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 explore the mediating effect of experiential avoidance and emotional eating between intolerable uncertainty and life satisfaction of college students.Methods:From October to December 2021, a total of 890 college students in the Beijing-Tianjin-Hebei region were tested by the intolerable uncertainty scale (simplified version), the acceptance action scale second edition, the Dutch eating behavior questionnaire and the life satisfaction scale. All data processing and analysis were preformed by SPSS 22.0 software, and the mediating effect was tested by Pearson correlation analysis and Bootstrap analysis.Results:The intolerable uncertainty score was (26.43±7.64), the experiential avoidance score was (22.63±9.67), the emotional eating score was (26.43 ±11.83), and the life satisfaction score was (16.74±6.03). Intolerable uncertainty was significantly and negatively correlated with life satisfaction( r=-0.76, P<0.01), and was significantly and positively correlated with experience avoidance and emotional eating( r=0.66, 0.78, both P<0.01). Experience avoidance was significantly and positively correlated with emotional eating( r=0.70, P<0.01), and was significantly and negatively correlated with life satisfaction( r=-0.62, P<0.01). Emotional eating was significantly and negatively correlated with life satisfaction( r=-0.68, P<0.01). Intolerable uncertainty affects life satisfaction through four paths.The direct effect value of intolerable uncertainty on life satisfaction was -0.53, accounting for 70.23% of the total effect. The separate mediating effect value of experience avoidance was -0.11, accounting for 50.00% of the total indirect effect.The separate mediating effect value of emotional eating was -0.08, accounting for 36.36% of the total indirect effect, and the chain mediating effect value of experience avoidance and emotional eating was -0.03, accounting for 13.64% of the total indirect effect. Conclusion:Intolerable uncertainty can directly affect life satisfaction of college students and indirectly through experiencing avoidance and emotional eating.

Objective:Comparison of four methods in intraoperative abduction angles (AA) measurements of human cast immobilization in developmental dysplasia of the hip (DDH) by visual inspection and electronic software according to different body surface markers.Methods:Data were retrospectively collected from January 2019 to November 2021 in a total of 27 patients (54 hips) who underwent closed or simple open reduction. There were 6 males and 21 females with an average age of 13.2 months. Five doctors used visual inspection and mobile phone software to measure the AA of the hip joint immediately during the operation, and compared with the postoperative MRI measurement results (AA-MRI). The four methods of intraoperative measurement were: Junior visualization (AA-JV), the intersection angle between the line connecting the center of the popliteal fossa and the contact center of the plaster frame and the line connecting the two ischial tuberosities; the same methods as method one by Senior visualization (AA-SV); the intersection angle between the line connecting the center of the popliteal fossa and the center of the anus and the line connecting the ischial tubercle (anus-popliteal, AA-AP); the intersection of the vertical line between the center of the popliteal fossa and the groin and the horizontal line of the center of the anus and the vertical line connecting the two ischial tuberosities intersect (anus-groin crease-popliteal, AA-AGCP). The t-test, correlation coefficient, linear regression and Bland-Altman test were used to evaluate the measurements. Results:Comparing the four intraoperative and postoperative AA-MRI measurement methods, AA-JV (42.69°±4.13°) < AA-SV (44.80°±4.08°) < AA-AGCP (46.25°±5.15°) < AA-MRI (47.68°±4.21°) < AA-AP (51.77°±5.30°), and the difference between AA-JV and AA-SV, AA-AP and AA-AGCP was statistically significant ( t=2.53, P=0.013; t=5.47, P=0.001), there was no significant difference between AA-AGCP and AA-MRI ( t=1.57, P=0.118). The inter-group agreement of the five methods ICC test ranged from 0.807 to 0.892, and the intra-group average agreement of AA-MRI was 0.948. All ICC results were greater than 0.75 with good agreement. Linear regression results showed that the four intraoperative measurement methods had a good or moderate linear relationship with AA-MRI, AA-AGCP ( R 2=0.499)>AA-AP ( R 2=0.318)>AA-SV ( R 2=0.253)>AA-JV ( R 2=0.217), AA-AGCP was the best measurement method. The results of Bland-Altman scatterplot of AA-AGCP and AA-MRI were in good agreement, the mean and standard deviation of bias were -0.796±3.247, and the limit of agreement was 95% LoA (-7.16, -5.57). Conclusion:The AA method of visualization before Spica casting was smaller than truth. The method AA-AGCP objectively by landmarks was the advocated means measuring abduction angle during operation with highly consistency, agreement and easily performed.

