摘要
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 became a global healty problem, great achievements have been made in research and development of Western anti-osteoporosis drugs. Further improvement is being made since. World health Organization (WHO) published an important document, Guidelines for Preclinical evaluation and Clinical Trials in Osteoporosis ,in 1998. In China, many herbal medicines in composite formulation have been tested for prevention and treatment of osteoporosis. More than thousand study reports were published in many academic journals in the Plast 20 years. Up to now, part of these herbal preparations are availaple on the market or under clinical evaluations. As the WHO Guidelines do not deal with the characteristios and the values of fraditional Chinese medicainal herbs in prevention and treatment of osteoporosis, there is no standard available on the methodoogies for evaluating fraditional Chinese medicine. On the other hand, WHO did pay attention to traditional medicine and endorsed General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine at a WHO consultation meeting held in Hong Kong in 2000. In conjunction with this, we made an initiation for establishing Gereral Guidelines for R&D of Traditional Chinese Medicine and its Preclincal Evaluation and Clinical Trils in Prevention and Treatment of Osteoporosis and Fragility Fractures (abbreviated as “TCM-OP Document”),which not only meets the International Standard but also displays the characteristics of traditiona Chinese medicine. This “TOM-OP Document will receive WHO's recognition and may serve as an evaluaton standard to be endorsed by Chinese Ministry of Health and Chinese medical profession so as to contribute to wide acceptance of traditional Chinese medicine in prevention and treatment of osteoporosis.”
出处
《中国骨质疏松杂志》
CAS
CSCD
2004年第3期356-361,366,共7页
Chinese Journal of Osteoporosis
