近年来,国内有大量中药新药申请,大多集中在消化系统领域,如消化性溃疡或慢性胃炎;但是几乎所有的新药试验均设计相同、结果类似。实际上,物质基础的不同,必然会带来治疗效应上的差异。因此,新药审评机构专门召集国内部分知名专家就此问题进行讨论,希望能给业界一点建议,同时也鼓励研究者应根据研究目的的不同,选择采用不同的试验设计。 In recent years, there are a large number of Chinese new drug applications in China, mostly concentrated in the field of digestive system, such as peptic ulcer or chronic gastritis; but almost all new drug tests have the same design and similar results. In fact, the difference in material basis will inevitably bring about differences in therapeutic effects. Therefore, the new drug review agency specifically convened some well-known domestic experts to discuss this issue, hoping to give the industry a bit of advice, but also encourage researchers to choose different experimental designs depending on the purpose of the study.