Clinical Trial Research Of Traditional Chinese Drug Xe Yin Deficiency And Heat Treated Type 2 Diabetes And Related Indicators Of The Pharmacodynamic Tests Compared

XE is a pre-chinese-drug to cure NIDDM,which extracted from traditional Chinese medicine X. On the condition of getting XE's clinical research certification of SFDA,we formulated the clinical scheme,and carrired out the I II III period clinical researchs obeying the GCP. Through four years,five national drug clinical research base hospitals' hard work,we got XE's acute safty and effection results.The clinical research proved that XE was safe to healty people and NIDDM patients,it can decrease FBS,PBS,HbAlc,high TG and high TC decrease IR,improve the NIDDM patients' symptom . There's no any serious AE happened.On the base of clinical research and parmacokinetics results ,a meaningful compare can be hold to try to discover the relationship between drug's action on human body and animals.The compare proved,there's no species specific of the XE's action to FBS,PBS,HbAlc and high TC ,but there are difference to high TG between human and model animal.The results of compare between clinical research and parmacokinetics is meaningful to the research of NIDDM.