Study On The ADR Of Traditional Chinese Medicine Injection From An Empirical Perspective

As a product of Chinese medicine essence of traditional and Western medicine advanced preparation technologies, traditional Chinese medicine injections(TCMI) for the application of traditional Chinese medicine (TCM) has opened up a broad space for development, but there have been more and more adverse reactions (ADR) and a variety of potential risks. Therefore, evaluative research for the adverse reactions of TCMI has important theoretical and practical significance. This study can provide more scientific and intuitive reference for the prevention and control of TCMI ADR and clinical rational drug use, and provide new ideas and new methods of ADR evaluation.In this thesis, the safety evaluation of TCMI is goal of this study, ADR-related factors are objects of study and system theory is introduced into the evaluation of the adverse reactions of TCMI. Qualitative and quantitative analysis combined with a combination of theoretical analysis and empirical test. Gray relational analysis, principal component analysis and logistic regression analysis were used to study the induced ADR-related factors and occurrence in the clinical application of TCMI. The results of these evaluation methods were compared and the proposals were presented to the prevention and control of the adverse reactions of TCMI and clinical rational drug use.The results of this study include:(1) More of ADR varieties of TCMI are mainly concentrated in the injection of heat-clearing class, and promoting blood injection. Systemic damage and skin and its appendages are the most common ADR of TCMI. The adverse reactions of male to female ratio is roughly the same, and the average ages of male patients and female patients have no significant difference.(2) Gray relational analysis and principal component analysis was used to evaluate the adverse reactions of TCMI to establish the application mode and the establishment of a comprehensive evaluation function. Both results are confirmed each other, and shed that the two methods for the evaluation of TCMI ADR are feasible and effective. Logistic regression analysis results indicate that the factors causing serious ADR are consistent with the factors that cause general ADR and related.(3) The empirical research results:Whether the initial drug and the original type of illness are the maximum impact factors of the Qing Kai Ling injection of ADR; Male, aged25to49patients suffering from respiratory tract infections, the initial medication, a history of allergy, the combined use of antibiotics, the dose more than20ml, small GS with liquid and with liquid dosage are more likely to lead to the Qing Kai Ling injection ADR and primary disease type, allergies and dosage of these three factors will bring about more serious ADR risk. With fluid type and history of allergies are the maximum impact factors of puerarin injection of ADR; With liquid using GS, a history of allergy, male, non-initial administration, drug combination, a small amount with liquid, older than50years old, suffering from cardiovascular and cerebrovascular diseases are more likely to lead to puerarin injection ADR and history of allergies, whether the initial medication, whether the drug combination of these three factors will bring about more serious ADR risk.