Access to the clinical application of medical technology is one of the core institutional contents of medical quality management， involving medical quality assurance， the achievement of patient safety goals， and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research， as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws， regulations， and ethical principles， combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions， a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions， the system of ethics committees and the requirements of review norms， technical plans and their review points， key points for the implementation of informed consent， technical teams and conditions， and other aspects.

Objective To investigate the age-related changes of biomechanical properties for humerus, femur and tibia in male rats and their application values in age estimation. Methods According to different weeks of age, 90 healthy male SD rats were divided into 2, 4, 6, 8, 17, 26, 52, 78 and 104-week groups with 10 rats in eachgroup. After the rats were executed by excessive anesthesia, humerus, femur, and tibia were separated and the attached soft tissues were removed. The length of the above-mentioned bones and the diameter of the middle section (compression site) were measured with vernier caliper, and the three-point bending test was conducted with electronic universal material testing machine to detect the ultimate load and displacement under ultimate load. Results There were significant differences in the ultimate load of humerus, femur and tibia among male rats in different age groups (P<0. 05). With the increase of week age, the ultimate loads of the humerus, femur and tibia increased first and then decreased, and reached the peak value in 52-week age group, showing a strong positive correlation with week age before 52 weeks ( r = 0. 884,0. 933,0. 929, P<0. 05). There was no significant difference in humerus and tibia. The displacement of femur under ultimate load was weakly positively correlated with week age (R= 0. 406,P<0. 05). The age prediction accuracy for automatic linear modeling of ultimate load for humerus, femur, tibia and three above-mentioned bones in rats before 52-week age was 78. 2% , 86. 8% , 84. 1% and 88. 3% , respectively. There was a strong positive correlation between the length of humerus, femur and tibia and the ultimate load (R= 0. 904, 0. 897, 0. 814, P<0. 05). The diameters of humerus, femur and tibia were strongly positively correlated with the ultimate load (R = 0. 759, 0. 814 and 0. 745, P<0. 05). Conclusions The ultimate loads of humerus, femur and tibia in male rats increased first and then decreased with age, and were positively correlated with age before 52 weeks, which could be used for age inference. The highest accuracy of age estimation was ultimate loads of three bones, followed by femur. The length/ middle diameter of humerus, femur and tibia were strongly positively correlated with the ultimate load.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Objective:To explore the differential expression profile of miRN in the development of diabetes nephropathy (DN), and further explore the mechanism of miR-126-5p involved in high glucose induced injury of renal tubular epithelial cells.Methods:Firstly, we downloaded existing chip data from the Gene Expression Integrated Database (GEO) and used GEO2R, miRanda, gene ontology (GO) analysis, and Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis to mine differential miRNAs. Subsequently, a high glucose induced HK-2 cell injury model was used and divided into three groups: high glucose model group, si-HOTAIR group, and si HOTAIR+ miR-126-5p inhibitor group. The three groups of cells were sequentially transfected with siRNA-NC, siRNA-HOTAIR, and siRNA-HOTAIR+ miR-126-5p mimic, and cultured in a medium containing 60 mmol/L glucose. Flow cytometry was used to detect changes in apoptosis levels in each group, while cell counting kit-8 (CCK-8) was used to detect changes in cell proliferation.Results:Through data mining analysis using GEO, it was found that compared to ordinary mice, DN mice had 74 upregulated miRNAs and 80 downregulated miRNAs in their kidney tissue. Enrichment analysis results showed that miRNAs could target signaling pathways such as Wnt, PKG, MAPK, and Rap1, and miR-126-5p was significantly downregulated. In the high glucose induced HK-2 cell injury model, the experimental results showed that the inhibitory effect on cell proliferation activity was more significant at a high glucose concentration of 60 mmol/L ( P<0.05); High glucose stimulation significantly reduced the expression of miR-126-5p ( P<0.05). The results of flow cytometry showed that compared with the high glucose model group, the apoptosis rate of the si-HOTAIR group significantly decreased ( P<0.05), while the apoptosis rate of the si-HOTAIR+ miR-126-5p inhibitor group significantly increased ( P<0.05). The CCK-8 experiment showed that compared with the high glucose model group, the cell viability of the si-HOTAIR group significantly increased ( P<0.05); The cell viability of the si-HOTAIR+ miR-126-5p inhibitor group was inhibited ( P<0.05). Conclusions:miR-126-5p can inhibit high glucose induced apoptosis in HK-2 cells and protect them.

