FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard.Due to the detailed contents of submission package,it's always a big challenge to submission institution and staff.It usually costs a lot of time for company or member to complete the validation before submission to FDA.Based on the ADaM submission package,this paper gives a clear picture of validation checkpoint checklist.For every checkpoint,it will see and find the ways to automatically validate through SAS macros or tools.So that it will decrease the manual checking workload,saving the time and shorten the submission period.

Objective To establish an experimental model of acute cerebral schistosomiasis japonica and explore the MRI manifestations of acute cerebral schistosomiasis. Methods Rabbits were divided into 3 groups with 10 rabbits in each group. The rabbits in the experimental group were directly injected with suspension fluid of Schistosoma japonicum eggs(0.9 mg,1 ml) by the cranial drilling method,those in the negative control group were given saline(1 ml)by the same method above-men-tioned,and those in the blank control group were not given any treatment. Antibiotic was given to the first two groups after the op-eration. The clinical manifestations of the 3 groups were observed,and the magnetic resonance imaging(MRI)was performed in 30 days post-operation,and then the brain tissues were taken for pathological examinations. Results All the rabbits in the ex-perimental group exhibited inappetence,various neurological symptoms including hemiplegia,and weight loss after the opera-tion;while those in the negative control group showed inappetence in 3 days after the operation,and 1 week later,the symptom disappeared;there were no adverse reactions in the blank control group. MRI of the experimental group showed nodular or patchy enhancement on T1WI enhancement,brain edema,abnormal ventricular dilatation,and needle augmentation. SWI dis-played hypointense in the abnormal enhanced nodules and flaky hypointense on the operation brain. In the negative control group,2 rabbits showed abnormal enhancement of the needle canal,and 1 showed mild dilatation of the ventricle. The blank control group showed normal manifestations. The pathological examinations showed abnormal appearances in 10 rabbits of the ex-perimental group,including 6 with S. japonicum egg granuloma nodules,nonspecific granuloma nodules coexisted with perivas-cular inflammation;no granuloma nodules were found in the negative control group,but 2 rabbits showed vascular inflamma-tion;the blank control group showed the normal brain tissue. Conclusions An experimental model of acute cerebral schistoso-miasis is successfully established in rabbits by intracranial injection of schistosome eggs. The MRI examination combined with the clinical manifestations can improve the accuracy of early diagnosis of cerebral schistosomiasis.

Objective:To analyze the surveillance results of iodine deficiency disorders in Fuzhou City, Jiangxi Province, so as to master the iodine nutrition level of key population and evaluate the prevention and treatment effect of iodine deficiency disorders in the city.Methods:From 2017 to 2019, counties (districts) under the jurisdiction of Fuzhou City in Jiangxi Province were divided into five sampling areas (east, west, south, north, and central). A township was selected in each area, and a primary school was selected in each township. Forty children aged 8 to 10 were elected in each primary school. At the same time, 20 pregnant women were selected from each area. Home salt samples and urine samples of children and pregnant women were collected to determine the contents of salt iodine and urinary iodine, and the thyroid of children was examined by B-mode ultrasonography.Results:A total of 6 001 salt samples from children's homes were tested. The median iodine content of children's home salt samples was 24.60 mg/kg, the coverage rate of iodized salt reached 99.77% (5 987/6 001), and the edible rate of qualified iodized salt was 96.20% (5 773/6 001). A total of 3 000 salt samples from pregnant women's homes were tested. The median iodine content of pregnant women's home salt samples was 24.81 mg/kg, the coverage rate of iodized salt reached 99.97% (2 999/3 000), and the edible rate of qualified iodized salt was 96.97% (2 909/3 000). A total of 6 001 children's urine samples were tested, and the median urinary iodine was 172.23 μg/L. A total of 3 000 pregnant women's urine samples were tested, and the median urinary iodine was 178.35 μg/L. The rate of goiter in children was 1.00% (8/800) in 2017, 1.33% (8/600) in 2018, and 1.12% (9/800) in 2019.Conclusion:The iodine nutrition level of children and pregnant women in Fuzhou City of Jiangxi Province is suitable and meets the requirements of iodine deficiency disorders elimination standard.

