OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.

Objective:To explore the expression of serum miR-224-5p in PDAC and its significance for early clinical diagnosis.Methods:From August 2018 to April 2020, 40 patients with PDAC (11 patients with early PDAC, 29 patients with advanced PDAC), 21 patients with chronic pancreatitis and 40 healthy volunteer controls admitted in Qingdao Municipal Hospital were enrolled. The level of serum miR-224-5p in each group was detected by qRT-PCR method, and the correlation with clinicopathological parameters was analyzed. The receiver-operating characteristic (ROC) curve of miR-224-5p, CA19-9 and miR-224-5p combined with CA19-9 were drawn, and the sensitivity and specificity of the diagnosis were calculated.Results:The serum miR-224-5p levels in early PDAC group, middle and late PDAC group, chronic pancreatitis group and healthy control group were 3.21(2.01, 4.60), 4.70(3.50, 8.26), 1.72(1.02, 2.78) and 1.38(0.89, 2.11), respectively; and the level of serum miR-224-5p in the middle and late PDAC group was significantly higher than that in the early PDAC group, and that in the early PDAC group was significantly higher than that in the chronic pancreatitis group and the healthy control group, and all the differences were statistically significant ( P<0.05). The sensitivity of serum miR-224-5p combined with CA19-9, miR-224-5p, and CA19-9 in the diagnosis of overall PDAC was 95.0%, 85.0% and 67.5%, respectively; and the specificity was 70.0%, 82.5% and 87.5%, respectively. The sensitivity for early PDAC was 90.9%, 72.7% and 63.6%, and the specificity was 85.0%, 72.5% and 87.5%, respectively. MiR-224-5p combined with CA19-9 has the highest specificity in the diagnosis of PDAC. The level of serum miR-224-5p in patients with PDAC was correlated with TNM stage, lymph node metastasis and distant metastasis (all P values <0.05). Conclusions:The expression of serum miR-224-5p was significantly up-regulated in patients with early PDAC, and The level of serum miR-224-5p in patients with PDAC was correlated with TNM stage, lymph node metastasis and distant metastasis. The sensitity of serum miR-224-5p and miR-224-5p combined with CA19-9 for early PDAC diagnosis were superior to CA19-9 alone, which can be used as a potential sensitive biological marker for early screening of PDAC.

Objective To investigate the oral health status of the first-grade primary school students in Shanghai and analyze its influencing factors.Methods In 2021,Huangpu,Xuhui,Jiading,and Jing'an districts were selected in Shanghai by random sampling method.The first-grade students of 8 primary schools in these 4 districts were enrolled by random cluster sampling.Oral clinical examinations and questionnaires were conducted according to the criteria of the Fourth National Oral Health Epidemiological Survey.EpiData 3.1 software was used to create the database.SPSS 26.0 software was applied for statistical analysis.Chi-square test was used to compare the caries prevalence between groups,and two independent samples non-parametric test was used to compare the decayed,missing and filled teeth(DMFT)between groups.Multifactorial logistic regression model was used to analyzse the influencing factors of caries.Results A total of 824 informed consent forms and questionnaires were collected,of which 764 were completed,with an effective rate of 92.7％.The total caries prevalence of the participating students was 65.6％(501/764),and the mean DMFT was 3.24±3.47.A total of 2 473 carious teeth were found in the participating students,and 671 teeth were filled,with a filling rate of 27.1％.There were 7.91±2.76 permanent teeth erupted per student,and 56.3％(430/764)of the students had all 4 first permanent molars erupted.Multivariate logistic regression showed that eating sweets＞3 times a day(P=0.030),eating regularly before bedtime(P=0.001),and parents'cognition of kids'poor oral health status(P=0.025)were the influencing factors for the detection of caries in children.Conclusion The first-grade primary school students in Shanghai have high prevalence of caries.Eating sweets＞3 times a day,eating regularly before bedtime,and parents'cognition of kids'poor oral health status(P＜0.05)are the influencing factors for the detection of caries in children.

Objective To investigate the expression level of serum miR-486-5p in patients with pancreatic cancer and the value of serum miR-486-5p combined with carbohydrate antigen 19-9 (CA19-9) in predicting the resectability of pancreatic cancer. Methods A total of 60 patients who were diagnosed with pancreatic cancer in Qingdao Municipal Hospital from September 2018 to December 2020 were enrolled, among whom 32 patients had resectable or borderline resectable pancreatic cancer (operable group) and 28 had unresectable pancreatic cancer (non-operable group), and a benign pancreatic disease group with 30 patients and a healthy control group with 44 individuals were also established. Quantitative real-time PCR was used to measure the serum level of miR-486-5p in each group, and the relative expression level of miR-486-5p was calculated to analyze its association with the clinical features of pancreatic cancer, including age, sex, tumor location, tumor size, TNM stage, lymphatic metastasis, and distant metastasis. The Mann-Whitney U test was used for comparison of non-normally distributed continuous variables between two groups, and the chi-square test was used for comparison of categorical variables. The receiver operating characteristic (ROC) curve was plotted, and a binary logistic regression analysis was used to calculate the combined predictive value and then investigate the value of serum miR-486-5p combined with CA19-9 in predicting the resectability of pancreatic cancer. Results The relative expression level of serum miR-486-5p in the operable group [2.16 (1.38~3.30)] and the non-operable group [4.65 (2.80~9.90)] was significantly higher than that in the benign pancreatic disease group [1.01 (0.52~1.53)] and the healthy control group [0.99 (0.24~1.01)] (all P < 0.001). There were significant differences in the number of patients with low or high expression of miR-486-5p between the patients with different TNM stages, presence or absence of lymphatic metastasis, and presence or absence of distant metastasis ( χ 2 =13.765, 5.157, and 6.638, all P < 0.05). Compared with CA19-9 alone, miR-486-5p+CA19-9 had a significantly better value in distinguishing the operable group from the benign pancreatic disease group (area under the ROC curve [AUC]=0.87, 95% confidence interval [ CI ]: 0.760-0.942; with a sensitivity of 81.3% and a specificity of 83.3%), distinguishing the operable group from the healthy control group (AUC=0.92, 95% CI : 0.836-0.970; with a sensitivity of 90.6% and a specificity of 86.4%), and distinguishing the operable group from the non-operable group (AUC=0.94, 95% CI : 0.884-0.998; with a sensitivity of 85.7% and a specificity of 93.7%) ( Z =2.841, 2.510, and 2.387, all P < 0.05), and the optimal cut-off values were 3.12, 3.21, and 6.63, respectively. Conclusion MiR-486-5p can be used as a serum biomarker for the diagnosis of pancreatic cancer, and miR-486-5p combined with CA19-9 has a better clinical value than CA19-9 alone in predicting the resectability of pancreatic cancer in the patients with benign pancreatic diseases and the healthy population.