中药临床试验安慰剂制作探讨

Exploration into the Preparation of Placebos Used in Chinese Medicinal Clinical Trial

中药安慰剂对照临床试验在中医临床试验中日益受到重视,但其制作研究仍相对薄弱。中药安慰剂的制作需要根据具体的临床试验设计、研究疾病的性质、试验药物的特点、服药方法等综合考虑,选择适当的工艺流程。其辅料的选择应以无明显偏性的粮食类为佳,在确保安慰剂潜在的药理活性能被专家接受基础上,如果难以做到与试验药物外观及口味一致,应当尽量使之类似于相同剂型的中药。

Placebo-controlled clinical trials have been more and more emphasized in traditional Chinese medicine （TCM） researches, while the preparation of TCM placebos is still to be improved. For this work, some elements should be taken into consideration comprehensively, including the design of clinical trial, the character- istics of researched disease, the nature of testing drugs, and the way of medication, etc. And the technological process for placebo manufacturing should be selected properly depending upon the basis of the above elements. Un-biased foodstuff is good as excipient for TCM placebos preparation. The placebo should be made in dosage-form similar to that of the testing drug as possible, if there are difficulties for simulating them in appearance and smell completely. However, its potential pharmacological activity meeting to the acceptance of researchers should be ensured.