ner. Furthermore, IL-10 and TGF-β1 showed a synergic effect. Conclusion IL-10 and TGF-β1, the cytokines of regulatory T cells, suppress the formation and bone resorption function of the osteoclasts.

Aged ; Carcinoma, Squamous Cell ; pathology ; surgery ; Cholecystectomy ; Gallbladder Neoplasms ; pathology ; surgery ; Humans ; Male

Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.
Clinical Trials as Topic ; Data Collection ; methods ; standards ; Humans ; Models, Theoretical ; Research Design

Objective To investigate the ability of T2 mapping in early detection of the change of cartilage collagen by quantitative analysis.Methods 20 porcine patellae were randomly assigned into 4 groups,3 treated groups and 1 control group.The samples of 3 treated groups were respectively immersed in PBS with 100 mg/100 mL,1 50 mg/100 mL and 200 mg/100 mL typeⅡ collagenase for 4 h,whereas control group samples in PBS for 4 h.T2 relaxation times of superficial,deep and full layers of cartilage and mean densi-ty after Van Gieson stain were measured.The correlation of T2 relaxation times and mean density were statistically analyzed.Results Gross pathology showed all articular cartilages maintained intact after treatment.T2 relaxation times of superficial and full layers and mean density increased significantly in any treated group in comparison with control group(P <0.05).Significant differences in T2 relaxation times of superficial layers and mean density were found between any two treated groups,whereas no difference of T2 re-laxation time of full layers was found between 100 mg/100 mL and 1 50 mg/100 mL treated groups(P >0.05).Pearson correlation analysis showed a close correlation(r=-0.837)between T2 relaxation times of full layers and mean density.Conclusion T2 map-ping can adequately detect the change of cartilage collagen in the early stage of osteoarthritis,and shows a good clinical application prospect.

No abstract available.
Animal ; Chlorides/metabolism* ; Endometrium/metabolism* ; Female ; Mice ; Sodium/metabolism*

In order to solve the problem of selection and in vivo delivery problem in siRNA treatment, hepatitis B virus (HBV) HBx gene which could be targeted by siRNA was studied. The siRNA expression plasmid which specific inhibits HBx expression was obtained by in vitro selection via a dual-luciferase plasmid including HBx-Fluc fusion protein expression domain. The selected siRNA expression plasmid was then encapsulated in PEG-modified cationic liposome, which was devoted into pharmacodynamic studies at both cellular and animal level. The results illustrated that the cationic liposome which encapsulated siRNA expression plasmid could effectively inhibit HBx gene expression both in vitro and in vivo.
Cations ; Gene Expression Regulation, Viral ; drug effects ; Hepatitis B virus ; genetics ; Liposomes ; chemistry ; Plasmids ; RNA, Small Interfering ; chemistry ; Trans-Activators ; genetics ; metabolism

Objective:To investigate the relationship between nutritional status and cognitive function in patients with Alzheimer's disease (AD),and to provide rationale for clinicians in nutrition intervention of AD patients.Methods:Sixty cases of elderly AD patients and 50 cases with normal elderly control were enrolled from the neurological department.Nutritional status and cognitive function were assessed using the laboratory parameters,mini nutritional assessment method (short-form Mini-Nutritional fine assessment,MNA-SF) and MMSE (Mini-Mental State,Examination,MMSE) survey.Results:Compared with control group,the AD group had significantly different laboratory index and MNA-SF score (P ＜ 0.05).MNA-SF scores were positively correlated with MMSE scores in patients with AD (r =0.59,P ＜ 0.05).Conclusion:The incidence of malnutrition in AD patients is high,and it is related to their cognitive function.The nutritional knowledge should be strengthened among doctors and nurses treating patients with AD.

OBJECTIVETo explore several numerical methods of ordinal variable in one-way ordinal contingency table and their interrelationship, and to compare corresponding statistical analysis methods such as Ridit analysis and rank sum test.

METHODSFormula deduction was based on five simplified grading approaches including rank_r(i), ridit_r(i), ridit_r(ci), ridit_r(mi), and table scores. Practical data set was verified by SAS8.2 in clinical practice (to test the effect of Shiwei solution in treatment for chronic tracheitis).