AIM: To investigate the apoptosis and molecular mechanism of human hepatocellular carcinoma HepG2 cells induced by ginsenoside Rh4.METHODS: Human hepatocellular carcinoma HepG2 cells were treated with ginsenoside Rh4 at doses of 10, 20 and 40 μmol/L, and the inhibitory effect of ginsenoside Rh4 on HepG2 cell viability was measured by MTT assay.The apoptotic rate of HepG2 cells was analyzed by flow cytometry.The morphological changes of the HepG2 cells were observed by Hoechst 33258 and TUNEL staining.The expression of apoptosis-related proteins Bax, Bcl-2, caspase-3 and caspase-9 was determined by Western blot.RESULTS: Ginsenoside Rh4 promoted apoptosis of HepG2 cells in a dose-dependent manner.TUNEL and Hoechst 33258 staining showed that the cells appeared obvious shrinking, swelling and rupture after treated with ginsenoside Rh4 for 24 h.The results of Western blot showed that with the increasing concentrations of ginsenoside Rh4, the expression of pro-apoptotic proteins Bax, cleaved caspase-3 and caspase-9 increased, while anti-apoptotic protein Bcl-2 decreased gradually.CONCLUSION: Ginsenoside Rh4 induces apoptosis of human hepatocellular carcinoma HepG2 cells, and the main mechanism may be related to down-regulation of Bcl-2 and up-regulation of Bax, cleaved caspase-3, and caspase-9.

This study aimed at exploring the inhibitory effect behind its mechanism on acid-soluble polysaccharides from G.incamatum in transplanted H22 tumor mice.Different indices,including tumor inhibitory rate,organ index of liver,thymus and spleen,IL-2,IFN-γ and TNF-α were detected for the evaluation of anti-tumor effects and the mechanism.Furthermore,HE staining and TUNEL assay were adopted to investigate the pathological changes of tumor tissue and cell apoptosis,respectively.As a result,the three dose groups of acidsoluble polysaccharides of G.incamatum successfully inhibited the proliferation of tumor cells,while organ indexes of spleen and thymus were improved and serum IL-2,IFN-γ and TNF-α increased.H&E staining and TUNEL assay showed the polysaccharides induced cell apoptosis,playing a significant role in the inhibition of tumor growth.In conclusion,acid-soluble polysaccharides of G.incamatum possessed significant anti-tumor effects,behind which the mechanism could be related to the regulation of immune regulation,cell apoptosis,and the protection of liver function.

Objective To extract hyperoside from the leaves of Acanthopanax sessiliflorus by complex enzyme method, and optimize the extraction process by orthogonal experiment. Methods Hyperoside was determined by HPLC. Effects of temperature,α-amylase, neutral protease and cellulase on extraction rate were detected by the orthogonal tests, and the optimum extraction condition of hyperoside from the leaves of Acanthopanax sessiliflorus was determined by complex enzyme method. Results The main influence factor was temperature,follows byα-amylase, neutral protease and cellulase according to orthogonal analysis.The best condition was as follows: dose of cellulase, neutral protease and α-amylase was 2%, 0. 5% and 3%, respectively, extract at temperature of 30 ℃for 10 min. Under this condition, the extraction rate of hyperoside in the leaves of Acanthopanax senticosus was 0.52%. Conclusion As compared with the traditional technics, compound enzyme increases the productivity of hyperoside.

This study was aimed to optimize the extraction process of hyperoside from leaves ofAcanthopanax senticosusby compounding-enzyme method and orthogonal experiment. The hyperoside compound was regarded as standard and determined by HPLC. Based on the experiments of 4 factors including the enzyme amount, temperature, extraction time and PH values, the extraction process of hyperoside was determined by the orthogonal experiments and variance analysis. The results of single-factor experiments showed that different enzymes showed different effects on the enhance yield of hyperoside. The effects of different factors showed that the order of PH, neutral protease, temperature, time, pectinase, xylanase and cellulose was from strong to weak. Through orthogonal analysis, the optimum conditions were 2% pectinase, 2% xylanase, 0.5% neutral protease, and 0.5% cellulose, under the temperature of 30°C, extraction time of 10 min, and pH = 4.5. Under these conditions, the extraction rate was 1.84%. The yield was increased 107% compared with traditional process. It was concluded that the use of compounding enzyme can increase the yield of hyperoside, which possessed a lot of economic benefits.

