OBJECTIVE: To strengthen the risk management in clinical drug trial so as to minimize the risk.METHODS: Based on modern risk management theory as well as the practical condition of the current clinical drug trial,an aggregate analysis was done and some opinions and suggestions were put forward.RESULTS: Under current model,it is objective and inevitable for the risks involved in clinical trial,but which could be reduced or avoided by taking some effective measures such as risk predication,standardization of clinical trial,ADR monitoring etc.CONCLUSION: There is risk in the drug clinical trial and it is necessary to conduct risk management.

0.05,thus a fixed effect model was applied.As compared with the control group,kakkonein in-jection has a higher total effective rate with the odds ratio at2.05and95%confidence interval at1.10～3.82(P

Objective: To study the effects of herbimycin A on proliferation and NO production stimulated by IL 1 in chondrocytes. Methods: IL 1 alone or in combination with herbimycin A was administered.Chondrocytes proliferation was detected by crystal violet dying method and NO production was detected by Griess method. Results: IL 1 inhibited chondrocytes proliferation. Herbimycin A dose dependently reversed the effect. Also herbimycin A could inhibit NO production induced by IL 1. Conclusion: The reversing effect of herbimycin A on chondrocytes proliferation may be mediated by NO.

Objective: To study the effect of lipopolysaccharides(LPS) on nitric oxide(NO) production in synoviocytes and inhibition of genistein on it.Methods: LPS or LPS+genistein stimulated synoviocytes in vitro .NO in culture medium was determined by Griess method.Results: LPS dose and time dependently induced NO production in synoviocytes; Genistein (6.25 50 ?mol/L) dose dependently inhibited the production of NO induced by lipopolysaccharide.Conclusion:The effect of LPS on NO production can be dose dependently inhibited by genistein,this may be mediated by tyrosine kinase(PTK).

AIM: To study effects and adverse drug reactions of mtrisone in the treatment of patients with severe acute respiratory syndrome. METHODS: The information of the medications in 680 patients with severe acute respiratory syndrome (SARS) in Xiaotangshan Hospital was collected by HIS system and the effects and ADRs of metrisone were staiated. RESULTS: The kinds of drugs of SARS patients who had been cured by metrisone were more than those which were not cured by metrisone. Condition of SARS patients who had been cured by metrisone was more serious than those which were not cured by metrisone. The ADRs rate, blood glucose and leukocyte of SARS patients who had been cured by metrisone are higher than those which were not cured by metrisone while blood K+ is lower. CONCLUSION: The utilization of metrison to SRAS patient should be more cautious to balance the effects and ADRs of metrisone.