Objective To analyze the scores of National Institutes of Health stroke scale(NIHSS),geriatric nutritional risk index(GNRI),motor function in dependence measure(MFIM)and the risk of stroke-related pneumonia(SAP).Methods Patients with stroke admitted from November,2021 to May,2022 were included.The scores of NIHSS,GNRI and MFIM at admission were collected,and they were divided into non-SAP group(n=232)and SAP group(n=86)according to whether pneumonia occurred within one week after stroke.According to the receiver operating characteristic(ROC)curve,the predictive ability of each score to SAP was evaluated,and each score was grouped according to the best cut-off point.logistic regression model and restricted cubic spline were used to analyze the relationship between each score and SAP.Results A total of 318 stroke patients were enrolled in the study including 86 in SAP group and 232 in non-SAP group.Logistic regression shows that,levels of NIHSS score(OR=32.783,95％CI:16.366～65.671,P<0.001),MFIM score(OR=0.052,95％CI:0.027～0.100,P<0.001)and GNRI score(OR=0.262,95％CI:0.144～0.476,P<0.001)were associated with SAP.Restricted cubic spline analysis shows that,there was a nonlinear dose-response relationship between SAP risk and NIHSS score(P-general trend<0.001,P-nonlinear=0.002),GNRI score(P-general trend<0.001,P-nonlinear<0.001).Conclusion NIHSS,MFIM,and GNRI scores are associated with the risk of SAP in stroke patients,and some of them have nonlinear relationships.

Objective To study on the application value of flipped classroom and PBL in the teaching process of sanitary chemistry experiment. Methods 112 students studied in School of Public Health in Nanchang University were considered as research subjects, including Preventive Medicine grade 2014 class 1 (observation group, n=57) and class 2 (control group, n=55). The students were taught with flipped classroom model in the control group , while flipped classroom combined with PBL was applied in the observation group. The learning effect of the two groups was evaluated by using the form of "Richter score scale"in the self-made form. The data was input using Epidata 3.0 and processed by SPSS 18.0, and it was analyzed by t test and 2 test. Results The evaluation index scores (learning attitude, ability improvement, learning cooperation, professional quality improvement) in the observation group were significantly higher than that of thecontrol group (P<0.05). Besides, the final test scores were also significantly higher in the observation group than those in control group [(83.56 ±10.81) vs. (69.37 ±10.45), t=7.059, P=0.000]. Conclusion Combining flipped classroom with PBL in the teaching process of sanitary chemistry experiment for the students majored in Preventive Medicine not only improves students' exam results, but also helps students improve their learning attitude, learning ability, professional quality and so on. Therefore, the teaching method is worthy of wider application.

Objective To study the prokaryotic expression and immune protection of triosephosphate isomerase(TPI)of Toxoplasma gondii in mice. Methods Total RNA was extracted from toxoplasma tachyzoites,and TPI fragment was amplified by PCR and cloned into the prokaryotic expression vector pET-28a(+). The target protein was induced with IPTG and purified by Ni-NTA affinity chromatography. The mice were immunized 4 times by emulsified TPI with adjuvant,and the last time was the strengthen immunization. At the same time,an adjuvant group and a normal group were set as controls. The blood samples were got from the tail vein of the mice,and the serum antibody titres were detected. All the mice were challenged with 400 toxo-plasma tachyzoites to observe the survival time. Results The TPI gene was amplified from T. gondii cDNA by PCR. The recom-binant vector TPI/pET-28a(+)was usefully constructed,and the TPI protein was expressed and purified. The serum antibody ti-tre could be more than 100 thousand. After infected with toxoplasma tachyzoites,the survival time of the mice in the experimen-tal group was longer than that of the mice in the control groups. Conclusion The TPI protein of T. gondii could trigger the im-munoprotection against T. gondii challenge in the mice.

Evidence-based medicine (EBM) is an emerging subject which allows us to make health-related policy based on evidence, and is also an important course in medical colleges and universities. Given the current educational objectives and characteristics of evidence-based medicine, this paper proposed an online and offline integrated teaching model of evidence-based medicine based on online platform for medical undergraduates. Online teaching was conducted using online platform which focus on the cultivation of evidence-based thinking and scientific research quality. Offline teaching was in-classroom teaching which focus on basic knowledge and skill learning. Practice of this model not only enriches teaching methods, but also improves the learning effect, thus this model needs to be explored and perfected in the future.

Objective To explore the association of smoking and smoking cessation with glycemic control in male patients with type 2 diabetes. Methods From December 2013 to January 2014, a total of 7763 male patients with type 2 diabetes, who received national basic public health service in Changshu county of Suzhou city, Huai'an and Qinghe districts of Huai'an city, Jiangsu province, were recruited by cluster sampling. Questionnaire survey and anthropometric measurements were conducted, and fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) levels were measured. Multiple linear regression model was used to evaluate the association of smoking and smoking cessation with glycemic control. Results The prevalence of current smoking was 45.5%in male patients with type 2 diabetes. The levels of FPG and HbA1c increased with number of cigarettes smoked per day compared with non-smokers (P<0.001). Among patients with drug treatment, the average increase of HbA1c level in current smokers with smoking duration ≥30 years and smoking index ≥40 pack-years were 0.27% (95%CI: 0.05%-0.49%) and 0.38% (95%CI: 0.23%-0.53%),respectively. FPG and HbA1c level decreased obviously with smoking cessation years among former smokers (P<0.05). Among the patients receiving no drug treatment, no dose-response relationships were observed between smoking duration, smoking cessation years and levels of FPG and HbA1c. Conclusion Cigarette smoking was negatively related with glycemic control in male type 2 diabetes patients, especially in patients with drug treatment. Smoking cessation may be beneficial for glycemic control. Smoking cessation should be encouraged for diabetes patients as early as possible.