This study was aimed to optimize the extraction process of double-marker components for Arctium lappa L. The central composite design and response surface methodology was used. According to 3 main factors, the extraction rates of arctiin and arctigenin was used as evaluation indexes. Multiple linear regression and two-order polynomial equation were used. The binomial fitting model was performed in the optimization of arctiin and arctigenin extraction technology. The results showed that the indentified optimized extraction technology of arctiin and arctigenin was 70% ethanol, 24-fold, ultrasonic solvent extraction for 15 minutes. It was concluded that this technology was able to extract large amount of arctiin and arctigenin, which provided experiment evidences for arctiin and arctigenin preparation. It also provided references for the development and utilization of arctiin and arctigenin.

PURPOSE: Cathepsin K is a potent collagenase implicated in human and animal atherosclerosis-based vascular remodeling. This study examined the hypothesis that serum CatK is associated with the prevalence of coronary artery disease (CAD). MATERIALS AND METHODS: Between January 2011 and December 2012, 256 consecutive subjects were enrolled from among patients who underwent coronary angiography and percutaneous coronary intervention treatment. A total of 129 age-matched subjects served as controls. RESULTS: The subjects' serum cathepsin K and high sensitive C-reactive protein (hs-CRP) and high-density lipoprotein cholesterol were measured. The patients with CAD had significantly higher serum cathepsin K levels compared to the controls (130.8+/-25.5 ng/mL vs. 86.9+/-25.5 ng/mL, p<0.001), and the patients with acute coronary syndrome had significantly higher serum cathepsin K levels compared to those with stable angina pectoris (137.1+/-26.9 ng/mL vs. 102.6+/-12.9 ng/mL, p<0.001). A linear regression analysis showed that overall, the cathepsin K levels were inversely correlated with the high-density lipoprotein levels (r=-0.29, p<0.01) and positively with hs-CRP levels (r=0.32, p<0.01). Multiple logistic regression analyses shows that cathepsin K levels were independent predictors of CAD (odds ratio, 1.76; 95% confidence interval, 1.12 to 1.56; p<0.01). CONCLUSION: These data indicated that elevated levels of cathepsin K are closely associated with the presence of CAD and that circulating cathepsin K serves a useful biomarker for CAD.
Aged ; Biological Markers/blood ; C-Reactive Protein/metabolism ; Cathepsin K/*blood ; Coronary Artery Disease/*blood/metabolism ; Female ; Humans ; Male ; Middle Aged

PURPOSE: Cathepsin K is a potent collagenase implicated in human and animal atherosclerosis-based vascular remodeling. This study examined the hypothesis that serum CatK is associated with the prevalence of coronary artery disease (CAD). MATERIALS AND METHODS: Between January 2011 and December 2012, 256 consecutive subjects were enrolled from among patients who underwent coronary angiography and percutaneous coronary intervention treatment. A total of 129 age-matched subjects served as controls. RESULTS: The subjects' serum cathepsin K and high sensitive C-reactive protein (hs-CRP) and high-density lipoprotein cholesterol were measured. The patients with CAD had significantly higher serum cathepsin K levels compared to the controls (130.8+/-25.5 ng/mL vs. 86.9+/-25.5 ng/mL, p<0.001), and the patients with acute coronary syndrome had significantly higher serum cathepsin K levels compared to those with stable angina pectoris (137.1+/-26.9 ng/mL vs. 102.6+/-12.9 ng/mL, p<0.001). A linear regression analysis showed that overall, the cathepsin K levels were inversely correlated with the high-density lipoprotein levels (r=-0.29, p<0.01) and positively with hs-CRP levels (r=0.32, p<0.01). Multiple logistic regression analyses shows that cathepsin K levels were independent predictors of CAD (odds ratio, 1.76; 95% confidence interval, 1.12 to 1.56; p<0.01). CONCLUSION: These data indicated that elevated levels of cathepsin K are closely associated with the presence of CAD and that circulating cathepsin K serves a useful biomarker for CAD.
Aged ; Biological Markers/blood ; C-Reactive Protein/metabolism ; Cathepsin K/*blood ; Coronary Artery Disease/*blood/metabolism ; Female ; Humans ; Male ; Middle Aged