ABSTRACT
Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.
ABSTRACT
Objective: To observe influence of anxiety or depression on prethrombotic state in patients with essential hypertension (EH). Methods: A total of 112 EH patients were equally divided into EH + A/D group and pure EH group. Levels of prethrombotic state indicators, including serum CD62P, von Willebrand factor (vWF), tissue type plasminogen activator (t-PA), plasminogen activator inhibitor (PAI)-1 and endothelin (ET)-1 were measured in two groups. Results: Compared with pure EH group, there were significant increase in levels of CD62P [(4.52±2.01) % vs. (8.38±1.96) %], vWF [(155.28±23.11) % vs. (185.23±22.21) %], PAI-1 [(54.35±13.21) ng/L vs. (79.88±14.53) ng/L] and ET-1 [(121.56±33.32) ng/L vs. (152.78±30.23) ng/L], P<0.05 all; and significant decrease in t-PA level [(19.37±11.46) ng/L vs. (9.56±8.32) ng/L, P<0.05] in EH + A/D group. Conclusion: Anxiety or depression can aggravate prethrombotic state of patients with essential hypertension through activation of platelets, influencing vascular endothelial function and fibrinolytic system imbalance.