ular perfusion in tumors objectively, which is potential in monitoring tumor vascular response to antiangiogenic therapy.

Objective: To explore the clinical significance of transcription factor Sp1 expression in hepatocellular carcinoma (HCC) and association between Sp1 expression and survival in HCC patients. Methods:With the use of immunoreactivity, Sp1 expres-sion and its correlation with other clinicopathological characteristics were examined in a tissue microarray that contains samples from 98 HCC patients. Results:HCC tissues expressed markedly higher levels of Sp1 than did adjacent normal liver tissues. Sp1 expression was closely associated with microvascular invasion, which suggests that HCC with more microvascular invasion is prone to have in-creased Sp1 expression. Overexpression of Sp1 correlates with significantly shorter overall survival and higher recurrence rates in HCC patients after curative resection. Conclusion:Transcription factor Sp1 may be an independent prognostic factor for both overall surviv-al and cumulative recurrence rate.

Objective:To review the historical evolution and current situation of approval system for marketing application of new chemical pharmaceuticals in China to provide reference for the establishment of more perfect approval system. Methods: Through clearing up the historical evolution of approval regulations for marketing application and combining with the current approval system,the development track of the regulatory system from the vulgar administration gradually transferring to the scientific management was ana-lyzed comprehensively. Results and Conclusion: The dividend of current approval system has appeared, meanwhile, the constantly improving process will lay the foundation for setting up the regulatory system conforming to the situation of China and in line with inter-national standards.

Aortic Valve Insufficiency ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; Humans ; Transcatheter Aortic Valve Replacement

Objective:To evaluate the effectiveness and prognosis of emergent transcatheter aortic valve replacement (TAVR) and to provide standardized procedural suggestion for the development of emergent TAVR in China.Methods:From January 2020 to April 2021, 12 patients who underwent emergent or salvage TAVR in the Second Affiliated Hospital Zhejiang University School of Medicine were retrospectively enrolled from the TORCH registry (Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population, a prospective cohort study; NCT02803294). Baseline, periprocedural and 30-day follow up data were collected. Post-operative data were compared with pre-operative data using Paired-Samples test.Results:Patients’ median Society of Thoracic Surgeons score (STS score) was 15.432%. There was a significant decrease of mean gradient after emergent TAVR procedure (1.69 m/s vs. 4.90 m/s, P<0.01). During the 30-day follow up, there were 1 patient (8.3%) died and 2 patients received permanent pacemaker implantation. No disabling stroke, acute kidney injury, major vascular complication occurred during the first month after emergent TAVR. Among the survival patients, there was a significant releasing of heart failure symptoms to New York Heart Association function stage Ⅰ/Ⅱ in 81.8% patients at 30-day follow up. Left ventricular ejection fraction also improved significantly from (47.4±9.5)% to 58.8±8.0% ( P= 0.026). The mean gradient were (1.57±0.30) cm 2 and no patients had a moderate or severe paravalvular leakage. Besides, a significant decrease of pro-B-type natriuretic peptide (1 089.9 pg/mL vs. 12 215.5 pg/mL , P=0.001) and troponin T (0.020 ng/mL vs. 0.337 ng/mL, P=0.003) were found at 30 days after emergent TAVR. Conclusions:For patients with severe aortic stenosis and acute cardiac decompensated, emergent TAVR is a safe and effective rescue treatment.

Objective:To evaluate the safety and effectiveness of a new Chinese-made surgical biopatch for atrial septum under the establishment of atrial septal defect animal model in miniature pigs.Methods:From June 2018 to April 2019, 26 pigs were divided into experimental group (15 pigs) and the control group (11 pigs). Animal models of atrial septal defect were established by traditional surgical methods. The to-be-evaluated and listed surgical biological patches (with a diameter of 10 mm) were implanted in the experimental group and the control group to repair the atrial septal defect. Cardiac ultrasound and blood examination of all animals were performed before and at 7, 30, 90, 180 days after operation, the results were analyzed with repetitive measurement and analysis of variance. At 90 days and 180 days after the operation, tissue samples were taken from animals after euthanasia. Pathological examination of heart and major organs were conducted. The independent sample t test and rank sum test were used to compare the data between the two groups, and the nonparametric was used to compare the patch calcification score between the two groups. Results:In total of 26 animals, 14 animals in the experimental group(6 at 90 days, 8 at 180 days) and 9 animals in the control group(4 at 90 days, 5 at 180 days) reached the end of the experiment. The other 3 animals (1 in the experimental group and 2 in the control group) died of arrhythmia, whole heart failure and right heart failure, the results of pathological examination showed that the causes of death were unrelated to the experimental materials. Cardiac ultrasound showed no patch leakage in all animals. There was no statistically significant difference in cardiac ultrasound and blood examination between the two groups at different time points after operation (all P>0.05). The pathological results showed that all the implants were intact and had good biocompatibility. There was no significant difference in the mean endothelialization rate between the experimental group and the control group at 90 and 180 days after operation ((80.8±29.1)% vs. (82.5±23.6)%, t=0.095, P=0.927; (78.8±36.4)% vs. (82.0±19.2)%, t=0.182, P=0.859) on 90 and 180 days, there was no significant difference in the patch calcification score between the two groups (1.00(1.25) vs. 2.00(0.75), Z=6.500, P=0.214; 0(0.75) vs. 1.00(2.00), Z=12.000, P=0.139). Conclusion:The new Chinese-made surgical biopatch for atrial septum has comparable safety and efficacy to that of the marketable patch in miniature pig atrial septal defect animal model.