Objective:To investigate the epidemiological characteristics, diagnosis, treat-ment and prognosis of gallbladder cancer in China from 2010 to 2017.Methods:The single disease retrospective registration cohort study was conducted. Based on the concept of the real world study, the clinicopathological data, from multicenter retrospective clinical data database of gallbladder cancer of Chinese Research Group of Gallbladder Cancer (CRGGC), of 6 159 patients with gallbladder cancer who were admitted to 42 hospitals from January 2010 to December 2017 were collected. Observation indicators: (1) case resources; (2) age and sex distribution; (3) diagnosis; (4) surgical treatment and prognosis; (5) multimodality therapy and prognosis. The follow-up data of the 42 hospitals were collected and analyzed by the CRGGC. The main outcome indicator was the overall survival time from date of operation for surgical patients or date of diagnosis for non-surgical patients to the end of outcome event or the last follow-up. Measurement data with normal distribu-tion were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and com-parison between groups was conducted using the U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was performed using the Logistic forced regression model, and variables with P<0.1 in the univariate analysis were included for multivariate analysis. Multivariate analysis was performed using the Logistic stepwise regression model. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-rank test was used for survival analysis. Results:(1) Case resources: of the 42 hospitals, there were 35 class A of tertiary hospitals and 7 class B of tertiary hospitals, 16 hospitals with high admission of gallbladder cancer and 26 hospitals with low admission of gallbladder cancer, respectively. Geographical distribution of the 42 hospitals: there were 9 hospitals in central China, 5 hospitals in northeast China, 22 hospitals in eastern China and 6 hospitals in western China. Geographical distribution of the 6 159 patients: there were 2 154 cases(34.973%) from central China, 705 cases(11.447%) from northeast China, 1 969 cases(31.969%) from eastern China and 1 331 cases(21.611%) from western China. The total average number of cases undergoing diagnosis and treatment in hospitals of the 6 159 patients was 18.3±4.5 per year, in which the average number of cases undergoing diagnosis and treatment in hospitals of 4 974 patients(80.760%) from hospitals with high admission of gallbladder cancer was 38.8±8.9 per year and the average number of cases undergoing diagnosis and treatment in hospitals of 1 185 patients(19.240%) from hospitals with low admission of gallbladder cancer was 5.7±1.9 per year. (2) Age and sex distribution: the age of 6 159 patients diagnosed as gallbladder cancer was 64(56,71) years, in which the age of 2 247 male patients(36.483%) diagnosed as gallbladder cancer was 64(58,71)years and the age of 3 912 female patients(63.517%) diagnosed as gallbladder cancer was 63(55,71)years. The sex ratio of female to male was 1.74:1. Of 6 159 patients, 3 886 cases(63.095%) were diagnosed as gallbladder cancer at 56 to 75 years old. There was a significant difference on age at diagnosis between male and female patients ( Z=-3.99, P<0.001). (3) Diagnosis: of 6 159 patients, 2 503 cases(40.640%) were initially diagnosed as gallbladder cancer and 3 656 cases(59.360%) were initially diagnosed as non-gallbladder cancer. There were 2 110 patients(34.259%) not undergoing surgical treatment, of which 200 cases(9.479%) were initially diagnosed as gallbladder cancer and 1 910 cases(90.521%) were initially diagnosed as non-gallbladder cancer. There were 4 049 patients(65.741%) undergoing surgical treatment, of which 2 303 cases(56.878%) were initially diagnosed as gallbladder cancer and 1 746 cases(43.122%) were initial diagnosed as non-gallbladder cancer. Of the 1 746 patients who were initially diagnosed as non-gallbladder cancer, there were 774 cases(19.116%) diagnosed as gallbladder cancer during operation and 972 cases(24.006%) diagnosed as gallbladder cancer after operation. Of 6 159 patients, there were 2 521 cases(40.932%), 2 335 cases(37.912%) and 1 114 cases(18.087%) undergoing ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) examination before initial diagnosis, respec-tively, and there were 3 259 cases(52.914%), 3 172 cases(51.502%) and 4 016 cases(65.205%) undergoing serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis, respectively. One patient may underwent multiple examinations. Results of univariate analysis showed that geographical distribution of hospitals (eastern China or western China), age ≥72 years, gallbladder