| objective:Through animal experiments and clinical observation, we want to discuss the mechanism and the therapeutic effect of XDRP to the type of Yin xu fei zao and Tan re yun jie for chronic pharyngitis patients, and lay a solid foundation for the development and application of the new drug.Methods:Animal experiments:(1) acute toxicity test:Maximum method of administration(2)anti-inflammatory test:The experiment of mouse'ear edema induced by xylene and granuloma induce by cotton pellet.(3) Anti-bacterial testClinical Observation:120 cases with chronic pharyngitis were randomly divided into two groups.70 of which were treated by XDRP, Served as treat group. And another 50 cases treated by LiYanling tablets, served as the control group.12 days as a course of treatment, we observe curative effect after two courses. It includes the changes before and after treatment about the patients, symptoms and clinical sign. In order to judge the therapeutic effect, tolerability and safety, patients make routine blood test, liver function, kidney function checks and ECG before and after treatment we also record adverse reactions at the same time.Results:Animal experiments(1)MTD> 48g/kg, the maximum tolerated dose in mice is equivalent to 120 times of the human dosage,It demonstrate the safety and reliability of XDRP in application.(2)XDRP has the good inhibiting effect in the model of mouse'ear edema induced by xylene and granuloma induce by cotton pellet.(3)XDRP could reduce the mortality rate in mice infected with Staphylococcus aureus, showing a certain degree of antibacterial activity in vivo.Clinical Observation (1) Comparison of overall efficacy of Chinese clinical symptoms:Symptoms and treatment effect of TCM as standard to assess, we compared the overall efficacy of clinical symptoms about two groups. The total effective rates of TG and CG were 88.6%and 74.0%respectively. Difference between the two groups has statistical significance (P<0.05). And the total effective rate about the model of Yin xu fei zao in TG is higher than the one of Tan re yun jie.(2) We observed all subjects according to the four safety evaluation criterion formulated by this study. There were no one to terminate the test due to the serious adverse reactions, and no one case of nausea, vomiting and other gastrointestinal irritation symptoms.Conclusion:Animal experiments show that XDRP can take a inhibiting effect for the early inflammatory exudation and the late connective tissue proliferation by blocking inflammation reaction; while reducing bacterial infection in vivo, which play a role in prevention and therapy of chronic pharyngitis, At the same time taking the drug safety, and no toxic side reaction. Clinical observations show that XDRP have a good clinical healing effect about the type of YXFZ and TRYJ, especially the one of YXFZ. In the course of therapy, there are no significant adverse reactions. It show XDRP is a safety Chinese material medical preparation for the chronic pharyngitis... |