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目前,中药的研发现状存在弊端,国外开展的西药探索性临床试验的思路值得借鉴。但中药不适合探索性临床试验,需建立自己的早期临床评价体系。中药早期临床评价体系的可行性,还需结合自身特点,参考现代医学的探索性临床试验现有指南,通过临床试验的切实开展加以论证。
At present, there are drawbacks in the research and development of Chinese medicine. The thinking of exploratory clinical trials of western medicine abroad is worth learning from. However, traditional Chinese medicine is not suitable for exploratory clinical trials, need to establish their own early clinical evaluation system. The feasibility of early clinical evaluation of traditional Chinese medicine system, but also with its own characteristics, refer to the existing guidelines of modern medicine exploratory clinical trials, clinical trials through the effective demonstration.