Objective To analyze the epidemiological characteristics of severe fever cases,with thrombocytopenia syndrome (SFTS) in Zhoushan,Zhejiang,2011-2013 and to provide evidence for the development of related strategies for prevention and control of the disease.Methods Data was collected from the studies and related demography of the cases with SFTS in Zhoushan,2011-2013.Clinical and epidemiological characteristics of the cases with SFTS were analyzed descriptively.Results During 2011-2013,45 SFTS cases were reported in Zhoushan city,with fatality rate as 11.11％ (5/45),including 41 cases (91.11％) reported in Daishan county.Most cases aged 50 or over,residing in hilly regions (93.33％).The epidemic peak was seen from May to July (84.44％).Incidence rates of the disease did not show significant statistical differences between males and females.Most cases were farmers (42.22％) and housewives (31.11％).Most patients complained of fever (97.78％),anorexia (91.11％),fatigue (62.22％),chill (44.44％) and other non-specific clinical manifestations but all appeared progressive thrombocytopenia and leucopenia.Sanitation condition of the patients was generally poor.68.89％ (31/45) of cases had farmed,mowed or involved in other outdoor activities in the previous two weeks,with some of them reported having exposed to tick bites.Three events were reported,epidemiologically.Conclusion SFTS in Zhoushan was a infectious disease with natural foci and caused by SFTSV.Ticks might serve as the main vectors for SFTSV,and might cause direct transmission between humans.Improving the environment for living and carrying out essential protective measures in outdoor activities seemed to be significant in decreasing the incidence rate of the disease.

Objective:To understand the iodine nutrition states of children in Dongtai City Jiangsu Province by analyzing the urinary iodine level of children aged 0 - 12 years old (prepubescent children), so as to provide scientific reference for prepubescent children's reasonable iodine nutrition intake.Methods:Under the guidance of the "National Iodine Deficiency Disorders Monitoring Program" (2016), Dongtai City was divided into 5 districts according to the east, west, south, north and middle locations. In each district, children aged 0 - 7 years old who underwent physical examination in township hospitals and prevention and health centers were selected to collect urine samples for urine iodine testing. One township was selected from each district, and one primary school was selected from each township. At least 90 children aged 8 to 12 (half boys and half girls) were selected from each primary school to collect urine samples for urine iodine testing. The urinary iodine levels of children of different genders, ages and regions were compared and analyzed.Results:A total of 2 934 urine samples were collected. The median of urinary iodine was 191.9 μg/L, ranging from 1.4 to 627.9 μg/L, the proportion of urine iodine content < 50 μg/L was 5.5% (162/2 934), the proportion of 50 - 99 μg/L was 10.9% (319/2 934), the proportion of 100 - 199 μg/L was 37.4% (1 096/2 934), the proportion of 200 - 299 μg/L was 28.3% (829/2 934), and the proportion of ≥300 μg/L was 18.0% (528/2 934). A total of 1 535 and 1 399 urine samples of boys and girls were collected. The medians urinary iodine of boys and girls were 202.3 and 177.7 μg/L, respectively, and the difference was statistically significant ( Z = - 5.487, P < 0.05). There were 106, 1 539, 753 and 536 cases of infants (0 - 12 months old), early childhood (1 - 3 years old), preschool children (4 - 6 years old), and school-age children (7 - 12 years old), the medians urinary iodine were 169.8, 189.6, 169.9 and 243.7 μg/L, respectively, the difference was statistically significant ( H = 127.395, P < 0.05). There were 642, 699, 422, 738 and 433 cases in different regions (east, west, south, north and middle) and the medians urinary iodine were 194.2, 172.7, 196.8, 200.5 and 196.6 μg/L, respectively, the difference was statistically significant ( H = 29.461, P < 0.05). Conclusions:Children aged 0 - 12 years old in Dongtai City are not deficient in iodine on the whole, but those with urinary iodine value higher than 200 μg/L account for a large proportion. Therefore, a reasonable iodine nutrition plan should be implemented according to the actual situation. In addition, individual iodine deficiency and excess should also be paid attention to.