cancer annual admission of hospitals, whether undergoing ultrasound, CT, MRI, serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis were related factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.45, 1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95% confidence interval as 1.21-1.74, 1.64-2.40, 0.59-0.80, 0.60-0.78, 2.19-2.70, 0.37-0.45, 1.43-1.86, 0.37-0.45, 0.35-0.43, 0.38-0.47, P<0.05). Results of multivariate analysis showed that geographical distribution of hospitals (eastern China or western China), sex, age ≥72 years, gallbladder cancer annual admission of hospitals and cases undergoing ultrasound, CT, serum CA19-9 examination before initially diagnosis were indepen-dent influencing factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.36, 1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95% confidence interval as 1.13-1.64, 1.16-1.73, 0.79-0.99, 0.57-0.78, 1.60-2.14, 1.38-1.77, 1.38-1.79, 0.35-0.43, P<0.05). (4) Surgical treatment and prognosis. Of the 4 049 patients undergoing surgical treatment, there were 2 447 cases(60.435%) with complete pathological staging data and follow-up data. Cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb were 85(3.474%), 201(8.214%), 71(2.902%), 890(36.371%), 382(15.611%), 33(1.348%) and 785(32.080%), respectively. The median follow-up time and median postoperative overall survival time of the 2 447 cases were 55.75 months (95% confidence interval as 52.78-58.35) and 23.46 months (95% confidence interval as 21.23-25.71), respectively. There was a significant difference in the overall survival between cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb ( χ2=512.47, P<0.001). Of the 4 049 patients undergoing surgical treatment, there were 2 988 cases(73.796%) with resectable tumor, 177 cases(4.371%) with unresectable tumor and 884 cases(21.833%) with tumor unassessable for resectabi-lity. Of the 2 988 cases with resectable tumor, there were 2 036 cases(68.139%) undergoing radical resection, 504 cases(16.867%) undergoing non-radical resection and 448 cases(14.994%) with operation unassessable for curative effect. Of the 2 447 cases with complete pathological staging data and follow-up data who underwent surgical treatment, there were 53 cases(2.166%) with unresectable tumor, 300 cases(12.260%) with resectable tumor and receiving non-radical resection, 1 441 cases(58.888%) with resectable tumor and receiving radical resection, 653 cases(26.686%) with resectable tumor and receiving operation unassessable for curative effect. There were 733 cases not undergoing surgical treatment with complete pathological staging data and follow-up data. There was a significant difference in the overall survival between cases not undergoing surgical treatment, cases undergoing surgical treatment for unresectable tumor, cases undergoing non-radical resection for resectable tumor and cases undergoing radical resection for resectable tumor ( χ2=121.04, P<0.001). (5) Multimodality therapy and prognosis: of 6 159 patients, there were 541 cases(8.784%) under-going postoperative adjuvant chemotherapy and advanced chemotherapy, 76 cases(1.234%) under-going radiotherapy. There were 1 170 advanced gallbladder cancer (pathological staging ≥stage Ⅲa) patients undergoing radical resection, including 126 cases(10.769%) with post-operative adjuvant chemotherapy and 1 044 cases(89.231%) without postoperative adjuvant chemo-therapy. There was no significant difference in the overall survival between cases with post-operative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.23, P=0.629). There were 658 patients with pathological staging as stage Ⅲa who underwent radical resection, including 66 cases(10.030%) with postoperative adjuvant chemotherapy and 592 cases(89.970%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.05, P=0.817). There were 512 patients with pathological staging ≥stage Ⅲb who underwent radical resection, including 60 cases(11.719%) with postoperative adjuvant chemotherapy and 452 cases(88.281%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemo-therapy and cases without post-operative adjuvant chemo-therapy ( χ2=1.50, P=0.220). Conclusions:There are more women than men with gallbladder cancer in China and more than half of patients are diagnosed at the age of 56 to 75 years. Cases undergoing ultrasound, CT, serum CA19-9 examination before initial diagnosis are independent influencing factors influencing initial diagnosis of gallbladder cancer patients. Preoperative resectability evaluation can improve the therapy strategy and patient prognosis. Adjuvant chemotherapy for gallbladder cancer is not standardized and in low proportion in China.

