ABSTRACT
On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.
ABSTRACT
ObjectiveTo compare the differences between residents who did and who did not participate in a community colorectal cancer screening based on the results of their colorectal colonoscopy and explore the reasons. MethodsThe residents who underwent a colonoscopy in a central hospital in Shanghai from 2017 to 2020 were divided into two groups according to whether they had been screened in the community， and t test and χ2 test were used to compare the results of the colonoscopy （detection of lesions） of the examinees with different ages， genders， whether they had a history of colorectal cancer， and whether they had been screened in the community. The correlation between whether they had participated in the community screening and the detection of lesions was analyzed by the logistic regression model. ResultsFrom 2017 to 2020， the hospital had performed a colonoscopy for 6 389 people， and 3 623 lesions were detected， with a detection rate of 56.71%. There were 413 residents who had been screened in the community， accounting for 6.46% of the total number of those receiving a colonoscopy. 243 patients were found with pathological changes， with a detection rate of 58.84%. Compared with the residents who did not participate in the community screening， the proportion of adenoma and polyp was higher in those who had participated in the screening （χ2=50.44， P<0.001）. Among the residents without a history of colorectal cancer， the proportion of adenoma and polyp was higher in those who had participated in the community primary screening （χ2=51.86， P<0.001）. Among the residents who had not participated in the community screening， the proportion of residents with colorectal cancer history was higher （χ2=74.33， P<0.001）. Multivariate regression analysis showed that there was no correlation between participation in community screening and detection of any lesions by colonoscopy （OR=0.905， 95%CI： 0.734‒1.117） or detection of colorectal cancer related lesions （OR=1.113， 95%CI： 0.901‒1.375）. ConclusionThe proportion of residents who have participated in community screening among patients undergoing colonoscopy is low， but the asymptomatic population initially screened by the community and the symptomatic population not initially screened by the community are homogeneous， and the detection rate of precancerous lesions such as adenomas and polyps is high. It is suggested that local measures should be taken to improve residents' colonoscopy response rate， so as to obtain better screening benefits.
ABSTRACT
Objective To evaluate the performance of fast Treponema pallidum(TP) detection in voluntary blood donors and optimize the strategy for pre-donation screening.Methods Before blood donation,the gold standard TP test strip was used to make a fast detection.After blood donation,the TP-ELISA was used to test the blood.Then,analyze the donors′ anti-TP positive rate,times and intervals of donating,false positive and negative of TP fast detection.Results From 2014 to 2015,among 73 990 donors who were tested by using fast TP detection,0.71% of them(529 donors) were positive.Among the positive donors,89.2% of them(472 donors) were first-time blood donors.35 donors′ donating intervals were more than 3 years,who accounted for 61.4% of the donors who had donated for more than once.The numbers of the false positive obtained from fast TP detection were 5 and the false negative was 15.By applying the fast TP detection before blood donation,the rate of anti-TP positive had been declined from 0.71% to 0.17%.Conclusion The rejection rate of TP positive can be significantly reduced by using fast TP detection before blood donation.The fast TP detection can be used to optimize the pre-donation screening and promote blood donation service efficiency and level,while donating times and intervals of the blood donors were also considered.