Objective:To evaluate the safety and effectiveness of a new Chinese-made surgical biopatch for atrial septum under the establishment of atrial septal defect animal model in miniature pigs.Methods:From June 2018 to April 2019, 26 pigs were divided into experimental group (15 pigs) and the control group (11 pigs). Animal models of atrial septal defect were established by traditional surgical methods. The to-be-evaluated and listed surgical biological patches (with a diameter of 10 mm) were implanted in the experimental group and the control group to repair the atrial septal defect. Cardiac ultrasound and blood examination of all animals were performed before and at 7, 30, 90, 180 days after operation, the results were analyzed with repetitive measurement and analysis of variance. At 90 days and 180 days after the operation, tissue samples were taken from animals after euthanasia. Pathological examination of heart and major organs were conducted. The independent sample t test and rank sum test were used to compare the data between the two groups, and the nonparametric was used to compare the patch calcification score between the two groups. Results:In total of 26 animals, 14 animals in the experimental group(6 at 90 days, 8 at 180 days) and 9 animals in the control group(4 at 90 days, 5 at 180 days) reached the end of the experiment. The other 3 animals (1 in the experimental group and 2 in the control group) died of arrhythmia, whole heart failure and right heart failure, the results of pathological examination showed that the causes of death were unrelated to the experimental materials. Cardiac ultrasound showed no patch leakage in all animals. There was no statistically significant difference in cardiac ultrasound and blood examination between the two groups at different time points after operation (all P>0.05). The pathological results showed that all the implants were intact and had good biocompatibility. There was no significant difference in the mean endothelialization rate between the experimental group and the control group at 90 and 180 days after operation ((80.8±29.1)% vs. (82.5±23.6)%, t=0.095, P=0.927; (78.8±36.4)% vs. (82.0±19.2)%, t=0.182, P=0.859) on 90 and 180 days, there was no significant difference in the patch calcification score between the two groups (1.00(1.25) vs. 2.00(0.75), Z=6.500, P=0.214; 0(0.75) vs. 1.00(2.00), Z=12.000, P=0.139). Conclusion:The new Chinese-made surgical biopatch for atrial septum has comparable safety and efficacy to that of the marketable patch in miniature pig atrial septal defect animal model.

Objective: This study aimed to analyze and summarize the implementation of the primary prevention program for stroke in Shanghai rural community and evaluate its preventive effect. Methods: A cluster sampling method was used to select approximately 50 000 community natural population from a town in Fengxian District of Shanghai. A primary stroke prevention program was established and implemented in the community from 2008 to 2010 and from 2012 to 2015. The prevention program inclueded stroke health education for the whole population, screening of high risk population of stroke, and therapeutic intervention and management plan for individuals aged≥50 years. The intervention measures were followed up every 2 months. From 2008 to 2015, new stroke cases were monitored dynamically and reviewed annually with classification of stroke diagnosis. The effect of community primary prevention of stroke program was evaluated by the dynamic changes in stroke incidence. Results: From 2008 to 2015, a total of 422 600 individuals were monitored, including 20 500 men and 217 600 women. In 2008, 7 828 individuals were screened and 2 129 individuals were at high risk of stroke were screened, with a high risk rate of 27.2%. In 2012, 2 877 individuals were screened, and 725 individuals were at high risk of stroke were screened, with a high risk rate of 25.2%. The standardized incidence of stroke in this community was 158.1, 105.4, 86.6, 77.6, 89.3, 77.4, 50.7, and 42.3 per 100 000 respectively. The overall incidence image roughly showed a downward trend except 2012(trend test P<0.01). There was no significant difference in the incidence of stroke between men and women in each year. The incidence of stroke increased significantly with age (trend test P<0.01). The age composition of stroke patients is slightly different between different sexes. The proportion of male patients with stroke aged <70 years was significantly higher than that of female patients with stroke, while the proportion of female patients with stroke age>70 years was significantly higher than that of male patients with stroke (P<0.01). Cerebral hemorrhage, cerebral infarction, and subarachnoid hemorrhage accounted for 20.76%, 75.14%, and 4.10%, respectively. Conclusion Based on lifestyle intervention and treatment and control of risk factors, screening high-risk individuals for therapeutic intervention in community population can significantly reduce the incidence of stroke.

EIDD-2801 is an orally bioavailable prodrug, which will be applied for emergency use authorization from the U.S. Food and Drug Administration for the treatment of COVID-19. To investigate the optimal parameters, EIDD-2801 was optimized