A method based on QuEChERS coupled with ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed for the determination of seven kinds of fluorescent white agent residues in mushroom.After mixing with 10 mL of water, the sample was extracted with acidified acetonitrile, cleaned up by C18, primary secondary amine (PSA) and MgSO4.The separation of seven kinds of fluorescent white agents was performed on a C18 column with a gradient elution of acetonitrile and 0.1% acidified water as mobile phase.The target compounds were detected by electrospray ionization mass spectrometry in positive ion mode with multi reaction monitoring (MRM).Under the optimum conditions, the method had good linear relationship in the determination of the seven kinds of fluorescent white agents in a certain concentration range, with correlation coefficients greater than 0.991.Moreover, the limits of detection (S/N=3) were 0.05-0.4 μg/kg, the limits of quantitation (S/N=10) were 0.2-1.3 μg/kg, and the average recoveries for seven kinds of fluorescent white agent residues in msushroom were 70.1%-109.2%.In comparison with previous methods, the new procedure has characteristics of simple sample preparation and higher sensitivity.

Objective:To establish the prediction model of postoperative Gleason score (GS) risk of prostatic cancer (PCa), and to compare the diagnostic efficacy of the model and each independent risk factor for PCa medium-high risk group.Methods:The clinical data of 362 patients who accepted transrectal prostate biopsy in the Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine from January 2018 to December 2019 were analyzed retrospectively, and a total of 343 patients with prostate cancer who met the enrollment criteria were selected. According to the GS grading system, these patients were divided into low risk group, moderate risk group and high risk group. At first, the single factor analysis and Spearman rank correlation were used to find out the effective indicators with good correlation with GS risk. Then, multiple linear regression equation was applied for multi-factor analysis to obtain the independent risk factors and the prediction model for predicting GS risk, and then the ROC curve was used to compare the diagnostic efficacy of each independent risk factor and prediction model for PCa medium-high risk group.Results:In the single factor analysis, the differences of all indicators in GS risk were statistically significant (all P<0.05). In the correlation analysis with GS risk, except for the indicators of prostate volume (all P>0.05), the other indexes had linear correlations with the different risks of GS (all P<0.05). Among them, the total prostate specific antigen and two-dimensional ultrasound (2D-US) score showed moderate positive correlations( rs=0.402, 0.579, all P<0.001), contrast enhanced ultrasound (CEUS) score showed a high positive correlation ( rs=0.709, P<0.001), and the rest indexes showed low positive correlations. Multiple linear regression was used to obtain two independent risk factors of 2D-US score ( X1) and CEUS score ( X2) for the prediction of GS risk, then, a prediction model was established: Y=0.863+ 0.066 X1+ 0.27 X2, the corresponding linear coefficient differences were statistically significant(all P<0.05). By the ROC analysis, the areas under the curves of 2D-US score, CEUS score and the prediction model were 0.838, 0.906 and 0.907, respectively. Conclusions:2D-US score and CEUS score are independent risk factors for predicting postoperative GS risk, and the diagnostic efficacy of the prediction model is higher than those of the 2D-US score and CEUS score for the medium-high risk group.

OBJECTIVE:To conduct the quality assessment of artificial Aquilaria sinensis by"cutting inducing technique", and provide reference for its scientific planting and harvest. METHODS:GC-MC and HPLC were adopted to detect the volatile in-gredients,characteristic spectrum,incense tetraol and alcohol-soluble extract contents in 3 batches of artificial A. sinensis(Num. 1, 2,3,respectively for 5,10,20 years)by"cutting inducing technique". RESULTS:The volatile ingredients of 3 batches of artifi-cial A. sinensis mainly consisted of aromatic compounds,sesquiterpene compounds,fatty acid compounds and chromone com-pounds. The characteristic spectrums of samples 2,3 were basically the same with the reference substance of A. sinensis. The in-cense tetraol contents of 3 batches of samples were 0.078%-0.254%,and alcohol-soluble extract contents were 12.4%-20.8%. The characteristic spectrum and the incense tetraol content of sample 1 were not conformed to the standards in Chinese Pharmacopoeia (2015 edition,part 1). CONCLUSIONS:Artificial A. sinensis by"cutting inducing technique"shows similar volatile ingredients to natural A. sinensis. The quality of artificial A. sinensis for more than 10 years is conformed to the standards in Chinese Pharmaco-poeia(2015 edition,part 1),which can be used as medicine,replacing the natural A. sinensis.

Objective:To explore the application of information management platform for Investigator Initiated clinical trials (IIT).Methods:Elaborate the design and application of Clinical Information Management Platform (CIMP). Discuss the obstacles in platform development.Results:Compared with regions where clinical research is more developed, there is still a lack of standardized and efficient information management methods in China. Through the construction of the IIT information management platform, the scientific management of the IIT and the SWOT analysis of the use of the platform have been conducted. Further exploration and improvement are needed in terms of the collaboration of the information platform, data standardization, and information sharing security.Conclusions:The management efficiency can be improved by applying CIMP, which will also promote the smooth implementation of IITs.

