骨质疏松成为全球关注的健康问题以来 ,有关西药的研究有很大的发展 ,与此相关 ,世界卫生组织 1998年发表了指导性文件《骨质疏松症临床前评估及临床试验指导原则》。在中国则有许多中药复方防治骨质疏松症的研究 ,在各种专业杂志上近 2 0年发表了近千篇论文 ,部分中药复方制剂已进入市场或正在进行临床前评估。然而 ,在世界卫生组织的指导原则中尚未考虑到中药的特点和地位 ,而中药的研究方法也还与上述指导原则有一些差距。世界卫生组织对传统医学正十分关注 ,2 0 0 0年在香港召开的咨询会上通过了《传统医学研究与评价方法学的总的指导原则》。因此 ,我们倡议建立《传统中医药防治骨质疏松症及其相关脆性骨折的临床前评估和临床实验的指导原则》(以下简称《TCM OP指导原则》) ,形成既符合国际通用原则 ,能获得世界卫生组织认可又体现中医药特点 ,能得到中国卫生行政领导及中国医药界同行支持的评估规范 ,为传统医药在更广泛更深入的程度上被接受做有益的探索。 Since osteoporosis has become a global concern, there has been a great deal of research on Western medicine. Related to this, the World Health Organization published in 1998 a guidance document “Guidelines for Preclinical Evaluation and Clinical Trial of Osteoporosis”. In China, there are many studies on the prevention and treatment of osteoporosis by Chinese herbal complexes. Nearly a thousand papers have been published in nearly 20 years in various professional journals. Some Chinese herbal compound preparations have entered the market or are undergoing preclinical evaluation. However, the characteristics and status of Chinese medicine have not yet been taken into consideration in the guidelines of the World Health Organization, and there are some gaps between the research methods of traditional Chinese medicine and the aforementioned guiding principles. The World Health Organization is very concerned about traditional medicine. In the consultation meeting held in Hong Kong in 2000, it adopted the “General Guiding Principles for Traditional Medical Research and Evaluation Methodology”. Therefore, we advocate the establishment of “Guidelines for preclinical evaluation and clinical trials of traditional Chinese medicine for the prevention and treatment of osteoporosis and its related fragility fractures” (hereinafter referred to as the “TCM OP guidelines”), which are in conformity with international common principles and can be obtained. Recognized by the World Health Organization and reflected in the characteristics of traditional Chinese medicine, it can be evaluated by the Chinese health administrative leaders and peer support in China’s pharmaceutical industry, and has been accepted as a beneficial exploration of traditional medicine in a wider and more in-depth extent.