Fu Yingkun, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2904-6.
In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.
近年来，随着中国政府和人民对中药上市后研究的重视程度不断提高，部分中药品种已经或即将开始上市后的评价研究。在上市后评价设计中，样本量计算起着决定性作用。它不仅能确保上市后评价的准确性和可靠性，还能保证如果不同受试药物之间确实存在具有临床意义的差异，预期试验将有足够的检验效能正确检测出这种差异。到目前为止，尚无针对中药的系统样本量计算方法。本文根据样本量计算的基本方法以及中药临床评价的特点，分别探讨了中药疗效和安全性的样本量计算方法。我们希望本文能对从事中药研究领域的医学研究人员和药学科学家有所帮助。
