目的 建立在藥物臨床試驗階段確定藥物最大安全劑量的方法。方法 利用連續(xù)重新評估的方法，充分利用已有的試驗數(shù)據(jù)，及時更新有關參數(shù)，同時結(jié)合目前多元比較中很流行的小樣本似然比率方法，從而得出最佳的答案。結(jié)果 從模擬結(jié)果來看，該方法效果很好。結(jié)論 目前使用的方法是根據(jù)事前的標準，由既定方法和計算公式得出藥物的最大安全劑量，不能根據(jù)最新的試驗數(shù)據(jù)及時調(diào)整模型參數(shù)，因此得到的結(jié)果往往不是最佳。本方法建立的確定藥物最大安全劑量方法能夠彌補這一缺點，更為準確。

Objective To evaluate the maximum safe dose of drug in clinical trials phase. Methods Continual reassessment method was used to update the model parameters continually according to previous trial data. When this method was applied, it was also combined with currently popular small-sample odd rate method. Results The back simulation results indicated that our method has very good effect in practical. Conclusion The current method is taking multiple medication trials based on simple prior standards and calculating the maximum safe dose. A disadvantage of this method is that it doesn’t use the latest trial data to update the model parameters in time, so the answer is often not the best one. The new method is more accurate and could redeem this defect.

國家自然科學基金項目（60872060）；上海市教委的科學基金項目（05QZ01）