中国的 N-of-1 试验。

N-of-1 trials in China.

机构信息

Evidence Based Medicine Center, College of Basic Medicine, Lanzhou University, Donggang West Road No. 199, Lanzhou 730000, China.

出版信息

Complement Ther Med. 2013 Jun;21(3):190-4. doi: 10.1016/j.ctim.2013.01.003. Epub 2013 Feb 18.

DOI:10.1016/j.ctim.2013.01.003

PMID:23642950

Abstract

CONTEXT

The N-of-1 trial design (randomized and blinded single-patient trials) has been popular abroad for 25 years or more. Many papers using the N-of-1 trials have been published in international medical journals. However, little is known about this methodology in China. Our purpose is to describe the current status of N-of-1 trials in China, to explain why they have not been more widely used, and to suggest a roadmap for the development of N-of-1 trials, especially for the study of Traditional Chinese Medicine (TCM).

METHODS

An electronic search was conducted using the Chinese Biological Medicine Database (CBM) and China National Knowledge Infrastructure (CNKI) with the keywords "N-of-1 trial, single case OR individual patient AND randomized". We also searched PubMed. The Chinese Science Citation Database (CSCD) as a citation was searched at last.

RESULTS

23 studies were retrieved from CBM and 34 from CNKI. There were 13 papers about N-of-1 trials in CBM and 17 in CNKI. Only 3 studies were rigorously designed (i.e., using randomization, control periods and blinding). The other 8 papers were descriptive and review articles, most of which were in TCM. One review was published in SCI-E and one in MEDLINE. Three papers were found in CSCD as citations. Only one of the retrieved studies was funded.

CONCLUSIONS

While N-of-1 trials may offer a good tool to individualize clinical care and enrich TCM clinical research, they have not been widely used to date. To spur the development of this method, we would like to suggest three points. First, the Chinese government should endorse and sponsor N-of-1 studies. Second, researchers and physicians should be systematically trained in the method. Third, thorough considerations on trials allow better research and focus on the patients' needs.

摘要

背景

N-of-1 试验设计（随机和盲法单病例试验）在国外已经流行了 25 年以上。许多使用 N-of-1 试验的论文已经发表在国际医学期刊上。然而，在中国，人们对这种方法知之甚少。我们的目的是描述 N-of-1 试验在中国的现状，解释为什么它们没有得到更广泛的应用，并为 N-of-1 试验的发展，特别是中医药（TCM）的研究，提出一个发展路线图。

方法

使用中国生物医学文献数据库（CBM）和中国知网（CNKI）进行电子检索，关键词为“N-of-1 试验、单病例或个体患者和随机”。我们还检索了 PubMed。最后，还检索了中国科学引文数据库（CSCD）的引文。

结果

从 CBM 检索到 23 项研究，从 CNKI 检索到 34 项研究。CBM 中有 13 篇关于 N-of-1 试验的论文，CNKI 中有 17 篇。只有 3 项研究设计严谨（即使用随机化、对照期和盲法）。其余 8 篇为描述性和综述性文章，大部分为中医药。一篇综述发表在 SCI-E 上，一篇发表在 MEDLINE 上。CSCD 中作为引文的有 3 篇。检索到的研究中只有 1 项有资助。

结论

虽然 N-of-1 试验可能为个体化临床护理提供一个很好的工具，并丰富中医药临床研究，但迄今为止，它们并没有得到广泛应用。为了促进这种方法的发展，我们想提出三点建议。首先，中国政府应支持和赞助 N-of-1 研究。其次，研究人员和医生应系统地接受该方法的培训。第三，对试验进行深入考虑，可以更好地研究和关注患者的需求。