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目的建立在药物临床试验阶段确定药物最大安全剂量的方法。方法利用连续重新评估的方法,充分利用已有的试验数据,及时更新有关参数,同时结合目前多元比较中很流行的小样本似然比率方法,从而得出最佳的答案。结果从模拟结果来看,该方法效果很好。结论目前使用的方法是根据事前的标准,由既定方法和计算公式得出药物的最大安全剂量,不能根据最新的试验数据及时调整模型参数,因此得到的结果往往不是最佳。本方法建立的确定药物最大安全剂量方法能够弥补这一缺点,更为准确。
Objective To establish a method for determining the maximum safe dose of drug in the clinical trials of drugs. The method makes use of the continuous re-evaluation method, makes full use of the existing experimental data, updates the relevant parameters in time, and obtains the best answer by combining with the popular sample likelihood ratio method of multiple comparisons. Results From the simulation results, this method works well. Conclusions The current method is based on ex ante standards, the maximum safe dose of drug can be obtained from established methods and formulas, and the model parameters can not be adjusted according to the latest experimental data, so the results obtained are often not the best. The method established to determine the maximum safe dose of drugs can make up for this shortcoming, more accurate.