Objective:To investigate the distribution characteristics of bacteria in urine of patients with ureteral stent crusting.Methods:Thirty-five patients who underwent ureteral stent placement at the Shandong Provincial Third Hospital, Shandong University Qilu Hospital, Jinan Central Hospital, and Jinan Jigang Hospital were selected from October, 2018 to March, 2019(the clinical study registration number is ChiCTR1800020025). The inclusion criteria were patients who had the stent intubated for 4 weeks after ureteroscopic lithotripsy, aged between 18 and 65 years. Exclusion criteria were patients with positive urine bacterial culture, severe gross hematuria, recent oral antibiotics, and patients with significant residual stones. This clinical study uses a cross-sectional study method, and those patients were divided into crusting group (n=23) and non-crusting group (n=12) according to the presence or absence of stent crusting. On the day of extubation, urine of the patients was collected for bacterial 16s DNA detection. The distribution characteristics of bacteria in urine of the two groups were analyzed using UPARSE, UCHIME and RDP calssifier. The total number of bacteria species, bacterial abundance and bacterial species with large-scale abundance in urine of the two groups were determined. The quantity of bacteria species and bacterial abundance in the urine between the two groups were compared, and the bacterial species with large-scale abundance in urine of the patients with stent crusting were identified.Results:There were no significant differences in general information such as age, body mass index, gender, affected side, type of stent tube, and stone composition between the two groups. Using 16s DNA sequencing to detect the bacteria in the urine of the two groups revealed that the number of bacterial species with abundance >1% was 11, and the number of bacterial species with abundance >0.01% was 74 in the crusting group. In the non-crusting group, the number of bacterial species with abundance >1% and >0.01% was 7 and 11, respectively. Compared with the non-crusting group, the number of bacterial species with abundance >1% in the crusting group was significantly larger ( t=5.12, P=0.000). In the crusting group, bacterial species with the top three abundance were g_Lactobacillus (23.1%), g_Bacteroides (18.8%) and g_norank_Bacteroides (17.1%). In the non-crusting group, bacterial species with the top three abundance were g_Escherichia-Shigella (32.2%), g_Enterococcus (24.9%) and g_Pseudomonas (18.2%). The three bacteria with the greatest difference between the two groups were g_ Lactobacillus ( P=0.010), g_Bacteroides ( P=0.004) and g_norank_Bacteroides ( P=0.004), respectively. Conclusion:The species and quantity of bacteria in the urine of patients with stent crusting are both significantly larger than those of patients without stent crusting. Bacteroides with larger-scale abundance in the urine of patients with stent crusting may promote the deposition of crystals on the stent wall through its structure, function and urease positive characteristics.

Objective To assess the level and trend of community acquired respiratory distress syndrome (CARDS) toxin after the infection of Mycoplasma pneumonia(MP),and evaluate the clinical characteristics,the level of immunoglobulin E (IgE) and interleukin-4 (IL-4) so as to find the association among these factors.Methods According to whether the child had wheezing symptoms,all the 63 children were divided into wheezing group (26 ca-ses) and non-wheezing group (3 cases).The levels of CARDS toxin were respectively detected in the acute stage of MP infection,3 and 6 months later after MP infection in different groups,moreover,IgE and IL-4 levels were monitored at the same time.Results (1) The mean level of IgE were (384.96 ± 316.62) × 103 IU/L and (87.32 ± 66.32) × 103 IU/L in wheezing group and non-wheezing group,respectively,and there was statistically significant difference (P ＜ 0.05).(2) The load of CARDS toxin in wheezing group and non-wheezing group were (1.87 ± 0.62) Delta Rn and (1.15 ± 0.48) Delta Rn in the stage of acute infection,respectively,and there was statistically significant difference (P ＜ 0.05).Nevertheless,differences between 2 groups after 3 months and 6 months were not significant.(3) In the acute stage,the level of CARDS toxin in the severe cases were higher than the mild cases [(2.37 ± 0.37) Delta Rn vs (1.21 ± 0.45) Delta Rn],and there was statistically significant difference (P ＜ 0.05).(4) IL-4 showed significant difference in the acute stage and 3 months later after acute infection between 2 groups,however,there were no difference between 2 groups after 6 months later.(5)The load of CARDS toxin showed no significant difference between 2 groups at 3 months [(0.96 ± 0.35) vs.(0.99 ± 0.40) Delta Rn,P =0.757] and 6 months [(0.67 ± 0.20) vs.(0.69 ±0.32) Delta Rn,P =0.641] later after MP infection.(6)The children in wheezing group coughed for (24.89 ±7.04) days after acute infection and the last time for non-wheezing group was (16.46 ± 4.79) days,and there was statistically significant difference(P =0.000).Conclusions The load of CARDS toxin decreased after acute MP infection and it was still detectable six months after onset in the blood.The level of CARDS toxin was associated with the cough and wheezing symptom and the severity of disease.