Objective:To evaluate the in vitro cross-neutralization of serum antibodies in human and mice immunized with inactivated SARS-CoV-2 vaccine against Delta and Beta variants. Methods:Human serum samples after a second and a third dose of inactivated SARS-CoV-2 vaccine and mouse serum samples after a two-dose vaccination were collected. The neutralizing antibodies in the samples against SARS-CoV-2 strains of prototype, Delta and Beta variants were detected using micro-neutralization assay in biosafety level Ⅲ laboratory. The seroconversion rates and geometric mean titers (GMTs) of antibodies were calculated.Results:The seroconversion rates of antibodies in human serum samples against different SARS-CoV-2 strains were all above 95%. After two-dose vaccination, the GMTs of neutralizing antibodies against the prototype, Delta and Beta strains were 109, 41 and 15, respectively. The GMTs decreased by 2.7 folds and 7.3 folds for the Delta and Beta variants as compared with the prototype strain. After the booster vaccination, the GMTs of neutralizing antibodies against the prototype, Delta and Beta strains were 446, 190 and 86, respectively. The GMTs of neutralizing antibodies against Delta and Beta variants decreased by 2.3 folds and 5.2 folds as compared with that against the prototype strain. The seroconversion rates of antibodies against different SARS-CoV-2 strains in mouse serum samples were all 100%. The GMTs of neutralizing antibodies against the prototype, Delta and Beta strains were 2 037, 862 and 408, respectively. The GMTs decreased by 2.4 folds and 5.0 folds for the Delta and Beta variants.Conclusions:Inactivated SARS-CoV-2 vaccine could induce a certain level of neutralizing antibodies against Delta and Beta variants in both human and mouse models. Moreover, a third dose of vaccine induced higher levels of neutralizing antibodies against Delta and Beta variants in human. This study provided valuable data for the clinical application and protective evaluation of the inactivated SARS-CoV-2 vaccine.

Objective With the fast development of Investigator-Initiated Trials (IIT),more and more resources from the national and local governments,universities and hospitals were invested.It is important to clarify the content and methodologies of quality evaluation of the IITs at the early approval stage to assure more complete and systematic quality assessment,improve resource allocation,enhance the research ability,as well as the protection of human subject.Methods This article summarized the content and related safeguarding measures of quality assessment during the early stage of project setup.Discussed relative practice and experiences of our center.Results The contents of quality evaluation include research topic,study protocol,research team and qualifications,quality assurance plan and risk management.The organizing work and attention of the research administrative department,qualified departments and experts,as well as information platform are the required safeguarding measures for effective assessment.Conclusions Quality evaluation of IITs at the early approval stage is critical segment of study quality assurance.More attention should be paid to make every effort counts.

Objective: To investigate the evaluating ability of real-time three-dimensional contrast-enhanced ultrasound (RT-3D-CEUS) for morphology of hepatocellular carcinoma (HCC) before radiofrequency ablation (RFA) treatment. Methods: Sixty patients with 88 targeted lesions were enroll in this study, who have received RFA in Hangzhou Xiasha Hospital. The pretreatment imaging data of CEUS and RT-3D-CEUS were retrospective analysis. Morphological features were assessed according to the size and shape of the lesions, and were compared between two modalities with the post-treatment response as the reference standard. Results: The size of lesion measured by CEUS and RT-3D-CEUS was similar in 70 out of 88 lesions (group A). In the other 18 lesions, the size measured by RT-3D-CEUS was larger than that by CEUS (group B). For the shape analysis, 38 lesions were spheroid by CEUS and 34 lesions by RT-3D-CEUS; 47 lesions were oval by CEUS and 41 lesions by RT-3D-CEUS; 3 lesions were irregular by CEUS and 13 lesions by RT-3D-CEUS. There were 78 lesions which shape assessed by two modalities consistently (group A′), and the other 10 lesions with inconsistent shape by two modalities (group B′). Three months follow-up results showed that 4 lesions appeared tumor residue (5.7%) in group A′ and 6 lesions (33.3%) in group B′. There was significant difference between these two groups (P=0.004). In the group A′, there were 6 lesions (7.7%) showed tumor residue, and 4 lesions (40.0%) in group B′. The difference between these two groups was also significant (P=0.012). Conclusion RT-3D-CEUS could be used to assess the size and shape of HCC accurately which is associated with the response of RFA.

Objective To explore the method for measurement of tritium in nuclear power plant liquid effluent purified by a mixed ion-exchange resin, to verify the feasibility of the method by experiments, and to provide technical support for the development of standard methods for the measurement of tritium in liquid effluent of nuclear power plants. Methods The purification effect of the mixed ion-exchange resin was determined by measuring the quenching factor, conductivity, and β-nuclide adsorption efficiency of the samples purified using the resin. A comparison was made between the ion-exchange resin method and the atmospheric distillation method for tritium determination. The precision and accuracy of the method were verified by calculating the relative standard deviation and the recovery in repeated measurement of samples with different activity concentrations and spiked samples. Results There were no significant differences in quenching factor, conductivity, and tritium activity concentration between the two methods. The adsorption efficiencies of EC20MB resin for common β-nuclides such as carbon, iron, nickel, strontium, yttrium, and cesium ranged from 99.28% to 99.88%. Repeated measurement of the same sample showed relative standard deviations of 5.2%-9.4% and recoveries of 86.8%-107%. Conclusion There were no significant differences between the results of the ion-exchange resin purification method and the atmospheric distillation method. The precision and accuracy of the method met the requirements of the ecological and environmental management authorities for monitoring tritium in liquid effluent from nuclear power plants. This method can be widely used in daily monitoring work.