RESULTSBecause of the linear relationship of rank_r(i) = N ridit_r(i) + 1/2 = N ridit_r(ci) = (N + 1) ridit_r(mi), the exact chi2 values in Ridit analysis based on ridit_r(i), ridit_r(ci), and ridit_r(mi), were completely the same, and they were equivalent to the Kruskal-Wallis H test. Traditional Ridit analysis was based on ridit_r(i), and its corresponding chi2 value calculated with an approximate variance (1/12) was conservative. The exact chi2 test of Ridit analysis should be used when comparing multiple groups in the clinical researches because of its special merits such as distribution of mean ridit value on (0,1) and clear graph expression. The exact chi2 test of Ridit analysis can be output directly by proc freq of SAS8.2 with ridit and modridit option (SCORES =).

CONCLUSIONThe exact chi2 test of Ridit analysis is equivalent to the Kruskal-Wallis H test, and should be used when comparing multiple groups in the clinical researches.

Objective:To investigate the epidemiological characteristics of human coronavirus (HCoV) in hospitalized children with respiratory tract infection in Hebei region, providing evidence for the diagnosis and prevention of children with respiratory tract infection.Methods:A retrospective study was conducted on 1 062 HCoV positive children hospitalized for respiratory tract infection in Children′s Hospital of Hebei Province from January 2015 to December 2020, aged from 33 days to 14 years, with a median age of 2 years. 27 932 (60.9%) were males and 17 944(39.1%) were females. And the gender, ages, seasonal distribution, HCoV-positive rates, co-detection distribution and clinical diagnosis of HCoV positive cases were analyzed by SPSS 25.0. Enumeration data were expressed by frequency and percentage; categorical variable were compared by the Pearson χ 2test. Results:The overall HCoV-positive rate was 2.31% (1 062/45 876), which was 2.37% (662/27 932) in male children and 2.23% (400/17 944) in female children. There was no statistically significant difference between genders (χ2=0.916, P=0.339). Children at age groups<1 years (2.44%) and 1-<3 years (2.63%) had higher HCoV-positive rates than those at age groups 3-<5 years (1.97%) and ≥5 years (1.38%) (χ2=27.332, P<0.01). The HCoV-positive rates from 2015 to 2018 were 2.13%, 2.45%, 2.28% and 2.23%. The HCoV-positive rate of 2019 (1.71%) was significantly lower than in 2016 (χ2=12.05, P<0.01), 2017 (χ2=7.34, P=0.01) and 2018 (χ2=6.78, P=0.01), but there was no significant difference compared with 2015 (χ2=2.84, P=0.09). The HCoV-positive rate of 2020 (3.37%) was significantly higher than in 2015 (χ2=13.636, P<0.01), 2016 (χ2=11.099, P<0.01), 2017 (χ2=15.482, P<0.01), 2018(χ2=18.601, P<0.01) and 2019(χ2=45.580, P<0.01). The positive rate was highest in spring (March to May) in 2015 and 2017 to 2018. February to April and July to September of 2016 were the peak periods of positive detection. No obvious seasonal change was observed in 2019 and the HCoV-positive rate of 2020 was extremely low from January to July, following significantly increased from August to December. 26.37% (280/1 062) of HCoV were co-detected with other respiratory pathogens and the most frequently identified mixed detection was RSV. Three or more pathogens were detected in 7.34% (78/1 062) of the HCoV-positive samples. Bronchopneumonia and bronchiolitis were more frequently observed in the single HCoV positive (61.89% and 16.75%) children compared to co-detected children(34.29% and 9.64%)(χ2=63.394 and 8.228, P<0.01). However, compared to those with HCoV mono-detection, co-detected children were more likely to have severe pneumonia (4.6% and 47.14%) (χ2=280.171, P<0.01). Conclusions:HCoV is one of the respiratory pathogens in children in Hebei region and more prevalent in spring. The susceptible population of HCoV is mainly children under the age of 3 years old. HCoV often co-detects with other respiratory pathogens, and the co-infection is one of the risk factors of severe pneumonia in children with respiratory infection.