Objective To investigate the inhibition mechanism of rohdea roth on hyphae formation by Candida albicans.Methods MTT assay was used to detect the minimum inhibitory concentration(MIC)and minimum fungicidal concentration(MFC)of C.albicans.The inhibitory effect of fungicidal adherence was detected by MTT assay.Inverted fluorescence microscope was used to observe effect on hyphae formation.The influence on Efg1 and Hwp1gene expression were detected by RT-PCR method.ResultsMIC and MFC of C.albicans were 16 mg/mL and 32 mg/mL, respectively.The inhibitory effects of rohdea roth on C.albicans adherence and hyphae formation were significantly inhibited,and the concentration was dose-dependent.After the concentration of 16 mg/mL acted on C.albicans for 6 h, hyphae disappeared completely.The results of RT-PCR showed that the gene expression of Efg1 and Hwp1 could be inhibited by rohdea roth.Compared with the control group,the expression of Efg1 and Hwp1in the experimental groupwere reduced by 84.18% and 59.57%(P<0.01).Conclusion The inhibitory effect of rohdea roth on the adherence and hyphae formation of C.albicans is mainly through inhibiting the expression of Efg1 and Hwp1genes.

Objective:To investigate the relationship between the distance from the upper and lower resection margin and the gastric cancer patients with R0 resection and no distant metastasis.Methods:Retrospective analysis of 281 patients with gastric cancer in our hospital,the relationship between the age,sex,tumor size,tumor size,vascular invasion,lymph node metastasis,TNM stage,type of gastric cancer,tumor location and operation mode was analyzed.To compare the survival time of patients with different upper and lower margins.Results:The increase of the distance from upper resection margin was significantly related to the tumor size＞5 cm,TNM stage,type of gastric cancer,tumor location,and the difference was statistically significant(P＜0.05);The distance of lower resection margin was significantly correlated with tumor size＞5cm,vascular invasion,lymph node metastasis and TNM stage,type of gastric cancer,and the difference was statistically significant (P＜0.05);Themedian survival timein patientsof upper resection marginr□3cm with 48 months of the 5-year follow-up period was significantly higher than that in patients of the resection margin＞3cmwith 46 months (P＜0.001).Themedian survival timein patientsof lower resection margin□3cm with 45 months of the 5-year follow-up period was significantly higher than that in patients of the resection margin＞3cm with 44 months (P＜0.001).Conclusion:Gastric cancer postoperative upper and lower resection margin was significantly related with tumor size,TNM staging factors,and the median survival time of upper and lower resection margin＞5 cm was significantly lower than that of the resection margin3 cm.

Objective To investigate the inhibition mechanism of gallnut on biofilm formation by MRSA 41577.Methods TTC assay was used to detect inhibitory effects of biofilms formation and mature biofilms.The of PIA on biofilm formation was studied using Congo red agar method.Micro-Ultraviolet Spectrophotometer was used to detect inhibitory effects of the release of eDNA.The influence for Baicalein on icaA and cidA gene expression were detected by RT-PCR method.Results The inhibitory concentration (MIC) and minimum bactericidal concentration (MIC) of MRSA 41577 BF were 0.5 mg/mL and 1 mg/mL, respectively.The inhibitory effect of galla on MRSA 41577BF formation and mature BF was significantly inhibited.Inhibition of MRSA 41577,the MIC and MBC of mature BF were 4 mg/mL and 16 mg/mL.Congo red test results show that Galla can inhibit the synthesis of MRSA 41577 PIA, and the concentration was dose-dependent.The results showed that gallnut could inhibit the release of MRSA 41577 eDNA, and the release amount of eDNA was 3.61μg/OD595 and 11.91μg/OD595 , respectively, when the concentration of gall was 1/2MIC.The release of eDNA was reduced by 69.7% (P<0.01).The expression of icaA and cidA genes in the control group was 9.7% and 6.67%, respectively.The expression of icaA and cidA in the control group was significantly lower than that in the control group ( icaA and cidA, and cidA gene expression were 100%, the expression of icaA and cidA genes were reduced by 90.3%and 93.3%, respectively (P<0.01).Conclusion The inhibitory effect of gallnut on the biofilm of MRSA 41577 is mainly through inhibiting the expression of icaA and cidA genes, and then affecting the synthesis of PIA and the secretion of eDNA .