Objective To investigate the changes of serum high-sensitivity C-reactive protein (hs-CRP) in cerebral infarction patients and its relationship with the condition of cerebral infarction and prognosis.Methods Ninety-seven cases with cerebral infarction patients (observation group) and 72healthy subjects (control group) were selected.The levels of hs-CRP at different periods were detected by enzyme-linked immunosorbent assay (ELISA) in observation group, and its relationship with the severity of cerebral infarction level degree and neurological deficit scores was analyzed and compared with control group.Results The levels of hs-CRP at the 24th day[(3.9 ± 1.8) mg/L]were lower than those at the 1,4,8th day [(5.8 ± 1.9), (6.4 ± 2.4), (5.7 ± 2.0) mg/L]in observation group, and the difference was significant (P＜ 0.05 ).The levels of hs-CRP showed positive correlation with neurological deficit scores (r = 0.214, P ＜ 0.01 ).Conclusions The levels of hs-CRP have close relationship with cerebral infarction, and it can be used as an important biological indicator in evaluating the severity and prognosis of cerebral infarction and has clinical value in prediction and intervention of cerebral infarction.

Knowledge management is an important method for the organization to manage information and knowledge systematically and make knowledge innovate continuously. Knowledge management includes the stages of knowledge acquisition, sharing and use, and finally achieves the goal of taking knowledge as the production factor and improving work efficiency in an organization. The core work of technical evaluation of medical devices is typical knowledge work, and the knowledge management system is of great significance to the review agency in improving work efficiency, promoting talent training, improving management level and service quality. This study briefly introduces the framework of the knowledge management system of medical device technical evaluation in the Center for Certification and Evaluation, SHFDA, and provides reference for relevant organizations to carry out knowledge management of medical device technical evaluation.
Knowledge Management

Referring to relevant normative documents, we summarized the commonly used statistical methods in clinical evaluation of
Humans ; Indicators and Reagents ; ROC Curve ; Research Design ; Sensitivity and Specificity