plasma miR-221 expression and disease stage were found to be significantly independent prognostic factors for the SCLC patients. Conclusion: Plasma miR-221 could be a useful biomarker for cancer detection, monitoring tumour dynamics and predicting malignant outcomes in SCLC patients, and may contribute to clinical decision making in treatments.

Objective To explore the changes of the expression of islet amylodi polypeptide ( IAPP ) and somatostatin( SS) of islet in type 1 diabetes mice, and the mechanism of the expression changes .Methods We established the diabetes model in C57BL/6J mice by low-dose streptozotocin ( STZ) injection.The excisions of the pancreas tails removed on the 3th, 7th, 10th, 14th, 21th and 28th day.Tissues were assessed by immunohistochemical SABC, immunofluorescence in the study .Results 1.Numerical density on area ( NA ) of IAPP positive cells in experimental group (EG) decreased since the 3th day, but average absorbance increased since the 7th day.2.NA of SS-IR cells in EG increased since the 3th day, and average absorbance increased since the 7th day.3.The results of immunofluorescence double staining showed that , IAPP and SS could coexpression in part of cells in islets .Conclusion The number of IAPP positive cells in type 1 diabetes is decreased , but the immunoreaction increased .Immunoreaction and number of SS positive cells increase .Both of them are involved in the pathogenesis of type 1 diabetes.

Gastric cancer (GC) is one of the most frequent malignant tumors. In order to systematically characterize the cellular and molecular mechanisms of intestinal GC development, in this study, we used 22 K oligonucleotide microarrays and bioinformatics analysis to evaluate the gene expression profiles of GC in 45 tissue samples, including 20 intestinal GC tissue samples,20 normal appearing tissues (NATs) adjacent to tumors and 5 noncancerous gastric mucosa tissue samples. These profiles allowed us to explore the transcriptional characteristics of GC and determine the change patterns in gene expression that may be of clinical significance. 1519 and 1255 differentially- expressed genes (DEGs) were identified in intestinal GC tissues and NATs, respectively, as determined by Bayesian analysis (P < 0.001). These genes were associated with diverse functions such as mucosa secretion, metabolism, proliferation, signaling and development, which occur at different stages of GC development.